[Letter to Donna Shalala from Neal A. Halsey and Andrea Ruff]

Oct-24-97 04:32P Please Note NEW FAX

1 410 '502 6733 P. 03 "

order to provide complementary data and anticipate the next phase of the
evaluation of antiretroviral therapy, we have made contingency plans to modify our
study design. As we and our colleagues have said for more than two years at
national and international meetings, if other studies document the effectiveness of
a practical short course regimen in a developing country population, then that
regimen will become the control arm for the Ethiopian trial. Our changes are not
being made to accommodate any outside groups. Changing trial designs to reflect
new information is standard procedure for research.
Drs. Wolfe and Lurie inappropriately have asked you to stop the ongoing trials
which will answer the critical question about the efficacy of short course regimens
in developing countries. To stop these trials now would do a grave injustice to all
people in developing countries and could make our proposed trial uninterpretable as
we would not know the efficacy of the comparison arm.
We do not understand why Drs. Wolfe and Lurie have chosen not to participate in
scientific meetings where these issues have been extensively discussed by
scientists from countries throughout the world. Instead, Drs. Wolfe and Lurie have
directed their efforts to manipulation of public opinion by presenting half-truths and
distortions in press releases. We and our Ethiopian colleagues have never been
contacted by Dr. Lurie or Dr. Wolfe. How can they pretend to speak for us? Our
position on these trials is well known to Drs. Lurie and Wolfe from our letter to Drs.
Varmus and Satcher, interviews with members of the press and an editorial in the
British Medical Journal (attached). Drs. Wolfe and Lurie have deliberately
misrepresented our position and actions in an attempt to undermine the ongoing
trials mentioned in their letter. The methods used by this group are highly
unprofessional and below the standard that any reasonable journalist would follow
in reporting a story.
We appreciate your ongoing support of these trials.
Sincerely,
Neal A. Halsey M.D. Andrea Ruff M.D.
Professor and Director Associate Professor
NAH/bk

enc: Editorial from British Medical Journal, October 18, 1997