BETHESDA _ An ad hoc review committee charged with re-thinking the mission of the National Institutes of Health (NIH)Recombinant DNA Advisory Committee (RAC) is responding toconcerns that RAC not duplicate FDA biotech product reviews andremain focused on wider societal issues.

The concerns were raised by NIH Director Harold Varmus, who hasultimate authority over RAC decisions, and the BiotechnologyIndustry Organization (BIO).

Varmus on Monday said RAC should "take a larger view of genetherapy." He noted that one of RAC's virtues was its opennesscompared to the FDA where decisions are made privately.

In a letter to Varmus discussed at the meeting, BIO Vice PresidentAlan Goldhammer said that RAC should sharpen its mission "toconcentrate on issues that raise novel scientific and ethical issues."Goldhammer said that "RAC should focus on areas directly related tothe NIH guidelines and where they have expertise." He pointed to theissue of genetic privacy which "is broad reaching and beingaddressed within the human genome project at NIH."

The RAC ad hoc review committee's recommendations are expectedto be finalized within three months.

Before Varmus's appearance, several members of the reviewcommittee said that RAC plays a vital role in educating the public."People are not comfortable with genetic research," said HelenHelsop, of St. Jude Children's Hospital in Memphis, Tenn.

"People have looked at this and they understand that discriminationand sometimes victimization have been based on a person's genes,"she said. "We need to ensure that science does not endanger thelarger public good. The public pays the bills [for genetic research]and the public pays the consequences."

Lack of public understanding about gene therapy was also cited byseveral members as evidence that RAC has a large public educationrole. A 1992 Lou Harris survey of 1,000 adults performed for theMarch of Dimes showed that the public knows relatively little aboutgenetic therapy.

Varmus urged the review committee to examine, for possibleadoption, the FDA's strict conflict of interest regulation. The RACshould also respond to industry's concerns that it not intervene in theinformed consent process developed by Institutional Review Boards,he said.

Varmus said that he has appointed a new advisory committee toreview the NIH's $200 million portfolio in gene therapy researchwhich he said will eventually determine how the institutes can bettersupport this type of research.

The new panel will meet May 15 and 16 and devote the next fewmeetings "to hear from leaders in gene research about what they thinkthe state of the field is now and how NIH and be helpful or hurtful,"Varmus said. Institutes focusing on cardiac and pulmonary diseasesand cancer have devoted the most resources to gene therapy butVarmus said other institutes "want to invest in this area." n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.