In the late 1990's, during one of the booms in the biotech and pharmaceutical fields, a number of faculty members at Harvard Medical School felt they were missing out on the potential financial gains from being affiliated with companies in these sectors. Such interactions were actually envisioned and indeed encouraged by the Congress in 1980, in the hope of speeding up the adoption of new diagnostics tools, medical devices, and drugs. The expansion of activity, though, led faculty members to ask Dean Joseph Martin to loosen up the schools' conflict of interest rules to permit more and broader relationships. (I was Administrative Dean of HMS at the time.) As noted in this article:
That review began as the ugly side of conflict problems became evident—notably the death of a patient in a gene-therapy experiment at the University of Pennsylvania. In May 2000, Martin announced that HMS would not modify its policies, and called for national debate on how best to maintain the integrity of research. That work, effected through discussion with peer institutions and through the Association of American Medical Colleges (AAMC), led to model guidelines in 2002.
The faculty of the medical school--comprising the professors on The Quad (HMS itself) and the thousands of faculty members in over a dozen Harvard affiliated hospitals--were deeply divided. One group wanted the policies to be liberalized. Another group wanted them to be made more strict. And many were unsure. While the national debate continued at the AAMC, the Harvard policies remain unchanged.
Several years later, Joe's successor, Jeffrey Flier, picked up the baton and issued a new COI policy, one consistent with the AAMC guidelines. This took a lot of work and his personal attention. While it required some compromises, Jeff held firm on many important provisions.
With that as background, I was stunned to read John Cummins' article in HealthLeaders Media, "Med Schools Failing on Conflict of Interest Policies." The summary:
Institute for Medicine as a Profession researchers compared changes in medical schools' policies from 2008 to 2011, and found that while many institutions made progress implementing some COI policies, nearly two-thirds still lacked policies to limit ties to industry, including gifts, meals, drug samples, and payments for travel, consulting, and speaking. Only 16% met national standards in at least half of the areas, and no school met all the standards.
[M]edical schools have a clear blueprint for conflict of interest policies that have been put forward since 2006 by groups that include the Association of American Medical Colleges, the Institute of Medicine, the American Board of Internal Medicine Foundation, and IMAP.
Several years have gone by now and many schools are not coming even close to meeting those policies.
I have only one thing to say to these schools, "Are you out of your mind?" The entire health care industry is in turmoil. The public thinks that you are part of the medical-industrial complex that pushes higher and higher costs onto the system. Indeed, by not having a strong COI policy, you are part of that complex because your faculty are reaping financial gain from companies trying to market new tools, devices, and drugs.
Please don't give us the story that this is too hard. If Harvard Medical School with, shall we say, some large egos among its faculty can reach a conclusion on these matters, any medical school can.
But the AAMC appears to have fallen to the lowest common denominator:
Heather Pierce, senior director, science policy for the Association of American Medical Colleges, says AAMC is "pleased" with the progress that medical schools have made in the last few years to strengthen COI policies.
"We are encouraged by the robust and continued dialogue surrounding these issues."
You may be encouraged, AAMC, but as the author of the cited study says:
It is too slow, it's not going quickly enough, and this really jeopardizes the public trust.
That review began as the ugly side of conflict problems became evident—notably the death of a patient in a gene-therapy experiment at the University of Pennsylvania. In May 2000, Martin announced that HMS would not modify its policies, and called for national debate on how best to maintain the integrity of research. That work, effected through discussion with peer institutions and through the Association of American Medical Colleges (AAMC), led to model guidelines in 2002.
The faculty of the medical school--comprising the professors on The Quad (HMS itself) and the thousands of faculty members in over a dozen Harvard affiliated hospitals--were deeply divided. One group wanted the policies to be liberalized. Another group wanted them to be made more strict. And many were unsure. While the national debate continued at the AAMC, the Harvard policies remain unchanged.
Several years later, Joe's successor, Jeffrey Flier, picked up the baton and issued a new COI policy, one consistent with the AAMC guidelines. This took a lot of work and his personal attention. While it required some compromises, Jeff held firm on many important provisions.
With that as background, I was stunned to read John Cummins' article in HealthLeaders Media, "Med Schools Failing on Conflict of Interest Policies." The summary:
Institute for Medicine as a Profession researchers compared changes in medical schools' policies from 2008 to 2011, and found that while many institutions made progress implementing some COI policies, nearly two-thirds still lacked policies to limit ties to industry, including gifts, meals, drug samples, and payments for travel, consulting, and speaking. Only 16% met national standards in at least half of the areas, and no school met all the standards.
[M]edical schools have a clear blueprint for conflict of interest policies that have been put forward since 2006 by groups that include the Association of American Medical Colleges, the Institute of Medicine, the American Board of Internal Medicine Foundation, and IMAP.
Several years have gone by now and many schools are not coming even close to meeting those policies.
I have only one thing to say to these schools, "Are you out of your mind?" The entire health care industry is in turmoil. The public thinks that you are part of the medical-industrial complex that pushes higher and higher costs onto the system. Indeed, by not having a strong COI policy, you are part of that complex because your faculty are reaping financial gain from companies trying to market new tools, devices, and drugs.
Please don't give us the story that this is too hard. If Harvard Medical School with, shall we say, some large egos among its faculty can reach a conclusion on these matters, any medical school can.
But the AAMC appears to have fallen to the lowest common denominator:
Heather Pierce, senior director, science policy for the Association of American Medical Colleges, says AAMC is "pleased" with the progress that medical schools have made in the last few years to strengthen COI policies.
"We are encouraged by the robust and continued dialogue surrounding these issues."
You may be encouraged, AAMC, but as the author of the cited study says:
It is too slow, it's not going quickly enough, and this really jeopardizes the public trust.
You touch on the critical issue of trust. It is still there on a personal basis but is gone for the industry, buried under a mountain of $$.
ReplyDeleteTrue, but if an institution does not have a good policy, it leaves the faculty unprotected--even if they have the best of intentions.
ReplyDeleteI think several things factor in here: a) doctors are ignorant or dismissive of the cognitive influences of such marketing manipulation, despite abundant hard evidence ( a similar ignorance of cognition is at work preventing improvement of diagnostic errors); b) no med school/hospital wants to turn down the generous and pervasive free money available from pharma in an era of tight budgets (see a) again) and c) med school/hospital leaders are too cowardly to risk the displeasure of their doctors who are already cranky over the Medicare SGR issue, upstart patients, and the health care law.
ReplyDeleteBut those explanations make it all the more inexcusable.
See also:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2297094
nonlocal MD