July 16, 2015

Research Your Doctor's Payments from Drug and Device Makers

For patients in our home territory of the District of Columbia, Maryland and Virginia, here are some quick links to look up your doctor's payments last year from manufacturers of drugs and medical devices.

District of Columbia.



This comes from the ProPublica database, which has obtained the numbers from the federal government in a newly implemented aspect of the Affordable Care Act.

The big players tend to be doctors who use a lot of medical devices like hip implants. For example, Randall Lewis, a Chevy Chase, Maryland orthopedist, and Charles Engh, a Virginia orthopedist, each received seven-figure payments from device makers last year.

Bookmark and Share

July 5, 2015

Medical Providers Reap Billions from Promoting Products (Updated)

Last year, the federal government launched Open Payments, a database that tracks the dollars that flow from drug and medical device manufacturers to medical providers. Last week, it reported that $6.5 billion was paid last year to doctors and hospitals, for a range of services and, well, graft.

More than 600,000 doctors received payments, as well as about 1,100 teaching hospitals.

As reported by the Associated Press (AP), $3.2 billion went to fund research, about $2.6 billion was for miscellaneous items and about $700 million represented investments and ownership stakes.

Approximately 8 in 10 dollars went to doctors, “whose prescribing decisions,” the story noted without editorializing on the potential conflict of interest of this arrangement, “affect the fortunes of pharmaceutical and medical device manufacturers.”

A more thorough analysis of this pay-your-pal arrangement was made by ProPublica and NPR, which identified individuals who reaped the biggest bounty.

Meet Dr. Ana Stankovic of New Hampshire, for whom, according to ProPublica/NPR, “[f]ew days went by last year [when she] didn't receive a payment from a drug company.

[Note: See postscript at the end of this piece for a response by Dr. Stankovic.]

“All told, 29 different pharmaceutical companies paid her $594,363 in 2014, mostly for promotional speaking and consulting, but also for travel expenses and meals, …”

Although she received payments on nearly every workday of last year, she still ranked only about 250th in her total take among the hundreds of thousands of U.S. doctors who received payments last year.

Although it’s hardly news that providers are well paid by the pharmaceutical industry, the newly released data demonstrate the range of specialists who cash in. They include dentists, optometrists, podiatrists and chiropractors, but, as the story made clear, “What is being seen for the first time now is how ingrained pharmaceutical companies and their sales reps are in the lives of those who write prescriptions for their products. A ProPublica analysis found that 768 doctors received payments on more than half of the days in 2014. More than 14,600 doctors received payments on at least 100 days in 2014.”

Some might not have collected a lot of money, just a little, but almost every day. Dr. Juichih Hsu, a family medicine practitioner in Maryland, received payments on 286 of the 365 days last year, more than anyone else. Sometimes, she received meals from several drug companies … on the same day.

Some observers consider this practice, well, networking. Dr. Aaron Kesselheim, associate professor of medicine at Harvard Medical School, told the reporters, "Every day it's another drug company coming in for a lunch. Sometimes it may be some drug companies are bringing breakfast and some are bringing lunch and it's just part of the culture of the practice."

Uh huh. And sometimes that culture seems rotten.

Dr. John Fritz, of New Jersey logged payments of $232,003 over 256 days last year from drug and device makers. In June, he was charged with fraud and bribery for referring patients over several years to a medical imaging company in exchange for about $500,000 in kickbacks. It’s logical to wonder about the connection.

Such extensive contact with industry reps, Kesselheim told ProPublica/NPR, can signal less than a best-practice approach to how doctors prescribe drugs; that is, they’re getting information from the companies that make the drugs, not necessarily in equal measure with the impartial science that analyzes them. "There's good evidence that that affects prescribing practices and physician behavior," Kesselheim said.

Are you surprised that the drugs Stankovic got paid to promote are unusually expensive for the patient? H.P. Acthar Gel, prescribed for multiple sclerosis, runs about $39,000 per prescription, despite no evidence that it works better than less expensive drugs. (Stankovic also was paid to promote a drug for serious a kidney disease called Soliris. It’s among the most expensive drugs in the world, but is considered highly effective.)

ProPublica/NPR found big differences in the number of industry interactions among physicians in different specialties. Rheumatologists, who specialize in the treatment of arthritis, lupus and scleroderma, averaged 40 days of interactions with drug and device companies, the most of any other large specialty. Next were endocrinologists (who treat diabetes, among other disorders) and two kinds of heart specialists, electrophysiologists and interventional cardiologists. Specialists with the fewest drug and device maker interactions were dentists, chiropractors, neonatologists and pathologists.

Among the commercial participants, Genentech Inc. spent the most on general payments (that is, not for research), $387.7 million, mostly royalties for its cancer drugs Rituxan, Avastin and Herceptin to City of Hope National Medical Center in Duarte, Calif., a major cancer center. AstraZeneca, Pfizer and Allergan were other big spenders in the category of general payments.

Royalty fees accounted for $803.5 million in general payment spending in 2014, more than any other category. Those fees, based on sales of a product, are paid by device manufacturers to physicians who work with the company to invent the device. Next came promotional speaking ($632.4 million) and consulting ($369.4 million). Food and beverages accounted for the highest number of payments by far, 9.4 million, but these had a relatively low value of $224.5 million.

Open Payments does not report the value of drug samples left at doctors’ offices nor most of the money companies spend on independently administered continuing medical education, which they support with unrestricted grants.

ProPublica has been tracking industry payments to doctors since 2010 through its online database, Dollars for Docs. (Research and ownership payments are not shown in Dollars for Docs.)

Professional networking can yield benefits for all participants, and in the case of medicine, patients, too, can benefit from productive relationships their providers have with the companies that make therapeutic products. But because those relationships are ripe for abuse, patients must be bold when their doctors recommend or prescribe any drugs or devices: Ask why he or she chose that particular therapy, what is expected from its use and how soon, what are the risks and potential side effects, and, if the provider has ever accepted payment from the manufacturer. If so, find out what it was for, and over what period of time. Ask if your doctor submits reports to Open Payments, which is voluntary for providers.

The answers will help you know whether your doctor is recommending something because it’s scientifically a good idea, because they want to keep their business relationship in good shape or both.

Postscript: Dr. Stankovic contacted me about the references to her in this blog post. The dollar numbers appear to be accurate, but she says the piece makes some misleading statements. I'm happy to correct anything that is not right.

* She says most of the money she was paid last year was for reimbursement of travel.

* She says she has a consulting practice that explains why she is paid this much.

* She believes she is not promoting expensive drugs because she has been paid to do so, but that she is educating doctors about certain orphan drugs for rare conditions within her specialty of kidney diseases. That explains the multiple sclerosis drug mentioned in the piece, which apparently also has a use for some rare kidney troubles.

There are plenty of doctors in the District of Columbia, Virginia and Maryland -- our home turf - who receive large sums from drug and device makers. A few of them have been paid well into seven figures. I placed links to the ProPublica database so readers can check those out.

Bookmark and Share

June 17, 2015

Conflict-of-Interest Issues Plague the New England Journal of Medicine

There is no justification for conflicts of interest in any business, but they’re particularly dangerous in medicine, where people’s lives are at stake. A recent airing of differences within the medical community about such conflicts hasn’t gotten much consumer play, but it should.

The prestigious New England Journal of Medicine (NEJM) recently published a series of articles about physicians who have relationships with the medical industry, and who submit their research articles in the hope of being considered for inclusion in the journal. It purported to analyze whether such scientific reviews were acceptable journal material if their writers had financial interests in the subjects they covered.

The series’ conclusion was, basically, that perceived problems with doctor-company ties are overblown.

The NEJM followed up with a poll of the journal’s readers that, as described on HealthNewsReview.org (HNR), asked them to judge the suitability of three hypothetical potential contributors. Each supposed expert had some kind of financial arrangement with the pharmaceutical industry (for example, speaking fees or research funding).

But the readers weren’t given the option to judge a potential author who had no conflict of interest. “This is striking,” said HNR, “considering that during the 1990s and up until 2002, the NEJM would not publish editorials or review articles by authors with any conflict of interest.”

Many reader/physicians weighed in on the poll and the original series, and they weren’t complimentary.

According to HNR, one emergency physician said, “Pharmaceutical company money, and the purchase of influence, has been the single most powerful distorting force in health care in a generation — this is undisputed. This overwhelming and uncontested monetary force has come between guideline panels and recommendations, government agencies and quality markers, health-care policies and subjects, and doctors and patients …. There is a reason more than two-thirds of Americans are taking a prescription drug, an embarrassing statistic,” and he wondered why the poll didn’t offer a nonconflicted contributor as a fourth candidate for review.

“The only reason to choose any of the individuals in these cases would be if there were no available alternatives,” he said.

Other NEJM respondents were concerned that the journal had not given editorial space for people opposed to its conflict-of-interest posture.

As HNR saw it, the reason is because the journal wanted to “frame” the discussion.

That’s sort of what drug companies do when they’re seeking FDA approval of a drug whose clinical trial results aren’t as persuasive as they should be, either in terms of effectiveness or safety; they present consumer witnesses to panels considering approval who speak more from emotion than science, as in the recent hearing about the “female Viagra” drug, for example, and in the worst cases, hide negative study results they know would doom their chances.

A day after HNR’s analysis of the mess at the NEJM, it reported about another journal, BMJ (British Medical Journal) that published the views of three former NEJM editors, who wrote, simply, “Justifying conflicts of interest in medical journals: a very bad idea.”

The three said it was “sad that the medical journal that first called attention to the problem of financial conflicts of interest among physicians would now backtrack so dramatically and indulge in personal attacks on those who disagree.”

They referred to an extensive body of literature the NEJM series mostly ignored that concluded that physician conflicts of interest had measurably negative effects on medicine and medical journals. They offered comparisons of such conflicts in other professions:

Judges are expected to recuse themselves from hearing a case in which there are concerns that they could benefit financially from the outcome. Journalists are expected not to write stories on topics in which they have a financial conflict of interest. The problem, obviously, is that their objectivity might be compromised, either consciously or unconsciously, and there would be no easy way to know whether it had been. Yet [NEJM ] seem[s] to think it is insulting to physicians and medical researchers to suggest that their judgment can be affected in the same way. Doctors might wish it were otherwise, but none of us is immune to human nature.”

The BMJ does not accept educational articles by authors with industry ties. The three former NEJM editors who wrote for it, according to HNR’s follow-up, predicted that the NEJM’s acceptance of these murky associations could either signal a decline in journal quality or galvanize strong opposition to them.

Let’s hope it’s the latter. This isn’t just a closed-club squabble; this is about scientific objectivity, and that affects everybody who will ever need medical care.

To learn more about financial relationships between medical professionals and industry, link to ProPublica’s data base, Dollars for Docs.

Bookmark and Share

June 9, 2015

Debate Rages Over Value of Psyche Meds

Psychotropic drugs are powerful agents that address a variety of mental issues. And although they are lifesavers for some people, antidepressants, antipsychotics and other such meds remain the subject of debate among medical professionals, most recently within the pages of BMJ (British Medical Journal).

Some people want antipsychotic meds to be heavily restricted, explained AboutLawsuits.com, while others insist they are safe for most users. In the BMJ article, some researchers claimed that the long-term side effects of many psychiatric drugs do more harm than good, and suggested that many drug trial designed purposefully underestimate their harms and overestimate their benefits.

For example, after reviewing several studies, Professor Peter C. Gotzsche, who helped found the venerable research nonprofit known as the Cochrane Collaboration, estimated that there are 15 times more suicides among people taking antidepressants than reported by the FDA because, he said, the FDA tallies suicides reported only within 24 hours of when patients stop taking these types of meds.

He cited figures from one study showing that nearly 2 in 3 deaths were unaccounted for among people taking antipsychotics. Another study that specifically analyzed users of benzodiazepine (tranquilizers, including Xanax and Valium) could be responsible for nearly 540,000 deaths annually in the U.S. and Europe.

These drugs are especially risky, as Patrick discussed in a recent newsletter, among older people for making them more prone to falls.

Gotzsche said the benefits of these drugs are widely overstated and that randomized trials don’t properly evaluate their effects. He went so far, according to AboutLawsuits.com, as to call them “biased,” because they include patients who already take other psychiatric drugs, which could corrupt the results.

Patients who take psychotropics long term, then stop cold turkey, often are given a placebo, or fake drug. Prescribers hope it will ease their transition, but Gotzsche said that instead, many patients experience withdrawal symptoms that drive them to suicide.

Gotzsche said the benefits would need to be “colossal” to justify the use of psychiatric drugs, and that in some cases, such as drugs meant to treat attention deficit hyperactivity disorder (ADHD), there’s often no benefit, never mind one that’s minimal, much less “colossal.”

“We could stop almost all psychotropic drugs without causing harm — by dropping all antidepressants, ADHD drugs and dementia drugs and using only a fraction of the antipsychotics and benzodiazepines we currently use,” Gotzsche is quoted as saying on AboutLawsuits.com.

Of course, his position drew significant backlash from other researchers, who claimed that evidence supporting the long-term use of antipsychotic medications was solid.

“More than one-fifth of all health-related disability is caused by mental ill health, studies suggest,” wrote Allan H. Young, professor of mood disorders at the Institute of Psychiatry and Psychology and Neurosciences at Kings College in London.

He said that the poor physical health typically associated with poor mental health raises the risk of mortality and lowers the life expectancy of mental health patients. The opposition researchers said that the increased death rate is only partly due to suicide, and mostly due to co-existing health disorders.

He supported monitoring by regulatory agencies after the drugs reach the consumer market to ensure they not only work as promised, but are safe. He said the success of such oversight was demonstrated by studies that looked at clozapine, a sedative prescribed to treat schizophrenia. They showed that long-term treatment was associated with lower mortality compared with patients who took no antipsychotic drugs.

But, according to AboutLawsuits.com, the BMJ editors also noted that Young has served as an advisor for major drug companies that manufacture drugs to treat some mental disorders, including AstraZeneca, which makes Seroquel, Lundbeck, which makes Abilify and Lexapro, and Eli Lilly, which makes Prozac.

Which makes us wonder about his credibility.

Bookmark and Share

June 8, 2015

An "Astroturf" Grassroots Campaign for a Female Viagra?

That's what one drug industry skeptic is calling the successful effort last week to persuade an FDA advisory committee to reverse itself and recommend the agency approve a drug for "female hypoactive sexual desire disorder" called flibanserin.

The objective evidence is that the drug, which has to be taken daily, is only a smidgeon more effective than placebo and carries with it a raft of disturbing side effects such as the possibility of dangerously low blood pressure when taken with alcohol.

But a "grassroots" campaign called Even the Score (get it? nudge nudge) sent "activists" to the FDA advisory meeting to propose the idea that since men have Viagra and Cialis, women needed a drug too, despite concerns about its marginal efficacy.

In a blog piece on Health News Review, author Alan Cassels wrote:

These campaigners were, of course, the type normally found when there is a backer with deep pockets, in this case the manufacturer of flibanserin, whose care and feeding of the activists was important to keep reinforcing the mantra that we need an FDA-approved aphrodisiac for women.

This activity is classic faux-advocacy. The vocal and articulate activists and the specialists-for-hire are all part of what my coauthor Ray Moynihan and I called “Astroturf Activists” in our book Selling Sickness. Astroturf looks and feels like real grass, but as we know, it’s plastic, has no real grassroots, and really represents no community other than the one created by the big industry (be it tobacco, oil or in this case, the drug industry) that pays their bills. I can assure you, having seen this dozens of times over the last two decades, if there was no drug company funder, there would be no Even the Score campaign.

The FDA reviewers, clearly interested in hearing all sides of the issue, were astonishingly swayed by the Even the Score astroturfers. These advocates skillfully employed all the tools of slick, tech-savvy modern PR — schmoozing with Congress, as well as Tweeting and Facebooking under the banner of “gender equity” — to convince the panel that women with low sexual interest should be considered very sick people who need a daily drug to make their sex drive more “normal” (as if such a thing as “normal” actually exists).

Read more from Cassels here.

Bookmark and Share

May 15, 2015

VA Illegally Substituted Cheaper Drugs in Psychiatric Care

Substituting one drug for another — say, a generic version for a brand name — often is perfectly fine in terms of what’s best for the patient. But when a Veterans Affairs hospital in West Virginia replaced certain psychotropic drugs with older versions, it put patients at risk, because the priority wasn’t good care, it was cheaper care.

As told by the Washington Post, a federal investigation last month concluded that the drug switch was a violation of VA policy, and that it resulted in a “substantial and specific danger to public health and safety,” according to the VA’s Office of Medical Inspector. The probe was aided by a whistle-blower within the department.

The U.S. special counsel acknowledged the important role of the whistle-blower, which is doubly interesting, given that so often, as we wrote recently, people working in military medicine who identify its shortcomings often are ignored at best, and suffer retribution at worst.

“At a time when many veterans are grappling with mental-health issues, this VA facility was cutting corners on needed drug therapy to save money,” the counsel said in a statement.

The Department of Veterans Affairs is not allowed to restrict drugs based solely on how much they cost, The Post story said. It’s required to supply certain medications when they are necessary for a patient’s health.

But that’s not what happened at a VA clinic in Beckley, W.Va. It had established what the investigation called a “blanket restriction” on administering two antipsychotic drugs, aripiprazole and ziprasidone, to help meet its cost-saving goals for fiscal 2013.

Aripiprazole is the generic name for the brand drug Abilify. It’s prescribed for schizophrenia, bipolar disorder and depression. Ziprasidone, which also can treat those disorders, is known by the brand name Geodon. Drugs in this class alter the activity of certain substances in the brain.

The West Virginia clinic’s pharmacy committee, which makes decisions about what drugs may be used, restricted the use of those two without allowing doctors to make a clinical determination about potential health effects on their patients. The sole reason the panel said “no” was to help meet cost-saving goals for its fiscal year (2013). To add insult to arrogant injury, when the committee made the decision, its chair wasn’t even a physician.

According to The Post, the Office of Medical Inspector “recommended” that the clinic study how the drug substitutions affected patients’ health. Wouldn’t you expect the adults in the room to demand such analysis?

The inspector also sought discipline of the pharmacy committee’s leadership, and installation of a physician as its leader. That seems to be the least anyone could do to rectify such a breach of medical ethics and patient safety.

The U.S. special counsel called these recommendations “immediate and appropriate measures” for resolving the drug-substitution problem, but also said that the whistle-blower has claimed that wrongdoing might be ongoing at the clinic.

The VA said it has initiated an investigation based on the findings and recommendations of the medical inspector’s report. In a statement, it said, “We will immediately take action where it is warranted to ensure the most current medical standards are strictly followed. We applaud the VA employee who contacted the OSC on this matter. [VA] Secretary [Robert A.] McDonald has made clear that employees who step forward to raise concerns have a direct bearing on the veteran outcomes we deliver, and this is an example of why that is important.”

The special counsel has closed the case “conditionally,” pending a follow-up report to address the allegations of continued wrongdoing. The analysis is due to be completed by May 11.

Wow, that’s fast even for a balky, bureaucratic federal agency that’s responsible, responsive and efficient (are there any?), so let’s hope this glass is half full and will be topped off this month not only with problem resolution, but by sending a strong message throughout the system of military medicine that such serious issues of patient safety will not go unnoticed or unpunished.

Learn more about military malpractice here.

Bookmark and Share

April 29, 2015

Doctors Who Took Bribes Resign from State Hospital

We’ve often written about the conflicts of interest that can compromise patient safety when doctors and other medical providers are paid for promoting drugs, devices or services. In another case of cross-my-palmism, the Texas Department of State Health Services (DSHS) has outed two doctors whose priorities appeared to have drifted away from patient safety.

As reported earlier this month by the Texas Tribune, when two psychiatrists at Terrell State Hospital were told they would be disciplined for accepting hundreds of thousands of dollars to promote the drugs Seroquel and Seroquel XR, they resigned.

Terrell State Hospital is one of 10 psychiatric hospitals operated by DSHS. Seroquel, made by AstraZeneca, is an antipsychotic often prescribed to treat schizophrenia, major depressive disorder and bipolar disorder. Several years ago, the drug earned an FDA “black box” warning, a mandatory alert on the label signifying an extreme risk; in this case, it was issued because the FDA determined that patients with dementia had an elevated risk of death by taking this drug.

Documents from the Texas agency showed that Dr. Anthony Claxton, Terrell’s clinical director, and Dr. Lisa Perdue, a psychiatrist, received massive amounts of money from AstraZeneca to promote the company’s drugs to other doctors and state regulators. When informed that they had violated department rules, both doctors resigned.

Claxton is accused of taking $231,000 from AstraZeneca for “promotional speaking and consulting services” at least 166 times since 2005. Perdue allegedly received $615,525 for 460 occasions since 2005. Texas state law forbids employees from accepting outside compensation that could affect their official duties.

Given the amounts involved here, and the time it takes to earn it, you have to wonder when these people had time to practice medicine … you know, their “official duties”?

The state claims that both doctors contacted members of the Executive Formulary Committee, the body that oversees drug standards in Texas, to advocate for adding AstraZeneca’s products to the state's list of approved drugs. Perdue supposedly used a pitch in that effort that was written by an AstraZeneca employee.

If your loved one was a patient at Terrell, how good would you feel knowing that his or her drug regimen might have been determined not by best medical practice, but by best promotion speech?

Remarkably, Claxton was surprised by the recent events. In a letter to the DSHS reviewed by The Tribune, he wrote, “I do not deny that I presented these programs,” adding that he thought he had received permission to do so. He also objected to “the timing of this action” because he was scheduled to retire in 76 days.

Perdue’s lawyer suggested that the state had violated her legal rights by demanding an immediate response to the allegations, and questioned the amount of money DSHS says she received. He didn’t deny she received payment, just how much. The lawyer defended her by saying she had promoted the drugs “on her own personal time” because she thought they “offered less toxic side effects for some patients.”

Then why didn’t she do it for free?

A spokeswoman for the Texas agency told The Tribune that the violations were discovered during an investigation into AstraZeneca by the Texas Attorney General, and that there was no evidence that the psychiatrists had compromised their patients’ health by overprescribing the drug.

Who knows if anyone looked for such evidence, and because the doctors resigned, we’ll never know because the state isn’t pursuing the case further.

Find out more about who takes money from drug companies, how much and for what at ProPublica.org’s, data base, Dollars for Docs.

Bookmark and Share

March 30, 2015

Orthopedists’ Conflicts of Interest Lead to Overtreatment

When a doctor calls out a whole field of medical specialists for conflicts of interest that risk harming patients, things must really be rotten in the state of orthopedics.

Dr. James Rickert, an Indiana orthopedist, has launched what he calls a “moral persuasion” campaign in the hope of getting his colleagues to stop performing needless surgeries, as reported on MedPageToday.com.

The medical profession in general is vulnerable to financial conflicts of interest, but Rickert, who founded the Society for Patient Centered Orthopedic Surgery, calls orthopedics “one of the worst offenders.”

Following is Rickert’s list of procedures that are frequently performed, are usually unnecessary, cost a lot and sometimes are harmful. If you or a loved one has had one of these surgeries without relief of symptoms, would that qualify you for a medical malpractice suit against the orthopedic surgeon? Not likely, unless you suffered a serious complication that left you worse off than before the surgery. Unfortunately, malpractice lawsuits are too complex, time-consuming and expensive to be worthwhile unless you suffered permanent, life-changing harm.

So be careful before going under the knife for any of Rickert's questionable "treatments":


Cost: $10,000

Cement is injected into a fractured vertebra. About 100,000 patients have it every year. It’s falsely marketed as relieving pain quickly, a claim not proved in clinical trials. Risks include compression fractures in adjacent vertebrae, dural tears (tissues covering the spinal cord and nerves), infections, cement migration (the material moves outside of the repair region) and nerve pain requiring subsequent surgery.

Rotator cuff repairs in elderly people

Cost: $15,000

The number of these surgeries increased by 141% between 1996 and 2006; about 600,000 occur every year in the U.S. It’s vastly overused on people with no symptoms. Complications include infection, bleeding, re-rupture of the rotator cuff, nerve damage, blood clots and the need for repeat surgery to correct problems with the first procedure.

Clavicle (collarbone) fracture repair ("plating") in adolescents

Cost: $13,000

Some adolescents get this treatment to improve athletic function, but Rickert said, "I don't know of any good indication, especially with conservative care being so successful."

Regardless of patient age, sports/activity and final clavicle shortening, there's generally no difference in pain, strength or range of motion. Risks include deep infections, pneumothorax (collapsed lung) and other complications.

Anterior cruciate ligament tear repair in low-risk people

Cost: $10,000

ACL surgeries are performed on about 100,000 patients’ knees every year. Many show no difference in rates of return to pivoting-activity sports one year later when compared with noninvasive rehabilitation and activity modification. Complications include infection, instability, stiffness, pain, patellar (kneecap) fracture and growth plate injury in children (ends of the bones are damaged).

Surgical removal of part of a torn meniscus

Cost: $6,000

About 700,000 patients with knee arthritis and no mechanical symptoms have this procedure every year. It doesn’t result in significant benefit in terms of pain relief or function compared with fake surgery in patients with degenerative meniscal tears.

Bookmark and Share

March 10, 2015

Former Patient Safety Advocate Settles Conflict of Interest Case

Last year we told the story of Dr. Chuck Denham, who went from a being a renowned patient safety advocate to being accused of accepting kickbacks for promoting drug company products while he was advising the National Quality Forum on best safety practices for medical providers.

Last week, as announced by ProPublica.org, Denham agreed to pay $1 million to settle those allegations. The deal also bars him from participating in Medicare and Medicaid programs.

His was quite the fall from grace to disgrace.

The National Quality Forum (NQF) is a nonprofit organization whose work is considered first-rate for objectivity and sound science.

Denham polluted its well by failing to disclose to the panel of experts he led for its Safe Practices Committee that he had received payments from CareFusion Corp., which produces ChloraPrep, a surgical antiseptic. Other members of the panel had not planned to endorse the product, but Denham had encouraged it to do so. The committee ended up recommending ChloraPrep to prevent infections.

Denham’s lack of ethics undermined the integrity of the NSF and, according the U.S. Justice Department, prompted fraudulent claims to government health-care programs. Because he was responsible for what has been called the patient safety movement’s first scandal, Denham also was lopped as editor of the Journal of Patient Safety, which has accepted responsibility for its lapses in oversight. Denham has not acknowledged wrongdoing.

Bookmark and Share

January 21, 2015

Companies Pay Doctors a Lot to Promote Redundant Unproven Drugs

To paraphrase Calvin Coolidge, “The business of America is business.” Even, we would add, when it should be about medical care.

According to a recent news report, “[T]he drugs most aggressively promoted to doctors typically aren’t cures or even big medical breakthroughs. … they are newer drugs that manufacturers hope will gain a foothold, sometimes after failing to meet Wall Street’s early expectations.”

So said a report earlier this month published by the New York Times and ProPublica.org (NYT/ProPublica). Using Open Payments, the federal government’s new database of drug and medical device manufacturers’ payments to medical providers, the reporters found a disturbing, if unsurprising, pattern of dual self-interest that’s all about sales, not the advancement of medical care.

“In almost all cases,” the story said, “older, cheaper products are available to treat the same conditions [as the drugs being promoted]. Companies typically try to differentiate the new drugs by asserting they are easier to use; carry fewer side effects; work faster than competitors; or have medical advantages.”

Assertion is not science. It’s marketing.

This is such a perennial story in the prescription drug world that longtime drug industry scourge Sidney Wolfe MD developed a "seven-year rule": Patients should avoid drugs until they've been on the market for at least seven years. Otherwise you the patient are really participating in an experiment to see if the drug is truly safe. The only rare exception for the seven-year rule is a new drug that is a genuine breakthrough, which rarely happens.

As an example, the reporters offered the blood thinner Coumadin. For many decades, it was the only drug available for millions of patients at risk for life-threatening blood clots. Today, “a furious battle is underway among the makers of three newer competitors for the prescription pads of doctors across the country.”

They are Pradaxa, Xarelto and Eliquis, and their manufacturers entice (some people might say “bribe”) physicians to prescribe them in part by subsidizing meals, promotional speeches, consulting jobs and educational opportunities. In the last five months of 2013, these companies spent more than $19 million on doctors and teaching hospitals.

It’s not about announcing new, cutting-edge treatments, as Dr. Joseph Ross told the reporters. It’s about selling a product to whomever will buy it. “They [the drugs] may have some unique niche in the market, but they are fairly redundant with other therapies that are already available,” said Ross, a professor of medicine and public health at Yale University School of Medicine. “Many of these, you could call me-too drugs.”

The three drug makers claim that their drugs are at least as effective as Coumadin for certain conditions. They claim that patients needn’t undergo regular blood tests as they do with Coumadin, and that patients needn’t limit their diet as much. (People who take Coumadin, or its generic version, warfarin, shouldn’t eat grapefruit or cranberries and they must limit their consumption of green, leafy vegetables.)

But as we’ve blogged, thousands of patients on Pradaxa, which was the first of the three to be approved by the FDA, have been harmed by uncontrolled bleeding, and its manufacturer, Boehringer Ingelheim, has been fined for covering up adverse outcomes in its research for the drug. There are similar concerns about Xarelto and Eliquis.

We recently blogged about the diabetes drug Victoza, which also came under scrutiny in the NYT/ProPublica story. Made by Novo Nordisk, Victoza was responsible for the most payments to doctors, by dollar amount — more than $9 million in the last five months of 2013, despite its questionable benefit/harm balance. Its packaging carries a “black box” warning, which is the most severe alarm about potentially harmful side effects, including an increased risk of thyroid cancer and pancreatitis.

Dr. Todd Hobbs, chief medical officer of Novo Nordisk in North America, told the reporters that the $9 million reflected Victoza’s newness and the need to address such safety concerns. We wonder why that money wasn’t spent on making the drug safer in the first place.

Eliquis ranked No. 2 on the doctor spend-o-meter, at nearly $8 million. Its corporate talking heads (Bristol-Myers Squibb and Pfizer) said such spending helps ensure that providers understand its appropriate use, and how important it is “to have a speaker program that adequately provides robust education to these physicians.”

In what other profession are you paid to learn how to use a tool that is your responsibility to understand?

The No. 3 drug in the doctor payment club was Brilinta, yet another blood thinner. It competes with Plavix, whose generic version is clopidogrel. Brilinta’s manufacturer, AstraZeneca, tabbed it for special promotion attention, noting that doctors are “indispensable partners in our efforts to bring new medicines to patients.”

We get that. We don’t get why being an indespensible advancement in science isn’t more important than being a huckster.

Of the top 20 most promoted drugs on the list, 14 were approved by the FDA since 2010. Some treat similar conditions, including diabetes, schizophrenia and chronic obstructive pulmonary disease, so, as one pharmaceutical company consultant told the NYT/ProPublica, “They’re fighting over the same doctors, I guarantee you.”

A troubling number of highly promoted, doctor-palm-greasing meds have caused harm. Samsca, which treats low sodium levels in the blood, can cause involuntary movements and seizures, side effects that emerged after it was approved by the feds. The manufacturers of some drugs, including Copaxone, Latuda, Xarelto, Daliresp and Humira, have been called out by the FDA for sleazy promotions.

Subsys, which we discussed recently, was approved to treat cancer pain. Its market is tiny (cancer patients who have developed a tolerance to opioids), but it still ranked No. 23 in spending on doctors, and it’s often used for off-label, or unapproved, uses, as you might expect with a drug whose consumer base is so limited.

It’s not only drugs, but medical devices that have hefty doctor promotional budgets. Among the heftiest is Intuitive Surgical’s da Vinci surgical robot system, which has been fraught with problems and lawsuits we’ve tracked. Da Vinci is promoted as less invasive for many procedures, but it’s crazy-expensive, and has caused serious complications and some deaths.

But in the last five months of 2013, Intuitive shelled out almost $13 million for physicians to promote the robot. About half of that amount, Intuitive said, was “pass through” spending: Surgeons or hospitals paid the company for services, and the company, in turn, paid doctors to provide them.

According to Open Payments, one doctor who was paid about $75,000 in the last five months of 2013 gave promotional talks about several of the most heavily marketed anticoagulants and blood thinners, particularly Brilinta.

He’s an emergency room doctor who said he offers a different perspective from the cardiologists and internists who usually prescribe those drugs because he treats complications of blood clots in the emergency room.

He told NYT/ProPublica that he reviews clinical studies before deciding to speak for a drug, and that he no longer speaks on behalf of Pradaxa. But he does get paid to speak for Xarelto, a drug he has taken himself for a deep vein thrombosis.

Well, at least he uses the product he hawks.

But, sadly, “Largely absent from the top of the [promoted drugs] list were drugs that cure disease,” the reporters found, “such as a new class of hepatitis C treatments, or those that significantly extend life, particularly for cancer patients. If a drug is either the first to treat a disease or is much better than existing drugs, said Dr. Sidney Wolfe, the founder and now senior adviser to Public Citizen’s Health Research Group, ‘they “sell themselves” on the merits of their unique benefits.’”

You can see how much money drug and device companies spend on interactions with doctors, (excluding research and royalties) with ProPublica’s Open Payments Explorer tool here.

Bookmark and Share

January 7, 2015

Niche-Market Drug Maker Rewards Doctors for Dangerous Prescribing Practices

It’s common knowledge that medical providers often are paid by pharmaceutical companies to promote their products. What's less well understood is how that clear conflict of interest creates danger for patients. Today, another lesson in how money and safe patient care don't mix well when it comes to powerful prescription drugs.

In November, The New York Times wrote about Insys Therapeutics, a pharmaceutical company whose drug Subsys is a powerful but restricted-use painkiller for cancer patients. The story disclosed that five of the 20 doctors who were paid the most by Insys for things like speaking fees and travel to promote Subsys recently had faced legal or disciplinary action.

Doctors like Judson Somerville, a pain specialist in Texas, who got $67,000 from Insys while he was under investigation by the Texas Medical Board. At the end of 2013, the board ordered him to stop prescribing painkillers because he had authorized employees to give patients pre-signed prescriptions, and three of them had died in 2012 of drug overdoses.

Doctors like Gavin Awerbuch, a Michigan neurologist who received $56,000 from Insys. He was arrested last year when federal prosecutors claimed he defrauded Medicare of $7 million and prescribed Subsys to patients who did not need it.

The Times investigation relied on the new Open Payments database to identify these dangerously irresponsible practitioners. (See our blog about Open Payments.) No one should be surprised that many of the 20 doctors, most of whom are pain specialists, were also top prescribers of Subsys.

