Posts Tagged ‘antipsychotic drug’

Doctors Paid Millions To Promote Drugs and Medical Devices

Thursday, September 29th, 2011

InjuryBoard Blog Network – September 29, 2011

AstraZeneca paid one Chicago doctor, Dr. Michael Reinstein nearly half-a-million dollars to promote Seroquel. In return, Dr. Reinstein provided AstraZeneca with a vast customer base.

The Chicago Tribune reportedthat drug companies paid more than $25 million to Illinois doctors to promote and use drugs from the pharmaceutical companies. Nearly 40 physicians got payments and perks exceeding $100,000 between 2009 and early 2011.

Eight drug companies paid more than $220 million to doctors and promotional speakers in 2010 to promote their drugs.

Starting in 2013, all drug and medical device companies must report such information to the federal government which will make these disclosures available to the public.

The most controversial payments involve consulting arrangements and promotional speeches. Drug company officials say they are funding talks that provide much-needed medical education, led by physicians who are experts in their fields. Critics say financial relationship between doctors and drug companies can threaten patient care by influencing physicians to prescribe certain medications whether or not they are the best choice.

Until 2009, drug company payments to doctors and other health professionals were closely held as trade secrets. However, some companies have begun reporting this information in advance of the 2013 requirements and pressure from lawmakers or as a condition of settling federal whistle-blower lawsuits.

ProPublica has created a database called Dollars for Docs identifying amounts paid to doctors for promotion of drugs and medical devices. Dollars for Docs has identified more than $760 million in disclosed marketing payments from only 12 companies between 2009 and the 2nd quarter of 2011.

“[The drug company payments] make it look like physicians are not impartial or are in the service of the drug companies, and can cause patients to wonder if physicians’ recommendations for treatment are being made because it was the best option based on their clinical expertise or because they have a relationship with the company,” [Hastings Center research scholar Josephine] Johnston said. “I don’t think many physicians have taken that risk (of patient distrust) as seriously as they should.”

In 2009, the Chicago Tribune reported on the millions of dollars paid by foreign drug maker AstraZeneca to doctors in order to promote its anti-psychotic drug, Seroquel. AstraZeneca paid one Chicago doctor, Dr. Michael Reinstein nearly half-a-million dollars to promote Seroquel. In return, Dr. Reinstein provided AstraZeneca with a vast customer base.

Dr. Reinstein was traveling the country telling doctors that Seroquel would help patients lose weight while the FDA was warning about Seroquel’s link to weight gain and diabetes. Even Seroquel executives called Dr. Reinstein’s conclusion that patients experienced no adverse side effects “suspect” and “hard to believe”. When faced with the choice of protecting patients or protecting profits, AstraZeneca and Dr. Reinstein chose profits over safety.

Johnson & Johnson’s DePuy Orthopaedics division also paid millions — more than $80 million — to surgeons to promote its artificial hip systems. The US Department of Justice brought charges against four medical device companies – including DePuy – in 2007, claiming the companies were using kickbacks to doctors in promoting their products. However, DePuy kept paying doctors:

  • $48 million to doctors in 2009
  • $33 million from January to September 2010

Some surgeons received more than $1 million in single year.

These payments create a direct conflict of interest between doctor and patient. Drug company sponsored research potentially taints results and doctors create the impression – and sometimes the actual effect – of choosing profits and drug company kickbacks over patient safety.

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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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AstraZeneca Fined $520 Million Over Illegal Marketing of its Antipsychotic Drug Seroquel

Thursday, April 29th, 2010

InjuryBoard.com
By Jane Akre
April 28, 2010

Pharmaceutical Giant, AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million after being fined by the federal government for illegally marketing the anti-psychotic drug, Seroquel.

Seroquel, also known as quetiapine fumarate, was approved by the FDA in 1997 to treat psychotic disorders. By October 2006, its use had expanded for use for bipolar depression and mania.

The Department of Justice alleges AstraZeneca illegally marketed Seroquel for uses other than those approved by the FDA such as Alzheimer’s disease, anger management, anxiety, ADD, dementia, depression, PTSD, mood disorders, among other uses considered “off-label.”

In 2008, Bloomberg reported that teenagers and the elderly were increasingly being given a class of anti-psychotic drugs not cleared by regulators. In adolescents, the medications are given for depression, autism and hyperactivity, and in the elderly for dementia and insomnia.

Half of Seroquel sales in 2006 were reportedly for off-label use.

In doing so, the company submitted false claims for payments from federal insurance programs including Medicaid, Medicare and TRICARE programs, Veterans Affairs, the Bureau of Prisons, and the Federal Employee Health Benefits Program.

Read entire article:  http://www.injuryboard.com/national-news/astrazeneca-fined-520-million-over-illegal-seroquel-marketing.aspx?googleid=280742

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