Posts Tagged ‘antipsychotic’

Treatment for PTSD may be killing veterans

Wednesday, September 1st, 2010

War in Context

by News Source on August 31, 2010

Associated Press reports:

Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.

Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department’s top drug expenditures and the No. 5 best-selling drug in the nation.

Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug’s risks. They want Congress to investigate.

In White’s case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day — more than double the maximum dose recommended for schizophrenia patients.

A short time later, White died in his sleep.

“He was told if he had trouble sleeping he could take another (Seroquel) pill,” said his father, Stan White, a retired high school principal.

Activist, Vince Boehm, communicated with the Whites and told Beyond Meds:

Stan and Shirley White lost two sons to war. Robert White, a staff sergeant, was killed in Afghanistan in 2005, when his Humvee was hit by a rocket-propelled grenade. But the death of Robert’s younger brother Andrew, who survived Iraq only to succumb to a different battle, is in some ways “harder to accept” says his father.

Struggling with PTSD compounded by grief over the death of his brother, Andrew sought help from VA doctors. Their first line of defense was to prescribe him 20 mg of Paxil, 4 mg of Klonopin and 50 mg of Seroquel. These medications helped at first, but later proved ineffective. Instead of changing the course of treatment, the doctors responded by continually increasing his dosage until the Seroquel alone reached a whopping 1600 mg per day. Within weeks of Andrew’s death, three more young West Virginia veterans died while being treated for PTSD with the same drugs, prompting Stan and Shirley White to begin a mission to find out what the deaths have in common.

Earlier this year, Martha Rosenberg reported on the same deadly cocktail being used to treat PTSD:

Sgt. Eric Layne’s death was not pretty.

A few months after starting a drug regimen combining the antidepressant Paxil, the mood stabilizer Klonopin and a controversial anti-psychotic drug manufactured by pharmaceutical giant AstraZeneca, Seroquel, the Iraq war veteran was “suffering from incontinence, severe depression [and] continuous headaches,” according to his widow, Janette Layne.

Soon he had tremors. ” … [H]is breathing was labored [and] he had developed sleep apnea,” Layne said.

Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband, told the story of his decline last year, at official FDA hearings on new approvals for Seroquel. On the last day of his life, she testified, Eric stayed in the bathroom nearly all night battling acute urinary retention (an inability to urinate). He died while his family slept.

Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.

Sgt. Layne was not the first veteran to die after being prescribed medical cocktails including Seroquel for PTSD.

Read the rest of this article here: http://warincontext.org/2010/08/31/treatment-for-ptsd-may-be-killing-veterans/

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The US Military’s Drugged Troops: Survey finds at least 1 in 6 service members is on some form of psychiatric drug

Tuesday, August 31st, 2010

Pharmalot
By Ed Silverman
August 31, 2010

The widely used Seroquel antipsychotic was never approved to treat post-traumatic stress disorder or the insomnia sometimes related to the afflication, but that hasn’t stopped the drug from being prescribed for that purpose by the US Department of Veteran Affairs and, in the process, becoming one of the VA’s biggest expenditures.

Since 2001, VA spending on Seroquel jumped more than 770 percent, while the number of patients covered by the VA increased just 34 percent, the Associated Press writes. Seroquel is now the VA’s second-biggest prescription drug expenditure since 2007, behind the Plavix bloodthinner. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001, and the growth in spending outpaces the growth in personnel who have gone through the military during that time.

Meanwile, thousands of soldiers have taken the med, and several soldiers and veterans have died, raising concerns among some military families the government is not being forthcoming about the risks, the AP writes, noting that they want Congress to investigate. The trend, by the way, is not confined to Seroquel. An investigation earlier this year found that at least one in six service members is on some form of psychiatric drug (background).

According to the VA, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD, the AP writes. And the US Defense Department’s deputy director for force health protection, Michael Kilpatrick, tells the news service that the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Read entire article:  http://www.pharmalot.com/2010/08/the-military-post-traumatic-stress-and-seroquel/

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Antipsychotic Drugs, U.S. Vets & Sudden Deaths: Families Call on Congress to Investigate

Monday, August 30th, 2010

Note from CCHR:  Our psychiatric drug database lists FDA advisory warnings on Seroquel causing sudden death, death, suicide, suicidal ideation, heart problems, as well as a Journal of Toxicology report dating back to 2001, warning of antipsychotic drugs causing stroke, cerebrovascular events (such as loss of brain function) seizures, toxicity, confusion and coma. Simply keyword search Seroquel here (or for a broader search, newer antipsychotics)  http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Questions loom over drug given to sleepless vets

By MATTHEW PERRONE (AP) – 1 hour ago

WASHINGTON — Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.

Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department’s top drug expenditures and the No. 5 best-selling drug in the nation.

Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug’s risks. They want Congress to investigate.

In White’s case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day — more than double the maximum dose recommended for schizophrenia patients.

A short time later, White died in his sleep.

“He was told if he had trouble sleeping he could take another (Seroquel) pill,” said his father, Stan White, a retired high school principal.

An investigation by the Veterans Affairs Department concluded that White died from a rare drug interaction. He was also taking an antidepressant and an anti-anxiety pill, as well as a painkiller for which he did not have a prescription. Inspectors concluded he received the “standard of care” for his condition.

It’s unclear how many soldiers have died while taking Seroquel, or if the drug definitely contributed to the deaths. White has confirmed at least a half-dozen deaths among soldiers on Seroquel, and he believes there may be many others.

Spending for Seroquel by the government’s military medical systems has increased more than sevenfold since the start of the war in Afghanistan in 2001, according to documents obtained by The Associated Press under the Freedom of Information Act. That by far outpaces the growth in personnel who have gone through the system in that time.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, but it has not been endorsed by the Food and Drug Administration as a treatment for insomnia. However, psychiatrists are permitted to prescribe approved drugs for other uses in a common practice known as “off-label” prescribing.

But the drug’s potential side effects, including diabetes, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits. While on Seroquel, White gained 40 pounds and experienced slurred speech, disorientation and tremors — all known side effects.

Last year, researchers at Vanderbilt University published a study suggesting a new risk: sudden heart failure.

The study in the January 2009 edition of the New England Journal of Medicine found that there were three cardiac deaths per year for every 1,000 patients taking anti-psychotic drugs like Seroquel. Seroquel’s unique sedative effect sets it apart from others in its class as the top choice for treating insomnia and anxiety.

AstraZeneca PLC, maker of the drug, said it is reviewing the study. The FDA is conducting its own review, citing the limited scope of the Vanderbilt study.

According to the Veterans Affairs Department, Seroquel is only prescribed as a third or fourth option for patients with difficult-to-treat insomnia stemming from PTSD.

Marine Cpl. Chad Oligschlaeger, 21, was being treated for PTSD when he died in his sleep at Camp Pendleton, Calif., in May 2008. Oligschlaeger was taking six types of medication, including Seroquel, to deal with anxiety and nightmares that followed two tours of duty in Iraq.

The military medical examiner attributed the death to “multiple drug toxicity,” indicating that Oligschlaeger, too, died from a drug interaction. Because of the complex reactions between various drugs, medical examiners do not attribute such deaths to any one medication.

After consulting with physicians, parents Eric and Julie Oligschlaeger now believe their son died of sudden cardiac arrest caused by Seroquel.

“Right now, I’m so angry, and I believe someone needs to be held accountable,” said Julie Oligschlaeger, of Austin, Texas. “The protocol absolutely has to change.”

The Defense Department’s deputy director for force health protection, Dr. Michael Kilpatrick, said the government has not seen any increase in dangerous side effects from Seroquel and other drugs.

Physicians interviewed by the AP said they began prescribing Seroquel because it was the only drug that offered relief from the nightmares and anxiety of PTSD.

“By accident, some people were giving them Seroquel for anxiety or depression, and the veterans said, ‘This is the first time I have slept six or seven hours straight all night. Please give me more of that.’ And the word spread,” said Dr. Henry Nasrallah of the University of Cincinnati, who has treated PTSD patients for more than 25 years.

Most of the soldiers and veterans seeking treatment for PTSD do so at hospitals run by the VA or the Defense Department.

The VA’s spending on Seroquel has increased more than 770 percent since 2001. In that same time frame, the number of patients covered by the VA increased just 34 percent.

Seroquel has been the VA’s second-biggest prescription drug expenditure since 2007, behind the blood-thinner Plavix. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001.

Spending on Seroquel by the Department of Defense, has increased nearly 700 percent since 2001, to $8.6 million last year, according to purchase records.

