Senior scientists and others at the National Institutes of Health (NIH) are preparing legal challenges to recently announced ethics regulations barring them from owning stock in drug and biotech companies and from consulting with universities and academic institutions.

The tough ethics regulations, announced February 1 by director Elias A. Zerhouni, "substantially overreach and will severely and irreparably compromise the NIH's mission," wrote the Assembly of Scientists, an organization representing senior NIH intramural researchers.

"These new regulations will discourage talented, innovative scientists from staying at or being recruited to the NIH, and preclude scientists already at the NIH from participating as full members of the scientific community," 18 members of the Assembly of Scientists argued in the February 22 issue of The NIH Catalyst, a newsletter circulated on the Bethesda, Md., campus.

The new rules require most intramural scientists, all senior officials, and those having contracting and grant-making authority to divest of all stock in drug and biotech companies. Other NIH employees are limited to no more than $15,000 in stock in any one biotech or drug company. The rules bar all NIH employees from consulting with or accepting payments from pharmaceutical, biotech, and medical device companies as well as from universities, hospitals, and research institutes that receive NIH funds.

The regulations, which go into effect in early April, are intended to address concerns raised after media reports and congressional investigations last year revealed that some NIH scientists and officials had received lucrative consulting contracts, fees, and stock options from pharmaceutical and biotech companies, many of which had dealings with the agency.

Some groups of NIH scientists have been meeting with lawyers from the American Civil Liberties Union to see if that organization would be willing to challenge the regulations on First Amendment Freedom of Speech issues. The Assembly of Scientists plans to engage a lawyer next week to represent their issues with Health and Human Services officials and possibly to seek a court injunction to delay implementing the rules. The group also is also developing alternative proposals.

Most of the NIH scientists concerned about the issue "are totally in favor of rules to prevent conflicts of interest, but we don't want the rules to be so restrictive as to avoid academic interactions," said Abner L. Notkins, chief of experimental medicine at the National Institute of Dental and Craniofacial Research. "We don't want to see the NIH deteriorate as a result of overly restrictive regulations," he told The Scientist yesterday. Notkins is not a member of the Assembly of Scientists executive committee.

The NIH Fellows Committee, a group representing more than 3000 fellows at the agency, recommended that trainees, fellows, and temporary researchers be exempted from the new regulations. This would allow them to receive money to attend conferences, workshops, and other professional development activities.

The Assembly of Scientists' executive committee discussed their concerns with Zerhouni and other officials yesterday (February 24). Zerhouni encouraged the scientists to report how the new regulations would personally affect them and to relay specific information about problems in recruitment and retention.

"There was almost no discussion about consulting," said Michael Gottesman, deputy director for intramural research who also attended the meeting. "Most people are aware that it's impossible to do that at NIH now," he told The Scientist.

The backlash from intramural scientists comes as the Los Angeles Times and the Washington Post reported this week that 50 to 80% of some 100 suspected cases of improper consulting activities have been cleared by NIH investigators.

In a guest editorial in The NIH Catalyst, Zerhouni characterized the agency's year-long conflict-of-interest controversy as a "divisive issue," a "painful episode," and an "unfortunate chapter in our history."

"I want to encourage a wide, direct, and open dialogue with all of NIH's staff to carefully evaluate" the new rules "for any unintended consequences or undue hardships—which I will do my best to address," Zerhouni wrote.