TIME: Almanac 1993/TIME Almanac 1993.iso/time/100989/10098900.054

Text File | 1992-09-23 | 6.6 KB | 130 lines

                4╢∩                                                              AMERICAN IDEAS, Page 18

Guerrilla Drug Trials


The Underground Test Of Compound Q Desperate activists try to
speed up the discovery of a cure for AIDS

By Dennis Wyss


    Bob Barnett sits on an examination table in San Francisco
while an intravenous needle drips an experimental AIDS drug into
his veins. The drug, called Compound Q, is a purified protein
extracted from a cucumber-like Chinese plant and one of the
latest promising glimmers in the search for a cure for AIDS.

    Across town, researchers at San Francisco General Hospital
Medical Center are conducting cautious, federally approved
Phase 1 toxicity trials with minute dosages of GLQ223, as
Compound Q is officially known. But for Barnett, a 37-year-old
former radio sales manager, as for thousands of others afflicted
with AIDS, precious time is running out. Barnett wants to know
if Compound Q works in larger therapeutic doses. He wants to
know now. "My options are death and doing this," he says.

    Barnett is one of 51 AIDS patients who, along with six
doctors, took part in underground trials of Compound Q this past
spring and summer. The clandestine study was organized by
Project Inform, a San Francisco-based group of activists who
believe the Food and Drug Administration's system for testing
potentially life-saving new drugs is unconscionably slow. On
Sept. 19, Project Inform director Martin Delaney revealed the
preliminary results of the underground trials to an intent crowd
of some 500 predominantly gay men in San Francisco. Although
many of the trial's volunteers, including Barnett, showed a
marked decrease in activity of the human immunodeficiency virus
(HIV) that causes AIDS, Delaney said, Compound Q could not be
considered a cure. But the desperation of the epidemic
guarantees that underground drug trials will continue; AIDS
activists say at least two dozen such experiments are under way
across the U.S.

    Hope flashed through the nation's AIDS community last
April, when researchers from the University of California at San
Francisco announced that, in test tubes at least, Compound Q
could kill HIV-infected cells while leaving healthy cells
unaffected. The substance quickly found its way into the U.S.
and to desperate AIDS patients, who administered the drug on
their own. "Word was out," says Dr. Alan Levin, medical director
of the Project Inform trials in San Francisco. "People started
getting it and injecting themselves in their kitchens."

    To Delaney, such haphazard self-medication posed its own
threats. "We said, `Instead of just passing it out to see what
happens, let's channel it into controlled clinical use,'"
Delaney recalls. He contacted James Corti, a Los Angeles-based
activist and importer of AIDS drugs who shipped 400 doses of
Compound Q out of China.

    Delaney then asked a group of doctors to design a protocol,
or test model, based on an FDA trial for a similar drug called
Ricin Toxin. Delaney says several FDA and National Institutes
of Health officials in Washington were told of Project Inform's
proposed trial, which was planned for patients in San Francisco,
Los Angeles and New York City. "At no time did anyone tell us
to stop," he says. An FDA spokesman in Washington claims
officials did not hear about the clandestine trials until well
after they began.

    Without revealing the purpose, Project Inform asked
Genelabs, Inc., a California biotechnology firm that
manufactures the drug in the U.S., to test samples of Compound
Q that Corti brought back from China. They wanted to make sure
it was identical to the Compound Q used in the FDA-approved
study. An attorney drew up guidelines that would keep the trials
within federal law. Each patient made a videotaped statement,
in the presence of an attorney and a witness, that he was
entering the trial of his own free will. "What we wanted was a
trial that was faster than the FDA, yet as safe," says Dr. Larry
Waites of San Francisco.

    The trial's volunteers were all men who had failed to
respond to conventional AIDS therapy, including AZT, so far the
only FDA-approved drug for treating the AIDS virus. To obtain
accurate readings on Compound Q's effectiveness, volunteers were
asked to stop using any other approved or unapproved drugs.

    The secret trials began on May 24 in San Francisco. For
three weeks, patients received infusions of Compound Q, some as
high as 17 times the dosage given patients in the San Francisco
General Hospital toxicity trials. For the first 48 hours, the
carefully monitored volunteers suffered side effects of sore
muscles, nausea, fever and fatigue. The side effects eventually
went away, and many patients, including Bob Barnett, began to
feel more energetic.

    The clandestine study became public in late June after a
San Francisco volunteer suffocated on his vomit after coming out
of a coma ten days following his first dose of Compound Q. The
FDA launched an investigation into the underground trials,
which Project Inform suspended. Two other volunteers have since
died, one in San Francisco and one in New York. Levin says the
death of one of the San Francisco men was indirectly related to
Compound Q, while the cause of the New York man's death has yet
to be determined.

    Some researchers raise serious doubts about the methodology
of guerrilla drug tests. Project Inform is strongly criticized
for bypassing an initial phase to establish Compound Q's safety
before proceeding to larger, therapeutic dosages and for not
having the trials reviewed by an external monitoring group. Says
Jere Goyan, dean of the University of California at San
Francisco School of Pharmacy and a former FDA commissioner: "If
you get people taking these drugs willy-nilly around the
country, you'll lose valuable information, and it will be at the
expense of future patients."

    To Delaney, such reasoning is flawed because it suggests
that some victims who might be helped by experimental drugs may
die while the traditional methods of testing drugs work their
slow and cumbersome way. Pressure from AIDS activists has
resulted in the FDA's allowing wider use of such experimental
AIDS drugs as r-erythropoietin, which is used to treat
AIDS-related anemia, before studies have been completed.
Compound Q faces much more rigorous testing despite the hint of
promise. "It's not a one-shot cure," Delaney warned the packed
community meeting. But Bob Barnett, a true believer in his right
to receive another dose of Compound Q, leaped to his feet with
the rest of the crowd to give Delaney a standing ovation.