BETHESDA, Md. — The director of the National Institutes of Health -- describing consulting payments from drug companies as a "systemic problem" that threatened the integrity of his agency -- has called for a summit of government and academic leaders to address conflicts of interest throughout American medical research.
Dr. Elias A. Zerhouni last week banned all of his agency's scientists from accepting consulting fees, stock or any other compensation from the biomedical industry. He also instructed the scientists to divest stock holdings in any biomedical company. The reforms, Zerhouni said in an interview, will put the NIH ahead of universities and private physicians in battling conflicts of interest.
Asked whether academic researchers should follow the NIH's lead, Zerhouni said:
"We need to have a summit discussion to say, 'Look, what is the interest of the public?' The interest of the public is to make sure the science that's done is not tainted.... We can't lose the public trust. Not just at NIH, but into research in general. There is work to be done. Stay tuned."
Zerhouni stopped short of saying that he would organize such a summit. But as the leader of an agency that will award about $21 billion in federal grants to academic researchers this year, he is in a strong position to demand change. Federal authority already exists, for example, to require all recipients of NIH research grants to comply with new ethical standards.
The crackdown on conflicts of interest at the NIH, the nation's leading agency for medical research, comes at a time when drug-industry influence on research choices, on the practice of medicine and on the prescribing of drugs is pervasive.
About one-fourth of biomedical researchers at universities have financial affiliations with industry, according to an analysis published two years ago by the Journal of the American Medical Assn. In neighborhood clinics and hospital emergency rooms, doctors have accepted fees from drug and device makers to enroll patients in studies aimed at promoting an array of biomedical products. Sometimes, patients are not informed that their doctor has a financial stake in their participation.
At the NIH, Zerhouni has transformed himself from a reluctant reformer to a leader in setting national conflict-of-interest standards.
Zerhouni defended his staff after the Los Angeles Times reported in December 2003 that NIH scientists -- including senior officials overseeing clinical trials -- had accepted stock options or industry consulting fees totaling millions of dollars, and that more than 94% of the top-paid agency employees were not filing public income-disclosure reports.
As recently as last summer, Zerhouni reiterated that he wanted most NIH scientists to remain eligible to enter private, paid consulting deals with drug companies. The freedom to enter those arrangements, Zerhouni said, would help "translate" discoveries from government laboratories into useful medical products.
Zerhouni did not mention at the time that the NIH maintained formal, structured collaborations with companies for the purpose of bringing to market such discoveries. Under those formal arrangements, NIH scientists are prohibited from taking any compensation from the participating companies.
In the interview this week, Zerhouni, 53, said that the more he learned about the industry ties to staff scientists, the less comfortable he grew. He realized, he said, that the potential for serious conflicts of interest was not confined to only the most senior agency officials, as he had previously maintained.
"What changed my mind," Zerhouni said, was when he saw that NIH scientists "were trading on that to be speakers for products, or whatever. That's when I said, 'Wait a minute, I'm wrong.' "
Zerhouni said he was particularly bothered to read recently in The Times that a senior agency scientist had participated in dozens of federal advisory sessions without declaring publicly that he was on the payroll of companies that stood to be affected by the panels' decisions.
Zerhouni was similarly displeased, he said, to learn that other NIH scientists had written articles for medical journals endorsing certain drugs -- without disclosing to readers that the manufacturers had paid them.
"If you are weighing in on behalf of the public, I want you to be there on behalf of the public," he said. "This is an absolute for me. Don't tread on your prestige, position, in a way that pretends to be completely objective."
Although most NIH scientists were beyond reproach, Zerhouni said, he ultimately concluded that the conflicts of interest were serious and could not be dismissed as "just a few bad apples."