WASHINGTON -- More than two decades after the U.S. Senatefirst held hearings on conflict of interest in biomedicalresearch, the National Institutes of Health appears to be closeto enacting guidelines.
"The NIH is expected within the next two to three months topropose conflict of interest regulations for persons receivingfederal grants," Rep. Ron Wyden, D-Ore., said at Monday'sbriefing of the Congressional Biomedical Caucus. The proposedguidelines "will set out the limits of financial arrangementswhich may exist between persons who work in these grant-receiving independent labs and the industry," Wyden said.
Wyden's interest in the issue stems from his Small Businesssubcommittee's investigation -- and ultimate scuttling -- of adeal in which the NIH-funded Scripps Institute would havesold 10 years' future research to Sandoz Pharmaceuticals Co. ofSwitzerland. Bernadine Healy, then head of the NIH, had toldWyden's subcommittee that the deal could destroy NIH'sextramural program.
Wyden's biggest concern was that the deal would set adangerous precedent for the non-industrial researchcommunity. At a second hearing before Wyden's subcommitteein June, Healy said about 50 of 375 agreements among NIHgrantees gave companies rights to not-yet-developedtechnologies extending years into the future.
At the least, Wyden said Monday, there should be "arequirement that NIH grant recipients...disclose to the NIHwhen they enter into these sorts of collaborations."
Scripps and Sandoz are expected to complete a more acceptableagreement within one to two months, said Wyden.
Monday's briefing came less than a month after a meeting ofthe Science Board of the FDA concerning conflict of interest.
"There are absolutely no regulations, laws, anything having todo with conflict of interest of clinical investigators submittingdata on products that may be subject to FDA approval," SidneyWolfe, head of the Health Research Group, a Ralph Naderspinoff, told those at the meeting. He alluded to an editorial inthe New England Journal of Medicine, saying "... the issue is notprimarily one of honesty ... but of unconscious bias, which maybe subtle and difficult to detect."
David Kipnis, a professor of medicine at Washington Universityand chair of FDA's Science Board, described his university'ssolution to the problem in its long-standing relationship withMonsanto. The agreement, signed in 1981, enables universityresearchers to apply for grants from Monsanto and allows thecompany to commercialize university research. It takes severalapproaches to limiting possibilities for conflicts of interest:
-- Grant applications go through the university rather thandirectly to Monsanto. A 10-member internal advisorycommittee composed equally of university and companyrepresentatives must pass on proposed grants by a majority ofat least two.
-- Support of university research by Monsanto is limited toabout 7 percent of the university's research budget.
-- University researchers may consult for industry, but theymust disclose all funding sources. They are advised not to takestock options.
-- Patents reside with the university and Monsanto has twoyears to exercise right of first refusal. University researcherswho leave for other non-profit independent researchinstitutions may take Monsanto-sponsored research with them,but they may not take it to other companies.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.