Posts Tagged ‘off-label’

Texas Doctors Prescribe $47 Million Worth of Antipsychotic & Anti-Anixety Drugs, Primarily for Kids—One Child Psychiatrist Alone Wrote 27,000 Prescriptions For Xanax

Sunday, December 12th, 2010

The Star Telegram – Dec 12, 2010

By Darren Barbee

The boy, 20 months old, is a maelstrom of tears and self-abusive behavior. Simply holding him sets off hours of crying, banging of his head or biting himself. His mother used drugs during her pregnancy. Clinical notes recommend he receive potent antipsychotic medication, one for adults suffering bipolar disorder and schizophrenia.State medical records

With little oversight and apparent carte blanche, a relative handful of Texas physicians wrote $47 million worth of Medicaid prescriptions for powerful antipsychotic and anti-anxiety drugs over the past two years, according to a Star-Telegram analysis.

The top five doctors alone wrote $18 million worth.

Most of the drugs have gone to children and adolescents, although prescribing the drugs to children, such as a toddler, is considered “off-label” — uses not approved by the federal Food and Drug Administration.

Now the state’s Medicaid program is among others under scrutiny, after Sen. Charles Grassley, R-Iowa, began investigating the use of mental-health drugs this year. Grassley, the ranking member of the Senate Finance Committee, told federal health officials to keep a better watch on top prescribers. His conclusion: Either some physicians have specialized expertise or the number of prescriptions suggests “overutilization or even health care fraud,” according to an October letter sent to the Health and Human Services Department.

Some advocates are concerned that the drugs are unsafe for children, who make up nearly 75 percent of Texas Medicaid’s 3.2 million recipients. In a 16-state study, Texas had the maximum rate of prescribing multiple mental-health drugs to youths in foster care. Although the number of prescriptions had dropped 19 percent by 2007, Texas was still tops, according to the June study.

John Breeding, a psychologist concerned that the drugs may cause permanent neurological and metabolic damage, told the state, “That so many of our very young children, younger than 4 or even 3 years old, are being given these drugs is so very sad and upsetting.”

And some doctors churn out prescriptions for children and others at an alarming rate. Antipsychotic drugs prescribed to children under 6 grew by 20 percent from 2007 to 2009, according to a November report by the Texas Health and Human Services Commission.

About 1.7 percent of children on Medicaid received antipsychotic drugs in fiscal 2009, state officials said.

Some children are overmedicated: One area doctor routinely prescribes five potent mental-health drugs simultaneously, said one of the state’s top prescribers. He said he tries to scale back the number of drugs the children are on.

Some experts believe that medication has pushed aside talk therapy, which might be effective and reduce medication needs.

“I do think that a lot of people receive medication without any therapy,” said Tami Mark, a researcher with Thomson Reuters in Washington, D.C. “Most of the literature suggests that therapy is effective and can improve the effectiveness of the medication. So it’s better to get both.”

Top prescribers

The child, 31/2, suffers from shaken baby syndrome. When stressed, he pulls at his ventilator hoses and tracheotomy tube so much that his hands must be tied to the bed. He is prescribed antipsychotics because other sedatives could suppress the breathing centers of the brain.

Grassley asked Texas and other states for the top 10 prescribers who billed Medicaid for certain drugs. The Star-Telegram used prescriber numbers to identify the doctors, then sorted and tallied the drugs they were prescribing. Also reviewed was information on other mental-health drugs that have cost taxpayers about $1.3 billion during the past five years.

The analysis and research found:

In the past two years, 72 Medicaid providers wrote 186,992 prescriptions, an average of 2,597 each.

The state’s top prescriber, child psychiatrist G.K. Ravichandran of Houston’s Shamrock Psychiatric clinic wrote 27,000 scripts for the anti-anxiety drug Xanax in the past two years. The next-closest physician wrote 6,300.

Under his license, 44,138 prescriptions for antipsychotic drugs were written, at a cost to Medicaid of $6.4 million.

Ravichandran did not respond to repeated requests for comment.

Dr. Fernando Siles, a child psychiatrist in Greenville, is the second most prolific Medicaid prescriber. He sees children from across North Texas, including Tarrant County.

