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The American Medical Association's main ethics committee (CEJA, or the Council on Ethical and Judicial Affairs) has released this report on medical education declaring that doctors and medical institutions "must not accept industry funding to support professional education activities."
To quote further from the report's executive summary:
"... Medicine must ensure that the values and core commitments of the profession protect the integrity of professional education. It must strive to deliver scientifically objective and clinically relevant information to individuals across the learning continuum. To promote continued innovation and improvement in patient care, medicine must sustain ongoing, productive relationships with the pharmaceutical, biotechnology, and medical device companies. However, industry support of professional education has raised concerns that threaten the integrity of medicine’s educational function."
The report goes on to recommend the banning of industry-supported CME, but does allow for one exception, which I found quite reasonable:
"Exception should be made for technical training when new diagnostic or therapeutic devices and techniques are introduced. Once expertise in the use of previously new devices has developed within the professional community, continuing industry involvement in educating practitioners is no longer warranted."
This would allow, for example, companies to pay for orthopedists to train surgeons in how to fit the latest artificial hips, or to hire cardiologists to teach physicians how to program the newest pacemakers. These are examples of the few cases in which the companies have special expertise that can't be learned via standard educational outlets, such as professional journals. Note that this exception does not apply to pharmaceuticals, because doctors can best learn about drug prescribing by reading and evaluating the medical evidence.
What are the chances that the AMA will adopt this recommendation? Here is a list of the many 2007 and 2006 CEJA recommendations which were approved, indicating that the organization is likely to take this new report very, very seriously.
Health Care Renewal discusses a disheartening development in the debate over the Massachusetts' law to ban drug companies from giving bribes--I mean, "gifts"-- to physicians. In the past, I wrote this rambling post about the issue, including links to several letters and editorials printed in the Boston papers. The latest article, published in the Boston Herald, quotes the head of GlaxoSmithKline's operation in the U.S. as implying that if the full legislature passes the ban (the State Senate has already done so), GSK will take their money out of Massachusetts and head to other states that do not "demonize" the pharmaceutical industry.
Yawwwwn. It's a threat we've heard before but it's actually quite embarrassing for GSK. Why does the company believe it needs to give pens and pizzas to doctors in order to get them to prescribe their drugs? Are their products so ineffective that bribery is the key incentive for their use? Read this excellent letter in rebuttal, written by Marco Cornelio, a medical student at Tufts. Cornelio writes, in part, "Instead of spending their money on such bribes, pharmaceutical companies ought to be using it for research to produce truly innovative, effective and safe medications."
Congress is scrutinizing direct-to-consumer drug marketing, and Allison Bass (author of a new book on the deceptive marketing of Paxil) posted this interesting entry on her new blog. Researchers at Duke University have listed cognitive techniques drug-makers use to distract them from comprehending all the pesky negative information that the FDA requires be disclosed. For example, in an ad for the allergy drug Nasonex, a distracting animated bee appears during the rapid fire recitation of side effects. But when the benefits of Nasonex are described, the bee hovers quietly.
In the past, I have supported DTC ads (see here) because I have felt the public health benefits may outweigh the problems with biased drug information. After reading about this new study, I may have to revise my position!
Recently, the New England Journal of Medicine published this interesting Sounding Board article by Aaron S. Kesselheim and Jerry Avorn, both of whom are physicians at Brigham and Women’s Hospital and Harvard Medical School. They are leading proponents of efforts to limit the use of prescription data-mining, and assisted the state of New Hampshire in its ultimately unsuccessful efforts to ban the practice (see this article for some background on various legislative actions).
At issue is whether prescription data-mining and other promotional activities are considered “free speech” and thus protected by the First Amendment. This has been a major argument of the pharmaceutical industry in its ongoing litigation in several states that are considering bans.
The authors distinguish personal speech, which is strongly protected by the First Amendment, from commercial speech. Whereas any limitation on individual free speech requires that the government have a clear interest in limiting a particular person’s speech (a high legal standard that is rarely met), limitations on commercial speech are based on different standards. The main framework used by courts is called the “Central Hudson Test,” after a 1980 case in which a utility company sued New York State over regulation of their advertising.
Based on that case, courts now allow limitations on commercial speech if three conditions are met. First, the government must have a substantial interest in the issue (in the case of prescription data-mining, the government indeed has a substantial interest in the relevant issue, which is public health); second, the proposed regulation must directly advance those interests (banning data-mining reduces the potential for non-scientifically based physician prescribing behavior); and third, the proposed regulation must not be more extensive than necessary to achieve its goals (the New Hampshire courts ruled against the ban partly because it agreed with Pharma arguments that there are less restrictive ways to counteract drug company misinformation, such as programs to better educate doctors about evaluating promotional claims).
I found this a valuable article for understanding some of these issues. Happy reading!
John Shelton, PhD, may well be one of the most influential people in the field of psychiatry—though he is not a psychiatrist, and you may never have heard of him. He is the publisher of the Journal of Clinical Psychiatry, and is thus, in my mind, both Dr. Jekyll and Mr. Hyde. Jekyll-wise, he produces an excellent journal, brimming with clinically relevant articles covering topics that front-line psychiatrists care about (as opposed to, for example, Archives of General Psychiatry, which is filled with basic science articles).
But in his Mr. Hyde persona, he publishes dozens of industry-supported CME Supplements, each of which is an advertisement for a product marketed by the sponsoring company. I’ve never been shy about criticizing these supplements (here), and nor have other critics (here).
