An Institute of Medicine report aimed at reining in financial relationships between physicians and industry is expected to exercise significant influence among lawmakers drafting legislation and policymakers at academic medical centers.
We will take the IOMs report into account as we determine which types of continuing medical education are sound and which are dubious, said Sen. Herb Kohl (D-Wis.) in a written statement. Kohl along with Sen. Chuck Grassley (R-Iowa) is a sponsor of the Physician Payments Sunshine Act, which would mandate public disclosure of medical-product company payments to medical providers.
Released last month, the report, Conflict of Interest in Medical Research, Education and Practice, has met with mixed response, with some healthcare stakeholders championing and others criticizing the recommendations.
Andrew Van Haute, associate general counsel for the medical device lobby group AdvaMed, says his organization sees some points of agreement in the IOMs recommendations. I think on the disclosure issue, they see the benefit of a strong federal disclosure vehicle so that information is in one place.
The IOM serves as an independent healthcare policy advisory group to government agencies and other organizations. The groups wide-reaching recommendations are the most recent in a slew of conflict-of-interest guidelines and policy papers issued within the past year by organizations such as the Association of American Medical Colleges, the North American Spine Society and Pharmaceutical Research and Manufacturers of Americaa drugmaker lobby organization.
But the IOMs recommendations are the most inclusive to date, suggesting steps to be taken by academic medical centers, lawmakers, healthcare journals, professional societies and accrediting bodies to eliminate any influence medical-products companies may have on the development of continuing medical education, or CME, clinical guidelines and research outcomes.
Our response is very positive, and there is an extraordinary amount of agreement, says Susan Ehringhaus, senior director and associate general counsel for the Association of American Medical Colleges, of her organizations reaction to the IOMs recommendations. Much of what we see in the IOM report also appeared in the AAMCs (2008) guidelines. But what we were also very glad to see is that the IOM extended their recommendations across the medical community spectrumnot just in the academic arena.
The reports 16 recommendations included creating a standardized disclosure format for institutions and individuals to use in reporting financial relationships with industry; prohibiting the acceptance of gifts from medical products companies; and prohibiting industry funding of professional medical organizations clinical guideline development. The group stopped short of recommending that industry be banned from funding CME events, saying instead that medical groups should work together to develop a new funding system that would ensure CME is free of industry influence.
Barbara Barnes, vice president of sponsored programs, research support and CME at the University of Pittsburgh Medical Center, says her organization supports the IOM recommendations and that its conflict-of-interest policy has already adopted many of the suggestions pertinent to academic medical institutions. When we instituted our conflicts-of-interest policy, we decided wed continue to accept commercial financing, but we centralized our CME program so we could have a handle on how the money was used and ensure that commercial support was not influencing content.
The IOMs recommendations also urge Congress to broaden any proposed conflict-of-interest legislationsuch as the proposed Physician Payments Sunshine Actso that it requires drugmakers, biotech companies and medical-device makers to publicly report financial relationships with doctors, researchers, academic medical institutions, professional societies and patient-advocacy groups. The recommendation echoes a similar one made by the Medicare Payments Advisory Committee late last year.
IOM committee member Eric Campbell, an associate professor at Harvard Universitys Institute for Health Policy, says the organization doesnt comment on specific pieces of legislation. He acknowledges, however, that the group hopes to influence both regulatory and voluntary policies on managing conflicts of interest. Were hoping as a committee to go beyond what weve traditionally relied upon, which are voluntary guidelines by groups like PhRMA, which is a lobbying organization, and whether or not companies are complying with their guidelines is incidental, Campbell says.
PhRMA Senior Vice President Ken Johnson says that while the IOMs recommendations could help advance ethical professional relationships, his organization was concerned about a perceived lack of balance in the suggestions. He says it is important to weigh the need to manage potential conflicts of interest against the possibility that overly restrictive policies could have negative consequences for patient care.
But Campbell says that although the IOMs recommendations are more definitive and comprehensive than those issued by other organizations, the group is not seeking to eliminate industry funding of research or legitimate consulting arrangements between medical professionals and industry. Many of the drugs and devices on the market today would not exist if it werent for the close relationships between medical professionals and industry. So, we are well-aware of the value of those relationships, Campbell said during a news briefing on the report.
While the IOM concludes that its recommendations could be implemented without discouraging the development of medical advances, not everyone familiar with the recommendations believes their effects would be so benign.
Joseph Zuckerman, M.D., president of the American Academy of Orthopaedic Surgeons, is concerned over a particular IOM recommendation that groups that develop clinical-practice guidelines not only ban industry funding of guideline development activities, but also exclude medical professionals who have relationships with industry from participating on panels that draft guidelines. Zuckerman says that his group has never accepted industry funding for guideline development activities, but that excluding physicians and researchers with industry relationships from participating in the process could ultimately be harmful for patients whose treatments are determined by such guidelines. On a practical level that can be difficult, because not infrequently the experts in the field have been sought out by industry for consulting purposes, Zuckerman says. The most important thing is disclosure of those conflicts.
Although most providers and industry officials claim public support of transparency, not all organizations have shown a willingness to follow through on voluntary disclosures. Most recently, for example, orthopedic devicemakers Biomet, DePuy Orthopaedics, Smith & Nephew and Zimmer completed the terms of an 18-month deferred prosecution agreement with the U.S. attorneys office in Newark, N.J., that required the companies to, among other mandates, publicly disclose the financial details of their physician-consulting deals and the names of doctors who enter into those deals. But when the agreement expired, none of the devicemakers had plans to continue voluntary disclosure of their consulting and research agreements. Only Stryker, which in a separate deal entered into a nonprosecution agreement, says it plans to continue disclosure of its agreements.
Rob Lyles, vice president and global business unit leader for stentmaker Cook Medical, says his company generally agrees with the IOM recommendations, but there is concern with the suggestion that industry funding of CME be completely blinded and the medical products companies have no say in how their donations are directed. I think on a macro level, I would be concerned that that scenario would lead to a lack of funding of CME, especially if (the rules) fall to the far side of the spectrumwhere a device manufacturer could potentially provide funding for CME that could go to pharmaceutical education or some other area if we have no power to direct its use, Lyles says. In a scenario where donations are truly blinded they could actually end up in places where its not used in the publics interest.
Officials at the free-market focused Center for Medicine in the Public Interest, or CMPI, take more vehement issue with the IOM report recommendations, however. The group, which has been backed by pharmaceutical industry contributors, put out its own evaluation late last month that derided the push toward public disclosure of medical product company payments to physicians and voiced support for status-quo industry funding of CME. Theyre focusing on the idea that commercialized medical knowledge is a corrupt thing, says Robert Goldberg, vice president and co-founder of the CMPI. We say to the contrarythat commercialization is very good for medical care. Because, to take an idea to mass application it needs all of the resources that industry can bring to bear.
Although others have no doubt that, if widely implemented, the IOM recommendations could have a transformative effect on the delivery of healthcare, they dont believe the ultimate outcomes will be negative. Definitely the recommendations would alter the relationship between industry and doctors in the way of banning gifts, says the University of Pittsburgh Medical Centers Barnes. But those werent beneficial to patients anyway.Submit a letter to the Modern Physician Reader Blog. Please include your name, title, company and hometown. Modern Physician reserves the right to edit all submissions.