Subsys is a fast-working narcotic that’s sprayed under the tongue. It’s given when other painkillers fail to provide relief, especially to patients with sharp bursts of pain. But like all opioids, it carries a high risk of dependency, and also can cause respiratory problems, even death, for people who don’t use painkillers regularly.

Somerville, a top prescriber of Subsys, told The Times that Insys never inquired about the Texas Medical Board’s ruling. He continued to speak about Subsys for a few months after the board’s decision and was lopped from the Insys speaker list only after the company found out about the disciplinary action.

Somerville, of course, disagreed with the medical board’s claims, and said it lacked evidence that he contributed to the patients’ deaths. “I’m very aggressive in trying to help my patients,” he told The Times. “I’m a very caring doctor. I like money, but that’s not my god, O.K.?”

Insys terminated its relationship with Awerbuch after he was arrested.

Even though the Insys payment data used by The Times included only a five-month period from 2013, it “provides unusual insight into the lengths that some drug companies go to cultivate relationships with doctors, and shows that Insys enlisted doctors with troubled track records to market its product to other physicians,” the paper said.

“The drug industry has long paid influential doctors to speak to peers as a way of building word-of-mouth marketing. But such practices can cross the line, legal experts said, when doctors promote uses of the drug that are not approved by the Food and Drug Administration, and when the speaking fees are paid in exchange for the doctors’ prescribing behavior.”

We’ve written often about multimillion-dollar settlements by drug companies to resolve federal charges that they inappropriately marketed their products. But because these companies make so much more money from selling the drugs than they do paying for illegally promoting them, the settlements are seen as simply the cost of doing business.

Insys aggressively marketed Subsys, its only brand-name product. Its efforts are notable because the market for Subsys is relatively small — it’s approved only for cancer patients who already take opioid painkillers, because, as the FDA explains, such patients have demonstrated a tolerance to those heavy drugs. But according to The Times, only 1% of Subsys prescriptions are written by cancer specialists.

Former sales representatives for the company told the paper that they were encouraged to approach pain doctors whose patients had a wide range of ailments, not just cancer, and to reward high-prescribing physicians with things like paid speaking engagements.

Insys paid doctors $2.8 million in the last five months of 2013. Although it’s a small company, that figure puts it in the company of major drug makers like Boehringer Ingelheim and Novo Nordisk, which market a lot of different products.

As the Pharmalot blog in the Wall Street Journal pointed out, about a year ago, the Office of the Inspector General of the U.S. Department of Health and Human Services issued a subpoena to Insys in connection with an investigation by a U.S. Attorney in California concerning potential violations of HHS programs. And a few months ago, Insys received another subpoena from a U.S. Attorney in Massachusetts seeking documents about the sales and marketing for Subsys.

Pharma business as usual.

Bookmark and Share

December 28, 2014

TV Doctors Are Entertainers, Not Medical Professionals

There could be many reasons why an accomplished cardiac surgeon like Dr. Mehmet Oz chooses to dish out the foolishly dangerous bunk he does on his TV show — money; ego; a free lifetime supply of green coffee bean extract…

We’re longtime critics of Oz using his medical credentials to peddle snake oil, a practice the U.S. Senate also found repugnant a few months ago, (see our blog, “Senate Smacks Down Dr. Oz for Diet Supplment nonsense.”) and now researchers from the University of Alberta in Canada have proved what a phony he is.

A study titled “Televised medical talk shows — health education or entertainment?” published in the journal BMJ, examined scores of episodes of “The Dr. Oz Show” and another popular daytime medical yakker, “The Doctors.” Both are seen by millions of viewers every day, as “charismatic hosts discuss new medical research and therapies while offering viewers their own recommendations for better health,” the researchers noted in a news release. “For show producers it’s a winning ratings formula, but for viewers eager for a healthier life, the results aren’t so clear cut.”

They’re being modest. It’s very clear — much of what these photogenic doctors tout is baloney. As Dr. Christina Korownyk, a professor in the Department of Family Medicine at the University of Alberta, commented, “The research supporting any of these recommendations is frequently absent, contradictory or of poor quality.”

The researchers were inspired to examine the “science” behind TV doctor claims after hearing concerns from several physicians whose patients took to heart the advice given on the shows.

“It got us reflecting,” Korownyk said, “what’s being said there? What kinds of things are being recommended and what kind of information is being provided?”

The team analyzed 40 episodes of “The Dr. Oz Show” and “The Doctors.” They focused on the information provided in the recommendations and answering the questions: Was there a benefit mentioned? Was it specific? Did the show quantify the magnitude of the benefit? Did they mention costs? Did they mention conflict of interest?

Researchers randomly selected 80 of the strongest recommendations from each show for further study, and concluded that only 1 in 3 recommendations from “The Dr. Oz Show” had believable evidence and only about half of those on “The Doctors” did.

Frequently, they concluded, viewers don’t get enough information to know if the hosts’ claims are supported by evidence.

Specific findings included:

  • most common topics discussed — dietary advice (“Oz,” 43.2% of the time; “Doctors,” 16.8% of the time)

  • most common recommendations — dietary advice (“Oz,” 39.2% of the time; consult a health-care professional, “Doctors,” 17.8% of the time)

  • frequency of mentioning benefits along with recommendation — “Oz,” 42.6% of the time; “Doctors,” 41.3% of the time

  • how often magnitude of the benefit was mentioned with the recommendation — “Oz,” 16.5% of the time; “Doctors,” 11% of the time

  • how often possible harms were mentioned — “Oz,” 9.8% of the time; “Doctors,” 7.6% of the time

  • how often costs were mentioned — “Oz,” 12.5% of the time; “Doctors,” 3.1% of the time

The study also showed that out of 924 total recommendations examined, in only four instances were potential conflict of interest mentioned.

As we’ve discussed, celebrities aren’t to be trusted when it comes to advising you about health-care choices. Televised medical talk shows might be entertaining, but they’re not science.

Bookmark and Share

December 21, 2014

In Military Hospitals, Whistle Blowing Is Bad for Your Health

Another takeout in the New York Times' coverage of poor quality in our nation's military medical system has this quote about what happens when doctors and nurses on the inside complain:

" ... brushed off, transferred, investigated, passed over for promotion or fired after they pointed out problems with care."

The Times had asked anyone with experiences of military medicine to write in to the Times' reporters, and today's piece talks about the dozens of responses from doctors and nurses trying to buck the culture of silence and obedience, which works most of the time for the military, but not for health care.

The newspaper is still looking for stories from individuals with first-hand knowledge of the military health care system. Go to this web page if you have one to tell. They won't publish your name without your OK.

December 18, 2014

Drug Company Employee Paid for Her Honesty with Her Job

An employee of Sanofi, a major pharmaceutical company, spoke up about the company’s kickback scheme intended to boost sales of its insulin medicines, and was rewarded by being fired.

That’s what Diane Ponte, a paralegal in the French company’s New Jersey office, claims in the whistle-blower lawsuit she filed against Sanofi. According to the Associated Press (AP), Ponte accuses Sanofi and more than 10 of its executives and former executives of spending millions to grease palms in the hope of influencing pharmacists to replace generic prescriptions for insulin with the Sanofi brand name version.

Ponte was fired in October, and a couple of weeks later, Sanofi's CEO was dumped because the board didn’t care for his management style, said AP, and because of slumping sales.

Ponte’s lawsuit alleges that his role in the kickbacks contributed to his ouster.

Ponte worked in Sanofi's diabetes division reviewing vendor contacts for their adherence to federal law. At the time, Sanofi operated under a corporate integrity agreement with the U.S. government mandating that it obey U.S. laws and report illegal activity. That agreement was the result of the company’s earlier failure, the AP story said, to follow federal health-care laws.

Corporate integrity agreements are now common in the pharmaceutical industry, and cases like this seem to show how toothless they are.

A statement by Sanofi, of course, denied retaliating against Ponte. It called her a "disgruntled former employee who is opportunistically attacking our company."

The lawsuit says that in March 2013, Ponte balked at approving nine contracts worth $34 million with two consulting firms, Deloitte LLP and Accenture PLC. Neither is a defendant in the suit. Ponte told her manager that she couldn't approve the contracts because they had been signed before she’d seen them, which was improper. They also called for huge payments although no services were being provided.

Ponte’s attorney, Rosemarie Arnold, told AP that the consulting firms used the money to induce hospitals, pharmacies and doctors to prescribe Sanofi insulin brands, including its top-selling product, Lantus.

"Accenture and Deloitte would make deals with the pharmacies whereby when a patient came in with a generic prescription for insulin, the pharmacist would push the Sanofi insulin," Arnold said. She said that if a prescription specified insulin made by Sanofi competitor Novo Nordisk, the pharmacists would urge patients and even contact their doctors to promote Sanofi’s product as a superior treatment.

Arnold said Sanofi did not report the bribery allegations or the internal probe.

The lawsuit claims that a Sanofi supervisor in the U.S. diabetes marketing division told Ponte that the CEO and the vice-president of the U.S. diabetes business knew she was withholding the consulting contracts and that the CEO was "extremely unhappy."

Arnold said the company conducted a "farce" internal investigation in which no one was disciplined, she said, but after which the supervisor and the VP, two key defendants, "retired" from Sanofi. The suit states that they each received "millions of dollars in severance packages and/or in their pensions," and both landed well-paid consultancies to Sanofi.

But Ponte’s treatment was different. She was criticized, threatened with violence and, the suit claims, physically assaulted by a manager. When she was fired in October, according to Arnold, a manager told her it was because she was a whistle-blower.

If Sanofi is like multiple other drug companies whose bad, illegal behavior we have regularly reported, Sanofi doesn’t perceive Ponte’s suit or any other breach of law as particularly troublesome. If they flout the law, get caught and have to pay, it’s just the cost of doing business in the U.S., where the billions of dollars they can reap in drug sales more than offsets any penalties for being scumbags.

Bookmark and Share

December 9, 2014

Patient Safety Journal Cleans Up After a Conflict-of-Interest Scandal

Early this year, the world of patient safety was rocked when conflicts of interest by one of its champions were exposed. The effects of the scandal continue to be felt, but also addressed.

In February, we told the story of Dr. Chuck Denham in our blog, “Apparent Conflict of Interest Sullies Panel of Patient Safety Experts,” and how, as a leader of the National Quality Forum (NQF), he faced charges of kickbacks after promoting hospital practices in which he had a financial interest.

Last month, the investigative news site ProPublica, in conjunction with NPR, called that incident "patient safety's first scandal," and detailed how it continues “to reverberate in the medical community, most recently in the current issue of the Journal of Patient Safety.”

The journal, we should make clear, is a peer-reviewed publication not to be confused with the newsletter of the same name, which has an excellent reputation, and which we read and refer to regularly.

Members of the journal’s editorial staff analyzed 10 of its articles written by Denham, who previously served as editor. They determined that nine had potential conflicts of interest, five of which he did not disclose. (Researchers who have any kind of relationship with any companies, materials, technologies or people involved in the study they are conducting are obliged to disclose such associations in any communications and/or papers they write pertaining to that work.)

In its review of Denham’s articles, the journal team concluded that although it's unlikely they resulted in patient harm, his work certainly did not enhance the publication’s credibility.

The Journal of Patient Safety was launched in 2005, but, according to ProPublica/NPR, had not adopted some of the conflict-of-interest standards of the International Council of Medical Journal Editors. But now, conflict-of-interest forms will be published with articles, and editors will publish disclosure statements and recuse themselves from decisions in which they might have conflicts.

Denham, who was not a practicing physician, but was considered to be a leader in patient safety as chairman of Texas Medical Institute of Technology (TMIT), a medical research organization. He also served as co-chairman of the NQF Safe Practices committee from 2006 to 2010. The National Qualify Forum reviews, endorses and recommends use of certain standards to improve the quality and delivery of health care.

As ProPublica/NPR summarizes, Denham’s reputation took the initial hit when the U.S. Justice Department accused him of taking $11.6 million in kickbacks from CareFusion, which manufactures ChloraPrep, a surgical antiseptic. Denham wasn’t a party in the civil case, which the company settled for $40 million, but prosecutors alleged that he was paid to influence the NQF to endorse ChloraPrep.

Denham has denied the allegations. But he never disclosed that his company had been paid by CareFusion while he was advocating for ChloraPrep in NQF's Safe Practices committee.

Both the NQF and the Journal of Patient Safety have severed their relationship with Denham.

After Denham left the journal, a new editorial board was appointed. In their Denham article review, they said they were surprised when he was named editor in 2011, as there had been no formal search process and he lacked the strong resume of published academic articles most serious scientific publications demand for such positions.

The journal’s publisher, Wolters Kluwer Health, told ProPublica/NPR that Denham was appointed because he was a prominent member of the editorial board and that he had been recommended by the previous editor.

The Denham articles reviewed in the journal’s study had no direct references to ChloraPrep, but there were several references to the NQF's Safe Practices guidelines. That’s a potential conflict of interest because CareFusion could have benefitted from Denham's control of the guidelines, the editors concluded.

"This is a clear violation of the standards of the Journal," the editors wrote.

Making lemonade out of lemons, Dr. Albert Wu, the journal’s associate editor, told ProPublica/NPR that the Denham controversy would help the patient safety movement evolve by bringing to light the potential of industry to corrupt medical practice.

"We're now much more aware that we need to be more vigilant," Wu said.

Dr. Eric Campbell, a professor of medicine at Harvard Medical School, lauded the journal’s move to come clean, and said it would go a long way toward building trust.

We agree. As we often say, you can’t prevent every mistake, but you can do the right thing after it occurs.

Bookmark and Share

December 1, 2014

Cost of Cancer Rises as Private Oncologists Affiliate with Hospitals

What if your doctor's office changed the sign on the door, and nothing else about it, except the price of care suddenly doubled? You'd be in the strange new world of cancer treatment.

Insurance companies are reducing reimbursements to oncologists, and the drugs they use for treatment are increasingly expensive. The only way many of these doctors can continue to treat their cancer patients is to sell their practices to a hospital system. But that doesn’t mean cancer treatment is business as usual — it means the same treatment is more expensive.

A story last week in the New York Times told the stories of oncologists who said they were forced into selling their practices because they couldn’t maintain a viable business receiving lower fees while the drugs they buy and sell to patients cost more.

The paper cites figures provided by the Community Oncology Alliance Practices, an advocacy outfit. Since 2008, of the nation’s 1,447 independent oncology practices, 544 were purchased by or entered contractual relationships with hospitals, 313 closed and 395 reported being in financial distress.

When cancer patients move from private to hospital care, “Because of quirks in the payment system,” The Times said, “patients and their insurers pay hospitals and their doctors about twice what they pay independent oncologists for administering cancer treatments.”

Dr. Barry Brooks, one source for The Times story who practices privately in Dallas, explained what’s happening in oncology like this: “Say there was a Costco that had very good things at reasonable prices. Then a Neiman Marcus comes in and changes the sign on the door and starts billing twice as much for the same things.”

The Times said cancer treatment is different from that of other diseases because of unique systems of reimbursement that include what drugs patients may get, and where they’re treated. As we wrote in our, “Calling Out the Corruption in Medical Care,” such systems invite conflicts of interest and put doctors in the position of making treatment decisions based not on what’s best for an individual patient, but on whether and how much he or she will be reimbursed.

Some observers say the Affordable Care Act (ACA) has accelerated private practice sales to hospitals because many people bought relatively spare Obamacare insurance plans that don’t cover the expensive cancer care they need. So doctors, who buy cancer drugs in advance, face budget problems when their patients can’t pay, and the overhead is crushing.

Doctors in private practice often send uninsured and Medicare patients to hospitals for their chemotherapy, and keep them as patients for office visits. As one such practitioner said to The Times, “The disgrace is that we have to treat people differently depending on how much money they’ve got. That we do diminishes me.”

Unlike other doctors, oncologists maintain a wide stock of drugs in their offices, and if the patient requiring one dies or can’t pay, the doctor takes the loss. “That used to be acceptable because insurers paid doctors at least twice the wholesale price of drugs,” The Times explained. “Now doctors are reimbursed for the average cost of the drug plus 4.3%, there are more and more drugs to stock, and drugs cost more.”

For private practitioners, the sale of chemotherapy drugs no longer generates impressive income, but it does for hospitals. They get higher reimbursement for administering drugs, deeper discounts for buying large quantities and many take advantage of the federal program that compensates research hospitals and hospitals serving poor people.

The ACA also requires documentation of efficiencies in medical care that some private practice doctors find onerous and time consuming. If they consolidate with a hospital, the drug purchases and paperwork are someone else’s problem.

Medical centers, of course, tout the advantages of this changing business model. An executive with the American Hospital Association told The Times that patients get tests such as CT scans and MRIs, lab work and pharmacy services all in one place. The convenience, and the facilities’ 24-hour care for everybody, including uninsured and underinsured people, justify the higher fees, he said.

Hospitals really want cancer patients, of course, because they use lots of hospital services. They generate a lot of revenue. But as these patients move from private suite to large medical center, the treatment is less personal and often less efficient. As The Times stated bleakly, “The private practice oncologist is becoming a vanishing breed, driven away by the changing economics of cancer medicine.”

Bookmark and Share

November 27, 2014

Suggested Reading: How Counterfeit Surgical Screws Found Their Way to Market and Cost People Their Health

Over the summer, the Center for Investigative Reporting (CIR) broke the story of surgeons who used counterfeit screws and rods in spine surgery, causing crippling outcomes and mounting lawsuits. Now, the CIR has published the back story in a chilling tale of greed and regulatory sloth.

Ortho Sol makes precision screws for spinal fusion surgery. In 2009, it repossessed some of its screws after Spinal Solutions LLC failed to pay for them. An Ortho Sol executive noticed that some of the screws it got back were counterfeit, that Spinal Solutions had replaced high-quality, safe equipment, with cheap knockoffs that had been implanted in the necks and backs of who knows how many people in the U.S.

Two years later, a whistle-blower from Spinal Solutions tipped off the FDA about the counterfeiting, and even then, the feds didn’t shut down the company. “By the time Spinal Solutions went broke in 2013,” CIR reports, “the company had sold millions of dollars in implants to a nationwide network of surgeons.”

Some surgical patients have suffered debilitating pain and infections from the counterfeit screws, but others whose doctors were among the recipients of Spinal Solutions shipments that mixed legitimate and counterfeit screws are left wondering about their future.

“What do they do if they find out there are these bogus parts that can come unscrewed?” Susan Reynolds told CIR. Her doctor used Spinal Solutions screws in her surgery in 2009. “I’m a walking time bomb.”

Many doctors received lucrative consulting deals from Spinal Solutions, and in return, used the company’s implants for their surgeries at hospitals in California, Nevada, Texas, Wisconsin and Maryland. CIR has no evidence they knew the screws were counterfeit, but some doctors have been accused of with taking kickbacks for using them.

Read the whole story from the Center for Investigative Reporting here, And see our original blog about the defective equipment, “Counterfeit Equipment for Spine Surgery Spurs Lawsuits,” here.

Bookmark and Share

November 23, 2014

Calling Out the Corruption in Medical Care

When physicians air their grievances on the New York Times op-ed page about how health care in the U.S. is undermined by dark forces, even skeptics should pay attention.

In a commentary last week called “How Medical Care Is Being Corrupted,” Drs. Pamela Hartzband and Jerome Groopman declared that “financial forces largely hidden from the public are beginning to corrupt care and undermine the bond of trust between doctors and patients. Insurers, hospital networks and regulatory groups have put in place both rewards and punishments that can powerfully influence your doctor’s decisions.”

A doctor’s treatment decisions, of course, should be based on what’s best for the patient, not what’s best for the infrastructure that’s supposed to enable the best care, not thwart it.

Hartzband and Groopman, who teach at Harvard Medical School, explain that cold numbers are poor drivers of quality care. What’s commonly called “metrics,” or numerical standards doctors are supposed to meet under contracts for medical care that reward “pay for performance,” are derived from whole population studies. That is, they’re generic standards for large groups of people, not measures to be applied to individual patients. People are different, and although metrics are useful in research and in shaping policy, they’re woefully inadequate in the assessment and support of a single human being.

Metrics, the writers say, do not account for patient preference, differing opinions or optimal practice for a given doctor-patient circumstance. Yet metrics are what the industry demands from providers if they expect financial support.

“[D]octors are rewarded for keeping their patients’ cholesterol and blood pressure below certain target levels,” Hartzband and Groopman cite as an example. “For some patients, this is good medicine, but for others the benefits may not outweigh the risks. Treatment with drugs such as statins can cause significant side effects, including muscle pain and increased risk of diabetes. Blood-pressure therapy to meet an imposed target may lead to increased falls and fractures in older patients.”

But physicians who meet designated targets for such values might receive not only a bonus from an insurer, but high ratings on the company’s website. Patients and potential patients generally would assume the high rating denotes high quality. The doctors who don’t meet the values are penalized financially through lower payments and “shamed” by lesser status on the website when, in fact, they might well be the superior practitioner, from the patient’s perspective.

It’s a great business growth model, and a lousy model for understanding human variables.

Doctors are only human; they’re not immune from the pressure to comply with the metrics. They might feel, say the writers, “pressured to withhold treatment that they feel is required or feel forced to recommend treatment whose risks may outweigh benefits.”

When you have a choice of drugs to treat a certain problem, there’s as much art as science in figuring out which is best for the patient. Genetics, living circumstances, age, gender, mobility … lots of things figure into the decision of who should get what drug.

Insurance companies don’t care. The writers decry how often larger co-payments are imposed on certain drugs as a way to dissuade doctors and patients from choosing higher-cost medications that, in the artful judgment of the people who know best, are the best match.

The writers offer WellPoint as an example. It’s one of the largest private underwriters of health care. It recently “outlined designated treatment pathways for cancer and announced that it would pay physicians an incentive of $350 per month per patient treated on the designated pathway.”

Bad call. As Hartzband and Groopman note, oncologists (cancer doctors) are hardly unified about what is optimal in cancer care. They regularly treat patients who deviate from treatment guidelines, and embracing that deviation is what drives one of the most significant recent advancements in cancer treatment — the concept of customized care, of targeted therapy.

It used to be that everybody with a certain kind of cancer, for example, got the same kind of chemotherapy drug in the same dose. Some did fine, some didn’t. But now cancer patients might get one of several kinds of chemotherapy drugs, they might be switched around or they might get a combination, depending on their genetic profile, the severity of side effects and other factors.

So, should oncologists make chemotherapy (or any drug) decisions based on these factors or based on adverse effects on payment? “Further,” the writers note, “some health care networks limit the ability of a patient to get a second opinion by going outside the network. The patient is financially penalized with large co-payments or no coverage at all. Additionally, the physician who refers the patient out of network risks censure from the network administration.”

How dare actuarial interests put doctors in a moral dilemma when a patient asks, as he or she should, “Is this treatment right for me?” What if the insurer covers the cost of one drug, but the doctor doesn’t believe it’s the “right” treatment?

Is health policy always and only about what’s best for a whole population? Can policy never bend to the individual good?

“We fear this approach can dangerously lead to ‘moral licensing,’” write Hartzband and Groopman — “the physician is able to rationalize forcing or withholding treatment, regardless of clinical judgment or patient preference, as acceptable for the good of the population.”

As medicine moves away from the old paternalism when patients never questioned, much less participated, in their care, it’s moving toward a new paternalism imposed by the insurers and regulators that control payment.

The writers propose that these powerful outside interests be subject to the same kind of transparency that the Physician Payments Sunshine Act established to expose (with mixed results) potential conflicts of interest by physicians with financial ties to pharmaceutical and device companies. “We propose a similar public website to reveal the hidden coercive forces that may specify treatments and limit choices through pressures on the doctor.

“Medical care is not just another marketplace commodity,” they conclude. “Physicians should never have an incentive to override the best interests of their patients.”

Bookmark and Share

October 6, 2014

Feds’ Website for Tracking Industry Payments to Docs Is Weak

Last week the federal government launched its long-awaited website tracking the money drug and medical device companies pay to doctors for various kinds of product and research support. But it’s less a new initiative for transparency than a disappointment.

Readers of this blog will recall that the Physician Payment Sunshine Act spawned Open Payments, the first public release of industry payment data, and was part of the Affordable Care Act (“Obamacare”). It was supposed to go live 18 months ago, but was delayed until now, and even with the extra time, tracks payments only from August to December 2013.

According to Open Payments, its database “creates greater transparency around the financial relationships of manufacturers, physicians and teaching hospitals.” The information comes from annual reports made to the Centers for Medicare & Medicaid Services (CMS).

But as reported by ProPublica.org and NPR, the site is “a very limited window into the billions in industry spending.”

When the site launched, the New York Times reported that pharmaceutical and device makers shelled out approximately $380 million to doctors in speaking and consulting fees. Some individuals received more than half a million dollars, and remember — that’s only for the initial five-month reporting period from last year.

Some doctors, according to The Times, earned millions in royalties from products they helped develop.

The Times reported that during those five months, drug and device companies made 4.4 million payments to more than half a million health-care professionals and teaching hospitals for a total tab of about $3.5 billion.

The Times called into question the value of Open Payments, at least for its debut: “[A]bout 40% of the records do not tie back to a specific professional or teaching hospital, accounting for 64% of the overall payments,” the paper said.

Consumers are invited to search the site to find out if their doctors received industry money (and possibly compromised their independent medical judgment) and if so, how much was paid by whom. But before you conduct a search, ProPublica/NPR advises you to keep five things in mind.

1. The data covers only a fraction of payments, from August to December 2013.

If you search for your doctor and can’t find him or her, that doesn't necessarily indicate he or she didn't receive a payment.

Also, those five months’ of data might not represent a company's spending over a whole year. Some companies might concentrate promotional talks, which can reward doctor/speakers handsomely, in the first part of a year, which wouldn't be represented in this data.

Some of these concerns will be resolved by the time the government releases data on payments for the full calendar year 2014, which is expected next summer.

2. Some data on research payments won't be released until the product in question is approved by the FDA, or four calendar years after the payment was made, whichever comes first.

The Sunshine Act permits drug and device companies to delay the publication of data related to research of new products or, in some cases, new uses for existing products. It’s not clear how much money is involved. And, again, just because a doctor’s name isn’t on the list as receiving a research payment doesn't mean he or she hasn't received one.

And the breadth of health-care providers is not represented in the database. Physicians (medical doctors and osteopaths), dentists, chiropractors, podiatrists and optometrists are included. But companies are not required to report payments to nurse practitioners or physician assistants.

3. Some data is being withheld because of company errors that led to cases of mistaken identity.

CMS acknowledged that 1 in 3 payment records submitted by companies for last year had data problems that could lead to cases of mistaken identity. The names associated with those payments were not released last week. Federal officials have asked companies to verify their data, which should be released publicly next year. (See our recent blog, “Feds Withhold Some Information From Doctor Dollars Database.”)

CMS officials discovered the problem while investigating a physician's complaint that payments were being attributed to him even though they were made to another physician with the same name, as we wrote in our blog. Looking into the matter, the feds discovered "intermingled data," meaning that some physicians were linked to medical license numbers or national provider identification numbers that weren’t theirs.

It serves no one’s interests to post inaccurate or misleading information; better to withhold and correct it than present an erroneous database.

4. Not all payments have the same significance.

The listed categories indicate varying levels of involvement with a company, from consulting and speaking fees to research payments, entertainment, travel and lodging and educational items.

Consumers on Open Payments see fees divided into different categories: consulting fees, speaking fees (called "services other than consulting"), research payments, honoraria, gifts, entertainment, food and beverage, travel and lodging, educational items, charitable contributions, royalties, ownership interests and grants.

Those different types of payments indicate different levels of involvement with a company.

Educational items, for instance, include medical textbooks and reprints of journal studies given to doctors. Research payments might include more than the pay somebody got to lead a study. Payments for clinical studies might include costs associated with patient care, supplies, as well as the time spent by health-care professionals treating patients and managing the study.

Educational items that directly benefit patients (such as informational posters) and medication samples do not have to be reported and you won't see their value reflected in the data.

5. This is the first federal release of this data: There will be mistakes.

Although the rollout of Open Payments isn’t as fraught as that of Healthcare.gov, the Obamacare insurance exchange, because it’s not nearly as complex, it's reasonable to expect some glitches. The same company that was responsible for launching Healthcare.gov also is responsible for the release of the payment data.

And drug and device manufacturers make mistakes. For example, doctors with similar names might be confused, so a payment made to one might be attributed to someone else.

The government gave doctors 45 days to review and dispute payments attributed to them before the information becomes public, but it's unclear how many did. Professional and trade groups say that process has been confusing.

The New York Times story illustrated how understanding the database requires more than just a quick look at a numbers tally. “When you look at why do drug companies and device companies make gifts and offer consulting payments and honoraria to physicians, the main goal is to influence prescribing practices,” Dr. Michael Carome told the paper. He’s director of Public Citizen’s Health Research Group. “The interest of those companies is to improve their financial bottom line, and not necessarily represent the best interest of patients.”

But, notes The Times, if some relationships might leave doctors open to scrutiny, other ties promote innovation. “Drug and device makers say they regularly consult with doctors to help them decide where the need is the greatest, and doctors conduct clinical trials that help get products approved,” the paper reported.

“Research, for example, accounted for nearly $1.5 billion of payments during the reporting period. Companies spent an additional $302 million on royalties and licenses, money that is paid to doctors and teaching hospitals for their role in developing companies’ products.

So if you have a question about what your doctor received, if you want to know if he or she has any kind of financial relationship with a medical company, ask him or her.

ProPublica’s Dollars for Docs site has been tracking payments by certain large drug and device companies for four years. It has information from 17 drug companies, which represent about half of U.S. drug sales from last year.

So Dollars for Docs probably has information you can't find on Open Payments. It enables you to search by name, state, company or payment category.

Bookmark and Share

September 7, 2014

Robotic and Traditional Bladder Surgery Show Similar Rate of Complications

For all its techno-wonder and new-age appeal, robotic surgery has racked up a host of problems, including unacceptable incidents of tears and burns to internal organs. Now, a new analysis of robotic versus traditional methods showed no difference in the rate of complications for surgical removal of the bladder.

Robotic surgery is a minimally invasive procedure in which surgeon-controlled instruments work in smaller spaces (and with smaller incisions) than traditional, or “open,” surgery. It’s used for a range of disorders involving the prostate gland, uterus, gallbladder and heart valves. In addition to an alarming number of adverse outcomes, training for robotic surgery has been shown to be deficient, and it’s also more expensive.

Hospitals and surgeons, with an investment in the equipment, want to use it as much as possible to justify the cost, but that could conflict with what’s best for the patient.

The recent study, published in the New England Journal of Medicine, (NEJM) looked at robot-assisted cystectomy, a procedure that removes the bladder, for 118 patients with invasive bladder cancer. They all shared similar baseline characteristics. According to MedPage Today.com, it was one of the first randomized comparisons of open versus robot-assisted surgery.

According to the U.S. Department of Health and Human Services, bladder cancer is the fourth most commonly diagnosed cancer in men and 10th most commonly diagnosed cancer in women in the U.S. It’s estimated that more than 72,000 people will be diagnosed with new cases of bladder cancer this year, and that more than 15,000 will die from it.

In the NEJM study, 90 days after surgery, 62 in 100 people who underwent robotic surgery had complications; 66 in 100 who had open surgery did. Complications defined as “severe” also showed comparable rates.

There were some qualifications: Surgeons using one method were different from those using the other, so one doctor’s technique couldn’t be compared exactly with another’s. All of the surgeons were experienced in their techniques, and all surgeries were performed at Memorial Sloan Kettering Cancer Center in New York.

As the researchers wrote, "Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation."

Cystectomy is the standard of care for nonmetastatic, invasive bladder cancer. “Invasive” means that the tumor has invaded at least the lining of the bladder; “nonmetatstatic” means the cancer has not spread beyond the original site.

Even though removal of the bladder is standard for these patients, it often leads to complications. Patients most likely to experience them are older and have other diseases. The recovery period generally is long.

Earlier studies, reports MedPage Today, suggested that the robot-assisted cystectomy resulted in fewer complications and a shorter hospital stay compared with open surgery but data from randomized trials — the most scientifically sound — were lacking. And a recent report that looked at results internationally showed that almost half of the patients who had the robotic procedure experienced complications within 90 days.

So the NEJM researchers devised a randomized clinical trial to compare open with robot-assisted laparoscopic cystectomy in patients with newly diagnosed invasive bladder cancer. Four surgeons performed all of the open cystectomies, and three did the robot-assisted cystectomy operations for the patients randomly assigned to either group.

In addition to patients in the robotic surgery group experiencing similar rates of complication to the open surgery patients, their stay in the hospital was no shorter — both groups averaged eight days as an inpatient.

Dr. Daniel Barocas told MedPage Today, "The investigators are really to be commended for undertaking this; this is a hard thing to do. The patients are to be commended for trusting their doctors enough to undergo a procedure that is not yet proven to be comparable to the traditional approach."

And as important as the study is, remember that it evaluated only one outcome of these surgeries — complications. Further studies are required to understand other important outcomes, including cancer control and return to work or to routine activities. As Barocas noted, cystectomy is a major operation, regardless of which technique is used. So a lot of people undergoing it can be expected to experience complications.

Still, if you are facing this procedure, find out all you can about not only the risk factors of each method, but the financial interests of the facility and the practitioners with regard to the possible use of robotic equipment. You can’t make an informed choice if you don’t have all the relevant information.

Bookmark and Share

September 2, 2014

Court Nixes Litigation Standards Set by Pathologists

What if a truck drivers' union tried to set standards for when juries could conclude that a driver was negligent in causing a motor vehicle wreck? Or what if a trucking company could defend its driver falling asleep at the wheel by showing that its other drivers had impeccable driving records?

That's about the situation the courts face with litigation guidelines set by two pathologists' groups about when misreadings of Pap smears by members of these groups should be judged negligent.

A recent ruling by the 11th Circuit Court of Appeals, the federal appeals court for the southeastern-most states, found the pathologists were wrong in trying to enforce their litigation standards. And it reinstated a lawsuit brought by a patient which had been thrown out by a trial judge because the plaintiff's expert had not followed the litigation guidelines promulgated by the College of American Pathologists (CAP) and the American Society of Cytopathology (ASC).

Here's a quotation from the 11th Circuit's decision in Adams v. LabCorp that shows the judges saw the difference between clinical practice guidelines promulgated for better patient care versus these litigation guidelines:

As an initial matter, it is important to put these guidelines in context. Both sets of them focus not on how cytotechnologists should go about their duties in examining slides, but instead on how courts should go about their duty to adjudicate claims against cytotechnologists and similar professionals. In the words of the guidelines, they are to be used in assessing Pap smear slides “in conjunction with litigation or potential litigation.” They are not objective, scientific findings; they are not guidelines followed by laboratories to screen for pre-cancerous or cancerous cells; they are policy proposals to limit how the courts can find the members of the organizations liable for professional negligence when they are sued.

