'Serious Misconduct' by NIH Expert Found

Scientist Did Not Report Sending Tissues to Drug Firm and Getting Paid, Report Says

A world-renowned Alzheimer's disease researcher at the National Institutes of Health took advantage of the agency's lax oversight by improperly forwarding valuable tissue specimens to a pharmaceutical company and then accepting hundreds of thousands of dollars in consulting fees from it, according to congressional investigators.

Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health, failed to tell agency officials about his arrangement with the drug giant Pfizer Inc., as required by federal rules, the investigators concluded in a 27-page preliminary report released yesterday.

Sunderland also did not properly disclose arrangements with another company, said the report, which found no wrongdoing by the drug companies. And though the NIH has not released the findings of its own investigation, the House report said the agency has concluded that Sunderland committed "serious misconduct, in violation of HHS ethics rules and federal law and regulation."

"I wish we were holding this hearing to congratulate him on some great discovery," said Rep. Joe Barton (R-Tex.), chairman of the Committee on Energy and Commerce, at a hearing yesterday of the oversight and investigations subcommittee. "Instead, we're going to have to discuss how he used his position to use NIH spinal fluid samples to further his own undisclosed personal consulting."

Sunderland, who has been subpoenaed to testify at a follow-up hearing today, has conceded that some disclosures were not properly filed -- in part, he has said, because of paperwork errors by office staff members.

"There was no effort to conceal this in any way," Sunderland's Washington attorney, Robert F. Muse, said yesterday, adding that "his failure to file was not unusual."

Until the NIH recently strengthened its conflict-of-interest rules, Muse said, many NIH doctors saw the requirements to disclose outside consulting as "basically a bureaucratic nuisance." They let their superiors know what they were up to through other channels, Muse said.

Several researchers linked to such failings have avoided closer scrutiny by leaving the NIH in the past two years. But Sunderland's request to retire has been denied -- an option the agency had because, unlike most NIH scientists, he is part of the commissioned corps, one of the nation's seven uniformed services.

Muse said that the denial is evidence that he is being made a scapegoat.

The congressional report builds on findings of conflict of interest among NIH researchers in 2004 and 2005, which led Director Elias A. Zerhouni to institute restrictions last year on drug company consulting and other outside activities by NIH employees.

The new focus is on blood and other tissue samples collected by NIH scientists for clinical research, and on the NIH's alleged lack of an inventory system or clear policies to ensure that those federally owned samples are used only for the purposes for which they were donated.

"It's important to remember that each of these samples originated in a person . . . that chose to make a gift so research could progress," Rep. Tammy Baldwin (D-Wis.) said at yesterday's hearing. "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."

At the heart of the investigation is Sunderland's use of spinal fluid collected in the early 1990s by an NIMH scientist, Susan Molchan, who later left the institute. When Molchan -- who once filed sex discrimination charges against Sunderland that were unsuccessful -- sought to resume her research in a different lab in 2004, she learned that many of her 10- to 15-year-old samples, which she hoped to retrieve, were no longer in the NIMH's freezers.

Acting on a complaint from her, House investigators found that Sunderland had sent thousands of specimens -- including some of Molchan's -- to Pfizer under an agreement not approved by NIH officials. Pfizer used the samples in its search for biological markers of Alzheimer's progression, which could have led to a potentially lucrative test. Sunderland ultimately received at least $285,000 in consulting fees for work relating to the specimens, investigators said, as well as more than $300,000 for giving talks and other activities.

"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 the NIH, the report concluded.

NIH spokesman John Burklow said the agency is "evaluating the process of material transfer out of NIH and will be clarifying current rules." Under the clarifications, he said, "all transfers of human samples will require an appropriate agreement signed off by a senior official."

The NIH's Office of Human Subjects Research in January also revised its guidance on the use of stored tissue samples. The new language requires careful tracking of all specimens and documentation of their fate.