NIH Seeks Outside Inquiry of Scientist

Ethics specialists at the National Institutes of Health have requested an outside investigation of an Alzheimer’s disease researcher who accepted more than $500,000 from a drug company without seeking permission or reporting the income to the agency as required, according to government officials familiar with the matter.

In response, the investigations unit of the inspector general’s office at the Department of Health and Human Services has opened an inquiry into the researcher, Dr. P. Trey Sunderland III, the officials said.

Among the circumstances being investigated is whether Sunderland’s conduct violated federal conflict-of-interest law, they said.

The inspector general’s office is empowered to subpoena documents and to question witnesses. It also may refer a matter for criminal prosecution to a local U.S. attorney’s office or to the Justice Department.

Based on interviews and public records, the Los Angeles Times reported last month that Sunderland’s paid services for Pfizer Inc. often overlapped with his government role. For instance, at the same time that Sunderland accepted consulting and speaking fees from Pfizer, he led a study of Alzheimer’s patients in which the company collaborated.

In the spring of 1998, Sunderland’s NIH staff began providing the company with samples of spinal fluid that the government employees collected from elderly patients who had visited the agency’s research hospital in Bethesda, Md. The research collaboration with Pfizer spanned about five years.

Sunderland, 53, has focused at the NIH on finding ways to detect Alzheimer’s disease before a patient develops pronounced symptoms. And Pfizer, along with a corporate partner, Eisai Inc., stands to gain billions of dollars in sales from the early-stage treatment of Alzheimer’s.

The Times article last month reported that Sunderland also was a paid consultant to Eisai in recent years, according to information recently provided to the NIH by his attorney. The two companies jointly market a drug called Aricept, which is approved for treating the symptoms of mild to moderate Alzheimer’s. The once-a-day pill generated worldwide sales of $1.6 billion in 2003, making it the top-selling Alzheimer’s drug.

Sunderland endorsed the use of Aricept during a televised presentation at the NIH in September 2003. Viewers of the event, broadcast by C-SPAN, had no way of knowing about Sunderland’s affiliation with Pfizer or with Eisai.

On more than 80 occasions from 1999 to June 2004, Sunderland was paid by Pfizer for speaking appearances at conferences in the U.S. and overseas, documents show.

Investigators are now examining whether Sunderland used vacation hours for all of his private appearances or whether he spoke for Pfizer while on government time, according to officials familiar with the inspector general’s probe.

Sunderland’s attorney, Robert F. Muse, declined to comment for this article. In a letter last month to the director of the NIH ethics office, Muse said Sunderland had not tried to hide his dealings with Pfizer or other companies.

“Dr. Sunderland has committed no unethical acts,” Muse wrote. “His failures have been in the context of not keeping and filing proper paperwork.”

Throughout the NIH, Muse wrote, the monitoring of financial relationships between the government scientists and their outside employers has been characterized by “indifference, lack of enforcement and administrative shortcomings.”

Internal NIH e-mails show that Sunderland was aware of agency conflict-of-interest rules that could ban him from taking consulting fees from a company, like Pfizer, that maintained a formal research agreement with the NIH.

In e-mail exchanges in March 1999 that had not previously been made public, an NIH ethics officer, Olga Boikess, asked Sunderland about a lecture that he had delivered at a psychiatric conference. On March 23, 1999, Sunderland replied:

“I can tell you that I have no CRADAs or MTAs with any European pharmaceutical company, so there should be no possible conflict of interest.”

CRADA is shorthand for “cooperative research and development agreement.” An MTA is a material transfer agreement, an arrangement to exchange proprietary material or information.

In 1998, Sunderland’s NIH staff had begun providing Pfizer with samples of the spinal fluids under terms of a material transfer agreement. Pfizer pledged to provide analyses of the samples.

Starting that year, and continuing through 2003, Pfizer paid Sunderland consulting and speaking fees totaling $508,050, records reviewed by The Times show. Related documents describe how Sunderland received fees from Pfizer as recently as June 3, 2004.

The NIH over the last decade has allowed employees who seek advance approval to enter into a wide variety of paid positions with pharmaceutical and biotechnology companies. However, NIH policies have consistently forbidden its scientists from accepting income from a company that is collaborating with their government laboratory.

Ethics specialists under the director of the NIH, Dr. Elias A. Zerhouni, requested the inspector general’s investigation of Sunderland, according to the officials familiar with the matter, who spoke on condition of anonymity. A deputy NIH director assigned by Zerhouni to oversee ethics matters, Dr. Raynard S. Kington, has said that he is not at liberty to discuss the specifics of any internal review or investigation.

However, an in-house newsletter at the NIH this month, paraphrasing Kington, said agency officials were “investigating every case that has come to light of inappropriate outside activities at NIH.” The newsletter quoted Kington as saying that “fairly soon, we’ll enter the penalty phase of these investigations.... Some employees have substantially violated rules and regulations.”

It has been nearly 13 years since an NIH scientist was prosecuted and convicted for an offense related to a conflict of interest. The scientist, Prem S. Sarin, repaid $25,000 to a German pharmaceutical company involved with AIDS research. A federal judge also sentenced him to two months of community service. He had faced a maximum sentence of about 20 years in federal prison, said his lawyer, W. Neil Eggleston.