Friday, April 18, 2008


St. Petersburg Times 
Drug research: To test or to tout?  
In the 1990s, drug companies trumpeted a new class of drugs, atypical antipsychotics: 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.  
By Robert Farley
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. 

Atypical antipsychotic drugs: left to right, ZyPREXA, SeroQUEL, ABILIFY and RISPERDAL.
[Martha Rial  - Times]
Atypical antipsychotic drugs: left to right, Zy prexa, Seroquel, Abilify and Risperdal

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.

• • •

Allen Jones knew the instant he was destined to be a whistle-blower. He says it was when his boss told him: "Quit being a salmon. Quit swimming against the stream with the pharmaceutical case."

It was a fluke that the case landed on his desk, and it was a fluke that he was even working in the office of the Inspector General in Pennsylvania.

Twice divorced, a single dad with custody of his kids, he had been swinging a hammer, doing rehab work on houses and flipping them. He figured signing on with the state would give him financial security and early retirement.

But life has a way of veering from script, and in 2002, he happened to draw a case where the state's chief pharmacist reportedly was earning money on the side — from a pharmaceutical company.

Jones learned that the chief pharmacist headed a government panel that would decide which drugs doctors should reach for first to treat severe mental illnesses in Pennsylvania. All of the drugs being touted as front-line were brand new, patented, and therefore exceptionally expensive. Yet some experts that Jones talked to said the new drugs were no better than the old ones.

"It didn't pass the smell test," he said. "There was too much opportunity for fraud."

He suspected that pharmaceutical companies promoting their new drugs were "buying off" state officials in positions to influence the prescription practices of doctors across Pennsylvania. Taxpayers were paying the freight for these high-priced drugs.

That's when Jones says his boss told him not to play the part of the salmon. Drop it, the politicians will never stand for a real investigation: "I was told point-blank, 'These pharmaceutical companies write checks on both sides of the aisle.' "

Jones ended up taking his concerns to the press. It wasn't long before a security guard escorted him from the building and into the ranks of the unemployed.


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