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December 4, 2006
FOR IMMEDIATE RELEASE
NIH SENIOR SCIENTIST CHARGED WITH CONFLICT OF INTEREST
Allegedly Supervised Research Projects in His Official Government Capacity During a Five Year Period While Being Paid as a Consultant on the Projects
Baltimore, Maryland - A federal criminal information was filed today charging Chief of the Geriatric Psychiatry Branch at the National Institute of Mental Health (NIMH), Pearson “Trey” Sunderland, III, age 55, of Chevy Chase, Maryland, with conflict of interest relating to his acceptance of $285,000 in consulting fees and additional travel expenses from a drug company without the required approval of and disclosure to National Institutes of Health (NIH) officials, announced United States Attorney for the District of Maryland Rod J. Rosenstein.
According to the criminal information, as Chief of the Geriatric Psychiatry Branch at the NIMH since 1997, Sunderland supervised the geriatric research conducted at NIMH, including the creation and management of collaborations with outside partners, such as other governmental agencies, educational institutions and businesses. The research centered on the onset and progression of Alzheimer’s disease.
As a senior NIH employee, Sunderland was required to disclose in annual reports all income earned from outside activities; outside employment arrangements held, including consultant positions with businesses; and travel expenses over $260 reimbursed by outside sources. In addition, before engaging in outside employment, Sunderland was required to file a form with Department of Health and Human Services (DHHS) and NIH ethics officials disclosing the name of the outside organization, the nature of the proposed employment and any compensation to be paid.
The “Unknown Biomarker Project”
In late 1997, representatives of the pharmaceutical company Pfizer, Inc. approached Sunderland about the possibility of the NIMH joining a scientific collaboration with researchers at both Pfizer and a British company called Oxford Glycosciences (UK) Limited (“OSG”) to discover new Alzheimer biomarkers, which are specific physical traits in the blood or cerebral spinal fluid of Alzheimer’s patients that might indicate or measure the presence and progress of the disease. Sunderland committed himself and the NIMH to the collaboration and from 1998 to 2003, Sunderland and his staff members participated in their official capacities to provide Pfizer and OSG with advice, expert opinions, statistical analyses and data interpretation. As required under the collaboration, in 1998, approximately 600 tubes of cerebrospinal fluid samples that had been previously collected from NIMH research subjects were delivered to Pfizer; and in 2000 approximately 200 additional samples of cerebrospinal fluid, blood serum and related clinical data were provided. The partnership resulted in the acquisition of longitudinal data capable of identifying and tracking clinical and surrogate markers of disease progression among Alzheimer patients and at-risk subjects.
According to the information, at the same time that Sunderland, Pfizer and OSG were finalizing arrangements for the NIMH to become the clinical partner in the collaborative project in early 1998, Sunderland initiated negotiations with Pfizer to be paid as a consultant for his work on the same project. On June 10, 1998, Sunderland signed an agreement to serve as a consultant on the project. Over the course of the five-year consultancy period, Pfizer paid Sunderland retainer fees totaling $125,000; fees for attending 14 one-day meetings at Pfizer company locations totaling $35,000; and related travel expenses.
The “Known Biomarker Project”
In July 1998, a few months after the formation of the“unknown biomarker project,” Pfizer representatives accepted Sunderland’s invitation to participate in another research project already underway at the NIMH to compare levels of “known biomarkers” present in the cerebrospinal fluid of thousands of past and present Alzheimer patients at the NIMH and other locations. For approximately five years thereafter, Sunderland and other researchers at the NIMH and Pfizer worked collaboratively in their official capacities to: collect and analyze cerebrospinal fluid samples of Alzheimer patients to obtain measurements of the known biomarkers; review and incorporate data from similar studies; and interpret the results. On April 23, 2003, some of the results of the project were published in the Journal of the American Medical Association in an article which listed Sunderland, members of his NIMH staff and Pfizer employees as the authors.
The information alleges that also in July 1998, Sunderland negotiated with Pfizer to be paid as a consultant for his work on the “known biomarker project.” Over the course of the five-year consultancy period for the “known biomarker project” beginning in November 1998, Pfizer paid Sunderland a total of $125,000 in retainer fees.
According to the criminal information, Sunderland did not disclose to his supervisors at the NIMH the existence of the Pfizer consultancy for the “unknown biomarker project” and the “known biomarker project” or the fees and expenses paid to him. Nor did Sunderland receive authorization from the DHHS and NIH ethics officials to engage in the consultancy.
Sunderland faces a maximum penalty of one year in prison and a fine of $100,000. Sunderland is scheduled for an initial appearance and arraignment on December 8, 2006 at 10:30 a.m.
An information is not a finding of guilt. An individual charged by criminal information is presumed innocent unless and until proven guilty at some later criminal proceedings.
United States Attorney Rod J. Rosenstein commended the investigative work performed by the Department of Health and Human Services - Office of Inspector General. Mr. Rosenstein thanked Assistant U.S. Attorneys Martin Clarke and Tarra DeShields, who are prosecuting the case.
This page last modified—November 20, 2006