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- <text id=89TT1767>
- <link 90TT0343>
- <link 90TT0175>
- <link 89TT2645>
- <title>
- July 10, 1989: Drugs From The Underground
- </title>
- <history>
- TIME--The Weekly Newsmagazine--1989
- July 10, 1989 You Bet Your Life:Pete Rose
- </history>
- <article>
- <source>Time Magazine</source>
- <hdr>
- MEDICINE, Page 49
- Drugs from the Underground
- </hdr><body>
- <p>AIDS patients are demanding -- and getting -- unproven potions
- </p>
- <p> 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.
- </p>
- <p> 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."
- </p>
- <p> 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.
- </p>
- <p> 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.
- </p>
- <p> 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.
- </p>
- <p> 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.
- </p>
-
- </body></article>
- </text>
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