In the past two years, Siles’ medical license was used to write 13,601 antipsychotic prescriptions at a cost of $4.6 million.

Siles, who treats solely Medicaid recipients, some as young as 3, has three nurse practitioners who also write prescriptions under his license, he said.

Many children referred to him are already on multiple antipsychotic drugs, and he tries to cut back, he said. “Fifty percent of the medications I prescribe, I did not start them on the medicine,” he said. “They came from other doctors.”

There may be other physicians who are also prescribing high volumes of antipsychotic drugs but aren’t as easily detected, state officials say.

Some physicians use a clinic to hide the volume of their prescribing, said Stephanie Goodman, spokeswoman for the Texas Health and Human Services Commission, which oversees Medicaid.

“To be quite honest, we feel like single doctors have started to bill under clinics to maybe hide that, to make it look like it’s not a single doctor prescribing all these,” she said.

State sanctions

The 13-year-old girl suffered depression and post traumatic stress disorder. She cut her arms and stomach. Her stepfather molested her, and then beat her when she refused to have sex. She cannot sleep at night for the nightmares of being locked in a closet. Prescribed an antipsychotic off label, she begins to have fewer flashbacks and nightmares.

Another top prescriber, Dr. Adolphus Lewis of Fort Worth, is a family physician who also treats the elderly. In one year ending in 1994, he wrote 61 prescriptions for one male patient, including enough Vicodin and Valium to pop seven pills a day.

The state medical board accused Lewis of prescribing “medically excessive” numbers of pills to a woman who later died, court documents show. Her death, which was due to respiratory failure, implicated three drugs, including two that Lewis previously prescribed, according to the documents.

Lewis did not respond to multiple requests for comment.

About 40 percent of the 72 top Medicaid prescribers among certain antipsychotic drugs have been disciplined by the state medical board. By comparison, last year the state disciplined less than 1 percent of the state’s 62,521 doctors.

In 2002, the Texas Medical Board restricted Ravichandran’s license for five years for “unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injury the public.” The restriction, which was not related to prescriptions, was lifted within three years.

Read the rest of the article here: http://www.star-telegram.com/2010/12/11/2697798/some-doctors-handing-out-prescriptions.html#tvg#ixzz17uj9SWtQ

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Nursing homes are seeking to end the psychiatric drug stupor

Sunday, December 5th, 2010

Note from CCHR: The wholesale psychiatric drugging of the elderly in both private and public nursing homes has reached epidemic levels, with the use of antipsychotics, antianxiety drugs (tranquilizers) and antidepressants  skyrocketing and patients being harmed and killed as a direct result.  These drugs are highly dangerous when prescribed to anyone, but when prescribed to the elderly the risks for diabetes, stroke and sudden death are greatly increased.    As stated in the article below, ” Instead of looking for causes of disruptive behavior among dementia patients, doctors typically prescribe drugs to mask the symptoms… because it’s the easy thing to do. … That’s true in hospitals, in clinics and in nursing homes.” It is for this reason we feel the more humane non-drug approach being undertaken by this particular chain of nursing homes in treating elderly patients  suffering from dementia should not only be commended, but employed by all nursing homes caring for the elderly.

The Star Tribune – Dec 4, 2010

by Warren Wolfe

Instead of treating behavioral problems with antipsychotic drugs, the Ecumen chain of 15 homes is using strategies including aromatherapy, massage, music, games, exercise and good talk. The state is helping out.

The aged woman had stopped biting aides and hitting other residents. That was the good news.

But in the North Shore nursing home’s efforts to achieve peace, she and many other residents were drugged into a stupor — sleepy, lethargic, with little interest in food, activities and other people.

“You see that in just about any nursing home,” said Eva Lanigan, a nurse and resident care coordinator at Sunrise Home in Two Harbors, Minn. “But what kind of quality of life is that?”

Working with a psychiatrist and a pharmacist, Lanigan started a project last year to find other ways to ease the yelling, moaning, crying, spitting, biting and other disruptive behavior that sometimes accompany dementia.

They wanted to replace drugs with aromatherapy, massage, games, exercise, personal attention, better pain control and other techniques. The entire staff was trained and encouraged to interact with residents with dementia.

