Articles Posted in Conflicts of Interest

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.

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.

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 (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.

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, 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, 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

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, 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.

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.

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.

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’s, data base, Dollars for Docs.

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

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.

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, 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.

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 (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.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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