Read the rest of this article here: http://www.google.com/hostednews/ap/article/ALeqM5iPPHBQ6w28w4kTXzANGm6kCzPN1gD9HTRUQ80

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Americas Mental Illness Epidemic

Thursday, August 26th, 2010

Rense.com
By Gary G. Kohls, MD
August 25, 2010

Tens of millions of innocent, unsuspecting Americans, who are mired deeply in the mental “health” system, have actually been made crazy by the use of or the withdrawal from commonly-prescribed, brain-altering, brain-disabling, indeed brain-damaging psychiatric drugs that have been, for many decades, cavalierly handed out like candy ­ often in untested and therefore unapproved combinations of drugs – to trusting and unaware patients by equally unaware but well-intentioned physicians who have been under the mesmerizing influence of slick and obscenely profitable psychopharmaceutical drug companies aka, BigPharma.

That is the conclusion of two books by investigative journalist and health science writer Robert Whitaker. His first book, entitled Mad in America: Bad Science, Bad Medicine and the Enduring Mistreatment of the Mentally Ill noted that there has been a 600% increase (since Thorazine was introduced in the US in the mid-1950s) in the total and permanent disabilities of millions of psychiatric drug-takers. This uniquely First World mental ill health epidemic has resulted in the life-long taxpayer-supported disabilities of rapidly increasing numbers of psychiatric patients who are now unable to be happy, productive, taxpaying members of society. Whitaker has done a powerful, albeit unwelcome job of presenting previously hidden, but very convincing evidence to support his thesis, that it is the drugs and not the diagnosis that is causing the epidemic of mental illness disability. Many open-minded physicians and many aware psychiatric patients are now motivated to be wary of any and all synthetic chemicals that can cross the blood/brain barrier because all of them are capable of altering the brain in ways totally unknown to medical science, especially when the patients are taking the drugs long-term..

In Whitaker’s second book Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America, he goes much further in advancing this sobering reality. He documents the history of the powerful forces behind the relatively new field of psychopharmacology and its major shaper and beneficiary, BigPharma. Psychiatric drugs, whose developers, marketers and salespersons are all in the employ of the giant drug companies, are far more dangerous than the drug and psychiatric industries are willing to admit: These drugs, it turns our, are fully capable of disabling ­ often permanently – body, brain and spirit.

More evidence to support Whitaker’s well-documented claims are laid out in two important new books written by psychiatrist and scholar Grace Jackson. Jackson did a beautiful job of researching and documenting, from the voluminous basic neuroscience research (which is uniformly ignored by the clinical sciences) the unintended and often disastrous consequences of the chronic ingestion of any of the five major classes of psychiatric drugs. Her second and most powerful book: Drug-Induced Dementia: A Perfect Crime, proves beyond a shadow of a doubt, that any of the five classes of drugs that are commonly used in psychiatric patients (antidepressants, antipsychotics, psychostimulants, tranquilizers and anti-seizure/”mood-stabilizer” drugs) have shown microscopic, macroscopic, biochemical, clinical and/or radiological evidence of brain shrinkage and other signs of brain damage, which can result in clinically-diagnosable, permanent dementia, premature death and a variety of other related brain disorders that can mimic mental illnesses. Jackson’s first book, Rethinking Psychiatric Drugs: A Guide for Informed Consent was an equally sobering book warning about the many hidden dangers of psychiatric drugs.

This sad truth is that the seemingly knee-jerk prescribing (without very much information being given to patients about the long list of serious long-term adverse effects) of potent and often addicting/dependency-inducing psychiatric drugs has become the standard of care in American psychiatry since the introduction of the so-called anti-schizophrenic “miracle” drug Thorazine in the mid-1950s. (Thorazine was the offending drug that all of Jack Nicholson’s fellow patients were coerced into taking at “medication time” in the Academy Award-winning movie “One Flew Over the Cuckoo’s Nest”.) Thorazine and all the other “me-too” early antipsychotic drugs are now universally known to have been an iatrogenic (= doctor or other treatment-caused) disaster because of their serious long-term, initially unsuspected, brain-damaging effects that resulted in a number of incurable neurological disorders such as tardive dyskinesia and Parkinson’s disease.

