Flooded with 1,300 comments by employees and threats of high-level defections, the head of the National Institutes of Health agreed yesterday to loosen some of the ethics rules he unveiled in February.
Under the final regulations, about 200 senior staff members will be required to divest large stock holdings in drug and biotechnology companies, NIH Director Elias A. Zerhouni said. That is far fewer than the 6,000 employees who would have had to divest under his original proposal to strengthen conflict-of-interest rules at the world's premier biomedical research agency.
Zerhouni also lifted a prohibition that would have kept NIH scientists from participating in academic and independent science organizations -- as long as they are not underwritten by a pharmaceutical company or other health care entity.
But Zerhouni refused to budge on the issue of outside consulting. Some scientists had balked at a proposal prohibiting paid work for biomedical, pharmaceutical or other health-related businesses. "Maintaining the ban is the best way to protect the agency at this juncture," he said in a telephone briefing.
Rep. Chris Van Hollen (D-Md.), whose district includes NIH's Bethesda campus, cheered the changes, especially regarding personal investments. The earlier version "swept a lot of people up in a net unnecessarily," he said in an interview. "This is focused more on the decision makers."
But Sidney M. Wolfe, director of the Health Research Group at the consumer organization Public Citizen, characterized the changes as a "huge retrenchment" that left plenty of loopholes for NIH employees to accept industry money. Although he said the ban on consulting was positive, he warned that researchers could collect money from companies "laundered" through a journal or a scientific association.
Congress prompted the new regulations after lawmakers discovered that dozens of scientists had not revealed income and other perks they received from for-profit companies, as required.
The divestment proposal Zerhouni announced in February was modeled after regulations at the Food and Drug Administration. Yet when he released those "interim final" rules, he was met with a firestorm of criticism from many of the 18,000 NIH employees and from some lawmakers.
Many warned that the broad divestment order would have severe economic repercussions and cause some top agency scientists to leave for more lucrative jobs. A handful made headlines through the spring with rumors of their impending departures because of the regulations. One prominent scientist from Duke University said the restrictions could keep him from accepting a job at the institute.
"There was a lot of Monday-morning quarterbacking at halftime," Zerhouni said. "Our intent had always been to work openly with everyone."
All along, Zerhouni said, he anticipated tweaking the plan. "In my opinion, some of these interim rules may have been calibrated a little too stringently," he said. Nevertheless, the final rules "are extremely stringent. Congress should be fully reassured we have addressed the fundamental issue of public trust and the integrity of the science."
He called the new rules the "most restrictive" in the biomedical research world, and said they will "maintain the integrity of NIH," assure the "public our advice is untainted, and at the same time continue the excellence of our programs."
With prior approval, NIH staff members will be able to accept pay for teaching, writing scientific articles and practicing medicine.
Lower-level employees will not have to file financial disclosures but will be asked to alert their bosses to potential conflicts.
The issue that provoked the most consternation was investment portfolios. Zerhouni decided to cap industry stock holdings at $15,000 for senior employees and their spouses. That group includes directors of the agency's 27 institutes, their deputies and other executive managers. Those senior staff members will not be allowed to hold more than $50,000 worth of broad health care funds that invest primarily in drug and biotech companies.
The final rules take effect Tuesday. Senior managers will have until Jan. 30, 2006, to divest of stocks that pose a conflict.