The long awaited report on conflict of interest from the Institute of Medicine has been released, and it is a landmark document in the history of medicine.
Before reviewing the report, what is the Institute of Medicine, and why is everybody making such a fuss about what it has to say? The IOM was created in 1970 by the federal government as part of the National Academy of Sciences. According to its website, “The nation turns to the Institute of Medicine (IOM) of the National Academies for science-based advice on matters of biomedical science, medicine, and health.”
You can think of the IOM as the most important advisor to Congress and the White House on medical issues. It is not formally a part of the government, and therefore none of its recommendations have the force of law. However, when the IOM speaks, everybody who is anybody listens very closely.
This 300 page report, formally titled “Conflict of Interest in Medical Research, Education and Practice,” can be accessed here.
Before reviewing the report, what is the Institute of Medicine, and why is everybody making such a fuss about what it has to say? The IOM was created in 1970 by the federal government as part of the National Academy of Sciences. According to its website, “The nation turns to the Institute of Medicine (IOM) of the National Academies for science-based advice on matters of biomedical science, medicine, and health.”
You can think of the IOM as the most important advisor to Congress and the White House on medical issues. It is not formally a part of the government, and therefore none of its recommendations have the force of law. However, when the IOM speaks, everybody who is anybody listens very closely.
This 300 page report, formally titled “Conflict of Interest in Medical Research, Education and Practice,” can be accessed here.
Pared down to the essentials, its recommendations are:
1. Drug companies must disclose any payments they make to doctors, hospitals, and many other institutions. This is similar to the proposed Physician Payments Sunshine Act, but goes further because it recommends that these financial disclosures extend to consumer groups (such as the National Alliance for the Mentally Ill), medical societies (i.e., the American College of Cardiology, which is the new poster child for industry money-lust), and medical education companies. Basically, IOM is saying, “no more hiding any money that you may be using to surreptitiously influence medical care.” This is an extremely powerful and sweeping recommendation, and will complete the process of bringing integrity back to medicine.
2. Doctors should no longer accept any free meals, gifts or other items from companies. Various academic medical centers have already announced such rules but they vary in the details. For instance, Johns Hopkins says "no gifts" except expensive medical textbooks and educational charts, and "no free meals" except for a long list of examples where free meals are okay. IOM endorses a very simple policy—no meals or gifts of any kind.
3. Doctors must not participate in speaker’s bureaus for drug companies.
4. Doctors must not do clinical research if they have a financial interest in the outcome of the research. As Dr. Carroll points out in Health Care Renewal, this rule would have prevented the unfortunate series of events involving Dr. Alan Schatzberg, Stanford University and the NIH.
5. Revamp the system of continuing medical education (CME) so that there is no more industry influence in the content.
The actual verbatim recommendation regarding CME is:
"RECOMMENDATION 5.3: A new system of funding accredited continuing medical education should be developed that is free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education. A consensus development process that includes representatives of the member organizations that created the accrediting body for continuing medical education, members of the public, and representatives of organizations such as certification boards that rely on continuing medical education should be convened to propose within 24 months of the publication of this report a funding system that will meet these goals."
Industry funding of CME was the most controversial issue faced by the IOM, and you’ll notice that the above recommendation is rather artfully crafted to avoid explicitly calling for a ban on industry funding. In the subsequent discussion, the IOM explains that some committee members were worried about “unintended consequences” of an immediate funding ban, such as fewer courses. But guess what? There are far too many redundant industry-funded courses anyway, on the same topics over and over again—treatment of carefully hand-picked conditions with drugs made by the sponsor.
Nonetheless, later in their report, the IOM makes quite a strong statement anyway. Some industry funding might be acceptable, they say, but only if funneled into pooled sources of money over which the companies have no control. Crucially, direct funding—which constitutes essentially all of industry-funded CME as currently practiced--would be forbidden under the new system:
“Both direct company funding to institutions for specific continuing medical education programs and direct company provision of unrestricted grants to institutions offer clear opportunities for undue influence, particularly for continuing medical education providers that also receive the great majority of their funding from companies. A plan for a system free from industry influence would exclude such funding as well as funding from company-controlled foundations.” (section 5, page 32).
The bottom line is that this report will serve as the authoritative guide for medical centers and policy makers for the next several years as they clean up conflicts of interest in medicine. Change is coming, big time.
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5 comments:
Well-written and informative post!
Your endorsement of the importance of this report means a lot. Thanks for clarifying its significance.
I'd hold off on writing any obituaries until after the wave of Pharma lobbyists have their way with lawmakers. That being said, I'd love to eat my words if congressional leaders or the president pick this up and run.
Here's recommendation 3.4, which calls for ALL payments to ALL groups be disclosed, including CME providers. For some reason, all the emphasis has been on doctors:
RECOMMENDATION 3.4 The U.S. Congress should create a national program that requires
pharmaceutical, medical device, and biotechnology companies and their foundations to publicly
report payments to physicians and other prescribers, biomedical researchers, health care
institutions, professional societies, patient advocacy and disease-specific groups, providers of
continuing medical education, and foundations created by any of these entities. Until the
Congress acts, companies should voluntarily adopt such reporting.
On close inspection this doesn't do much. Academic docs are already wary about taking payments that might get them in the papers. Pointing the finger at pt advocate organizations is a good thing. But they say new methods of paying for CME should be developed (how about drs get out their wallets?) but not that pharma funded CME should be banned. And all of it is recommendation. Fact is there should be no gifts, payments, funding of CME or pt advocate groups of any kind. The statement that medicine moves faster than law and we need pharma to pay for education is baloney. Drs. make a lot of money and should pay for their own damn education. But the only thing that will change that is legislation since docs will always wave a hand and so this doesn't apply to me.
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