Thorazine and all the other knock-off drugs like Prolixin, Mellaril, Navane. etc, are synthetic “tricyclic” chemical compounds similar in molecular structure to the tricyclic “antidepressants” like imipramine and the similarly toxic, obesity-inducing, diabetogenic, “atypical” anti-schizophrenic drugs like Clozaril, Zyprexa and Seroquel.

Thorazine, incidentally, was originally developed in Europe as an industrial dye. That doesn’t sound so good although it may not be so unusual in the closely related fields of psychopharmcology and the chemical industry, especially when one considers that Depakote, a popular drug marketed initially as an anti-epilepsy drug but now is being heavily used as a so-called “mood stabilizer”. Depakote, known to be a hepatotoxin and renal toxin, was originally developed as an industrial solvent capable of dissolving fat – including, presumably, the fatty tissue in human livers and brains.

Some sympathy and understanding needs to be generated for the various victims of BigPharma’s compulsive drive to expand market share and “shareholder value” (share price, dividends and the next quarter’s financial report) by whatever means necessary. Both the prescribers and the swallowers of BigPharma’s drugs have succumbed to BigPharma’s cunning marketing campaigns, the prescribers having been seduced by attractive drug company representatives and their “pens, pizzas and post-it note” freebies in the office, and the patients being brain-washed by the inane and unbelievable (if one has intact critical thinking skills) commercials on TV that quickly gloss over the lethal adverse effects in the fine print while urging the watcher to “ask your doctor” about the latest unaffordable wannabe blockbuster drug..

For a quick overview of these issues, I recommend that everybody with an open mind read a long essay written by Whitaker that persuasively identifies the source of America’s epidemic of mental illness disability (a phenomenon that doesn’t exist in Third World nations because costly psych drugs are not prescribed so cavalierly as in the US).

Whitaker and Jackson (among a number of other ground-breaking and whistle-blowing authors who have been essentially black-listed by the mainstream media and mainstream medical journals) have proven to most critically-thinking scientists, alternative practitioners and assorted “psychiatric survivors” that it is the drugs – and not the so-called “disorders” – that are causing our nation’s epidemic of mental illness disability. The Whitaker essay, plus other pertinent information about his books can be accessed at www.madinamerica.com A recent interview on Wisconsin Public Radio can be accessed at www.wpr.org (at their radio archives link) and a long interview with Dr.Joseph Mercola can be heard at: http://articles.mercola.com/sites/articles/archive/2010/05/08/robert-whitaker-interview.aspx

After reading and studying all these inconvenient truths, mental health practitioners must consider the medicolegal implications for them, especially if the information is ignored or if the information is dismissed out of hand by practitioners who might be tempted to not take the time to study this new information. Those people who are hearing about this for the first time need to pass the word on to others, especially their prescribing healthcare practitioners who should be equally concerned. This is important because the opinion leaders in the highly influential (for good or ill) psychiatric and medical industries have been marketed into submission without hearing the all the facts (which may have been intentionally hidden from them. If that is the case, they cannot be automatically blamed for proceeding in a practice that some day might represent malpractice. It shouldn’t have to be pointed out that is the solemn duty of ethical practitioners who are in positions of authority to fully examine potential malpractice issues and then warn others, especially their patients, of the dangers.

Sadly, it must be admitted that most of the over-worked, double-booked care-givers in medical clinics have not yet heard the news that most if not all of the brain-altering synthetic chemicals known as psychotropic drugs (which are treated as hazardous waste unless they are packaged in a swallowable capsule!) have been marketed as safe and effective – but only for short-term use. The captains of the drug industry know that the psychotropic drugs that they present for the FDA-approval have only been tested in animal trials for days and in clinical trials for 6 weeks. They also know ­ indeed they hope – that patients will be taking their drugs for years (despite no long-term trials proving safety and efficacy) as the only “treatment” for mental ill health. They know that their brain-altering drugs are also dependency-inducing (aka addicting, causing withdrawal symptoms when stopped), neurotoxic and increasingly ineffective (a la “Prozac Poop-out”) as time goes by.

The truth is that the people diagnosed as “mentally ill” for life are often simply those unfortunates who find themselves in acute or chronic states of crisis or “overwhelm” due to any number of preventable, curable and treatable (without the use of drugs) bad luck accidents such as poverty, abuse, violence, torture, homelessness, discrimination, underemployment, brain malnutrition, addictions/withdrawal, brain damage from electroshock “therapy” and/or exposure to neurotoxic chemicals in their food, air, water or prescription bottles.

