A proposed ban on consulting at the National Institutes of Health might make it more difficult to translate basic research findings into new drugs and therapies, according to pharmaceutical and biotech companies, who say they will need to tap new sources to provide expert help in ongoing research. The NIH announced in September that it would seek to ban its scientists from all outside paid consulting activities with drug and biotech companies for at least one year, while the agency reviews its procedures and develops more effective oversight systems.
"We will look elsewhere, to academia and research institutes," says Martin Mackay, senior vice president and head of research for Pfizer, New London, Conn. "But we would suffer, I think the industry would suffer, academia would suffer, and I do think, ultimately, patients would be affected," he says.
"There are a lot of experts in academia that we can...
DISCREPANCIES PROMPT PROPOSAL
At a June hearing of the House Energy and Commerce Subcommittee on Oversight and Investigations, NIH director Elias A. Zerhouni proposed that all senior NIH officials and any employee involved in extramural funding decisions be barred from any paid consulting with industry. But at the time, he said that most intramural researchers, or those who are employees of the NIH, would be permitted to consult with outside companies, subject to time and compensation limits.
At the same hearing, Rep. James Greenwood (R-Pa.) confronted Zerhouni with "a significant number of troubling discrepancies" between NIH's files and consulting records obtained from 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 the September decision to propose a wider ban on consulting.
Approximately 66 employees currently have approved consulting arrangements in place, says NIH deputy director Raynard Kington. Once the proposed ban is implemented, they would be instructed to cease those collaborations until the matter is resolved, he says.
The proposed ban, disclosed to employees in an E-mail message from Kington on September 24, would affect more than 5000 scientists, including intramural researchers. "We have identified vulnerabilities in our system that give us pause," Kington wrote. "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." Allowing intramural scientists to be paid consultants is questioned on the grounds that it presents a potential conflict of interest and conflict of time commitment, especially if they are receiving stock or stock options.
While noting that NIH continues to value interactions with industry, Kington says 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. "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 E-mail.
The proposed ban would cover only paid consulting activities unrelated to NIH employees' official duties. It would not affect industry interactions that are part of cooperative R&D agreements and material transfer agreements.
NIH ETHICS QUESTIONED
NIH's handling of outside ethics and conflict-of-interest issues has been the focus of congressional and other investigations over the past year following reports in the
Establishing a blanket prohibition against consulting by intramural scientists "would be both harmful and unfair," says Paul W. Kincade, president of the Federation of American Societies for Experimental Biology in Washington, DC. "Interactions between academia, including the NIH, and industry are mutually beneficial and are very important in the translation of discoveries to cures," says Kincade. "It's important for scientists who are doing the experiments to be in close touch with the need and to understand what's involved in translating their discoveries."
Nevertheless, there is widespread agreement that even the appearance of financial conflicts should be avoided. "Absolutely no way, no how, should there even be the appearance of conflicts of interest," says Dan Eramian, vice president of communications at the Biotechnology Industry Organization, an industry trade group. "But until it all shakes out, what it will be like a year from now, we just don't know."
A drug industry spokesman was similarly reserved. "We will further judge the NIH proposal once more details become apparent and after we determine the proposal's impact on ongoing research," says Court Rosen, spokesman for the Pharmaceutical Research and Manufacturers of America in Washington, DC, which represents brand-name drug companies.
Pharmaceutical companies want scientists from NIH, academia, and research institutes to help them use early discovery and research data to make better decisions in drug development, thereby cutting development costs, says Kenneth Kaitin, director of the Tufts University Center for the Study of Drug Development in Boston. "They want to leverage basic research to lower R&D costs and improve success rates, meaning the likelihood of developing a marketable product," he says.
Mackay declined to discuss specific consulting cases because they are under investigation. But according to documents released by the House subcommittee, many of the NIH arrangements with drug and biotech companies involved participating in meetings and consulting on specific research projects.
"While the reasons change from case to case, the general notion is the same: to get somebody on board to consult with who really understands this basic information and can help them leverage it," Kaitin says. In Pfizer's case, collaborations involve target molecules validated by academia and institutes. "We take these targets and come up with chemicals to drive the drug discovery process," Mackay says. "Most of the collaborations involve areas of science where we do not have all the basic knowledge we need, so we use consultants."
If NIH scientists are no longer to fill this role, companies will find others who can. "I suspect a lot of them will look to academic centers," Kaitin says. Mackay agreed. "We will look elsewhere. We collaborate all over the world and in the US and will continue to do that."
The proposed NIH ban will not go into effect until approved by Tommy G. Thompson, secretary of the Department of Health and Human Services, and the Office of Government Ethics (OGE), a process that could take months. In a July 2004 report the OGE recommended that NIH intramural scientists be prohibited from outside consulting.
Kincade 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 says. "Everyone I know values the relations between academia, industry, and government. I'm sure the NIH leadership does, too. For there to be a ban, even a temporary one, there must be serious reasons."