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SCHOOL OF MEDICINE ~

STANFORD UNIVERSITY. STANFORD. CALIFORNIA 94505

JOSHUA LEDERBERG April 14, 1978
JosePH D. GRANT PROFESSOR
or GENETICS

L Hon. Paul N. McCloskey, Jr.
Congress of the United States
House of Representatives
Washington, D.C. 20515

Dear Pete:

I am certainly very pleased with the position that you have
been taking with respect to the continued support of the WHO
program in human reproduction. I would concur with everything
you said about the unique place of WHO in dealing with this global
problem. It has I believe done very well in striking an effective
balance between the need for early substantive progress in research,
on the one hand,and the development of indigenous capabilities
throughout the world on the other. It is also certainly true that
the requested levels of expenditure are pitifully small in relation
to the challenge;but this is hardly an argument against sustaining
the program at at least this minimum level.

‘Having said all that, I would still have to enlarge that the
problem of effective contraception cannot be considered in isolation.
In fact, one of the most serious obstacles ‘to efforts to develop,
and perhaps to the rational deployment of,new agents is the
concern about side effects, especially cancer, which I am sure will
attend every agent that has such a profound effect on human
physiology as to be a reliable block to a central biological
process. The incipient wreckage of the long-term WHO-supported
field trials of depo-provera,which are a nearly certain consequence
of the FDA's position on the further development of this substance
as a therapeutic agent,in the United States,illustrate : what I mean.
The prospect of such a scare should no longer be regarded as a
potential and unlikely accident but as a virtually certain
accompaniment to efforts to introduce any new agents. It is surely
obvious that had the present climate prevailed 15 years ago we would
not even be able to use the existing oral contraceptives.

Given the FDA's mandate to assure the perfect safety of the
American population at whatever cost, it is hard to see any

administrative procedures that could ameliorate this situation. I
think it does mean that we should be more careful to anticipate the

SEP 25 1978

CO: H- Crier,
McCloskey, P.N. -2- ° 4-14-78

magnitude of this overhanging threat at a very early stage of the

R&D on newly introduced substances; which is to say that there really
is no way to draw a line, between research on preventive measures in
cancer, from important applications in human reproduction. What has
been mainly lacking on the cancer side, especially at the end of the
spectrum that has to do with the ground work for regulatory policy,
is any inquiry into mechanism. After all, according to the law, it
is sufficient to introduce an agent into an animal and demonstrate

a statistical increase in tumors and that case is won.

I certainly do not expect these remarks to influence your very
good efforts in the present context, but I thought they might be
helpful in your larger consideration of the problems and opportunities
for progress in this field.

I hope you will forgive me for being so tardy about responding
to your earlier communications but they came at a time when I was
simply overwhelmed by other events; and I am glad now to be able to
get back into dialogue with you.

Yours sincerely,

J6@shua Lederberg,
Professor and Chairman
Dept. of Genetics

P.S. I have had the opportunity to see a good bit of the work of
WHO at fairly close hand; but I would be really interested to
see the Helman committee report that you mention in your letter
to Chairman Long.

a

JL/gel