BETHESDA, Md. _ The Recombinant DNA Advisory Committee(RAC) provisionally endorsed National Institutes of Health DirectorHarold Varmus' proposed plans to reduce the committee's role in theprocess of approving gene therapy protocols. Despite concerns thatwithout approval authority the RAC served no useful purpose, theadvisory body decided to continue to exist as a forum for creatinggene therapy policy.
The RAC agreed to the major points in Varmus' proposal whichincluded RAC review in cases where the gene therapy is truly novelas well as reducing RAC membership from 25 to 15, but thecommittee voted to take more control over the public conferencesintroduced in the Nov. 22 proposal.
The RAC voted 12 to 0 with two abstentions to report to Varmus thatthe proposal represented a reasonable compromise but that theyneeded more time to address issues such as informed consents andhow they will interface with the FDA at their March 1997 meeting.Varmus, however, can choose to publish the final rules in the FederalRegister prior to that meeting.
"We have got to face the fact that this is no longer our ball," saidRAC member Stephen Straus of the National Institute of Allergy andInfectious Disease. "The best we can offer is a forum for policydiscussion and evaluation."
Varmus originally proposed eliminating the RAC in the July 8Federal Register. After a public comment period which revealedoverwhelming support for the committee that has provided oversightof genetic experiments since 1975, Varmus proposed to maintain thecommittee in a reduced form which would no longer offer approvalsof gene therapy protocols. By law, Varmus can't implement thesechanges until the RAC members offered their input.
Last December when the committee was discussing its role afterimplementing expedited review for gene therapy protocols that didn'trepresent significant changes to current protocols, the membersunanimously agreed that without the authority to approve novelexperiments, they served no useful purpose.
"I certainly know that I will be a lot less enthusiastic about discussinggene therapy if there is no one to listen to what we say," said RACmember Karen Rothenberg of the University of Maryland School ofLaw.
However, Gary Chase, of Georgetown University Medical Center,pointed out that the committee could have a significant role indiscussing the extremely bad proposals and putting these experimentsinto public focus.
Other members were concerned about the means by which thecommittee would decide to review a protocol. The committeeeventually unanimously agreed that if after reading the protocolsummaries, three members wanted review, the protocol would comebefore the RAC. Requests by the FDA and the NIH director wouldalso trigger RAC review.
The biggest changes to the Nov. 22 proposal came in the role of andcontrol over gene therapy policy conferences. Originally, proposed tobe conducted after the quarterly RAC meetings, the committeeproposed that the conferences be held prior to the RAC meetings andserve as fodder for policy recommendations to the director.
"We are not going to be the only game in town when it comes to genetherapy policy," said Straus. "The best we can do is inform ourselvesand the public on these issues."
In March the committee will attend to compliance issues, how tohandle proprietary information and concerns about overseasprotocols. n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.