Posts Tagged ‘diabetes’

Profiting from mental ill-health

Tuesday, March 15th, 2011

There’s a reason psychiatrists prescribe drugs rather than talking therapy: the latter makes no money for pharmaceutical firms

The Guardian
By Harriet Fraad
March 15, 2011

More than one in ten Americans takes Prozac; the US comprises 5% of the world's population, yet consumes two thirds of psychological medications. Photograph: Stone/Jonathan Nourok/Getty

The New York Times recently led with a front-page splash about psychiatry’s propensity to prescribe pills, “Talk Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy”. That news is already widely known in the mental health field, but it has vast ramifications for Americans trying to maintain their sanity in our market-driven and medical system for delivering mental healthcare.

What does the turn to drug therapy mean for the mass of Americans?

Mental illness has not decreased with the change from talk therapy to drugs. In fact, as Robert Whitaker’s book diagnoses, mental illness in America has become an established epidemic. So-called miracle drugs like Prozac are taken by 11% of the population – and Prozac is only one of the 30 available antidepressants on the market. Antidepressants are accompanied by anti-anxiety and anti-psychotic drugs. Xanax, America’s leading anti-anxiety medication, is so ubiquitous that Xanax generates more revenue than Tide detergent, reports Charles Barber in his Comfortably Numb.

Anti-psychotics drugs alone net the pharmaceutical industry at least $14.6bn dollars a year. Psycho-pharmaceuticals are the most profitable sector of the industry, which makes it one of the most profitable business sectors in the world. Americans are less than 5% of the world’s population, yet they consume 66% of the world’s psychological medications.

Do these psycho pharmaceuticals work to restore mental health? Actually, the evidence is overwhelming that they fail. Antidepressants, the most popular psycho-pharmaceuticals, work no better than placebos. They work 25% of the time and stop working when the user stops taking them. In addition, they may actually harm patients in the long run. They disrupt brain neurotransmitters and may usurp the brain’s organic soothing functions.

Psycho-pharmaceuticals are less effective in the long run than talk therapy. Talk therapy, like drugs, does change brain and body chemistry; unlike drugs, though, talk therapy has no side-effects. Instead, talk therapy gives a patient tools that usually help to solve future problems. The latest research is most clearly expressed in both Irving Kirsch’s Antidepressants: The Emperors New Drugs and Gary Greenberg’s, Manufacturing Depression, both published last year. Kirsch is one of the world’s leading psychiatrists; Greenberg is one of the world’s most prestigious psychologists. Their views are echoed by many voices in the field of mental health. Why is prestigious and extensive research so widely ignored by doctors and patients alike? Our market-driven healthcare system gives us clues.

All 30 of the available antidepressants have suffered lawsuits within five years of their appearance on the market. These suits are often settled with large payments and gag clauses. The new generation of anti-psychotics are the latest case in point. Anti-psychotics were the single biggest targets of the False Claims Act. Every major company selling anti-psychotics – Bristol Meyers Squibb, Eli Lilly, Pfizer, Johnson and Johnson and AstraZeneca – has either settled investigations for healthcare fraud or is currently being investigated for it. Two recent settlements involving charges of illegal marketing set records for the largest criminal fines ever imposed on corporations. Their corporate logic is expressed in the words of Dr Jerome Avorn, a medical professor and researcher at Harvard: “When you are selling a billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

There is also the widespread practice of paying physicians and psychiatrists heavy subsidies to recommend psycho-pharmaceuticals to their colleagues in small meetings at which a drug company representative is present. If doubt or criticism of the discussed drug is expressed, the doctor’s stipend stops. Another legally acceptable tool is to publish praise of a company’s drug in a scholarly article, which is often written by drug company personnel and simply tweaked by the physician whose name appears on the article. The physician is paid handsomely for such a service.

