MASSACHUSETTS INSTITUTE OF TECHNOLOGY Cambridge, Massachusetts 02159 
Center for Cancer Research 
Room E17-529B 
September 6, 1978 
Dr. Donald S. Fredrickson 
Director 
Department of Health, Education and Welfare 
Public Health Service 
Natinal Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson, 
It has recently come to my attention that the revised guidelines 
which should become effective this fall have restricted cloning of 
primate DNA in bacteria at the P2-EK2 level and have not included the 
option of P3-EK1. This arbitrary decision will seriously delay or block 
several significant experiments; particularly in the area of expression 
of human genes in bacteria. An example of a life saving development 
which this decision woikld seriously delay would be the creation of a 
bacterial strain which produces human interferon. I know this ruling 
will force such research out of the USA and from under the jurisdiction 
of the guidelines. Ultimately the USA public will have to pay for the 
development of such drugs in firms held by foreign counties. 
I hope this can be changed before the revised guidelines are finally 
issued. However, if this is not possible, it is essential that rapid 
flexibility be built into the new guidelines. For example, it should be 
possible for one committee to grant exceptions to the guidelines and for the 
exceptions to be immediately effective. 
With such flexibility it might not be necessary to continuously 
revise the total guidelines. This would save the expense of frequently 
issuing new guidelines. 
Sincerely yours. 
Phillip A. Sharp 
Associate Professor 
PAS /ms 
[A-82] 
