Federal Audit Faults Universities Over Researchers' Financial Conflicts of Interest

November 19, 2009

Universities involved in federally sponsored medical research rarely take steps to investigate, reduce, or eliminate financial conflicts of interest among their scientists, a government audit report said Thursday.

The report, by the inspector general of the Department of Health and Human Services, is the latest in a series of audits over the years that have criticized both universities and the National Institutes of Health, which distributes $24-billion a year in research money, as insufficiently attentive to biases affecting the reliability of American medical research.

In the new audit, the inspector general reviewed data from the federal government's 2006 fiscal year and found universities almost always trust scientists to judge whether their stock holdings or payments from outside medical companies pose any conflict of interest.

The inspector general also found that universities almost never require the scientists to make any meaningful changes in those financial relationships when conflicts are acknowledged, and that the NIH does little, if anything, to police the matter.

"With so much funding at stake, the question of research integrity becomes crucial," the inspector general said in the report. "It is vital to public health and safety that this research not be biased by researchers' conflicts."

Tougher Rules Coming?

The NIH, in a statement of response to the audit, said it continued to evaluate such complaints. Agency officials announced in May that they would begin a process for writing new regulations that might lead them to impose tougher rules against financial conflicts of interest.

Many of the new regulations under consideration would deal with the concerns and recommendations raised in the inspector general's report, Sally J. Rockey, acting NIH deputy director for extramural research, said in the statement.

The NIH "strongly believes that it is vital that all research be conducted with the highest scientific and ethical standards," Ms. Rockey said. "The introduction of bias in the conduct of NIH-supported research is antithetical to these principles and will not be tolerated."

The NIH, however, has been facing such complaints for years. The health department's inspector general in January 2008 filed a report similar to the one it issued on Thursday, saying the NIH relied largely on universities to police themselves, with more than 90 percent of financial conflicts reported by institutions lacking explanations of how the matters had been resolved, and the NIH rarely asking for details.

And in 2001, the federal government's main audit agency, known then as the General Accounting Office, warned against the NIH's practice of giving universities much of the responsibility for policing financial conflicts of interest in biomedical research.

Condemnation From Critics

While NIH officials have repeatedly expressed concern about financial conflicts, they have also been reluctant to take on a greater enforcement role. Ms. Rockey, in an interview with The Chronicle in May, said that any regulatory changes made by the NIH would not seek to overturn the fundamental understanding that universities have primary responsibility for monitoring their employees.

"We feel it is appropriate that the institutions manage their financial interests," she said.

That position has brought condemnation from critics led by Sen. Charles E. Grassley, a Republican of Iowa, who issues frequent reports of cases in which researchers have accepted corporate money or benefits that could pose ethical conflicts.

Senator Grassley is pursuing legislation that would require companies to report all payments to researchers, and he has repeatedly demanded that the NIH stop providing money to researchers who are also paid by companies that have a financial stake in the outcome of their work.

Conflicts at 41 Institutions

The inspector general's latest report was based on evaluations of cases at 41 institutions that voluntarily reported financial conflicts of interest to the NIH in the 2006 fiscal year. The report notes that the NIH also conducted its own review in fiscal 2006 at 18 institutions that together accounted for about a quarter of its research-grant awards the previous year. That NIH review found "no instances of intentional noncompliance" by the universities, but a series of problems in identifying financial conflicts and obtaining disclosures from researchers.

The report also cites individual cases such as that of Charles B. Nemeroff, who resigned from Emory University after Mr. Grassley found that the psychiatry-department chairman had collected about $2.5-million from pharmaceutical companies from 2000 to 2007 but disclosed only about $1.2-million of it to the university. Dr. Nemeroff had been studying the effects of the antidepressant drug Paxil, and the payments largely came from the drug's manufacturer, GlaxoSmithKline.

Dr. Nemeroff, who was not identified by name in the inspector general's report, was hired last month by the University of Miami to head its psychiatry department. The hiring was announced just as the university's president, Donna E. Shalala, issued a statement on November 2 promising a renewed commitment to toughening the institution's conflict-of-interest policies, as part of a strategy to "ensure the integrity of everything we do: academically, scholarly, fiscally, and professionally."

A university spokeswoman said Ms. Shalala was not willing to discuss the matter and was referring all questions to the dean of the university's medical school, Pascal J. Goldschmidt. Dr. Goldschmidt, in an interview, said he studied Emory's review of the matter and concluded that Dr. Nemeroff had made an error in handling his financial disclosures but had not allowed the company payments to affect the quality or conclusions of his research.

Dr. Nemeroff is a well-recognized leader in his profession, Dr. Goldschmidt said, and "we should provide a second chance, particularly when that person has so much to contribute to the health and wellness of our fellow human beings."