[Letter to Dr. Merson from Jon Cohen]

TO: CATHERINE DASEN
FROM: JON COHEN
March 25, 1992
Dear Dr. Merson,
Catherine Dasen asked that I send along specific questions for
the Science article I am writing about AIDS vaccine liability
issues. Let me first briefly give you a sense of where I am
heading.
AIDS vaccine liability issues have been discussed since the
beginning of AIDS vaccine research. Until now, most every
discussion I've read--whether it be in the scientific literature,
the press, or government/WHO/CIOMS reports--has been highly
theoretical. In fact, the discussion to date has drowned in
theory, with several participants of the Keystone Project on AIDS
vaccine liability even arguing that there was no real problem. My
intent is to document real problems and discuss possible
solutions. I am speaking with every AIDS vaccine developer I can
think of, lawyers, legislators, the U.S. Department of Health and
Human Services, the NIH, and, I hope, you. I realize that this is
a sensitive issue for most everyone, but I am convinced that
unless it is discussed frankly, unless people describe real-life
hurdles that vaccine liability issues are creating, the problem
will be back-burnered until a crisis emerges. And with efficacy
trials now on the horizon, the question is only going to become
more tangible. In that vein:
1. How have AIDS vaccine liability concerns affected WHO? Have
you formally discussed the issue? Have you sought insurance for
clinical trials? Has any vaccine developer asked you to
indemnify?
2. From your vantage, have liability concerns in any way delayed
AIDS vaccine research? If so, how? Do you anticipate liability
concerns delaying the start of any trials you are involved with?
3. Do you know of any specific instances of companies staying out
of (or exiting) the AIDS vaccine business because of liability
concerns?
4. What is WHO doing to protect itself and trial participants?
5. Can you share any documentation with me that discusses WHO's
discussions and decisions about the AIDS vaccine liability
question? Any communications with governments, companies,
universities, or individual researchers would be helpful.
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