9764 
Federal Register / Vol. 50, No. 47 / Monday, March 11, 1985 / Notices 
background. To establish definitively the 
nature of any increased expression, 
heterologous genes would have to be used. 
But it is precisely those experiments which 
Mr. Rifkin now seeks to ban. Thus, his 
proposal would forever seal off this 
promising area of research. 
Dr. Clowes said the Americun public 
had expressed its point of view on this 
topic and called attention to the several 
hundred letters from individuals 
opposed to the proposed prohibition. Dr. 
Clowes quoted from a letter from Ms. 
Kristie Baird of Elizabethtown, 
Kentucky, who wrote, "I believe that 
anytime it is possible to save people's 
lives, it should be done.” 
Dr. Friedman first addressed Mr. 
Rifkin's statement that the American 
public is not educated. Dr. Friedman 
said in fact the American public is 
educated and has made a basic decision 
that research on animals to ameliorate 
human disease is not only acceptable 
but should be done. 
Dr. Friedman said one person's ethics 
may differ from another's. In his mind, 
treating human diseases and alleviating 
human suffering is a primary moral 
imperative. Dr. Friedman said Mr. 
Rifkin's proposal would eliminate one 
method of researching certain diseases 
and making broad gains in the therapy 
of these diseases. 
Dr. Friedman said the language of Mr. 
Rifkin’s proposal is very vague. For 
example, the term "genetic trait” is used 
but not defined. One could argue that a 
whole gene could be transferred without 
affecting a genetic trait; e.g., eye color 
may depend on a number of genes, and 
transferring one of these genes may not 
change eye color. 
Dr. Friedman said it is difficult to 
define a unique gene because in some 
cases the gene of one species differs 
from the gene of another species by a 
single base pair. The differences within 
members of the species may be more 
broad than the differences between the 
species. In addition, gene exchange 
between species probably occurs in 
nature; viruses pick up genetic material 
and probably carry such material across 
species lines. 
Dr. Gottesman reviewed the current 
status of gene transfer experiments 
under the NIH Guidelines for Research 
Involving Recombinant DNA Molecules; 
(1) Any experiment which involves the 
introduction of recombinant DNA into 
humans must be reviewed by RAC and 
approved by NIH; this would include 
both proposed introduction into somatic 
or germline cells although no germline 
experiments are anticipated in the near 
future; and (2) experiments in which 
recombinant DNA is introduced into 
animals are covered by Section III— B of 
the Guidelines and are subject to review 
and approval by the local Institutional 
Biosafety Committee (IBC). 
Dr. Gottesman said gene transfer 
experiments are an important tool 
through which questions about gene 
regulation and the development of 
complex systems such as animals or 
humans can be addressed. She pointed 
out that at this time no other method 
exists for approaching these types of 
studies. Dr. Gottesman said these 
studies will result in advances in 
treating human diseases, in treating 
animal diseases, and in using animals 
more efficiently as food sources. She 
said Mr. Rifkin’s proposal would 
prohibit these types of experiments and 
would stop extremely important 
research. 
Dr. Gottesman said she is aware of 
the controversy surrounding the ethics 
of using animals in research; however, 
the viewpoint that animals should not 
be used in research is one which she did 
not share. She did not think the majority 
of people in this country shared this 
viewpoint. She thought most people 
would come down very strongly in favor 
of using animal models to test disease 
therapies. 
Dr. Gottesman said she was 
overwhelmed by the number of letters 
received in response to the Federal 
Register announcement of the proposed 
prohibition. Anyone who has attempted 
to obtain public reponse to any type of 
announcement knows how hard it is to 
obtain comments. Yet in addition to the 
approximately fifty letters from 
scientists who considered it important to 
write both for their own research and 
for society’s ability to treat human 
disease or deal with hunger, over 250 
letters have been received from the 
general public. Dr. Gottesman said 
clearly a number of people in this 
country consider this type of research 
extremely important. 
Dr. Gottesman recommended that 
RAC not only not pass the proposed 
amendment to the Guidelines, but she 
urged RAC to approve a motion 
indicating that RAC considers gene 
transfers experiments to be very 
important research which should be 
fostered. 
Dr. Landy said the American people 
are entitled to an intelligent and 
national discussion of the ethical issues 
raised by technological advances. Dr. 
Landy felt, however, Mr. Rifkin had 
behaved irresponsibily in ignoring all 
that is known about genetics and 
evolution and had obfuscated the issues. 
Dr. Landy said increasing the human 
lifespan has increased the world 
population. Technology for producing 
more food, more efficiently is necessary. 
Dr. Landy quoted from a letter from Dr. 
Charles Yanofsky of Stanford 
University: 
Modern medicine has already done much 
to keep individuals with genetic defects alive 
to the child-bearing age and beyond. Since 
society and the medical profession welcome 
these efforts, we must not prohibit 
exploration of any possibility of correcting a 
serious genetic defect. 
Dr. Landy said many of the undesired 
consequences of animal breeding 
alluded to by Dr. Fox are a result of 
limitations in animal husbandry. 
Recombinant DNA technology may 
allow introduction of a particular 
desirable gene into an animal without 
introducing undesirable traits, and this 
is an argument in favor of continuing 
research in this area. 
Dr. Landy said he was impressed by 
the number and breadth of the letters 
the NIH received concerning Mr. Rifkin's 
proposal. There are letters from high 
officers of academic and research 
institutions, not only in the sciences but 
also in the humanities and law; letters 
from individual scientists engaged in 
research and education, including many 
of recognized international stature; 
letters from private foundations 
dedicated to improvement of human 
welfare; letters from organizations and 
individuals concerned with animal 
husbandry and efficiency of food 
production; letters from medical 
practitioners and educators in heath 
care delivery; and rather touching letters 
from individual citizens concerned 
about the future prospects for solutions 
to now intractable health problems. 
Dr. Wensink said the issues are clear 
cut and well-described. He thought 
clearly defined potential benefits have 
been enumerated and are opposed by 
unsupported, mythical fears of risks. 
Dr. Bowman said gene transfer may 
be the only feasible way of curing a 
disease such as cystic fibrosis. She said 
to even consider stopping the gene 
transfer research needed to address this 
disease is out of the question. 
Dr. McKinney said he wished to point 
out that in addition to proposing 
modifications to the NIH Guidelines, Mr. 
Rifkin has chosen to interpret how the 
NIH should apply the proposed 
modifications; Mr. Rifkin contends the 
NIH should extend its purview to 
commercial companies engaged in 
recombinant DNA research under a 
licensing agreement with an NIH funded 
institution which cited the NIH 
Guidelines in the licensing agreement. 
Dr. McKinney said Mr. Rifkin was 
attempting to involve the NIH, which is 
not a regulatory agency, in an area 
where it has no authority. Dr. McKinney 
[431] 