As far as we are aware, this is the first time that an industry group has promulgated a set of guidelines that attempts to define and limit the evidence courts should accept when the group’s members are sued. The members of the CAP and ASC have a substantial interest in making it more difficult for plaintiffs to sue based on alleged negligence in their Pap smear screening, and their guidelines do just that.

The guidelines, if enforced, would have made it not just difficult, but VERY difficult to impossible, to prove that a laboratory had been careless or negligent in reading a patient's Pap smear. Here's an excerpt from the ASC's guidelines:

A violation of a reasonable prudent practitioner standard of practice based on how specific Pap tests were screened and interpreted can only be established through an unbiased blinded rescreening review process that includes the contested case as one of a number of normal and abnormal GYN cytology samples representing a variety of disease states. Focused review or review with knowledge of subsequent development of carcinoma inevitably biases the objectivity of the review against the laboratory and does not reflect standard practice.

Hindsight bias is an issue, and every honest expert witness I've dealt with tries to make sure to keep that in mind and not let it unduly influence his or her view of a case. But these guidelines essentially use an elephant gun to go after a flea.

In practical terms, the ASC guidelines would require the plaintiff to hire an independent pathologist to go to the defendant laboratory, whereupon the pathologist would be put to a test devised by the defendant: the specimens at issue would be salted in with a group of other specimens, some normal, some not, and the pathologist would then study the specimens under the microscope as if they were specimens seen in the ordinary course of lab work.

(Except, of course, that most labs, LabCorp included, use "cytotechnologists," non-doctors, to first screen the specimens and point out potential abnormalities for the pathologists to then study more closely. And the issue in this case was that the cytotechnologists at LabCorp had not even flagged this patient's smears as possibly worrisome.)

And what if the independent pathologist passes the test devised by the defendant lab and correctly diagnoses the mix of normal and abnormal specimens? The test of the plaintiff's expert is still not over, because the ASC guidelines go on to say:

Courts and experts should recognize that a false‐negative result by itself is not sufficient proof of negligence. Rather, the courts should evaluate whether the overall Pap‐test practices of the laboratory meet the standard of care and whether unbiased blinded rescreening consistently detects significant abnormalities not initially identified by the laboratory.

I've italicized two key pieces. First, "overall practices of the laboratory" seems to mean that as long as the lab overall has a good track record, it shouldn't be found negligent for messing up on one patient's specimen, even if it was wrong that one time. This would be like a trucking company saying, "Never mind that our driver fell asleep at the wheel; we have a nearly spotless driving record other than this one time."

A fundamental aspect of American tort law is that the defendant's conduct is judged on the specific case, and it's not relevant to prosecute or defend a case based on what happened on some other occasions (with a few exceptions when the allegation of wrongful conduct is that the defendant had failed to detect a pattern in the prior events). This prevents plaintiffs from using prior bad events unfairly, and it prevents defendants from using prior good events unfairly.

The second italics is on the word "consistently." That means the pathology groups want their members to be found guilty ONLY if no experts can be found to defend their reading on a particular occasion. So only the most egregious cases could go forward, since it's child's play to find an expert who will give a pass to conduct that other experts will criticize.

In the Adams case, the plaintiff had hired an expert of sterling credentials, Dr. Dorothy Rosenthal of Johns Hopkins Hospital. She had not only spent 40 years training cytotechnologists how to read Pap smears, she also had worked on the pathologists' committee that set the medical standards for when cells on a Pap smear look cancerous, when they look borderline, and when they are benign.

The lab had criticized Dr. Rosenthal for doing a non-blinded review of Ms. Adams' Pap smears, but as the 11th Circuit pointed out, the lab's own expert witness did exactly the same non-blinded review. And the 11th Circuit was troubled by the one-sided nature of the litigation guidelines:

...the ASC's guidelines condemn non-blinded review because it “biases the objectivity of the review against the laboratory,” but express no concern about non-blinded review biasing the assessment of defense experts against plaintiffs. Clearly, the purpose of the guidelines is to raise the bar only on the plaintiffs' side of the courtroom.

The litigation guidelines go way too far on hindsight bias, as the court observed:

...both sets of guidelines treat the mere risk of review bias as intolerable. They do not specify the frequency or degree to which review bias actually affects reviewers’ judgments. Nor do they cite any empirical evidence supporting their assertion that knowing the outcome “inevitably biases” the reviewer. Yet they insist that a court should exclude expert testimony unless the expert has eliminated entirely the possibility of any review bias. That would be a radical reworking of [Federal Evidence] Rule 702, which requires courts to determine that the expert’s method is reliable, not that it is free of any possibility of bias.

The lab also claimed that Dr. Rosenthal's opinions were "Ipse Dixit" -- Latin for, "because I say so" -- but the Court said that was wrong too, since the expert had used the same atlas showing what abnormal cervical cells look like that the defendant's employees had used:

Dr. Rosenthal used a well-established classification system to assess the cells: the same Bethesda System that LabCorp's cytotechnologists use. In her deposition testimony she went picture-by-picture, pointing to specific places in each one where Ms. Adams's cells showed abnormalities and classifying those abnormalities using the same Bethesda classification system that is used by LabCorp's cytotechnologists and nearly every other professional in the field of cytopathology. And the Bethesda Atlas, which is maintained by the ASC, provides numerous examples of each abnormality that Dr. Rosenthal identified, including “classic examples” of abnormal cells as well as “borderline” cells. As Dr. Rosenthal explained in her deposition, the images in the Atlas could be used to assess whether her opinion was in step with the established standards in the field. The fact that Dr. Rosenthal applied an established diagnostic system in which she was well versed contributed to the reliability of her methodology.

One puzzle remains: these guidelines have been around since at least 2000, in the case of ASC, but only now in 2014 reached the attention of a federal appeals court. Maybe that's because trial courts before the one that was reversed here by the 11th Circuit could see so plainly that the "litigation guidelines" were an improper attempt by a self-interested professional group to stack the deck of lawsuits against its members.

Bookmark and Share

August 25, 2014

Feds Withhold Some Information From Doctor Dollars Database

Next month the federal government’s database of drug company and medical device manufacturer payments to doctors is supposed to launch. But it won’t be as we expected.

As reported by ProPublica.org, about one-third of the records will be withheld because of data inconsistencies. Keep in mind that although the Physician Payments Sunshine Act was passed in 2011 as part of the Obama administration’s health-care reform, and the database, Open Payments, was supposed to be available to the public last year, it has been delayed until now.

Withholding information seems to be trending: A few weeks ago, courtesy of USA Today, we blogged about the feds not reporting some serious hospital errors on its Hospital Compare website.

Open Payments is supposed to disclose payments industry makes to doctors for research, consulting, speaking, travel and entertainment as an effort to clear up — and, one hopes, clean up — conflicts of interest and the appearance of them. If your doctor chooses a certain kind of implant for your hip replacement, and he or she also has been paid to promote it at surgeon conventions, can you be sure that choice for you is completely for medical reasons? Or because the doctor likes getting two paychecks?

The first Open Payments release, scheduled for Sept. 30, covers payments made from Aug. 1 to Dec. 31, 2013.

The Centers for Medicare and Medicaid Services (CMS) has been investigating physician claims that payments were being attributed erroneously. The agency reported that, indeed, one physician’s payments were being recorded as being sent to another one with the same name. The feds said they found "intermingled data”— medical license numbers or national provider identification numbers linked to the wrong people — that had to be corrected before being made public.

These data won’t be included in the database until the next reporting cycle, which is June 2015.
CMS did not tell ProPublica how many records were involved, but it could be as many as tens of millions.

Certainly, it is in no one’s interest to publicize erroneous information. But it’s troubling that, like the rollout of the state and federal health insurance exchanges last year, a federal health-care initiative once again has proved to be balky, tardy and sloppy.

Before CMS makes the data public, it has allowed physicians 45 days to review and contest entries they believe are inaccurately attributed to them. When a physician in Louisville, Ky., found payments attributed to him that should have been attributed to a doctor with the same name in Florida, ProPublica reports, CMS suspended the verification system for 11 days to investigate. And now, physicians have until Sept. 8 to review their data, even though CMS has promised to stick with the Sept. 30 deadline for public access.

This vigilance is to be commended … except that when CMS promised not to post anything that hadn’t been validated, it didn’t mention that one-third of its records won’t appear on Sept. 30.

And, because some physicians told ProPublica that some of the data being withheld was accurate, you wonder about the quality of the whole program.

One physician said that only three entries for him currently show up, although several other legitimate ones from a device maker should be there. Another doctor reported that what he thought were legitimate payments attributed to him from three difference device makers or drug companies weren’t recorded under his name.

Supposedly, according to a follow-up by CMS, consumers will be given an explanation about the missing payments when the database launches. But doctors told ProPublica that they didn’t see such a notice on the verification site.

We’ve often blogged about websites that provide information about doctor behavior and pay, among them ProPublica’s Dollars for Docs. It lists approximately $2.5 billion in payments to doctors, other medical providers and health-care institutions that have been disclosed by 15 pharmaceutical companies since 2009. It can be searched by state and company, and filtered by category and year.

Dollars for Docs shows payments by companies that have made information public, typically under settlement agreements with the government to resolve allegations of improper marketing. ProPublica also has researched company websites for information.

“On each payment record in Dollars for Docs,” according to the site, “you can find details about the drugs each company makes, how it describes the service performed and questions you can ask your doctor about his or her relationship with the companies.”

It’s not as comprehensive as what the law requires CMS to do, but it’s a fine resource, especially in light of the fact that CMS is not really doing what it’s supposed to.

Bookmark and Share

July 6, 2014

Can Doctors Avoid Conflicts of Interest?

As editor-in-chief of JAMA for 11 years, Dr. Catherine DeAngelis was known for her outspoken views about the deficiencies of U.S. health care and the drug industry. Her recent commentary, “Conflicts of Interest in Medical Practice and Their Costs to the Nation's Health and Health Care System,” continues her campaign to expose what’s wrong with our medical care.

“Many, if not most physicians practicing today have, or have had, conflicts of interest that clearly do not result in their patients’ best interest,” she writes in the Milbank Quarterly, a health policy journal. She defines conflicts of interest as “a conflict between the private interests and the official responsibilities of an individual in a position of trust.”

That sorry situation, as summarized by MinnPost.com, has become widespread over the last couple of decades, largely driven by pharmaceutical companies whose marketing and scientific divisions seem to be one and the same.

We’ve blogged about the slimy intersection of these two forces, and their harmful effect on patient safety. DeAngelis traces their roots back to medical school, with “the free black bags, instruments or books given to medical students by a pharmaceutical company, or even the doughnuts, coffee, soft drinks and free lunches provided at teaching conferences.”

It’s not long before those … kindnesses … escalate to “the free food, tickets to sporting and other events, sponsored trips to resort locales and the shower of other gifts given to physicians by the pharmaceutical representatives assigned to them,” says DeAngelis.

Often, the recipients of this largess claim that their clinical and prescribing practices are not influenced by it, but if that were true, DeAngelis wonders, “[W]hy would pharmaceutical companies spend billions of dollars on these items, and why would they partially reimburse their marketing representatives according to the number of prescriptions written by the physicians to whom they are assigned?”

Sunlight is spreading over this smarmy practice of drug and device manufacturers showering practitioners with attention and treats — ProPublica’s Dollars for Docs is one site where you can track how the industry greases practitioners’ palms — but DeAngelis explains how much more disinfectant is required to clean up the mess.

“What about the free drug samples provided to physicians for their patients?” she asks. Some people say free samples help patients who otherwise can’t afford the drugs they need. If so, she asks, “[W]hy are the vast majority of these free samples for new (meaning those still under patent protection) and expensive drugs that are almost exclusively for illnesses that require the drug’s frequent or continued use?”

She’s concerned as well about academics who conduct research and/or write practice guidelines or review papers who are subsidized by Big Pharma. “Most Americans are surprised to learn that the clinical research funded by Big Pharma dwarfs the annual investment by the National Institutes of Health. Moreover, much of this industry-sponsored research is tainted by bias that is not always clearly stated.”

If you’re not happy to name the members of your team, doesn’t that suggest there’s something sordid about the game you’re playing?

DeAngelis decries the practice of physicians, biomedical and health-care researchers working for a pharmaceutical company’s marketing division instead of its scientific division. One example is “expert physicians” serving as industry-sponsored speakers using data provided by the pharmaceutical company. “Invariably” she writes, “such ‘chaperoned’ presentations accentuate the positive and downplay the negative (including price differentiation) aspects of the drug being promoted.”

Then there’s the common but illegal habit of promoting a drug for off-label use. DeAngelis describes how insidious drug companies and their willing medical partners operate in this arena:

Imagine the following and, unfortunately, common scenario: At a major clinical or health-related lecture, a physician paid by the pharmaceutical company is “planted” in the audience. The “plant” raises his or her hand and supposedly innocently asks the presenter if he or she has ever used the drug for an illness for which the drug has not been approved by the … FDA. The presenter then discusses off-label uses of the drug for this or that illness or symptom. Remember that physicians in the United States can write prescriptions for any drug, whether or not it has been approved by the FDA for that illness. So why not add a few more uses, which can translate into multiple sales and millions of dollars in unexpected revenue?

Later this year, as we’ve noted, the Physician Payment Sunshine Act, a provision of the Affordable Care Act, requires drug and medical device manufacturers to report what they pay individual physician on a website accessible to consumers.

Will that public disclosure persuade physicians to uphold their Hippocratic oath to do no harm, to always act in the best interest of their patients and reject the free meals and trips, the lucrative speaking and consulting fees Big Pharma offers?

Says DeAngelis, “We can only hope.”

Bookmark and Share

June 29, 2014

Senator Smacks Down Dr. Oz for Diet Supplement Nonsense

Dr. Mehmet Oz , a popular TV personality, is better known for his charisma than his medical expertise, and no wonder why — he’s constantly hawking dubious treatments, and recently the chair of the U.S. Senate's Consumer Protection panel called him out for it.

Oz's shilling for diet supplements now has the attention of comic John Oliver, to devastating effect, but readers will have to go all the way to the end of this piece to get the link.

Oz testified at a Senate hearing about deceptive advertising for over-the-counter diet supplements and products. According to CBS News, Sen. Claire McCaskill told him, "I get that you do a lot of good on your show [“The Dr. Oz Show”]. But I don't get why you need to say this stuff because you know it's not true."

The “stuff” is the outrageous, even false claims he routinely makes about “miracle” dietary and health supplements (See our blog, “Pulling Back the Curtain on Dr. Oz”).

Oz defended himself by claiming that if you can inspire someone to start a weight-loss regimen by using products readily available, you’re doing a good thing.

He isn’t concerned that these useless products have no scientific foundation and encourage people to believe in magic. He is concerned about getting “folks to realize there are different ways they can rethink their future."

But as McCaskill told CBS, he’s just fueling the sketchy diet industry with unscientific claims. That’s not how you “rethink” your future; that’s how you waste money on worthless products that serve only to set back a true effort at nutritional reform and weight loss.

A couple of years ago, Oz promoted a product on his show called green coffee bean extract. Half a million bottles of the pills were sold, and the Federal Trade Commission filed a lawsuit against the manufacturer for false advertising.

Oz defended his endorsement of it by citing a clinical study that McCaskill criticized because it was funded by the product's manufacturer.

"People want to believe you can take an itty-bitty pill to push fat out of your body," McCaskill said during the hearing. But "the scientific community is almost monolithically against you."

The civil justice blog PopTort.com also found fault with Oz’s latest performance. In addition to the coffee bean extract claim, it reported, McCaskill cited two others Dr. Oz has made on his program that stretch credulity:

  • "I've got the No. 1 miracle in a bottle to burn your fat. It's raspberry ketone."

  • "Garcinia cambogia: It may be the simple solution you've been looking for to bust your body fat for good."…

PopTort noted that Oz features alternative medicines on his show, and that Consumer Reports just published a study that found that 2 in 3 Americans think the word "natural" on the label of a packaged or processed food means it contains no artificial ingredients, pesticides or genetically engineered organisms. In fact, it means exactly nothing, as federal labeling rules do not exist for that term.

And Oz’s support of so-called “natural” treatments reinforces the lie that it does mean something.

According to CBS, Oz agreed to testify at the hearing because he supports lawmakers’ efforts to make companies accountable, require transparency about their products' claims and ensure safety.

Some members of Congress want to give the FDA the power to regulate supplements, which it does not have now. The Dietary Supplement Health and Education Act allows safety and efficacy testing of supplements to be done by the manufacturer. By law, companies selectively may provide information to the FDA and consumers. If a product is suspected to be unsafe, the FDA must investigate before it can remove the product from the market.

The proposed Dietary Supplement Labeling Act would require all companies and manufacturers to register their products with the FDA and disclose information about known risks and adverse effects. It also would require them to include more information on product labels.

As McCaskill told Oz, "I know you know how much power you have. … You can be part of the police here or you can be part of the problem."

Clearly, comedian John Oliver believes he’s the latter. Oliver did a hilarious and informative takedown of Oz on his HBO TV show, “Last Week Tonight with John Oliver.” In addition to portraying Oz as the huckster he is, Oliver indicted the lack of “regulatory zeal” by a Congress that succumbs to the lobbying of the supplement industry.

Bookmark and Share

June 1, 2014

Burn Surgeon’s Testimony Tainted by Conflict of Interest

Clothing and furniture containing flame retardants have come under scrutiny because their chemicals may not retard flame but do pose health risks. Recently, proposed legislation in Washington state brought the issue additional attention when a burn expert testified before lawmakers that flame retardants do prevent fire casualties, despite the fact that he had been paid nearly a quarter million dollars as part of an industry campaign to promote their use.

The story, recounted in a 2012 series by the Chicago Tribune, continued last month when the newspaper reported that Dr. David Heimbach, facing disciplinary charges in Washington, had surrendered his medical license. State officials had charged that he not only lied about his objectivity, but had fabricated testimony.

It was a sad end to an ostensibly brilliant career. Heimbach, a burn surgeon, was head of the burn center at Harborview Medical Center in Seattle for 25 years and had received an award from the Dalai Lama for his care of burn victims around the world.

In 2011, he testified before state lawmakers that babies had burned to death in fires fueled by furniture lacking flame retardants. The legislators were considering requiring furniture manufacturers to use flame retardants.

But Heimbach’s burned babies did not exist — he had made up their stories while serving as a consultant to a chemical-industry front that had paid him handsomely for his prominent name and voice in defending flame retardants, “despite research that shows they don’t provide any meaningful protection from home fires,” according to The Tribune.

The Tribune investigative series, “Playing with Fire,” reported how Heimbach’s testimony was only part of a campaign of deception by the industry to promote the use of flame retardants, which can migrate from furniture into human bodies, with numerous harmful effects.

Heimbach had told the paper that his testimony about babies dying in fires was meant to be only anecdotal. Later, through an attorney, he said he changed the facts to protect patient privacy.

Washington’s Medical Quality Assurance Commission brought the charges against Heimbach, citing his association with Citizens for Fire Safety. The Tribune showed that organization to be founded, funded and controlled by major manufacturers of flame retardants. “When states considered laws that would ban or limit the use of flame retardants,” said The Tribune’s latest story, “Citizens for Fire Safety stirred the public’s fear of fire and downplayed the health risks linked to the chemicals, such as cancer, neurological deficits, developmental problems and impaired fertility.”

Citizens for Fire Safety described itself as a “coalition of fire professionals, educators, community activists, burn centers, doctors, fire departments and industry leaders, united to ensure that our country is protected by the highest standards of fire safety.” Heimbach’s image, of course, imparted additional credibility, for which, according to commission records, it paid him $240,000 in 2010 and 2011. He never mentioned that during the legislative hearings at which he testified. He claimed to be unaware of the coalition’s industry ties until reading about them in the Chicago Tribune.

After the Tribune published its initial stories, California, which had established the standard, widespread use of flame retardants in American furniture, changed its regulations to allow furniture manufacture without them. And the chemical industry front group that paid Heimbach? It folded.

Heimbach, whose surrender of his license excuses him from paying any penalties, has retired to Hawaii. A true example of a career going down in flames.

Bookmark and Share

May 25, 2014

Harmful Spine Treatment Infuse Got an Assist from the FDA

The lawsuit-generating spinal treatment Infuse was approved by the FDA in 2002, and, according to a disturbing investigative report by the Milwaukee Sentinel and MedPage Today, the feds gave it the nod even though concerns about its safety were raised and it had been tested on so few patients as to make conclusions about its usefulness meaningless.

The problems caused by the spinal implant, which is supposed to encourage bone growth and fuse the gaps between vertebrae after fusion surgery, resulted in Medtronic, its manufacturer, recently agreeing to pay $22 million to settle about 950 lawsuits, and reserving another $140 million to settle an anticipated 3,800 additional claims.

"It appears the clinical trials, unfortunately, were not designed to adequately test for safety of the product," said one Sentinel/MedPage source, a chief of spinal surgery at a major metropolitan hospital.

The FDA approved Infuse not as a life-saving drug or an intervention that reduces disability significantly; it was approved as an alternative to traditional spinal fusion surgery.

As the story notes, testing new biologic agents usually requires clinical trials involving 1,000 to 3,000 people. But because the FDA invited Infuse on the market as a combination device, not a biologic agent, its trial involved a paltry 277 subjects. Medtronic’s website refers to Infuse as “biologic device.”

Biologic drugs, as the Sentinel/MedPage story explains, also are known as bio-pharmaceuticals. “They replicate natural substances in the body such as hormones, antibodies, or, in the case of Infuse, growing bone. Traditional drugs are made by combining chemicals. But biologics are manufactured in a living microorganism, such as plant or animal cells, and can pose special safety risks such as infections, immune system disorders and cancers.” One study found that about 1 in 4 of 174 biologic drugs had been the subject of safety-related regulatory actions after they got on the market.

Because Infuse was approved in a "noninferiority" trial, Medtronic did not have to prove it was any better than the traditional treatment.

"It should not have gone through the device approval process," a health researcher in orthopedic surgery told the Sentinel/MedPage "It should have gone through the biological testing process."

The story’s revelations won’t surprise readers of this blog (see our post, “Medtronic Spinal Treatment Is Riskier and No Better than Bone Graft ”); it showed that more than 6,500 reports of Infuse-related problems have been registered with the FDA's medical device reporting system since Infuse was approved.

The complications include cancer, sterility and pain.

Adding another “ick” layer to the approval of a product that harms people, according to the Sentinel/MedPage, is the group of spine surgeons who received millions of dollars in royalties from Medtronic and who had co-authored papers failing to acknowledge the link between Infuse and several serious complications. In some cases, the medical journals publishing the papers didn't fully disclose Medtronic's financial relationship with the authors.

Can you say “conflict of interest”?

So questionable was this product even among orthopedists that The Spine Journal, according to the Sentinel/MedPage, dedicated a whole issue to its deficiencies. It referred to research that found that Infuse had complication rates 10 to 50 times greater than the complication rates estimated in the papers written by the doctors whose priority wasn’t helping patients get well, but helping their own bottom lines.

The FDA, for its part, issued the usual “what, me?” response to Sentinel/MedPage inquiries. An email from its spokeswoman said Infuse was approved based on clinical and nonclinical data that "demonstrated a reasonable assurance of safety and effectiveness," and that an advisory panel of outside experts reviewed the evidence and voted unanimously to recommend approval.

She said the FDA has reviewed the thousands of adverse events reports about Infuse, post-approval studies and medical literature, and continues to believe there is a reasonable assurance of safety.

Bookmark and Share

May 7, 2014

Why Free Drug Samples Lead to Higher Drug Costs

A new study published in JAMA Dermatology gives yet more evidence that theres no free lunch in the medical industry. This study found that when doctors receive free samples from pharmaceutical companies, they’re more likely to prescribe the expensive, brand-name medicine even if other drugs, including generics, are available and equally effective.

As analyzed by a story on NPR, the JAMA study showed that dermatologists who accepted free brand-name acne drugs were likelier to prescribe the expensive medications than doctors who are forbidden from accepting samples. And the difference in cost is not marginal.

The average cost of medicines prescribed by docs who accept and distribute freebies is $465 per office visit. It’s about $200 for patients who see doctors who can't hand out samples.

One practitioner, who wasn’t involved in the study, told NPR, “When a doctor gives a sample to a patient, it's a very strong endorsement of a drug. Patients think the physician has chosen this sample because it's the best drug for them. They don't realize that the doctor might have chosen it because a drug rep gave him samples and it was what he had around the office.”

Once somebody gives a patient a free trial drug, it’s difficult for some docs to prescribe a different generic drug, because it looks inconsistent. So some physicians, not just dermatologists, end up prescribing an expensive branded drug when a less expensive option is available. And most physicians, according to the study, don’t even realize the influence free samples have on costs.

The researchers analyzed the prescribing habits of 3,500 dermatologists in private practices across the country. They compared that data with prescribing patterns at Stanford University clinics, where doctors aren't allowed to take samples from drug companies.

The private practice doctors recommended brand-name medications for almost 8 in 10 patients. The Stanford clinic doctors recommended name-brand medications only 1.7 in 10 times.

The experience of the Stanford clinicians is very telling, too, about patients’ perceptions and expectations. When they stopped accepting free dugs and giving them away, patients complained. NPR said one recent study, “Why Didn't Your Doctor Prescribe A Generic? Look In The Mirror,” found that more than 1 in 3 doctors surveyed sometimes prescribed a brand-name drug because a patient requested it, even when a generic version was available.

Sometimes, it is good medicine and good economics for practitioner to provide samples, especially when patients don’t have insurance coverage or are on tight budgets. Some brand-name drugs are available in different doses or in a time-release formula, which can be more convenient or better absorbed for some people.

But it’s largely the patient’s responsibility to ensure their drug bill isn't being inflated unnecessarily. That’s not expensive only for the individual, it raises everybody’s health-care costs.

As we’ve always advised, when your doctor prescribes a medicine, ask:

  • Why is this the best treatment?

  • What will happen if I don’t take it?

  • Are there alternatives and/or a generic version?

  • When can I expect to see results?

  • What are the side effects, and how likely am I to experience them?

  • What are the risks?

  • Are there foods or other medicines I should avoid when taking this medicine?

Bookmark and Share

May 1, 2014

UCLA Settles Whistleblower Lawsuit Over Conflict of Interest

Later this year, the Physician Payments Sunshine Act takes full effect. It’s part of the Affordable Care Act (ACA, or “Obamacare”), and requires public disclosure of financial relationships between health-care companies and physicians. (See our blog, “Which Doctors Line Their Pockets with Big Pharma Money?.”)

Clearly, it’s overdue. One example why is last week’s settlement by UCLA, whose orthopedic surgery department agreed to pay $10 million to its former chairman. Dr. Robert Pedowitz had sued the University of California system, alleging that its premier medical school allowed doctors to accept payments from the medical device industry that might have compromised patient care.

As explained in the Los Angeles Times, the settlement was reached just before closing arguments were set to begin.

Pedowitz, a surgeon, had been recruited in 2009 to run UCLA’s orthopedic surgery department. He sued in 2012, saying university officials, regents and fellow surgeons failed to act on his complaints about widespread conflicts of interest and later retaliated against him.

During the trial, Pedowitz testified that he was concerned about colleagues who had financial ties to medical device manufacturers and other companies, because such relationships could influence patient care and/or medical research. The best care, and the best research, is objective; it can’t be colored by what the practitioner gets out of it.

Pedowitz also claimed that UCLA allowed potential conflicts of interest because of the potential financial benefit from the medical products or drugs developed by its staff.

Commenting on the lawsuit’s outcome to the L.A. Times, Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession, said some medical schools “can be dependent on the money these big-earning specialties like orthopedic surgery bring in. They are the cash cows and they can set their terms. This is not the first time I've heard of medical schools having policies that are not well enforced."

The case brought to light one UCLA orthopedic surgeon who had received $250,000 in consulting fees from Medtronic, which makes products including Infuse. It supposedly promotes spinal bone growth but, as we wrote last year, involves a risky procedure that isn’t proved to be superior to other spinal treatments.

At trial, Pedowitz testified that he was concerned that the surgeon was trying to enroll patients in a research study involving Medtronic while he was accepting its money. "I saw this as an obvious problem," Pedowitz testified.

The surgeon, Dr. Nick Shamie, testified that he had followed university policy, and hadn’t pursued the study because finding patients had been too difficult.

His wasn’t the only doctor-manufacturer relationship highlighted in the case. And even before Pedowitz joined the university, it had been criticized by Congress after another top spine surgeon failed to report nearly $460,000 in payments he had received from Medtronic and other medical companies while researching their products' use in patients, according to government records.

Several patients, according to The Times, are suing that doctor, Jeffrey Wang, and UCLA for negligence, fraud and malpractice in connection with surgeries involving Medtronic's Infuse bone graft. Wang is no longer with UCLA.

The Pedowitz settlement terms include his departure from the UCLA faculty; in 2010, he had stepped down as department chairman after expressing his concerns to UCLA officials. He filed a whistleblower retaliation complaint in 2011.

Mark Quigley, the attorney who represented Pedowitz, said the lawsuit wouldn’t have been filed had the UC system enforced its own policies. "What good are all the policies if they protect the wrongdoers and fail to protect the actual whistleblower?" he asked.

Bookmark and Share

April 23, 2014

Making the Most of Medicare’s Doctor Pay Report

Last week, we introduced readers to the new, searchable federal database (“How Much Did Your Doctor Make From Medicare?”) showing what doctors were paid in 2012 by Medicare. It’s an important new tool showing your tax dollars at work, and how practitioners in your area might be using (and possibly abusing) this important health-care program.

But like every other informational resource, the database is most useful only when you put its data into context; when you understand how different practices and specialties demand different use of medical resources. Naked numbers aren’t very useful.

An insightful commentary by Charles Ornstein in the Los Angeles Times shows why the Medicare pay information is helpful, and why it’s limited. Ornstein is a Pulitzer Prize-winning journalist at ProPublica, the investigative news service that introduced Dollars for Docs, a data base of payments by a dozen pharmaceutical companies to health-care professionals for promotional activities, consulting and research.

Ornstein reminds readers that this autumn, as part of the Affordable Care Act, the federal government will release data on personal, promotional and research payments to doctors from all pharmaceutical and medical device companies, not just the ones represented on Dollars for Docs. “Armed with this information,” he writes, “patients will be able to at least ask whether their doctors have prescribed a drug because it is the best one for their patients — or because of a financial relationship.”

But data can be misleading. “There's a big difference between, say, a hospice doctor giving almost every patient a narcotic and a podiatrist doing the same thing,” Ornstein points out. There’s a big difference between doctors who treat the urban poor, who tend to be sicker when they seek treatment, and those who treat affluent folks with sufficient health insurance.

To get the most out of the Medicare information, you must know what is available, what's missing and how to interpret it. Raw numbers, Ornstein reminds, don’t tell you “whether one doctor's patients are sicker than another's and need different therapies. They won't tell you about a doctor's bedside manner or willingness to return a phone call at 3 a.m. They won't tell you about a doctor's surgical skill.”

Another story in the Los Angeles Times mentioned that one doctor, according to the Medicare information, received millions in Medicare payments that seemed off the charts in comparison to his peers. But it turned out that all eight of the doctors in his practice billed Medicare under his name, so it looked as though a single practitioner received payments that, in fact, went to eight people.

So Medicare’s database is a place to start, but for context, don’t overlook other avenues of information, such as review sites including Healthgrades and Yelp, where consumers offer opinions of their doctors — but be aware that your priority for a practitioner might not be the same as some other patient's.

Research practitioners on state medical board websites to see if someone has faced disciplinary action. (See our blog, “How to Find Out If Your Doctor Has Been in Trouble.”)

If you’re really ambitious, you can research lawsuits to unearth malpractice and other medical-legal histories.

It’s all an effort to help you get the best care for your needs. As Ornstein summarizes, “Access to information is crucial if patients are to have any hope of answering that most basic of questions: How does my doctor practice medicine?”

“We're still a ways off from having enough information to do an overall comparison of the quality of care from one physician to another,” he writes. “But Medicare should be applauded for its new release of data, and it should continue to do more. It should also encourage private insurers and other public programs to follow suit.”

Bookmark and Share

April 20, 2014

Choosing Wisely Campaign Protects Its Own

We’ve been champions of the Choosing Wisely campaign, an initiative by several medical specialties to call out procedures they advise doctors and patients to view with skepticism. But now it looks like there's a big "Not in My Back Yard" problem with the program.

Last year, for example, our blog “Orthopedic Treatments You Should Reject” outlined five treatments the American Academy of Orthopaedic Surgeons said appeared to have little worth.

So it’s disappointing to realize, as a story by KaiserHealthNews and the Chicago Tribune recounted last week, that some of the largest medical associations participating in Choosing Wisely tabbed rare treatments or those performed by practitioners in other fields instead of those that are lucrative for them. "They were willing to throw someone else’s services into the arena, but not their own," said Dr. Nancy Morden, whose research into the societies’ advice was published in the New England Journal of Medicine.

The campaign was a welcome change in a medical profession that historically had been reluctant to spurn unnecessary treatments, often because they are money-makers for the practitioners. Of course, that also means they add costs for patients and insurers, aren’t proved to improve health and sometimes can cause harm.

Since 2012, 54 specialty societies in Choosing Wisely have recommended procedures to avoid, and the lists have been distributed to more than half a million doctors. Hospitals that use them report diminishing use of unnecessary procedures.

And Morden’s study did find that some specialties pointed the finger at their own indulgences — gastroenterologists, radiologists and clinical pathologists among them. For example, as our blog reported, the Society of General Internal Medicine advised against getting an annual physical exam.

Other medical specialties said they hadn’t included their own procedures if the concerns about them were about overuse, because in some cases, for some patients, they are appropriate, such as stents for heart patients and spine surgery, two procedures we have advised patients to scrutinize very closely before undergoing.

Those societies tended to focus on limiting testing that others do. Morden, a researcher at the Dartmouth Institute for Health Policy & Clinical Practice in New Hampshire, examined everything named on the first 26 Choosing Wisely lists. More than 8 in 10 targeted radiology, medications and cardiac and lab tests — not physician services.

The American College of Cardiology included the use of cardiac testing in four circumstances, but didn’t address what scientific evidence indicates is the most frequent type of overtreatment in the field — implanting stents, which are small tubes used to prop open arteries of patients who are not suffering heart attacks. More measured, and often more successful treatments for potential heart problems, are prescribing certain medicines and making changes in lifestyle.

