NIH Internal Audit Finds"Serious Misconduct"

We have posted frequently, most recently here and here, about conflicts of interest affecting top US National Institutes of Health (NIH) scientists and leaders. Two months ago, we posted about the case of Dr Thomas J Walsh, Head, Immunocompromised Host Section, Pediatric Oncology Branch, Center for Cancer Research and the National Cancer Institute (NCI). A Los Angeles Times investigation had suggested that Dr Walsh, while working full-time for the NIH, had received money from several pharmaceutical companies, and also had had spoken for these companies' products at several US Food and Drug Administration (FDA) meetings.

David Willman just wrote another article for the Los Angeles Times on the conclusions of an internal NIH investigation of Walsh. According to the article:

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.

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.

In summary,

'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.

'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.'

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.

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.

The evidence continues to accumulate about the scope of conflicts of interest affecting top officials of the NIH, once the bastion of research integrity.

At least the stringency of NIH conflict of interest regulations has been restored by the current Director.

It would be nice if some of the other organizations that seem to be shot through with conflicted leaders, such as some notable prestigious academic institutions, might think about similarly stringent rules.