Those labeled as the “mentally ill” are just like us “normals” who have not yet decompensated because of some yet-to-happen, crisis-inducing, overwhelming (however temporary) life situation. And thus we have not yet been given a billable code number (accompanied by the seemingly obligatory – and unaffordable – drug prescription or two signifying we are now chronically mentally ill. Unlabeled, we are likely to remain off prescription drugs but with a label and in “the system”, it is hard to “just say no to drugs.”

The victims of hopelessness-generating situations like simple bad luck, bad circumstances, bad company, bad choices, bad government, big business, and a competitive society that generates a few winners but mostly losers. America tolerates, indeed celebrates, punitive and thus fear-inducing social systems resembling in many ways the infamous police state realities of 20th century European totalitarianism, where people who were different or just dissidents were thought to be abnormal and therefore “disappeared” into insane asylums, jails or concentration camps without just cause or competent legal defense. And many of them were and are drugged with disabling psychoactive chemicals against their will.

The truth is that most, if not all, of BigPharma’s psychotropic drugs are lethal at some dosage level (the LD50, the lethal dose that kills 50% of lab animals, is calculated before efficacy testing is done), and therefore the drugs must be regarded as dangerous. The chronic use of these drugs is a major cause of cognitive disorders, brain damage, loss of creativity, loss of spirituality, loss of empathy, loss of energy, loss of strength, fatigue and tiredness, permanent disability and a multitude of metabolic adverse effects that can readily sicken the body, brain and soul by causing insomnia or somnolence, increased depression or anxiety, delusions, psychoses, paranoia, mania, etc. So before filling the prescription, it is advisable to read the product insert labeling under WARNINGS, PRECAUTIONS, ADVERSE EFFECTS, CONTRAINDICATIONS, TOXICOLOGY, OVERDOSAGE and the ever-present BLACK BOX WARNINGS ABOUT SUICIDALITY.

Long-term, high dosage or combination psychotropic drug usage could be regarded as a chemically traumatic brain injury (TBI) or, as drugs like Thorazine were known in the 1950s and 60s, a “chemical lobotomy”. That is a useful way to conceptualize this serious issue, because such chemically brain-altered patients are often indistinguishable from those who have suffered a physically traumatic brain injuries or been subjected to ice-pick lobotomies which were popular in the 1940s and 50s – before the drugs came on the market.

America has a mental ill health epidemic on its hands that is grossly misunderstood because it is worsening, not by the supposed disease progression, but because of the neurotoxic, non-curative drugs that are somehow regarded as first-line “treatment.”
Read the rest of this article here: http://www.rense.com/general91/edi.htm

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Professor of Bioethics—Co-opted by market forces, clinical drug trials are now just covert instruments for promoting drugs

Friday, August 20th, 2010

MinnPost.com

By Susan Perry |

In the September issue of Mother Jones magazine, Dr. Carl Elliott, a professor of bioethics at the University of Minnesota, writes about the suicide in 2004 of 26-year-old Dan Markingson, who was enrolled at the time in a U of M industry-funded clinical trial of the antipsychotic drug Seroquel (quetiapine).

It’s a disturbing tale (the unsuccessful efforts of Markingson’s mother to get her son released from the trial and into other treatment are particularly heartbreaking) and one that, as Elliott acknowledges, was first told in the Pioneer Press by Jeremy Olson and Paul Tosto.

But Elliott’s purpose in writing the article wasn’t only to revisit the tragic details of Markingson’s story. “[T]he more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported,” he writes. “The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.”

Those hazards include questionable informed consent (is a young man who’s experiencing psychotic episodes competent to give his consent?) and financial conflicts of interest. According to Elliott, the U of M psychiatry department earned $15,648 for each person it enrolled in the Seroquel study. In addition, the study’s two U of M investigators, Drs. Charles S. Schulz and Stephen C. Olson, personally earned a combined $811,045 between 2002 and 2008 from Big Pharma, including $261,364 from AstraZeneca, the maker of Seroquel.

At the time Markingson entered the Seroquel study, reports Elliott, the investigators were having serious problems recruiting subjects. Did that factor lead them to enroll someone into the study who shouldn’t have been?

