Robert Carow 
4321 Chestnut Street 
Bethesda, Maryland 20014 
28 September 1976 
Donald D. Fredrickson, M.D. 
Director 
National Institutes of Health 
Department of Health, Education 
and Welfare 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
This letter is written In response to your solicitation of 7 
September 1976 regarding patent policies for certain processes In 
recombinant DNA research. I am very pleased to be afforded the oppor- 
tunity to comment on this Issue. Please note at the outset that these 
comaents are made In my dual roles as citizen and professional econ- 
omist and do not necessarily reflect the views or policies of the 
Association of American Medical Colleges with which I am associated. 
The NIH decision to permit continuation of recombinant DNA 
research by its grantees was made after a lengthy period of debate. 
Flowing from these debates were lists of risks and opportunities 
believed to be Inherent in the recombination process. Tour eval- 
uation of the risks and opportunities followed resulting in the de- 
cision to permit continuation of the research under the Guidelines. 
As you are aware, the absence of actuarial data on the risks 
and opportunities inherent In the recombinant experiments has precluded 
formal beneflt/rlsk analysis. This has necessitated reliance on an 
Informal consensus among experts. I concur in your conclusion that 
most researchers In the field believe the opportunities outweigh the 
risks. Nonetheless, I would like to emphasize the subjective nature 
of this evaluation; a point you have made In this regard during 
your testimony before the Subcommittee on Health, Senate Committee 
on Labor and Public Welfare, September 22, 1976: "Like many of the 
potential benefits, these risks remain speculative, for there is still 
scanty evidence that genes from one form of life can be expressed In 
any other form." I believe our true state of ignorance regarding the 
r lsk/opportunity balance must not be forgotten in the ongoing evaluation 
of the research and its ramifications. Including the choice of patent 
policies for Inventions resulting from the research. 
The lack of actuarial evidence, and the consequent reliance on 
expert speculation must lead to the conclusion that the opportunity/ 
risk ratio, if positive, is nonetheless precarious. Our state of 
Ignorance forces this conclusion on us. Patent policy must be viewed 
in this context. 
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