Panel Challenges NIH Handling of Rules Violations

A congressional subcommittee chairman and a top administrator of the National Institutes of Health agreed on at least one point Wednesday: Private financial deals between drug companies and NIH scientists that have come to light in recent years have posed the worst scandal in the agency’s history.

“This is the largest scandal in all of the NIH’s existence,” said Rep. Edward Whitfield (R-Ky.), chairman of the House Energy and Commerce subcommittee on investigations. To which NIH Deputy Director Raynard S. Kington nodded and replied, “We certainly hope it will be the last.”

Citing internal ethics investigations over the last three years, Kington said the agency had disciplined 34 NIH scientists who had violated conflict-of-interest rules. Six scientists were suspended or placed on probation and the others were admonished orally or by letter, according to NIH documents.

NIH officials also assured the panel that they had recommended the termination of two other senior scientists who accepted drug company money without obtaining required advance approval.

“When violations were found, NIH implemented sanctions ranging from oral admonishments to letters of reprimand to suspensions,” Kington told the subcommittee. “In all cases where individual scientists failed to take [personal] leave to conduct outside activities, they were directed to pay back that leave to the government.”

But Kington’s assurances were challenged by Republicans and Democrats on the subcommittee. They noted that despite previous statements of concern and outrage from senior NIH officials, no employee had been fired, and they said most of the disciplinary actions had been tepid.

The session marked the sixth congressional hearing since January 2004 that centered on NIH conflicts of interest.

“This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave,” said Rep. Joe L. Barton (R-Texas), chairman of the Energy and Commerce Committee.

Much of the contentious afternoon session focused on two researchers: Dr. P. Trey Sunderland III, a geriatric psychiatrist who has researched Alzheimer’s disease, and Dr. Thomas J. Walsh, who has researched fungal diseases in cancer patients.

Their cases are pending before an administrator at the U.S. Public Health Service Commissioned Corps, a uniformed branch of the service. A resolution of Sunderland’s case has been delayed because of a separate investigation by the U.S. Justice Department, Bush administration officials said.

Panel members pointed out that Sunderland had been allowed until last month to retain most of his NIH privileges and that he had taken several trips at the expense of the government, visiting Hawaii and Geneva.

At a congressional hearing in June, Sunderland’s boss, Dr. Thomas R. Insel, director of the National Institute of Mental Health, said Sunderland’s receipt of more than $600,000 in fees from Pfizer Inc. was unacceptable.

Yet Barton said Wednesday that several months earlier, Insel had “recommended a $15,000 retention bonus” for Sunderland.

Barton and other subcommittee members also said that Sunderland had shipped samples of spinal fluid drawn from patients at the NIH to a New York hospital, where he had intended to take a new position. Those samples were returned in recent months after the shipments came under fire from the congressional panel. Officials said the samples should not have been transferred out of NIH custody.

Barton chided Dr. John O. Agwunobi, the Bush administration’s assistant secretary for health, for not demanding swift resolution of the Sunderland case. “You’re sittin’ on your bottom, and you’re not doing anything about it,” Barton said, adding that Sunderland had been allowed to flout rules with impunity. “It’s a farce.”

In Walsh’s case, the researcher accepted about $100,000 in fees from drug companies without required advance permission. On Wednesday, Barton criticized the director of the National Cancer Institute, Dr. John Niederhuber, as doing little to address Walsh’s conduct except to recommend termination by the Commissioned Corps.

Niederhuber confirmed that he had recommended in December that Walsh be fired. But Niederhuber also lauded Walsh as “probably the world’s expert on antifungal agents.”

Documents distributed at Wednesday’s hearing suggested that Walsh was paid $12,000 by Pfizer to help prepare the company for an October 2001 meeting held by a Food and Drug Administration advisory committee. Walsh had collaborated with the company in leading a major study of its antifungal drug, Vfend.

The NIH recently opened a separate internal review of Walsh’s appearances with pharmaceutical companies at public and private FDA meetings. Merck & Co. identified Walsh as a consultant when he appeared at a January 2001 FDA advisory committee meeting that focused on the company’s new antifungal drug. Walsh vouched for the effectiveness of Merck’s drug, and the committee voted unanimously to recommend its approval.

Kington told the subcommittee on Wednesday that the NIH was now “clarifying its policies regarding the presentation of scientific information” to FDA advisory committees.

U.S. conflict-of-interest law generally prohibits a federal employee from representing an outside party before a government agency. Walsh and his attorneys have said he did not make any appearance before the FDA as a representative of any company.

In addition to all of the internal reviews, Kington noted that a policy enacted last year prohibits all NIH employees from accepting consulting fees, stock or stock options from drug companies. The previous rules allowed agency scientists to accept unlimited sums of compensation from industry.

A July 2005 report by the U.S. Office of Government Ethics concluded that the NIH was infused with a “permissive culture.” Kington said Wednesday that agency officials were confident that the problems were a thing of the past, “with new restrictions in place and a more efficient and rigorous ethics program underway.”

The subcommittee members appeared unconvinced.

“I believe that the tentacles of the drug companies influence the research at NIH, much to the consternation of the American people,” said Rep. Bart Stupak (D-Mich.).

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david.willman@latimes.com