AIDS Drug Still Spurs Debate; But It Was Seen As 1990s Panacea

By Julie Jette; JULIE JETTE

The Patriot Ledger

The $704 million settlement between drug company Serono and federal prosecutors announced this week involves a drug for treating AIDS that has faced controversy for more than a decade.

Serostim, a form of human growth hormone, is used to treat AIDS wasting, a potentially deadly AIDS-related syndrome in which patients lose a significant amount of their lean body mass.

Because it can increase muscle mass and reduce fat, it has also been used illegally by body builders.

But at one time it was viewed as a life-saver: AIDS activists fought hard for expedited approval of Serostim in the early-1990s, when few AIDS drugs were available and many patients were dying of wasting.

“At the time the FDA approved Serostim, AIDS wasting was an AIDS- defining syndrome and the leading cause of death for people with AIDS,” said Renee Connolly, a spokeswoman for Serono, a Swiss biotech company with U.S. headquarters in Rockland. The FDA followed its 1996 approval with a confirmatory approval in 2003 after Serono conducted a more extensive study. Some of those same activists who fought for Serostim’s early approval were later critical of the company’s pricing for the drug – a 12-week course can cost up to $21,000. Soon after Serostim hit the market, a more powerful blend of drugs known as an “AIDS cocktail” also became available, reducing demand for Serostim.

Among the whistle-blowers who helped federal prosecutors gather enough evidence to draw a guilty plea was the AIDS Health Care Foundation of Los Angeles, dedicated to helping people with AIDS.

Tom Myers, general counsel for the foundation, said it decided to get involved because of the large amounts of Medicaid funds that were being directed toward Serostim, funds his organization felt would be better directed toward other AIDS drugs.

“We knew from the get-go that fortunately the syndrome that Serostim was approved for was pretty much a non-factor if people were compliant with their treatment,” Myers said. “This is all limited taxpayer dollars that was being used for a completely unnecessary drug.”

Federal prosecutors claim that as many as 85 percent of Serostim prescriptions were unnecessary. They say that Serono’s sales force bribed doctors with trips to generate prescriptions, used instruments designed to generate phony test results, and gave kickbacks to pharmacies that helped push the drug.

As part of the settlement, Serono plans in December to enter a guilty plea for two counts of criminal conspiracy, but company officials and other AIDS activists say that Serostim remains a critical drug in the arsenal of tools used to fight AIDS.

Matt Sharp, director of treatment education for the Test Positive Aware Network of Chicago, participated in one of the first trials of Serostim.

In the 1980s and early 1990s, he said “wasting was a really significant problem, people were dropping dead of it.”

He said a late colleague, Bill Thorne, discovered a medical paper about the potential of human growth hormone to treat it.

“He looked at that and followed up with (Serono),” and helped convince the company to start testing the drug, Sharp said.

“We worked closely with the investigators, helped develop the trial, and many of us, including me, were involved in that trial,” Sharp said.

Sharp said the drug helped keep him alive until he was able to begin taking the “AIDS cocktail” combination of drugs that has helped many HIV-positive patients forestall AIDS symptoms.

“It was basically a stair-step for me, buying time,” he said.

For Serono, the advent of the AIDS cocktail meant a decrease in demand for Serostim, because fewer patients developed the wasting syndrome.

Sharp, 49, who said he is now in good overall health, has continued using the drug. He said he is using it to fight lipodystrophy, a condition in which HIV-positive people gain fat around their midsection.

Sharp said the tendency for some HIV patients to gain the weight is related to the drugs they take to fight the virus.

Part of Serono’s civil settlement, however, involved payment to settle claims on the government’s part that Medicaid should not have been paying for Serostim to treat lipodystrophy. Serono is currently in a late-stage clinical trial to determine whether Serostim is effective in combating a form of lipodystrophy that’s associated with HIV patients.

If the FDA approves the use, Serono will be able to receive payments when doctors prescribe it for that condition.

Sharp said that even with the AIDS cocktail, AIDS wasting has not disappeared. Some patients do not easily tolerate the AIDS cocktail drugs, others have drug-resistant forms of the disease, and patients who are late to seek testing and treatment often appear at doctors’ offices already suffering from wasting. However, Sharp said, “we certainly don’t see it like it was.”

Julie Jette may be reached at jjette@ledger.com.