Under the pressure of legal settlements and embarrassing disclosures, eight pharmaceutical companies began posting doctors’ names and compensation on the web. ProPublica compiled these disclosures, totaling $320m, into a single database that allows patients to search for their doctor. Receiving payments for publishing articles written by drug companies is not illegal.

Two doctors, Dr Joseph Biederman and Dr Timothy Wilens of Harvard University Medical School, illustrate the close and cozy relationship between medical “scholarship” and drug companies. Drs Biederman and Wilens netted $1.6m each from drug companies for their work in recommending powerful anti-psychotic drugs for children. Biederman, Wilens and other extremely well-rewarded child psychiatrists are in part responsible for giving children the diagnosis of paediatric bipolar disorder for which anti-psychotic drugs like Risperidal and Zyprexa are used.

Experts agree that there is no long-term improvement in children’s lives from taking anti-psychotic drugs. In fact, these drugs have a substantiated pattern of metabolic problems and rapid weight gain that often leads to diabetes. The use of bipolar diagnoses and bipolar medications is one small example of how market-driven mental healthcare works in the United States. It illustrates the transformation of US healthcare into a system dominated by some of the richest corporations in the world.

Caring about profit is first, and that is why psychiatry has turned to drug therapy.

Read article here:  http://www.guardian.co.uk/commentisfree/cifamerica/2011/mar/15/psychology-healthcare

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The New Child Abuse: The Psychiatric Diagnosing and Drugging of Our Children

Friday, December 17th, 2010

The Huffington Post—Dec 17, 2010

by Peter Breggin

Every society has found its own methods to abuse its most vulnerable members: children; women; the elderly; ethnic, racial and religious minorities; the poor; the mentally distressed or distressing; the physically disabled; those with unconventional lifestyles. All of these have been widely abused and all remain victims of abuse to varying degrees in societies throughout the world.

Just as it is certain that these abuses can never be fully eliminated, it is also certain that these same abuses will expand to the degree that individual citizens justify or ignore them and fail to take a stand.

In the past, the most rampant abuses have been justified on moral, religious, patriotic or ethnic grounds. But increasingly we will see the worst abuses rationalized on scientific and medical grounds. It’s the modern way.

Science and medicine have so successfully rationalized and justified our society’s most devastating and pervasive form of child abuse that it remains almost wholly unacknowledged, though it is known to every sentient adult and to most children. Probably every adult and half-grown child in America knows and can identify at least one child who is the victim of this abuse. Those who teach, coach, minister to or otherwise serve children may know dozens or even hundreds of children who are victims of the new child abuse.

Our society’s particular form of child abuse is the psychiatric diagnosing and drugging of our children.

The diagnoses are becoming almost innumerable including LD, ADHD, OCD, oppositional defiant disorder, bipolar disorder, and Asperger’s and autistic spectrum disorders. Increasingly children also fall victim to psychological tests that allegedly identify frontal lobe dysfunctions characterized by inattention or flawed executive functions.

Like the diagnoses, the drugs administered to children have mushroomed to involve every class of psychiatric medication, including stimulants, antidepressants, tranquilizers, mood stabilizers and anti psychotic agents. The FDA has increasingly given official approval for giving children especially deadly anti-psychotics such as Risperdal, Zyprexa, Geodon and Seroquel. Meanwhile, anything that can sedate the child’s growing brain from anti-hypertension drugs to anti-seizure drugs are routinely dispensed with callous disregard for their harmful impact.

It’s not uncommon to find children subdued and crushed by multiple psychiatric drugs. Probably 10 to 20 percent of our children will at some time be diagnosed or drugged. This number includes nearly every child in special education classes, foster care or on SSI/SSDI. Any child singled out by child services and educational or psychiatric authorities is likely to fall victim to psychiatric drugs.

The Psychopharmaceutical Complex is the source of these abuses: the pharmaceutical industry, organized psychiatry and medicine, NIMH, insurance companies and various other groups supported by the drug companies. Few parents are abusers; they are misled and intimidated by the “authorities” and often medicate their children against their better judgment.

