WASHINGTON _ In response to overwhelming public oppositionto the elimination of the National Institute of Health's RecombinantDNA Advisory Committee (RAC), NIH director Harold Varmus hasoffered a compromise that not only maintains the oversight entity,albeit in a reduced form, but appears to satisfy both industry andpatient advocates.
Varmus proposed in the Nov. 22 Federal Register that RACmembership be reduced from 25 to 15 and that the committee nolonger harbor regulatory authority to approve individual gene therapyexperiments but will instead discuss novel gene therapy protocols. Inaddition, Varmus proposes to initiate regular Gene Therapy PolicyConferences (GTPCs) to air public concerns over the direction ofgenetic experiments.
"It is a fair proposal," said Carl Feldbaum, president of theBiotechnology Industry Organization (BIO), which supportedVarmus' earlier proposal to eliminate the RAC on the grounds thatthe current situation represented two regulatory hoops where onewould suffice. "This is not so much a science issue as it is a politicaland public affairs issue."
This summer, Varmus proposed to abolish the committee on thegrounds that it performed activities that were redundant with the FDAand squandered NIH's imprimatur on protocols with a questionablescientific base. In addition to ceding all regulatory authority over tothe FDA, Varmus planned to establish the Office of RecombinantDNA Activities Advisory Committee (OAC), which would becomprised of 6 to 10 members. He also intended to regularly conveneGene Therapy Policy Conferences to inform the public of issues ingene therapy, as well as continue to make the comprehensive NIHdata base of human gene transfer clinical trials publicly available.
Seventy-one comments from scientists, ethicists, patient advocatesand industry representatives were submitted to the NIH in response tothat proposal. The response ran 2 to 1 against the elimination of theRAC.
"This represents a 180-degree turn from his previous proposal and itmakes me feel good that democracy worked," said Abbey Meyers,RAC member and president of the National Organization for RareDisorders, a patient information and advocacy group. "Since theRAC will review novel protocols, it can allay the public's fears thatscientists are going to reengineer the human race."
Because the FDA makes no ethical considerations in its closed-doorapproval process, Meyers considers the committee's role vital indiscussing the ethics of new gene therapy protocols _ especiallythose focused on enhancing physical traits rather than curingdiseases.
As a result of the public comments, Varmus came up with his newproposal, which revives the RAC, but removes its ability to approveexperiments. The committee will serve as a public forum for newgene therapy protocols. Varmus' new plan also keeps the GeneTherapy Policy Conferences proposed to be held after RAC meetingsas well as keeping the data base of protocols public.
Both BIO and the Pharmaceutical Researchers and Manufacturers ofAmerica (PhRMA) agreed that the RAC served a useful purpose as apublic forum. "The public forum concept is important, and NIH viathe RAC would seem a pretty appropriate way to fulfill that role,"said John D. Siegfried, deputy vice president of regulatory andscientific affairs at PhRMA. "Just as long as the RAC doesn't goback into the business of review."
RAC members will vote on the new proposal at their Dec. 9 meeting.n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.