Federal Register / Vol. 50, No. 47 / Monday, March 11, 1985 / Notices 
9765 
urged the RAC to reject Mr. Rifkin’s 
proposal. 
Dr. McGarrity said Mr. Rifkin's 
statement that RAC ignores the public is 
false. Public members have long been 
part of RAC's composition, and RAC has 
actively sought to include the public in 
its deliberations. Dr. McGarrity said Mr. 
Rifkin underestimates the intelligence 
and knowledge of the public. Dr. 
McGarrity stated that Mr. Rifkin's 
contention RAC would be saying there 
are no ethical problems if Mr. Rifkin's 
proposals are not approved is utter 
nonsense. Dr. McGarrity said major 
points of concern exist, but the scientific 
approach examines the data and bases 
a decision on a case-by-case review. 
Dr. Walters responded to Mr. Rifkin's 
implication that RAC has always given 
permission to proceed. Dr. Walters 
noted that until recently NIH procedures 
permitted the local IDCs and 
Institutional Review Boards (IRBs) to 
approve human gene therapy protocols 
without RAC review and NIH approval. 
The NIH Guidelines were revised to 
require the much more rigorous process 
of national review. 
Dr. Walters said transfer of genes into 
the human germline would involve the 
use of in vitro fertilization (IVF). NIH 
funded IVF research is currently under a 
de facto moratorium; national review by 
an Ethics Advisory Board is required, 
and at present, such a board does not 
exist. 
Dr. Walters said animal welfare, 
either in the laboratory or in animal 
husbandry, is a real issue. RAC, 
however, is not the appropriate group to 
address this issue. Some states have 
animal welfare rules and the NIH Office 
for Protection from Research Risks is 
participating in the process of revising 
existing Public Health Service animal 
welfare guidelines. Dr. Walters felt local 
review committees charged with animal 
welfare are the appropriate bodies to 
deal with this issue. Dr. Walters 
suggested RAC reject Mr. Rifkin’s 
proposal in light of the potential benefits 
gene transfer research might provide. 
Dr. Fox though public support of gene 
transfer research is based on fear of 
death and suffering. He said Aristotle’s 
original meaning of "telos” was not a 
final endpoint but the organism’s 
intrinsic nature expressed in the here 
and now. Society's responsibility is to 
the present not to the future. He said we 
are not progressing anywhere. 
Dr. Fox contended that what is often 
regarded as progress is simply dealing 
with residual problems passed from one 
generation to the next. He said humans 
have a tremendous responsibility to the 
animal kingdom, and he is concerned 
with RAC’s human-centered rhetoric 
and rationalizations. He said he had to 
leave to wash his hands. 
Dr. Miller of the Food and Drug 
Administration said he wished "to 
address some glaring factual errors in 
Dr. Fox's remarks in what I thought was 
otherwise a rather absurd presentation." 
Dr. Miller said early field trials of 
bovine growth hormone in dairy cows 
suggest the cows utilize food stocks 
more efficiently with as much as a 15 
percent improvement in milk output 
without a concomitant increase in food 
consumption, in effect, "getting 
something for nothing” through 
improved nitrogen utilization. 
Dr. Miller said Dr. Fox had not 
understood the function of zinc 
supplementation in the diet of Dr. 
Brinster's genetically engineered mice. 
Dr. Miller explained that the 
recombinant vector was constructed so 
that the human growth hormone gene is 
under the control of a zinc-sensitive 
promotor. Dietary zinc supplementation 
increases the activity of the human 
growth hormone gene, and the mice 
grow larger than normal. However, in 
the absence of zinc supplementation, 
they are of norma) size and do not 
suffer. 
Dr. Miller said adopting Mr. Rifkin’s 
proposal would inflict incalculable harm 
on several very important areas of 
scientific inquiry; e.g., the study of 
genetic susceptibility to diseases such 
as breast cancer. Harm would also be 
inflicted on research aimed at 
developing therapies for human genetic 
diseases since animal studies which are 
necesssary prior to human clinical trials 
could not be carried out. 
Dr. Miller said Mr. Rifkin’s proposal 
is: 
* * * yet another highly contrived issue that 
is another manifestation of what 
‘Nature’ * * * alluded to in characterizing 
Mr. Rifkin as someone whose nuisance to 
substance ratio is high. 
Dr. Joklik said he questioned what he 
was hearing when the proposition is 
made that progress is not only elusory 
but possibly even undesirable, or when 
the implication is made that the health 
of this nation is no better today than it 
was 100 years ago, or when the 
discussion centers on what was in 
Aristotle's mind when he used certain 
phrases. 
Dr. Joklik said the practical benefits of 
this type of research for humankind is 
unquestionable; the evidence supporting 
this position is irrefutable. He called 
absurd the proposition that the prospect 
of benefit to untold humans through 
generations to come shoidd be 
outweighed by putative discomfort to a 
small number of laboratory animals. 
Dr. Joklik said a concept of "species" 
was being invoked in support of Mr. 
Rifkin's proposals. Dr. Joklik said he is a 
member of the International Committee 
for the Taxonomy of Viruses which has 
been trying to develop a definition of 
species with regard to viruses. Dr. Joklik 
said it has been utterly impossible for 
this committee to arrive at a definition 
of a species. Species are constantly 
evolving, and the transfer of genes from 
one "species" to another has occurred 
throughout evolution. 
Dr. Joklik supported Dr. Gottesman’s 
recommendation that RAC forcefully 
state research on gene transfer be 
fostered and not hindered. 
Dr. Rapp supported Dr. Joklik’s 
comments. He pointed out that medical 
research has tremendously benefited a 
variety of animal species. The 
development of a rabies vaccine is one 
example. 
Dr. Rapp said Dr. Fox does not like 
the fact that humans are human- 
centered, but species tend to be self- 
centered. Dr. Rapp stated that 
stewarding and handling animals in a 
humane manner is important, but to 
think about preventing certain lines of 
research in any species is a very 
dangerous idea. If this concept were to 
be seriously supported, society should 
consider the "telos” of bacteria and 
viruses. 
Dr. Rapp said he supported Dr. 
Gottesman’s proposal that RAC issue a 
statement in support of this type of 
research. He agreed ethical issues might 
exist, but the consequences of forfeiting 
all benefits of gene transfer research for 
what at the moment appear to extremely 
minor risks are so great that RAC should 
not support Mr. Rifkin's proposals. 
Dr. Saginor said that: 
* * ‘ although some of Mr. Rifkin’s original 
purposes may have been sincerely based, it 
appears that various catch phases are uttered 
and written to engender pubic fear and 
potential press coverage with almost 
McCarthy-type tactics. I want to address a 
statement such as “a quick vote" * * * by 
our committee. I resent the overt implications, 
and I resent this playing to potential 
inflammatory press quotes, and I particularly 
resent you implying that our committee and 
subcommittees do not care * * * and do not 
carefully consider various ramifications of 
our decisions before a vote is taken. 
Dr. Saginor said it is important to 
address the issues and not strike fear 
into the American public. He said he 
strongly supports Dr. Gottesman’s 
suggestion. 
Dr. Gottesman moved that: 
The RAC reject the amendments proposed 
by Mr. Rifkin and published in the Federal 
Register of September 20, 1984. Section II. 
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