Two principles are self-evident: First, convincing children that they have “something wrong” in their heads such as genetically crossed wires or biochemical imbalances is the surest way to rob them of self-esteem, personal responsibility, self-mastery and the hope of an unlimited future. Second, convincing children that they have a psychiatric diagnosis or treating them as if they have one and teaching them to rely on psychiatric drugs is a prescription for their becoming lifelong mental patients.

Two other principles require a little more thought or scientific evidence: First, all psychoactive substances from alcohol and marijuana to psychiatric drugs reduce and compromise the function of brain and mind, and none improve it. Whether or not we like the feelings we get from them, all psychoactive substances impact us precisely by producing a partial disability of our highest mental and spiritual life. More concretely most are poisonous to brain cells. I call this “the brain-disabling principle” of psychiatric treatment and have described and documented it in a lengthy medical text book with more than 1,000 scientific references.

Second, all psychiatric drugs have potentially horrendous and even lethal adverse effects from chronic depression and growth stunting caused by stimulants to diabetes, severe obesity, disfiguring neurological disorders and shortened lifespan caused by “antipsychotic” agents. You can confirm and expand on these observations by googling antipsychotic drugs or reading my various books on the subject, especially “Brain-Disabling Treatments in Psychiatry, Second Edition.” The names of the diagnoses will change. The chemical structures of the drugs will change. The promotional strategies will change. But, in my opinion, it will always be abusive to psychiatrically diagnose and drug children.

Now comes the challenge. Put yourself into the emotional and spiritual life of a child who has been diagnosed and will soon be drugged. Be empathic, but not in a disheartening way. Be empathic by connecting with love to the child’s inherent desire to love and be loved, to benefit from rational discipline, to play and to have fun, to grow up and to take responsibility, to learn, and to reach to his or her self-determined stars.

Are you able to put yourself in that child’s place? How does it feel to be told you’re not normal, that you have a disorder, that you’re special but not in a good or hopeful way? How does it feel to be different, let alone mentally impaired? And what impact will it have on you when the expectations of your parents and teachers are tailored to your limitations?

Be genuinely empathic. Children will say almost anything to adults to cover up their shame or to appease them. Beyond that, the medication spellbinding effects of psychiatric drugs impair the individual’s ability to perceive or evaluate the emotional and cognitive disruption that the psychoactive substances are causing. Put yourself in the child’s place and know what he or she must feel about being stigmatized and marginalized by psychiatric diagnoses.

Now imagine yourself inside the head of the child being drugged. The drug makes you feel different and you don’t like it, but everyone says you need it. You don’t want to have to take a drug to make you normal. But you’re a kid and there’s nothing you can do about it.

Gradually your brain and mind struggle to adapt to the brain-disabling chemical that’s crossed your blood brain barrier and disrupted your normal biochemical functions. As an aspect of medication spellbinding, you become so accustomed to your more flattened emotions and reduced mental acuity that you hardly notice the difference anymore.

And now consider this: All these children will grow up with brains drenched in toxic substances, literally polluted in the extreme. Think about the known adverse effects and dare to imagine the even more subtle changes in the function of the brains of each child, brains forever chemically altered.

These children will never know what evolution or God really intended them to become before these toxic intrusions.

Do not be misled that the medical and scientific authorities, and the weight of the universities and government, wholly support this rampant abuse of children. From the systematic abuse of women, children and minorities throughout the ages to the institution of slavery and the Holocaust, those in authority have condoned and benefited from these abuses. Authority at the top of society always justifies these widespread abuses, otherwise the abuses would never get started, nor would they persist.

