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Congress Probes Alleged Payment for NIH Patient Samples

14 June 2006 (All day)
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C. McCarty, House Energy and Commerce Committee

Pleading the 5th.
NIMH Alzheimer's disease researcher Trey Sunderland and former co-worker Karen Putnam declined to testify today at a Congressional hearing.

A Congressional probe has accused a National Institutes of Health (NIH) investigator of sending thousands of patient tissue samples to a drug company, then improperly receiving $285,000 in consulting payments from the firm. The accusations are the latest against Trey Sunderland, a prominent Alzheimer's disease researcher who 2 years ago was found to have failed to report consulting deals to the agency.

At a hearing yesterday and today, the panel also took NIH officials to task for their handling of human tissue samples. "We have found a lack of a centralized database and a lack of oversight at NIH that could, and probably does, leave NIH laborator[ies] vulnerable to the risks of theft and abuse," full committee chair Joe Barton (R-TX) said yesterday. NIH officials agreed that they need to tighten procedures, but cautioned that a central database of samples might not be the right solution.

The House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations has already looked into large payments to several senior NIH scientists for consulting for industry. That investigation led NIH last year to impose strict new limits on consulting by NIH intramural scientists (Science September 2, 2005). Sunderland is also under investigation by the Department of Health and Human Services Inspector General's Office and the Department of Justice.

The new House investigation began after a former member of Sunderland's lab, Susan Molchan, told the committee last year that she had had trouble obtaining some of her spinal fluid samples from Sunderland. Staffers eventually learned that Sunderland, chief of the Geriatric Psychiatry Branch at the National Institute of Mental Health (NIMH), sent Pfizer 3200 samples of spinal fluid and 388 plasma samples, along with clinical data, for a study of Alzheimer's biomarkers. In April 1998, Pfizer signed a Material Transfer Agreement (MTA) with NIMH, the proper procedure for sharing samples with an outside research group.

But around the same time, Sunderland signed a consulting agreement with Pfizer that eventually paid him $285,000, according to a 26-page bipartisan report released yesterday by the subcommittee. This agreement, and another with Pfizer for which he was paid more than $300,000 over 6 years, were not reported to NIH. The report also raises questions about whether Sunderland had obtained proper informed consent from some patients to use their samples for the Pfizer study.

At today's hearing, NIH officials said the MTA and consulting agreement would not have been approved because they improperly commingled official duties and outside consulting activities. "You could have collaboration and consulting, but not with the same party," said NIMH director Thomas Insel. Instead, Insel said, Sunderland should have signed a cooperative agreement with Pfizer, for which Sunderland would not have been paid, that would have preserved NIH's rights to intellectual property and data. Sunderland and one of his former co-workers, Karen Putnam, were subpoenaed to testify at today's hearing but invoked their constitutional right to decline to answer questions. Sunderland's attorney, Robert Muse, has told the subcommittee that his client's reporting lapses were paperwork oversights and says "there is no truth to the allegation that Dr. Sunderland received a penny from Pfizer for the samples."

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