Healthy Skepticism Library item: 17441

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Garber K
Committee Questions a Top Psychiatrist
US News & World Report 2008 Jun 26
http://www.usnews.com/articles/news/national/2008/06/26/committee-questions-a-top-psychiatrist.html

Abstract:

An official of the American Psychiatric Association is asked about drug company ties

Full text:

Earlier this year, Alan Schatzberg, the chairman of the psychiatry department at Stanford University School of Medicine, was named president-elect of the American Psychiatric Association, arguably the most influential psychiatric group in the country. His appointment came at a critical and busy time. The APA has just embarked on a massive, multiyear effort to rewrite its diagnostic manual, which defines and classifies mental illnesses and provides a basis for their treatment.

Sen. Charles Grassley (R-IA) leads an investigation of financial relationships between drug companies and researchers.
Schatzberg, however, now finds himself in a less comfortable position: the latest subject of a broad Senate investigation into financial relationships between drug companies and researchers. Led by Sen. Charles Grassley of Iowa, the ranking Republican on the Senate Finance Committee, the investigation has already raised questions about prominent researchers at the University of Cincinnati and Harvard University-in particular, about the adequacy of their reporting of income from drug companies. Now Grassley has added Schatzberg and Stanford University to the investigation, congressional records show.

Like many of his medical colleagues, Schatzberg has received money from drug companies for work done on their behalf: consulting, lecturing, advising. Most universities and hospitals require such ties to be reported regularly, since significant financial relationships have been shown to bias research. (On average, researchers receiving money from drug companies are more likely to report positive findings in studies of the companies’ drugs.) But disclosure policies vary from university to university or from hospital to hospital, and increased scrutiny of researcher-drug company ties has recently led to calls for tighter rules. Thus, Grassley is exploring whether tougher guidelines are needed to ensure transparency, fair play, and the proper use of federal research funds.

In Schatzberg’s case, Senate investigators found “a lack of consistency” between what he earned from drug companies and what he reported to Stanford, according to congressional records. Together, the discrepancies total about $70,000. Grassley is also questioning the rigor of Stanford’s guidelines for disclosure. Schatzberg, for example, is cofounder of Corcept Therapeutics, which has applied for approval from the Food and Drug Administration to market the drug mifepristone [RU-486, an FDA-approved abortifacient] for psychotic depression. According to Securities and Exchange Commission filings, Schatzberg owns more than $6 million of Corcept stock. Stanford, however, requires researchers to specify only whether they own more than $100,000 of stock, Grassley says.

“Obviously, $6 million is a dramatically higher number than $100,000,” Grassley said in the Senate on Monday. “I am concerned that Stanford may not be able to adequately monitor Schatzberg’s conflicts of interest with its current disclosure policies and submit to you that these policies should be re-examined.” Grassley also said that Schatzberg sold nearly $110,000 of Corcept stock in 2005, just months after beginning clinical trials on mifepristone, but was not required to report the sale to the university.

In response to Grassley’s initial inquiry this spring, Stanford says it conducted “an extensive investigation” and has determined that Schatzberg did nothing wrong. “We believe that Dr. Alan Schatzberg…has fully complied with the university’s rigorous conflict of interest policy,” the university said in a statement to U.S. News. The university said that Schatzberg-contrary to a claim made by Grassley-did disclose to the Senate a $22,000 payment from Johnson & Johnson in 2002. Other discrepancies were most likely due to “misunderstandings” arising from “differences in record keeping,” the statement said. In an E-mail to U.S. News, Schatzberg said: “I can confirm Stanford’s statement that I have fully complied with its disclosure policies.”

On the question of adequate financial oversight, the university says its disclosure policies promote “well-managed interactions” between industry and academia. Schatzberg had informed school officials of his involvement with Corcept Therapeutics and promised not to participate “in any human subject research involving mifepristone,” the statement said. The university also said that after a further review, it was aware of the true value of Schatzberg’s Corcept stock.
In practice, such provisions can become rather nuanced. Schatzberg, for example, is listed as the coauthor of a 2006 paper on mifepristone as a treatment for psychotic depression. The study had a favorable outcome, finding that the drug was more effective than a placebo in reducing psychotic symptoms. At the end of the paper, however, the authors note that Schatzberg “played no direct role in the recruitment, assessment, or follow-up of subjects enrolled in this study [and] was not directly involved in the analysis of data stemming from this research.”

The Grassley-Stanford exchange is just one facet of a much larger investigation. This past spring, Grassley sent letters to about 30 psychiatrists at different universities, and investigations began shortly thereafter. Earlier this month, it was reported that two prominent psychiatrists at Harvard University belatedly reported more than $1 million of income from drug companies and may have violated university, if not federal, rules.

Grassley’s investigation seems to hinge on two key themes: transparency and regulation. Last year, he introduced, with Sen. Herb Kohl of Wisconsin, the Physician Payments Sunshine Act, which would require drug companies to report most payments made to doctors and researchers. But he says he is also concerned about insufficient oversight. Each year, the government gives about $24 billion to the National Institutes of Health, which awards grants to researchers. Like any institution, NIH wants to make sure grant recipients use the money for scientific advancement, not to advance their own purposes. But because conflict-of-interest disclosure standards differ from one place to the next, conflicts sometimes go unnoticed. “There is an idea here that we can’t leave it up to a mom and pop approach-school by school, department by department-to manage conflicts of interest,” says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. As a result, some people are calling for a national policy, something to set uniform standards for researchers. Other observers believe that universities must simply become tougher enforcers. Regardless, “Grassley is putting their feet to the fire,” Caplan says. “He’s saying: If you don’t get going on this, we’ll be here next week and the week after.”