NIH rules retain ban on pharma consulting
NIH Director Dr. Elias Zerhouni initiated the prohibition via a set of interim rules issued in February, following a series of congressional hearings on NIH ethics and the agency's own internal investigation into rules violations committed by 44 of its senior employees. Nine of them may have violated criminal laws.
"The rules you see today are extremely stringent in terms of biomedical research, and with the ban on consulting for paid activities, I think Congress should be fully reassured we've addressed the fundamental issue of public trust in the science," Zerhouni said at a press conference.
However, the rules are somewhat looser when it comes to divesting stock holdings in organizations such as pharmaceutical and biotech companies. All 18,000 agency employees and their families would have had to meet a $15,000 maximum per company for such holdings under the initial proposal, and 6,000 would have had to sell all their shares. The $15,000 cap per company has been narrowed to about 200 senior decision makers, who must meet it by Jan. 30, 2006. About 6,000 other employees doing clinical research will end up disclosing in more detail their pharma or biotech holdings to officials, who will determine the existence of conflicts and may ask the employees to divest such shares.
Academic interactions are among other exceptions. Subject to prior approval, scientists can participate in continuing medical education (CME) activities and serve as officers of scientific organizations or on data or safety monitoring boards. Participation in CME programs depends on pharmaceutical company grant support being of the unrestricted kind.
"The actions are predicated on a no-strings-attached relationship with the activity, otherwise our scientists will not participate," Zerhouni said, adding, "Clearly we do not want to impede the normal academic interactions that scientists and our employees need to have with the rest of the world."
The final regulations, which go into effect next week, were developed with the Department of Health and Human Services (HHS) and the Office of Government Ethics (OGE). Zerhouni said the rules reflect extensive feedback from NIH scientists and others. He said about 1,300 comments were received.
"Many employees said we should loosen the ban on outside consulting," he said. "We elected not to... but I think we realized very early that going through this process of adjustment in a large agency with a complex function would require tailoring. It's impossible to have a one-size-fits-all approach."