AIDS Treatment New, no. 183

AIDS
TREATM E NT
NEWS

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Issue Number 183
September 17, 1993
Published twice monthly by
John S. James
P.O. Box 411256
San Francisco, CA 94141
415/ 255-0588

Contents
Vaccine Controversy: The Arm y gpl 60 Trial.................................................................................... 1
Cosalane: New Approach to HIV Drug............................................................................................. 3
MEGACE Now Approved for AIDS: New Formulation..................................................................... 4
Recent Journal Articles
AZT: European-Australian Study Shows Benefit, Especially in Early Treatment....................... 4
Ateviridine: Upjohn "BHAP" Drug May Be Useful After AZT Resistance...................................... 5
TMP-SMX: High Treatment Dose Can Cause Hyperkalemia....................................................... 6
Lym phom a: EBV Test M ay Help in Diagnosis................................................................................ 6
Resources
September Scientific American: Special Issue on the Immune System........................................... 6
AIDS Treatment in Prison: Booklet Useful for Non-Prisoners, Too................................................. 6
Announcements
AZT Muscle Problems: L-Carnitine Study Recruiting.................................................................... 7
HIV-Related Nerve or Muscle Problems - IVIG Study Recruiting.................................................. 7
New York: Community-Based Aspirin Study Recruiting.......................................................... 7
California: Breast Cancer Research, Needle Exchange, Insurance Reform -
Calls, Letters Needed Before O ctober 10.................................................................................. 8

Vaccine Controversy:
The Army gpl 60 Trial
by John S. James
Three East Coast AIDS organizations are seeking professional and community input on what should be done
concerning a bitterly controversial trial of an AIDS treatment vaccine. Decisions must be made quickly; otherwise,
the trial will go ahead as currently planned and test only a
single vaccine. Neither this outcome, nor stopping the trial
without an alternative, is satisfactory. A Federal panel of
leading vaccine experts has recommended that another
trial, to compare several vaccines, be conducted instead.
This article can only outline the basics of a situation
described in the July 17 New Scientist as "bizarre events...
descending into political farce."
The controversy started when Congress appropriated
$20 million for the Department of Defense (DoD; the
Army is the lead organization within DoD to conduct this

research) to test a vaccine made from the gpl 60 protein of
HIV, to treat persons already infected with the virus. Only
one company, MicroGeneSys, Inc., of Meriden, Connecticut, had a gpl60 product (named VaxSyn, produced by
genetically engineered insect cells) with enough safety
data to enter a large trial with thousands of people; most of
the other vaccines which have enough data are based on
gp 120 instead. Leading scientists and health officials have
been very concerned that Congress specified a particular
product in legislation, instead of letting decisions about
which drugs to test be determined by scientific review.
(MicroGeneSys got the appropriation by an effective
lobbying campaign, including hiring ex-Senator Russell
Long of Louisiana to lobby Congress.)
The law allowed the trial to be scuttled if the National
Institutes of Health, the Food and Drug Administration,
and the Department of Defense agreed (within six months)
that the trial as specified was not scientifically justified -
in which case the money would be used for other AIDS
research instead. So NIH convened a panel of vaccine
experts to decide what to do. But instead of making a