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Legislators question HHS ethics

Scientists' outside consulting at issue

WASHINGTON -- Top legal and ethics officials within the Department of Health and Human Services have repeatedly allowed government scientists to engage in lucrative consulting deals with pharmaceutical and biotechnology companies while ignoring the concerns of lower-level ethics officers, according to evidence presented at a House subcommittee hearing yesterday.

In one highlighted case, top HHS officials during the Clinton administration insisted that then-director of the National Cancer Institute Richard Klausner be deemed eligible to receive a $40,000 award from the University of Pittsburgh even though the university is a major NCI grant recipient -- and despite the fact that the NCI had just settled a lawsuit brought against it by a major Pitt researcher, on terms favorable to the university.

At a minimum, the proximity of those events gave the appearance that Klausner was being rewarded by the university for helping to settle the suit, said ethics officers who told the subcommittee yesterday they were uncomfortable with the arrangement but were pushed by HHS general counsel to endorse it.

In another case, a pair of scientists employed by NCI and the Food and Drug Administration were twice approved to do outside consulting for a California technology company even though that company appears to be in competition with a Maryland company that already had a formal arrangement with the government to use the same scientists' expertise.

How is it, subcommittee chairman James Greenwood, Republican of Pennsylvania, wondered aloud, that the scientists were allowed to profit personally from a deal that may have undercut a taxpayer-funded public-private collaboration?

The investigators' descriptions of these and other examples punctuated a tense, five-hour hearing.

The investigation by the Energy and Commerce subcommittee on oversight and investigations -- and others ongoing by the General Accounting Office, the Office of Government Ethics, and the HHS inspector general -- has already prompted NIH director Elias Zerhouni to make substantial changes in the way that agency approves and tracks its scientists' outside endeavors, which can add hundreds of thousands of dollars to the researchers' annual income.

Yesterday the questions spilled over to the FDA, where ethics officers recently approved a request by agency scientist Emanuel Petricoin to accept payments from a company trying to develop products that would plausibly be regulated by the agency.

''These decisions are the opposite of what people have the right to expect from their ethics officials," said Representative Henry Waxman, Democrat of California.

In response to congressional inquiries, acting FDA commissioner Lester Crawford said yesterday he has issued a new policy requiring that center directors -- not lower-ranking officials -- must review all employee requests for outside work.

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