Reject the authorities. Rely on common sense, sound ethics and real science. Allow yourself to become empathic toward these abused children. Then become angry, energized, motivated and engaged. Educate yourself. My books and those of many others will introduce you to a new world of science, education and philosophy about childhood and children. Find your own way to protest and to make a difference. Join us at empathictherapy.com in our efforts to protect our nation’s children from psychiatric abuse and to offer them genuine love, inspiration, service and education.

http://www.huffingtonpost.com/dr-peter-breggin/the-new-child-abuse-psych_b_788900.html

Peter R. Breggin, M.D. is a psychiatrist in private practice in Ithaca, New York, and the author of dozens of scientific articles and more than twenty books. His two most recent books are  Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime and Brain-Disabling Treatments in Psychiatry, Second Edition: Drugs, Electroshock and the Psychopharmaceutical Complex. Dr. Breggin’s professional website is www.breggin.com. Dr. Breggin and his wife Ginger have founded a new organization, The Center for the Study of Empathic Therapy, Education and Living (www.empathictherapy.com). It will hold an international conference in Syracuse, New York, April 8-10, 2011.

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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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Psychiatric Hospital staff ‘puzzled’ by teenager’s fatal overdose—maybe they should brush up on their drug warnings

Tuesday, November 2nd, 2010

Note from CCHR:  This is pure negligence.  A teenager who was under psychiatric “care” was  found dead with two antipsychotic drugs in his system.  The consulting psychiatrist says he is “puzzled” about his death and that they have “no explanation at all.”  Really.   Perhaps the good doctor should brush up on the international drug regulatory warnings for the drugs they are prescribing.    CCHR’s psychiatric drug database contains 24 international drug regulatory warnings on Antipsychotic drugs, and 49 international studies citing side effects including diabetes, obesity, blood clots, heart problems,  cardiac events,  cancer, tumors, death/sudden death. Moreover, if as the psychiatrist claims,  this teenager was found to have two antipsychotics in his system, only one of which was prescribed (so they say) then obviously the psychiatric hospital staff is beyond negligent if in fact a teen already under the influence of mind-altering drugs, was able to get his hands on and ingest another psychiatric drug unbeknown to any of the staff.

A teenager with schizophrenia was found dead in a psychiatric hospital with a cocktail of drugs in his bloodstream, an inquest heard.

Patrick Bennett was discovered in his bed by a shocked nurse at Fulbourn Hospital, and a post-mortem revealed he had taken two anti-psychotic drugs – only one of which he had been prescribed – and paracetamol.

But doctors told an inquest in Huntindon they had no idea how the 19-year-old obtained them, and that he was too mentally ill to have planned and carried out a suicide.

Sue Lancaster, a staff nurse at the hospital, spoke of the moment she found the body of Mr Bennett, of Pound Lane, Kimbolton, on the morning of August 12, 2009.

She said: “It was then I saw his face and knew he was dead. His face still haunts me.”

Fellow nurse Margaret Molina said she was “certain” she had given Mr Bennett the correct dosage of 4.5ml of clozapine, an anti-psychotic drug, on the night before his death.

When asked about his behaviour, she added: “He didn’t seem clearly anxious or upset in any way, he just seemed bewildered.”

Dr Emilio Fernandez, a consultant psychiatrist who had assessed Mr Bennett, said he had “severe impairment in many daily activities”.

He told the inquest doctors suspected Mr Bennett had been hiding tablets in his mouth, so he was switched to a liquid form of clozapine.

He said this switch made his behaviour “more warm”, and he was transferred to a different ward days before his death.

Dr Fernandez described Mr Bennett as “one of the most severe cases I have ever seen in my life” who would not have had the “ability to plan or carry out any suicide attempt”.

He added: “We are all very puzzled about this, we have no explanation at all.”

Search international warnings and studies on antipsychotic and other psychiatric drugs here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Search for deaths reported to the US FDA from antipsychotic drugs here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

Read the rest of the article here:  http://www.cambridge-news.co.uk/Home/Hospital-staff-puzzled-by-teenagers-fatal-overdose.htm

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$257 Million Lawsuit Award Against Antipsychotic Drug Maker: One of the largest in the history of the state & expected to set nationwide precedent

Sunday, October 17th, 2010

The Advertiser

Lawsuit Award May Set  Record

by William Johnson

$257 million verdict in a product liability lawsuit.

