House Committee Scrutinizes NIH Scientist

An NIH scientist may have exploited human tissue samples for personal gain, and his actions highlight a critical need for better monitoring of such samples when they are released to industry or elsewhere, says a report released June 13 by the House Energy & Commerce Committee.

The report is the result of a year-long, bipartisan Commerce Committee investigation that focused on the actions of Trey Sunderland, chief of the Geriatric Psychiatry Branch of NIH's National Institute of Mental Health. The report says Sunderland shipped 3,200 tubes of human spinal fluid and 388 tubes of human plasma collected for Alzheimer's research to Pfizer under a 1998 Material Transfer Agreement. Sunderland subsequently received more than $600,000 in payments from Pfizer for consulting work or speeches related to the samples during the period 1998???2004.

The Commerce Committee's concerns are twofold: First, investigators say there is "reason to believe" that Pfizer's sole interest in consulting with Sunderland was because he provided the tissue samples. The committee noted that collecting the tissue samples cost taxpayers $6.4 million. What's more, the committee notes that the NIH Office of Management Assessment has found that Sunderland's misconduct violated ethics rules as well as federal law and regulation, yet he has not been prosecuted or disciplined to any measurable degree.

Another concern outlined in the Commerce Committee report is that NIH has "no uniform, centralized, and mandatory authority regulating the handling of human tissue samples. Some NIH laboratories kept a written record on the maintenance of these samples, but other NIH laboratories did not." The lack of a formal inventory control or tracking system at NIH, the committee report says, "left NIH wholly vulnerable to theft and diversion of valuable human tissue samples."

At a Commerce Committee hearing focused on the collection, storage, and tracking of such human tissue samples in NIH's intramural research program, Sunderland refused to answer any question about his activities, invoking his Fifth Amendment right against self-incrimination. Representatives from NIH, however, did testify and noted that NIH was aware of Sunderland's collaboration with Pfizer and the decision to transfer samples, but that he had not sought approval for or disclosed the fees he received for his consulting activities.

NIH representatives told the Commerce Committee that NIH had completed an internal investigation of Sunderland last year as part of its conflict of interest policy overhaul (C&EN. Sept. 5, 2005, page 14). The agency then made disciplinary recommendations for Sunderland to the Public Health Service Commission Corp., which is technically his employer. In addition, investigations of Sunderland are currently under way by the Department of Justice and the Department of Health & Human Services.

"These hearings underscore the need to enact NIH reauthorization and reform legislation," Committee Chair Joe Barton (R-Texas) said in a statement. "The NIH director must have some baseline of information about NIH assets. If we are going to gain new efficiencies and hopefully more effective ways to translate research into better healthcare, enacting NIH reauthorization legislation is of the highest importance."