In November, a federal judge recommended that as many as 6,000 lawsuits against drug giant AstraZeneca for the ill effects of the company’s anti-psychotic Seroquel should be returned to their home state courts for trial. Seroquel, the company’s second-best selling drug with annual sales of $4.45 billion, is notorious for the company’s cover-up of data from clinical trials showing potentially harmful effects from the drug, including diabetes, weight gain, stroke and death.
Just days before the judge’s order, an independent review commissioned by the British government found severe side effects, including stroke and death, suffered by people with dementia when taking Seroquel and other anti-psychotics. In response to the report, the UK government stated, “There is inevitably an element of risk with the prescribing of any medication. However, there is clear evidence that anti-psychotic drugs are currently being over prescribed, when alternative non-pharmacological approaches to dealing with anxiety and behavioural problems are available and should be used.” The report found that only about 20% of dementia patients prescribed antipsychotics receive any benefit from the risky drugs.
A recent Chicago Tribune report found that Illinois nursing homes were cited for thousands of cases in which elderly residents who exhibited no symptoms of psychosis were improperly dosed with Seroquel and other antipsychotics. AstraZeneca paid one Chicago-area psychiatrist nearly $500,000 over a decade for establishing a customer base of thousands of indigent, mentally ill residents in Chicago-area nursing homes.
The litigation against AstraZeneca has exposed a litany of company misdeeds around Seroquel:
- AstraZeneca covered-up knowledge that use of Seroquel could lead to severe weight gain and diabetes. A New York Times report noted the company’s fraudulent interpretation of studies to minimize the risk began as early as 1997, and noted a 1999 email from a company executive who asked, “…how do we face the outside world when they begin to criticize us for suppressing data.” One expert has stated that the risk of diabetes for people on Seroquel is 70 percent greater than for the general population.
- AstraZeneca engaged in illegal off-label promotions of Seroquel, and company documents suggest that questionable marketing was approved at the highest levels. In one off-label scheme, sales staff were told to use Winnie-the-Pooh characters (Tigger as bipolar, Eeyore as depressed) in order to market the psychiatric drug for pediatric patients. As theNew York Times noted, “As a result of aggressive marketing, Seroquel has been increasingly used for children and elderly people for indications not approved by the Food and Drug Administration.” Also, a company employee appears to have altered the wikipedia entry for Seroquel, deleting a National Institute of Health warning that teens taking the drug could be prone to suicide. In late October, the company paid $520 million to settle two lawsuits and two federal investigations of illegal promotions of Seroquel.
- AstraZeneca covered-up a company study showing that Seroquel performed worse than several other drugs; two months after the company learned of the study findings, a doctor paid by the company presented the data at a medical conference as showing Seroquel to be “more effective” than the other drugs.
- The company’s medical director for Seroquel admitted to lawyers in 2007 that he hadnumerous sexual relationships with women involved in clinical research on the drug, and traded sex for trade secrets.
The recent problems are only the latest in a string of AstraZeneca misdeeds. AstraZeneca was one of three drug makers found guilty in 2008 of defrauding Medicare by overcharging for drugs and encouraging doctors to prescribe their products over competitors through pricing that rewarded the physicians for prescribing certain drugs. Former New England Journal of Medicine editor Marcia Angell has charged that the company’s clinical trials of its top-selling drug Nexium were rigged to show greater efficacy than a cheaper competing product. In 1996, aBusiness Week cover story exposed “dozens of cases” of women who accused then-CEO of Astra USA Lars Bildman and other top executives with sexual harassment. One male sales manager told the magazine, “If ever there was a company where sexual harassment was rampant, this is it.”
In 2008, AstraZeneca CEO David Brennan took home over $2.5 million.
http://corporatecrime.wordpress.com/2009/12/03/astrazeneca-tales-of-a-deadly-drug-pusher/
1 comment:
In an FDA advisory committee hearing on using Seroquel in children there was a dramatic and sustained increase in heart rate and blood pressure. This is especially concerning as half the children were also on stimulants yet significant increases in HR and BP occurred on addition of Seroquel. Even though this was a 3 week study and the exposures in children are much higher than in adults in the FDA request for pediatric studies the FDA reviewer had recommended that NO long term safety data was needed. It's noteworthy that FDA documents indicate this reviewer was promoted within a day or two of making this recommendation.
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