Posts Tagged ‘$520 million’

Oh That? Seroquel Marketing Undeterred by This Week’s Deceptive Marketing Settlement

Tuesday, March 15th, 2011

OpEdNews  March 15, 2011

by Martha Rosenberg

Google the word “depression” and the first search result you’ll get is for the antipsychotic Seroquel XR.

Visit WebMD and the home page hosts similar ads for Seroquel XR, above and adjacent to the lead news story.

Who would know AstraZeneca inked the largest multi-state consumer protection settlement on record relating to deceptive Seroquel marketing just this week? For $68.5 million? Only a year after inking a similar settlement related to burying side effect and safety information for $520 million with the government?

Who would know AstraZeneca has already settled nearly 25,000 personal injury lawsuits pertaining to Seroquel with more to come says ABC news?

First approved in 1997, Seroquel has enjoyed the camel-nose-under-the-tent phenomenon known as indications creep. First approved for schizophrenia, it was later approved for bipolar disorder and psychiatric conditions in children. But it was Seroquel’s 2009 approval as an add-drug for depression that helped it reach its spectacular sales of $5.3 billion in 2010 thanks to the US’ walloping depression “market” of 20 million.

Seroquel’s blood sugar, weight gain and heart side effects are well known. That’s why FDA regulators opposed its use as a first choice, stand-alone treatment for the 10 percent of the US population with depression when safer drugs exist. “I saw no clear advantage demonstrated in efficacy,” said Dr. Wayne Goodman who chaired the FDA panel considering the depression indication. “There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug.”

The drug also can cause increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, cataracts, seizures, increases in blood pressure and movement disorders in neonates when their mothers take it.

Seroquel’s fraud trail is also well known with more than six conflict of interest scandals swirling around Seroquel researchers and promoters. Psychiatrist Richard Borison was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme which helped establish Seroquel’s original perception as safe.

But how many realize Seroquel’s cost to the individual taxpayer and health insurance consumers at a Red Book price of almost $500 per month per person?

Auditors with the Michigan Corrections Department say the state could save $350,000 a month by switching just half of its Seroquel prescriptions to another pill. (Anyone know a school that could use $350,000 a month?) And North Carolina spends $29.4 million per year on Seroquel prescriptions. Who knows how much else states and taxpayers are paying to control the metabolic side effects that emerge with Seroquel?

Reports are also starting to surface about the effect $6,000-a-year Seroquel prescriptions, many unnecessary and inappropriate, are having on rising insurance premiums themselves for private insurance holders.

In fact, the public is really paying twice for the irrepressible Seroquel marketing. First for drug purchases in state and private plans (and the advertising) and second in side effects from a drug whose safety continues to be in doubt.

http://www.opednews.com/articles/Oh-That-Seroquel-Marketin-by-Martha-Rosenberg-110315-836.html

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AstraZeneca paying $68.5M to settle off-label marketing charges for anti-psychotic Seroquel

Thursday, March 10th, 2011

ABCNews.com

by Matthew Perrone AP Health Wire, March 10,  2011

Thursday's deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

AstraZeneca will pay $68.5 million as part of a multistate settlement over allegations that the drug developer promoted its blockbuster psychiatric drug Seroquel for insomnia, Alzheimer’s and other unapproved uses.

The New Jersey Attorney General’s Office announced the agreement Thursday, describing it as the largest multistate pharmaceutical settlement of its kind. New Jersey will receive $1.85 million from the deal with 36 other states and the District of Columbia as party to the settlement.

The states alleged that salespeople for AstraZeneca promoted its anti-psychotic Seroquel for off-label, or unapproved uses, and did not disclose side effects of the pill, which include weight gain and muscle spasms.

“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas Calcagni, acting director of New Jersey’s division of consumer affairs.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, though the majority prescriptions are for off-label uses like insomnia. The drug, approved in 1997, is AstraZeneca’s second-best-selling product, with U.S. sales of $5.3 billion last year. But that success has been marred by frequent allegations that the company illegally marketed the drug and downplayed its risks.

