Healthy Skepticism Library item: 6411

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Publication type: news

Loftus P.
California Investigates Marketing of Anti-Psychotic Drugs
Dow Jones Newswires 2006 Nov 3

Full text:

PHILADELPHIA (AP) — California’s top law-enforcement official is investigating drug makers’ marketing practices for blockbuster anti-psychotic medications.
At least three pharmaceutical companies, AstraZeneca PLC, Eli Lilly & Co.
and Bristol-Myers Squibb Co., have disclosed they received subpoenas from the California attorney general’s office seeking information about their respective anti-psychotics. The drugs are approved to treat bipolar disorder and schizophrenia.

Eli Lilly, which makes Zyprexa, and AstraZeneca, maker of Seroquel, indicated that the subpoenas received in September sought information about their marketing practices for the anti-psychotics, as well as the drugs’ status on California’s “formulary,” or list of preferred drugs for a state insurance program.

Lilly of Indianapolis said in a regulatory filing Friday its subpoena was related to “our efforts to obtain and maintain Zyprexa’s status on California’s formulary.” Also, Lilly said the subpoena concerned “remuneration of health care providers.” AstraZeneca of the Britain disclosed its subpoena in a document posted on its Web site last week.

New York-based Bristol-Myers “has received a subpoena from the California state Department of Justice seeking documents in connection with Abilify,”
spokesman Craig Stoltz told Dow Jones Newswires Friday. “Bristol-Myers is cooperating with the investigation.” California’s attorney general heads the state justice department. Additional details including the timing or exact nature of Bristol’s subpoena weren’t immediately available.

Tom Dressler, a spokesman for the California attorney general, confirmed subpoenas were issued to AstraZeneca and Eli Lilly but declined to comment about Bristol-Myers. He said the office is “trying to get more information about the marketing of these specific products and their status on the Medi-Cal formulary,” referring to the state insurance program.

Marketers of other anti-psychotics, including Johnson & Johnson of New Brunswick, N.J. and Pfizer Inc. of New York, couldn’t immediately be reached.
Newer anti-psychotics have become big moneymakers for drug companies, with Zyprexa posting $4.2 billion in sales and Seroquel generating $2.76 billion last year. Abilify, a newer drug, posted sales of $912 million in 2005.

But the drugs also have faced scrutiny over their effectiveness and safety.
One government-funded study released earlier this year found that an older drug, clozapine, was more effective in treating certain patients with schizophrenia than three newer drugs: Zyprexa, Seroquel, and J&J’s Risperdal. Clozapine is sold under the brand Clozaril by Novartis AG of Switzerland.

In another government-funded study, an older anti-psychotic called perphenazine was found to have similar effectiveness to three newer ones:
Risperdal, Seroquel and Pfizer’s Geodon. This study showed Zyprexa to be more effective than the other drugs, but also linked it to more weight gain and higher blood sugar.

Last year, Lilly established a $690 million fund to settle lawsuits that generally alleged Zyprexa led to diabetes or related problems in people taking the drug. The company said the claims were without merit.

J&J has previously inquiries from federal investigators over its marketing of Risperdal, according to regulatory filings. J&J said it was cooperating and responding to the subpoenas.

More recently, a study concluded there was little benefit of using anti-psychotics to treat symptoms of Alzheimer’s disease, despite the relatively common practice of doctors prescribing the drugs for that use.

AstraZeneca said last week it’s in the initial stages of responding to the California request for information, but a spokeswoman declined further comment.
Lilly indicated in its regulatory filing it couldn’t predict the outcome of the matter, and that it could hurt the company’s financials. A Lilly spokesman couldn’t immediately be reached.