IOM calls for national conflict of interest disclosure program

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In addition to individual recommendations for the medical community to reduce conflicts of interest, the Institute of Medicine (IOM) has suggested that Congress create a national reporting program that requires pharmaceutical, medical device and biotechnology companies to make public all payments to physicians, researchers, healthcare institutions, professional societies, patient advocacy and disease groups and providers of continuing medical education.

The report, “Conflict of Interest in Medical Research, Education, and Practice,” released April 29, stated that such expanded and standardized disclosure would provide “important information for physicians, patients, researchers, health plans, regulators, policy-makers, financial donors and others who rely on research, practice guidelines, educational programs and the quality and efficiency of medical care.”

The IOM recognized the difficulty of such a culture change. “Totally eliminating all conflicts might involve more change than could be justified in light of how research, education, and medical-care system have evolved,” the report stated. However, a “greatly expanded requirement for public disclosure would create incentives and monitoring tools that would reduce the risk posed by some of the conflicts that it might not be practical to eliminate.”

The IOM report also called for academic medical centers and teaching hospitals to ban faculty from accepting gifts or making presentations managed by industry. It asked that continuing medical education (CME) be funded without industry support and that researchers not conduct trials involving human participants if they have a financial interest in the outcome. 

A section of the report examining psychological research stated that the evidence indicates that when individuals stand to gain by reaching a particular conclusion, “they tend to unconsciously and unintentionally weigh evidence in a biased fashion that favors that conclusion.”

Researchers suggested that “even well-intentioned individuals can succumb to conflicts of interest,” which makes the “effects of conflicts of interest so insidious and difficult to combat.”

The report addressed three areas of concern: medical education, medical practice and the development of clinical practice guidelines.

Regarding medical education, the report concluded that, in general, “industry financial relationships do not benefit the educational missions of medical institutions in ways that offset the risks created.” It recommended that faculty not accept gifts from industry or claim authorship of ghostwritten publications. Also, it suggested a broad-based consensus process to develop a new system for funding high-quality accredited CME that is free of industry influence.

In medical practice, there are instances where payment to physicians to participate in industry-funded trials often exceeds fair-market value and trials sometimes are conducted as a pretense to change prescribing and testing habits of physicians. Community physicians should follow the same restrictions as academic faculty regarding gifts, including meals, and presentations or articles whose content is controlled by industry, the report noted.

Financial relationships with pharmaceutical, medical device and biotechnology companies could create conflicts of interest regarding the development of clinical practice guidelines, according to the report. It recommends that guidelines be developed with greater transparency and accountability and that groups involved in developing practice guidelines not accept direct industry funding. In addition, individuals with conflicts of interest should be excluded from the panels that draft guidelines.

The reported noted a drop of about 7 percent in the real income of physicians from medical practice from 1995 to 2003, “a pattern that contrasts that of other professional and technical workers.”  Drug companies in 2004 spent nearly $60 billion in marketing, including $20 billion in sales calls, $16 billion in free drug samples and $2 billion in meetings.

“The public needs to be able to trust that physicians' decisions are not inappropriately influenced by their financial relationships with industry,” the report concluded.

A joint statement from the American College of Cardiology, American College of Radiology, American College of Emergency Physicians, American College of Rheumatology, and American Society of Plastic Surgeons said that public funding for education and research is limited.

“Without continued external support from industry, our societies will be unable to provide the same level of outstanding education and cutting-edge science that has advanced the quality of patient care in this country,” the organizations wrote.

The societies emphasized that they adhere to Accreditation Council for Continuing Medical Education standards, and that they each are “committed to the very highest ethical standards” and that they strive for “responsible, transparent relationships, in which industry support has no influence on educational content, quality measures or scientific research.”

The societies are considering developing an ad hoc “self-funded coalition for medical associations to develop and articulate best practices and a common code of ethics for managing relationships with industry.”

The statement concluded that relationships with industry will remain “vital to the quality of care in the United States” until “new sources of public funding for education and research are identified.”