Seroquel’s side effects, including blood sugar increases, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits from patients. The drugmaker had settled nearly 25,000 personal injury lawsuits related to Seroquel at the end of 2010, with 3,950 remaining.

Pharmaceutical companies are prohibited from marketing drugs for unapproved uses, though doctors are free to prescribe them as they choose.

London-based AstraZeneca denied any wrongdoing.

“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” said company spokesman Tony Jewell, in a statement.

Thursday’s deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

The new settlement stemmed from a separate three-year investigation led by the Attorney General of New Jersey. As part of the agreement AstraZeneca must publish any gifts or payments to physicians on a public website. The company also agreed to make sure that payment incentives to sales representatives do not encourage off-label promotion.

Allegations of off-label drug marketing have become increasingly common in the past decade, with the drug industry eclipsing all others as the source of fraud-related settlements with the federal government. Approximately 80 percent of the $3.1 billion in penalties collected last fiscal year by the government came from the health care sector, including drugmakers, insurers and hospitals, according to Taxpayers Against Fraud.

http://abcnews.go.com/Business/wireStory?id=13105486

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Antipsychotic Drug Seroquel— Diabetes Lawsuits Hurt AstraZeneca Profits

Monday, November 8th, 2010

LawyersandSettlements.com, November 7, 2010

by Heidi Turner

Among Seroquel side effects is a reported increased risk of Seroquel diabetes.   Lawsuits alleging patients suffered serious Seroquel side effects reportedly hurt AstraZeneca’s third-quarter results.

Seroquel Diabetes Lawsuits Hurt AstraZeneca ProfitsAccording to the UK Press Association, AstraZeneca set aside $203 million to resolve approximately 18,000 claims in the US that Seroquel, a schizophrenia treatment, caused diabetes and other serious Seroquel side effects. A further $270 million was reportedly put aside for other claims and to cover AstraZeneca’s legal costs.

In August 2010, AstraZeneca said it settled approximately 17,500 lawsuits alleging Seroquel caused diabetes and other injuries for approximately $200 million. The lawsuits alleged the drug maker failed to adequately warn patients about the drugs’ risks.

Further eroding AstraZeneca’s profits are the effects of generic competition.

According to the San Francisco Chronicle (10/28/10), AstraZeneca reported net income of $1.55 billion in the third quarter, compared with $2.12 billion in the same quarter in 2009. The Wall Street Journal (08/10/10) reports worldwide sales of Seroquel reached almost $5 billion in 2009.

Meanwhile, an advocacy group called Taxpayers Against Fraud Education Fund alleges that the pharmaceutical industry is the number one source of Department of Justice (DOJ) fraud-related settlements. Number one on the list of pharmaceutical companies to settle with the DOJ was Allergan Inc., which paid $600 million to settle allegations of illegal marketing of Botox.

Second on the list was AstraZeneca, which paid approximately $520 million for the alleged illegal marketing of Seroquel.

Marketing of drugs is not illegal. What is illegal is marketing drugs for uses that have not been approved by the US Food and Drug Administration (FDA). Although Seroquel is approved to treat schizophrenia and bipolar disorder, it is not approved for use as a sleep aid, or to treat post-traumatic stress disorder or obsessive-compulsive disorder. It is also not approved for use in children younger than age 10, according to the US FDA-approved medication guide.

A study published online in BMJ (09/22/10) suggests that Seroquel is linked to an increased risk of blood clots. According to the study, of the patients included who were diagnosed with venous thromboembolism (VTE), 8.3 percent had received an antipsychotic medication in the two years prior to diagnosis, compared with 5.3 percent of those not diagnosed with VTE. The highest risk of VTE was found in patients who took quetiapine (known by the brand name Seroquel).

http://www.lawyersandsettlements.com/articles/15347/seroquel-side-effects-diabetes-16.html

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BNET: ‘The Dog Ate AstraZeneca’s Homework! Evidence on Misleading Drug Ad Disappears From Company’s Files’

Wednesday, July 7th, 2010

BNET
By Jim Edwards
July 7, 2010

AstraZeneca (AZN) says it has lost a crucial internal document that would explain how an ad for its antipsychotic Seroquel misleadingly claimed there was “no weight gain” with the drug and described its “favorable weight profile.” But the company admits it kept the six-year-old envelope that once allegedly contained the ad’s approval certificate, according to a ruling by the U.K.’s Prescription Medicines Code of Practice Authority.

