Attachment IV - Pace 17 
Timothy J McDermott 
81 Joy Street f 1 
Boston, MA 021 1i* 
617-^20-14615 
Birector, Office of Recombinant 
DMA Activities 
Building 3' » Boor 3B 10 
'rational Institutes of Health 
Be the s da, MD 20205 
February 1?, "9£5 
Bear Sir/Kadam: 
I an writing to comment or. the "Points to Consider in the Design and Sub- 
mission of Human Somatic- Cell Sene Therapy Protocols" submitted by the 
•working group on Humar Sene Therapy of the TTH 1 s recombinant DN.A Advisory 
Committee, Hr Hoc :5 — "-63 Tiled :-35« 1 will refer to the outline provided 
in the Points to Consider document to identify ny specific area of comment. 
In section I 3 L c, '"That precautions will be taken, if any, to protect others 
[eg patients sharing a room, health-care workers or family members ) from 
such potential hazards?" , I emphasize that the danger for the phlebotonist 
from accidental needle puncture "seif innoculation) should be de'.lt with 
in a straight forward fashion. Cne model that could be expanded o : is 
the general hospital protocol for screening all accidental needle punctures. 
The emphasis of these protocols is to identify the hazard (eg is the patient 
ZBsAg - positive) and to provide the best proven titive measures early on 
for the person who has been accidentally stuck (victim). 
In regards to an experimental protocol such as Human Somatic- Cell Therapy 
I emphasize the prudence of following closely (ever.' i_-c months) pertinent 
physiological parameters of the health-care worker (victim) in the best 
interest not only of that tersor. mat in tromotir.g a more thorough under- 
standing of this new therapy. 
In section I B _ b, "Is there any expectation that recombinant DM' will spread 
from the patient to others or to the ervironent?" I propose that persons 
undergoing this therapy be prevented from ever donating blood. Some 
"flag'’ (eg Social Security -) should be stored within the American Red Dross ' 
blood inventor:/ system so that blood donors having undergone cell therapy 
will be automatically inter tified in routine processing. 
-lease consider these suggestions in 
in which they were offered. 
the sincere and constructive spirit 
f Timothy Iff McDermott MT(ASCP) 
'ep'VjTa Biochemistry 
Mount '.uhum Hosuital 
Cambridge, MM 02238 
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