Within six months, they eliminated antipsychotic drugs and cut the use of antidepressants by half. The result, Lanigan said: “The chaos level is down, but the noise is up — the noise of people laughing, talking, much more engaged with life. It’s amazing.”

Now the home’s operator, Shoreview-based Ecumen, has started a project called Awakenings throughout its 15 long-term care nursing homes. It’s based on Lanigan’s work and funded with a two-year, $3.7 million state grant.

“We saw what Eva was doing — something everybody in the industry talks about — and we were impressed,” said Mick Finn, an Ecumen vice president. “We said, ‘Hey, this is real. Can we all do this?’ ”

The dangers of drugs

Powerful antipsychotic drugs have been used for years to reduce agitation, hallucinations and other debilitating symptoms among people with mental illnesses.

They also are widely used “off label” to quell disruptive behavior among people with Alzheimer’s disease and other forms of dementia.

Medicare spends more than $5 billion a year on those drugs for its beneficiaries, including about 30 percent of nursing home residents. Several studies have concluded that more than half are prescribed inappropriately. The drugs are especially hazardous to older people, raising the risk of strokes, pneumonia, confusion, falls, diabetes and hospitalization.

“There’s a bunch of problems, not least of which is those drugs can kill you,” said Dr. Mark Kunik at Baylor College of Medicine in Houston who spoke last month at the Gerontological Society of America’s annual meeting in New Orleans.

Instead of looking for causes of disruptive behavior among dementia patients, doctors typically prescribe drugs to mask the symptoms, he said, because “It’s the easy thing to do. … That’s true in hospitals, in clinics and in nursing homes.”

Federal regulators are cracking down on homes that don’t routinely reassess residents on psychotropic drugs. But use remains widespread.

“Whether you have Alzheimer’s or not, there’s a reason people get frustrated or upset — pain, urinary tract infections, hunger, fear of strangers or loud noises or strange settings, maybe drug interactions,” Kunik said. “If you figure that out, you likely can find a safer, nonpharmacologic treatment.”

Treating loss with love

About 150 miles south of Two Harbors, Bernice Brockelman, 91, was snacking on cookies last Wednesday beside the Christmas tree at Ecumen Parmly LifePointes, a nursing home in Center City — all the while alternating quickly from calm to worry to calm.

“Can I stay here tonight? I don’t know where to go. Can I stay with you?” she asked Christy Johnson, the home’s therapeutic recreation director. Though Johnson reassured her, she asked the question again — and again and again.

In an effort to calm her while preparing to wean her from pills, the Parmly staff invited Brockelman into a game of Bingo and to recite the Polish phrases she learned from her immigrant parents. Then she spotted a male visitor.

“Hey, is he married?” she asked with a sparkle in her eye.

“When she’s feeling good, Mom’s an outrageous flirt and she can be really funny,” said her daughter, Judy Balthazor of Center City. “But often there is the repetitive questions, the worry, sometimes just being washed out. I can’t wait for them to get her off her drugs.”

Until the Awakenings project, few at the home knew Brockelman’s whole story — the loss of both parents when she was in high school, of her husband at age 46, then two sons, a close friend and a nephew. Found to have psychosis and dementia, she “just shut down because she had so many losses,” Balthazor said.

Now, the Parmly staff is gaining deeper knowledge of 15 residents who are on psychotropic drugs and who frequently are agitated or upset. They are about to start weaning the residents from the drugs, but they’ve already started a range of activities tailored to each.

Some say nursing homes cannot afford to replace drugs with personal attention because it requires too much staff time.

“Our guess is that it will take the equivalent of two extra people at each home, spread across all job categories,” said Finn, Ecuman’s vice president. “Can we afford it? We think we have to, because it’s the right thing.”

Brockelman, who lived nearly all of her life in northeast Minneapolis, loved to bake, so now she helps make bread and cookies. She danced and was physically active, so she walks with an aide and taps her toes to polka music. A devout Catholic, she attends several weekly church services. She plays Bingo with aide Jenna Miller and sometimes other residents.

“When [you] understand who Beatrice has been in the past, you know her a lot better in the present,” Miller said. “With the Awakenings project, I have permission to spend the time I need with Bernice so she feels safe and loved.”

http://www.startribune.com/lifestyle/health/111326224.html?page=1&c=y

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Justice to Pharma: “Do the Perp Walk!”

