Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health, provided Pfizer with human tissue samples in exchange for payments in violation of HHS ethics rules and federal laws, according to a preliminary report released on Tuesday by investigators for the House Energy and Commerce Committee, the Washington Post reports. The report was presented on Tuesday at a hearing of the House Energy and Commerce Subcommittee on Oversight and Investigations (Weiss, Washington Post, 6/14). According to the report, Sunderland provided Pfizer with more than 3,200 samples of spinal fluid and 388 tubes of plasma collected for Alzheimer's disease research. The report estimates that NIH spent $6.4 million to collect the samples, which were donated by volunteers with Alzheimer's, relatives of Alzheimer's patients and individuals with normal risk for the disease (Henderson, Boston Globe, 6/14). The report states that "records and interviews provide reasonable grounds to believe" that Sunderland "personally received $285,000 in compensation from Pfizer" in exchange for the samples (Kaiser Daily Health Policy Report, 6/13). Sunderland also received more than $300,000 from Pfizer outside consulting and speaking engagements, the report states (Washington Post, 6/14).

Disclosure
Sunderland failed to inform NIH officials about his agreement with Pfizer, as well as an agreement with a different company, according to the report. Neither Pfizer nor the other company committed any wrongdoing, the report states. In addition, the report states that NIH -- which has not released the results of an internal investigation into the issue -- has concluded Sunderland committed "serious misconduct, in violation of HHS ethics rules, and federal law and regulation" (Washington Post, 6/14). NIH in August 2005 adopted new ethics rules under which agency scientists cannot enter outside consulting agreements (Boston Globe, 6/14).

Comments
NIH spokesperson John Burklow said that the agency is "evaluating the process of material transfer out of NIH and will be clarifying current rules." Under the clarified rules, "all transfers of human samples will require an appropriate agreement signed off by a senior official," he said (Washington Post, 6/14). He added, "It is important to note that the specific consulting arrangements in question, had they been known to NIH, would not have been approved under the present or previous ethics regulations." Burklow said that NIH officials "share the committee's concerns in regard to the ethical management of human tissue samples and the development of rigorous and uniform policies" (Willman, Los Angeles Times, 6/14). Robert Muse, an attorney for Sunderland, said, "Contrary to the House committee report, Dr. Sunderland did not receive any payments from Pfizer for human tissue samples. He acted properly, ethically and legally in his relationship with Pfizer" (Boston Globe, 6/14). Muse said, "There was no effort to conceal this in any way" (Washington Post, 6/14). Pfizer spokesperson Kate Robins said that the company had a transfer agreement approved by NIH that allowed Sunderland to provide the samples. She added, "The payments over a six-year period were reasonable and customary for an expert of Dr. Sunderland's stature and reflect the fair-market value of his consulting services" (Boston Globe, 6/14).

Broader Concerns
The report also raises concerns about the level of oversight over the samples collected by NIH. "In sum, the records and interviews conducted in this investigation raise serious questions of misconduct in connection with, and inadequate oversight and control over, human tissue samples" at NIH, the report concludes (Washington Post, 6/14). Committee Chair Joe Barton (R-Texas) said, "After extensive investigation on a bipartisan basis, we have found deeper concerns regarding human tissue samples at NIH than we first believed," adding that the results "underscore the need to enact NIH reauthorization and reform legislation" (Carey, CQ HealthBeat, 6/13). Barton added, "NIH tells us it has no centralized inventory system that could tell the NIH director how many vials of tissues are in freezers at a particular institute" (Boston Globe, 6/14). Rep. John Dingell (D-Mich.) said, "NIH lacks adequate controls for human tissue samples, human subject protection and the scientific conduct of many of its senior employees" (Los Angeles Times, 6/14). Rep. Tammy Baldwin (D-Wis.) said, "It's important to remember that each of these samples originated in a person ... that chose to make a gift so research could progress," adding, "What is most shocking to me is the carelessness in the way in which some at NIH seem to be treating such a precious commodity" (Washington Post, 6/14).

Broadcast Coverage

CBS' "Evening News" on Tuesday reported on the allegations against Sunderland. The segment includes comments from Arthur Caplan, chair of the department of medical ethics at the University of Pennsylvania and director of the university Center for Bioethics; Susan Molchan, an NIH clinical researcher who studies Alzheimer's disease; and House Energy and Commerce Subcommittee on Oversight and Investigations Chair Edward Whitfield (R-Ky.) (Keteyian, "Evening News," CBS, 6/13). The complete segment is available online in RealPlayer.

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.