The award came late Thursday evening in a case involving the drug

Risperdal, a popular antipsychotic administered for the treatment of schizophrenia and bipolar disorder manufactured by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson.

The jury, which has been hearing the case for almost two months, found the firm misled Louisiana doctors about the possible side effects of the drug.

State Attorney General Buddy Caldwell’s office had argued the New Brunswick, N.J.-based company had violated a state law against misrepresentation and fraud.

Caldwell’s office argued the company sent letters to more than 7,500 doctors and made more than 27,000 phone calls that improperly claimed the drug was safer than other competing medications and minimized Risperdal’s link to diabetes.

The drug has been prescribed to more than

10 million people worldwide and generates about $2.1 billion in annual sales for Janssen.

“This verdict sends a loud message to those who knowingly try to defraud the system. Those who deceive the state must pay,” Caldwell said in a statement Friday.

Michael Heinley, a spokesman for Janssen, said the company is disappointed with the jury’s decision and will appeal.

“We believe the jury was not appropriately instructed on applicable legal standards and that critical and highly relevant evidence was excluded,” Heinley said Friday.

The St. Landry Parish jury’s judgement, which has yet to be formally filed, is expected to set a nationwide precedent.

The drug is also the subject of more than 26 lawsuits throughout the nation that allege it causes strokes, diabetes and other potentially fatal complications in adults.

The state, represented by the Opelousas law firm of Morrow, Morrow, Ryan and Bassett, had originally asked for $440 million in direct damages with other factors that could have pushed the total award to more than $2 billion.

While the state did not get all it asked for, St. Landry Parish Clerk of Courts Charles Jagneaux said the verdict still amounts to the largest judgement ever assessed in the parish and one of the largest in the history of the state.

The Associated Press contributed to this story.

http://www.theadvertiser.com/article/20101016/NEWS01/10160309/1002/Lawsuit-award-may-set-record

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Johnson & Johnson to Pay $257 Million Over Antipsychotic Drug Marketing Tactics

Friday, October 15th, 2010

By Jef Feeley and Margaret Cronin Fisk

Oct. 15 (Bloomberg) — Johnson & Johnson lost a $257.7 million jury verdict in Louisiana for making misleading claims about the safety of the company’s Risperdal antipsychotic drug.

J&J officials defrauded the state’s Medicaid system by wrongfully touting Risperdal as superior to competing antipsychotic drugs and minimizing its links to diabetes, said jurors in state court in Opelousas, Louisiana.

Yesterday’s verdict is the second trial loss in a state lawsuit brought over Risperdal marketing. A West Virginia judge in a non-jury trial last year awarded $3.95 million, finding the company misled doctors about the risks and benefits of Risperdal. New Brunswick, New Jersey-based J&J appealed.

Michael Heinley, a spokesman for J&J’s Ortho-McNeil Janssen Pharmaceuticals unit, said the company is disappointed with the jury’s decision and will appeal.

“We believe the jury was not appropriately instructed on applicable legal standards and that critical and highly relevant evidence was excluded,” he said in an interview.

The jury found 35,542 violations of the state’s Medical Assistance Programs Integrity Law and imposed a penalty of $7,250 for each. The total $257.7 million verdict is the fifth- largest in the U.S. so far in 2010, according to data compiled by Bloomberg.

‘False and Misleading’

“You can’t come into Louisiana and disseminate false and misleading information,” Patrick Morrow, who represented the state, said after the verdict in a phone interview. “I’m sure this matter will be in the appellate courts for years to come. This is the first step.”

The state’s case centered on drug safety claims that J&J and Ortho-McNeil Janssen made in November 2003 correspondence to 700,000 doctors. In those letters, J&J touted Risperdal as safer than competing antipsychotics such as Indianapolis-based Eli Lilly & Co.’s Zyprexa and London-based AstraZeneca Plc’s Seroquel. Risperdal global sales peaked at $4.5 billion in 2007, declining after the company lost patent protection.

