The National Institutes of Health (NIH) yesterday (February 1) announced a series of "sweeping" new ethics reforms that 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.

Intramural scientists would be permitted to maintain part-time clinical and medical practices for private patients and, under certain circumstances, to lecture and teach at universities, publish in peer-reviewed journals, and write and edit articles and textbooks as long as industry funding does not influence the content.

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.

"My goal here is to create a 'bright line' that is so clear that crossing that line will not be allowed or permitted," said NIH Director Elias A. Zerhouni yesterday. "Nothing is more important for NIH than preserving the public's trust in our advice, our science, and in our ability to provide public health advice with no taint of conflict of interest or the appearance of conflict of interest."

The regulations 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. The rules, which implement a 1-year moratorium on consulting Zerhouni requested last September, were developed over the past half year as Zerhouni and other NIH officials realized the agency's ethics approval and oversight mechanisms had "vulnerabilities," as Deputy Director Raynard Kington wrote in a memo to employees last September.

The Los Angeles Timesreported last week that P. Trey Sunderland III, chief of geriatric psychiatry at the National Institute of Mental Health, is being investigated for receiving more than $517,000 in consulting fees, honoraria, and expense reimbursements since 1999 without permission and without reporting the income as required.

Kington yesterday said officials are nearing the "penalty phase" of their case-by-case review of questionable ethics situations. Penalties for violating ethics rules can range from counseling and reprimand for minor violations to removal from their jobs for the most egregious infractions. Criminal sanctions may also apply if laws had been broken. Kington declined to discuss specific cases or say how many cases are under review.

The new rules, termed "interim final regulations," will go into effect when published in the Federal Register, probably within the next few days. Comments will then be accepted for 60 days. Officials will monitor the impact of the new rules on NIH's ability to recruit and retain intramural scientists as well as the scientists' ability to interact with colleagues in academia.

Paul Kincade, president of the Federation of American Societies for Experimental Biology, yesterday said it was "very unfortunate" that NIH leadership had felt it necessary to impose the ban. "We have to look very carefully at the details to try to evaluate whether this is really going to compromise the ability of the scientists to do their work and interact with the community," he told The Scientist. "It seems like many scientists on the NIH campus will be penalized because of the thoughtless actions of a few."

Zerhouni said reaction from intramural scientists so far has been "mixed." He plans to meet with NIH employees today (February 2) to discuss the new rules.

NIH's consulting rules were liberalized in 1995 by then director Harold E. Varmus, allowing scientists greater freedom to interact with pharmaceutical companies and to engage in outside consulting activities. Varmus, now president and chief executive of the Memorial Sloan-Kettering Cancer Center in New York City, was traveling yesterday and was not available for comment.