Agency accused of 'illusion of integrity'

NIH grilled over handling of ethics breaches.

Washington DC

The US National Institutes of Health (NIH) has successfully switched to a new ethical culture and is spending millions on ensuring that rules about employee investments and outside activities are obeyed — according to a top agency official.

“There have been some bumps in the road, but most people would say it has gone reasonably well,” says Raynard Kington, deputy director of the biomedical agency, which is based in Bethesda, Maryland.

Not everyone agrees. Kington was speaking to Nature two days after a hearing on 13 September in which unhappy congressmen grilled him and other agency officials. One described the NIH as an “ethical Potemkin village where a hollow system appears to provide the illusion of integrity”.

“The NIH has changed its rules and that's a good thing, but they don't appear to really be doing anything to enforce the old rules against their most serious transgressors,” said Republican congressman Joe Barton of Texas, chairman of the House Committee on Energy and Commerce. The committee's investigative subcommittee had summoned Kington and others to raise concerns about NIH management.

New ethics rules came into force at the agency one year ago (see Nature 437, 9; 200510.1038/437009a), after a series of revelations about lucrative consultancy payments from companies collected by senior NIH scientists, often as they worked with or promoted the companies' drugs. Under pressure from Congress, NIH director Elias Zerhouni banned employees from doing any outside consulting for pharmaceutical and biotechnology firms. The new rules also force senior scientists to limit stockholdings in biomedical companies to $15,000. No scientists may hold shares in companies directly related to their research.

John Agwunobi testifies at a congressional hearing to evaluate ethics reforms at the NIH. Credit: D. COOK/AP

Kington told Nature that the agency has had “very high compliance with the new rules” and that he hasn't had to take any disciplinary action. He adds that the agency is investing several million dollars in improving relevant databases, and that he is about to hire a chief ethics officer to monitor compliance.

Within the NIH there seems to be resigned acceptance of the rules. One senior agency scientist, who asked not to be identified, says that generally the rules “don't change most people's day-to-day life. The NIH is still a really good place to work. You can do your research.”

But there has been an impact on morale. “We feel that Zerhouni didn't cover our backs,” says the scientist. “Admitting we had to change the rules — it was almost like tacit agreement that there were pervasive problems with the system. And I don't think that any of us feel that was the case.” NIH spokesman John Burklow counters that view. “Dr Zerhouni defended the agency and its scientists through public statements and at congressional hearings,” he says.

At last week's congressional hearing, the agency was tackled about two researchers who remain on the NIH payroll despite recommendations from their institute directors that they be fired. An internal investigation found that Trey Sunderland, an Alzheimer's researcher, accepted more than $700,000 in consulting fees without disclosing them to his bosses, in violation of existing NIH rules. And Thomas Walsh, an infectious-disease specialist, received more than $100,000 in unapproved consulting and speaking payments from 25 companies (see 'Scientists hit back at the press'). Both men have declined to comment.

The NIH doesn't have the authority to fire either of them because they are formally employed by the Commissoned Corps, a branch of the Public Health Service. To dismiss them, the corps must convene a board of inquiry. John Agwunobi, assistant secretary for health, told the subcommittee that it did so for Sunderland early this year, but added that because criminal charges are being considered against Sunderland, the board has been put on indefinite hold. Agwunobi, who oversees the corps, said that a board of inquiry was convened early this month to hear the Walsh case.

That didn't seem to satisfy his interrogators. “In both these cases, we are troubled about whether the NIH and the Commissioned Corps acted appropriately,” said Republican congressman Ed Whitfield of Kentucky, subcommittee chairman. “Both the corps and the NIH seem passive, taking the minimal steps to enforce the rules that are the foundation of maintaining public trust.”

Box 1: Scientists hit back at the press

In an unusual attack, more than 100 infectious-disease experts have signed an editorial criticizing a Los Angeles Times article that, they contend, unfairly impugned one of their colleagues.

The commentary by 109 scientists from 16 countries was published last week by Clinical Infectious Diseases. It attacks a 16 July article by reporter David Willman that examined two trials of antifungal agents, led by Thomas Walsh of the National Cancer Institute. In the past, Walsh has received financial support from the drugs' makers.

The scientists say that Willman maligns Walsh by implying that he used inadequate doses of control drugs to make the new drugs seem more effective. They also dispute what they describe as Willman's implicit suggestion that subjects without fungal infections were inappropriately included in the trial. “It is our responsibility to stand up for clinical research and for a colleague whose integrity has been very unfairly attacked,” says corresponding author Elias Anaissie of the University of Arkansas for Medical Sciences in Little Rock.

Willman, a Pulitzer prizewinner who first exposed lucrative consulting contracts among senior researchers at the National Institutes of Health (see Nature 426, 739; 200310.1038/426739a), is unmoved. “Anaissie et al. fail to cite a single inaccuracy in my work,” he says. “Our coverage has brought to light matters of public importance.” He notes that questions about the trials were first raised by others in the field (see, for example, N. Engl. J. Med. 341, 1152–1155; 1999).

Since going to press, Nature has learned that Thomas Walsh is on the editorial advisory board of Clinical Infectious Diseases. The editorial attacking David Willman's article was accepted for publication at the journal within several hours of being submitted, according to Sherwood Gorbach, the CID editor. "We didn't want to slow things down," he says. "This is a hot topic and it is news." Still, he says: "It wasn't as if it went through without a careful reading."

Sidelines

M.W.