NIH researcher accused of misconduct

Agency says official didn't report fees from work for drug companies

September 10, 2006|By David Willman

WASHINGTON -- A senior researcher at the National Institutes of Health engaged in "serious misconduct" by entering into dozens of unauthorized private arrangements with drug companies and failing to report annually the outside income, totaling more than $100,000, a confidential internal review by the agency has found.

Officials at the NIH concluded late last year that the actions of Dr. Thomas J. Walsh, who has helped lead major clinical trials involving cancer patients, might result in dismissal from federal government service. No disciplinary action has been taken.

The internal review, conducted by lawyers and other ethics specialists within the office of the NIH director, found that from 1999 to 2004, Walsh received fees totaling $100,970 from pharmaceutical and biotechnology companies. He accepted fees from 25 companies and has led government-sponsored research involving some of those companies' drugs.

"Dr. Walsh has engaged in serious misconduct, in violation of the Department's Standards of Conduct Regulations and federal law and regulation," the review concluded.

The previously unreported findings shed light on the depth of conflict-of-interest problems that have persisted at the NIH - the government's pre-eminent agency for medical research on humans. The NIH's handling of disciplinary decisions related to Walsh and other senior scientists is expected to be a focus of a congressional hearing scheduled for Tuesday.

In written comments to NIH ethics officials, private attorneys for Walsh said that the agency's rules were complicated and that his motives were beyond reproach. NIH officials said the rules were well known and should have been followed.

"Dr. Walsh fails to acknowledge that the reason for the `complex set of rules' governing NIH staff in regards to real or potential conflicts of interest is to prevent the integrity of the agency and its science from being called into question," the summary said. "His assertions that his reputation is sufficient to dismiss any questions about his impartiality cannot be the standard that he or the agency use in deciding to adhere to well-publicized rules."

The summary, dated in December, also said that Walsh's "conduct continued over time and involved at least 38 separate instances where he chose not to follow agency procedures. He actively chose not to adhere to policies because it was inconvenient or time-consuming; he knew it was likely his participation [with the drug companies] would have been disapproved. His actions reflected negatively upon the agency."

The Los Angeles Times obtained copies of the internal findings and conclusions last week. Based on interviews and documents gathered earlier, the newspaper reported in July that Walsh had appeared alongside company representatives at public and private meetings held by the U.S. Food and Drug Administration and that he received fees from Merck & Co. and Pfizer Inc., with whom he has collaborated in his government work. Clinical trials he helped lead influenced FDA approvals of four antifungal drugs.

Walsh's appearances at the FDA meetings - with representatives of Merck, Pfizer and Fujisawa USA Inc. - are the subject of a newly opened inquiry by the NIH director's Office of Management Assessment, according to people familiar with the matter.

U.S. conflict-of-interest law generally prohibits a federal employee from representing an outside party before a government agency, regardless of whether the employee accepts payment for the appearance.

Another NIH review, which ended three months ago, "did not identify issues of concern with the design or methodology" used in two clinical trials overseen by Walsh. When results of those trials were published, in 1999 and 2004, other research physicians had questioned in letters to the New England Journal of Medicine whether cancer patients with suspected fungal infections were given "control" drugs at dosages that were strong enough to be effective.

Reached briefly by phone Friday, Walsh referred questions to NIH press aides. He earlier declined to answer questions from the Times regarding details of his arrangements with several companies, but also said that he had never served as a representative or advocate for any pharmaceutical company.

At Tuesday's hearing, members of the House Energy and Commerce Committee's investigative subcommittee are expected to question officials about their handling of ethics matters, including the cases of Walsh and another senior NIH researcher, Dr. P. Trey Sunderland III.

Sunderland, who has specialized in researching Alzheimer's disease, accepted hundreds of thousands of dollars in drug-company fees - including about $612,000 from Pfizer - without obtaining required advance approval. In June, Sunderland asserted his Fifth Amendment right against self-incrimination while declining to answer questions before the congressional subcommittee.

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