Conflicts of interest under investigation as policies begin to change

Conflicts of interest (COI) in the biomedical research world moved to center stage once again when Sen. Charles Grassley (R–Iowa), ranking Republican on the Senate Finance Committee, revealed evidence last month that psychiatrist Charles Nemeroff of Emory University in Atlanta had not disclosed nearly $1 million in industry payments (mostly from GlaxoSmithKline). Even though the payments were legal, the case raises questions about oversight of academic consulting activities, violation of government disclosure requirements, and ultimately the validity of evidence to support new drug approvals by FDA.

Several senators, including Grassley, want to enact the Physician Payment Sunshine Act, which would require pharmaceutical and medical device companies to publicly disclose payments to physicians of $500 or more. Industry is showing support for the measure, perhaps seeing it as preferable to the proliferation of differing state disclosure laws, as well as ongoing COI investigations involving marketing and research practices.

The Institute of Medicine (IOM) will address these issues in a report on COI in medical research, education, and practice. A highly credentialed panel has been evaluating the role of pharmaceutical and medical product manufacturers in funding clinical research, managing publication of research results, and supporting continuing medical education (CME) of health professionals.

The report will propose principles for managing COI and for ensuring the objectivity and validity of biomedical research. The panel has examined disclosure policies and codes of conduct at academic medical centers, pharmaceutical companies, professional societies, and government agencies. Yet repeated disclosure failures and lax institutional oversight raise questions about how effectively voluntary efforts can enforce appropriate safeguards. And expanding government support for more medical evidence reviews and practice guidelines is causing concern in some quarters about additional opportunities for industry to influence medical practice.

Meanwhile, some universities and manufacturers are revising policies and establishing new disclosure and funding practices. Lilly and Merck recently made headlines by announcing that they will voluntarily disclose all payments of more than $500 made to physicians for advice, speeches, and other services. Lilly began posting educational grants and charitable contributions last year and will add payment information next year, followed by fees for conducting clinical research.

Concern about the appearance of undue influence on physicians is reducing industry support for medical education of physicians and healthcare professionals. Neither manufacturers nor academic institutions want to cut off the more than $1 billion that industry provides each year for CME; proponents on both sides maintain that such programs are vital to keeping physicians aware of the latest disease treatments. However, CME funding has already begun to change.

Last summer, Stanford University Medical Center said it would halt direct funding of CME courses by drug and device makers. Instead of making individual grants to specific programs, medical schools want pharmaceutical companies to fund CME through central educational funds. Pfizer has adopted such an approach and has also said that it would end direct support of CME through commercial educational providers.