HHS Office of Inspector General Investigates NIH Researcher Over Allegations of Conflict of Interest
The investigations unit of the HHS Office of Inspector General is looking into whether P. Trey Sunderland, an NIH researcher working in the field of Alzheimer's disease, violated federal conflict-of-interest law, the Los Angeles Times reports. Sunderland allegedly accepted more than $500,000 from a pharmaceutical company without receiving permission or reporting the income to NIH as required, according to those familiar with the case, the Times reports.
An in-house newsletter at NIH, which requested the investigation, said agency officials were "investigating every case that has come to light of inappropriate outside activities at NIH" and "fairly soon, we'll enter the penalty phase of these investigations. ... Some employees have substantially violated rules and regulations." According to the Times, an NIH employee has not been prosecuted or convicted of conflict of interest for nearly 13 years.
Last month, the Times reported that "Sunderland's paid services for Pfizer often overlapped with his government role." According to the Times, Sunderland received payments from Pfizer for consulting and speaking while he was leading a study on Alzheimer's in collaboration with the company.
However, Sunderland's staff in 1998 began providing Pfizer with samples of spinal fluid collected from elderly patients at a NIH research hospital. The collaborative research lasted about five years. During that period, Sunderland was paid for 80 speaking appearances by Pfizer and received fees totaling $508,050 between 1999 and 2003, according to a Times analysis of records.
Investigators are seeking to determine whether Sunderland used vacation days for speaking events or if he spoke for Pfizer while on government time. In addition, in a March 1999 e-mail to Olga Boikess, an NIH ethics officer who questioned a lecture Sunderland delivered at a psychiatric conference, Sunderland wrote, "I can tell you that I have no [cooperative research and development agreement] or [material transfer agreement] with any European pharmaceutical company, so there should be no possible conflict of interest."
In 1998, Sunderland's staff began providing Pfizer with the spinal fluid under a material transfer agreement, the Times reports. Sunderland also served as a paid consultant to Eisai. Eisai and Pfizer jointly market the Alzheimer's treatment Aricept.
Sunderland's lawyer, Robert Muse, wrote in a letter to the director of the NIH ethics office, "Dr. Sunderland has committed no unethical acts. His failures have been in the context of not keeping and filing proper paperwork." Muse said that Sunderland never tried to conceal his collaboration with Pfizer or other companies.
He added that NIH monitors financial relationships between researchers and outside companies with "indifference, lack of enforcement and administrative shortcomings" (Willman, Los Angeles Times, 1/28).
In December 2003, a Times article reported evidence of hundreds of consulting payments from pharmaceutical and biotech companies to a number of NIH employees.
In response, the House Energy and Commerce Oversight and Investigations Subcommittee began to investigate the allegations. NIH Director Elias Zerhouni in January 2004 directed an NIH Blue Ribbon Committee on Conflict of Interest Policies to investigate the allegations. As part of the investigation, subcommittee Chair Jim Greenwood (R-Pa.) contacted 20 pharmaceutical companies about consulting agreements they had with NIH employees and found that of the 264 reported agreements, about 100 were allegedly unknown to agency officials.
Zerhouni in June 2004 proposed a number of revisions to NIH ethics rules, such as a ban on consulting agreements for senior NIH officials, but an OGE report in July found that the proposal would not adequately address conflict-of-interest concerns (California Healthline, 9/24/04).