California investigates antipsychotic medications
Last Update: 6:11 PM ET Nov 3, 2006
(Updates to include Pfizer's receipt of subpoena in the sixth paragraph and adds comment from Lilly spokesman in the fourth paragraph.)
California's top law-enforcement official is investigating drug makers' marketing practices for blockbuster antipyschotic medications.
At least four pharmaceutical companies - AstraZeneca PLC (AZN), Eli Lilly & Co. (LLY), Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) - have disclosed in recent days they received subpoenas from the California attorney general's office seeking information about their respective antipsychotics. 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 antipsychotics, 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." Lilly spokesman Phil Belt said the company is cooperating with the request for information. AstraZeneca of the U.K. 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, Bristol-Myers' antipsychotic, spokesman Craig Stoltz told Dow Jones Newswires Friday. "Bristol-Myers is cooperating with the investigation." California's attorney general heads the state justice department.
Pfizer of New York also has received a subpoena from the California attorney general's office seeking information about the Geodon antipsychotic, spokesman Bryant Haskins told Dow Jones Newswires Friday. The company is cooperating fully with the request, which was received in September, he said.
Tom Dressler, a spokesman for the California attorney general, confirmed subpoenas were issued to AstraZeneca and Eli Lilly but declined to comment about other companies. 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.
The marketer of another leading antipsychotic, Johnson & Johnson (JNJ) of New Brunswick, N.J., couldn't immediately be reached.
Newer antipsychotics 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 (NVS) of Switzerland.
In another government-funded study, an older antipsychotic 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 received 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 antipsychotics 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.
Eli Lilly gets subpoena from Calif AG related to Zyprexa
Last Update: 11:26 AM ET Nov 3, 2006
DOW JONES NEWSWIRES
Eli Lilly & Co. (LLY) said Friday that it received a subpoena from the California Attorney General's office requesting documents related to the company's antipsychotic drug Zyprexa.
According to a filing with the Securities and Exchange Commission, the September subpoena specifically seeks documents in connection with the company's efforts to maintain Zyprexa's status on the state's formulary, marketing and promotional practices for the drug and remuneration of health care providers.
As reported last week, U.K. drug company AstraZeneca PLC (AZN) received a similar subpoena from the California Attorney General for its antipsychotic drug Seroquel.
2 comments:
Zyprexa 10 mg is the typical maximum dose.I heard/read that in 1998 Eli Liily sold a 50 mg tab.
I took it right off the bat in 1996 actually before that in hospital inpatient setting 'trial study'
Eli Lilly is in trouble for using their drug reps to 'encourage' doctors to write zyprexa for non-FDA approved 'off label' uses.
The drug causes increased diabetes risk,and medicare picks up all the expensive fallout.There are now 8 states going after Lilly for fraud and restitution.
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Daniel Haszard
It is hardly surprising that these things happen when those individual scientists who raise these problems are subjected to bullying and when the whistleblowers are shot. Small problems beget bigger problems. Some good articles are collated
here
http://honestmedicine.typepad.com/medical_watch/2006/12/ten_important_a.html
and
http://www.aaas.org/spp/sfrl/per/per46.pdf
Daryl
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