Subject: ACT UP/NY Treatment + Data Digest #46 (initial installment)
Date: Aug 11 1990 (92 lines)

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  Treatment & Data Digest - ACT UP/NY
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DIGEST #46  June 4, 1990

(The Treatment + Data Digest is a weekly review of issues
addressed by ACT UP/NY's Treatment + Data committee during its
past week of activities.)

PROMISING CRYPTOSPORIDIOSIS TREATMENT WITHHELD BY JANSSEN...

     Diclazuril is an experimental drug which is being
investigated as a treatment for cryptosporidiosis, a devastating
opportunistic infection of AIDS which causes unrelenting diarrhea
and can be fatal.  No approved therapy exists for the infection,
but a phase I trial of diclazuril underway has shown promising
results, without significant toxicity.  For those patients who
respond, a seven day course of diclazuril results in two or three
weeks of remission, after which all patients relapse.  Therefore,
maintenance therapy is essential.  The FDA rountinely approves
"continuation protocols" for drugs which are showing signs of
efficacy with acceptable toxicity.  However, the pharmaceutical
sponsor must formally apply for permission to conduct a
maintenance protocol.  Janssen Pharmaceutica, the manufacturer of
diclazuril, had refused until last week to file the necessary
documents.  The prinicipal investigator (PI) in the trial expects
the continuation protocol to be operating within a week.  In the
meantime, however, patients who complete a successful course of
diclazuril therpay are forced to stop the drug since the protocol
only calls for seven days of treatment.  The diclazuril horror
story has reminded T+D that access to drugs after the completion
of clinical trials should be a primary demand of ACT UP.  People
who volunteer for clinical trials do so at personal risk, and
they should have the right to continue the treatments after the
trial is complete if they feel it is providing them benefit.

AND ASTRA IS HOARDING FOSCARNET

     ACTG #093 is a trial of the anti-CMV drug Foscarnet for
people with CMV retinitis who are unable to take the standard
treatment, DHPG.  Untreated, CMV retinitis results in blindness.
While both Foscarnet and DHPG are able to stop the disease from
spreading, they do not cure it and must be taken for life.
However, ACTG 093 is ending, and now patients who fail DHPG will
have no treatment options.  Astra Pharmaceuticals, the
manufacturer of Foscarnet, has been notoriously uncompassionate
throughout the development of Foscarnet.  They recently declined
to apply for a Treatment IND for the drug (which would have
provided expanded access to it), despite the FDA's stated
willingness to approve such a program.  Astra's footdragging
probably results from the low profit potential of Foscarnet. As
usual, profit motives are dictating AIDS research agendas, to the
detriment of PWAs.  Drugs like Foscarnet which have limited
markets but are essential nonetheless to those who need them
should be aggressively tested by the government rather than
allowed to languish in the for-profit drug development pipeline.

IMUTHIOL AVAILABLE ON THE UNDERGROUND

     DTC (Imuthiol) is an immunomodulator which has been
demonstrated to prevent opportunistic infections and retard
disease progression in people with HIV infection (Lang J, and
others.  Randomized, double-blind placebo controlled trial of
ditiocarb sodium ("Imuthiol") in human immunodeficiency virus
infections.  Lancet: pages 702-706, 1988.  Reisinger EC, and
others.  "Inhibition of HIV Progression by Dithiocarb," Lancet
335: pages 679-682, 1990.  Hersh E, and others, STUDY USA 87:
"Study of Diethyldithiocarbamate in Patients with AIDS and AIDS
related complex," Double-blind, randomized, multicenter study.
In press, 1990.)  For reasons which are largely obscure, the FDA
recently denied the manufacturer's request to release
Imuthiol/DTC through the Treatment IND mechanism.  This is
unconscionable, since Imuthiol/DTC is assocaited with little
toxicity and clear clinical benefit.  (The primary side effect of
DTC is an unpleasant reaction which occurs when alcohol is
consumed with it -- Imuthiol/DTC is chemically related to the
anti- alcoholism drug Antabuse.)  Imuthiol/DTC is now available
through the PWA Health Group in New York at a cost of $30 for one
month's supply.  The friendly foks at the Health Group will be
happy to answer any questions about the benefits and risks of
Imuthiol/DTC.  Their telephone number is (212) 532-0280.

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