“Even by the standards of a fairly ugly history [of clinical drug trials with ethical breaches] in medical history — even by those standards, this [case] jumps up,” Elliott told me in an interview last week. “There were so many things that went wrong — the consent process, the commitment order under which [Markingson] was recruited into the trial, the financial incentives of the university, the financial incentives of the investigators, and the sheer worthlessness of the trial. Anyone who looked into this and knew anything about clinical research would say this is terrible.”

Elliott sees the trial’s worthlessness as a particularly abhorrent part of the story. The Seroquel study was designed as a marketing tool, he suggests, not as a true scientific inquiry. Such studies, he writes, present a huge ethical problem that isn’t being properly addressed by the oversight systems currently in place:

What is simply assumed [when bioethicists and regulators debate the risks of a clinical trial], without much consideration at all, is that the research is being conducted to produce scientific knowledge. This assumption is codified in a number of foundational ethics documents, such as the Nuremberg Code, which was instituted following Nazi experiments on concentration camp victims. … But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation [involving various prescription drugs] suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to “generative commercially attractive messages”?

Or, as Elliott told me: “I don’t think anybody who enrolls in a clinical trial thinks, “I know this study is risky, but I think it’s worth it to help Pfizer or AstraZeneca market their drug.”

Read the rest of this article here:  http://www.minnpost.com/healthblog/2010/08/20/20742/disturbing_suicide_tale_u_of_m_professor_reexamines_ethics_questions_of_drug_trial

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AstraZeneca, UKs 2nd biggest drug maker, said to pay $55 million to settle about 5,500 lawsuits over antipsychotic drug

Wednesday, August 4th, 2010

Bloomberg News
By Jef Feeley and Phil Milford
August 4, 2010

AstraZeneca Plc, the U.K.’s second- biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel, people familiar with the accords said.

The settlements, with an average payout of about $10,000 per case, resulted from mediation involving 26,000 suits filed over Seroquel, the people said. The London-based company previously agreed to pay $2 million to resolve more than 200 allegations that Seroquel causes diabetes in some users, people familiar with those accords said last month.

“It implies that the overall exposure is very low” for AstraZeneca, Navid Malik, an analyst at Matrix Corporate Capital in London, said today in an interview. “$10,000 per patient doesn’t seem high” to settle drug-safety suits.

AstraZeneca is moving to resolve Seroquel claims as it faces expiring patents on the drug and the ulcer treatment Nexium in the next four years. Seroquel, the company’s second- biggest seller after Nexium, generated sales of $4.87 billion last year, or 15 percent of AstraZeneca’s total revenue.

The 5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing, the people said. The company hasn’t disclosed terms of the accords and wouldn’t comment on them yesterday. The settlements stemmed from mediation ordered by the judge in Orlando, Florida, who was overseeing all federal-court litigation over the drug.

Read entire article here:  http://www.businessweek.com/news/2010-08-04/astrazeneca-said-to-pay-55-million-over-seroquel.html

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Austrailan Psychiatrist Patrick McGorry’s Global Agenda for “Pre-Psychosis Risk Syndrome” Takes A Hit from Former DSM Task Force Member, Psychiatrist Allen Frances

Friday, July 30th, 2010

Note: The diagnosis being pushed for global implementation, “Pre-Psychosis Risk Syndrome” by “Australian of the Year,” Psychiatrist Patrick McGorry, takes a hit from a worthy opponent, Psychiatrist Allen Frances, former Chairiman of the DSM Task force. For more information about Patrick McGorry’s global agenda, click here:http://www.cchrint.org/2010/06/16/australian-psychiatrist-patrick-mcgorry-wants-his-pre-drugging-agenda-to-go-global/

DSM5 in Distress
Psychology Today
by Allen Frances, MD

The DSM 5 Workgroup that first suggested the inclusion of “Psychosis Risk Syndrome” has halfway come to its senses. It has dropped this stigmatizing name in a last ditch repackaging effort to salvage the proposal. The criteria set remains essentially the same, but is relabeled with the equally awkward title: “Attenuated Psychotic Symptoms Syndrome”. The suggestion remains just as dangerous and stigmatizing, whatever it is called.

