NIH Audit Criticizes Scientist’s Dealings

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 [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 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.

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 on 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.

Members of the House Energy and Commerce Committee’s investigative subcommittee are expected to question officials at the hearing this week 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 5th Amendment right against self-incrimination while declining to answer questions before the congressional subcommittee.

Neither Sunderland nor Walsh has been publicly disciplined, and each maintains his senior government position. Directly or through their lawyers, Sunderland and Walsh have said that they aimed to advance research that benefits patients. Both have worked for more than 20 years at the NIH as members of the U.S. Public Health Service Commissioned Corps, a uniformed branch of the service that is led by the surgeon general.

Officials at the NIH have said recently that they lack authority to discipline members of the corps -- several of whose members have drawn scrutiny related to conflict of interest. The summary of the NIH internal report on Walsh noted, implicitly, his status within the corps: “It has been determined by the Office of Human Resources [at NIH] that if he were a civilian employee, his actions would lead to a recommendation for his proposed removal.”

The Bush administration official that oversees the surgeon general and the corps, Assistant Secretary for Health John O. Agwunobi, said through an aide that he could not discuss details of the pending cases because of privacy concerns.

“The commissioned corps is very concerned about these allegations and will take appropriate action should wrongdoing be found,” said Christina Pearson, a Health and Human Services Department spokeswoman. “However, our review must be coordinated with other reviews already in process.”

Walsh was referred to a corps administrator nine months ago “for action” by a deputy NIH director, Dr. Raynard S. Kington, and by Dr. John Niederhuber, the then-acting director of the National Cancer Institute.

Walsh, 54, a medical graduate of Johns Hopkins University, arrived at the National Cancer Institute in 1986 and now heads a pediatric research and treatment unit. Walsh is well recognized in his field and has won government honors. Along the way, he collaborated with drug companies in his official role and, privately, as a paid advisor or speaker.

The industry compensation received by Walsh and Sunderland came to light because of a series of events over the past three years: After The Times reported in December 2003 that ranking NIH officials had received hundreds of company consulting payments or grants of stock or stock options, the House committee asked the agency to disclose all such transactions over a five-year period. When the NIH was slow to respond to the committee’s broad request, lawmakers elicited information from 21 drug companies.

The companies’ responses identified scores of NIH researchers who were not previously known to have received payments. One company, Merck, listed fees to Walsh that had not been reported to the NIH. Meanwhile, NIH Director Elias A. Zerhouni also was urging employees to report any previously undisclosed outside arrangements.

For Walsh, the first questions from NIH ethics officials centered on his arrangements with Merck. The NIH’s internal review found that, at the same time Walsh accepted $3,000 in fees for attending separate Merck-sponsored events in 2000 and 2001, he was leading a formal “cooperative research and development agreement” between Merck and the National Cancer Institute.

Months before his case was referred for possible disciplinary action, the NIH ethics review panel concluded privately that Walsh should not have engaged in the simultaneous government and paid arrangements with Merck.

“The review panel finds that the scientific subject matter of the activities overlap directly with Dr. Walsh’s research at NIH,” the agency’s chief ethics lawyer, Holli Beckerman Jaffe, wrote in June 2005.

“In addition, while Dr. Walsh was a paid speaker for Merck on two occasions, he was collaborating with Merck, and one of its competitors, in his official capacity,” Jaffe said. “Accordingly, the panel finds his unapproved outside activities with Merck to be highly problematic.”

A subsequent summary of the NIH’s internal review added, “this situation is one in which a reasonable person could question Dr. Walsh’s impartiality.”

The new documents show that when Merck paid Walsh a $2,000 fee in September 2000, it was to discuss the company’s new antifungal drug, Cancidas, at a company-sponsored meeting with medical-opinion leaders in Montreal.

Four months later, Merck identified Walsh as a consultant at an FDA advisory committee meeting at which the company made its case for the drug’s approval.

Walsh told the FDA committee on Jan. 10, 2001, that, based on his and his government staff’s review of data from a Merck study, Cancidas effectively combats a fungal infection called aspergillus. The committee unanimously recommended approval.

Later that month, FDA staff approved Merck’s application to market Cancidas. Through 2005, the drug had generated $859 million in U.S. sales.

And, in the months leading up to an October 2001 FDA advisory committee meeting on Pfizer’s antifungal drug, Walsh received $12,000 in fees for conferring three times with company representatives, the internal NIH documents show. Walsh has said he did not accept company payment for appearing at any FDA meeting.

Walsh’s lawyers have said in letters to NIH officials that his government decisions were not swayed by the compensation from Merck or any other company. They also have stressed Walsh’s diligence throughout his career.

Jaffe, the NIH ethics lawyer, told officials in a memo that if Walsh had sought permission to accept compensation from Merck, “it is highly unlikely that Dr. Walsh would have been granted approval.”

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david.willman@latimes.com