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Federal Register / Vol. 51. No. 122 / Wednesday. June 25. 1986 / Notices 
■PWPf TW— I ■— TT- I f ■■■! I — ■ TM ■ ■ — ' ■ 1 — — - 1 — — M — fm ! ■ 
hormones, enzymes, and antibodies. 
Once human genetic engineering is 
established as a clinical treatment for 
some human disorders it is reasonable 
to expect, from pest experience, that the 
research community will seek 
applications of gene therapy beyond the 
initial range of cases where some social 
consensus may have been reached. At 
the present time, beyond the 
applications of HSCT to the treatment of 
life-threatening or severely disabling 
diseases, r.o justification has been 
offered for the contention that the 
potential benefits of such therapy will 
outweigh the risks to people ar.d serve 
the general welfare. 
"Committees like the RAC or 
Institutional Review Beards serve their 
social purpc3e after society has reached 
seme consensus over broad policy 
issues. The burden of jprocf must be on 
those who wish to introduce a new 
technology. Cr.ce bread consensus is 
reached, the RAC and the IRBs con then 
implement those policies and. among 
other things, rendor decisions involving 
grey areas. To date, the prospect of 
applying HSCT to cre-d disease has not 
drawn significant public opposition. 
Beyond such usc3. we berm to er.tar a 
range of cortroversiul^pplications 
about which there has not bean 
adequate national debate By stipulating 
the boundaries within which NTH will 
review HSCT protocols, 
acknowledgement is given to the limited 
nature of public discussion ar.d 
consensus c.n the use cf human genetic 
•Ogtesering 
"Arguments advanced tor torbidciing 
all uses a? HSCT are based on the 
prediction that once .ve begin to accept 
cr.y use of this technology, a!! uses aro 
legitimized. Support for ihi3 thesis is 
nourished by past failures of our 
regulatory system to control 
applications of technology that have 
been extended beyond their initial 
public purpose in away that transgress 
tho boundaries of democratic control. 
The establishment of restricted zones Of 
application of HSCT at the cutset will 
make it possible to support the most 
urgent and humane applications of 
HSCT with less fear that such support 
gives tacit approval to other uses that, 
propelled by economic and professional 
pressures, may slip through the review 
process. 
"Many technical problems must be 
overcome if HSCT is to be used in 
clinical treatment. It is imperative that 
this therapy net be used on people, even 
experimentally, until the technical 
problems of targeting and delivery to 
specific cells or tissues have been 
solved. However, the pressure to test 
gene therapy on human subjects is 
building rapidly. Some investigators are 
even willing to forego the usual 
requirement that human trials await 
successful animal tests on the grounds 
that, as a life-saving measure, a patient 
is entitled to ‘anything available.’ We 
oppose ‘.his view. Moreover, we do net 
believe that informed consent by itself is 
a sufficient standard fer protecting the 
dignity of individuals with life- 
threatening or severly disabling 
illnesses against inappropriate and 
adventuresome uses cf medical 
technologies. 
“2. Enhancement Tharapics. 
"The application jf HSCT for the 
alteration of human characteristics such 
as height or si- n tore raises profound 
ethical problems. For example, clinically 
healthy individuals who wish to receive 
genetic therapy to increase their height 
because Thortr.ers’ .s devalued in 
society a.*z seeking a technological 
solution in response to n 3-cial problem. 
The concept of an ideal height ideal 
si. In color. or ideal •ve jr' is a sociel 
construction. Genetic technologies 
designed to correct normal variations in 
human phenotypes '•dp to legitimize on 
ideology that p'ace? inferior value or. 
certain ?\pr?;sicr.s of human diversity'. 
Those who would apply genetic 
therapies to bring an individual closer to 
a ‘normal range - arz cueght up in an 
Inherent contradiction. First, the 
measure af normal range’ changes for 
each generation and for each culture. 
Second, the universal application of 
such dt.! r:ry would artificially alter the 
normal range without offering any not 
benefits. Moreover, the mere availability 
of growth enhancement therapies, for 
example, crea’es a psychological 
atmosphere that further enhances the 
social value of ‘tallness’ ar.d thereby 
worsens the problem consequently. The 
potential r via of genetics in 
erhuncement therapies must be viewed 
as a social issue that warrants broad 
public debate. N!H needs to enunciate 
clear restraints of the use of HSCT for 
the purpose of enhancement so as to 
avoid 3 slow and incremental drift 
toward such applications without 
adequate social assessment. 
"3. Genetic Therapy fer the Prevention 
of Disease. 
"On the premise that genetic variation 
may explain differences in the onset of 
environmentally induced diseases, some 
companies have initiated genetic 
screening programs to identify workers 
who arc supposedly at greater risk from 
exposure to certain chemicals in the 
workplace. This shifts the responsibility 
for reducing occupational disease from 
management to workers. The 
availability of gene therapy could put 
undue pressure on workers, who would 
have to choose between therapy or loss 
of jobs. Many people in society strongly 
oppose the alteration of human genome 
as a means to protect individuals 
against unnatural, hostile environments. 
The moral opprobrium over this use cf 
HSCT is independent of personal risks. 
The proposed addition to the guidelines 
makes explicit the restriction against the 
use of human subjects for 3ucii 
purposes. 
"4. Genetic Manipulation of the 
Human Germ Line. 
"Considerable opposition has been 
expressed from many segments of 
society against any genetic manipulation 
of human germ line calls. -Germ line 
manipulation through genetic additions 
or deletions in the sperm, egg. or zygote 
would be tantamount to 
e p^rimeniaticn cn future generations 
wit: no possibility or informed consent. 
It would also set up a direct path to 
programs of eugenics. Consequently. 
NTH should state, at ‘he outset, that no 
germ lire manipulation will be 
approved." 
CMD’j "Mandatory Information 
Requirement for Federal Assi3tar.ee 
Fragrant Announcements" [43 FP. 30332) 
requires a statement concerning the 
official government programs nr. (fined 
in the Catalog of Federal Corns: is 
Assistance. Normally NTH lists in its 
enrouncements tho number and ‘itie of 
affected individual pregrams fer the 
guidance of the public. Because the 
guidance in this notice covers not cniy 
virtually every' NTH program but also 
-essentially every' federal research 
program in which CNA recombinant 
molecule techniques could be used, it 
has been determined to be not cost 
effective or in the public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In addition. Nil.' could 
not be certain that every federal 
pregram would be included as many 
federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the 
NTH Guidelines. In lieu of the individual 
program listing. NIH invites readers to 
d rect questions to the information 
address above about whether individual 
programs listed in the Catalog of 
Federal Domestic Assistance are 
affected. 
Dated: June 16, 1986. 
Bernard Talbot. 
Acting Director. National Institute of Allergy 
ar.d Infectious Diseases. 
[FR Dec. 86-14379 Filed 8-24-86; 8:45 am| 
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