The U.S. Food and Drug Administration responded with a warning letter saying J&J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to rival medicines.

7,604 Letters

Lawyers for the state asked jurors to hold J&J liable for the 7,604 letters it sent to Louisiana doctors and regulators making those claims along with more than 27,542 sales calls in the state made by the drugmaker’s representatives in 2003 and 2004.

The state sought a total of $351 million in damages, including penalties of $10,000 for each fraudulent claim and misrepresentation in violation of the Medical Assistance Programs Integrity Law.

Read the rest of the article here: http://www.businessweek.com/news/2010-10-15/j-j-told-to-pay-257-7-million-over-risperdal-marketing-tactics.html

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Antipschotic Drugs—Side Effects May Include Lawsuits

Monday, October 4th, 2010

The New York Times
By Duff Wilson
October 2, 2010

FOR decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins.

cover
Department of Justice Statements on the Five Major Companies Selling Anti-Psychotic Drugs:
AstraZeneca
Bristol-Myers Squibb
Eli Lilly
Johnson and Johnson
Pfizer

While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatory schizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases.

Anointed with names like Abilify and Geodon, the drugs were given to a broad swath of patients, from preschoolers to octogenarians. Today, more than a half-million youths take antipsychotic drugs, and fully one-quarter of nursing-home residents have used them. Yet recent government warnings say the drugs may be fatal to some older patients and have unknown effects on children.

The new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.

Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill, Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.

The companies all say their antipsychotics are safe and effective in treating the conditions for which the Food and Drug Administration has approved them — mostly, schizophrenia and bipolar mania — and say they adhere to tight ethical guidelines in sales practices. The drug makers also say that there is a large population of patients who still haven’t taken the drugs but could benefit from them.

AstraZeneca, which markets Seroquel, the top-selling antipsychotic since 2005, says it developed such drugs because they have fewer side effects than older versions.

“It’s a drug that’s been studied in multiple clinical trials in various indications,” says Dr. Howard Hutchinson, AstraZeneca’s chief medical officer. “Getting these patients to be functioning members of society has a tremendous benefit in terms of their overall well-being and how they look at themselves, and to get that benefit, the patients are willing to accept some level of side effects.”

The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers — despite recent crackdowns.

Some say the answer to that question isn’t complicated.

“It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

NEUROLEPTIC drugs — now known as antipsychotics — were first developed in the 1950s for use in anesthesia and then as powerful sedatives for patients with schizophrenia and other severe psychotic disorders, who previously might have received surgical lobotomies.

But patients often stopped taking those drugs, like Thorazine and Haldol, because they could cause a range of involuntary body movements, tics and restlessness.

A second generation of drugs, called atypical antipsychotics, was introduced in the ’90s and sold to doctors more broadly, on the basis that they were safer than the old ones — an assertion that regulators and researchers are continuing to review because the newer drugs appear to cause a range of other side effects, even if they cause fewer tics.

Contentions that the new drugs are superior have been “greatly exaggerated,” says Dr. Jeffrey A. Lieberman, chairman of the psychiatry department at Columbia University. Such assertions, he says, “may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.”

“At the same time,” he adds, “the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical evidence.”

Others agree. “They sold the story they’re more safe, when they aren’t,” says Robert Whitaker, a journalist who has written two books about psychiatric medicines. “They had to cover up the problems. Right from the start, we got this false story.”

The drug companies say all the possible side effects are fully disclosed to the F.D.A., doctors and patients. Side effects like drowsiness, nausea, weight gain, involuntary body movements and links to diabetes are listed on the label. The companies say they have a generally safe record in treating a difficult disease and are fighting lawsuits in which some patients claim harm.

