On Tuesday, April 28, the Institute of Medicine (IOM) made public its sweeping recommendations on “Conflict of Interest in Medical Research, Education and Practice.”
While the tone of the IOM press material and draft report suggests a rather modest call for change in the relationships among the industry, organized medicine and prescribers, the press statements of the participants and a careful reading of the report (over 350 pages) illuminate an intent by the Committee to aggressively limit the role of the industry in organized medicine and policy making.
“The IOM recommendations seem both naïve and foolish,” according to John Kamp, Executive Director of the Coalition for Healthcare Communication. “On the same day that the world’s health leaders were working with research-based drug companies to address the possible swine flu pandemic, IOM proposed new limits on full participation in public health decision making and implementation. Instead of expanding prohibitions, enlightened leaders should embrace industry collaboration to advance the tangible and immediate health needs of the nation’s citizens and move forward on long-needed healthcare reform.”
At the Tuesday press conference, Bernard Lo, Chair of the Committee on COI, and the other presenters offered a vision of organized medicine with very restricted involvement of the biopharmaceutical industry, enforced by:
- New disclosure laws and procedures imposed on industry
- New voluntary codes to be created by academic medical centers, societies, patient groups and others
- The creation of a new 2-year “consensus process” for a new paradigm for CME and other industry relationships
For example, both Eric Campbell and Chairman Lo said that disclosure is a necessary but limited first step to manage all financial relationships. Many relationships should be prohibited, others aggressively managed by other means. Chairman Lo also said that “speakers bureaus” should be prohibited.
Here are some of the highlights of the recommendations discussed at the press conference:
- Commercial support for CME should be revised using a 2-year “consensus process”. No public mention was made of the significant regulatory policies of FDA and HHS, the voluntary guidelines of PhRMA and AdvaMed, and the accreditation mandates of ACCME.
- On promotional education, the presenters said doctors should not participate in programs where the content is controlled by industry. The report recognizes that industry must control the presentations because of FDA rules, and Chairman Lo made clear that this is intended to restrict the participation of “medical professionals” FDA-regulated education.
- Disclosure of industry contributions should be mandated by law, and be published on a government website using uniform definitions and categories. Academic institutions, journal publishers, specialty societies and others would be able to develop their own disclosure mandates, but these would need to be tough and transparent, and the groups should publicize and discredit any individuals and groups that did not fully comply.
- Although it was not directly stated in the report, Chairman Lo and others made clear that the “medical professionals” should avoid all industry activities other than research. They backed into it by acknowledging that industry involvement in academic research was necessary, but then saying that financial relationships of any additional type would be inconsistent with research and participation in guideline or standard setting committees. And although medical researchers with financial ties to industry could participate if their expertise was necessary, these researchers should not participate in deliberations, drafting or voting on such standards.
It is not clear what practical effect this report may have on these activities, but some things should be noted.
- First, IOM is the government think tank on medical issues and its reports are very influential in Congress. For example, the IOM recommendations to the FDA in 2006 were largely embodied in the initial drafts of what became the Food and Drug Amendments Act of 2007.
- Second, the disclosure recommendations largely track the MedPAC recommendations, which were mainly driven by IOM report sponsor American Board of Internal Medicine, and could well boost the prospects for passage of a version of the Grassley/Kohl “Sunshine Act” drafts.
- Third, the makeup of the IOM committee and how they are selected is in doubt as the IOM encourages supporters to recommend panel members, also prior to the start of the committee meetings 7 of the 17 panel members had made public statements in articles, books and journals with strong conflict of interest statements.
- Fourth, these recommendations will be carefully reviewed by many Obama healthcare advisors, and thus could reappear as administration recommendations.
- Fifth, many IOM recommendations are consistent with the recent reports of the Macy Foundation, AAMC and other national medical organizations. Additional recommendations are expected from these and other groups, and they too may have a high profile among Washington policy makers.
- Sixth, implementing the report’s recommendations could severely hinder the industry’s ability to disseminate information on new procedures and medical breakthroughs if researchers are excluded from participating in industry-funded education programs that come under the definition of FDA-regulated education. This is a critical and successful pathway for disseminating important new findings.
Meanwhile, recognize that many of the recommendations are in practice, such as the PhRMA code restrictions on interactions with physicians, ACCME’s guidelines for commercial interest, academic center mandates on faculty and researchers, and individual company decisions to report payments on their websites. And, many consent agreements with HHS include pledges to follow certain guidelines or publish payments on websites.
Reading the report’s recommendations, one could surmise that these newly enacted reforms and recent guidelines were either ignored or deemed ineffective — potentially an embryonic decision without the hard data to support such sweeping recommendations. However well-intentioned the report’s recommendations may be, careful consideration must be given to any unintended consequences that could hinder the dissemination of important medical breakthroughs that may improve patient care.
To summarize, we quote the New England Journal of Medicine (NEJM): “Although specific recommendations may be criticized as either too strong or too weak, the IOM’s overall proposals are comprehensive and — if adopted — would most likely have substantial effects on individual physicians and medical institutions. However, there has been no shortage of previous reports and calls for change; the new report lists 16 of the ‘more prominent reports’ that were released between 2001 and 2008 alone. So the institute’s proposals could merely provide more fodder for discussion — or perhaps mark a turning point in controlling conflicts of interest in medicine.”
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