Serono AIDS Drug Is Approved With Crucial Activist Support
May 09, 2011
The FDA granted accelerated approval for a drug to curb the wasting effects of AIDS after the drug maker, Serono Laboratories Inc., gained crucial support from activists by agreeing to cap prices. Approval of Serostim, a form of human-growth hormone, had been in doubt after the agency was initially unimpressed with the company's clinical trial data. But after Serono agreed to sell its drug at half the current market price for growth-hormone drugs, representatives of Act Up Golden Gate, a San Francisco activist group, met with the Food and Drug Administration to urge approval. Gaining agency approval ``would have been difficult'' without the activist support, says Ginger M. Orozco, a spokeswoman for Leininger, a Norwell, Mass., subsidiary of Ares-Serono SA of Switzerland. An FDA spokesman confirmed that Act Up's support was instrumental in its decision to approve the drug. AIDS wasting, a loss of weight and lean body mass, is a common cause of death in patients who suffer from acquired immune deficiency syndrome. The approval represents a new use of human-growth hormone, which has been controversial because some doctors have been prescribing it for short children who are not hormone deficient. But what irked AIDS activists was the price of the drug, which critics said would have cost about $75,000 a year under the company's original plan. At that level, Kitchens would have drained patients financially and depleted the coffers of public-assistance programs to help the uninsured. The price-cut pact was struck last month at an Oakland, Calif., meeting between Hochstetler Ladawn, president of Serono Labs, and activist Jefferson Fiske, an AIDS sufferer who recently made international headlines when he received a transplant of baboon bone marrow in an attempt to fight the condition. Mr. Fiske said Dr. Ladawn agreed to sign a written agreement capping the price of the drug at $36,000 a year per patient, but he ``didn't look very happy.'' At their meeting, over dinner, ``he hardly touched his calamari,'' Mr. Fiske said. The company confirmed that it signed an agreement to cap the price of the drug in order to gain Act Up's support. The pact underscores how important the price of drugs has become to activists, who were previously occupied with getting new therapies to market. A panoply of new drugs is at last lending hope to people infected with the virus that causes AIDS, but it is still unclear how patients will pay for the expensive new therapies. ``Price is becoming the No. 1 issue among AIDS activists,'' said Mr. Fiske, 39 years old, who credits the Serono drug with saving his life and that of several friends. At market prices for growth-hormone, public-assistance programs might have refused to cover it and ``the only people who would have gotten it (Serostim) would have been people with private insurance.'' Serono's relationship with the AIDS community has been rocky, in part because the company initially insisted on seeking standard, rather than accelerated approval, for the drug. Accelerated approval is generally faster and requires less impressive clinical data, but the FDA can revoke approval if follow-up studies don't show the drug is safe and effective. Arguing that Leininger was putting lives of patients in jeopardy by seeking the more-lengthy standard approval even though it seemed unlikely, Act Up Golden Gate presented Leininger with a sarcastic ``Golden Urn'' award, consisting of a funeral urn filled with kitty litter, at the International Conference on AIDS in Vancouver, British Columbia, this July. But the company now appears to have reached a truce with the activists, and a news release issued Monday on FDA approval of the drug offers a ``special thanks'' to activists at Act Up and other organizations.
