TIME: Almanac 1990/1990 Time Magazine Compact Almanac, The (1991)(Time).iso/time/071089/07108900.003

Text File | 1990-09-17 | 4KB | 67 lines

MEDICINE, Page 49

Drugs from the Underground

AIDS patients are demanding -- and getting -- unproven potions


    As the AIDS epidemic progresses, the disease is doing more than
snuffing out individual lives. The virus is attacking the
all-important system the U.S. uses to test new drugs. Under
pressure from AIDS activists, the Food and Drug Administration
announced last week that it would allow wider use of two
experimental drugs before rigorous clinical trials have
conclusively established the value of these medications. AIDS
patients hailed the decision, but it set precedents that could
weaken the scientific safeguards that have long protected the
desperately ill from quack remedies.

    Even as the FDA was easing its rules, AIDS sufferers were still
searching for a cure on the black market for unapproved drugs. It
was revealed last week that an underground network of doctors in
four cities has been conducting a clandestine trial of a drug known
as Compound Q. In test tubes, it can destroy cells infected with
the AIDS virus, but it has not yet been proved to be safe and
effective in humans. In the unofficial trial, 42 patients have
received Compound Q, which is derived from a Chinese cucumber-like
plant. Among those taking the drug is Robert Pitman, 48, of San
Francisco. Says he: "I was prepared to get it however I could. I
was desperate enough that I would have injected it in my own living
room."

    The secret study, organized by a San Francisco-based group of
AIDS activists called Project Inform, came to light after one of
the patients died. He went into a coma, later awoke but then choked
while vomiting -- ten days after his first Compound-Q treatment.
The FDA has launched an investigation of the study.

    The Compound-Q affair has heightened concern about the
widespread use of unproven drugs. "There is always a tension
between treatment of a patient and the need for solid drug
testing," says Dr. Frank Young, the FDA commissioner. But AIDS has
increased that tension. Those with the disease have protested for
years that the FDA's traditional methods of testing an experimental
drug's safety and effectiveness were too slow. "People have lost
faith in the system," says Richard Dunne, executive director of
Manhattan's Gay Men's Health Crisis.

    Beginning in 1984, the FDA permitted the Syntex pharmaceutical
firm to give doctors free ganciclovir, a drug used to treat eye
infections that frequently blind AIDS patients, under a special
program that allows "compassionate use" of unproven drugs. Doctors
who have dispensed the drug are convinced that it works, but all
the conventional controlled studies have not been done.
Nonetheless, the FDA last week approved ganciclovir for full
marketing and sales. The agency also gave the go-ahead for wider
distribution of another unproven drug, erythropoietin, which is
used in cases of AIDS-associated anemia.

    Although FDA officials dispute the notion, some experts are
concerned that the use of unproven medications may be getting out
of control. So many AIDS patients are taking a pharmacological stew
of approved and experimental drugs and potions that it is difficult
to gauge the effectiveness of any single drug. Underground studies
of experimental drugs, like the Compound-Q effort, confuse an
already complex situation and frustrate scientists. "They're
violating all the standards of safe testing of new compounds," says
Dr. Paul Volberding, an AIDS specialist at the University of
California at San Francisco. The haphazard use of experimental
drugs may help some AIDS patients in the short run, but it will
slow down the quest to discover the best ways to treat the many
people who will contract the disease in the future.