[Letter to Lynne Mofenson from Cheryl Healton]

05-13-02 04:24 PM P03

developed nations.
This brings me to my second point w contemplated trials of 076 treatment components in
Africa and possibly elsewhere. My comments at the Pediatric Policy meeting reflected
my view that these plans present a major dilemma. I have already read various
documents from the recent CDC meeting which our Dean, Allen Rosenfield attended.
We know that in virtually all areas in Africa, AZT treatment is not now available and
probably will not be In the future. Unfortunately other major pressing health problems
probably greatly outstrip the priority the African people would place on this treatment.
Therefore, we must choose between treating everyone in the U.S. with a more complex
regimen than may be necessary and testing a drug on a population of people to which
the drugs likely will never be broadly available. Obviously, observational clinical
studios of women who receive only IV and newborn component etc. will eventually
begin to sort out the differential effects even without African or Thai trials.
It seems that the situation Is a "no win" that could have been avoided if the original
study design had been more comprehensive and contemplated the developing world as
a potential recipient. Whether in the final analysis, given the situation we -are in$ it is
justified to proee with an African trial Is open to question. 1 would be surprised If a
fully Informed African mother to be would willingly be randomized to a condition likely to
be sub-optimal (ite., less than 076).
I hope this brief note has clarified my views4 I did not intend to misrepresent the facts,
but rather to express a personal opinion. 1 hope you understand that my criticism of the
vaccine approach was directed at the bloatech Industry and International planning,
though obviously the U.S. Government has an Important role In bringing key parties
together.
Please feel free to send me any Information on these matters which might expand my
understanding.
Sincerely,
Cheryl He, rPH/

Dictated not read