WASHINGTON _ Protection of human research subjects and theuse of genetic information took center stage at the inaugural meetingof the National Bioethics Advisory Committee (NBAC).
Established by executive order in October 1995, the group is chargedwith providing advice and making recommendations to the president,other government bodies and the public on bioethical issues.
In the wake of public outcry over disclosures about Cold Warradiation experiments and an increasing concern about the use ofgenetic information ranging from privacy to patenting, the presidentrequested that the committee attend to these issues first.
"One of the great things about beginnings is that everything seemspossible," said Harold Shapiro, president of Princeton University andchair of the committee of bioethicists, physicians biotechrepresentatives and lawyers. "Yet, the task we have before us is veryold. Societies have worried from the beginning of time about how todeal with new knowledge and new technologies."
The NBAC, which met last Friday, is one in a long line of ethicsadvisory committees established since the 1970's when theTuskeegee Syphilis Study outraged the nation. The study, whichbegan in 1932, involved hundreds of black men with syphilis whoremained untreated _ in order to track the course of the disease _even after penicillin became readily available. A commissionestablished in the 1970s produced a report that established things likeinformed consent and respect for the person. But two decades later,NBAC is wrestling with the same issues.
"This is a reflection of just how difficult the issue is," said Gary Ellis,chair of the human subjects research subcommittee of the NationalScience and Technology Council.
Revelations by the Department of Energy that mentally retardedchildren and other people unable to understand the risks involvedwith being exposed to radiation also lead to national discussions onthe ethics of human experimentation. The committee intends toexplore the adequacy of informed consent and the review humanexperiments receive. In particular, several members of the committeequestioned how effective local institutional review boards (IRB) wereat assessing the ethics of a given human experiment.
"The typical IRB is inundated with work," said committee memberBernard Lo, director of medical ethics at the University of California,San Francisco. Lo questioned how well an IRB could do its job whenit spent _ like the IRBs at UCSF _ on average seven minutes perstudy.
Regardless of what the committee ends up recommending, Ellis notesthat last year the U.S. government spent $2,789,715 on survivors andfamily members of Tuskeegee participants. "We will never repay thedamage done from that experiment," said Ellis. "But, it reminds us ofthe cost of missteps in our work."
As genetic discoveries mushroomed over the past decade, committeemember Steven Holtzman, chief business officer of MillenniumPharmaceuticals Inc. in Cambridge, Mass., noted that genetics isoffering medicine alternatives.
"However, these self-same technologies that hold this enormouspromise for good, can also undoubtedly be misused: to stigmatize, todiscriminate, to promote social agendas for human improvement asconceived by this or that group," Holtzman said.
In the face of these challenges, Congress and state legislatures havebeen trying to grapple with increasingly complex issues of privacy.
Francis Collins, director of the National Center on Human GenomeResearch, said there have been a plethora of bills introduced this yearattempting to protect genetic privacy. Collins maintained billspertaining to genetic information alone would fail to offer the desiredprotection while unduly stigmatizing genetic information.
"It is my belief that we cannot extricate genetic information frommedical information," said Collins. "As a result, the best approachmay be to treat genetic information as any medical information."
While the NBAC's agenda currently is focused on immediate issues,committee member David Cox, professor of genetics at the StanfordUniversity School of Medicine in Palo Alto, Calif., suggested that"genetics could serve as the wedge for broader discussions ofbioethics."
The committee is set to meet every two to three months and membershave two-, three- and four-year appointments.
"My hope for this commission is that we may play a seminal role inshaping the way our society and governmental authorities think aboutthe implications of the new genetics and thereby help create a soundbasis for public policy in this area," said Millennium's Holtzman.
BIO Takes A Stand On Genetic Privacy
As the NBAC began to address the tangled web of genetic privacyissues, the Biotechnology Industry Organization (BIO) called forfederal standards protecting all medical records including any geneticinformation in a policy statement issued on Sept. 18.
Noting that current genetic and medical privacy laws are a patchworkof state statutes or only protect the currently insured, BIO PresidentCarl Feldbaum told BioWorld Today that "working these issues outwill require something on the order of federal civil rights legislation."
The BIO statement maintains that "genetic testing providesinformation that is comparable to that obtained by using otherdiagnostic methods" and that it "forms part of the continuum ofmedical information." As such, the BIO statement urges Congress toenact comprehensive legislation that would protect the privacy of allmedical information including genetic information.
Collins echoed such reasoning in his presentation to the NBAC. Healso noted that the act of video rentals is afforded more privacy underthe law than medical information, genetic or otherwise. And,according to Collins, that information already is being used todiscriminate. He cited a survey of Fortune 500 companies whichrevealed that 40 percent of them used medical information in hiringdecisions.
Glenn McGee, assistant professor of bioethics at the University ofPennsylvania, called BIO's statement "extraordinarily prescient." Healso noted that BIO's position is not one that necessarily favors thebiotechnology, but "ethically it is the only way to go." n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.