As I walked by the J Clin Psych booth at the APA meeting earlier this week, I saw Dr. Shelton in the flesh, and went up to him and introduced myself. He is a slim gregarious man with white hair and a ready smile, but when he looked at my name tag, he frowned. “The blogger!” he exclaimed. “There he is.” Surprised that he knew me right off the bat, I was a little flustered, and said, “Yep, that’s me….and I wanted to thank you for accepting my letter.” (I was referring to a soon-to-be-published letter in which I complain about bias in this recent BMS-funded supplement). “Look,” he said, “we put your letter through our review process, which is what we do for all our articles.”
The conversation was brief but cordial. I reiterated that I have no problem with the main journal but that the supplements appear to be promotional, almost without exception. He and Jane Eckstein, who is the director of their CME operation, maintained that the content is developed completely independently of drug company input. This is the standard bone of contention between those on different sides of the commercial CME divide, and both arguments are predictable, so I didn’t tarry long at the booth.
As I left, I realized that it all depends on what you define as “bias.” If you define it as inaccurate information, then Shelton and Eckstein are correct, since their supplements are carefully vetted for accuracy. But if you define it as manipulating the choice of accurate information to serve a promotional objective, then Team JCP is guilty as charged, since each supplement covers a topic of commercial benefit to the sponsor, and information is chosen to highlight advantages of the sponsor’s product.
To argue that the information is accurate and helpful to readers is not relevant. The information in drug ads is also accurate (the FDA makes certain of that) but nobody would argue that they are not also promotional.
Dr. Shelton mentioned that commercial CME covers important off-label uses, which FDA forbids companies to discuss (although recent guidelines may change this). But, in fact, doctors who don’t participate in industry CME are also free to teach about off-label uses, and they do so, frequently.
The debate will continue. And while I believe that you are doing the wrong thing, Dr. Shelton, I applaud you for being willing to engage with the “enemy”!
About 20,000 psychiatrists attend the APA annual meeting, and as you wander around the convention center, you bump into people you wouldn't ordinarily be rubbing shoulders with. Even people you might go out of your way not to rub shoulders with. This is a good thing, because you find out quickly that your "enemy" is no monster, but a person just like you. And possibly not an enemy at all.
Two examples from the 2008 meeting stand out; I'll describe one today and one tomorrow.
As I was browsing the publisher's exhibit area, I saw Stephen Stahl at the Cambridge University Press booth, signing copies of the latest edition of his immensely popular textbook, Essential Psychopharmacology. Apart from being a prolific author, Stahl is the head of NEI (Neuroscience Education Institute), a medical education company specializing in industry-funded CME. I mentioned him in this prior post, when I put him in the company of Charles Nemeroff as one of the more industry-conflicted psychiatrists in the profession.
Well, I went up to him and introduced myself, and we got talking about industry influence in psychiatry. "We're moving away from pharma funding," he said. For example, he said that he plans to stop participating in industry-supported symposia. "I consult with industry," he said, "and so I shouldn't be doing these symposia." I told him that I was on an APA work group tasked with adapting to future loss of industry funding. I asked him how he thought the organization would manage. "We're not going to make as much money," he said, "and maybe we shouldn't. Sometimes we just have to do the right thing."
I was impressed. But it was ironic that our short conversation was just then interrupted by a Pfizer employee asking him to sign her copy of his book. "We'll be seeing you tonight, Dr. Stahl," she said graciously. I don't know what event she was referring to, but I do know that the Pfizer was giving away his book at their display in the exhibit hall, and had scheduled him to sign copies for the dozens of psychiatrists happy to stand in line for a freeby.
Nonetheless, I believed Dr. Stahl was sincere in his plans to reduce his spigot of industry money, and I hope that we'll start seeing changes in NEI's business model over the coming year.
Tomorrow: Close encounters with John Shelton, publisher of Journal of Clinical Psychiatry.
Here I am at the No Free Lunch booth in the Exhibit Hall of the annual meeting of the American Psychiatric Association. The Pristiq coffee lounge is buzzing with caffeine-seeking psychiatrists a few yards away. Beyond that, a quarter mile of exhibits, small and large, some from drug companies, publishing companies, software companies, and physician placement firms.
We offer a No Free Lunch Pen Amnesty program, in which doctors can exhange their drug company pens for our No Free Lunch pens.
Hundreds of psychiatrists have strolled by, amused and intrigued. Many are skeptical, believing that lunches and pens do not influence their prescribing habits. Others tell stories about having prescribed Invega after the Risperdal rep came by and later wondering why on earth they did so. Another doctor said that, as an intern, he prescribed nothing but Zoloft because the Pfizer rep got to him before the other reps.
These are great discussions, often coming back to the question of "so what?" Are patients actually harmed by drug company gifting? These are difficult questions. My own feeling is that patients want me to make my prescribing decisions based on scientific grounds, and not based on the giving of gifts. I don't need the gifts, and I can get much more reliable information about drugs by reviewing the journals checking internet websites.
Time to sign off--the exhibit hall just closed, and they are turning the lights on and off. More stories later this week!
The American Medical Association's main ethics committee (CEJA, or the Council on Ethical and Judicial Affairs) has released this report on medical education declaring that doctors and medical institutions "must not accept industry funding to support professional education activities."
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