FDA Chief Warns of False Hope on AIDS Drugs

Federal health officials at a Senate hearing Wednesday answered criticism that their agencies are moving too slowly to make experimental drugs available to AIDS patients, and one predicted that “frighteningly few” AIDS drugs will be available in the future because most will be proven worthless or toxic.

Dr. Frank E. Young, commissioner of the Food and Drug Administration, which has come under bitter attack from gay rights groups, told Sen. Edward M. Kennedy (D-Mass.), chairman of the Senate Labor and Human Resources Committee, that by 1991 only one or two of about 320 compounds expected to be tested “will result in successful therapies.”

He projected that testing of an estimated 520 substances now thought to have potential will result in development of only five or six effective products by 1995, and that, by the year 2000, perhaps nine or 11 useful compounds would be derived from 720 experimental products.

Thus, Young said, it would be “a tragedy” to make experimental drugs widely available before they are thoroughly tested, because most of them ultimately will be shown to be ineffective or risky.

Wary of ‘False Hope’

“While we do not want to deprive people of hope, we also do not want to generate or perpetuate the false hope of a worthless product,” he said.

Last year, the FDA announced an expedited system for making experimental drugs more accessible to desperately ill patients, but only after “a reasonable body” of safety and efficacy could be demonstrated. Young said that under the new system, 178 substances are in various stages of human testing. These include 39 antiviral drugs, three vaccines and 34 drugs to treat the opportunistic infections that characterize acquired immune deficiency syndrome and eventually kill most AIDS patients.

Azidothymidine, or AZT, is so far the only antiviral drug licensed to treat AIDS. It was approved for marketing in March, 1987, after only 3 1/2 months, compared to the two years or longer the drug approval review process typically takes, Young said. Later, AZT was used as the model in drafting the new regulations, Young said.

Nevertheless, the FDA has been criticized in recent months, mostly by gay rights groups hit hard by the epidemic, who believe that AIDS patients should have the choice of taking experimental or risky drugs--even if the chances they will be effective are slight.

Free Choice Urged

“If there is even a chance that a candidate AIDS therapy could be useful--that it might buy a few months of extra life for certain people with AIDS--we cannot afford to ignore it,” said Dr. Barry Gingell, director of medical information for the Gay Men’s Health Crisis in New York.

Of the FDA’s revised regulations, he said the review process for new drugs is still too slow.

Gingell, who has AIDS, added: “The FDA’s well-meaning gesture has backfired. If it has done anything, it has falsely and cruelly raised the hopes of people with AIDS. Facing AIDS is tough enough. It is no act of kindness to tell us that help is on the way when the reality is nothing has changed at all.”

Kennedy said he thought the agency should “get (AIDS drugs) out and get (them) into people.” He said he is “worried that there may be mixed messages going to terminally ill patients (who now) feel let down.”

AIDS is caused by a virus that destroys the body’s immune system, leaving it powerless against certain cancers and otherwise rare infections. It also can invade the central nervous system and cause severe neurological disorders. It is commonly transmitted through sexual intercourse, through the sharing of unsterilized hypodermic needles and from mother to fetus.

In the United States, AIDS primarily has afflicted homosexual and bisexual men, users of intravenous drugs and their sexual partners. As of Monday, 67,273 Americans were known to have contracted AIDS since 1981, of whom 37,974 had died.