The drug industry watchdog also alleges AZ’s Seroquel management team “pressured and manipulated” executives around them in order to make sure negative data on Seroquel was buried. The PMCPA ruled that AZ had breached its code of practice, which requires companies to operate in “a professional, ethical and transparent” manner.

If there’s a lesson here for managers, it’s this: Simply winning the legal war isn’t good enough. Consumers — and your own employees, as the Seroquel case shows — expect companies to go above and beyond. (AZ has mostly won the litigation filed against it which alleges the company failed to warn patients that Seroquel causes weight gain and diabetes. It settled with the Department of Justice for $520 million.)

Many of the allegations in the PMCPA case are familiar, but what’s new is the source: One of the complainants was an unnamed male former AZ executive, employed at the company from 1992 to 2001, who from 1995 to 2000 was responsible for the medical aspects of the U.K. launch and subsequent marketing of Seroquel.*

In terms of the ad, the BBC reported in January that AZ had published a misleading ad in the British Journal of Psychiatry in April 2004. The PMCPA asked AZ to produce all the documentation behind the ad. Here’s its characterization of AZ’s response:

… for a product that had been marketed for more than 12 years in the UK, the company did not believe that it could reasonably investigate and respond to such a broad request in relation to specific clauses of the code.

The Code requires companies keep relevant documents for three years, AZ argued, and the ad itself was at least five years old, thus, “AstraZeneca had been unable to produce the certificate approving the advertisement from its archive.” But:

The Appeal Board noted from the AstraZeneca representatives at the appeal that although the job bag for the advertisement at issue still existed, it did not contain the relevant certificate.

How unfortunate!

More seriously, the PMCPA appeared to take seriously the ex-employee’s allegation that AZ buried or manipulated data on Seroquel long after the company became aware of weight-gain effects on its patients. The executive alleged that in 1997 he was told by a colleague…

Read entire article here:  http://industry.bnet.com/pharma/10008835/the-dog-ate-astrazenecas-homework-evidence-on-misleading-drug-ad-dissappears-from-companys-files/

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A good start: Antipsychotic drug maker to pay half billion in fines for illegal marketing

Thursday, May 20th, 2010

FoodConsumer
By Dr. Mercola
May 20, 2010

Drugmaker AstraZeneca has agreed to pay $520 million to settle federal investigations into marketing practices for its schizophrenia drug Seroquel. This makes AstraZeneca the fourth big drug company in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs.

The company was accused of misleading doctors and patients by spotlighting favorable research while failing to adequately disclose studies showing that Seroquel increases the risk of diabetes.

The New York Times reports that:

“AstraZeneca still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug’s risks.”

Dr. Mercola’s Comments:

The illegal and unsafe actions of drug companies make headlines yet again as AstraZeneca agrees to pay a $502 million fine to settle the federal charges of using illegal marketing tactics to drive up sales of its blockbuster drug Seroquel.

Although this sounds like a lot of money, it’s little more than a symbolic slap on the wrist when you consider how much money they’ve made from the drug already. According to the New York Times, the antipsychotic drug Seroquel pulled in $4.9 BILLION in sales last year!

You see from the company’s perspective it’s merely another cost of doing business.  For every dollar they are fined they are making ten. While not all of their profit was due to their illegal marketing practices, the fine was only a one-time fine, while revenues have poured in over many years and will continue to do so in the future, as a result of these illegal activities.

Read entire article:  http://www.foodconsumer.org/newsite/Non-food/Drug/drug_company_illegal_marketing_20-5100730.html

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