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AIDS activists remain wary of Serono Distrust comes as Serono pushes new use for treatment
  By Ross Kerber, Boston Globe Staff -- November 14, 2005
As the calamari arrived at their table in a restaurant overlooking San Francisco Bay, Hisham Samra wrote the number "50" on a piece of paper and slid it to Jeff Getty, a member of the AIDS activist group Act Up.
Samra, at the time president of Swiss drug maker Serono SA's Massachusetts unit, was proposing his company limit the cost of its experimental treatment to treat AIDS wasting to $50,000 a year. Getty said he talked Samra down to $36,000.
In return, Getty and other AIDS activists would help convince US regulators to approve Serostim.
That 1996 meeting became a milestone in Serono's work with the AIDS community, though not in the way either diner intended. Instead, AIDS activists say Serono violated its promise with aggressive sales tactics. Now the soured relations between the two threaten to haunt Serono as it tries to move forward with a new AIDS use for Serostim.
Those sales tactics, which included bogus tests designed to boost demand for the drug, resulted in patients' insurers paying far more than more than $36,000 a year for Serostim, the activists say.
They proved just as costly to Serono. In October, the company agreed to pay $704 million to state and federal officials to settle criminal and civil charges that it illegally promoted Serostim. In announcing the results of the investigation, Michael J. Sullivan, US attorney for the District of Massachusetts, said nearly 85 percent of prescriptions written for Serostim weren't necessary.
The settlement came as Serono seeks to have the FDA approve Serostim to treat an AIDS-related condition known as lipodystrophy. Some AIDS activists have said the bad blood with Serono won't necessarily influence what position they may take on any new uses for Serostim. But it's clear this vocal and influential constituency, which often weighs in with regulators on AIDS drugs, now doesn't trust Serono and will be skeptical of any new promises or clinical claims from the company.
"This is a company that will have a very hard time convincing people they're for real," said Terje Anderson, executive director of the National Association of People With AIDS, a large patient group.
The ongoing issue with the AIDS community also comes as Serono, Europe's largest biotech drug maker, last week said it is exploring options that could include a sale of the company.
Serono would not allow executives to be interviewed, and it declined to respond directly to the criticisms of Anderson and others. "All the allegations have been resolved," its general counsel, Thomas Gunning, said in a statement.
Since the meeting with Getty, Serono has replaced some US executives, including Samra, and set up a program to make sure it complies with federal rules. Samra could not be reached for comment. Gunning also said Serono has given away millions of dollars worth of free Serostim. Serono "remains committed to the AIDS community," he said.
Serostim, a synthetic human growth hormone, is given as an injection to promote bone and muscle tissue growth. Other biotech firms sell the same drug for non AIDS-related medical conditions. But a Serono study showed AIDS patients treated with Serostim could increase lean body mass by 3.5 pounds compared with a placebo, at a time when AIDS wasting often led to fatal organ failure.
With lobbying from Getty and other activists, the FDA approved the sale of Serostim in 1996 and gave Serono exclusive rights to market it for the treatment of AIDS wasting for seven years based on the strength of the study.
But just as Serono got Serostim approved, other drug companies were bringing to market protease inhibitors, a new class of drugs that dramatically improved the treatment of AIDS, and reduced the incidence of wasting. Serostim sales, which peaked at $137 million in 1999, fell to $89 million in 2003. Sullivan said Serono, faced with this threat from protease inhibitors, pushed hard to prop up sales of Serostim during this period.
Getty said after he helped Serostim win FDA approval later in 1996, he began receiving calls from friends whose insurance was being billed more than twice the $36,000 Serono had agreed on. Getty said he complained about the billings to Serono.
"Once they got the drug approved, they didn't care what anybody said," said Getty.
Another Serono critic was Gary Cohan, a Beverly Hills, Calif., physician who specializes in AIDS treatment. In interviews, Cohan said Serono sales representatives around 2000 offered to pay for each patient he would agree to enroll in a new clinical study of Serostim that he believed was mainly intended to boost the number of prescriptions written. He said he declined to cooperate and complained to Serono.
Cohan says Serono also gave him an electrical device to measure a patients' lean body mass to determine whether they would benefit from Serostim. As part of its pending settlement with federal and state authorities, Serono agreed to admit that some of these tests for body mass were unnecessary and the devices used software that wasn't approved by the FDA for that purpose.
The company has also agreed to admit that in 1999 it offered certain doctors free trips to a medical conferences in Cannes, France, if they prescribed certain amounts of Serostim. Both violations contributed to the unnecessary amounts of Serostim being prescribed, prosecutors said.
The resulting high costs remain a source of tension with the AIDS community, and the deal with prosecutors won't change the relationship, said Kevin Frost, vice president for clinical research at the American Foundation for AIDS Research in New York, a nonprofit scientific organization.
"Settlement or no settlement, I think the issues that have hung over Serono in its dealings with the community, I don't think that will change," Frost said.
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