Tuesday, November 07, 2006

California DoJ Investigates Big Pharma for Bribes

Will we see an investigation for questionable marketing practices in Ontario? Probably not. Will the Ontario Securities and Exchange Commission start investigating their arm of these big Pharma companies for giving monetary remuneration to health care providers who prescribe anti-psychotics when they shouldn't be prescribed just to increase their sales and their value on the stock market? Probably not.

The Ontario Securities and Exchange Commission, the Ontario Provincial Police or the RCMP didn't follow up on the YBM scandal (see post below) from the Russian mafia putting up a bogus company on the Toronto Stock Exchange to launder it's money that implicated a number of politicians. Ontario's municipal police forces don't even want to co-operate and take an information when it comes to obstruction of justice by the investigtors of the College of Physicians and Surgeons of Ontario so expecting the CPSO to monitor bribes given to doctors from big pharma's marketers or investigating conflicts of interest is a useless and futile act.

I'm not sure if you can believe that OHIP is actually investigating the psychiatry out patient research programs for diagnosis fraud at St. Joseph's Hospital in Hamilton. It's probably just lip service by the Ministry of Health.

The California Securities and Exchange Commission has requested documents from the makers of Zyprexa (Eli Lily) and Seroquil (AstraZeneca) to look at their marketing practices and selling drugs to people who shouldn't be on them, which should be investigated here in Ontario - particularly Hamilton.

Canada's big Pharma should be investigated in Ontario as well as the policitians and Colleges that turn a blind eye to members and non-members of Colleges who use psychological tests from California that diagnose mental illness without benefit of having Canadian norms or provinical standards of testing.

California's drug marketing doesn't vary from state to state so that should mean that it doesn't vary from the United States into Canada or Ontario either just as these the selling of these psychological tests don't vary.


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AP
California Investigates Anti-Psychotics
Friday November 3, 4:30 pm
By Peter Loftus, Dow Jones Newswires

California Investigates Marketing of Anti-Psychotic Drugs

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 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.

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November 03, 2006
Antipsychotic Marketing Investigation Broadens

Pfizer and Lilly have received subpoenas from the California attorney general related to antipsychotic promotional practices, the firms told "The Pink Sheet" DAILY.

Lilly, which markets Zyprexa (olanzapine), disclosed in a Nov. 3 Securities & Exchange Commission filing that the California AG subpoena, received in September, is "seeking production of documents related to our efforts to obtain and maintain Zyprexa's status on California's formulary, marketing and promotional practices with respect to Zyprexa, and remuneration of health care providers."

Geodon (ziprasidone) marketer Pfizer confirmed it had also received a subpoena in September from the California AG.

Lilly and Pfizer are the latest drug makers to come under scrutiny regarding antipsychotic promotional practices. The attorneys general for California and Alaska launched separate inquiries into AstraZeneca's marketing of schizophrenia and bipolar disorder treatment Seroquel (quetiapine) in September (1"The Pink Sheet" DAILY, Oct. 30, 2006).

Lilly's marketing practices for Zyprexa do not vary from state to state, the company told "The Pink Sheet" DAILY.

According to the SEC filing, Lilly has "implemented and [will] continue to review and enhance a broadly based compliance program that includes comprehensive compliance-related activities designed to ensure that our marketing and promotional practices, physician communications, remuneration of health care professionals, managed care arrangements, and Medicaid best-price reporting comply with applicable laws and regulations."

- Brooke McManus (b.mcmanus@elsevier.com)

Contents copyrighted C F-D-C Reports, Inc. 2006; protected by U.S. Copyright Law.

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2 Comments:

Anonymous Daniel Haszard said...

This is the kicker...Zyprexa is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.
So how the heck does Zyprexa get to be the 7th largest drug sale in the world?

Eli Lilly is in deep 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 7 states (and counting) going after Lilly for fraud and restitution.
--
Daniel Haszard

7/11/06 3:54 PM  
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14/1/10 12:06 AM  

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