Wednesday, November 17th, 2010

PharmaExec.com – November 17, 2010

by Walter Armstrong

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next?

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.” Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

http://blog.pharmexec.com/2010/11/17/lauren-stevens-charged-with-obstruction/

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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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New study finds Anti-seizure drugs, increasingly prescribed for people labeled “bipolar,” induce suicide & death

Tuesday, August 31st, 2010

Natural News
By David Gutierrez
August 31, 2010

Popular anti-seizure drugs may seriously increase a patient’s risk of suicide and violent death, according to a study conducted by researchers from Brigham and Women’s Hospital and Harvard Medical School, and published in the Journal of the American Medical Association.

The drugs, known as anticonvulsants, were initially designed for the treatment of epilepsy but are now widely prescribed “off-label” for conditions such as bipolar disorder, migraine headaches and pain.

“We all know the range of uses of these medications is very, very wide,” researcher Elisabetta Patorno said.

The researchers examined the prescription and medical records of more than 300,000 people above the age of 14 who had been prescribed an anticonvulsant for the first time between July 2001 and December 2006.

All of the drugs, they found, significantly increased a patient’s risk of attempted or successful suicide, as well as violent death by other causes. During the course of the study, there were 801 attempted suicides, 26 successful suicides and 41 violent deaths.

“We found increased risk for suicidal acts beginning within the first 14 days after treatment initiation, opening the possibility that anticonvulsant medications could induce behavioral effects prior to the achievement of their full therapeutic effectiveness,” the researchers wrote.

Based on prior studies, the FDA ruled in 2008 that all anticonvulsants must carry labels warning that they double the risk of suicidal thoughts and actions. These older studies had not been able to determine if any drugs posed higher risks than others, however.

Read entire article here:  http://www.naturalnews.com/029614_suicide_anti-seizure_drugs.html

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Psychiatric drug use skyrockets in U.S. military

Monday, July 26th, 2010

Natural News
By David Gutierrez
July 26, 2010

Use of prescription psychotropics has skyrocketed among U.S. military personnel in recent years, according to an investigation by Military Times.

At least 17 percent of active-duty military personnel are currently taking an antidepressant, including as many as 6 percent of all deployed troops. In contrast, the rate of antidepressant use in the wider U.S. public is only 10 percent.

Overall, one in six military service members takes at least one type of psychiatric drug. The numbers are probably higher than estimated, since troops are also known to share and trade prescription drugs with each other, even while in combat zones.

Data obtained from the Defense Logistics Agency show that overall use of psychiatric drugs increased by 76 percent between 2001 and 2009. More specifically, use of anti-seizure drugs increased 70 percent, use of sedatives and anxiety drugs increased 170 percent, and antipsychotic use increased 200 percent.

Spending on anticonvulsants increased from $16 million to $35 million per year, spending on anxiety drugs and sedatives increased from $6 million to $17 million, and spending on antipsychotics increased from $4 million to $16 million.

Although antidepressants are among the drugs most commonly taken by military personnel, their use increased only 40 percent between 2001 and 2009. Spending actually dropped by 16 percent, likely reflecting the new availability of less-expensive generic drugs.

According to a 2009 study by the Veterans Affairs Administration, approximately 60 percent of psychiatric drug use by military personnel is for “off-label” uses not approved by the FDA. Thus, antipsychotic drugs intended for the treatment of schizophrenia are now being widely prescribed for post-traumatic stress disorder symptoms such as anger, headaches, nervousness and nightmares.

“Patients may be exposed to drugs that have problematic side effects without deriving any benefit,” said Robert Rosenheck of Yale University. “We just don’t know. There haven’t been very many studies.”

Further compounding concern over side effects, many troops regularly mix two or more drugs together into untested cocktails. The effects of multiple drugs acting in unison have rarely been tested. When both drugs act on the same organ — in this case, the brain — the chance of unforeseen interactions is even greater.

“In the case of poly-drug use — the ‘cocktail’ — where you are combining an antidepressant, an anticonvulsant, an antipsychotic, and maybe a stimulant to keep this guy awake — that has never been tested,” Breggin said.

