perm filename POLICY.NS[W85,JMC] blob sn#782664 filedate 1985-01-26 generic text, type T, neo UTF8
n063  1506  26 Jan 85
BC-GENES 1stadd
NYT NEW YORK: from the agency.
    In principle, there are two main types of gene therapy. The first is
somatic cell gene therapy, intended to affect only the patient's body
cells, not the reproductive cells. This is the only type of gene
therapy considered in the document ''Points to Consider in the Design
and Submission of Human Somatic-Cell Gene Therapy Protocols.''
    The other main category, treatment that does affect the egg or sperm
cells and potentially would be passed on to the patient's children,
is highly controversial, and it is thought that this therapy will not
be tried for the near future.
    The document published Tuesday offers 30 days for comments. A final
version of the guidelines will be drafted after public comments have
been studied and after the document has been discussed at the
Recombinant DNA Advisory Committee of the National Institutes of
Health.
    The National Institutes of Health, with headquarters in Bethesda,
Md., are the federal government's main agency for support and conduct
of medical research.
    The guidelines are defined as ''points to consider'' to distinguish
them from the National Institutes of Health guidelines for the
conduct of gene splicing research in general, which have been in
effect since 1976.
    While the ''points to consider'' do not dictate the specific nature
of any experimental treatments to be tried, they do pose questions
and ask for data that give strong hints on what the institutes'
review committee is likely to find acceptable. One of the document's
questions for research workers asks whether reserch in primates is
planned before human trials begin.
    One panel member, Dr. W. French Anderson of the National Heart, Lung
and Blood Institute, an expert in gene therapy research, said the
committee was divided on the importance of primate studies in
preparing for tests in humans. In fact, he said, so far as is known,
none of the groups working in this field have either published or
completed studies in primates.
    The ''points to consider'' ask about the types of human cells that
are to be treated and about the efficiency of the transplantation
process. By asking further specific questions on these points, the
document strongly hints that bone marrow cells will be the first
acceptable target cells and that genetically engineered viruses would
be the probable means of transplanting the genes into the human cells.
    The document closely linked the policy of public review to
Americans' need to understand the nature and implications of gene
therapy. ''The public review of these protocols will serve to educate
the public not only on the technical aspects of the proposals but
also on the meaning and significance of the research,'' it said.
    The document also asks prospective gene therapists what steps will
be taken to assure that ''accurate information is made available to
the public with respect to such public concerns as may arise from the
proposed study.'' nn
    
nyt-01-26-85 1807est
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