NIH Audit Criticizes Scientist's Dealings
A researcher received more than $100,000 from drug firms. The agency calls it 'serious misconduct' but has issued no penalty.
By David Willman, Times Staff Writer
September 10, 2006
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 preeminent 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 Thursday. 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
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 three antifungal drugs. Walsh's appearances at the FDA meetings — with representatives of Merck, Pfizer Inc., 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.
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