Under a proposal announced last week, all employees of the National Institutes of Health (NIH), including intramural scientists, would be barred from engaging in paid consulting activities with drug and biotech companies for at least 1 year while the agency reviews its procedures and develops more effective oversight systems.

The proposed ban, disclosed to employees in an E-mail message last Friday (September 24), will affect more than 5000 scientists, including several hundred who have existing consulting arrangements in place. Those scientists will be instructed to cease those collaborations once the ban is implemented, NIH officials said.

"We have identified vulnerabilities in our system that give us pause," NIH Deputy Director Raynard Kington wrote in the E-mail message. "It is clear to us that if these activities are to continue, we will need a substantially expanded system of oversight to assure Congress and the public that conflicts of interest are prevented."

While noting that NIH continues to value interactions with industry, Kington said the year-long moratorium will give the agency time to develop information systems to track outside activities, finish reviewing specific cases, and develop ethics training programs. In addition to the 1-year ban for all employees, the proposal also includes a previously announced permanent ban on consulting for all senior NIH staff, including institute directors.

"Although this has been a difficult decision, I along with the leadership of NIH believe that it is in the best interest of the NIH," Kington wrote in the message, a copy of which was obtained by The Scientist.

NIH's handling of ethics and conflict-of-interest issues has been the focus of congressional and other investigations over the past year following reports that that NIH officials and scientists had received millions of dollars in consulting fees and stock options from pharmaceutical and biotech companies.

The moratorium represents a policy shift on the part of NIH Director Elias A. Zerhouni, who had acknowledged deficiencies in policies and procedures but had steadfastly resisted banning all outside paid consulting arrangements, especially for intramural scientists. "I plead with you to be open-minded about the academic activities of our scientists," Zerhouni told lawmakers in May.

The proposed bans will not go into effect until approved by Tommy G. Thompson, secretary of the Department of Health and Human Services, and the Bush administration's Office of Government Ethics (OGE). In a July 2004 report, the OGE recommended that NIH intramural scientists be prohibited from outside consulting.

As of Friday, NIH had not submitted the proposal, officials said, and no date for doing so had been established. The proposed action does not affect "official duties," such as collaborations with industry when part of a cooperative research and development agreement, NIH spokesman John Burklow told The Scientist.

At the June hearing of the House Energy and Commerce Subcommittee on Oversight and Investigations, Zerhouni proposed that all senior NIH officials and any employee involved in extramural funding decisions be barred from any paid consulting with industry. But most intramural researchers would be permitted to consult with outside companies, subject to time and compensation limits.

At the same hearing, Rep. James Greenwood (R-Penn.) confronted Zerhouni with "a significant number of troubling discrepancies" between NIH's files and consulting records obtained from some 20 drug companies. NIH had no records of more than 100 such consulting contracts despite strict requirements and established procedures for approval. Zerhouni noted "grave concerns" about the matter and promised to investigate. It was that investigation that led to last week's decision. "Although NIH has not completed our review and analysis of individual consulting activities, we have identified vulnerabilities in our system that give us pause," Kington wrote.

Paul Kincade, president of the Federation of American Societies for Experimental Biology, expressed concern over banning outside interactions for intramural scientists. "This is a very serious policy change, but we have to respect Dr. Zerhouni and believe there are powerful reasons for doing it," he told The Scientist.

"Everyone I know values the relations between academia, industry, and government. I'm sure the NIH leadership does, too," Kincade said. "For there to be a ban, even a temporary one, there must be serious reasons."