; Environmental Law Institute 
\ 1616 P St. NW 
/ Washington DC 20036 
September 26, 1986 
Director 
Office of Recombinant DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda, MD 20892 
Dear Sir: 
According to the June 25, Federal Register, NIH has received a proposal from the 
Committee for Responsible Genetics to modify the NIH Guidelines to limit certain 
experiments in the area of human gene therapy. I would like to support this proposal. In 
my view, it represents a timely effort to place prudent limitations on the most 
controversial application of modern genetic engineering techniques — human genetic 
therapy. 
The proposal would add language to the NIH guidelines prohibiting human gene 
therapy in two categories: 1) Somatic cell line modifications not aimed soley at the relief 
of life-threatening or severely disabling conditions, and 2) all alterations of germ line 
cells. 
The proposal reflects the approach that currently governs the informal approval 
process for experimental protocols in this area, but goes further in establishing clear 
boundaries beyond which— for the time being— research should not proceed. 
Limitations on research should not be imposed lightly. In this case, however, they 
are justified. The social and ethical implications of work on the manipulation of human 
genes are unprecedented. These techniques promise relief from human suffering but, 
especially those that modify germ lines, have a frightening potential for social 
engineering. Even the somatic cell alterations intended to enhance quality of life raise 
important, even profound, social and biological questions. Some of these concern the 
biological role of human genetic diversity, the social value of normalcy, and the fairness 
of the availability of such therapies. 
Despite the importance of the questions concerning it, gene therapy has barely 
surfaced as an issue of national debate. In this as in many other cases, technological 
progress seems to be outstripping the rate at which society can assimilate it. 
The effect of these guidelines is to provide the opportunity for public discussion of 
the therapy before proceeding any further down the path of its implementation. In the 
meantime, the proposal allows the most urgent and humane applictions of human gene 
therapy to proceed. 
I urge you to adopt them. 
Sincerely, 
Margaret 6. Mellon, Ph.D. 
1616 P Street, N.W., Suite 200 
Washington, D.C. 20036 
Recombinant DNA Research, Volume 1 1 
[223] 
