It now seems pretty clear that researchers at major universities — including the head of psychiatry at Emory University — failed to properly disclose their financial ties to drug companies. And evidence of that failure suggests academic medical centers are not capable of policing their faculty’s potential conflicts of interest.
Documents released recently by congressional investigators show that Emory’s Dr. Charles B. Nemeroff received $2.8 million in consulting fees from drug companies from 2000 to 2007; he was paid for, among other things, serving on advisory boards and giving lectures about new drugs to psychiatric colleagues. But on conflict-of-interest forms filed with Emory, Nemeroff reported his income from drug companies was much less than that, $1.6 million.
Investigators paint a disconcerting picture of Nemeroff and his financial connections to drug companies. The documents also seem to show that Emory was wholly dependent on Nemeroff to make good on his promises to fully detail his income from drug makers. Failure to disclose financial conflicts is a violation of rules governing federally funded research and could jeopardize Emory’s $251 million in National Institutes of Health funding.
In 2004, Nemeroff agreed to Emory’s demand that he limit his income from any single drug manufacturer to less than $10,000 a year. But congressional investigators found that Glaxo-SmithKline alone paid Nemeroff $170,000 that very same year. In both 2005 and 2006, Nemeroff also greatly exceeded the $10,000 limit, according to documents provided by GlaxoSmithKline, while Nemeroff filed disclosure forms with Emory attesting he was within the yearly limits.
From 2000 through 2006, Nemeroff earned $960,000 from GlaxoSmithKline alone, but he declared less than $35,000 on his disclosure forms. During some of that time, Nemeroff was the principal investigator of a five-year, $3.9 million grant from the National Institute of Mental Health for testing GlaxoSmithKline-provided drugs. Had Emory known about his higher income, it would have been required to inform the institute of his potential conflict or remove him as principal investigator.
(Nemeroff voluntarily resigned his department chairmanship after news of the congressional investigation was reported in The New York Times. Emory emphasized his resignation is temporary, pending the outcome of the university’s investigation of his actions.)
The Emory physician is the latest in a string of high-profile academic researchers whose ties to drug companies have shaken up the relationship between medical scientists and Big Pharma. Last spring, Sen. Charles Grassley (R-Iowa) — who has been pushing the investigation in the Senate — reported that a University of Cincinnati researcher told her medical school that she had earned $100,000 from 2005 to 2007 from eight drug firms. But documents from one firm, AstraZeneca, revealed she was paid $235,000 from that company alone for her work during those years. In June, Grassley’s investigators reported that two well-known Harvard child psychiatry researchers apparently underreported their payments from drug companies to the university for a seven-year period by hundreds of thousands of dollars each.
The congressional probe provides further evidence of just how tangled medical research has become with medical marketing. It begins with company sales representatives sponsoring lunches for medical students and extends to doctors’ offices being festooned with drug advertisements encouraging patients to “ask your physician” about their latest product. It also extends to lucrative contracts among scientists, universities and manufacturers that sometimes include sharing large profits from patents for new drugs or products.
Much, if not most, of the research done for these products — many of them with the potential to save and improve lives — is scientifically grounded and conducted ethically. Still, it’s difficult for consumers to determine the credibility of work if the drug companies are underwriting not just the researchers, but also the universities that employ them.
Grassley’s investigators released a letter from Nemeroff to Emory officials labeled “confidential” in 2000; the doctor warned the university that it shares some of the potential conflict connected to his work. In the letter, Nemeroff pointed out that his service on the advisory boards of several large drug companies resulted in endowed chairs and other monetary awards to Emory. The same could be said for other well-known researchers, the academic medical centers that employ them and among the medical speciality societies where word of new products is most effectively spread.
Grassley’s investigation has focused heavily on drug company connections to psychiatry researchers, including Dr. Alan F. Schatzberg, a well-known Stanford University researcher and the president-elect of the American Psychiatric Association. Schatzberg holds $4.8 million in stock in a drug development company, and Big Pharma accounts for about 30 percent of the psychiatry association’s $62.5 million annual budget.
A subsequent investigation by Stanford found that Schatzberg complied with the university’s disclosure and conflict-of-interest rules. Nevertheless, the university decided to clamp new restrictions on industry financing of doctors’ continuing education courses at its medical school.
Drug company contributions will now have to go into a pool of money to the university that can be used for any class, even ones that never mention a company’s products. (In the past, drug companies routinely funded specific courses, usually those associated with new clinical practices in areas where their products could be used.) Five other major medical schools have developed similar rules for how to use continuing education grants from drug makers.
These recent disclosures are more evidence that the requirements for reporting payments from the drug industry — in essence an honor system that relies on the researchers to tell their universities what they are earning — are simply inadequate. At a minimum, Congress should approve Grassley’s proposal requiring annual disclosures by companies of payments of $500 or more to researchers, a suggestion several pharmaceutical manufacturers have voluntarily adopted.
But much more needs to be done. The culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing. Disinfecting it may result in a temporary reduction in the amount of money going into research and continuing physician education. But in the long run, the nation’s medical schools will want to enhance the reputation of faculty members who are doing quality, independent research unencumbered by questions about whether they are protecting the lives of patients or protecting their own wealth.
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