Aug. 6, 2007

Scrutiny of Researcher-Industry Ties

A prominent U.S. senator is examining drug company support of academic researchers, the extent to which university scientists report such income, and what, if anything, the institutions do with that information.

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Sen. Charles Grassley (R-Iowa) has, as the senior Republican and former chairman of the Senate Finance Committee, kept a watchful eye on college governance and other aspects of higher education finances and potential conflicts of interest. Grassley’s comments came in a speech on the Senate floor Thursday in which he called for a national reporting system of drug company payments to doctors, which he said was essential to ensuring that patients might know about potential conflicts of interest for doctors who might prescribe medications — or researchers who might study the efficacy of such drugs.

In his speech Thursday, Grassley said that to get a sense of the current state of reporting by researchers, he had sent letters to several universities seeking information about the quality of the reporting system by which academic researchers report their outside income to their institutions.

Grassley did not say how many institutions had received his inquiries, and aides to the senator could not be reached over the weekend for additional information. But in his speech Thursday, which was first reported in The New York Times, Grassley said that the early responses had uncovered some problems.

First, the senator said, colleges and universities often do not monitor or audit the information the researchers report, so “the only person who knows if the reported income is accurate and complete is the doctor who is receiving the money.”

Second, “these disclosures are usually kept secret,” so for a doctor “getting thousands of dollars from a drug company — payments that might be affecting his or her objectivity — the only people outside the pharmaceutical industry who will probably ever know about this are the people at that very university, if they are even keeping track of it, and we don’t know that they are keeping track of it. But most Americans never get a fair chance to see this information.”

Grassley cited as an example in his speech information he had received from the University of Cincinnati about one of its researchers. The scientist, Melissa DelBello, had been among the subjects of a May article in the Times about the pharmaceutical industry’s influence in psychiatrists’ prescribing of drugs to children. In that article, Grassley noted, DelBello, in response to a reporter’s question about the support she received from drug companies, had said: “Trust me, I don’t make much.”

“Well,” Grassley said Thursday, “I decided to find out how much, and I went directly to the University of Cincinnati who, by the way, has been extremely cooperative, helpful, and responsive. Soon I figured out just how much ‘not that much’ money is.” Grassley said that DelBello’s disclosure forms showed that she had received $180,000 over two years for lectures, consulting fees and other services from one drug company, AstraZeneca, for which she did research.

In separate e-mail messages over the weekend, DelBello and Richard A. Puff, a spokesman for the University of Cincinnati, took issue with certain aspects of Grassley’s speech and The New York Times account of it, and clarified other aspects of them.

Puff said that DelBello’s comment in May that she did not “make much” money from drug companies had actually come in response to the reporter’s question “about how much money she was given for making a single, individual presentation. Her comment was misrepresented and then repeated by Sen. Grassley.” Added DelBello: “I was and have been misquoted by the NYT.” (The Times reporter, Gardiner Harris, could not be reached Sunday to respond to the suggestion that he had misrepresented DelBello’s comment.)

Puff also said that “the implication of what Sen. Grassley said was that she was disingenuous in what she was paid. She has been completely open in disclosing her payments. She’s made complete disclosures to the university and its IRB. Furthermore, she’s made full disclosure to the Senate Finance Committee.... Additionally, Dr. DelBello has disclosed her funding at all speaking engagements and she’s disclosed in the patient consents of her studies.”

To Grassley’s suggestion that Cincinnati or other universities were not doing enough to ensure the veracity of what their researchers report, Poor acknowledged that “we don’t ask for tax returns.... We do trust our faculty when they make these disclosures.... We’re talking about highly principled researchers and clinicians.”

However, when a faculty member discloses a conflict, “our [institutional review board] will follow up with them to gather more information and an explanation about the conflict, and the IRB often requires that this is disclosed to study participants,” Puff said. “Additionally, we’ve recently completed a multiyear project in which we’ve tightened our controls. There’s a strengthened conflict of interest reporting policy for researchers. There are tighter regulations on human subject research in which we ask our faculty to explain in more details potential conflict of interest.”

Grassley said he was “not saying this money was a payoff or suggesting there is something inherently bad with accepting drug company money.” But “for the sake of transparency and accountability,” he added, “shouldn’t the American public know who their doctor is taking money from? After all, anybody can go on the Internet and see who is funding the campaigns for federally elected officials. Because doctors are expected to look out for the health and well-being of their patients, shouldn’t we hold doctors to similar standards?”

— Doug Lederman

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