San Francisco Chronicle - The Voice of the West, 901 Mission Street, San Francisco, CA 94119 - 1 Mar 1996, p.B1
Carl T. Hall, Chronicle Staff Writer

Another drug company, Serono Laboratories Inc. of Norwell, Mass., claims to have assembled evidence that growth hormones can help reverse AIDS-related wasting -- one of the most common killers of people infected with HIV.

The problem, in which the body starts to burn lean-muscle tissue instead of fat for energy, arises in an estimated 15 percent to 40 percent of late-stage AIDS cases. It makes people more vulnerable to deadly infections, and is said to be a factor in nearly nine out of 10 deaths attributed to AIDS.

Today, a scientific panel advising the U.S. Food and Drug Administration is scheduled to take up Serono's application to launch full- scale marketing of its growth hormone, marketed as Serostim, in AIDS-related wasting cases.

The FDA is not bound by the recommendations of such panels but typically follows their advice. Approval is by no means certain, despite two rounds of late-stage clinical tests that appear to demonstrate the Serono drug works.

If the FDA does give the Massachusetts company a green light, it would amount to a stunning victory in a high-stakes clinical gamble that Genentech scientists thought they had already lost.

Genentech's growth hormone, marketed as Protropin and Nutropin, is virtually indistinguishable from Serono's. The two drugs differ mainly in how they are made.

Genentech scientists tried giving their hormone in combination with another drug, a growth factor called IGF-1, to 93 AIDS-wasting patients during clinical trials conducted during the early '90s.

That effort was abandoned in 1994. Tests showed some early weight gain, but the benefits vanished after the 12-week treatment.

"The results were negative. It was really disappointing," said Dr. Kip Martha, Genentech associate director of medical affairs.

One factor may have been the dose: Fearing side effects, Genentech administered a much smaller amount of growth hormone than was used in Serono's trials. Patients in Genentech's study also may have differed in several respects from those in the more recent studies. Martha said a full comparison has yet to be made.

Martha declined to make any predictions on Serono's prospects. However, based on published data, he said "it does look encouraging."

If the FDA approves Serono's drug, Genentech can't automatically begin marketing its own human growth hormone as an AIDS- wasting weapon. Instead, it would need to do its own clinical trials and also prove why it failed the first time.

Growth hormone has long been a standard therapy for hormone- deficient children. Experts said it's not clear that the hormone actually benefits most AIDS patients, despite widespread interest.

Bill Thorne, a member of the San Francisco group ACT UP Golden Gate who has been pushing for wider access to growth hormone, said it rejuvenated his lover, Ronald Nemeth, enough to allow a vacation abroad in 1994.

"In December (1993) he was bedridden and paralyzed," Thorne said. Six months later, after experimental treatment with Serono's growth hormone, "he was able to go to the Mediterranean and walk through Pompeii." But Nemeth subsequently died of other AIDS- related complications.

Brenda Lien, director of information and advocacy at Project Inform in San Francisco, said she knows of some people who have had "phenomenal success" with the drug and some "who have showed no benefit."

Serono filed its marketing application based partly on a late- stage clinical study conducted in 1993. The study, directed by Dr. Morris Schambelan, a top endocrinologist at the University of California at San Francisco, showed an average gain of 6.6 pounds of lean- body weight, and a loss of 3 pounds of fat, among 178 patients given the growth hormone. A control group on placebo showed little or no change in weight or body composition.

Still, some doctors maintain the jury is still out on the key question: whether the growth hormone actually can prolong survival.

"It's very clear that growth hormone can help patients put on lean-body mass," said Dr. Donald Abrams, assistant director of the AIDS program at San Francisco General Hospital. But he said an additional study is needed to gauge survival benefits.

Another issue is cost.

Even under a cut-rate early-access program for Serono's hormone, the drug sells for $150 a day. Daily shots would be required for at least three months in the initial stage of treatment, followed by an ongoing maintenance program.

Nevertheless, about 800 patients already have been given the drug under the early-access program, launched under heavy pressure from advocacy groups in December 1994.

Medi-Cal, the main California insurance program for the indigent, and similar programs in nine other states have agreed to reimburse 85 percent of the drug's cost on average.

That is viewed as a vote of confidence in growth hormone for AIDS-related wasting.

"People have benefited from it," said Kathy Mulligan, an assistant professor and co-director of the growth hormone studies at UCSF. "We have been giving it to some people for upwards of three years with no alarming side effects."
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