NIH scandals trigger demands for overhaul

BETHESDA, Md. – The jewel of American medical research is starting to lose some of its glitter.

Long known for impeccable science, the federally funded National Institutes of Health is in tumult over disclosures that hundreds of the government agency’s scientists have worked as consultants for drug and biotechnology companies or accepted cash prizes from universities that depend on the NIH to fund research.

The NIH is one of the world’s leading research centers, pooling the talents of its 5,000 scientists to confront public-health crises.

In the rarefied world of advanced medical research, the sprawling, university-like campus of the NIH is hallowed ground. But the disclosures of potential ethical breaches have generated outraged calls for changes from members of Congress. The NIH has responded with anguished mea culpas and promises to fix the problem.

“It is clear from the cases we have reviewed that some NIH scientists are either very close to the line or have crossed the line,” said Rep. James Greenwood, the Pennsylvania Republican who is leading a congressional probe of outside consulting by NIH scientists. “This has been a persistent problem at NIH for years, not because of confusion but because of a deliberate permissive attitude.”

NIH leaders have been scrambling to reassure the public that research remains untainted by the influence of drug companies seeking to test products in NIH studies or by universities that collect billions from the NIH for research. But they acknowledge that public confidence has been undermined and staff morale battered.

“I would say that they would like to return to the public esteem that they were held in before this became an issue,” said Michael Gottesman, deputy director of research on the NIH’s Bethesda campus.

Greenwood, chairman of the oversight and investigations subcommittee of the House Energy and Commerce Committee, has been probing consulting contracts between NIH scientists and Pfizer, Wyeth Pharmaceuticals, AstraZeneca and other major pharmaceutical companies. Committee investigators also are zeroing in on major research universities’ practice of granting prizes to top NIH scientists as well as a little-known legal loophole that permits the NIH to boost scientists’ salaries far above those of other senior federal employees.

In what committee investigators say was a particularly glaring conflict, a former top NIH official, Robert Klausner, signed off on the 1997 settlement of a University of Pittsburgh lawsuit against the NIH around the time the school awarded him $40,000 for past research achievements.

Klausner declined to testify before the committee. But Edgar Swindell, a government ethics lawyer, testified before Greenwood’s subcommittee in May that within days of the settlement, a top Bush administration official pressured him to find a justification for the prize.

“I’m the one who signed the approval” for the prize, Swindell said. “It’s not a decision I look back on with fondness or pride.”

In another case, two top medical researchers became consultants to a firm when a direct competitor already was using the same scientists and the NIH on similar research.

NIH scientist Lance Liotta and Emmanuel Petricoin, a microbiologist at the Food and Drug Administration, said in May that they believed there was no conflict because the consulting work did not overlap initially. But Greenwood said such arrangements could raise firms’ concerns that discoveries in research projects with the NIH might be leaked to competitors.

“There are few situations more destructive of public-private partnerships than this one,” Greenwood said. “What company will want to enter into (a research agreement) with the NIH if this is the way conflict-of-interest issues are managed?”

The number of NIH scientists who do outside work for drug or biotechnology companies has ranged from a little more than 100 to more than 200 at any given time, according to NIH director Elias Zerhouni. The NIH only recently began asking all its scientists to disclose the compensation they receive as a result of the contracts, so it does not know with certainty how much private money is flowing to its scientists.

The outside consulting took off in the mid-1990s when then-director Harold Varmus lifted a cap on outside income, according to committee investigators and NIH officials. The explosive growth of pharmaceutical and biotechnology companies created sharp competition for top-tier scientists. Varmus argued that the changes in ethics rules were needed to attract talent.

At the same time, the NIH invoked an obscure law that permitted agencies to exceed congressionally mandated pay limits. That strategy now permits the agency to boost pay for some researchers by $50,000 to $60,000 a year. Top NIH researchers can earn as much $300,000 in government salaries and tens of thousands more from consulting.

NIH officials said it would be a mistake to eliminate outside income.

At the highest levels, they said, NIH salaries are not competitive with university or industry pay, which can reach $1 million a year for top researchers.

But convincing Congress that such arrangements should continue could be tough for Zerhouni. Some of the NIH’s harshest critics say the cloud hanging over it may not be lifted until such outside income is banned.