Probe Targets Government Scientists' Consulting

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http://www.washingtonpost.com/ac2/wp-dyn/A37744-2004May18?language=printer

 

 

Probe Targets Government Scientists' Consulting

 

By Rick Weiss

Washington Post Staff Writer

Wednesday, May 19, 2004; Page A01

 

Top legal and ethics officials in 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 the director of the National Cancer Institute, Richard D.

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 institute had just settled a lawsuit brought against

it by a 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 a more recent case, a pair of scientists employed by the 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 firm that already had a formal arrangement with the

government to use the same scientists' expertise.

 

How is it, the subcommittee chairman, James C. Greenwood (R-Pa.), asked, that

the scientists were allowed to profit personally from a deal that may have

undercut a taxpayer-funded public-private collaboration?

 

Representatives' descriptions of these and other examples punctuated a tense

five-hour hearing that significantly widened a congressional investigation into

possible conflicts of interest in the federal biomedical enterprise.

 

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 prompted

National Institutes of Health Director Elias A. 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 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.

 

Officials there also approved Petricoin's request to accept free travel and an

honorarium to speak at a beach resort conference sponsored by ImClone Systems

Inc. and Bristol-Myers Squibb Co. -- two companies not only regulated by FDA but

also at the heart of the recent Martha Stewart scandal surrounding the cancer

drug Erbitux. (Petricoin later decided not to take the trip.) " These decisions

are the opposite of what people have the right to expect from their ethics

officials, " said Rep. Henry A. Waxman (D-Calif.).

 

In response to congressional inquiries, acting FDA Commissioner Lester M.

Crawford said yesterday that he has issued a new policy requiring that center

directors -- not lower-ranking officials -- review all employee requests for

outside work.

 

Crawford also has initiated an internal review of such arrangements involving

FDA employees. And Zerhouni has begun to seek information on the amount of money

NIH employees have received in their outside deals -- information that has until

now been incomplete.

 

As with other cases of possible conflict of interest raised by the committee in

recent months, none of the scientists involved has been accused of breaking

government ethics rules, which vary by agency but generally forbid federal

employees from directly leveraging their positions in ways that lead to real or

perceived personal gain.

 

Greenwood expressed suspicion that the prize Klausner received -- the Dickson

Prize for Medicine -- was a payoff for his cooperation with the University of

Pittsburgh. The prize was given to Klausner in 1997 for work he did before 1995

-- a breach of university rules that say the prize is to be given for work in

the current year, Greenwood said.

 

" Giving the prize to Klausner in 1997 was like giving the Academy Award to a

well-liked actor who just didn't happen to make any movies that year, " Greenwood

said.

 

Edgar Swindell, who in 1997 was acting director of the HHS ethics division, told

the subcommittee he and other ethics officers were under strict orders from

then-HHS General Counsel Harriet S. Rabb to assess such requests in purely legal

terms, without regard to concerns about ethics or " how this might appear on the

front page of The Washington Post. " Those ethics rules, while warning about

appearances of conflict, allow federal officials to receive " bona fide " awards

even from grantee institutions.

 

" So even though this is the ethics division, you're not supposed to use any

ethics, " Rep. Joe Barton (R-Tex.) fumed.

 

" It's not a decision I look back on with fondness or pride, " said Swindell, now

HHS's associate general counsel for ethics.

 

Swindell said he has not felt the same pressure to approve marginally acceptable

ethics decisions since the arrival of the Bush administration. But he conceded

that he helped prepare the now controversial waiver that current HHS Secretary

Tommy G. Thompson signed allowing then-Medicare administrator Thomas A. Scully

to negotiate outside employment while he was still in his government position.

In December Scully joined an Atlanta law firm that represents drug makers,

hospitals and other health care businesses.

 

The FDA's Petricoin and NCI researcher Lance Liotta told the subcommittee they

saw no conflict, at least at first, when they requested and received ethics

approval to consult for Biospect of South San Francisco, a company developing

technologies that may aid disease detection. The two were already part of a

federal partnership in which they spend some of their government time

collaborating with Bethesda-based Correlogic Systems.

 

The two scientists did not tell either company they were working for the other

because, Liotta said, " there was no overlap in my mind. " But Greenwood noted

that the two companies' descriptions of their business goals are very similar,

and that Correlogic's co-founder complained to the NCI when he found out about

the Biospect deal.

 

Although ethics officials had twice approved the dual arrangements, both

scientists terminated their Biospect arrangements last week because, they said,

they began to see evidence that Biospect's business plan was evolving in a way

that might constitute a conflict of interest for them.

 

Both Liotta -- who an NIH official said earned as much as $45,000 from the

Biospect deal -- and Petricoin were accompanied yesterday by their lawyers.

 

The subcommittee also focused on the growing number of NIH employees hired under

" Title 42, " a special provision that boosts their salaries while allowing them

to sidestep certain reporting requirements for outside collaborations.

 

Zerhouni has recently sought to tighten financial reporting requirements for

many of those hired under that provision but has argued for the importance of

allowing NIH scientists to earn competitive salaries and in some cases to do

outside consulting.

 

Several subcommittee members said they are giving serious consideration to

banning all such arrangements.

 

 

 

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