Healthy Skepticism Library item: 17440

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: Electronic Source

Silverman E
A University Clams Up Over A Conflict Of Interest
Pharmalot 2008 Apr 9
http://www.pharmalot.com/2008/04/a-university-clams-up-over-a-conflict-of-interest/

Full text:

The officials at the University of Cincinnati are remarkably quiet this week. Over the past two days, they have received an inordinate amount of attention because a psychiatry professor, Melissa DelBello, has again been singled out by Chuck Grassley, the Iowa Republican on the US Senate Finance Committee, for receiving grants from the NIH and large fees from AstraZeneca while also working on a key study of its Seroquel antipsychotic.
At issue is whether the NIH and the university are monitoring such conflicts. The NIH has stonewalled, simply because Norka Ruiz Bravo, the NIH deputy director for extramural research, believes it “would be not only inappropriate but pretty much impossible.” But what about the university? Richard Puff, a spokesman, has not gotten back to us promised. What does this public institution have to fear? Maybe the Senate Finance Committee.
Last summer, it turns out, DelBello and Puff were chatting up a storm after Grassley first made an example of her. She e-mailed Insider Higher Ed that The New York Times, which wrote about her AstraZeneca fees a year ago, quoted her incorrectly. And Puff argued in his own e-mail that Grassley was off base, although his choice of language wasn’t particularly prudent, given that he was talking about a US Senator interested in an investigation.
“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 (institutional review board). 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,” he wrote.
And when a faculty member discloses a conflict, “our IRB 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 wrote. “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.”
But when asked about Grassley’s contention that the university didn’t do enough to verify what researchers report, Puff began to sputter. “We don’t ask for tax returns…We do trust our faculty when they make these disclosures,” he wrote. “We’re talking about highly principled researchers and clinicians.” Such remarks may only pique the interest of the committee. Maybe that’s why Puff isn’t huffing and puffing this week.