Florida Medicaid Antipsychotics 1

A St. Petersburg Times special report Drug research: To test or to tout? By Robert Farley, Times Staff Writer April 13, 2008 In the mental institution in One Flew Over the Cuckoo’s Nest, Nurse Ratched is obsessed with keeping order on the ward. She dispenses pills that sedate the residents into near zombies. The novel was published in the 1960s, when Haldol and Thorazine were the drugs of choice to fight schizophrenia. They calm patients but also can cause uncontrollable shakes. In the 1990s, drug companies trumpeted a new class of drugs, atypical antipsychotics, that they billed as a dream solution: better treatment, fewer shakes. They wanted the Food and Drug Administration to let them say their drugs were safer and more effective than Haldol. But the FDA said no, because the drug companies had submitted biased studies, according to documents obtained by the St. Petersburg Times. It happened when Eli Lilly and Co. asked for approval of Zyprexa, and again when Janssen asked for approval for Risperdal. The FDA said Risperdal could come to market. But there was a caveat: “We would consider any advertisement or promotion labeling for Risperdal false, misleading or lacking fair balance … if there is a presentation of data that conveys the impression that (Risperdal) is superior to haloperidol (generic for Haldol) or any other marketed antipsychotic drug product with regard to safety or effectiveness.” Believing they had invented better drugs, not to mention the opportunity …
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