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 for outsized profits, the drug companies were undaunted by the FDA's red light.

Prohibited from touting their drugs as better? No problem. They paid academics and doctors who said it for them.

The companies funded study after study that found — little surprise — the new drugs were better and safer. State by state, the companies funded committees that set treatment guidelines that decreed atypicals should be the drugs of choice.

Despite the FDA ostensibly reining them in, the drug companies remade the marketplace.

Atypicals have become the overwhelming drug of choice, and not just for schizophrenia and bipolar disorder, the crippling illnesses they were approved for. Doctors commonly prescribe them to treat anxiety, depression and ADHD in children. They're even given as sleep aids.

The new drugs can cost 20 times as much as the old, so taxpayers pay a small fortune in Medicaid expenses. In Florida alone in the past five years, taxpayers spent more than $1.1-billion on the new antipsychotic drugs.

The drug companies, meantime, enjoy billions in profits.

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Education

Tags:

• florida
• ahca
• abilify
• geodon
• risperdal
• seroquel
• zyprexa
• atypical
• antipsychotics
• antipsychotic

[DannyHaszard]

Eli Lilly Zyprexa suits

They called it the *Five at Five* (5 mg at 5 pm to keep nursing home patients subdued and sleepy) and *VIVA ZYPREXA* (Zyprexa for everybody) campaigns to off label market Eli Lilly Zyprexa as a fix for unapproved usage. Big Pharma companies that have relied on fraud to market industry's worst pharmaceuticals--antipsychotic drugs--which have become industry's most profitable cash cow. ---

Daniel Haszard Zyprexa victim activist