The cases, both civil and criminal, against many of the world’s largest drug makers have unveiled hundreds of previously confidential documents showing that some company officials were aware they were using questionable tactics when they marketed these powerful, expensive drugs.

Such marketing, according to analysts and court documents, included payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors. All of these are tools that federal investigators say companies have used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.

Lawyers suing AstraZeneca say documents they have unearthed show that the company tried to hide the risks of diabetes and weight gain associated with the new drugs. Positive studies were hyped, the documents show; negative ones were filed away.

According to company e-mails unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study showing that users of Seroquel, then a new antipsychotic, gained 11 pounds a year, while the company publicized a study that asserted they lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on an unfavorable study.

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data,” John Tumas, then AstraZeneca’s publications manager, wrote in a 1999 e-mail. “We must find a way to diminish the negative findings,” he added. “But, in my opinion, we cannot hide them.”

Tony Jewell, an AstraZeneca spokesman, said last week that the company had turned over all that material to the F.D.A. as part of the approval process and updated its label over the years to show the latest safety information.

Dr. Stefan P. Kruszewski, a Harvard-educated psychiatrist who once worked as a paid speaker for several drug makers, became a government informant and now consults for plaintiffs suing drug companies. Earlier in his career, he spoke at events for Pfizer, GlaxoSmithKline and Johnson & Johnson as an advocate of antipsychotics. He said one company offered him incentives of $1,000 or more every time he talked to an individual doctor about one of its drugs.

“When I started speaking for companies in the late 1980s and early ’90s, I was allowed to say what I thought I should say consistent with the science,” he recalls. “Then it got to the point where I was no longer allowed to do that. I was given slides and told, ‘We’ll give you a thousand dollars if you say this for a half-hour.’ And I said: ‘I can’t say that. It isn’t true.’ ”

Slides for one new antipsychotic drug contended that it had no neurological side effects. “They made it all up,” Dr. Kruszewski said. “It was never true.”

Read entire article:  http://www.nytimes.com/2010/10/03/business/03psych.html?_r=2

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Pharmaceutical Company AstraZeneca Settles Allegations of Off-Label Marketing and Paying Kickbacks, Pays $520M

Wednesday, September 29th, 2010
ASC REVIEW
By Jaimie Oh
September 29, 2010
Pharmaceutical manufacturer AstraZeneca, based in Wilmington, Del., has agreed to pay $520 million to settle allegations that it had illegally marketed its antipsychotic drug Seroquel, according to an AZ Central news report.

Under the Food, Drug and Cosmetic Act, a company is required to specify each intended use of a product in its application to the Food and Drug Administration. After the FDA approves the product for its specified uses, any promotion by the manufacturer for other uses, or “off-label” uses, renders the product misbranded. AstraZeneca had been accused of marketing Seroquel as off-label treatment for insomnia and psychiatric conditions, according to the report.

The company had also been accused of paying kickbacks to physicians. The physicians allegedly agreed to be authors of articles written by the company and its agents about the off-label uses of Seroquel. Additionally, physicians were allegedly paid to travel to resort locations to advise AstraZeneca about marketing the off-label use of the drug, according to the report.

Although it has agreed to settle the allegations, AstraZeneca is denying any wrongdoing. State Medicaid programs, including Kansas, will receive a portion of the pharmaceutical company’s settlement.

Read the AZ Central news report about AstraZeneca’s settlement.
Read other coverage about pharmaceutical company fraud.

- New Jersey-Based Pharmaceutical Company to Pay More Than $41M to Settle Allegations of Kickback Violations, Off-Label Marketing

- Omnicare Pays $21M to Settle Allegations of Medicaid Fraud

- Justice Department Files to Intervene in Whistleblower Kickback Case Against Pfizer

Read rest of this article here http://www.beckersasc.com/stark-act-and-fraud-abuse-issues/pharmaceutical-company-astrazeneca-settles-allegations-of-off-label-marketing-and-paying-kickbacks-pays-520m.html

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