DC Medical Malpractice & Patient Safety Blog

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.

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.

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.

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.

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.

... 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.

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/.

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.

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.

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.

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.

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.’’

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.”

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.

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.

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.

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.

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.

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.

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.

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.

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."

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.

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.

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.

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.

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.

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.

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."

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.

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.

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.

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.