ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Sunday, July 21, 1996 TAG: 9607190090
SECTION: EDITORIAL PAGE: 3 EDITION: METRO
SOURCE: DORIS ZALLEN and GAIL ROSS
IT SEEMS the end of an era. The director of the National Institutes of Health has announced his plans to disband the Recombinant DNA Advisory Committee.
In the mid-1970s, scientists were concerned about the possible harmful consequences of their new ability to defy species barriers by shifting about the genetic material - DNA - and to permanently change an organism by importing into it the genes of another. They declared a moratorium, a first in scientific history, and voluntarily ceased from performing many types of experiments. They decided to wait until they could agree how to carry out such work safely. The solution was a new mechanism: the Recombinant DNA Advisory Committee
The focus of the committee has changed over time. During the past six years, its major function has been to review all studies of human gene therapy proposed by investigators from institutions that receive any federal funding.
Since its inception, the committee has consisted of scientists/ physicians, lawyers, ethicists and public representatives. The discussions of the committee are public. Anyone can attend and can contribute to the discussions examining the safety, scientific validity and ethics of each study. The minutes of every meeting are published in the Federal Register.
In addition, and importantly, investigators were required to provide periodic updates on the safety and efficacy of the studies, and to report any adverse effects to patients enrolled in the studies.
Has the committee reached the end of its reasonable life span? Is now the time to jettison it and leave all the crucial decisions behind closed doors of laboratories, biotech companies and the Food and Drug Administration? We think not.
Human gene-therapy research is new, and still raises disquieting medical, social and ethical questions: Should gene therapy be done on fetuses? Should germ-line gene therapy (a form of gene therapy that can alter the genes of generations to come) be allowed? What about the possible use of gene therapy to enhance features of otherwise perfectly healthy individuals? Taller? Thinner? Or, perhaps in the future, smarter? Heterosexual?
Addressing such questions requires more than just scientific input. It needs the rich diversity of ethicists, lawyers, social scientists and others who can critically examine these questions. And these issues must be examined in a forum where the public is welcome and its voices can be heard.
Gene therapy is indeed "big business," with hundreds of millions of dollars spent in development over the past five years. Much of the money comes from private pharmaceutical companies that employ the talents of university-affiliated scientists.
Investigators and pharmaceutical companies have complained that the advisory committee impedes progress, that the committee takes too long to review and approve a protocol. But in fact proposed experiments can be submitted to the committee and the FDA in parallel, and the time it takes for committee approval has been less than for FDA approval..
Some investigators have expressed resentment that their studies are critiqued in an open forum. Progress reports of the committee show that while gene therapy appears to be safe, none of the more than 130 studies approved so far yields undisputed evidence that genes can be transferred in sufficient amounts to bring about any cures. Such public information flies in the face of information disseminated by companies of the effectiveness of their approaches and negates the "hype" that gene therapy can already cure diseases like cancer and cystic fibrosis.
Some scientists and biotechnology executives argue that gene therapy has now been shown to be safe and should now be considered like any other medical treatment. However, it is clear that gene therapy has not yet "worked" and that new technologies, which may not be safe, will have to be devised before a breakthrough occurs.
As a replacement for the advisory committee, the NIH director proposes holding three or four conferences a year during which different sets of experts will come to the National Institutes of Health to discuss a specific topic.
This proposal is not satisfactory. How the public might learn about or participate in such conferences is not explained. Nor is it clear how a panel, no matter how expert, can come to closure on difficult issues - issues that will affect generations to come - in a short period of time. Even if it did, no one would be obliged to take the conclusions into account.
A major reason for the success of the Recombinant DNA Advisory Committee for more than two decades has been its ability to take time to understand the issues and to provide wise and informed guidance, not "shoot from the hip" evaluations. Part of its success has been its attention to the actualities of the experimentation - what is really going on or being planned.
We need to foster collaboration and extended discussion, not quick assessments done in the abstract by ad hoc groups or one-time-only blue-ribbon panels. In addition, with the genetic manipulation's potential to change the very nature of human life, there needs to be a mechanism by which the public is accurately informed of advances in the field and can make its concerns known.
Through Aug. 7, the NIH is seeking public comment on this plan. Written comments may be sent to the Office of Recombinant DNA Activities, Office of Science Policy, 6000 Executive Boulevard, Suite 302, Bethesda, MD 20892-7010. (FAX: 301-496-9839). In the end, it is the public that pays the bills and bears the burdens should anything go wrong.
Doris Zallen, associate professor of science and technology at Virginia Tech, and Gail Ross, associate professor of psychology in pediatrics at Cornell University Medical College in New York, are recent members of the Recombinant DNA Advisory Committee.
LENGTH: Long : 102 linesby CNB