The Sunderland Case
Dr. Trey Sunderland

FEDERAL RESEARCHER APPROPRIATES THOUSANDS OF TISSUE SAMPLES

A federal researcher gave thousands of human tissue samples under the control of the government to a pharmaceutical company with whom he maintained a secret relationship. In turn, the company, Pfizer, paid Dr. Trey Sunderland more than half a million dollars in consulting fees and travel expenses for tissues that cost the government 6.4 million dollars to collect. Quite a bargain for Pfizer.

How could this happen? Because the government's oversight of its own tissue collections is unacceptably lax. Dr. Sunderland was only caught by accident. It all began to unravel when a researcher at the National Institutes of Health, Dr. Susan Molchan, asked for some tissue samples she had collected years before on Alzheimer's patients.

Molchan wanted to use the samples on a new Alzheimer's study she was beginning.

But Dr. Pearson ("Trey") Sunderland III, the Chief of NIMH's Geriatric Psychiatry Branch, told her that 95% of the samples had been destroyed when storage freezers malfunctioned. Because Dr. Sunderland was unable to substantiate his assertion that the freezers had malfunctioned, the NIH and a Congressional committee launched investigations to determine what had happened to the samples.

Congressional staff discovered that Dr. Sunderland had provided the pharmaceutical company Pfizer with over 3,000 tissue samples and associated clinical data. The samples came from 538 research participants - possibly including Dr. Molchan's research subjects - over a 15 year period. Collecting samples from these participants had cost an estimated $6.4 million of U.S. taxpayers' money.

Sunderland appeared as a co-inventor on a patent application entitled "Nucleic Acid Molecules, Polypeptides and Uses therefor, Including Diagnosis and Treatment of Alzheimer's Disease." And, as his consulting contract with Pfizer dictated, Dr. Sunderland assigned his rights to Pfizer. The U.S. has no patent rights in this application, despite the substantial federal investment in the collection of the tissue samples.

Over the years, Pfizer paid Dr. Sunderland about $285,000 for consulting fees and approximately $311,000 for lectures and travel expenses. At one point, an NIH ethics officer asked Dr. Sunderland if he had any outside consulting arrangements. Dr. Sunderland replied that he "[did] not have any outside positions to note." In fact, Dr. Sunderland was working privately with Pfizer at that time.

Dr. Sunderland and his attorney tried to downplay the significance of his failures to disclose outside activities. They characterized the failures to disclose as mere "paperwork violations," trying to shift the blame to his administrative staff. NIH investigators were not willing to attribute such "clerical malfeasance" to the staff, especially since Pfizer documents showed that Dr. Sunderland had failed to disclose at least 140 separate activities with that company alone.

In a two-day Congressional hearing on the matter, Trey Sunderland invoked his Fifth Amendment right not to testify. He was believed to be the first NIH official to do so.

Sunderland was ultimately charged with violations of a federal law which acts to prevent conflicts of interest - 18 U.S.C. 208(a), which carried with it a potential 5-year prison sentence if his actions were willful. Sunderland was allowed to plead guilty to a misdemeanor charge with two years of probation and 400 hours of community service at a geriatric psychology service. He also agreed to pay the government $300,000.

One of the research participants, Paul W. Lewis, who had provided tissue samples stated that Sunderland got away without "much more than a slap on the wrist." Mr. Lewis asked the NIH to return the samples he had provided for Alzheimer's research, but, as of the last reports, whether the NIH will honor this request (or whether the sample still exists) is unknown.


Related Articles

David Willman, "Case Study: Dr. P. Trey Sunderland III; $508,050 from Pfizer, but No 'Outside Positions to Note,'" Los Angeles Times, Dec. 22, 2004, at A26.

John Burklow, Spokesman, NIH Office of the Director, "NIH Statement Regarding House Hearing on Human Tissue Samples," (June 13, 2006).

"Human Tissue Samples: NIH Research Policies and Practices, Hearings Before the Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce," 109th Congress (2006).

109th Congressional Committee on Energy and Commerce, Press Release, "Leading NIH Scientist Refuses to Testify in Congressional Investigation."

109th Congressional Committee on Energy and Commerce, Press Release, "Barton Condemns Lax Enforcement of Ethics at NIH."

News in Brief, "NIH Researcher Confesses to Breach of Ethics," 444 Nature 802 (Dec. 14, 2006).

David Willman, "NIH Researcher is Ordered to Forfeit Pfizer Payments" Los Angeles Times, Dec. 23, 2006, at A22.


[ Back to Tissue Disputes ]

© 2007 WhoOwnsYourBody.org. All rights reserved.