The failure of a clinician to disclose nearly $1 million in industry payments has turned the spotlight on conflicts of interest
in the biomedical research world. Sen. Charles Grassley (R-IA), ranking Republican on the Senate Finance Committee, recently
uncovered evidence that psychiatrist Charles Nemeroff of Emory University in Atlanta ignored demands to disclose payments
from GlaxoSmithKline. Even though the payments were perfectly legal, the case once again raises questions about oversight
of academic consulting activities, violation of government disclosure requirements, and ultimately the validity of evidence
to support new drug approval by FDA.
As a result of such questions, senators including Grassley are seeking to enact the Physician Payment Sunshine Act, which
would require pharmaceutical and medical device companies to disclose payments of more than $500 to doctors. Industry has
grudgingly supported the measure as preferable to a proliferation of different state disclosure laws and ongoing investigations
into conflicts of interest (COI) involving marketing and research practices.
Elsewhere, the Institute of Medicine (IOM) has convened a blue-ribbon panel headed by University of California San Francisco
professor Bernard Lo and former National Institutes of Health (NIH) official Wendy Baldwin to evaluate 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 panel is examining disclosure policies and codes of conduct at academic
medical centers, pharma companies, professional societies, and government agencies. The panel's report, due next year, will
propose principles for managing COIs and for ensuring the objectivity and validity of biomedical research.
Repeated disclosure failures and lax institutional oversight have raised doubts, however, about the enforcement of appropriate
safeguards. And expanding government support for more medical evidence reviews and practice guidelines has raised alarms about
even more opportunities for industry to influence medical practice. Meanwhile, universities and pharmaceutical manufacturers
are revising policies and establishing new disclosure and funding practices. The University of Minnesota Medical School is
weighing full disclosure of all relationships between faculty and the drug industry, as well as a ban on gifts from medical
companies. Eli 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 clinicians conducting research.
While neither manufacturers nor academic institutions are eager to cut off the more than $1 billion industry provides each
year for CME, the desire to avoid any appearance of undue influence is taking a toll on industry support for medical education
of doctors and health professionals. Both sides maintain that such programs are vital to keeping physicians alert to the latest
But the cutoffs have already begun. 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 now want pharma
companies to fund CME through central educational funds. Pfizer adopted such an approach, and says it will end direct support
of CME through commercial educational providers.
FDA faces similar challenges in establishing partnerships with industry to support its Critical Path Initiative (CPI) for
translating biomedical research and genetic discovery into new therapies. Such collaborative efforts raise concerns about
industry influence over regulatory decisions, along with a host of legal issues. Congressional objections to any industry
financial support for FDA programs (even user fees) have blocked federal funding of the Reagan-Udall Foundation for fear it
would provide a back door for industry to influence FDA decisions on market approval for new drugs. Reagan-Udall chair Mark
McClellan, a former FDA commissioner now at the Brookings Institution, is working to establish bylaws and safeguards to separate
outside funders and foundation operations in order to gain budget authorization for Reagan-Udall next year.