Healthy Skepticism Library item: 6108

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Publication type: news

Willman D.
Panel Challenges NIH Handling of Rules Violations : House members call disciplinary action tepid in the 'largest scandal' in agency history.
Los Angeles Times 2006 Sep 14
http://www.latimes.com/news/nationworld/nation/la-na-conflicts14sep14,1,273997.story

Full text:

Panel Challenges NIH Handling of Rules Violations
House members call disciplinary action tepid in the ‘largest scandal’ in agency history.
By David Willman, Times Staff Writer
September 14, 2006

WASHINGTON – 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.).
david.willman@latimes.com