Scientists at the National Institutes of Health (NIH) may consult with pharmaceutical and biotech companies as long as they spend fewer than 500 hours a year in these outside activities, publicly disclose all payments, and do not receive stock or stock options, according to recommendations being readied by NIH's "blue ribbon" panel on conflict of interest policies, a draft copy of which was obtained by the Los Angeles Times last week.
NIH officials would give "special scrutiny" if outside compensation exceeded half the employee's annual salary. To prevent even the appearance of conflicts, top NIH officials would be barred from engaging in any paid outside consulting whatsoever.
The newspaper reported in December 2003 that several high-level NIH scientists and officials had received more than $2.5 million in consulting fees and stock options from drug companies over the past 10 years. NIH director Elias Zerhouni has since suspended approval of all new consulting arrangements and restructured the agency's system for implementing ethics regulations. The panel is scheduled to present its final recommendations to Zerhouni on May 6.
An NIH spokesman yesterday said the agency had no comment on the matter.
The draft recommendations strike a balance between banning all outside consulting and permitting the freedoms that staff scientists and directors have enjoyed since 1995, when then–NIH director Harold Varmus eased restrictions on NIH scientists.
"There are clear advantages for practicing scientists at NIH or at research institutes and medical schools throughout the country to consult with biotechnology and pharmaceutical companies," said Paul Kincade, president-elect of the Federation of American Societies for Experimental Biology. "But it's often the case the most important thing to a scientist is his credibility. They have to operate within guidelines, and those guidelines have to be transparent to the public," he told
The draft NIH recommendations "seem to be quite compatible with positions that AAMC [Association of American Medical Colleges] have taken with its own members with regard to these matters," David Korn, senior vice president for biomedical and health sciences research at the AAMC, told
Paid consulting arrangements with industry are "essential to accomplishing the goal of technology transfer," the draft report maintains, according to the Los Angeles Times report. According to the NIH, about 200 scientists, fewer than 3% of the staff, are involved in outside consulting. Zerhouni has defended these arrangements as helping to translate research discoveries into therapies.
"There should be a difference between a scientist who has authority [in the grant process] and those who do not," Zerhouni told a Senate subcommittee hearing January 22. "We do want to translate that knowledge to the field."
"I am a nascent tenure-track investigator, recently recruited to start an independent basic science lab at the NIH. As such, no one has yet shown the slightest interest in paying me for my opinions on anything," said Joseph A. Mindell, an investigator in the Membrane Transport Biophysics Unit at the National Institute of Neurological Disorders and Stroke. "On the other hand, should a company show an actual interest… I will have an opportunity not only to share my expertise, but also to appreciate a more applied perspective from which my own work can benefit," he told the panel last week (April 5).
At least three institute directors told the Los Angeles Times that senior NIH officials should be prohibited from receiving any compensation from drug and biotech companies, one of the panel's recommendations. Kincade called such comments "courageous and appropriate."
"As you rise to leadership in the NIH, it becomes harder and harder to interact in consulting arrangements without the appearance of conflict, if not the actual conflict," Kincade said.