Some major universities are reviewing the way they handle funding from drug companies in the wake of criticism from Sen. Chuck Grassley, who is pressing the federal agency that controls government health-research money to get tougher on universities that don't disclose ties to the industry.Late Tuesday, Mr. Grassley (R., Iowa) fired the latest salvo, stating in a letter that a researcher for the University of Texas who worked on a National Institutes of Health study involving the GlaxoSmithKline PLC antidepressant Paxil did not disclose more than $150,000 in consulting and speaking fees paid to her by the company. Mr. Grassley has raised similar criticism of other universities, including Stanford, Harvard and University of Cincinnati.
Another 20 universities, including Brown, which was involved with a controversial study on Paxil funded by Glaxo, have been contacted by the Senate Finance committee, on which Mr. Grassley is the ranking Republican, over questions of potential conflict of interest with drug makers.
The director of NIH, Elias Zerhouni, met Tuesday with Senate Finance staff. Mr. Grassley wants NIH to start yanking grants to universities that fail to report their researchers' outside income from drug firms, as required by law.
NIH gave more than $23 billion last year to educational institutions. Dr. Zerhouni has been publicly skeptical about NIH's ability to pull grants, but Mr. Grassley said, "Starting today, the NIH could send a signal that business as usual is over....The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."
Last month, Stanford announced a policy to restrict drug-company funding of continuing medical-education programs. It also removed a renowned researcher as lead investigator on an NIH project, following questions from Mr. Grassley. Harvard has said that it is reviewing its conflict-of-interest policies.
Mr. Grassley made statements about Karen Wagner based on a comparison of records from the University of Texas and from Glaxo. Between 2000 and 2008, Dr. Wagner was engaged in an NIH study on the use of Paxil to treat teenage depression and another study on teen anxiety.
The university's legal counsel said they will look for any discrepancies in Dr. Wagner's disclosure reports. Dr. Wagner did not respond to requests for comment.
The University of Texas has received more than $5 billion from NIH since 2000.
"Universities have been treading on dangerous ground with their increasingly complex financial ties to industry," said Jerome Kassirer, former editor of the New England Journal of Medicine. "They are worried that these things could ultimately affect their tax-free status," he said.
Many faculty members remain on company speakers' bureaus, he added.
Dr. Wagner was considered one of Glaxo's "opinion leaders," speaking at many medical meetings about Paxil, according to documents from civil suits. Paxil has been linked to teenage suicide and suicidal behavior. The company has said the drug is safe. Dr. Wagner was a co-author of the Brown study on Paxil that has come under attack for allegedly overstating the drug's safety.
In 2000, the first year of the NIH grant, Dr. Wagner, who is based at the University of Texas Medical Branch in Galveston, received $53,000 from Glaxo, which included a trip to Paris to speak at a company meeting, Glaxo confirmed.
From 2003 to 2004, while receiving additional funds from Glaxo, Dr. Wagner served on the university's committee policing conflict of interest.
Barry Burgdorf, the university's vice chancellor for legal affairs said there didn't appear to be a major problem with the 15-branch university's disclosure system.
By: Alicia Mundy
Wall Street Journal; September 11, 2008