KHN/Tribune refers to a study showing that as many as 1 in 8 stent procedures should not have been performed, and at hospitals where stenting was most overused, about 6 in 10 stents were deemed inappropriate.

But, as one cardiologist told KHN/Tribune, "Let's face it, angioplasty and stenting is a big business, it's highly profitable for hospitals, and it's highly remunerative for physicians. There's a tremendous impetus to not rock the boat and not to call attention to the fact that we do too many procedures in stable patients for whom outcomes would be the same if not even better if treated medically."

Orthopedics is another specialty whose Choosing Wisely recommendations protected its members’ interests but not necessarily those of patients and insurers. The American Academy of Orthopaedic Surgeons discouraged patients with joint pain from taking certain dietary supplements, from using custom shoe inserts or overusing wrist splints after carpal tunnel surgery and from a procedure some doctors use to bathe an aching knee in a saline wash.

Although the advice to spare yourself the cost of glucosamine supplements is good, the loss of that commerce doesn’t affect doctors. And the knee saline injections are seldom done anyway. When Morden reviewed 2011 Medicare billing records for the procedure, she found "zero claims."

"That's how pathetic that item is," she told KHN/Tribune.

One orthopedic surgeon nominated other, more significant procedures he told the reporters were overused but were not on the Choosing Wisely lists, including replacing hips and knees when the patient’s pain is minimal and can be managed with medicine, and surgically inserting metal plates into broken collarbones, rather than letting the injury heal with the help of a sling.

"The abuse of surgery is due to the overwhelming control of the profession by the implant manufacturing companies," he told KHN/Tribune.

Being a spine surgeon is a lucrative profession: According to one survey, the median compensation is more than $730,000 per year, so it might seem upstanding that the North American Spine Society included a procedure using bone growth material for neck fusion on its “avoid” list. But it’s not clear how many spine surgeons even perform it anymore. The FDA issued a safety alert against the procedure it in 2008 because it could cause the neck to swell, compress airways and make breathing and speaking difficult.

This group’s members didn’t mention spinal fusion, which more than doubled in frequency between 1998 and 2008, according to one study. Patients with back pain are more likely to be referred to another physician, probably for things like injections and surgery, instead of physical therapy, which usually should be the first line of treatment.

As the KHN/Tribune story notes, “where the lists have been actively embraced, the rate of those services has dropped. Last year, the Cedars-Sinai Health System in Los Angeles added 120 Choosing Wisely recommendations into its computerized patient records so that they would pop up on a screen whenever a clinician tried to authorize one.”

The use of benzodiazepines and other sedative-hypnotics to treat the elderly have decreased at Cedar-Sinai as a result of Choosing Wisely recommendations by the American Geriatrics Society. That’s good, because these drugs can cause elderly patients to fall.

At Anne Arundel Medical Center in Annapolis, "Choosing Wisely" lists are broadcast on hospital television screens, posters decorate the walls of doctors' offices and the lists are included in communications mailed to county residents. The lists also are embedded as links in electronic patient records so physicians can easily review them.

Those are all excellent measures as far as they go, but as the NEJM study suggests, they just don’t go far enough.

Bookmark and Share

April 9, 2014

How Much Did Your Doctor Make from Medicare?

Now you can find out, by checking this huge database of names and dollars just released from Medicare. The New York Times made the data searchable by doctor's name, specialty and location.

The database shows total payouts by Medicare to individual doctors by name for 2012. It includes all Medicare "Part B" payments, which include not only the doctor's office visit fee, but charges for medicines and procedures administered in doctors' offices. Medicare payments to institutions like hospitals are not included.

Already news media have found some eyebrow-lifting numbers. One ophthalmologist in West Palm Beach, Florida, Salomon Melgen, received more than $20 million for 2012. His lawyer issued a statement cautioning that the vast bulk of the money went to pay drug companies for expensive drugs used in treatment.

Another high-dollar specialty is cardiology. By my count, in the one town of Ocala, Florida, seven of the 34 cardiologists in the database received seven-figure payments in 2012. One, Asad Qamar, got $18 million.

I checked my own internist's building in downtown Washington, D.C., and noticed that ten radiologists in the building all pulled down more than $300,000 in Medicare payments that year. (You can see for yourself by selecting "diagnostic radiology" and zip code 20036 in the database.)

The New York Times found that 2 percent of the 880,000 doctors paid by Medicare in 2012 received nearly a quarter of all the payments.

It will take a while to sort out the meaning of this vast trove of data, reportedly the largest ever released by Medicare.

Commenters on news sites are already drawing their own pre-fabbed conclusions, some arguing, for example, that this proves that all of government is vastly corrupt and inefficient, with others saying the data show the need for a single-payer medical system with doctors paid by salary.

Stay tuned for more on a story that is only starting to unfold.

Bookmark and Share

February 25, 2014

Hospital Promotion: Poor Judgment Looks Like Conflict of Interest

For all its techno-wonder, robotic technology is fraught with problems, including organ damage, that make it unsuitable for many surgical procedures. It also has a record of poorly trained surgeons, not to mention the under-reporting of adverse outcomes.

Then there’s conflict of interest, or what sure looks like it.

A story covered by ProPublica.org, the investigative news site, examined the role of a dozen members of the surgical team at the University of Illinois Hospital and Health Sciences System who were featured prominently in an advertisement for the da Vinci robot. The copy read, “We believe in da Vinci surgery because our patients benefit.”

Paul Levy, former chief executive of the prestigious Beth Israel Deaconess Medical Center in Boston, was among readers who had a problem with the ad. “While I have become accustomed to the many da Vinci ads,” he told ProPublica, “I was struck by the idea that a major university health system had apparently made a business judgment that it was worthwhile to advertise outside of its territory, in a national ad in the New York Times.

At the bottom of the ad for the robotic device, made by Intuitive Surgical Inc., was this notice: “Some surgeons who appear in this ad have received compensation from the company for providing educational services to other surgeons and patients.”


When you are paid to promote a technology for which your patients also pay when they are subject to it, it looks as though cashing in is more important than ensuring that a procedure is the best possible treatment for the problem at hand. Is that what happened here?

Robotic surgery is a minimally invasive procedure in which the surgeon uses a computer to remotely control small instruments. The systems are expensive, and because they’re hot, new technology with marketing potential, surgical facilities that invest in them are highly motivated to use them, whether or not the robotic method is the best one for a given surgery.

As we’ve pointed out, in some cases such as hysterectomy and prostatectomy, they often aren’t.

For a long time medical professionals have been subsidized by pharmaceutical and medical device companies, and we’ve written about Dollars for Docs, a ProPublica database of who is getting paid by these commercial interests.

And although ads featuring physician testimonials for prescription drugs and medical devices are common, featuring a whole hospital department gave Levy pause.

“I was stunned that a public university would allow its name and reputation to be used in that way,” he said, and after reading the university’s website, concluded that the ad violated the university’s code of conduct and administrative procedures, and probably even state law.

Levy began a series in his blog, "Not Running a Hospital,” about the ad. One post read, “The University has allowed its reputation to be used in a nationally distributed advertisement produced and owned by a private party, in benefit to that party's commercial objectives. This is not consistent with ‘exercising custodial responsibility for University property and resources.’”

Later posts noted that some of the white-coated people featured in the ad weren’t doctors, or even medical professionals.

As it turned out, the ad was paid for by Intuitive, and neither the university nor the people depicted were paid for appearing. Still, it was questionable enough that the university asked Intuitive to suspend the ad, and announced it was using the incident as a teaching moment; it promised to assess its policies about these kinds of promotions.

Levy’s indictment didn’t exactly endear him to the university. A university official told ProPublica that the Boston Globe had called out Levy for lapses in judgment over a personal relationship with a female employee when he was with Beth Israel Deaconess. Levy was fined $50,000 by the hospital’s board of directors, copped to his errors and apologized.

ProPublica wanted to know how Levy’s past was relevant to the kerfuffle over the da Vinci ad. The university official said, essentially, consider the source.

As ProPublica makes clear, the cross-pollination of caregivers and device makers isn’t unusual. Hologic Inc. advertised in a trade journal last year using the staff of Methodist Hospitals in Indiana to promote its mammogram machine. Accuray, which makes the CyberKnife, a competitor of da Vinci, offers physician testimonials in its website videos, which don’t disclose if the doctors have been paid.

So although the Illinois University story is muddied with misinformation and drowning in bad blood, you have to get back to basics: When the medical establishment appears to engage in a conflict of interest, it isn’t thinking about patient safety; it’s thinking about its bottom line.

Bookmark and Share

February 21, 2014

Appeals Court Affirms Jury Verdict against Orthopedic Surgeons Society

An orthopedic surgeon who fought back and won a court case after the society of orthopedic surgeons slammed him for testifying that another surgeon had committed malpractice has now won an appeal of the legal case.

We reported last March on Dr. Steven Graboff's successful lawsuit against the American Academy of Orthopedic Surgeons (AAOS), when the trial judge rejected the AAOS's bid to overturn the jury verdict against it. We called our report: "When 'Peer Review' Has an Ulterior Motive."

The ulterior motive here is that the bone doctors set up their "peer review" program to go after doctors who testified in court that a surgeon had committed malpractice.

Now, eleven months later, the U.S. Court of Appeals says the trial judge was correct in refusing to throw out the jury verdict. The jury had found that the AAOS's report of its "peer review" of Dr. Graboff did not include "false statements" but did cast Dr. Graboff in a "false light," by failing to tell the full story of what had happened. The jury also found that the Academy acted knowing that its published report about Dr. Graboff was untrue or "in reckless disregard for the truth." The appeals court rejected the idea that there was anything inconsistent in the jury's finding that there were no false statements but that the AAOS report about Dr. Graboff did cast him in a false light. As the court noted, a report about someone can include literally true statements but by leaving out the rest of the story can create a false impression.

You can read the appeals court decision here.

Bookmark and Share

February 11, 2014

Apparent Conflict of Interest Sullies Panel of Patient Safety Experts

The National Quality Forum (NQF) reviews, endorses and recommends use of certain standards to improve the quality and delivery of health care. Its committee of patient safety experts, for example, is charged with defining guidelines for safe clinical practices that hospitals use to set protocols that minimize errors and promote good patient care. According to a recent investigation by ProPublica, the independent nonprofit news agency, one of the committee’s 12 members appears to have used his influence to benefit a company with which his own business had millions of dollars in contracts.

Although he was not a practicing physician, Dr. Charles Denham was a leading advocate for patient safety who, says ProPublica, invoked a study during discussions about preventing hospital infections endorsing ChloraPrep, an antiseptic skin cleanser made by CareFusion, the company in question. The panel’s 2010 guidelines ended up recommending the product.

Those guidelines remain in effect, although NQF officials say the endorsement did not corrupt them.

Denham did not disclose his relationship with CareFusion during the panel’s deliberations, despite rules requiring such disclosures. “The revelations,” says ProPublica, “call into question the inner workings of the Quality Forum, whose guidelines are regarded as the gold standard for best health care practices.”

In January, the U.S. Justice Department settled a $40 million whistleblower lawsuit with CareFusion. The suit called money paid to Denham's business a “kickback” for him to influence NQF standards and boost sales of ChloraPrep.

Denham said the allegations were false, but, as ProPublica says, “[T] he case has shaken the patient safety world, prompting speculation about a star figure’s motives and questions about the inner workings of the Quality Forum, …”

Last week, ProPublica reports, Sen. Charles Grassley demanded copies of contracts and conflict-of-interest policies from the NQF in response to the allegations of kickbacks paid to influence its patient safety guidelines. Grassley is the senior member of the Senate Committee on Finance, which has oversight responsibility for Medicaid, Medicare and other government health programs.

The NQF severed its relationship with Denham in 2010, and said it took steps to protect its guidelines from commercial influence. But committee members told ProPublica they believe the process was compromised.

They said they were surprised to see the ChloraPrep-specific formula in the 2010 guidelines. The transcript of the committee’s discussion in 2009 shows Denham suggesting its endorsement, but no final agreement among members to recommend it.

Last month, the NQF told the news organization that it would review all the recommendations listed in its 2010 “Safe Practices for Better Healthcare” report.

The NQF was created in 1999 by presidential commission. The nonprofit accepts private donations and collects fees from members, including consumer groups, health plans and medical providers.

Five years ago, ProPublica reports, the federal government hired the NQF to endorse measures to show whether health-care spending achieves value for patients and taxpayers. By 2012, that initiative represented nearly three-quarters of the organization’s $26 million in revenue.

A product given an NQF endorsement can mean riches.

Dr. Peter Pronovost, head of patient safety at Johns Hopkins Medicine, is a member of the clinical practices committee. He told ProPublica that no one on it was aware of Denham’s financial ties to CareFusion. Denham did not mention them during the 2009 meeting when members were asked to disclose their financial relationships.

“He clearly lied,” Dr. Christine Cassel, the Quality Forum’s president and CEO, told ProPublica. “He just didn’t say anything about any of his business relationships.”

Denham heads the Texas Medical Institute of Technology, a nonprofit that conducts patient safety research, and Health Care Concepts, a for-profit company involved in the whistleblower case. He’s renowned for his motivational speeches.

In 2007 and 2008, the NQF it received $485,000 in donations from a foundation affiliated with Cardinal Health, a company that spun off CareFusion in 2009. Between 2006 and 2009, Denham’s Institute donated $725,000 to the NQF.

The Justice Department lawsuit accused CareFusion of marketing ChloraPrep for off-label uses, and alleged that the money paid to Denham's company was part of an effort to boost sales and included financing a study published in the New England Journal of Medicine.

Published in 2010, the study’s authors all reported ties to Cardinal Health, and found that ChloraPrep reduced the risk of surgical site infection by 41% compared to a common alternative.

Pronovost told ProPublica that the Denham mess shouldn’t poison all of the NQF’s work. He said the lack of scientific rigor of the safe practices committee reflected Denham’s influence, but that the process behind the NQF’s other measures is stronger.

But, he said, it does raise significant concern about oversight of the burgeoning quality improvement industry.

“It’s an enormous business,” Pronovost said. “Hundreds of millions or billions of dollars are at stake, but our transparency procedures haven’t matured.”

Dr. Bob Wachter, a hospitalist at UC San Francisco and patient safety maven, has an interesting blog piece lamenting his own failure to realize that something didn't quite add up with Denham. The main clue was pretty basic: There was a lot more money washing around the guy and his institute than fit with the nonprofit safety image.

Bookmark and Share

December 24, 2013

Big Name in Big Pharma Ceases Its Unsavory Drug Payments

We’ve been among the many voices decrying the practice of pharmaceutical companies paying doctors to promote their drugs. Now, in a welcome announcement, GlaxoSmithKline says that it’s not going to grease those palms anymore.

As reported by the New York Times, in addition to not paying doctors to hawk their wares, the Big Pharma big player is not going to tie the compensation of its sales representatives to the number of prescriptions doctors write for its drugs. That can promote the inappropriate — and illegal — use of drugs for nonapproved purposes.

Both practices have been widely criticized as conflicts of interest with the real potential of causing patient harm.

Glaxo is among the largest drug companies in the world, according to The Times, with third-quarter sales of more than $10 billion.

The decision to clean up its act is refreshing in the pharmaceutical industry and comes, as The Times points out, at a “sensitive” time for the British company. It’s under investigation for bribery in China, where accusations have been made that Glaxo paid doctors and government officials to boost drug sales.

We’ve written about the billions of dollars in fines Glaxo has paid for paying kickbacks, illegally marketing drugs and withholding safety information. Now, one hopes, the company has developed a corporate conscience.

Glaxo said sales representatives would be paid based on their technical knowledge, the quality of service they provide to clients to improve patient care and the company’s business performance -- changes it made in the U.S. in 2011 and must continue according to a corporate integrity agreement with the Justice Department. Now it says it will extend those practices globally.

The company’s chief executive, Andrew Witty, told The Times that the proposed changes were not related to the China situation, but were part of a years-long effort “to try and make sure we stay in step with how the world is changing. We keep asking ourselves, are there different ways, more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?”

Um … it took 40 years to know that? To know that paying doctors to speak on your company’s behalf at conferences and professional meetings might be exploiting the trust practitioners have for their peers? That such behavior might have unfair influence in doctors’ prescribing habits? That a drug might be prescribed inappropriately because someone got paid to pimp it?

And are we cynical to wonder if Glaxo’s change of heart has anything to do with the provision of the Affordable Care Act (ACA, or “Obamacare”) that all payments by pharmaceutical companies must be made public? (See our blog, “Dollars for Docs: Learn How the Big Bucks Flow From Manufacturers.”)

Many companies, including Glaxo, report many such payments now, but the new ACA requirements might seek more info than what’s already being provided, and will be searchable on a government website.

Whatever. Glaxo has decided that by 2016, no longer will it pay health-care professionals to speak on its behalf about its products or the diseases they treat “to audiences who can prescribe or influence prescribing,” according to a statement. It will stop subsidizing doctors to attend medical conferences, which is prohibited in the U.S. by an industry-imposed ethics code but that still happens in other countries.

But Glaxo will continue to pay consulting fees to doctors for market research because it needs to know what practitioners think about its products. The company said that effort would be limited.

The Glaxo news was welcome in the medical community. One Times source, Dr. Raed Dweik, chairman of the innovation management and conflict of interest committee at the Cleveland Clinic, told the paper, “As a physician, I periodically meet with these sales reps and they usually come in armed with information about me that I don’t even know,” he said, like the number of prescriptions he writes for the drug company’s product. “I feel that’s not really a comfortable interaction to have.”

Bookmark and Share

November 10, 2013

Hospital Suspends Black Lung Program Under Black Cloud

A multipart story investigating how Johns Hopkins Medicine assessed coal miners’ claims of suffering from black lung disease has prompted suspension of its program. “Breathless and Burdened,” a yearlong effort by the Center for Public Integrity (Center), examined how doctors and lawyers, allegedly at the behest of the coal industry, helped to deny benefits claims of miners sick and dying of black lung, even as disease rates are on the rise and an increasing number of those workers turn to a system that is supposed to help alleviate their suffering.

As announced earlier this month by the Center and ABC News Johns Hopkins has suspended its black lung program while it reviews how medical opinions from its doctors helped coal companies deny disability benefits to sick miners.

“Following the news report we are initiating a review of the pneumoconiosis B-reader service [black lung X-ray reading],” read a statement by the medical facility. “Until the review is completed, we are suspending the program.”

“We take very seriously the questions raised in a recent ABC News report about our second opinions for pneumoconiosis including black lung disease, and we are carefully reviewing the news story and our pneumoconiosis service.”

Johns Hopkins said its diagnoses and reports have never been questioned by authorities, and that there are no financial incentives for the department or its personnel associated with the black lung program.

Caused by inhaling coal dust, pneumoconiosis, or black lung disease, compromises lung function and makes breathing increasingly difficult. There is no treatment or cure.

The decision to suspend the program, according to the Center/ABC story, was made as congressional representatives from coal states said they have begun working on new legislation to address “troubling concerns” raised in the report.

The focus is on Dr. Paul Wheeler, head of the Johns Hopkins unit that read X-rays of coal miners seeking black lung benefits. Since 2000, more than 1,500 cases have been decided in which his unit rendered an opinion. In how many of those cases did Wheeler find severe black lung?

Not one.

Wheeler testified in court that the last time he recalled finding a case of severe black lung, a diagnosis that qualifies a miner to receive federal benefits, was in “the 1970s or the early 80s.”

As reported last year by NPR and the Center for Public Integrity, “Incidence of the disease that steals the breath of coal miners doubled in the last decade, according to data analyzed by … the National Institute for Occupational Safety and Health (NIOSH).”

In some areas, cases of black lung disease have quadrupled since the 1980s.

That something is rotten in the state of Johns Hopkins’ department of radiology prompted outrage from miner advocates, including the United Mine Workers, the union that represents coal miners.

“You don’t have to be a doctor at Johns Hopkins to know black lung disease when you see it,” said Richard Trumka, president of the AFL-CIO, and a former president of the union’s affiliate, the United Mine Workers. Trumka noted that his father died from the disease.

“Whatever penalties or punitive actions that can be taken with respect to Dr. Wheeler should be,” Phil Smith, spokesman for the union, told the Center/ABC. “But whatever they are, they will pale in comparison to the pain and suffering he has caused thousands of afflicted miners. There is no penalty which will make up for that.”

For his part, Wheeler told the journalists that he stood by his opinions.

If you read the series of stories, you’ll wonder why.

Bookmark and Share

November 3, 2013

Urologists Who Own Radiation Equipment Use it More … and Probably Unnecessarily

A couple of weeks ago, we wrote about urologists who, according to clinical guidelines, use too much radiation to treat prostate cancer pain. Here’s some related have-you-no-shame prostate cancer news brought to you by your local urologist.

According to a study in the New England Journal of Medicine, (NEJM) an awful lot of urologists are making decisions about treatment for their prostate cancer patients based on whether or not they own intensity-modulated radiation therapy (IMRT) facilities. One-third of men whose doctors own such equipment get that therapy for about $35,000 per treatment course. But before they were financially invested in radiation equipment, the same doctors prescribed that therapy for only 13 of 100 of their patients.

As discussed in Bloomberg Businessweek.com, prostate cancer is the most common tumor diagnosed in the U.S.; nearly 240,000 men will get a diagnosis of prostate cancer this year. As we’ve blogged often (here and here), a diagnosis of prostate cancer presents a complicated scenario; the range of appropriate treatment moves from watchful waiting (no intervention unless and until the pathology changes in certain ways) to hormone therapy to surgery, chemotherapy and radiation. As Businessweek summarizes, “While only about 12%, or 29,270 men, will die from it this year, all will have to decide how, and whether, they want to treat the cancer.”

They shouldn’t have to do so through the filter of a physician who can line his or her pockets if one therapy is chosen over another.

The men treated with radiation in the NEJM study were newly diagnosed. They were at low risk of dire consequences because their cancer hadn’t spread. The 10-year survival rate for all prostate cancer is 98%, and for many people with the study subjects’ diagnosis, watchful waiting is appropriate—not radiation.

Jean Mitchell, the author of the report and a professor of public policy at Georgetown University in Washington, D.C., compared the use of the radiation therapy among urologists before and after they acquired the $2 million machines for their practices. She studied use of the technology among doctors who didn’t own it, and urologists at 11 National Comprehensive Cancer Network centers, the country’s gold standard of care.

Analyzing claims data from Medicare, Mitchell found that urologists who didn’t own the equipment prescribed use of it for more than 15 in 100 of their patients in 2010, compared with about 14 in 100 five years earlier. Among the NCCN, the ratio was the same for both years—about 8 in 100. But among docs who began to refer patients to treatment facilities in which they had a new ownership interest, it was 44 in 100.

In an interview with Businessweek, Mitchell said, “The patients are going to do what their physician tells them to do. The patient becomes almost like an ATM machine, with the doctor extracting as much revenue as they can.”

A urologists’ association spokesman said the doctors who own radiation oncology equipment use the technology appropriately. Would you expect anything different?

As Businessweek notes, physicians aren’t allowed to refer their patients for treatment in facilities they own because of the financial conflict of interest. But for patients’ convenience, radiation, as well as some other in-office “ancillary” services such as blood work and X-rays, are exempted from that law. Why radiation, which is a treatment and not an ancillary service, was exempted is not clear, Mitchell told the news outfit.

We’ve outlined the harms of overtreatment and those of radiation. The practitioner/owner scenario has great potential to harm patients from both.

Mitchell’s study found that doctors who owned the IMRT were treating men 80 and older just as aggressively as younger men with early stage prostate cancer. While prostate cancer usually grows slowly, the side effects of radiation (erection and urinary problems, for example) can be immediate. So using this treatment on older patients opens the door for them to experience harm and no benefit.

Medicine is not immune to greed: Mitchell’s study, Businessweek notes, supports similar findings with other forms of self-referral. Some urologists have pathology labs within their practices, giving themselves more business by biopsy. We’ve noted other medical specialties with physician-owners who line their pockets primarily because they can.

If you or a loved one is diagnosed with early-stage prostate cancer, and the urologist advises radiation treatment, ask why it is appropriate; what results are expected, and how soon; what the risks are; and … who owns the facility where the treatment is recommended to occur.

Bookmark and Share

October 13, 2013

How Big Pharma Peddles Influence in FDA Panel Meetings

When the federal government wants to set medical policy and testing standards, it assembles a panel of experts to analyze the state of that particular medical art and make recommendations to the FDA. You would hope—and expect—that the process would be strictly analytical and scientific, uncontaminated by outside commercial interests.

In at least one recent case, you would be wrong.

As reported by the Washington Post, a panel that shaped the government’s policy for testing the safety and effectiveness of painkillers was subsidized by pharmaceutical companies that paid hundreds of thousands of dollars for, essentially, access. They wanted to influence the thinking of the FDA, according to emails secured through a public records request.

The emails show that the companies paid as much as $25,000 to attend a meeting of academics intended to provide advice to the FDA on how to analyze evidence from clinical trials.

The communications suggest that the regulators had become too cozy with the companies who profit in the $9 billion U.S. painkiller market. FDA officials who regulate these meds also served on the steering committee of the panel, which met in private, and co-wrote papers with employees of pharmaceutical companies.

We’ve written in several posts about the questionable control of painkillers (here and here), and The Post’s story is yet more evidence that the FDA has been less than conscientious in addressing the epidemic of addiction to prescription drugs such as Oxycontin and other opioids.

“Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written.” Craig Mayton, the attorney who made the public records request, told The Post.

It’s not as if the FDA was unaware of this conflict of interest. “Even as the meetings were taking place,” according to The Post, “the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an e-mail to organizers, an official from the National Institutes of Health worried whether the arrangements made it look as if the private meetings were a ‘pay to play' process.”

And although FDA officials did not benefit financially from participating in the meetings, two later worked as pharmaceutical consultants. The whole scenario portrays an agency that blurred the line between the regulators and the regulated.

FDA officials offered, in our estimation, a lame explanation, saying that strict rules of transparency and funding apply to the public-private partnerships that the agency engages in. But the group in this case was not initiated by the FDA, so it was a private partnership to which those rules did not apply.

The group was organized by two medical professors, one from the University of Rochester and one from the University of Washington, and the emails describe their efforts at financing and organizing the group’s meetings.

The professors got as much as $50,000 each for a meeting. The funds supported their academic research and expenses “or to cover a small percentage of faculty effort,” they said. In one email, they proposed receiving $5,000 each for a four-hour meeting near the FDA offices.

The meetings concerned the best methods for measuring the effectiveness of painkillers. One professor told The Post that their intent “was to help everybody develop better drug trials.” Both professors were responsive to The Post, but the Pharmaceutical Research and Manufacturers of America declined to comment.

The goal of the group was to publish “consensus” statements on scientific matters related to testing the drugs, and one of the professors said the scientific guidelines the group produced were of high quality.

The meetings included 30 or 40 people, including academics, FDA and National Institutes of Health (NIH) officials, and often as many as 14 representatives from pharmaceutical companies. Only the companies paid fees to attend.

Science might have been the subject of the meetings, but the subject of the emails was money.

When some drug companies balked at the $20,000 fee to attend the meeting, the organizers were firm. “20k is small change, and they can justify it easily if they want to be at the table,” one professor wrote to the other after an Eli Lilly representative objected to the price. “Everybody has been very happy with [the meetings] and they are getting a huge amount for very little money (impact on FDA thinking, exposure to FDA thinking, exposure to academic opinion leaders and their expertise, journal article authorship, etc.) and they know it,” according to The Post.

In his interview with the paper, the professor said that the costs of running such a meeting could run as high as $150,000, and they never knew how many sponsors they could attract. To make its gatherings more transparent, the group posted to its website copies of meeting presentations.

Still, some of the government officials seemed to find the whole thing fishy. One NIH staffer indicated that the fees paid by drug companies for private meetings could be criticized for influencing outcomes, and suggested holding the meetings at the NIH, and opening them to all interested parties to avoid the appearance of a “pay to play” process.

A lot of people thought this didn’t pass the smell test. None of them did anything about it.

Bookmark and Share

August 12, 2013

Conflicted Care: Physicians With a Financial Stake in the Medical Devices They Use

In reflecting on five years of “reading medical journals and writing to inform patients of the hazards of medical care,” patient safety advocate John James says he has “learned some difficult realities.”

Our blog posts frequently mirror his observations.

“Perhaps foremost is that when people want to believe that their health-care system is safe and just, their opinions are not going to be easily swayed by data and facts, regardless of how reliable the source may be. Secondly, people want to believe that physicians always have their interest at heart; this naïve supposition is not easily replaced by caution when seeking medical care. Thirdly, most people are less interested in preventing their own poor health than getting treatment when a preventable disease has gotten the best of them. Finally, most people cannot view the health-care industry in terms of how it affects less fortunate Americans – for them it is about me and my health care.”

In a poignant example of his second point, consider a recent fraud alert issued by the Department of Health and Human Services’ Office of the Inspector General. It addresses physician-owned businesses that market implantable medical devices “ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).”

We wrote about the alert when it was issued in the spring, and now, the Wall Street Journal probes the smelly entities knows as physician-owned distributorships (PODs).

“Surgeon in Probe Is Working in Detroit-Area Hospitals,” concerns the story of Dr. Aria Sabit. He had a decided preference for an obscure brand of spinal implants, but many of his surgeries had tragic outcomes. Dozens of medical malpractice lawsuits were filed. The California medical board, the FDA and the Department of Justice, the Journal reports, are investigating Sabit because he had “an ownership interest in the company that distributed, and profited from, the surgical devices he switched to, people familiar with the matter say.”

Federal prosecutors say Sabit is part of a broader civil investigation into a network of doctor-owned spinal-implant distributorships operated by two former medical-device company employees that earned millions of dollars for its investors over six years.

“Physician-owned distributorships … have proliferated in medicine,” the Journal writes. “Distributorships, whether owned by physicians or not, act as intermediaries between medical-device makers and hospitals: In exchange for marketing and stocking devices, the distributors get a cut of each sale. When surgeons own the distributorship, that commission goes into their pockets. And [because] surgeons often dictate to their hospitals which devices to buy, they can effectively steer business to themselves.”

Apparently, Sabit’s dicey doings didn’t dissuade other hospitals from seeking his “talents.” Sabit, the Journal reports, is a senior staff member at a Michigan hospital, and has privileges at several others in the region.

He continued to use spinal implants from Apex Medical Technologies, the distributorship in which he had an ownership, on patients in Michigan until last June.

In depositions for the malpractice cases filed against him in California, Sabit has been … inconsistent, sometimes saying he didn’t receive monetary benefit from Apex implants, sometimes saying he didn't know if he did.

“A Detroit Medical Center spokeswoman,” according to the Journal, “says it wasn't aware that Dr. Sabit owned part of a spinal-implant distributorship. ‘We are currently looking into this,’ she said.”

The spokeswoman told the paper that the medical center wasn't aware of any problems during Sabit's time in California when it recruited him to join its surgical staff in 2011, and only later learned about the malpractice suits when they were filed. He, of, course, has denied the allegations.

Another Wall Street Journal story, “Does My Surgeon Profit From My Implants?” delineates how the owner-and-provider role common among spine, hip and knee surgeons is spreading to cardiac surgeons, and how difficult it is for patients to know if their surgeon is involved in a POD, unless the doctor discloses the information.

Incorporation documents for PODs in the Reliance Medical Systems network, the Journal reports, name Adam Pike and Bret Berry or one of their business associates as officers. They say nothing about any surgeons or their ownership structure. “The only clue about the companies' business,” the story says, “is in their names, which all include the terms "Spine," "Spinal," "Medical," or "Surgical."

Pike is listed as a "registered agent," and Pike Industries Inc. and Berry Medical Enterprises Inc. are "managing members/managers." The company’s address is a post office box in Jacksonville, Fla.

This sounds more like a covert mail drop than a legitimate business.

The Journal says that Pike and Berry shared ownership of each POD with a different group of surgeons. Each investor got an equal stake and received an equal profit distribution based on the POD's overall sales.

The Reliance network grew to include at least 11 PODs in six states by last year, when Pike and Berry bought out all the surgeon investors when PODs starting drawing scrutiny from the Justice Department.

As we suggested earlier this year, if your doctor recommends a procedure, or if you are having surgery to implant a medical device, find out:

  • What is the purpose of this procedure/device, what results can I expect, and how soon?

  • Are there alternatives?

  • Why am I having the procedure at this particular facility?

  • What is your financial interest in the equipment used or the facility where it’s performed?

To report suspected fraud involving physician-owned entities, contact the Office of the Inspector General’s hotline at (800) 447-8477, or online here.

Bookmark and Share

July 25, 2013

Suggested Reading—Medical Price Fixing

The Washington Monthly recently published a fascinating story—fascinating in the way of horror movies. Called “The shadowy cartel of doctors that controls Medicare,” it's about how medical provider fees are determined.

Author Haley Sweetland Edwards traces the secretive process to reach the inevitable conclusion that, essentially, the value of an MRI, a heart stent, surgical anesthesia, is a matter of price-fixing that in any other context would be illegal.

There are 31 medical members of the Specialty Society Relative Value Scale Update Committee (RUC) convened by the American Medical Association. One was an anonymous source for Edwards. That doctor described the process: "No one ever says the word 'price.’ But yeah, everyone knows we're talking about money."

Their work is so secret most medical professionals have no idea what the RUC does.

RUC members send their list of “recommended values” to the Centers for Medicare and Medicaid Services, which almost never denies them. Edwards writes:

The RUC … enjoys basically de facto control over how roughly $85 billion in U.S. taxpayer money is divvied up every year. And that's just the start of it. Because of the way the system is set up, the values the RUC comes up with wind up shaping the very structure of the U.S. health care sector, creating the perverse financial incentives that dictate how our doctors behave, and affecting the annual expenditure of nearly one-fifth of our GDP.

This screwy system means that although the prices Medicare and private insurers pay for certain procedures have increased, fees for other services have declined or stagnated. The RUC, which is dominated by specialists, spends most of its time reviewing specialty procedures, which change quickly as technology advances, rather than common treatments such as office visits, which is how primary care doctors and other generalists make a living.

This system incentivizes lucrative overtesting while basic care gets the shaft. No wonder medical specialists are proliferating as we suffer from a serious shortage of primary care practitioners.

If you have the nerve, read her full report by linking here.

Bookmark and Share

June 25, 2013

Rooting Out Conflicts of Interest from Clinical Treatment Guidelines

Although people skills are critical to good doctoring, at heart physicians are (or are supposed to be) scientists. They are obliged to remain current with the science in their field. Because the body of knowledge never stops growing, that’s a big job. And conflicts of interest make it tougher, when the writers of practice guidelines are in the pocket of Big Pharma.

