The growth of human germline engineering -- manipulation of the genespassed from one generation to the next -- will have profound implicationsacross science and medicine, and the technology needs both open explorationand thoughtful scrutiny by a coalition of public agencies and independentadvisory boards, according to a report published today by UCLA followingits national conference on this emerging field.
The report, published by the UCLA Program on Science, Technology andSociety, recommends that the U.S. Food and Drug Administration work closelywith existing national advisory commissions to regulate human germlineengineering, suggest revisions to patent law regarding germline techniquesand revise current policies that affect this powerful technology.
The report also recommends that the United States resist internationalefforts to block the exploration of human germline engineering and thatno state or federal legislation is now needed to regulate germline genetherapy. "Questions about human germline engineering are often counteredwith the response that the technology is too distant for us to worry aboutnow -- but that stand is no longer valid," said Gregory Stock, conferenceco-organizer and director of the UCLA Program on Science, Technology andSociety.
"The technology exists to do primitive human germline engineeringnow, although not with the safety and reliability we demand of human medicine,"Stock said. "Our hope is that by identifying key issues and suggestingresponsible policies, we can open this subject to broad and thoughtfulpublic review as human germline engineering is developed."
Germline Engineering: Background
The summary report is based on the presentations and discussion at UCLA's"Engineering the Human Germline" conference, the first-ever nationalgathering to explore the challenges and issues surrounding one of the mostintriguing scientific issues of the age.
"This conference will provide a foundation for the public-policydebate about germline engineering that is certain to come," said Stock."Our participants offered a realistic scientific assessment of thetechnology's potential over the next 20 years -- and discussed the largerimplications and challenges of the technology."
Human germline engineering involves applying medical techniques to ahuman fertilized egg to treat diseases and disorders that are identifiedat the genetic level, such as cancer, diabetes and other conditions withgenetic components. Germline engineering has no connection to cloning.
Key Points of Interest
The UCLA report identifies several points of broad interest that aroseduring the discussion:
Two distinct approaches to germline engineering in humans are developing:the addition of new genes using artificial chromosomes, and the correctionof specific defects in existing genes.
Germline engineering will eventually be much easier and more versatilethan current genetic therapy on adult cells.
Germline engineering will be introduced gradually as research expandsand clinical techniques are developed, so policymakers and practitionerswill have considerable time to reflect on its profound implications.
Germline changes could be implemented in ways that would require theconsent of the recipient for their applications, and would prevent themfrom being automatically inherited by the next generation.
The fundamental discoveries that will lead to germline engineering willoccur whether or not researchers deliberately pursue them, because theywill be produced through research that is deeply embedded in mainstreamefforts toward other important biomedical goals. Thus the question is notif human germline engineering will develop, but when and how.
Public Policy Recommendations
Based on the discussion at the conference, the UCLA Program developedeight principal public policy recommendations to establish a foundationfor the responsible development of human germline engineering:
The Food and Drug Administration should explicitly assert its authorityto regulate human germline engineering;
The Recombinant Advisory Commission should revise current policies andagree to entertain germline proposals;
The Ethical, Legal and Social Implications Program of the Human GenomeProject should lead an exploration of the challenges and potentials ofhuman germline engineering;
The United States should oppose efforts by UNESCO or other internationalbodies to interfere with the exploration of human germline engineering;
No state or federal legislation to regulate germline gene therapy shouldbe passed at this time;
The National Bioethics Advisory Commission should recommend revisionsto U.S. Patent law to address the challenges of germline technology andthe widespread patenting of human genes;
A temporary voluntary moratorium on the cloning of humans should besupported by researchers and clinicians;
Any legislation to prevent the act of human cloning should explicitlystate that it does not restrict research.
UCLA "Engineering the Human Germline" conference: Background
Held March 20 at UCLA, "Engineering the Human Germline" broughttogether more than 1,000 scientists, physicians, educators, policy-makersand others to establish a solid scientific foundation for future public-policydiscussions, evaluate its potential for the next 20 years, examine thescientific and ethical arguments surrounding germline engineering, andfoster public discussion.
Sponsored by the UCLA Program on Science, Technology and Society andthe Center for the Study of Evolution and the Origin of Life, "Engineeringthe Human Germline" was funded by the Greenwall Foundation and theAlfred P. Sloan Foundation. The program featured presentations by leadingscientists in the field, including W. French Anderson, Andrea Bonnicksen,Mario Capecchi, John Campbell, John Fletcher, Leroy Hood, Daniel Koshland,Jr., Michael Rose, Lee Silver and James Watson.
To view the UCLA Human Germline Summary Report on the Internet, go tohttp://www.ess.ucla.edu/huge. For a document file by e-mail, write to email@example.com.
For a printed copy of the report, call (310) 825-9715, or write to theUCLA Program on Science, Technology and Society, 5676 Geology, UCLA, LosAngeles, CA 90095.
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NOTE: The policy recommendations presented in the report are in generalagreement with the thrust of the conference, but they are solely thoseof UCLA's Science, Technology, and Society Program and do not intend torepresent either the views of the symposium participants or the institutionof UCLA as a whole.