Goal is to address conflict of interest in clinical studies and CME programs
Each year, clinical laboratories and laboratory medicine associations receive less financial support from industry vendors and suppliers. This is a response to tougher Medicare compliance requirements and tighter ethics guidelines. Now comes a report from the Institute of Medicine calling for further reforms on how companies work with physicians to conduct clinical trials and publicize the findings.
The IOM committee’s report, Conflict of Interest in Medical Research, Education and Practice, stresses the importance of preventing bias and mistrust upfront, rather than trying to remedy damage after the fact. It focused specifically on financial conflicts of interest involving pharmaceutical, medical device, and biotechnology companies.
The report does not seek elimination of industry-sponsored research or legitimate consulting arrangements between medical professionals and industry, noted IOM committee member Eric Campbell, Associate Professor at Harvard Institute for Health Policy, in a report from Modern Healthcare. “Many of the drugs and devices on the market today would not exist if it weren’t for the close relationships between medical professionals and industry,” he acknowledged.
The IOM report offered recommendations aimed at academic medical centers, professional societies, healthcare journals, lawmakers, and accrediting bodies. These recommendations are designed to eliminate the influence of medical companies on continuing medical education (CME), clinical guidelines and research outcomes.
Among the 16 recommendations, one was to create a standardized disclosure format for individuals and institutions to report financial relationships with industry. Another was to prohibit acceptance of gifts and funding from medical products companies for the clinical guidelines developed and published by professional medical organizations. The IOM report stopped short of banning industry sponsorship of CME events, but suggested that medical groups work together to develop a new system for funding educational programs “free of industry influence.”
One far-reaching recommendation was the IOM report’s call for Congress to create a national reporting program. Under this program, pharmaceutical, medical device, and biotechnology companies would be required to make public all payments to physicians, researchers, healthcare institutions, professional societies, patient advocacy and disease groups, and providers of continuing medical education. Public reporting would enhance accountability, allowing academic medical centers, medical journals, and others to verify disclosures made to them by faculty members, article authors, and others.
Such a bill, the Physician Payment Sunshine Act, has already been introduced to Congress. If passed, beginning in 2010 the government would require yearly reporting of all physician payments over a cumulative value of $100 dollars, with the first report due by March 31, 2011. This information would be made public by September 30, 2011.
Campbell noted that IOM doesn’t comment on specific legislation, but the group hopes to influence both regulatory and voluntary policies. “We’re hoping as a committee to go beyond what we’ve traditionally relied upon, which are voluntary guidelines by groups like PhRMA, which is a lobbying organization,” he said.
The Center for Medicine in the Public Interest (CMPL), a group backed by the pharmaceutical industry, vehemently opposes the IOM report, according to Modern Healthcare. CMPL President Robert Goldberg contends, “…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 the emphasis on these reform efforts is in other areas of healthcare outside of laboratory medicine, new guidelines and these proposals do cover in vitro diagnostics (IVD) manufacturers and other companies that sell products and services to clinical laboratories and pathology groups. Facing more restrictive ethics guidelines and tougher Medicare compliance requirements, the cumulative effect is to reduce the availability of funding from these sources to support education programs offered by individual laboratories and laboratory industry associations and societies. – P. Kirk