Writing in the New York Times earlier this month, Dr. Jerry Avorn, professor of medicine at Harvard and author of “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs,” has captured the difficulty of digesting the big, endless meal that turns continuing education into clinical practice.

Docs get help, he says, from medical groups that issue clinical-practice guidelines derived from experts sorting through reams of clinical research and drug studies, and publishing summaries about what treatments work best.

But their advice can be imperfect. Avorn cites recent recommendations from the American Association of Clinical Endocrinologists for diabetes treatment. It placed many drugs higher in the prescribing hierarchy than some familiar, popular and generic drugs like metformin. The organization also emphasized that established treatments like insulin and glipizide are risky.

But several of new, promoted drugs are expensive and lack the proven records of clinical effectiveness and safety that the older drugs have. It’s one thing to have new treatment choices, and another to have them because their manufacturers might have had a role in the development of the guidelines because some their authors were paid consultants of the manufacturers.

We’ve covered this conflict of interest before.

Avorn recalls practice guidelines for treating anemia in patients with kidney disease that recommended high doses of the drug erythropoietin. But such doses substantially increased the risk of heart attack, stroke and death, “with little countervailing benefit,” he writes. “Here, too, the professional society that issued the guidelines, as well as many of the doctors who formulated them, received funding from companies marketing the drug.”

Pharmaceutical companies love to flog their new, expensive drugs, never mind, says Avorn, that “there is much less muscle behind efforts to encourage the use of established, off-patent drugs, even when the weight of evidence and experience recommends them.”

And when the medical literature reports solidly conducted trials resulting in thoughtful, balanced clinical guidelines, doctors need help harvesting the crop, then sorting the wheat from the chaff.

Enter several groups — including the Institute of Medicine, the American College of Physicians and the Cochrane Collaboration, a network of experts who evaluate clinical research — that sift through medical information to synthesize and present the honest science.

Docs also get help from the Independent Drug Information Service, a nonprofit service funded by the state of Pennsylvania and the District of Columbia. It assesses medical literature absent of any product-driven bias. Then it dispatches pharmacists and nurses to doctors’ offices to guide them through the treatment recommendations the analysis yields.

It’s a front-line defense against the pharmaceutical industry, which deploys armies of sales representatives to promote their products directly to doctors. Such practices, as we’ve noted, can be rife with exploitation.

“A few large health systems,” Avorn writes, “ including Kaiser Permanente and the nation of Australia, have adopted this curator-docent approach, which has been shown to improve doctors’ clinical decision making. The programs can also control costs over time, as they counter the influence of drug companies promoting the most expensive new drugs, whether or not they’re an improvement. But to make a significant difference, many more health-care systems, both private and public, must adopt them.”

Bookmark and Share

May 20, 2013

Treatment Risks Climb When Drug Companies Plant Stories in Research Journals

Medical providers, insurance companies and well-informed medical consumers know that drugs, devices and treatments aren’t considered best-practice—or even credible—unless and until research has been conducted, the results reviewed by scientific peers and the results published in a reputable journal.

So how was it, health reporter Martha Rosenberg asks on KevinMd.com, that blockbuster drugs such as Vioxx (an arthritis drug withdrawn from the market in 2004 because of heart risks) and Baycol (a cholesterol drug withdrawn in 2001 because of muscle degeneration) were deemed safe, and that their benefits outweighed their risks?

These, and many others, Rosenberg writes, passed peer muster after journal reports were published that were written by drug companies or their hired writing hands. Gee, if you’ve spent millions developing a drug and you’re given license to appraise its effectiveness and safety, wouldn’t you make sure the story had a happy ending?

We regularly write about drug company conflicts of interest, and Rosenberg’s post adds to this stinky body of “knowledge.”

“Scratch the surface of many blockbuster drugs that went on to be discredited, or even withdrawn as risks emerged,” she writes, “and an elaborate ‘publication plan’ emerges, developed by the drug company’s marketing firm. For example, at least 50 articles promoting hormone replacement drugs like Prempro were planted in medical journals by Pfizer’s (then Wyeth) marketing firm DesignWrite…” You can read that document, courtesy of the University of California, San Francisco’s Drug Industry Document Archive.

One of DesignWrite’s articles published in the Journal of Women’s Health was called “Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” The answer was “no.” Another DesignWrite offering appeared in the Archives of Internal Medicine, “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease.”A third, also from DesignWrite, in the Archives of Internal Medicine, championed “The Role of Hormone Therapy in the Prevention of Alzheimer’s disease.”

Rosenberg calls the marketing firm’s so-called science “egregiously flawed.” Hormone therapy has a demonstrable association with breast cancer, heart disease and Alzheimer’s. Still, the papers have not been retracted from the journals, two of which are published by the American Medical Association.

Parke-Davis/Pfizer also engaged in planned research plants with regard to its anti-seizure drug Neurontin. It wanted to expand the drug’s use to people suffering from migraines, bipolar disorder and other problems for which it had not been given FDA approval. Such “off-label” uses are the prerogative of practitioners, but manufacturers are not allowed to promote them for any use not approved by the FDA.

We wrote about the unethical use of fake Neurontin trials a couple of years ago in our blog, “The Difference Between Pharmaceutical Research and Marketing Blurs Yet Again.” Rosenberg notes that within a three-year period, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin, and made 43,000 reprints from one for dissemination by its sales representatives.

“Researching, writing and submitting papers to medical journals — and reworking and finessing them if accepted — is a demanding, time consuming job which drug companies have made into pay dirt. … ‘publication plans’ for their products —elaborate grids with the names of journals where papers have run, are slated to run, have been submitted and have been resubmitted, the marketing firms apparently not taking ‘no’ for answer. Do the journals know they are part of such machinations?” Rosenberg asks.

Not only is iffy science given cred by these journals, the stench of conflict grows stronger when you realize that journals make money off such dreck when they license reprint rights for drug company promotion.

Several years ago, when it came to light that some researchers were subsidized by companies whose products they were testing, journals loudly announced they were raising their standards, scrutinizing submissions and adding disclaimers to address even the appearance of conflicts of interest. But, says Rosenberg, “Often the disclosures are relegated to a barely readable paragraph linking authors identified by initials, not names, to 60 or more drug companies. Worse, the disclosures don’t appear in abstract databases like PubMed but are hidden behind a financial firewall available only to paid subscribers who have access to the full articles.”

So if John Q. Public wants to read a full study, he must shell out a meaningful amount. And that’s for only one journal.

Rosenberg is not optimistic that this status quo can be changed any time soon. The problem, of course, is that it’s just too lucrative for both journals and drug companies to stop scratching each others’ backs at the cost of patient safety.

She highlights a well-established class of drugs called TNF blockers that includes Humira, Remicide, Enbrel and Cimzia. They treat various forms of arthritis formerly considered fairly rare, but promoted to “under-diagnosed” by their manufacturers in the hope of enlarging their market to people with a tenuous, at best, connection to them.

She warns consumers about taking their planted “quizzes” to encourage self-diagnosis, and practitioners about ghostwritten journal stories that minimize the drugs’ dangerous side effects, including suppression of the immune system.

As Rosenberg writes, “Recently, research by drug industry-funded authors has appeared in medical journals to dispel data linking TNF blockers to increasing incidences of hospitalizations, malignancies, cardiovascular events and Herpes zoster. Looks like another publication plan.”

And another strike against patient safety.

Bookmark and Share

May 5, 2013

Pharmaceutical Company Sued—Again—for Paying Kickbacks

Manufacturing an excellent product and marketing it well should ensure commercial success. A new lawsuit suggests that it wasn't for Big Pharma player Novartis AG—the company was charged last month with fraud, allegedly for paying kickbacks to pharmacies that switched transplant patients from a less expensive generic drug to to its brand name med, Myfortic.

Paying kickbacks, it seems, seems to be part of the Novartis business plan: In the same week, the U.S. intervened in a private suit from 2011 that claims the company allegedly crossing the palms of physicians with the intent of increasing sales two drugs that treat hypertension, Lotrel and Valturna, and its diabetes drug Starlix.

According to the stories on Bloomberg.com, Novartis, was sued in federal court last month for violating the False Claims Act. That’s the same law Lance Armstrong is accused of violating for defrauding the U.S. by using banned substances when he was sponsored by the U.S. Postal Service.

For seven years, the U.S. says, the Myfortic payments were disguised as rebates and discounts to at least 20 pharmacies that switched patients to Myfortic from drugs sold by other companies. The cost to Medicare and Medicaid was tens of millions of dollars in false claims, the complaint says.

The damage isn’t just financial—patient safety is at issue. “Hundreds, possibly thousands, of transplant patients have undergone switches in their medication as a result of recommendations from pharmacies that were based on undisclosed financial, rather than independent clinical, considerations,” according to the complaint.

Myfortic is an immunosuppressant that helps prevent organ rejection for kidney transplant patients. The drug competes with another manufacturer’s drug, CellCept, which has been available as a generic since 2009. In 2011, Bloomberg reports, Medicare reimbursed Myfortic at more than twice what it did for generic CellCept.
In the older lawsuit, Novartis supposedly treated physicians to luxe dinners, fishing trips, outings at Hooters (class acts!) and provided speaker fees to juice sales; that is, they’re accused of buying physician prescribing loyalty. That commitment should be borne only of science and patient communication. The U.S. says Medicare, Medicaid and other federal health-care programs paid millions for these kickback-inspired claims as well.

In the Myfortic complaint, the U.S. called Novartis a “repeat offender. So, are the penalties for this skanky behavior insufficient, or is Big Pharma just too big to notice them? It wasn’t even three years ago, according to Bloomberg, that Novartis agreed to pay $422.5 million to settle charges that it paid kickbacks and illegally promoted drugs for off-label uses (that is, to treat problems for which the FDA had not given approval; doctors are allowed to prescribe drugs for off-label use, but manufacturers are not allowed to market them for such uses).

We’ve examined the idea that for pharmaceutical companies, paying penalties for illegal drug promotion is just a cost of doing business, and that some doctors are expert practitioners of going to the pharma well.

As part of the 2010 deal, Novartis signed a five-year corporate integrity agreement with the U.S. Department of Health and Human Services requiring promotional activity reforms. The document said that Novartis could be excluded from federal health-care programs for a “material breach.”

We’re waiting.

Bookmark and Share

April 21, 2013

Psychiatric Guidelines Are Riddled With Conflicts of Interest

The Practice Guideline for the Treatment of Patients with Major Depressive Disorder is the primary resource for clinicians who treat patients with depression, which often involves prescribing drugs. Researchers from the University of Massachusetts, Boston, examined financial and intellectual conflicts of interest involved in the process of defining the guidelines to see if outside influences affect patient care.

Their conclusion isn’t pretty: “The prevalence of conflicts of interest among panel members was high. The quality of the evidence cited raises questions about the validity of the recommendations.”

The study, published in the Journal of Evaluation in Clinical Practice, showed that all of the people who devised the guidelines, published by the American Psychiatric Association (APA), had numerous financial ties to drug companies that manufacture antidepressants.

That’s like compiling a buying guide for safe automobiles when all of the authors work for Ford.

A lot of attention has been paid lately to psychotropic drugs (those that affect brain function, emotions and behavior) because of widespread concern that they are overprescribed and misprescribed. (See our recent blog posts, “Misuse of Antipsychotic Drugs Is Off the Charts,” and “Atypical Antipsychotic Use High in Children.”)

We’re all familiar with the suspect marketing behavior of drug manufacturers, but this study is an indictment of the behavior of the people we personally must trust with our lives.

The researchers evaluated the quality of the evidence the committee used to advise prescribing antidepressant medication. The APA recommends drugs as a first-line treatment for all levels of depression, but the study found that more than one-third of the research panelists cited in support of drugs for depression did not examine outpatients with major depressive disorder; 17 percent of their references didn’t measure clinically relevant results.

“The recommendation for antidepressants for mild depression is not congruent with the evidence,” the researchers said, noting that guidelines produced by the National Institute for Clinical Excellence say that antidepressants should not be first-line intervention for mild depression, and that Dutch guidelines recommend them as first-line treatment only in cases of severe depression because people may be exposed to unnecessary harm.

In order not to put patients at risk, the researchers said, it’s critical for groups developing clinical practice guidelines to pay attention to the quality of the studies they cite as well as to any bias resulting from conflicts of interest.

Every member of the APA guideline committee disclosed financial ties to the pharmaceutical industry. Some members had nine such relationships; some had 33.

None of them should have any.

Most of the committee members participated in pharmaceutical companies’ speakers’ bureaus. According to a UMass news release about the study, doctors serving on a speakers bureau are known as “Key Opinion Leaders” or “KoLs” because they are so important to the marketing of a drug. And some members of a separate independent panel charged with mitigating any effect of committee conflicts had undeclared financial relationships with drug manufactures.

Do these sound like people who should be treating your disorder, much less advising other professionals how to do it? Or do they sound like people who should be kept as far away from a clinical setting as the moon is from the Earth?

Bookmark and Share

April 14, 2013

Your Doctor’s Financial Interest Shouldn't Determine Your Medical Care

Now there's a headline we should never have to write. But consider this: If you think kickbacks are the sleazy kind of financial reward more commonly associated with organized crime than medicine, you’re probably not aware of PODs—physician-owned distributors. Last month, the Department of Health and Human Services’ Office of the Inspector General (OIG) issued a fraud alert about this worrisome commerce.

Doctor-owned medical devices or services—such as scanning equipment, laboratories or the sale/manufacture of implantable devices, which is the particular focus of this alert—are ripe for abuse and conflicts of interest. As described on AboutLawsuits.com, the alert focused on PODs that sell medical devices that were ordered by the practitioners themselves for use in procedures they perform on their own patients at hospitals.

“We are particularly concerned about the presence of such financial incentives in the implantable medical device context,” the alert reads, “because such devices typically are ‘physician preference items,’ meaning that both the choice of brand and the type of device may be made or strongly influenced by the physician, rather than being controlled by the [facility] where the procedure is performed.”

According to the OIG, PODs are “inherently suspect under the anti-kickback statute.” That’s because you can’t be certain that the decision to refer a patient for testing was made with complete medical objectivity if part of the cost paid for it is returned to the person who made the referral.

Violation of the statute, by the way, is a felony punishable by a maximum fine of $25,000, imprisonment for as long as five years, or both. Conviction gets you excluded from Federal health-care programs. That’s serious, but it pales in comparison to the damage a patient can suffer because someone’s priority was self-enrichment instead of patient safety.

As AboutLawsuits explains, the additional profits for the doctors often are shared with the hospitals or ambulatory surgical centers where the procedures are performed.

In addition to corrupting medical judgment, the PODs can contribute to the overuse of medical devices. The harm of that, as we’ve noted, is a higher incidence of false positives, leading to unnecessary worry and additional tests that might be invasive, painful and pose risks of their own, such as radiation or infections. Overuse also increases costs for patients, insurers and public health-care programs. The OIG also says it promotes unfair competition.

The OIG says a disclosure statement of financial interest, which often occurs in doctor testimonials that a patient should choose a certain facility, is not sufficient to overcome the whiff of conflict of interest. The only interest a doctor should have in referring a patient for a particular test at a particular facility is the best, most appropriate medical care. That usually doesn’t come with a side order of line-my-pocket.

As AboutLawsuits points out, kickback warnings have concerned the OIG in the past. In 1989, a special Fraud Alert on Joint Venture Arrangements was issued that discourages hospitals from using PODs and doctors from joining them.

According to an OIG letter in 2006 about doctors’ financial interests in PODs, “The strong potential for improper inducements between and among the physician investors, the entities, device vendors and device purchasers should be closely scrutinized under the fraud and abuse laws.”

Whenever your doctor recommends a procedure, or if you are having surgery to implant a medical device, not only are you well within your rights to ask the following questions, as a matter of self-protection, you should.

  • What is the purpose of this procedure/device, what results can I expect, and how soon?

  • Are there alternatives?

  • Why am I having the procedure at this particular facility?

  • What is your financial interest in the equipment used or the facility where it’s performed?

If you are having a device implanted, find out the name, model and manufacturer. Then check the FDA’s MedWatch site to find out if there are adverse event reports about it.

Bookmark and Share

April 11, 2013

Study of Premature Babies Failed to Inform Parents of Risks

Several prestigious universities, including Stanford, Duke and Yale, conducted a research study on behalf of the federal government to examine which of two levels of oxygen given to extremely premature babies was better at preventing blindness without increasing the risk of brain damage or death. The purpose and execution of the study were solid; the ethics weren’t.

As widely reported, including by the New York Times, the universities failed to inform the parents of the 1,300 hundred babies that the risks of being in either group included blindness and death. The federal Office for Human Research Protections, whose job is to protect people participating in government-financed studies, detailed the ethical breach last month in a letter to the University of Alabama, Birmingham, the study’s lead site of the 23 universities involved. The babies’ families, says The Times, have yet to be notified of what the government learned.

The consumer advocacy organization Public Citizen found out about the letter, and informed the media of it on Wednesday. Public Citizen wrote a letter to HHS Secretary Sebelius asking her to step up the discipline of the universities involved, and to personally and publicly apologize to the families of the 1,300 babies.

The study, published in the New England Journal of Medicine, occurred from 2004 to 2009, and involved babies born from 24 to 27 weeks of gestation—full term babies gestate for 39 to 40 weeks. Such premature infants are extremely fragile and at high risk of death and eye disease.

Babies in the study who received the higher level of oxygen were more likely to develop the eye disease, called retinopathy of prematurity, and blindness; those who got less were more likely to die. Of the 654 low-oxygen babies, 130 died; 91 of 509 high-oxygen babies developed the eye ailment.

“The researchers,” according to the letter, “had sufficient available information to know, before conducting the study, that participation might lead to differences in whether an infant survived, or developed blindness, in comparison to what might have happened to a child had that child not been enrolled in the study.”

The consent form the parents were given to sign so their babies could participate in the study noted only the risk of abrasion of the infants’ skin by an oxygen monitoring device, and that the possible benefit to participating was a decreased need for eye surgery, depending on the group the infant was assigned to. (To learn more about informed consent, see our backgrounder.)

The vice president for research at the University of Alabama, Birmingham, told The Times that the study kept the infants within the standard band of treatment for oxygen levels. But the letter from the Office for Human Research Protections, which is an agency of the Department of Health and Human Services, found the consent form wanting, and that the risks of participating in the trial “were not the same as those receiving standard care.”

The consent form, it said, should have explained that “there is significant evidence from past research indicating that the oxygen provided to an infant can have an important effect on many outcomes including whether the infant becomes blind, develops a serious brain injury or even possibly whether the infant dies.”

The consent form, said The Times, had been approved by all of the participating universities.

Consent forms generally cover every possible adverse event because the institutions conducting research are careful not to expose themselves to legal liability. But as Dr. Arthur Caplan told The Times, parents often rely more on what doctors say in deciding whether to participate than on the fine print of a consent form. Caplan is the medical ethicist at New York University Langone Medical Center.

Treating extremely premature infants has always been challenging. Administering oxygen is indicated because preemies’ lungs are underdeveloped and they struggle for air. But the higher oxygen levels that were thought to improve their odds of survival led to many cases of blindness. So doctors usually make treatment decisions based on each individual, often in consultation with parents, and nothing having to do with such tiny babies is without risk.

The researchers said their approach also was flexible and that the infants in the study weren’t necessarily confined to rigid bands of oxygen levels. But because they wanted to determine the effects of two different levels, they tried to keep half the subjects in the low zone and half in the high zone. Also, they said a similar group of infants born around the same time in the same hospitals who did not participate in the study, but were eligible, died at higher rates than those in the low-oxygen group..

Still, assuming risk is not a unilateral decision to be made by practitioners. It’s unconscionable that parents were deprived of knowing all the concerns in their childrens’ participation in this study.

Some readers of The Times’ story, however, had a more nuanced appreciation of the ethical breach.

“Death or blindness is a terrible choice,” said one. “The retrospective finding that similar patients (in the same hospital at the same time) who did not participate in the study suffered more deaths and blindness illustrates the dire nature of the patients' condition and the extra care bestowed on them by the researchers. Also that oxygen delivery to the infants was appropriately adjusted by the researchers—evidence that their clinical care was not adversely affected in any way by the research. Nevertheless, the federal agency is right that the parents should have been given all the available information before they signed the consent.”

Another, who identified herself as a health researcher who has written consent forms, said “This is an explanation of how research ethics works, I am not making a judgment about whether the concept of this study was right or wrong.

“Many readers are expressing anger that parents were not informed in the consent form about the risk of death and blindness with oxygen treatment. These are extremely preterm babies, who without treatment would likely die and even with treatment, may die or face a lifetime of complications. If oxygen treatment is standard of care, then any competent physician treating this baby would tell the parents about the risk of death and blindness before starting the treatment. The key question here is whether participating in the study increased these risks. If the risk of blindness and death with oxygen treatment for babies in the study is the same as babies receiving oxygen treatment and not in the study, then there would be no requirement to mention those risks again in the consent form. If there was increased risk of these outcomes due to participating in the study, then the consent form would be required to mention it. Researchers are not obligated to mention the risks of a procedure that the person has already made a decision to participate in. It is the responsibility of the consulting physician and the hospital to make sure the parents are informed of the risks of that procedure before agreeing to undergo it.”

Bookmark and Share

April 11, 2013

Suggested Reading: Several New Takes on the Dangers of Prescription Drugs

Sometimes, we read an article or book about health, medicine and/or patient safety that’s fascinating but too long to summarize fairly in a blog post. So here’s a shout-out to a few recent stories you might want to look up, on a common theme.

According to the Centers for Disease Control and Prevention (CDC), drug overdose death rates in the U.S. have more than tripled since 1990 and have never been higher. Most of these deaths, says the CDC were caused by prescription drugs. In the last several months, the Los Angeles Times has published a series of investigative articles about the epidemic of prescription deaths. The four-part series explains how legal drugs have deadly outcomes, how reckless doctors and rogue pharmacists contribute to the problem, how regulatory authorities allow problems to fester and what they can do to address it. Link here.

Also, see our blog, “Doctors Don’t Know Dangers of Narcotics, and FDA Leaves Drug Makers in the Driver’s Seat.”

“NPR’s Akathisia Blind Spot,” was posted on Paul John Scott’s website devoted to “groupthink in science medicine and fitness—popular culture and the madness of crowds.” In the eloquent essay, he indicts the media for continuing to ignore a major side effect of a class of anti-depressant drugs known as SSRIs—selective serotonin reuptake inhibitors--including Celaxa and Lexapro. “[T] he problems with SSRIs and suicide seems no closer to being articulated in the culture at large, let alone resolved, beyond a few ardent voices and the small print on some drug labels that, thanks to the silent skepticism of so many, no one really knows what to think of.” Link here.

“Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” Dr. Ben Goldacre’s new book, addresses our culture’s willingness to believe that drug treatment is based on evidence, that doctors are familiar with the latest drug studies, that drug research is pure science unpolluted by conflicts of interest and that when it comes to drug safety, regulators have our back.

As readers of this blog know, that’s fiction. Goldacre shows how the manipulation of the prescription drug market has been protected from public scrutiny because it’s too complex to capture in a sound bite. Goldacre untangles the tale in the hope that all patients and medical professionals can understand the tricks and distortions inherent in Big Pharma. Link here.

Bookmark and Share

March 29, 2013

When "Peer Review" Has Ulterior Motives

A federal judge this week upheld a jury verdict against the American Academy of Orthopedic Surgeons, finding sufficient evidence for the jury's decision that the AAOS acted with "reckless disregard for the truth" in publicizing its discipline of an orthopedic surgeon who had testified that another surgeon had committed malpractice.

The decision was written by U.S. District Judge Joel Slomsky, who was nominated to the federal bench by George W. Bush and sits in Philadelphia. Read the judge's decision against the orthopedic surgeons' society here.

The surgeon who successfully sued the AAOS is Steven Graboff, MD, whom the AAOS suspended for two years after he testified against an AAOS member. The jury found that the AAOS report about its disciplinary action cast Dr. Graboff in a "false light" because of various errors. The AAOS report remains on its publicly accessible website.

The AAOS is one of a number of doctor organizations with "peer review" programs for reviewing expert testimony against members. The programs exercise vast economic power over the members' testifying activities, as the court found. Responding to an argument from the orthopedic surgeon group that the expert witness had not shown enough economic harm from its slam of him, the judge wrote:

The AAOS is well aware of its clout in the profession of orthopaedic surgeons and created its compliance program and standards to control the occupation of its members as experts.16 It is also aware that its enforcement program and standards would affect the income of doctors because the loss of AAOS accreditation has a substantial impact on the ability of an expert to work in that industry. Further, the presence of the standards alone, however noble they are as a mission statement, can have a chilling effect on orthopaedic surgeons who serve as expert witnesses against other orthopaedic surgeons.

The ostensible goal of these expert witness "review" programs is "truth" in testifying, but the judge's decision summarizes the evidence at trial supporting the jury's verdict that AAOS did not run an unbiased review system.

The bias started with the doctor the orthopedic surgeons picked to set up and run its testimony review program: Dr. Peter Mandell, an orthopedic surgeon who had stopped treating patients and focused his practice on testifying for insurance companies in workers' compensation cases (i.e., testifying against patients).

Dr. Mandell, as Judge Slomsky found, is the head of the AAOS Committee on Professionalism, the first body to hear charges that an orthopedic surgeon has testified in violation of the AAOS expert witness standards.

(By the way, only members of the AAOS are eligible to start complaint proceedings against an orthopedic witness; that means that any patient who feels aggrieved by a surgeon's testimony against the patient -- like Dr. Mandell's testimony against a worker's comp claimant -- has no recourse.)

Dr. Mandell is also head of the AAOS Council on Advocacy, which lobbies in Washington for "tort reform" to curb malpractice lawsuits.

Hmm. Coincidence?

The expert witness review program, Dr. Mandell testified (with admirable candor) in the Graboff lawsuit, came about because orthopedic surgeons were upset about high jury verdicts against orthopedists in malpractice cases.

Any scientist knows that biased decision makers produce biased outcomes. That's why medical research usually requires "double blinded" studies so that doctors studying a new drug or device don't subconsciously tilt the results one way or the other from knowing which way something should come out.

But in this case, the old doctors' joke may hold true. Q: What's the definition of a double-blind study? A: Two orthopedic surgeons examining the same patient.

Bookmark and Share

February 20, 2013

Obesity Analysis Is Larded with Potential Conflict of Interest

An article published last month in the New England Journal of Medicine (NEJM) about obesity research prompted a lot of health journalists to respond, but their interest wasn’t about this growing (sorry) health problem—it was about the possible conflict of interest that the otherwise prestigious journal might have sidestepped.

Both Gary Schwitzer, editor of HealthNewsReview.org and Kevin Lomangino, a contributor to that site as well as editor-in-chief of Clinical Nutrition Insight, were moved to comment. As Lomangino wrote, the NEJM article “was a ‘mythbusting’ paper designed to separate fact from fiction and expose nonsense masquerading as truth. … as the authors point out, … clinging to unsupported beliefs can ‘yield poorly informed policy decisions, inaccurate clinical and public health recommendations, and an unproductive allocation of research resources and may divert attention away from useful, evidence-based information.’

“But can we trust this particular team of mythbusters?” Lomangino asked after reviewing the disclosure at the end of the article listing all of the companies that paid the authors for a variety of things, including board membership, consulting and lecture fees, licensing agreements and to conduct research. It’s such a hefty catalog—Lomangino calls it “epic"—that you want to laugh at the way it concludes: “No other potential conflict of interest relevant to this article was reported.”

Among the various interests listed with, as Lomangino said, “considerable skin in the obesity game,” are Coca Cola, Pepsi, Kraft, National Cattlemen’s Association, World Sugar Research Organisation, Jenny Craig and drug companies that make weight-loss medications.

“I don’t think there is much doubt,” Lomangino said, “that these relationships influenced the content of the paper, and not for the better. How else to explain the choice of ‘facts’ that the authors chose to highlight in the paper, and those they inexplicably left out?”

Yeah, that’s pretty telling—good science doesn’t pick and choose the data it reports.

Lomangino discussed three interventions the authors say are “suited to clinical settings” in the “facts” section of the paper. Two of them — meal replacements such as low-calorie drinks and bars and weight-loss drugs—are well represented in the list of disclosures. But not represented on the list nor in the article is another intervention—counseling and behavioral therapy. It’s curious, Lomangino wrote, that the authors didn’t think it worthwhile to discuss the benefits of that approach.

Especially when you consider that such an intervention can be successful. The U.S. Preventive Services Task Force (see our blog about this agency) reviewed nearly 40 trials using counseling/therapy for weight loss and deemed it of sufficient value to warrant reimbursing qualified counselors. “But,” wrote Lomangino, “the disclosure list doesn’t indicate any obvious financial stake in this approach for the authors. Could that have had anything to do with their decision not to mention it?”

Everyone knows that a huge contributor to this country’s obesity problem is our fondness for soda and other sugary drinks. Then you realize that the authors say nothing in the paper about soft drinks or sugar and obesity, you look at the inclusion of Coke, Pepsi and the sugar research organization in the disclosure club and you say ‘what’s wrong with this picture?’

“I’m not saying it’s an undisputed fact that cutting out soda reduces obesity (although the evidence from clinical trials seems to be close to erasing any doubts…),” Lomangino wrote. “But considering the huge implications and obvious widespread confusion related to this issue, I think it’s strange that the authors didn’t include some kind of evidence-based discussion.”

“Strange”? He’s being kind. We’re thinking it’s more like “deficient,” or maybe “disingenuous.” “Deceitful,” even. The authors believed that the myth of sex as a big calorie burner deserved their analysis more than the effects of consuming Coke. They believed sex-as-exercise deserved their analysis more than examining whether you can lose weight with the help of dietary supplements, on which Americans spend billions of dollars each year; more than a discussion of the “myth” that eating dairy products can help you lose weight.

“I’m a little surprised,” Lomangino wrote, “that the article didn’t have more to say on these topics, and I can’t help but wonder if their decision-making had anything to do with ties to Basic Research, which according to WikiPedia makes the Zantrex-3 weight loss supplement, or multiple relationships with global dairy interests.”

Lomangino didn’t suggest that these relationships directly compromised the information the authors included, or that they consciously tailored the content to benefit their funders. He acknowledged that they provided a lot of useful, evidence-based information, and, like he, want to see better research in nutrition.

But no thinking person can ignore the possibility that their business relationships have the potential to influence the data and information they choose to present, and how they present it. And when you tiptoe down that path, you add to what the article authors describe as “poorly informed policy decisions, inaccurate clinical and public health recommendations, and an unproductive allocation of research resources.”
Conflicts of interests abound in medicine and medical research. But it’s pretty unusual when those on its front lines make its potential harms so easy to see.

Bookmark and Share

February 11, 2013

Which Doctors Line Their Pockets with Big Pharma Money?

As we reported last year, part of the Obama administration’s health-care reform includes the Physician Payments Sunshine Act. It requires drug companies to disclose payments they make to doctors for research, consulting, speaking, travel and entertainment. Sometimes, such compensation influences treatment decisions and encourages overuse of drugs and devices. And these relationships are ripe for conflicts of interest.

So where are we in this process of finding out who’s getting what from whom?

According to the public interest news site ProPublica.org, things are moving slowly, but they’re moving. Final regulations were announced last month, but the release of payment data won’t happen until September 2014. The information was supposed to become public beginning this year, but since federal officials released the proposed regulations in December 2011, they’ve been collecting and analyzing comments about them.

Either there was a tsunami of comments, or the government is a bit tardy.

The first group of data to be released reflects payments made from August to December of this year. The reporting companies must turn the data over to the government by March 2014, then doctors have 45 days to review it for accuracy before it becomes public. Companies must report every year.

The information helps patients find out if their doctors receive money from any companies whose products they prescribe. If they do, these docs might be influenced to treat their patients in a way that might not be in the patients' best interests.

Until now the only similar resource has been a ProPublica initiative, Dollars for Docs. It has tracked payments since 2009 from a dozen drug companies, most of which were required to post the information on their websites as part of lawsuit settlements with the federal government. Mostly, the companies allegedly engaged in illegal marketing practices, such as off-label promotion. That’s when they promote a drug or device for a treatment purpose for which it hasn’t been approved by the FDA. Such settlements total billions of dollars.

Soon, Dollars for Docs will be updated through 2012 and include payment info from 15 companies.

Everyone—drug companies, lawmakers and consumer advocates—has been frustrated with how long it has taken the Centers for Medicare and Medicaid Services (CMS) to release the final rules for collecting and publishing the data. But at least it’s happening.

Any payment larger than $10 made to a U.S. physician or teaching hospital must be reported by date of payment and include a description of the service provided, the amount paid and which company products the payment involved. Speaking fees, consulting payments, research, gifts, food, entertainment, honoraria, research grants, royalties and license fees are included.

Fines for failure to report range from $1,000 to $10,000 for each incidence. A deliberate failure to report can cost $1 million.

According to ProPublica, some practitioners are rolling in the payment (graft?) green.

One Los Angeles-area doctor got more than $300,000 in speaking fees in 2009 and 2010 alone just from the companies in its database. Those businesses account for less than half of all U.S. pharmaceutical sales, so who knows how much more dough is in promotional play?

It’s interesting—dismaying?—to note that more than 250 physicians who were drug company speakers and consultants had been disciplined by their state medical boards or other regulatory agencies.

Find out if your physician is one of them at the Dollars for Docs link.

Bookmark and Share

November 1, 2012

Surgery Decisions Shouldn’t Be Larded With Conflicts of Interest

The health and medicine watchdog HealthNewsReview.org recently laid bare how regulatory absence can poison what’s supposed to be an objective, scientific analysis of the suitability of a surgical procedure.

In excerpting an article that has been accepted for future publication in Arthritis Care & Research, HealthNewsReview shows the wide cracks in how the FDA approves some medical devices. Known as the 510(k) expedited review process, the exercise allows certain devices to be approved for sale “without formal testing in clinical trials as long as they confer low or moderate risk to patients and are structurally similar to a previously approved device.”

We’ve examined how devices are approved by the FDA, and how nonsensical the 510(k) process can be. On its face, an expedited process has merit. Many people otherwise without treatment for their medical problems can receive relief faster when bureaucracy gets out of the way. But speed doesn’t always result in good medicine.

As the journal article points out, a “previously approved” device might have been approved under 510(k), “leading to daisy chains of approved devices going back for decades, most of which have not undergone rigorous premarket assessment in human subjects.”

