107 
Editorial by Richard Goldstein, Ph.D. Copyright © 1977 by the New 
England Journal of Medicine, Vol. 296, pp. 1226-8, May 26, 197T! 
Reprinted by permission. 
PUBLIC-HEALTH POLICY AND 
RECOMBINANT DNA 
The issue of recombinant DNA research (i.e., gene 
manipulation) has been discussed widely in the pub- 
lic press and scientific journals. The controversy has 
been the focus of numerous meetings sponsored by the 
National Institutes of Health and most recently by the 
National Academv of Sciences. It is regrettable, there- 
fore, that the report in this issue of the Journal by C. 
Cohen completely ignores the centra 1 questions in the 
debate. It dismisses potential hazards associated with 
the technology while attempting to lay down a priori 
principles on which to make judgments of little rele- 
vance. The report is an entertaining intellectual exer- 
cise with no bearing on the facts involved. Worse yet, 
Cohen demonatrates a lack of understanding of sci- 
ence and its history, and particularly of the specifics of 
recombinant DNA research. The real issue — a de- 
termination of sound public-health poli . y taking into 
account both potential benefits and hazards — is not 
addressed. Rather, the bulk of his thesis revolves 
around questions of complete prohibition, a position 
not shared even by critics of the research whose views, 
in my opinion, he so distorts. Cohen seems unaware of 
the difference between reasonable constraint, a view 
espoused to varying degrees by most of those on both 
sides of the debate, and absolute prohibition. This 
view' sets back the controversy instead of construc- 
tively helping to define the issues. It is a disservice to 
the proponents of the research who have struggled so 
diligently at self-regulation. 
Recombinant DNA technology makes it possible to 
remove DNA from any organism, to chop the DNA 
enzymatically into smaller sequences of genes, to 
splice these genes into an appropriate vector (usually 
a virus or plasmid), and then to use the vector to in- 
fect an animal, plant or bacterial cell of choice. The 
end result then is the insertion of the foreign genes of 
interest into a new host. This revolutionary technic 
permits genetic information to cross species barriers 
readily. It has allowed genes derived from animal cells 
and their viruses to be implanted into bacteria, and 
bacterial genes to be inserted into animal cells. The 
usual “time gap (a potential safety valve) between a 
fundamental discovery in basic science and its appli- 
cation as a technology disappeared in record time 
with recombinant DNA studies. With its capacity to 
rearrange the genetic heritage of millions of years of 
evolution, this technology appears to offer a power to 
transform living organisms comparable to the power 
of nuclear fission to transform matter. 
Recombinant DNA technology will have profound 
effects on biomedical sciences, industry and society at 
large. There is indeed the potential for benefits of 
large magnitude. With regularity, bacteria are now 
being implanted with nonbacterial genes. These genes 
are then reproduced as the genetically m6dified bac- 
teria reproduce, thereby making it -possible to obtain 
the gene products for which the implanted genes code. 
So programmed, bacteria are envisioned as factories 
for the production of hormones, antibiotics, antibod- 
ies and enzyrrtes of potential use in medicine and in- 
dustry, as well as other gene products needed for ba- 
sic research. So engineered, the normal control sys- 
tems regulating bacterial growth and function may be 
circumvented. 
Recombinant DNA technology is now in wide- 
spread use in basic-research laboratories, with the 
number of such experiments constantly increasing. A 
not unreasonable estimate is that 10 15 to 10 16 recom- 
binant organisms per year will be produced in the lab- 
oratories and that this number will be substantially 
increased by industrial involvement.' Like the bene- 
fits of nuclear-power plants, the benefits of recombi- 
nant DNA research are likely to come with mixed per- 
il. The National Institutes of Health and other pro- 
ponents of the technology are to be lauded for their ef- 
forts in struggling with this dilemma and the result- 
ant development of guidelines for future studies. In 
some instances these guidelines seem particularly ef- 
fective when dealing with the more obvious concerns 
of public-health nature by prohibiting overtly dan- 
gerous classes of experiments — for example, the clon- 
ing of recombinant DNA’s from known oncogenic vi- 
ruses or pathogens. 2 
The real shortcoming of the guidelines is that they 
do not give equal importance to potential problems 
developing from less obvious situations than the 
known pathogens mentioned above. The enormous 
complexity of micro-organisms and ignorance of their 
intricately complicated ecology make it impossible to 
predict with certainty the end effect of any transplant 
of large numbers of genes into the micro-organism of 
choice, Escherichia coli K-12, or a further enfeebled ge- 
netically modified strain derived from K-12. Esch. coli 
