A senior researcher at the National Institutes of Health shared thousands of tissue samples with drug giant Pfizer and appears to have netted at least $285,000, House investigators say.
The investigators, citing an NIH review of the arrangement, contend that the work violated the agency's ethics rules and would not have been approved had he sought permission.
The arrangement also raises questions about how the government protects human tissue samples - one of its most precious resources when it comes to medical research - said Rep. Joe Barton, R-Texas, chairman of the House Energy and Commerce Committee.
The committee's inquiry focuses on Dr. Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health and an expert on Alzheimer's disease.
His outside work has prompted scrutiny from committee investigators before. About two years ago, the committee said that Sunderland had received $517,000 since 1999 in consulting fees or expense reimbursements from Pfizer Inc. and that there was no record that he received prior approval for those activities or disclosed it in his financial report filings.
The NIH reviewed the case and tightened its rules for outside work arrangements. It also referred an allegation to Health and Human Services' inspector general that Sunderland may have conducted outside activities during government work hours without taking leave.
In the meantime, congressional investigators continued to probe Sunderland's work with Pfizer on an Alzheimer's drug. They concluded there were "reasonable grounds" to believe $285,000 of the $517,000 he received from Pfizer was for work derived from giving the drug company access to spinal- fluid and plasma samples.
Sunderland's attorney, Robert Muse, said his client "didn't receive a dime for providing anything to Pfizer. He received fees for consulting as well as for lectures."
The transfer of spinal fluid samples was done under a 1998 material transfer agreement between the National Institute of Mental Health and Pfizer.
At the heart of the investigation is Sunderland's use of spinal fluid collected in the early 1990s by an NIMH scientist, Susan Molchan, who later left the institute. When Molchan -- who once filed sex discrimination charges against Sunderland that were unsuccessful -- sought to resume her research in a different lab in 2004, she learned that many of her 10- to 15-year-old samples, which she hoped to retrieve, were no longer in the NIMH's freezers.
Acting on a complaint from her, House investigators found that Sunderland had sent thousands of specimens -- including some of Molchan's -- to Pfizer under an agreement not approved by NIH officials. Pfizer used the samples in its search for biological markers of Alzheimer's progression, which could have led to a potentially lucrative test.
Sunderland ultimately received at least $285,000 in consulting fees for work relating to the specimens, investigators said, as well as more than $300,000 for giving talks and other activities.
Sources: The Arizona Republic and WaPo
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