And lax regulation invites conflicts of interest. Using a hypothetical example, the writers demonstrate how, because surgeons have few constraints on their choice of medical device, “many are able to decide for themselves when they wish to begin using newer models.”

In the authors’ scenario, a surgeon, Dr. Jones, reviews a total hip replacement procedure with the patient, a man in his 50s. Dr. Jones makes sure he understands his options, and the patient signs the surgical consent form. Everything seems kosher but, although the risks and benefits of total hip replacement were detailed, shouldn’t the patient have participated in the decision about which implant device to use?

The authors say that without regulatory demand, not all the evidence must be presented that would fully inform the patient about technical considerations and the surgeon’s personal beliefs and possible conflicts of interest.

What if Dr. Jones has received consulting fees from the manufacturer of one of the devices under consideration? As the authors note, “Orthopedists who receive industry support express, on average, a greater sense of shared goals and priorities with their vendors and sales representatives than surgeons who don’t.”

Doesn’t the patient deserve to know that?

Doctors with financial interests in medical devices aren’t limited to orthopedics—the industry is rife with cross-pollination of science and commerce in all manner of devices and drugs. Among the most active players are pharmaceutical manufacturers and the doctors they pay for research, consulting, speaking, travel and entertainment to (see our post).

Patients can’t make a fully informed decision about surgery unless they’re offered a clear, complete picture of all aspects of the procedure. To that end, the article authors suggest that for their hypothetical hip-replacement, “the informed consent process … be enriched with a greater focus on shared decision-making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values.”

Yes, it’s challenging. But it’s necessary and only fair, for this and any surgical procedure.

Bookmark and Share

August 9, 2012

The Torturous Tale of Anemia Drugs: How Many People Did They Harm?

Three anemia drugs--Epogen, Procrit and Aranesp--have generated more than $8 billion in U.S. sales. Epogen became the single costliest medicine under Medicare, and taxpayers shell out as much as $3 billion a year for these drugs.

A growing body of research has shown that the drugs’ benefits, including quality-of-life issues such as “happiness,” are seriously overstated. Worse, according to a long story in The Washington Post, their potentially lethal side effects, including cancer and strokes, were long overlooked.

Anemia occurs when the body produces too few red blood cells, which carry oxygen from the lungs to the rest of the body. The drugs are artificial versions of a natural hormone called erythropoietin, which stimulates the body to produce red blood cells. Before the drugs’ advent, patients were given transfusions of red blood cells, a cumbersome process that can take hours.

Epogen and Procrit were approved by the FDA in 1989 for patients with kidney disease. Amgen manufactured both; Procrit was licensed by Johnson & Johnson. Amgen’s Aranesp was approved in 2001.

Last year, an 84-page Medicare research study determined that among most kidney dialysis patients, who compose the drugs’ largest market -- the kidneys are where the natural hormone is made -- there was no solid evidence that they made people feel better, improved their survival or had any “clinical benefit” except a higher red blood cell count. As The Post said, “It was a remarkable finding of futility: While drugmakers had seen billions in profits over 22 years, much of it from taxpayers, millions of patients had been subjected to dangerous doses that might have had little advantage.”

One of those patients was Jim Lenox. On the day the frail cancer patient received his last injection in 2008, he was awaiting discharge from the Baltimore Washington Medical Center. Then a nurse said he needed another dose of anemia drugs.

His wife, Sherry, wondered why, because his blood readings had been close to normal. But the Lenoxes deferred to the professionals and accepted an injection of Procrit, which his cancer clinic normally billed for $2,500 each.

Hours later, Lenox was dead.

The story behind the anemia drugs is long and complicated, and illustrates how the financial incentives that are integral to the U.S. health-care system contribute to its inefficiency and lethal potential. We wrote about this smarmy situation last year.

Drug trials conducted by both Amgen and Johnson & Johnson missed the dangers and promoted the benefits that years later would be deemed unproven. The companies took more than a decade to fulfill their research commitments. And when bureaucrats tried to curb the largest doses, Congressional lobbyists were successful, and regulators opened the spigot.

The fault of dangerous drugs being promoted on the open market is shared by doctors, clinics and hospitals, whose budgetary pressures contribute to a “more is more” philosophy. The more they treat, the more they earn, the bigger the dose, the bigger the payoff.

Unlike medications you fill at a pharmacy, drugs administered by physicians, such as the anemia group, can be profitable for them.

Big Pharma offered doctors incentives to give large doses and they offered volume discounts. Most critical, The Post says, was the lobbying pressure, under which Congress and Medicare administrators forged a system in which doctors and hospitals were reimbursed more for the drug than they paid—as much as 30 percent, according to the Medicare Payment Advisory Commission, a group that advises Congress. The markup on patients covered by private insurance was even larger.

At the peak of the drugs’ use in 2007, more than 8 in 10 Medicare dialysis patients were receiving the drug at levels higher than the FDA now considers safe, according to federal statistics. (Other patients got the drugs, but records kept on dialysis patients are better.)

“An oncologist could make anywhere from $100,000 to $300,000 a year from this alone. And all the while they were told that it was good for the patient,” Charles Bennett, from the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina, told The Post.

During his cancer treatment, Jim Lenox was given Aranesp several times at a clinic. The insurance company reimbursed it about $900 for each, although the clinic would have paid about $600.

The profit margin for Amgen was far higher than the industry average. Much of it came from the pockets of taxpayers. A Washington University professor of medicine who had been paid by Amgen to promote the drug, called its success “a paradigm for the pharmaceutical industry.” He later turned critic after Aranesp’s dangers became known while Amgen continued to promote higher doses.

Both companies declined the paper’s requests for interviews and claimed that their primary interests were serving patient needs and providing consumer information.

The market expanded to nearly all dialysis patients, not just the estimated 16 in 100 who require blood transfusions, and the size of the average dose more than tripled. The FDA approved the drugs to treat anemia in cancer and AIDS patients, as well as those getting hip and knee surgery.

The drugmakers agreed to conduct safety studies, but the full results were never published. Amgen filed a “clinical study report” with the FDA in 1995, claiming its research commitment was fulfilled. The FDA did not deem the study completed until March 2004, almost 15 years after the company agreed to conduct it.

Another study in conjunction with the drugs’ approval was supposed to have 400 patients. Eleven years after initiating it, Johnson & Johnson said it was having difficulty recruiting enough, so statistically significant conclusions were elusive. And the FDA said significant amounts of data were missing.

With FDA approval, Johnson & Johnson halted the study in 2004. Medicare researchers later noted that patients in the trial who took the drugs appeared more likely to die than those who took a placebo, or fake, inert drug.

The drugmakers committed to doing another study, which was supposed to be completed by 2008. It still isn’t finished and Amgen doesn’t expect to finish until 2017 — nearly 25 years after the drug was approved for use in cancer patients.

Still another study funded by Amgen involved dialysis patients with a history of heart trouble. It was supposed to study the effect of the drugs in boosting certain blood levels close to normal, instead of simply higher than the anemic levels, which had been medically acceptable. That trial was stopped three years after it began because patients in the “normal” higher-dose group were dying or having heart attacks at a higher rate than those in the lower-dose, lower-level group.

What should have been a clear warning wasn’t: The FDA didn’t limit the recommended dosing levels, and the reason for the “increased mortality” at the higher doses, according to the label, “is unknown.”

In 2006, a study published in the New England Journal of Medicine reported that kidney patients taking higher doses were linked to higher risks of hospitalization, strokes and death. Some Danish researchers stopped a trial of Aranesp in cancer patients because of an increase in deaths and tumor growths.

Finally, the FDA ruled out the drugs’ use for cancer patients considered curable and for patients considered only slightly anemic. Maximum recommended doses were lowered, and the agency told doctors to use the smallest amount possible to avoid a blood transfusion. The agency removed the quality-of-life claims from the label.

Last year, nearly two decades after the Office of the Inspector General first suggested it, economic incentives to use more of the drugs on patients in dialysis were withdrawn. Medicare implemented a system under which health-care providers are allowed a certain amount of money per dialysis patient, rather than more money for each dose.

“The effects were immediate,” The Post reports, “suggesting again that health is not the only factor that doctors weigh in treating patients. After a quarterly sales plunge in April, Amgen chief operating officer and President Robert Bradway blamed the drop on the new payment scheme.”

Still, no major class-action lawsuits have been mounted, presumably at least in part because the patients taking the drugs were already ill. Amgen has been hit with whistleblower lawsuits alleging that the company engaged in illegal sales tactics.

But for people like Sherry Lenox, questions remain: Although her husband’s death certificate says he died of cancer, did he? Or was he he killed by the drugs he took to treat it?

Bookmark and Share

August 6, 2012

Overeager Surgeon Does His Melanoma Patient No Favor

For many people, the word “melanoma” often prompts the same response as the word “snake”— fear and, if announced as a personal warning, panic.

Indeed, the worst form of skin cancer can be deadly if ignored or treated improperly. Several years ago we sued a dermatologist whose dereliction in treating a patient with moles led to his death. But like so many other kinds of cancer, many people are harmed because their symptoms or their disease is overtreated by fear-mongering surgeons. This was the case in a story published in the Archives of Internal Medicine called “What the Surgeon Should Have Said to My Patient with Thin Malignant Melanoma.”
The writers, two medical doctors, explained how the patient presented with a colored lesion on his shoulder. A simple biopsy revealed a stage 1A malignant melanoma which, on a relative scale, is a small, early-stage cancer. This one was 0.5 mm deep. It had no ulceration nor evidence of palpable lymph nodes, either of which should have raised more questions. The surgeon, who specialized in oncology, played the fear card in encouraging the patient to have a procedure known as a sentinel node biopsy.

According to the authors, he said, “It is up to you, but you have a risk that there is spread into your lymph nodes. It has been shown that patients with nodal disease operated on at an early stage do better than those having total lymph node resection at a later stage when an enlarged lymph node is palpable. By doing this procedure, I could save your life.”

A sentinel node biopsy involves injecting a radioactive substance, dye or both near the tumor. Then the surgeon uses a probe to locate the lymph node(s) containing the injected marker—that’s the “sentinel.” The affected nodes are removed and analyzed for the presence of cancer cells. The point is to see where cancer cells are likely to spread from the primary tumor.

As noted in a companion story in the same publication, performing sentinel node biopsy on patients with early-stage melanomas is not considered best practice. But nearly 1 in 10 such melanomas are overtreated with such invasive procedures. About 30,000 of these melanomas are diagnosed every year, so thousands are overtreated in this way.

The risks of sentinel node biopsy include:

  • infection;

  • hematoma (swelling of clotted blood caused by a break in a blood vessel wall);

  • nerve damage.

In addition, the procedure can cost about $15,000.

Patients in the only scientifically sound study on sentinel lymph node biopsy had lesions that measured at least 1.2 mm. The death rate from malignant melanoma was nearly identical in the group with sentinel lymph node biopsies compared with those whose lymph nodes were biopsied only if enlarged. But patients with microscopic disease did better than those with lymph nodes that were enlarged and palpable.

The journal writers note that it’s wrong to compare outcomes of patients with palpable nodes with those who have normal-sized lymph nodes, because the latter group’s disease is at an earlier stage, and when it’s discovered incidentally is usually less aggressive. In short, it’s possible that their positive sentinel nodes might not progress because of the body's natural immunity. “The unambiguous finding of this trial,” the writers reported, “is that there was no advantage of sentinel node biopsy over observation.”

The surgeon in this case not only was too eager to practice his skills, he was malfeasant; he neglected to discuss treatment options with his patient and their possible side effects weighed against their benefits.

According to the journal authors, the surgeon should have said, “A wide excision alone [cutting around the lesion] gives you an excellent chance of cure. No studies have shown that sentinel node biopsy will improve your chances, and we do not know if you would benefit from the discovery of microscopic lymph node disease.”

If you want to more about melanoma and how to assess the value of treatment options, link to the website LifeMath.net, which tries to make sense of “the enormous number of fundamentally discrete events that occur among the many molecules, genes, and cells of which we are comprised.” Click on the cancer and melanoma tabs.

Here's a discussion on our firm's web site about the vital issue of "informed consent" in medicine.

Bookmark and Share

July 22, 2012

TV Doctors: Good Entertainment, Bad Medicine

We couldn’t have said it better than the Los Angeles Times: “ Television is great for sports, reality shows and reruns of ‘The Big Bang Theory,’ but if you're getting your health information from TV, you might not be as well-informed — or as healthy — as you could be.”

We would add that you also might be courting harm. See our newsletter, “Those TV News Doctors: Good Advisors or Fear Mongers?”

Whether it’s “Celebrity Rehab with Dr. Drew” or “The Doctors,” America can’t seem to get enough of practitioners giving medical advice, especially if they’re dishing dirt on famous people or strutting hunkily in their scrubs. They have medical degrees, they’re confident and articulate, and it’s a whole lot easier to flick on the TV than schedule a doctor’s appointment, and sit in the waiting room 30 minutes beyond the time you were supposed to be seen about your upset tummy.

There’s a problem with seeing doctor TV as an authority rather than entertainment, Dr. Steven Woloshin, professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice, told The Times. Sometimes, TV doctors who are accomplished in one field might be discussing topics beyond their areas of expertise or certification.

Dr. Mehmet Oz is a practicing cardiothoracic surgeon and a professor of surgery at Columbia University who gained media fame appearing on the Oprah Winfrey show. Photogenic and warm, he inspires responses from his audiences to his advice on how to keep a great head of hair as much as on ability to repair somebody’s heart.

Americans are desperate to lose weight, so nutrition is a frequent topic on these shows. But, "Just because someone's on TV, just because they're wearing scrubs, doesn't mean they're an expert on nutrition," Woloshin, a specialist in internal medicine, said.

Oz recently told his TV viewers that coconut oil is a "super food" that "helps you lose weight.” He got all science-y, demonstrating that the fatty acids in coconut oil dissolve easier than the saturated fat in meat. But Christine Tenekjian, a dietitian at the Duke University Diet and Fitness Center, pointed out that the considerable caloric load of coconut oil would override the modest benefits it might have on metabolism. “We have people who come in with all sorts of misconceptions that they heard on TV,” she told The Times. “They cling to it as gospel.”

In the spring, “The View” aired an episode with Dr. Steven Lamm, who, not coincidentally, was promoting his book, “No Guts, No Glory.” The professor of medicine at New York University championed several probiotic and nutritional supplements from a company called Enzymedica Inc., guaranteeing that "… in three to five years, everyone is going to be on a probiotic, everyone is going to be on a digestive enzyme."

He said these products are crucial to overall gut health. He must know something nutritional scientists don’t. "There's no evidence that probiotics improve your health if you take them every day," Lynne McFarland, a probiotic researcher at the VA Puget Sound Health Care System in Seattle, told The Times.

Some people, such as those with pancreatic disease, are prescribed digestive enzymes. But to pop them like cough drops is simply a fad.

We reported last week how Pinsky was paid by pharmaceutical company GlaxoSmith Kline to promote its antidepressant Wellbutrin. Guess who paid Lamm for his consulting services? Enzymedica. Although he told The Times that he has no financial stake in the company's products, don’t you think TV viewers deserve to know that his advice might have been less than objective?

As publisher of Health News Review, Gary Schwitzer is a frequent critic of shallow health journalism and how it engenders the gullibility of consumers. He said “The View” illustrated another problem with health-as-entertainment – the show's hosts constantly interrupted Lamm, so even if he had a helpful, coherent message he was given little opportunity to share it. "It's like getting your health information by listening to people talk on the train," he told The Times.

Sometimes, nutrition advice purveyed on TV isn’t just questionable, it’s dead wrong. “The Talk” is another daytime talk show directed toward a female audience. Early this year, it fed viewers’ celeb-and-weight-loss lust a segment featuring so-called “celebrity nutritionist” Cynthia Pasquella. She touted apple cider vinegar as “very alkalizing for the body, which promotes weight loss.”

Woloshin begs to differ, noting that all vinegars are acidic, which is the opposite of alkaline. And that even if you could “alkalize” yourself via salad dressing, there’s no evidence that it confers a benefit. Tenekjian agrees, saying no studies suggest that vinegar helps with weight loss.

Then there’s advice to boost your sex life. TV land found the perfect doctor to deliver this information in Travis Stork, the hunky ER doc on “The Doctors.” Last winter he told viewers about a “love potion” called Oxytocin Factor , an over-the-counter version of the hormone oxytocin. The ob-gyn doc on the show, Dr. Lisa Masterson, described oxytocin as the hormone that promotes the bonding of babies to their mothers and of women to their men. She put a few drops of Oxytocin Factor on pediatrician Dr. Jim Sears, who joked, “I feel like bonding right now.”

This isn’t medicine, this is sophomoric posturing. Commented Dr. David Feifel, a professor of psychiatry at UC San Diego, “[The segment] was pretty ridiculous and irresponsible, in my opinion." He told The Times that real oxytocin can promote bonding when delivered directly to the brains of people or animals, but had "no idea" where anyone got the notion that a few drops on the back of the neck would do anything at all.

A spokeswoman for Nutriceuticals Inc., manufacturer of Oxytocin Factor, said the doctors on the show didn't use the product as directed; it’s delivered via either nasal spray or oral drops.

Oh, that makes it better.

If you enjoy watching doctors on TV, stick to reruns of “ER,” where you know the stories and most of the medicine is fiction. If you want to see real doctors wearing their scrubs on a TV set rather than in an OR theater, fine—just don’t confuse what they say as medical advice to live by.

Bookmark and Share

July 18, 2012

Big Pharma Bust: Unsavory Details Behind the GlaxcoSmithKline Lawsuit

Last week we reported about the widely publicized criminal behavior of pharmaceutical giant GlaxoSmithKline, and the $3 billion fine it will pay for its crimes. Thanks to Kaiser Health News (KHN), consumers can get the gory details of just how Big Pharma inflates drug sales and the cost of health care.

It’s about doctors who leverage their medical celebrity into roles as drug shills. It’s about doctors who accept fancy trips and recreational pursuits from the companies who supply their wares It’s about spinning research results into fictional scenarios that make a great story and really bad patient care.

Courtesy of KHN, here are some of the players and their playgrounds with which Glaxo promoted the depression drugs Paxil and Wellbutrin and the diabetes drug Avandia.

  • Glaxo paid Dr. Drew Pinsky (radio call-in show “Loveline,” reality TV show “Celebrity Rehab with Dr. Drew”) $275,000 to promote Wellbutrin “in settings where it did not appear that Dr. Pinsky was speaking for” Glaxo.

  • On a radio show Pinsky said the active substance in Wellbutrin “could explain a woman suddenly having 60 orgasms in one night” even though Wellbutrin was approved to treat only major depression.

  • Glaxo promoted Wellbutrin “knowing that much of the cost of the unapproved, nonmedically accepted and/or inappropriate uses would be borne by federal health care programs.”

  • In 2000 and 2001, Glaxo flew psychiatrists to resorts (El Conquistador in Puerto Rico and Renaissance Esmeralda in Palm Springs, Calif.) to promote Paxil for children, even though it was unapproved for that use. “Results suggest that the Paxil Forum had a significant impact on Paxil market share in the months after attendance,” according to a Glaxo memo.

  • Glaxo paid what prosecutors described as kickbacks to doctors in the form of consulting fees, entertainment, travel and “sham advisory boards.” It tracked their prescribing habits. A Glaxo memo emphasized that only “KEY Customers” (high-prescribing doctors) should get free tickets to Boston Bruins and Celtics games.

  • “When I asked for the business he laughed,” one Glaxo sales rep said of a doctor whom he had treated to a St. Louis Cardinals baseball game. “I didn’t really see the humor in it. How could he think I wouldn’t ask for the business when I’ve treated his family to a day at the ball park.”

Most doctors who accept this graft would say that they wouldn’t prescribe a drug they didn’t believe in, so as long as they do anyway, what’s the harm in being treated well by its makers? We think it’s the patient’s decision, not the provider’s, as to what is and isn’t a conflict of interest.

So if you’re going to accept gifts, people should know about it. The 2010 health-care reform legislation supports that notion, and as of next year, the Physician Payment Sunshine Act will require doctors to disclose such activity.

In the meantime, you can look up any number of palm-crossing transactions between doctors/researchers and the medical drug and device industry on the “Dollars for Doctors” page of ProPublica, a nonprofit investigative news operation.

Should anyone doubt that these professional courtesies have the potential to affect someone’s health adversely, consider this comment posted at the end of the KHN story earlier this month:

“I’m on a brand medicine that has a generic. The brand drug is at least ten times the cost of the generic. I have asked my doctor to switch me to the generic and he refuses. He always says to me, ‘I’m the doctor. If you don’t like how I do things, there’s the door.’ The trouble with making my exit is that I’m not sure I can find another doctor that takes Medicare and I’m sure my current doctor will put me on the black list. He’s done to his other patients and I’m sure he’ll do it to me.”

Bookmark and Share

May 20, 2012

Conflict of Interest Kills Pain Control Advocacy Group

Here's another tale of Big Pharma insinuating itself into places it doesn't belong, to the detriment of quality care and patient safety.

Established to support patients with chronic pain, their families and the health-care professionals who serve them, the American Pain Foundation claimed to be the pain community’s largest advocacy group. Early this month, it abruptly shuttered its operation, attributing its demise to economic circumstances.

As several news organizations reported, that’s hardly the whole story.

Given the boom in prescription pain medicine—according to Marketplace.org, prescriptions for painkillers such as Oxycontin and Vicodin have quadrupled in the last decade—Americans clearly are hurting. You’d think there would be plenty of support for an organization that salved the pain.

But as explained in an investigative report by ProPublica, the foundation shutdown had to do with a U.S. Senate committee investigation into makers of narcotic painkillers and groups that champion them. According to ProPublica, 9 of every 10 dollars of the foundation’s funding in 2010 came from the drug and medical-device industry.

And—surprise!—its guidelines for patients, journalists and policymakers had minimized the risks associated with opioid painkillers and had exaggerated their benefits.

Senators Max Baucus, D-Mont., and Charles Grassley, R-Iowa, sent letters to the foundation and drug companies citing an "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers."

Drug companies, they wrote, "may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs' safety and effectiveness."

The senators are looking into the whole pain-control industry and medical oversight agencies to expose the financial connections among them. In addition to the American Pain Foundation and drug makers, recipients of the letters included the American Academy of Pain Medicine, American Pain Society, the Federation of State Medical Boards (the trade group for agencies that license doctors) and The Joint Commission (an independent nonprofit that accredits hospitals).

The U.S. Government Accountability Office (GAO) reported in 2003 that the Joint Commission had partnered with Purdue Pharma, the maker of Oxycontin, to distribute pain educational materials. In 2007, Purdue had pleaded guilty to federal criminal charges that it misled regulators, physicians and consumers about Oxycontin's risk of addiction.

No one denies that opioids might be appropriate for people in serious pain. But like any other drug, their benefits must be measured against their potential harm, and you can’t do that when manufacturers and so-called “advocates” supply inaccurate or incomplete information.

As quoted in the ProPublica story, Dr. Andrew Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn, N.Y., and president of Physicians for Responsible Opioid Prescribing, said, "These groups, these pain organizations … helped usher in an epidemic that's killed 100,000 people by promoting aggressive use of opioids. What makes this especially disturbing is that despite overwhelming evidence that their effort created a public health crisis, they're continuing to minimize the risk of addiction."

Sales of these potent drugs have risen 300 percent since 1999. And opioids were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. In 2009, the use and misuse of the drugs were cited in more than 475,000 emergency department visits, nearly doubling the 2004 number. The figures come from the Centers for Disease Control and Prevention (CDC).

One in 8 high school seniors surveyed for a research paper in the Archives of Pediatrics & Adolescent Medicine said they had used prescription opioids for nonmedical reasons.

Another report in the Journal of the American Medical Association found that the rate of newborns diagnosed with drug withdrawal jumped threefold from 2000 to 2009. The rate of mothers using opioids at the time of delivery was five times higher in 2009.

Typically, medical professionals and patient advocacy groups acknowledge that drug overdoses are a legitimate concern, but say that most deaths involve illegally obtained drugs. They also say that patients' risk is low if they do not have addictive personalities, and people who suffer from serious pain should not be deprived of relief.

No, they shouldn’t. But narcotic manufacturers also shouldn’t be bankrolling advocacy groups whose job is to provide objective and complete information about drugs.

Bookmark and Share

May 13, 2012

Sunshine Dims with Delay on Big Pharma Payment Reports to Docs

Here’s another arrow for the quiver of people exasperated with government.

As part of its health-care reform, the Obama Administration proposed that drug companies be made to disclose payments they make to doctors for research, consulting, speaking, travel and entertainment. The rationale, as reported by The New York Times, was evidence that such payments can influence treatment decisions and boost costs by encouraging the use of more expensive drugs and medical devices.

Disclosure, the thinking goes, would make doctors more disposed toward making decisions in the best interests of patients instead of their bottom lines. As we’ve reported, drug and device company largess can be ripe for conflicts of interest.

According to The Times, about 1 in 4 doctors takes cash payments from drug or device makers; nearly 2 in 3 accept routine gifts of meals for themselves and their staff. The Times also concluded that doctors who take money from drug makers often practice medicine differently from those who do not—they’re more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Some companies have begun posting some payment information on their web sites, sometimes as the result of legal settlements with the federal government. Under the new proposal, if a company has even one product covered by Medicare or Medicaid, it must disclose all payments to doctors other than its own employees. The federal government will post the information on a public Web site.

The penalty for noncompliance could be $10,000 for failure to report. A company that knowingly fails to report payments could be subject to a $100,000 penalty for each violation, to a maximum of $1 million a year.

Comments about the proposal were accepted until Feb. 17, then Medicare officials were to issue final rules with the force of law.

Here’s where the archers among us start to take aim. As reported on FDA Law Blog, earlier this month the Centers for Medicare & Medicaid Services (CMS) announced “that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before Jan. 1, 2013.”

The regulation requires the first report to be submitted by March 31, 2013 for payments made in this calendar year, but CMS already has exceeded one deadline--under the Patient Protection and Affordable Care Act (ACA), payment-reporting procedures were supposed to be established by of Oct. 1, 2011.

The postponement gives CMS time to review more than 300 comments about the proposed rule, and also affords manufacturers additional time to prepare for the disclosure reports. Although the CMS didn’t expressly say the March deadline was extended, it’s implicit in the delay.

On news of the extension, Sen. Charles Grassley, R-Iowa, one of the sponsors of the Physician Payments Sunshine Act, said, “It’s disappointing that CMS won’t even collect data at all this year. The process has dragged on long past the statutory deadline for implementation. Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later. It’s important that CMS get this right in every way, including the usefulness and accuracy of the information. Given all of the extra time, CMS will have no further excuses for not accomplishing these goals.”

We’d like to believe him. But when it comes to excuses in Washington, supply always
seems to exceed demand.

Bookmark and Share

March 21, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions

Lots of people are unhappy with the process by which the FDA approves medical devices, including patients who’ve suffered harm from deficient products and manufacturers who claim burdensome bureaucracy stands between them and profit.

Congress has acknowledged that the process is less than ideal, and supposedly is trying to establish fair access to safe new technology. Pending legislation includes efforts to speed up device approval, many of which we recently suggested were tainted with lobbying dollars. Patient advocates want the FDA to spend more time reviewing implantable and life-sustaining devices.

Now, a survey by the Union of Concerned Scientists (UCS) captures the conflicted feelings of some FDA employees. Many believe that political and corporate interests wield too much influence when the agency is considering the value and marketability of medical devices.

According to a story in the Minneapolis Star Tribune, some employees feel pressured to approve devices despite misgivings they might have about their safety.

Survey participants were asked, “Have you ever been pressured to approve or recommend approval for a device or product despite reservations about the safety, efficacy or quality of the product?” One in 4 said yes.

The results were decidedly more cynical than a similar poll in 2006. At that time, most employees of the FDA’s Center for Devices and Radiological Health trusted agency leadership and felt it was headed in the right direction.

This time around, as the Star Tribune reported, “dozens of employees reported experiences in the past year where they believe the medical device industry hurt public health by withholding information or by forcing changes in FDA policy.”

Dr. Jesse Goodman, chief scientist and deputy commissioner for science and public health, applauded the growing worker confidence to be candid, then undercut the survey’s message by saying that the survey’s response rate was low enough to make “definitive conclusions difficult.”

But maybe he did get the message. He also told the Star Tribune that some things in the survey "should still concern us. … some scientists still fear retribution for sharing concerns about the FDA. Some believe that business interests frequently influence science-based regulatory decisions."

UCS got responses from 997 employees across the agency—17 percent of those asked. Of the respondents, 158 worked in the center for devices.

Some respondents reported experiences within the last year in which they lacked complete scientific data to make conclusions about outcomes for devices seeking approval.

In addition to expressing concern about undue influence for approvals, some survey participants called into question the FDA’s ability to monitor the performance of medical devices once they were on the market. Again, 1 in 4 said they lacked confidence that the FDA had enough authority to assure patient safety for available devices. Many members of the medical profession share this concern.

"When inappropriate influence clouds scientific judgment at the FDA, public health and safety suffer," said Francesca Grifo, director of the Scientific Integrity Program for UCS.

To voice concern about malfunctioning medical devices and for guidance where to register your beliefs about the process, visit the website of the Consumer Union’s Safe Patient Project.

Bookmark and Share

March 15, 2012

Drug Company Payments to Doctors—To Whom, How Much and for What?

ProPublica, a nonprofit enterprise that conducts investigative journalism in the public interest, continues to build its database of medical industry payments to medical professionals and health-care institutions. It’s a fine resource for anyone seeking to know the extent of the medical back-scratching that used to occur only outside the bright glare of transparency.

As we explained a few months ago,“Dollars for Docs” tracks payments from drug companies to care providers for things like speaking fees and drug promotions. As explained on the ProPublica website, thanks in part to a legal settlement, these sweet deals now must be posted on company websites. As of this writing, 12 companies are participating. By federal law, all companies must make these reports by 2013, and the information will appear on a government website.

ProPublica’s database is updated regularly. Consumers can mine information about their physicians, their state or other topics that can signal science-advancing research or potential conflicts of interest.

Here are a few things we found recently about company payments to doctors in Maryland:

  • From the first to second quarters of 2011, Cepahlon paid Dr. Mohamed Al-Ibrahim of the SNBL Clinical Pharmacology Center of Baltimore $1,498,675 for clinical research.

  • From the second to fourth quarters of 2009, GlaxoSmithKline paid Dr. Ralph V. Boccia of Bethesda $129,400 for speaking fees.

  • From the first to second quarters of 2011, Cephalon paid Dr. Bruce Cheson of Rockville $11,133 for travel expenses.

  • Bookmark and Share

February 10, 2012

Honesty with Patients Is Optional with Some Doctors

A large survey of doctors published in the prestigious journal Health Affairs finds that while physicians generally subscribe to the idea that honesty is the best policy, they don't always practice honesty with patients, especially when it conflicts with their self-interest.

The article by Lisa Iezzoni, MD, of Harvard Medical School and others, says:

[A]pproximately one-third of physicians did not completely agree with disclosing serious medical errors to patients, almost one-fifth did not completely agree that physicians should never tell a patient something untrue, and nearly two-fifths did not completely agree that they should disclose their financial relationships with drug and device companies to patients. Just over one-tenth said they had told patients something untrue in the previous year.

The authors conclude:

Our findings raise concerns that some patients might not receive complete and accurate information from their physicians, and doubts about whether patient-centered care is broadly possible without more widespread physician endorsement of the core communication principles of openness and honesty with patients.

In 2013, patients will be able to look up data on their doctors' financial ties with drug and device manufacturers, thanks to the new Affordable Care Act. Tentative regulations setting up the reporting system were published in December by the Food and Drug Administration.

As the New York Times' Robert Pear reported recently, researchers have found that payments can influence doctors’ treatment decisions because they steer patients to more expensive drugs and medical devices.

First published on Technorati.

Bookmark and Share

January 24, 2012

Conflict of Interest Strikes Again at the FDA

On his GoozNews website, journalist Merrill Goozner recently tackled the decision by Health and Human Services Secretary Kathleen Sebelius to overrule FDA scientists and ban the sale to minors of the over-the-counter morning-after contraception pill. He noted that opponents called it a blatant political move by the White House to woo social conservatives.

It’s part of a pattern, Goozner suggests, that Capitol Hill pols might be influencing other FDA decisions. To wit: the agency’s appointment last month of at least three scientists to a drug safety advisory committee charged with reviewing birth control products made by Bayer. The scientists, it seems, had financial ties to Bayer. The FDA did not disclose their connections, as reported in an investigation by BMJ and the Washington Monthly.

The committee recommended that Bayer’s problematic birth control pills (sold as Yaz and Yasmin) remain the market despite the FDA’s own reports of dozens of deaths from blood clots. (We recently wrote about Bayer’s questionable marketing efforts for the troubled drug.) The tsunami of lawsuits filed against the company weren’t compelling to the committee, which, Goozner reported, said the benefits of having another birth control option on the market outweighed the risks.

The committee vote was controversial from the start; we’d go as far as to call it hypocritical.

Before the meeting, Goozner noted, the FDA ruled that the committee’s usual consumer representative, Dr. Sidney Wolfe from Public Citizen, couldn’t participate because he had publicly called for banning the drugs. The agency also refused to distribute a legal/scientific brief prepared for plaintiffs’ attorneys by Dr. David Kessler, who once headed the agency, because it said he submitted it too late. Apparently, punctuality is more important than patient safety.

Goozner draws the smelly political connection in referring to U.S. senators who introduced legislation last year relaxing the FDA’s conflict of interest policies. “The ostensible goal?” Goozner asks. “To speed up the review of medical products. That legislation followed statements by the FDA Commission[er] Margaret Hamburg that the agency was having difficulties finding people without conflicts of interest to serve on its 55 committees.”

Conflict of interest laws can be suspended if the agency needs a particular person’s expertise; it grants a waiver provided the conflict is disclosed to the public or if it is deemed too minor to affect someone’s judgment. But the price of compromised judgment is not quantified.

Goozner says that U.S. universities, research institutes and private practices yield a large resource of nonconflicted experts who are “just as knowledgeable as people who sign consulting deals with industry. Moreover, eliminating the whiff of impropriety that appointing scientists with conflicts of interest brings would maintain the public’s faith in the integrity of the process, even if the appointee swears up and down that is or she isn’t biased by the relationship.”

When political expedience compromises patient safety, it’s no longer grist simply for Beltway chatter. As one practicing cardiologist quoted by Goozner said, “Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process.”

Goozner isn’t the only prominent critic of the FDA’s shady process. As noted on AboutLawsuits.com, the Project on Government Oversight wrote a letter requesting that a new meeting about Yaz/Yasmin be held.

