264 • Impacts of Applied Genetics— Micro-Organisms, Plants, and Animals 
ISSUE: Should Congress begin prepar- 
ing now to resolve issues that 
have not yet aroused much pub- 
lic debate but that may in the 
future? 
As scientific understanding of genetics and 
the ability to manipulate inherited characteris- 
tics develop, society may face some difficult 
questions that could involve tradeoffs between 
individual freedom and societal need. This will 
be increasingly the case as genetic technologies 
are applied to humans. Developments are oc- 
curring rapidly. Recombinant DNA technology 
was developed in the 1970’s. In the spring of 
1980, the first application of gene replacement 
therapy in mammals succeeded. Resistance to 
the toxic effect of methotrexate, a drug used in 
cancer chemotherapy, was transferred to sen- 
sitive mice by substituting the gene for resist- 
ance for the sensitive gene in tissue-cultured 
bone marrow cells obtained from the sensitive 
mice. Transplanted back into the sensitive mice, 
the bone marrow cells now conferred resist- 
ance to the drug." In the fall of 1980, the first 
gene substitution in humans was attempted." 
Although this study was restricted to non- 
human applications, many people assume from 
the above and other examples that what can be 
done with lower animals can be done with hu- 
mans, and will be. Therefore, some action might 
be taken to better prepare society for decisions 
on the application of genetic technologies to 
humans. 
OPTIONS: 
A. A commission could be established to identify 
central issues, the probable time-frame for ap- 
plication of various genetic technologies to 
humans, and the probable effects on society, 
and to suggest courses of action. The commis- 
sion might also consider the related area of 
how participatory democracy might be com- 
bined with representative democracy in deci- 
sionmaking. 
"Jean L. Marx, "(iene I'ransfer (iiven a New I'wist," Science 
208:2.'5, April 1980, p. 386. 
"(lina Bari Kolala and Nicholas Wade, "Human Gene Treatment 
Stirs New Debate," Sctence 2 10:24, October 1980, p. 407. 
B. The life of the President's Commission for the 
Study of Ethical Problems in Medicine and 
Biomedical and Behavioral Research could be 
emended for the purpose of addressing these 
issues. 
The 11-member Commission was established 
by Public Law 95-622 in November 1978 and 
terminates on December 31, 1982. Its purpose is 
to consider ethical and legal issues associated 
with the protection of human subjects in I'e- 
search; the definition of death; and \'oluntai’v 
testing, counseling, information, and education 
programs for genetic diseases as well as any 
other appropriate topics related to medicine 
and to biomedical or heha\ ioral research. 
In July and September 1980, the Cxjmmission 
considered how to respond to a statement from 
the general secretaries of the National (xjuncil 
of Churches, the Synagogue (Council of America, 
and the United States Catholic (xjnfei'ence that 
the Federal Government should consider ethical 
issues raised by genetic engineering. The i(>- 
quest was prompted by the Su[)r('me Court deci- 
sion allowing patents on "new life forms.” I'he 
general secretaries stateil that "no gcnernment 
agency or committee is cui'iTMitly (‘\('rcising 
adequate oversight or conti’ol, nor addressing 
the fundamental ethical (|uestions (of geiKMic 
engineering) in a major way," and ask('d that the 
President "provide a way for rc’pi'csentativ cs of 
a broad spectrum of oui' society to consider 
these matters and acK ise the go\(>rnment on its 
necessary role.”" 
After testimony from \arious e.\|)erts, the 
Commission found that the Go\crnment is al- 
ready exercising ade(|uate o\ (*rsight of the "bio- 
hazards” associateil with I'DNA research and in- 
dustrial production. The Commission decided to 
prepare a report icU'ntifving \\ hat are and are 
not realistic prohUMiis. II will concenlrale on the 
ethical and social aspects of genetic lechnolog^\ 
that are most rc^Unant to medicine and liio- 
medical research. 
The Commission could he asked to stu(h the 
areas it identifi(\s and to broaden its cox er.ige to 
"StillCMUMil by Ibc f'cnci iil sec rrl.it ii-s I '' ( .ilhiilH ( uni, i 
rncc, Oi if’ins. NC I loriimrnl.irv Srr\u r Mil III No 7 liilv I 
1980. 