Among the side effects that some health professionals worry about are impaired motor skills, reduced reaction time, increased suicide risk, irritability, aggressiveness and hostility.

“Imagine causing that in men and women who are heavily armed and under a great deal of stress,” psychiatrist Peter Breggin said.

Read entire article:  http://www.naturalnews.com/029285_psychiatric_drugs_military.html

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Drug maker to settle 200 lawsuits for failing to warn patients of diabetes risks caused by its antipsychotic drug

Friday, July 23rd, 2010

AboutLawsuits.com
July 23, 2010

AstraZeneca has agreed to settle Seroquel lawsuits filed by about 200 people who claim that the drug maker failed to adequately warn about the risk of diabetes and other side effects of their antipsychotic drug. The Seroquel settlements are reportedly the first payments AstraZeneca has made out of an estimated 26,000 claims that have been presented against the company.

Bloomberg News reports that AstraZeneca has agreed to pay $2 million as a settlement for the Seroquel lawsuits, which comes out to an average of about $10,000 per claim. It is not clear what injuries were involved in these claims, or what the circumstances are for the cases. All of the settled lawsuits involved plaintiffs represented by one attorney, and Bloomberg News reports that the agreement came as a result of court-ordered mediation.

Although AstraZeneca has previously indicated that they would fight all Seroquel cases at trial, company officials now indicate that they will continue to negotiate with plaintiffs’ attorneys.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Originally approved by the FDA in 1997 for the treatment of schizophrenia, it has been frequently prescribed off-label for uses that were not approved as safe and effective at the time, such as anxiety, obsessive dementia, compulsive disorders and autism.

In July 2006, all Seroquel lawsuits filed in federal courts throughout the United States were consolidated for pretrial litigation before U.S. District Judge Anne Conway in the Middle District of Florida as part of a multidistrict litigation (MDL). In May of this year, Judge Conway determined that the majority of the work in the Seroquel litigation was complete, and began remanding cases back to the original jurisdiction where they were filed for trial.

Read entire article:  http://www.aboutlawsuits.com/settlement-for-seroquel-lawsuits-reached-in-some-cases-11647/

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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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Eli Lilly’ s confidential settlement with seven states over its antipsychotic drug Zyprexa

Thursday, September 24th, 2009

Bob Van Voris, Margaret Cronin Fisk and Jef Feeley
Bloomberg.com
September 21, 2009

Eli Lilly & Co. agreed to settle, on confidential terms, lawsuits filed by seven states alleging the company improperly marketed its antipsychotic drug Zyprexa, a court-appointed official said.

“All of the states have essentially settled for the same” non-monetary arrangements, said Michael Rozen, special master appointed by the court to help settlement negotiations. The money terms, which weren’t disclosed, “have fallen roughly in line,” he said at a hearing today in federal court in Brooklyn, New York.

Lawyers told U.S. District Judge Jack B. Weinstein, who is overseeing the cases, that finishing the settlements may be delayed while the parties determine how much money the U.S. government plans to claim in compensation for federal dollars spent on Zyprexa through state Medicaid programs.

If completed and approved in court, the settlements would leave four suits filed by states pending against Lilly.

Read entire article: http://www.bloomberg.com/apps/news?pid=20601103&sid=aUgLzDmvzVK0

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Lawsuit says NAMI (pharma front group that gets millions in Pharma $) was Trojan Horse used to push antipsychotics on kids

Thursday, September 17th, 2009

Jim Edwards
BNET
September 16, 2009

Pfizer funded the National Alliance for the Mentally Ill in order to turn the nonprofit into a “Trojan Horse” that would promote the antipsychotic drug Geodon for off-label use in children, according to a former pharmaceutical sales rep.

Mark R. Westlock of Fenton, Mo., was a rep for Pfizer from 1991 to 2007, when he claims he was forced to resign. His whistleblower suit against Pfizer was included in the a $2.3 billion Bextra settlement.

Following Pfizer’s funding, the NAMI web site suggested that Geodon be used in children even though the FDA had approved it only for adults, Westlock claims.

Read entire article: http://industry.bnet.com/pharma/10004316/pfizer-turned-nami-into-trojan-horse-to-push-geodon-off-label-to-kids-suit-claims/

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