We join this chorus of voices for competence and transparency in government -- especially when it concerns the public's health.

Bookmark and Share

January 2, 2012

Unnecessary Testing Happens When Doctors Own Medical Equipment

When a diagnostic test result is negative, usually it’s cause for relief. But when the preliminary results of a study showed that nearly 9 in 10 MRI scans were negative, eyebrows were raised.

Not because the test results were questionable, but because of who owned the equipment used to conduct them. As described in a story on MedPage Today, the study, presented at a meeting of the Radiological Society of North America, involved patients who were sent for testing by physicians who had a financial interest in the MRI equipment.

It also showed that doctors with a financial stake in the device referred much younger patients for the test than those referred by practitioners who did not benefit financially from use of the imaging equipment.

It’s a pretty straight line from that set of data to conclude that docs with a financial interest in the medical device might be ordering unnecessary scans. So said the researchers. We have written about such conflicts of interest as well.

Increased spending on diagnostic imaging, one researcher noted, is due to several factors: imaging technology has improved, patients demand its use and clinicians are practicing defensive medicine (that is, ordering tests that might be of questionable need or usefulness in an effort to suppress lawsuits if somebody experiences an unwelcome outcome -- a concept that many of us challenge as more myth than reality). Two-thirds of the cost of imaging tests goes to the physician-owners, of whom only 1 in 3 is a radiologist. Hospitals and other providers get the rest.

That’s why the researchers decided to study whether nonradiologist clinicians who owned scanning devices were more likely to order imaging tests for, in this case, lumbar spine scans.

They reviewed charts for 500 such cases. Some of these patients were seen at a medical practice with a financial stake in the MRI and some were seen at one that did not. All scans were read by radiologists with no financial interest in the equipment.

They found no difference in the average number of lesions among scans that were positive (meaning that the severity of the problem was the same in both groups). The difference in the number of negative scans order by doctor-owners, however, was astounding. And the age difference in patients for that group was notable as well—they were more than seven years younger on average.

"We're not saying these studies are necessarily unnecessary, but when there's a clear difference between the scans ordered for these two groups, and the only difference is whether the [clinician] owns the scanner, that makes you think there's a tie," said one physician who served as an adviser on the research. "We're not sure if it's conscious or unconscious."
"Still," he said, "if the positives are the same, but one group has more negative scans, then at a minimum you have to wonder what the reason for ordering that scan is."

Yes, you do. You need, he said, stricter and more transparent information about scanner ownership. You need to re-examine federal Stark laws, which regulate physician self-referral of Medicare and Medicaid patients. Stark allows these programs to pay physicians for tests if the devices used are in their offices. You need, he said, to figure out ways to slow the growth of medical costs.

One way is to know whose pockets are lined when tests are prescribed that might not be necessary to solve a problem someone might not even have.

Bookmark and Share

November 9, 2011

Dining with Drug Reps Proves Unappetizing

As the saying goes, keep your friends close and your enemies closer.

Not that we know for sure that behavioral economist Dan Ariely considers pharmaceutical manufacturers “enemies,” but we know he’s onto their practices that are not exactly in the best interest of patients. He and a colleague recently had dinner with a few pharmaceutical sales representatives to find out the tricks of their trade, which is getting doctors to prescribe their companies’ drugs.

Trick No. 1: “One of [the reps] told us a story about how he was once trying to persuade a reluctant female physician to attend a seminar about a medication he was promoting. After a bit of schmoozing, she finally decided to attend – but only after he agreed to escort her to a ballroom dancing class.” A fine example of, Ariely says, if-you-scratch-my-back-I’ll-scratch-yours.

Trick No. 2: “[B]ring meals to the doctor’s office. … [O]ne office even required alternating days of steak or lobster for lunch in exchange for access to the well-fed doctors.”

Trick No. 3: “When the reps were in the physician’s office, they were sometimes called into the examination room (as ‘experts’) to inform the patients about the drug directly. And the device reps experienced a surprisingly intimate level of involvement in patient care, often selling medical devices in the operating room, while the surgery was going on.” (Comment by Patrick Malone: What's really shocking is that these sales reps have at most a bachelor's degree and a few weeks of training from their employers.)

So, Ariely asks, what should be done about this shocking insinuation of commerce into medicine? “[R]ealize that doctors have conflicts of interest. …[P]lace barriers that will prevent this kind of schmoozing, and keep reps from accessing doctors or patients.”

And have dinner with somebody else.

Bookmark and Share

November 7, 2011

Doctor's Conviction Goes Far Beyond Mere Malpractice

Propofol is a surgical anesthetic safely used only in a hospital operating room or a comparably equipped medical facility with continuous monitoring of the patient's heart rate and breathing. The idea of using propofol as a sleep aid in a private home, with a doctor occasionally looking in? Unthinkable, before Michael Jackson's death.

Now Dr. Conrad Murray has been convicted of manslaughter for his role in Jackson's death. Murray was supposed to be Jackson's personal doctor, a unique physician with only one patient, who was paid $150,000 a month by Jackson's concert agency to keep the singer healthy.

Medical malpractice occurs when a doctor violates basic patient safety rules and causes harm to a patient. But this was much worse. Dr. Murray was guilty not just of breaking rules, but of a fundamental conflict of interest. Apparently seduced by his large monthly salary, he threw his medical judgment out the window and let Michael Jackson wheedle him into dangerous and ultimately fatal behavior with powerful prescription drugs. If he had "just said no," like any ethical, responsible physician would have done, Jackson presumably would have shopped for some other doctor to supply him drugs. But then Jackson's death would have been on some other hands, and Murray would not be facing prison and loss of his medical license.

While this is a particularly egregious example, conflicts of interest are common in medicine, from unnecessary surgery to advocating drugs, surgical devices and other treatments based on the doctor's relationship with the drug or device manufacturer.

Bookmark and Share

October 24, 2011

Under Scrutiny, Orthopedic Device Manufacturers Cut Dough Flow to Surgeons

A review of money paid over three years from orthopedic device manufacturers to orthopedic surgeons is an eye-opening manual of influence-peddling at best and conflict of interest at worst.

A study published in Archives of Internal Medicine concluded that once surgeons were required to disclose these payments, they declined in both total number and amount. Also notable was the increase in the proportion of consultants with academic affiliations.

The study was prompted by the U.S. Department of Justice (DOJ), which in 2005 investigated payments to orthopedic surgeons by the five largest manufacturers of artificial hips and knees.

“There is ongoing discussion of physician relationships with the pharmaceutical industry and medical device manufacturers,” the study authors wrote. “Our objective was to use data made available by [the DOJ] lawsuit to describe the extent of orthopedic surgeons’ financial relationships with implant manufacturers.”

The study defined the number of surgeons receiving payments and the amounts paid, comparing that data in the years before, right after and a couple of years after the DOJ settlement with the manufacturers in 2007.

In 2007, the manufacturers paid 939 orthopedic surgeons more than $198 million. In 2008, they paid 526 surgeons more than $228 million, but this figure includes $109 million in royalty buyouts from one company.

When limiting analysis to only the three companies that reported data for all four years, the authors found that the average payment by device makers per surgeon was $212,740 in 2007, $193,943 in 2008, $246,867 in 2009 and $233,108 in 2010.

But the proportion of surgeons receiving payments who had academic affiliations increased from fewer than 4 in 10 in 2007 to more than 4 in 10 in 2008. A similar pattern was seen in 2009 and 2010 for the three companies that continued disclosing payments by choice.

Of course, without mandatory disclosure, who knows how much was paid to whom. The authors concluded, “There is a need for clearer specific requirements for disclosure to allow for meaningful long-term analyses to be performed.”

In an accompanying commentary titled "Industry Payments to Physicians," Dr. Robert Steinbrook of the Yale School of Medicine analyzed the study findings. “Unfortunately, the public data provide no information about how the payments relate to research and device development, the choice of hip or knee implant or other aspects of patient care,” he said.
“The disclosure of industry payments should not divert attention from the real issues with regard to conflict of interest. These are the minimization or elimination of financial ties between physicians and industry in areas other than research support, bona fide consulting related to basic and clinical research, and legitimate payments related to intellectual property.”

“In the United States, the rules regarding the disclosure of industry payments are about to change,” Steinbrook notes. “With mandatory disclosure of payments and amounts imminent, there should be many new opportunities to better control conflicts of interest in medicine.”

Here, here.

Bookmark and Share

October 9, 2011

The Award for Most Fear-Mongering Health Care Statement of the Year ...

... goes to Skip Lockwood, head of a prostate cancer advocacy group called Zero. When the US Preventive Services Task Force recommended against routine screening of men with the PSA blood test, Lockwood said the PSTF's advice "condemns tens of thousands of men to die this year and every year going forward..."

Prostate cancer kills about 30,000 American men a year, so if Lockwood is right, that means the PSA test would have prevented MOST of those deaths. If it was that obviously beneficial, why would so many doctors and health care leaders have such doubts? Last year, in a less publicized statement based on the same research studies, the American Cancer Society also pulled the plug on its advice for screening with the PSA test.

The fact is that fears of just this kind of over-the-top reaction caused the PSTF to delay its advice for two and a half years after definitive studies came out from Europe and the US showing that PSA testing just doesn't do the job of putting any measurable dent in the death rate from prostate cancer. The PSTF was cowed by the blowback to its last big recommendation: that the numbers don't justify routine mammograms for women in their 40s.

PSA testing has generated a billion dollar industry of urologists doing surgery on men, with high rates of impotence and incontinence in their wake. At the risk of making a bold statement in the opposite direction of Mr. Lockwood's, it's almost malpractice now to put men into routine prostate cancer screening when the odds are much greater for harm than help.

Even the inventor of PSA testing came out last year against its routine use in low-risk men. The test is best reserved for high-risk men who need monitoring after they've already had prostate cancer and need to know if it's coming back.

But don't try to confuse the advocates with scientific facts. They'd rather play on emotions.

Article first published as The Award for Most Fear-Mongering Health Care Statement of the Year ... on Technorati.

Bookmark and Share

September 18, 2011

Dollars for Docs: Learn How the Big Bucks Flow from Drug Manufacturers

In 2013, by law all drug and medical-device companies will be required to report to the federal government how much they spent promoting their products. It’s a long-overdue effort to shine a cleansing light into the murky closets of Big Pharma.

The figures will reflect not only expenses for advertising but fees for doctors who are paid to speak about their wares in what are often described as "educational" seminars.

Until 2009, such pharmaceutical company payments were not disclosed. But the enormous sums came to light under pressure from lawmakers or as a condition for settling federal whistle-blower lawsuits. Some companies have reported the first full year’s payments, and thanks to the stark comparisons of how much they paid, some appear to be tightening their purse strings.

As described in a series of articles by the investigative service Pro Publica, this world of conflicting interests is wide and deep and soon to be accessible to any patient who wants to check up on the professionals who treat them.

In its recent gob-smacking dish, Pro Publica reports that eight pharmaceutical companies, including the nation's three largest, doled out more than $220 million last year to promotional speakers for their products. Industry leader Pfizer, with drug sales of $26.2 billion last year, spent $34.4 million on speakers, ranking third among the eight companies. Eli Lilly and Co. spent the most on speakers, $61.5 million, and had about half the sales of Pfizer.

The data about payments to health professionals in 2010 published by Pro Publica also includes information about expenditures for travel, meals and other perks that encourage people to think nice things about the companies that make their lives so comfortable.

Some companies have reduced their doctor-payment budgets since disclosure has become common. Cephalon paid physicians nearly $9.3 million in 2009 for speaking and consulting, and $5 million last year. AstraZeneca cut speaker spending from about $22.8 million in the first half of 2010 to about $9.2 million in the second half.

And, no surprise, some physicians have reduced their shill-for-pills work in the bright light of public disclosure. One pulmonologist was paid at least $88,000 for promotional talks on behalf of GlaxoSmithKline in 2009, but last year she declined the work out of concern that patients would think her advice was tainted.

And that’s the bottom line for patients: Can you trust the advice or treatment of someone who is paid by companies whose products are vying for a role in your care?

Like the hematologist who was paid $49,250 from Cephalon in 2009, and $177,800 (plus $35,500 for travel) in 2010? Is it any wonder that he didn’t return calls from Pro Publica’s reporters?

One pain specialist who spoke and consulted for four companies has earned $522,113 since 2009. In a companion commentary published in the Los Angeles Times, the Pro Publica reporters noted that this anesthesiologist’s slides identified him as the director of pain management at a well-known urban hospital. But that hospital’s spokesman said the physician has never held that title and that his pain clinic is not part of the hospital, even though he does have admitting and treating privileges.

He didn’t return calls either.

Maybe the poster girl for questionable behavior courtesy Big Pharma is Dr. Christiana Goh Bardon, who, as Pro Publica reports, “runs a hedge fund in Boston that bets on the rise and fall of health-care companies. She was paid nearly $308,000 to ‘provide input on our BioTherapeutics business development plan,’ Pfizer spokeswoman Kristen Neese wrote in an email.

“Bardon, who started her hedge fund after her Pfizer contract ended, was required to sign a confidentiality agreement and not allowed to invest in Pfizer or any of the biotech companies that Pfizer was looking at acquiring or partnering with for projects, Neese said.

“Bardon said in a voice-mail message that she does not currently practice as a physician and her work was based on her business acumen.”

From a patient safety point of view, business and medicine do not make a happy marriage. It’s in patients’ best interest to know who and what are influencing their doctors’ decisions. Until 2013 when all companies post their payments for your review, ask your doctor if he or she is being paid by pharmaceutical or device manufacturers. If you’re prescribed a drug, ask if there’s a generic or older version available, and if it has more side effects than a competitor’s drugs.

You can also review your state’s medical licensing board website for disciplinary or criminal issues your physician might have had.

To see if your physician has been on the Big Pharma payroll, search the Pro Publica database called Dollars for Docs at http://projects.propublica.org/docdollars/.

Bookmark and Share

July 25, 2011

Beware Drug Companies that Pretend to Be Your Social Media Friend

Technology is a wonderful thing. Most of us rely on it to do our jobs, remain informed, communicate and plan and participate in recreational activities.

But like a wonder drug that can render a dread disease a manageable irritant, technology has side effects and some of them are dark, indeed. Writing on his health news blog, Gary Schwitzer recounts the ominous tale of a pharmaceutical company's sly efforts to pretend to be a Facebook friend but whose motives were clearly mercenary.

Marilyn Mann is a well-informed medical consumer; she has to be, she's a breast cancer survivor whose daughter has heterozygous familial hypercholesterolemia (FH), a genetic disease that elevates LDL cholesterol to dangerous levels. She is an administrator of a Facebook group--Familial Hypercholesterolemia (FH) Discussion Group--that enables networking for people with FH and their family members.

Schwitzer reports that recently, Mann got a message from a public relations woman who had joined the Facebook page: "A few months ago, I had emailed you about some research I was doing about a new treatment for FH. I am now working with a pharmaceutical company, and the company currently has a drug in development to help treat people with severe FH that may not be responding to current therapies."

The PR woman continued: "I am trying to do exactly what you are doing--to educate patients and physicians about this disease and to raise awareness so that undiagnosed patients can get the help they need. ... I thought it might be good for us to connect so that I can explain to you a little about what the company is doing and to see how we can work together to reach a larger audience. Through my work in FH, I am regularly in touch with many of the world's leading researchers and the people who work at the company to discuss ways we might be able to collaborate...."

On its face, the approach was friendly and compassionate. Mann spoke with the PR woman, who disclosed that she was working for Genzyme, the company developing the drug to treat FH. The woman wanted Mann to recruit journalists to generate stories about people with FH.

Mann politely declined, saying, "Genzyme's purpose is to sell their products. My purpose is to help patients. Those two goals are not the same."

Not only was the PR person actively trying to manipulate the news--there's a difference between raising awareness about a disorder most people never heard of and working to ensure your employer has skin in the game--but her behavior could be seen as a form of electronic stalking. "I think it was creepy for this PR woman to join the Facebook page,"Mann told Schwitzer, "lurking there and observing on behalf of her drug company client. The idea of having a drug company planting human interest stories in the press is yucky ...a big corporation pulling string behind the scenes. I'm not interested in being used in that way."

As the informed person she is, Mann knew about the Genzyme drug, believed it had limitations based on trials and so informed the PR person.

The PR rep had clearly identified herself, her employer and the nature of her interest in the Facebook community. So why was her attempt to exploit it so unseemly?

As Schwitzer noted, it wasn't just the attempt to join a discussion group because of its potential usefulness for a certain company, it was the attempt to influence news coverage that that was so offensive. Whether you're voting for your local school board, signing a legal contract or making a determination about treatment for a medical condition, you need objective, complete information. Such decisions aren't made by listening to feel-good human interest stories.

Genzyme intended its FH drug not as first-line therapy, but as an additional treatment for people whose cholesterol is not controlled with a statin. Typically, those patients have the most severe forms of FH. It is their stories Genzyme wants the media to tell, not those of people who can control their cholesterol with a statin--they don't need another drug.

Schwitzer says tactics like those of Genzyme might fall under the category of "disease mongering," an effort to "sell" sickness by profit-driven interests beyond the boundaries of what science and medicine accept. The subject is well covered in PloS Medicine by writers Ray Moynihan and David Henry. The point, they say, is to sell products, not to inform, educate or otherwise help medical consumers understand and maintain their health.

If you're a member of a medical-topic social media group, be aware that sometimes a fox gains entry to the henhouse with very little commotion. If you're asked to tell your story, or to find other people who will, make sure it's for the greater good, and not just somebody's bottom line.

Bookmark and Share

July 18, 2011

The Difference between Pharmaceutical Research and Marketing Blurs Yet Again

The road from conception to useful application for a new drug therapy, when properly navigated, is fully mapped, carefully followed, scientfically rigorous and honestly appraised. Not so with a big study of the lucrative drug Neurontin, according to Yale researchers.

In the case of Neurontin, a drug to treat epilepsy, critical parts of that journey took a few unauthorized detours, according to a report in the Archives of Internal Medicine.

Researchers at the Yale School of Medicine reviewed documents relating to the epilepsy drug gabapentin, a drug patented as Neurontin by Pfizer in 1994, that they concluded were misrepresented by the pharmaceutical company as a clinical trial.

Instead, they said, it was a “seeding trial,” which they described as “An important and expensive form of marketing, … a study of an approved drug or device in which the primary objective may not be to answer an important scientific question but rather to introduce a new product and induce clinicians to use it.”

In other words, seeding trials juice the market by enticing practitioners to sample and prescribe a drug that’s already FDA-approved.

Joseph Ross, M.D., said that Study of Neurotonin: Tritrate to Effect, Profile of Safety (STEPS) “was a seeding trial posing as a legitimate scientific study. The trial itself, not trial results, was part of a marketing strategy used to promote gabapentin and increase prescribing among investigators without informing trial patients or investigators."

As noted in the Los Angeles Times, the STEPS study also was intended to fend off efforts by a competitor to introduce a rival drug.

The breach wasn’t against the law, but it wasn’t ethical because the purpose was primarily to promote, not to discover, and because trial participants and physicians might be unaware of the studies’ true purpose.

The Yale team said STEPS’ stated purpose was to examine doses of gabapentin within a patient population of 2,759. Two articles about its results were published in scientific journals, but, the team noted, outside sources had questioned the study’s design as uncontrolled (that is, it didn’t include a separate, or "control," group of participants who didn’t receive the drug). In addition, it was not a blind study. Scientific rigor demands that study participants remain unaware—blind—about whether they are receiving a drug or a placebo (fake drug).

There's more. The Yale team said, "Data quality during the study was often compromised," and some documents appeared to suggest that marketing personnel helped to collect data and witnessed the trial, not just the results.

Article first published as Neurontin Research Was So Flawed It Deserved to Be Called Marketing, Not Science on Technorati.

Bookmark and Share

June 30, 2011

The Going Rate for Compromising A Surgeon's Principles and Patient Safety: $16 Million

That's the sellout price for a spine surgeon. Give or take a few million.

Like police officers, whose thin blue line separates them from “the other,” medical researchers and doctors are loath to diss their fellow professionals. But this week, the code of omerta was breached with a series of critical reports in The Spine Journal about industry-sponsored research in general and the use of a bone growth product in particular.

As noted in the New York Times, “It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.”

At the center of attention is Infuse, a product manufactured by Medtronic that’s used in more than 100,000 spinal fusion surgeries in the U.S. each year to encourage growth of new bone so the spine fusion "takes." The Spine Journal articles claimed that researchers subsidized by Medtronic exaggerated the benefits of Infuse and minimized the risks.

All surgical procedures and all medical products carry some element of risk, large or small. Dumbfoundingly, some of Infuse’s defenders claimed it had no risk. None. Zip. Nil. Uh-huh, and I’m vacationing next month on Jupiter.

In a joint editorial, five doctors wrote, “It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research.”

Objective research and the “do no harm” vow apparently have their price, and for some of the so-called “scientists” championing Infuse, it is $12 million to $16 million—the median amount collected by researchers from Medtronic. Median. That means half got more. Clearly, for Medtronic, corrupting science is a good investment: In the most recent fiscal year, Medtronic earned an estimated $900 million from Infuse.

Infuse was approved by the FDA in 2002 for one type of spinal fusion, and as required, Medtronic reported complications in its use that the agency considered sufficiently significant to require the company to list them on the product label. But, as the New York Times explained, “in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.”

In addition to its approved use, Infuse is used for other spinal procedures. The Justice Department, however, has been conducting a criminal investigation to determine whether Medtronic illegally promoted such off-label uses, which the company denies.

At this point, Medtronic's credibility, and that of the people who speak for its scientific authority, is thin.

Bookmark and Share

June 23, 2011

What doctors are paid and how it affects your care

Chances are, you or a family member has been the beneficiary of a freebie from the doctor’s office, and we don’t mean a cherry lollipop when the kids got their tetanus booster. We’re talking drugs, often of the prescription variety, that a pharmaceutical representative has left after a marketing visit to the doctor’s office. "Samples," they're called.

We've covered the dangers and the hidden costs of "samples" for both doctor and patient previously in this blog, Today's topic is a little broader: the many tentacles of the pharmaceutical industry that reach into the doctor's office and that can affect the care you and your loved ones get. More specifically, there is a possible pay-for-play attitude that’s harder for doctors to resist as medical costs continue their upward thrust and doctors say they feel increasingly marginalized.

In “Doctor Compensation and Industry Influence,” writer Ed Silverman notes that “The ongoing controversy over financial ties between physicians and the pharmaceutical industry centers, of course, on concerns that medical practice may be unduly influenced,” and that doctors are indignant that people could believe their medical judgment would be influenced by swag. But many doctors are unhappy with their compensation, citing costly and lengthy education and training, stressful and protracted relations with insurance companies, rising malpractice insurance premiums and patients armed with an Internet medical degree and questions about diagnoses and treatment.

There’s a lot going on here, and although much of doctors’ dissatisfaction is righteous, it’s unfair for them to expect patients to:

be sympathetic about the costs of an education they chose to pursue;
suffer their ill will in the face of greedy or incompetent insurance companies; and
simply accept that mistakes will be made and that retaining legal counsel is disloyal and unfair.

And it’s just flat-out arrogant and dismissive for physicians to prefer patients who never ask questions, who aren’t invested in their own health care and whose default is to defer to the guy in the white coat because he’s over-educated and underpaid. That’s not good for the patient or, ultimately, the practice of medicine.

A recent survey by Medscape, “Do doctors earn enough?”, generated a robust response within the medical community, and not necessarily for the numbers report (orthopedic surgeons and radiologists earn the most--$350,000 median income—and pediatricians the least-- $148,000 median), but for the ancillary issues.

Responding to the survey in “Mo money mo problems,” physician Sean Pannick drew a line of clarity for parties on both sides of the worth issue: “Doctors should look at their income and ask themselves--and their patients--whether it fairly reflects the quality of their work. Patients, on the other hand, also need to be mindful of the financial component to the doctor-patient relationship. They may not know (or want to know) that money matters when it comes to doctors, who often profit more from a series of tests and procedures than a simple clinical assessment. Conversations in the consulting room already mask a number of hidden agendas, and the issue of renumeration (sic) is another one that lurks beneath the surface.”

Absent a truly malfeasant practitioner, the quality of care a patient receives from his or her doctor probably isn’t influenced markedly by occasional, reasonable attention from members of the medical industrial complex with something to sell. But it might be affected by the efficiency of ordering a test over the harder work of having a conversation.

It is your duty to yourself and your loved ones to get the best possible care, and that means asking questions. If you wonder if your doctor has gotten paid to represent a medical product or service, ask. If you have read something on the Internet that might relate to the problem you’re presenting in the exam room, broach the subject. If your doctor is too busy, distracted or feeling too undercompensated to engage, it’s time to go doctor shopping.

Bookmark and Share

March 11, 2011

"When you're a hammer, everything looks like a nail"

Yet more evidence that expensive technology drives treatment decisions in medicine: A new survey of prostate cancer treatment shows that once a hospital invests the $1 million to $2.5 million it takes to get a surgical robot, men in the area start to get a lot more prostate removal surgery than they otherwise would.

Although heavily marketed, robotic surgery has never been proven to reduce the two big risks of prostate removal: incontinence and impotence. And each surgery with a robot is about $2,000 more expensive than those done the traditional way.

An excerpt from a New York Times piece on the new study:

One reason for the increase in operations in hospitals that own a surgical robot may be that the technology helps a hospital lure potential surgical patients away from the competition. But the data also suggest that once a hospital obtains a robot, patients who might be candidates for nonsurgical options are more likely to be steered toward robotic surgery instead.

“This may be the medical embodiment of the phrase, ‘If you’re a hammer, everything looks like a nail,’”said the lead study author, Dr. Danil V. Makarov, assistant professor of urology at New York University’s Langone Medical Center. “If you have the technology, it will get used.’’


“If you’re a hospital and you get a robot, clearly you want to use it,’’ said Dr. David Penson, a study co-author and director of the Center for Surgical Quality and Outcomes Research at Vanderbilt University. “There are some real pressures here that have nothing to do with science,” he said. “We have this interplay of patients’ fascination with technology coupled with business interests on the part of the hospital and device makers, pushing people to try a new technology perhaps before it’s been fully tested.’’

And here's a good bottom line point for patients, also from the Times article:

“For patients, there are a lot of choices in prostate cancer,’’ said Dr. Makarov. “Knowing that technology can influence both what they want and what their physician may advise them should make them a little more skeptical and maybe make them ask a few more questions.’’

Bookmark and Share

February 19, 2011

Medical Malpractice in Breast Biopsies

Most breast lumps found in women need to be looked at under the microscope to make sure they're not cancer. But new research says too many women are getting unnecessarily aggressive open biopsies, which produce a scar, when most of them could get enough tissue for sampling with a simple needle stick.

About 1.6 million breast biopsies are done every year in the United States, with about 200,000 of those resulting in a diagnosis of invasive cancer, which requires more treatment. That means that about seven in eight women who undergo biopsy receive the good news of no cancer (or the pre-invasive diagnosis of ductal carcinoma in situ).

Needle biopsy is the gold standard for the initial investigation of most suspicious breast lumps, except for those that a needle cannot reach. It can be done with numbing local anesthetic and a quick needle stick, which sometimes needs to be guided by x-ray imaging when the lump cannot be felt. In that case the needle biopsy is done by a radiologist, not a surgeon.

An open biopsy requires a one-inch incision, which leaves a scar, and must be done with either general anesthesia or sedation. It costs about twice as much as a needle biopsy, both for the surgeon's fee and the hospital's fee. And that could be the economic motivator for the persistently high rates of open biopsies still done in the U.S., according to researchers.

The new study of breast biopsies in Florida found that three in ten were done by the more expensive and scarring open technique, when the rate should be less than one in ten.

A New York Times piece on the new study quoted Dr. Melvin J. Silverstein, a breast cancer surgeon at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., as saying it was “outrageous” that 30 percent of breast biopsies were done by surgery. The article went on:

He said some of the unnecessary procedures were being performed by surgeons who did not want to lose biopsy fees by sending patients to a radiologist.

“I hate to even say that,” Dr. Silverstein said. “But I don’t know how else to explain these numbers.”

Bookmark and Share

January 20, 2011

Hype Busters: Helping You Get Better Health Care

An overdose of news media hype has long been a problem for consumers who want high quality health care but don't want to bounce from health fad to health fad. Naive and uncritical journalists who write about health care issues are a huge source of the hype overdose. So it's great to learn about a Web resource that systematically and thoroughly reviews health news and rates the quality of the stories.

The site is the somewhat stodgily named HealthNewsReview.org. With a foundation grant, it employs a team of medical journalists and physicians to critically review health news in major publications. The stories get rated on a scale of one to five stars, based on how well the following issues were addressed:

* What's the total cost?
* How often do benefits occur?
* How often do harms occur?
* How strong is the evidence?
* Is this condition exaggerated?
* Are there alternative options?
* Is this really a new approach?
* Is it available to me?
* Who's promoting this?
* Do they have a conflict of interest?

The site says its goal is: Holding Health and Medical Journalism Accountable. And it lives up to that by naming names and taking no prisoners on current health news.

A recent Wall Street Journal piece that suggested Vitamin B12 as a potential cure-all got a low two-star rating for putting out a series of unsubstantiated claims with loose anecdotes and little evidence.

A Denver Post article on an "anti-gravity treadmill" scored a lowly one star for glorifying an unproven product.

NPR and CNN Health scored highly for their well done columns on the recent research about antibiotics for kids with middle ear infection.

I give the site five stars for being a very useful resource. It asks the right questions about medical news and gives straight answers. I'm particularly keen on conflicts of interest and other things that tend to get underplayed in much coverage: for example, the hidden harms of touted new medical devices.

Article first published as Hype Busters: Helping Patients Get Better Health Care With a Dose of Skepticism on Technorati.

Bookmark and Share

November 10, 2010

Maryland Hospital Pays Feds in Cardiac Malpractice Scandal

St. Joseph Medical Center in Towson, Maryland will pay $22 million to the federal government to settle claims that it engaged in a decade-long, illegal kickback scheme with the cardiology group MidAtlantic Cardiovascular Associates, which was co-founded by Mark G. Midei - the cardiologist accused of performing hundreds of unnecessary heart procedures.

More than 100 patients have filed malpractice lawsuits against the hospital and Midei. He was taken off duty in May 2009 under suspicion that he had falsified patient records to justify unneeded stent procedures.

Dr. Midei filed a suit against St. Joseph last month in which he said that officials there ruined his reputation by warning nearly 600 patients about his work. He denies all allegations against him.

Read more in the Washington Post article here.

Bookmark and Share

October 11, 2010

"The Mammography Wars" and Doctors' Conflicts of Interest

It was nearly a year ago that the U.S. Preventive Services Task Force caused a huge uproar with the mildest imaginable recommendation about mammograms, and now two physician researchers say it might be time to point out that certain emperors are wearing no clothes.

In their Sounding Board article in the New England Journal of Medicine, Drs. Kerianne Quanstrum and Rodney Hayward note that some of the harshest cries against the Preventive Services Task Force came from those doctors with the highest vested self-interest in maintaining the importance of mammograms: radiologists with the Society for Breast Imaging. Yet nobody seemed to notice the obvious conflict of interest.

As the authors note:

When a given service is successfully extended to more people with more intensity, the profession providing that service tends to grow in importance and profitability. In the United States, where medical specialists often enjoy an exalted status in the minds of the public, if experts shout loudly that every woman 40 years of age or older must be screened annually for breast cancer, then breast cancer must be important, screening must be a basic human right, and doctors who provide this service must have great value and authority.

But what if those experts are basing their recommendations on more than the interest of patients alone? In any other industry, we accept the idea as natural that those providing a service or product hold their own and their shareholders' interests as a primary objective. Why have we failed to acknowledge that the same phenomenon occurs in health care? Although it is true that individual medical providers care deeply about their patients, the guild of health care professionals — including their specialty societies — has a primary responsibility to promote its members' interests. Now, self-interest is not in itself a bad thing; indeed, it is a force for productivity and efficiency in a well-functioning market. But it is a fool's dream to expect the guild of any service industry to harness its self-interest and to act according to beneficence alone — to compete on true value when the opportunity to inflate perceived value is readily available.

The objective facts, as Quanstrum and Hayward point out, are that the well known economics law of diminishing marginal returns applies in health care as much as anywhere. In mammograms, as the rareness of the tested condition increases, the hidden costs of the test goes up and the value goes down.

So for women between ages 60 and 69, you can save one life by subjecting only 400 women to mammogram screening (in the process of 5,000 screening visits and 400 false alarms in the same group over 13 years of follow-up). That's enough of a benefit to encourage everybody in the age group to get annual screening.

But in women between ages 40 and 49, the data show that to save a single life, you need to subject 1,900 women to screening and endure 20,000 screening exams with 2,000 false alarm tests during eleven years of follow-up. That puts the risk-benefit equation in more of a gray area where you cannot say definitely that no one should have it, or that no one should not have the screening.

And that was exactly the point of the Preventive Services' recommendation: To put the issue into the hands of individual doctors and patients and let them decide if family history or individual anxiety are enough to make the patient want to have the test. That's not a cop-out, it's a prudent bow to individual self-determination.

Here's another quote from Drs. Quanstrum and Hayward:

We must acknowledge that just as in any other profession or industry, self-interest is unavoidably at work in health care. Rather than even acknowledging practice guidelines offered by vested experts, we ought to borrow from the wisdom of sound governance and implement a system of checks and balances when it comes to the interpretation and application of medical evidence. At the same time, we need to recognize that these two tasks are distinct. Although the interpretation of medical evidence is (or ought to be) a scientific exercise, the application of that evidence, as in guideline formation, is ultimately a social exercise.

Decisions regarding practice guidelines can, and certainly should, be informed by evidence. But they will always require value judgments regarding how much evidence is sufficient to dictate care, for example, or whether and to what degree costs should be considered. By separating the processes of evidence review and guideline formation, fair disagreements about the quality or substance of the evidence can occur separately from, and before, disagreements about the implications for clinical care.

Bookmark and Share

June 10, 2010

Malpractice Suit Exposes "Ghost Surgery" at the Cleveland Clinic

Sometimes patients sign up for surgery with an experienced surgeon who then allows a doctor in training, with far less experience, to do the actual surgery. If this hasn't been disclosed up front by the surgeon and agreed to by the patient, the switcheroo is called "ghost surgery," and it's not acceptable. But exactly that has now occurred at the prestigious Cleveland Clinic, according to allegations in a new malpractice lawsuit reported by Diane Suchetka in the Cleveland Plain Dealer.

Retired Air Force Colonel David Antoon says in his legal complaint filed in court that he, his wife, and the surgeon, Dr. Jihad Kaouk, signed a consent form in advance agreeing that only Dr. Kaouk would do the surgery to remove Mr. Antoon's prostate gland. He alleges in the suit that he has been left incontinent of urine and sexually impotent as a result of Dr. Kaouk allowing junior doctors to do the surgery.

The patient also contends that the hospital ombudsman who investigated his informal complaints told him there was no such consent form in his records at the hospital.

Surgical volume is critically important to a good outcome for prostate surgery, as previously reported on this patient safety blog. The author of one study in the Journal of the American Medical Association said he didn't feel comfortable about his own competence with the "robot" device now widely used for prostate removal until he had had several hundred cases under his belt. So it's understandable why Mr. Antoon would feel outraged that his wishes weren't followed.

I discussed "ghost surgery" in my book, "The Life You Save." Here is my advice for how you can avoid having this happen to you:

First, have a good discussion with the surgeon about who is going to do the critical parts of your surgery. If you don't feel comfortable turning over those aspects of the surgery to a doctor in training, then say so.

Second, follow up by putting it in writing. One simple way to do so is on the consent form. It usually says something like "I authorize Dr. Jones and/or his designee to perform _____ [type of surgery filled in here] on me." All you have to do is cross out the phrase "and/or his designee" and initial your cross-out.

Third, if you're in a teaching hospital, you might want to consider some compromise that lets trainee doctors do the non-critical parts of the procedure. But you have every right to insist that only the experienced doctor do the delicate, critical work. If the surgeon resists your wishes, you may have to go to another surgeon.

Bookmark and Share

June 7, 2010

Why Is U.S. Health Care So Expensive?

A new report comparing the United States to other industrialized countries has a depressing list of all the ways that America outstrips other countries in money spent but lags behind in health quality results. For example:

* Per person, the U.S. spends twice as much on health care as on food, and much more than the average Chinese person spends on EVERYTHING. (See slide #1 of the interactive graphic of the McKinsey Global Institute report here.)

* "Branded" prescription drugs are 77 percent more expensive in the U.S., and because we use a more expensive mix of drugs than other countries (being quicker to adopt new and expensive drugs), the average spending on drugs per person is more than double other industrialized countries. (Slide #8.)

* We lag behind 22 other advanced countries in life expectancy but spend around $650 billion more per year than our population's mix of health conditions would predict. (Slide #4)

* Administration costs -- paperwork, claims processing, etc. -- are on average five times more expensive in the United States. (Slide #9.)

* The care in the U.S. is much more intense than elsewhere -- more expensive surgical procedures, more diagnostic tests, but we spend less on prevention than elsewhere.

* We also are shifting more to outpatient care instead of care with overnight stays in hospitals, but that has not cut costs. The outpatient care is much more profitable for providers than inpatient care, and it tends to be more intense.

The New York Times did some arresting graphics on the McKinsey report. Click here to see them. Note that the U.S. appears as a red dot, "peer" European economies like Germany and the UK are yellow dots, and other industrialized countries are gray dots.

The red dot never wins on these graphs -- except on expense.

Bookmark and Share

June 1, 2010

Conflicts of Interest: Not Bad People, Just Human

Recent news on this blog about unnecessary heart stents in Baltimore and overly complex back surgeries across America may give some readers the wrong idea. This malpractice and patient safety blog is not about good versus evil and picking a doctor to trust because you decide he or she is a "good" trustworthy person. Instead, it's about recognizing that doctors are human too and are subject to the same self-interest as the rest of us -- and this can subtly tilt them to make recommendations for treatments that may not really help us.

I was struck by this when reading a letter to "The Ethicist" column in the New York Times Magazine. The writer was a husband whose wife had been told she needed a CT scan, and the doctor sent her to a radiology lab that he owned. The husband said: "I'm OK with this lab -- I say you either trust the specialist or you don't -- but my wife is not so sure."

Columnist Randy Cohen responded by quoting bioethics professor Katie Watson of Northwestern University:

"I trust my physicians not to be criminals who intentionally order unnecessary tests to feed their yacht habits. I also trust them to be human beings, which means they're vulnerable to subconscious influences and incentives just like the rest of us."

That's exactly right.

This is not to excuse those doctors who create conflicts of interest for themselves that they could easily avoid. There's no reason to buy a CT scanner for your office when there are plenty of others available.

Nor is it to excuse the doctor for failing to disclose up front to the patient that he has an ownership interest in the imaging machine. Patients shouldn't have to cross-examine their doctors to get this basic information.

But it is to say that patients need to learn how to be sophisticated consumers of the medical industry. This is not a question of "do I trust or don't I?" And it's not a matter of trading naive trust for paranoid suspicion. It's just to recognize that we're all human, and that the medical industry unfortunately has many built-in conflicts of interest for doctors that require patients to look out for themselves when it comes to getting sound medical advice.

So ask lots of questions, do your own research, and get second and third opinions. You'll be healthier for it.

Bookmark and Share

May 28, 2010

Surgery for Back Pain: Less Is More

Nearly every week, I hear about a patient who had surgery to relieve terrible chronic back pain and ended up far worse off than before. One of the biggest problems is that money motivates surgeons to talk patients into much bigger and more complex operations than they really need -- and then those surgeries result in predictable complications.

The greed allegation sounds a bit harsh, but it comes straight from the top: The Journal of the American Medical Association, in an editorial by a leading Stanford orthopedic surgeon, Eugene Carragee, and in a study carried out by a group of doctors at Oregon Health and Science University led by Dr. Richard Deyo.

The Oregon study found that the rate of complex surgeries for back pain in Medicare patients jumped by 15-fold over a recent five-year period, but there was nothing in the patient population -- like increasingly complicated back deformities -- to justify the increase.

Joanne Silberner of NPR reported:

Deyo says there's no reason to think people suddenly started developing the spinal deformities that justify the complex surgeries. He offers several possibilities for the upswing. "Many surgeons genuinely believe that the more invasive procedures offer some benefits," he says. "But certainly there are important financial incentives at play as well." Surgical fees for simple decompressions are about $600 to $1,000. The complex surgeries earn surgeons as much as 10 times more. He says another possible factor is the tendency for both doctors and patients to go for a new, more expensive approach just because it sounds better.

The problem is that the more complex surgeries carry at least double the risk of a bad outcome, according to the Deyo study.

Most back pain that isn't relieved effectively with medicines or other non-surgical therapies is caused by disk herniation or spinal stenosis. Spinal stenosis is growth of bone near a nerve coming out of the spinal cord which presses on the nerve root and causes pain to radiate down a leg. The vast majority of patients who need back surgery because of spinal stenosis can be benefited from a fairly simple lumbar decompression. This involves removing bone, ligament and facet joint material which is compressing the nerve root. This operation has a high degree of success as it's been developed over the last 20 years.

According to Dr. Carragee's editorial, if the patient also has some deformity of the spine -- front to back or side to side -- the simple lumbar decompression can result in spine instability with increased deformity, so those patients might need a fusion where adjacent vertebrae are fixed together with bone grafts. But even here, simpler techniques get just as good results than more complex procedures that add metal or other instrumentation into the back.

A very small minority of patients, says Dr. Carragee, have spines that are so collapsed and twisted that the spine is unbalanced and tilted forward and the patient has severe pain and poor quality of life. These are the patients who might qualify for the complex surgeries now being done so commonly. Techniques have improved in the last ten years, but the surgeries in these patients still carry a very high complication rate -- 30 to 40 percent. And a lot more patients are getting the complex, multi-level surgeries than is warranted by the medical evidence, according to Dr. Carragee and other researchers.

Consumer Reports has rated spinal surgery as No. 1 on a list of overused tests and treatments.

As quoted by NPR, Dr. Deyo said he would like his study to alter the practice of medicine. "The effect I would hope it would have is to have surgeons and patients choose the least invasive procedure that would accomplish the surgical aim," he says. But he's pessimistic about it, unless there's a change in the financial incentives.

This is yet another area of medicine where it pays for patients to be skeptical and to get multiple opinions. It fits our natural instincts to think that bigger and more elaborate surgeries have a higher likelihood of success, but the human body proves over and over that it prefers minimal interventions.

Bookmark and Share

May 23, 2010

Update on Baltimore Cardiac Malpractice: Victims of One Doctor Could Exceed One Thousand

The scandal of Dr. Mark Midei, the cardiologist at St. Joseph's Medical Center in the Baltimore suburb of Towson, Maryland, is scaling new heights in the number of victims counted. The hospital mailed letters to 585 Midei patients informing them that an independent review shows they may have received heart stents unnecessarily for artery narrowing that Midei grossly exaggerated. But now, according to the Baltimore Sun, many more patients are coming forward whose procedures were done outside the two-year arbitrary time limit the hospital set for its own review. It appears now that the total number of cases of unnecessary heart stents could easily exceed one thousand.

Read more here.

Bookmark and Share

May 22, 2010

Baltimore Medical Malpractice Scandal Shows Systemic Problems of Hospital Peer Review

Hundreds of patients appear to have received cardiac stents that they didn't need from Dr. Mark Midei, a cardiologist at St. Joseph's Hospital in Towson, Maryland. So why did no one at the hospital blow the whistle? And why did the patients not realize that Midei was rushing them into unwise and risky surgery?

Heart surgery is highly profitable, and there are no incentives for doctors or hospital administrators to rock the boat by raising questions when one cardiologist is putting stents into far more patients than his colleagues.

As for the patients, we Americans have a bias toward dramatic action. If one doctor tells us we need a stent to prop open the coronary arteries in the heart, and another doctor says all we need to do is take a pill every day, most of us will tilt toward the big intervention. Which can be a big mistake, because we then get a piece of metal permanently implanted in a blood vessel, and we have to take medicines anyway for the rest of our life to avoid getting blood clots from the metal that could cause a devastating stroke or more heart damage.

Recently in this blog, I pointed readers toward an excellent review by the Harvard Medical School of the scientific evidence on who should -- and shouldn't -- get the balloon and stent treatment for opening their heart arteries. Many studies have found that unless a patient is having repeated symptoms, the stent treatment does nothing to extend his or her life, even if an artery looks dramatically narrowed.

In the case of Dr. Midei, it appears that outright fraud might have been involved. You have to have a significant narrowing of the artery, 70 percent or more, to even start to qualify for stent treatment, and Midei aggressively over-read his own X-ray studies of the heart's blood vessels to make it seem that patients had much worse narrowing than they really did, according to the published allegations about his practice.

This raises a Fox/Henhouse issue: How is it that a cardiologist can do his own testing to see if someone needs treatment, and then be the one to profit mightily if the decision is yes, they need it? Should second opinions be mandatory on any patient with blood vessel narrowing?

Dr. Bob Wachter, a patient safety pioneer at UCSF medical school in San Francisco, wrote a thoughtful blog on this topic. I'm reprinting part of it below, and urge readers to read the whole article here.

Dr. Wachter writes:

Obviously, the Mideis of the world could be caught by requiring that every cath [blood vessel X-ray] undergo an independent second reading. Some insurers in New Jersey now require such readings before they authorize a stent, and at least one SoCal Kaiser hospital mandates that each cath be presented at a conference before a treatment decision is rendered, analogous to what many tumor boards do for cancers.

Such required peer review might have benefits beyond simply preventing the rare case of fraud. If done well, it might also ensure that other conflicts of interest and non-evidence-based decisions are avoided to the degree possible. For example, a meta-analysis in last month’s Annals of Internal Medicine illustrates the limited value of percutaneous coronary interventions – whereas older studies found that PCI was more effective than medical therapy in treating angina, more recent studies show that these differences have narrowed or even vanished. I’d guess that, when recommending a treatment for a patient with mild angina and a 60% LAD lesion, a peer review group is more likely to pay attention to this kind of evidence than the average cath jock – who may not only be staring at his kid’s private school tuition bill but also at a patient whose bias is to see a stent as a more intuitively satisfying solution than “just medications.”

Some will argue that mandating second opinions for every cath is the equivalent of hitting a nail with a sledgehammer, and they might well be right. However, I do favor at least random over-reads of a sample of catheterization studies. Something like this already happens in a few specialties. In many teaching hospitals, a random sample of pathology studies is reviewed by a second provider. In a few forward-thinking practices, radiologists re-read a sample of x-rays, looking for discrepancies. In response to this case, in fact, St. Joseph’s now requires that 5% of its cath cases undergo a random and blinded re-review. Random audits won’t catch every case of fraud, any more than IRS audits catch every tax scofflaw. But they do help keep people honest, particularly if the audits are coupled with a culture in which the docs welcome feedback and strive for continuous improvement.

Speaking of which, the Midei case made me wonder about the institutional culture at St. Joseph’s. Was Midei a rogue interventionalist working in isolation? Perhaps so – it's common for no other doc to be looking over the shoulder of a cardiologist and his cath readings. But cardiologists don’t perform caths on desert islands – they are assisted by cath techs and nurses. In my experience, these folks become as adept at reading cath films as any physician. If the allegations against Midei are true, it strains credibility to think that no one in the lab knew that inconsequential lesions were being read as tight stenoses and treated with stents.

And what about the hospital administrators? Stents are big business. When Johnson & Johnson first launched their drug coated Cypher stent in 2003, Dr. Midei told the Baltimore Sun, “This is the hottest thing in cardiology in years.” And it was: Maryland hospitals chalked up nearly $250 million in stent business in 2009, and St. Joseph’s stent revenues were $38 million, up more than 50% in 5 years. Before the case broke, St. Joseph’s advertised itself as the busiest cath hospital in Maryland, averaging nearly 20 interventional cases daily. While it is possible that no St. Joe’s leader knew precisely what was happening, I'm guessing that some did but chose to look the other way: the pressure to steer clear of the golden-egg-laying goose must have been intense. Perhaps the fact that the hospital’s CEO and two other senior executives resigned after the case broke provides a clue as to who knew what when.

Cases like this one are terribly troubling, not just because they harm individual patients but because they do violence to the trust that is so fundamental to the physician-patient relationship. Part of the solution must be more robust oversight procedures, such as mandatory second readings of randomly selected cath films.

But these cases also force us to consider the kind of culture that could allow such a fraud to take root and go on for years – a culture that likely prized the hospitals’ and physicians’ financial health over the clinical health of their patients. If the allegations are true, the penalties should be severe, not only for Dr. Midei but also for leaders who knew – or should have known – what was going on, yet remained silent.

Patients need to know that this is not just an issue of a few rogue bad apples. Medicine's fee-for-service payment system pushes doctors toward advocating for more aggressive and profitable interventions. The only way to find out what your body really needs is to shop for second and third opinions, every time. I have more on this subject in chapter 9 of my book, "The Life You Save."

The chapter title says it all: "The Second Opinion: Always Your First Choice."

Bookmark and Share

March 29, 2010

New Health Care Law Will Expose Drug Manufacturers' Gifts to Doctors

The free meals, trinkets and other goodies now lavished on doctors by the prescription drug industry will soon be a matter of public record for each doctor in the United States, under a provision of the new health care reform law. A searchable database goes into effect in 2013 that will let anyone plug in a doctor's name and find out how much largesse that doctor received in the past year. This is a positive development for patient safety in the United States.

Readers of this blog know from past reports that even small "gifts" from manufacturers are highly effective in influencing doctors' prescription writing habits. The industry spends about $1 billion a year in free meals for doctors and many more dollars in countless free pens, scratch pads, textbooks and other trinkets branded with the names of various drugs being promoted. (As we reported in another post, deep-sea fishing trips and golf junkets are also part of the blandishments.)

Do small gifts matter? Yes, as the Pew Prescription Project points out in an excellent fact sheet that summarizes the studies on how doctors' decisions about drugs are influenced by manufacturers. As the Pew researchers write:

[T]he evidence is clear: gifts, even small ones, change behavior. Such marketing drives up drug costs and sometimes puts patients at risk. Social science research ... shows that a gift of any size imposes on the recipient a sense of indebtedness. This need for reciprocity is a deep-seated human reaction. It creates in the recipient, whether consciously or not, a sense of obligation to repay favors, gifts, invitations, etc. Research shows that it takes extraordinarily little to bias an individual’s interpretation and processing of information. Such bias is both subtle and unintentional.

Now, that's "subtle and unintentional" bias on the part of the doctor receiving the gift. Most doctors will deny heatedly -- and honestly -- that drug freebies have any role in how they prescribe medicines. The manufacturers, who study this closely, know otherwise. There is nothing "unintentional" about the way they spend money on seemingly innocuous trinkets like pens.

The new reporting law requires the drug manufacturers to report to the government everything of value given to any doctor or teaching hospital, starting January 1, 2012 (and the government web site has to be up by September 30, 2013).

Manufacturers do not have to report gifts worth less than $10, but if the total of those gifts in one year to any doctor reaches $100, then all gifts have to be reported. There are a few other exemptions and other details worth reading in this "Sunshine" fact sheet from Pew.

Free samples of drugs also will be covered by another part of the law. As I have reported before, thoughtful doctors don't even accept free samples because that can bias their prescriptions away from "tried-and-true" medicines toward newer drugs with uncertain safety records.

I have a chapter in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, educating consumers on how to use prescription drugs safely. One of my key points is that people need to realize that the first few years a new drug is on the market -- during the time of its heaviest promotion by the manufacturer -- is also the most dangerous time for the patient to try the drug, because early users are basically guinea pigs.

This new law infringes no doctor's freedom to accept gifts from industry, and doesn't impact any patient's freedom to patronize such doctors. But with education and "sunshine" about how these gifts create conflicts of interest for the doctor, we can hope that the torrent of freebies will start to slow. All patients will be better off if the education doctors get about new drugs is not influenced by industry gifts.

Bookmark and Share

February 11, 2010

Big Profits in Cutting Corners on Quality for Owners of Long-Term Care Hospitals

The handsome silver-haired doctor in the long white coat, standing at the nurse's station in a photograph accompanying a New York Times story, is the national medical director for a chain of for-profit long-term care hospitals. But he puts in barely ten hours a week for Select Medical Corporation, which has no physicians in its top management. Or nurses for that matter.

The founders of the publicly traded company, a father and son team, have made about $200 million since they started Select in late 1996, according to the Times. They also own stock worth many millions more.

From barely a handful in the entire country in the 1980s, the number of long-term care hospitals now exceeds 400, with growth fueled by Medicare payment rules that penalize hospitals when patients languish too long with a particular condition but reward those same hospitals if they can transfer the patient to a long-term care facility. Many of the long-term care hospitals -- and nearly all in the Select chain -- actually consist of a wing or floor within another hospital, so patients can be transferred just a floor or two and for reimbursement purposes be tagged as located in a wholly different facility.

According to the Times report, many of the long-term care hospitals have no doctors in the building overnight as routine practice. They have heart monitors watched by untrained clerks, or not watched at all. Patients have died from lack of appropriate attention.

Here are government inspection reports obtained by the Times from a Freedom of Information request. Statistics show that bed for bed, Select hospitals have four times as many official findings of poor quality than the average hospital.

Medicare rules pay long-term care hospitals more if the patient is hospitalized at least 25 days, but then reimbursement declines drastically for patients who need longer treatment. It's no surprise that the average length of stay at Select hovers at 25 days.

What is the appropriate role of profit making in American health care? Money can certainly drive improvements in technology and medications, but we have to question the role of profits in routine medical care.

Bookmark and Share

February 2, 2010

A Doctor Chooses Paid Speeches for Drug Makers Over Academic Prestige

New ethics rules that bar Harvard doctors from giving speeches paid by drug manufacturers have prompted one doctor to give up his prestigious academic position in favor of keeping the income from the speeches. The physician is Dr. Lawrence M. DuBuske, an allergy and asthma specialist who is quitting his positions at Boston's Brigham and Women’s Hospital and Harvard Medical School. According to the Boston Globe, Dr. DuBuske made about $100,000 in three months last year giving some 40 speeches for six drug makers, including GlaxoSmithKline.

The ethics rules were put in place by Partners HealthCare, the physicians' group that employs most Harvard-connected doctors.

One Globe reader put this in a good perspective:

It's a good thing that he resigned. Now, when he speaks, the information he presents will be judged by the standards of a paid speaker employed by an entity with interests, rather than a disinterested academic. Meanwhile, he remains an expert allergist, and will likely find a place to practice.

The contacts between drug companies and academic medicine are extensive. They should be. You want the best, smartest, most creative docs involved in drug (and device) production. But the money involved is huge, and some will get seduced by the Green Side of the Force. Full disclosure of interests is a step, but only a step.

For patients, it helps to know if the prescription the doctor is writing for you has even a hint of a special interest from the drug maker. The many blandishments that drug makers lavish on doctors -- even small things like pens and scratch pads, plus free meals and "fees" for speaking at seminars -- are known to do their job of creating subtle influence on the prescription writer.

That's why I recommend that patients look for doctors who have the "no free lunch" philosophy: they accept nothing whatsoever, including samples, from the drug makers. That leaves their judgment completely independent.

You can read more about the "no free lunch" movement in medicine at this website.

I have a whole chapter in my book, "The Life You Save," on how to become a smart consumer of medicines.

Bookmark and Share

December 29, 2009

More on Those Glossy Ads for Cancer Treatment

Several thought-provoking letters appear in the New York Times responding to the recent piece about the cancer treatment industry's advertisements. One letter was from Dr. James Rickert, of Bloomington, Ind., president of the Society for Patient Centered Orthopedics:

To the Editor:

As a cancer survivor who has faced recurrent bouts of disease, I agree that the intense marketing campaigns used by cancer centers only heighten the stress and anxiety of the difficult treatment decisions that all cancer patients face. It becomes nearly impossible, at a time when one feels that any poor decision could be fatal, to wade through all the non-science-based claims for success.

As a physician who treats many patients with terminal metastatic disease, I have seen that this marketing often leads to heart-wrenching guilt and second-guessing by patient and family alike when treatments fail. Rather than being allowed to accept that their disease was incurable despite the best medical care, patients often feel that they are somehow to blame for choosing the wrong institution in which to receive treatment.

This is a distressing example by our nation’s finest medical centers of the shameful practice of placing financial concerns before the needs of the patients that they claim to serve.

If our academic medical centers cannot offer better patient-centered, evidence-based care than this, where in the world shall the medical community look for leadership?

Dr. Rickert makes an even better case than I could about the dangers of relying on advertising to make important decisions.

Bookmark and Share

December 19, 2009

Cancer Treatment Industry Markets Hope to Desperate Patients:

The ads are striking: Handsome, smiling people, very much alive, victors over cancer -- thanks to their choice of a prestigious cancer center for their treatment. But are they true?

The cancer centers -- with brand names like Sloan-Kettering and Massachusetts General -- cannot prove that the patients are alive because of something unique about their institutions. But they don't have to prove anything, under the law. If a drug manufacturer wanted to make a similar claim, it would have to line up statistical evidence, and the ads would have to have a lot of disclaimers. The ads from the cancer centers have no such disclaimers, and little to no backup from statistics.

Natasha Singer has a thoughtful article in the New York Times exploring these ads and what patients who are looking for cancer treatment should do.

The marketing executives who craft these ads say they're not even aimed at current patients -- but are more "reputation advertising," as one told the Times.

The article has a good sidebar that gives tips for how patients should shop for cancer treatment.

A regular community hospital can be fine for common cancers like colon, but for anything unusual, it's best to look for a center that sees a lot of that condition.

The National Cancer Institute designates Comprehensive Cancer Centers for their scientific excellence and comprehensive approach. Here is a list from the NCI. Ironically, these are some of the same centers with the heavy advertising budgets.

In my book, "The Life You Save: Nine Steps for Finding the Best Medical Care -- and Avoiding the Worst," I discuss the importance of a multi-disciplinary approach where doctors from different specialties collaborate together on figuring the best line of attack to a particular patient's cancer. Most advanced centers have "tumor boards," where these collaborative discussions occur, usually at no extra charge to the patient.

Bookmark and Share

October 22, 2009

A Small Step Forward in Curbing Drug Industry Influence on Doctor Education

Most doctors have to take regular continuing education courses to maintain their medical licenses. But what if the courses have a hidden agenda -- promoting the drugs of a sponsoring manufacturer?

That hidden influence has occurred far too often for the comfort of patient safety advocates, who want prescribing doctors to receive fair, balanced and neutral advice in the important subject of what prescriptions to write for sick patients.

Now the group that gives the official seal of approval for continuing education courses is taking tentative steps to curb the drug industry's influence on these courses. The group is called the Accreditation Council for Continuing Medical Education (ACCME). Its approval is necessary for a doctor to get official credit for any course taken. The head of the ACCME, Dr. Murray Kopelow, told the New York Times he will:

First, make public in the next few weeks a list of the classes and educational companies that have already been found to have broken the rules against commercial bias. This list was previously secret. Apparently there are less than a dozen names on the list as of now.

Second, consider further steps such as requiring the sponsor of a course found to be biased to send out corrective material to the doctors who took the course.

A doctor who is pushing for these and stronger reforms is Dr. Bernard Carroll, who filed a lengthy complaint about an online course on treatment of major depression, which he said was strongly biased by hiding bad information about the drugs of the sponsor, AstraZeneca.

The Times reported:

Dr. Carroll faulted the accrediting council for taking nine months to resolve the complaint, allowing the program to rerun and failing to notify doctors who had taken it. “They’re more interested in protecting the providers than watching what gets put out there as education,” Dr. Carroll said in an interview.

Here is Dr. Carroll's own blog posting on the subject.

The steps taken so far by the accrediting body are modest, but go in the right direction. Let's keep watching. As another industry critic, Dr. Bernard Lo, said, it's okay for the drug industry to support medical education. What's not okay is to create commercial bias in favor of one or another company's products.

Bookmark and Share

September 22, 2009

"Ghostbusters" Are Weeding Out Fake Authors at Medical Journals

A few brave medical journal editors are cracking down on the common practice of drug companies ghost-writing articles for authors who are willing to lend their names to drug industry propaganda. But at other journals, editors seem to have a "don't ask, don't tell" policy. For patients, it is vital that the truth come out.

The problem with ghost-written medical articles is that they purport to be something that -- once the disclosure of who wrote them is made -- they clearly are not: independent, objective evaluations of which medications work best for a particular disease. Instead, the ghosted articles turn out to be elaborate infomercials, disguised by the author's prestigious name and studded with multiple footnotes and the other signs of scholarly elbow grease. Yet because they are published under false pretenses, these articles can be very effective at selling their sponsors' products.

What first broke open this scandal was lawsuits against Wyeth for breast cancer and other injuries caused by its hormone drugs Prempro and Premarin. Attorneys for the patients found multiple examples in the manufacturer's records of prominent medical researchers putting their names on articles written by someone hired by the drug company.

Some of the medical school professors who were caught tried to brazen their way out of it by saying that of course, they wouldn't put their name on something they didn't agree with, and they just happened to agree with every single word that was written for them. For example:

Dr. Gloria Bachmann of the Robert Wood Johnson School of Medicine said in a published report: “This is my work, this is what I believe, this is reflective of my view.”

With shameless attitudes like that rife in the medical academic world, it's important for the editors who control what goes into the journals to step up and enforce some accountability. The first steps down that road have been cautious at best. As the New York Times reported:

Dr. Cynthia E. Dunbar, the editor in chief of Blood, said that, in the future, the journal would consider a ban of several years for authors caught lying about ghostwriting, in addition to retracting their ghosted articles.

But, said Dr. Dunbar, who is a hematologist at the National Institutes of Health in Bethesda, “I hope we don’t have to do that.”

The Times reported on another journal that took a stand:

In an editorial last week calling for a zero tolerance policy, the editors of the medical journal PLoS Medicine, from the Public Library of Science, called for journals to identify and retract ghostwritten articles and banish their authors.

“Any papers where this breach is substantiated should be immediately retracted,” the editors wrote. “Authors found to have not declared such interest should be banned from any subsequent publication in the journal and their misconduct reported to their institutions.”

Click here to read the full editorial.

Other journal editors told the Times that because they banned ghostwriting, they didn't really have to have a specific policy enforcing the ban. Huh???

For an amusingly arch, tell-it-like-it-is take about medical ghostwriting from someone outside the medical industry, I recommend English professor Margaret Soltan's blog, University Diaries.

The ghostwriting scandal, and the cautious, tepid response from many in the medical journal world, are the latest proof of why I advocate that patients be skeptical about prescription drugs, especially those with expensive marketing campaigns behind them. Read more in Chapter 7 of my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." The chapter is titled: "Drugs: A Dose of Reality About the Prescription Drug Industry and How You Can Safely Use Medicines."

Bookmark and Share

August 6, 2009

Does My Doctor Have a Conflict of Interest? Why You Should Care

Whether or not a patient should get an expensive imaging scan or some other elaborate and expensive test is not always clearcut. But what should be clearcut is that doctors should not have a thumb on the scale when they're balancing harms versus benefits. The balancing ought to be focused entirely on what's in the patient's best interest. The news story about what happened when a group of urologists in Iowa ordered a new CT scanner for their office sheds light on this conflict of interest issue.

According to the article by Shankar Vedantam in the Washington Post, the doctors at Urological Associates in Iowa were ordering fewer than one dozen CT scans per month for their insured patients in the months before their office bought its own CT scanning machine. That number jumped to 55 scans per month soon after the doctors got their own machine and started getting direct insurance payments for its use.

Defenders of the doctor-owned machines say it's more convenient for patients not to have to go to some other building for their scan. That's no doubt true -- if the scan is really needed in the first place. The problem is that self-interest colors the doctor's calculation, whether subtly or blatantly.

You might say "so what," but no test is without its downside, and excessive radiation from unnecessary CT scans can ultimately cause cancer in some patients -- as many as one in one hundred cancers are traced to radiation exposure. Not to mention bankrupting our health care system in the meantime.

Congress is considering outlawing the practice of what is called "self-referral," referring the patient to a test on a machine that the doctor owns. At the least, Congress should make it mandatory that doctors disclose any self-interest they have in testing, so that patients can take it into account in deciding whether they want the test.

I discuss doctor conflicts of interest in Chapter 9 of my new book, "The Life You Save." Chapter 9 is called "The Second Opinion: Always Your First Choice." It explains why you the patient need to understand if your doctor may have some ulterior influence on his or her thinking, and how it's always a good idea to get a second opinion before undergoing any major procedure.

Bookmark and Share

August 5, 2009

The Medical Industry's Own "Steroids in Baseball" Scandal

Another reason for careful patients to be skeptical about overly hyped prescription drugs came this week with news about the extent to which articles in important medical journals are "ghost-written" by drug manufacturers.

According to an article in the New York Times by Natasha Singer, newly released papers from lawsuits involving Wyeth's hormone replacement drugs Premarin and Prempro show that over several years, Wyeth repeatedly hired ghost writers who placed 26 articles in 18 prestigious medical journals, all promoting the drugs in the guise of objective analysis by medical experts:

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

The Times article made an interesting comparison to professional baseball's steroids scandal.

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

“The filter is missing when the reader does not know that the germ of an article came from the manufacturer,” said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.

The same concern about ghostwriting applies to patients who read literature on the Internet. People can be easily misled if they think an article is truly objective.

My advice, as I write in my book, "The Life You Save," is to rely on truly independent groups like the Medical Letter and Public Citizen's Health Research Group for objective information about drugs.

Some top medical journals like the Journal of the AMA now require authors to fill out detailed forms describing exactly how much input they had into the writing of an article. But many do not have such requirements. Consumer, beware.

Bookmark and Share

June 9, 2009

Too Much Medical Care Is Dangerous and Expensive

A New Yorker article by Dr. Atul Gawande, a surgeon, focused on why McAllen, Texas has higher medical costs than just about anywhere in the country. Dr. Gawande concluded that much of the problem could be traced to the very aggressive, intervention-oriented style of medicine practiced there -- all stemming from the fee-for-service payment system that rewards the doctors who practice intensive, high-cost care. His article achieved new prominence this week when President Obama told White House aides and members of Congress that after reading the article, he decided "This is what we've got to fix."

The President was quoted on that by Senator Ron Wyden in an article in the New York Times by Robert Pear.

Aggressive, high-cost medicine has never been proven to make anyone healthier or live longer. Why do the McAllen doctors order so many tests and procedures? Because they make more money from our fee-for-service system. The answer is to reorganize care so that doctor don't have a built-in conflict of interest where they prosper economically the more stuff they order. But that reorganization is easier said than done. Dr. Gawande rightly looks to models like the Mayo Clinic, where doctors are on salary. Read more about this on Dr. Bob Wachter's health care blog.

One interesting sidelight to Dr. Gawande's article is that he nails the old bug-a-boo of the medical industry: so-called "defensive medicine" in which doctors supposedly order lots and lots of tests not out of any perceived medical necessity but out of fear of being sued for malpractice. A group of McAllen surgeons tried this explanation out on Gawande, but he rightly pointed out to them that Texas has some of the strongest tort reform in the country, so he was skeptical.

He didn't mention, but might have, that other states like California, which in the 1970s made it almost impossible to sue for malpractice except for the most egregious cases, have enjoyed no medical cost savings that anyone has been able to count. Health care economists have proven that what explains disparities in medical costs is high numbers of specialists in a community and correspondingly low numbers of primary care doctors.

That Congress is just now discovering the realities of medical economics, which have been published in study after study over the last three decades, is itself pretty scary.

Bookmark and Share

May 20, 2009

Vermont Pioneers Crackdown on Drug Industry Freebies to Doctors

Starting July 1, Vermont residents will be able to learn exactly how much money any doctor in that state is receiving from the drug and medical device industry. The state is also banning most gifts like free meals to doctors, nurses, pharmacists and other health care providers.

This is an important step forward in eliminating the conflicts of interest that plague use of prescription drugs in the United States.

Vermont already has publicized non-doctor-specific data on drug industry payments intended to influence doctors. Even in a small state like Vermont, the total spent last year was $2.9 million, with most of the money targeted to doctors thought to be influential with their peers. The biggest single payment was $112,000 to a psychiatrist. And the drugs which topped the list for money paid were Strattera, a drug for attention deficit disorder, and Cymbalta, for depression and anxiety.

The new legislation was reported in an article by Natasha Singer in the New York Times.

Doctors and drug companies often deny that free meals and payments of consulting fees have any influence on doctors' prescribing habits. The mere fact that the industry spends hundreds of millions of dollars each year on such marketing suggests otherwise. Commendably, the Vermont Medical Society supported the new disclosure law.

Patrick Malone discusses conflicts of interest and how patients can use drugs -- sensibly, skeptically and safely -- in his new book: The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

Bookmark and Share