Why the halfway reversal by the Workgroup at this late date? The “Psychosis Risk” proposal has stimulated widespread opposition (even I am told from within the Workgroup itself). The arguments against it are simply overwhelming. The false positive rate in predicting psychosis would be between 70-90%, meaning that between two and nine youngsters would be misidentified for every one accurately identified. The treatment most likely to be used would be antipsychotic medications. These have no proven efficacy in preventing psychosis, but most definitely have terrible side effects- especially enormous weight gain and its life threatening complications. These medications are overprescribed to those least able to resist- the young and those who are most financially disadvantaged.

Finally, the name “Psychosis Risk” was filled with ominous threat and stigma. Having a label that suggests one is at risk to soon develop a psychosis would cause the mislabelled person much unnecessary worry, unnecessarily reduced ambitions, and create great risk of discrimination in getting work or insurance – thus further exacerbating the risk side of the already totally unbalanced risk-benefit ratio.

As an early intervention strategy, everything that could possibly be wrong was wrong with “Psychosis Risk Syndrome”. An extremely inaccurate diagnosis would lead to widespread treatment with an ineffective but dangerous medication. To top it off, the writing of the criteria set is remarkably vague and internally inconsistent. That “Psychosis Risk” was an obvious nonstarter finally got through to the DSM 5 Work Group.

Seemingly, this should have been an end of story moment and we could all breathe a sigh of relief. The obvious and correct next step would be to withdraw the proposal for official recognition and instead relegate Psychosis Risk to where it belongs- in the DSM 5 appendix of suggestions that require further research. Instead, the Work Group is trying to save the suggestion by changing its name and ditching some of its overly ambitious claims.

The idea is to avoid the criticism regarding the high false positive rate by withdrawing claims that the “patients” described are likely to go on to psychosis and that the risk syndrome diagnosis can help to prevent this outcome. But the diagnosis now rests on a new set of equally questionable assumptions, that-1) the people described would have come for treatment anyway; 2) there will be no increase in overall diagnosis, just more accurate diagnosis;
3) inappropriate antipsychotic use can be contained by physician education; and, 4) the new name will carry less stigma.
.
The Work Group has always been well intentioned, but is as dead wrong in its new claims as it was in its old. Were this diagnosis to be made official- however renamed – it would certainly be used (and probably widely misused) to diagnose youngsters who previously would have avoided diagnosis and treatment. Particularly given the imprecise writing of the criteria set, it will mislabel many teenagers- especially those who are using substances, but also those who are creative or eccentric, and/or have difficult relationships with their parents. The experts on the Workgroup might make these mistakes infrequently, but they can’t responsibly make suggestions that are usable only by experts like themselves. Once official, the diagnosis will be misused in ways they never imagined or would accept and will lead to even greater misuse of antipsychotics. And the Work Group can’t rely on the wonders of physician education to clean up the mess they will be making. Most of the physician education will come from the very drug companies that have already shown themselves remarkably adept at furthering the overprescription of antipsychotics to children and teenagers.

Read the rest of the article here: http://www.psychologytoday.com/blog/dsm5-in-distress/201007/psychosis-risk-syndrome-just-risky-new-name

More information on Patrick McGorry and Pre Psychosis Risk Syndrome: http://www.cchrint.org/2010/05/21/meet-the-psychiatrist-pushing-for-a-brave-new-world-of-pre-drugging-kids%E2%80%94patrick-mcgorry/

http://www.cchrint.org/2010/06/16/australian-psychiatrist-patrick-mcgorry-wants-his-pre-drugging-agenda-to-go-global/

http://www.cchrint.org/2010/06/29/pre-crime-try-pre-diagnose-and-pre-drug-psychiatrists-target-infants-as-mental-patients-2/

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

Wednesday, July 7th, 2010

BNET
By Jim Edwards
July 7, 2010

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

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

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

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

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

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

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

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

How unfortunate!

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

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

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AstraZeneca Denied Antipsychotic Drug’s Link to Diabetes for Years After Admitting Link to Japanese Physicians

Thursday, June 17th, 2010

Natural News
By David Gutierrez
June 17, 2010

Drug giant AstraZeneca attempted to obscure the connection between one of its blockbuster drugs and diabetes risk for years after it knew of the problem, according to documents recently unsealed as part of lawsuits against the company.

More than 15,000 patients have sought damages from the company, alleging that they were harmed by side effects from its atypical antipsychotic Seroquel. According to the plaintiffs, AstraZeneca deliberately hid information linking the drug to an increased risk of weight gain and diabetes. The lawsuits have been consolidated into a single case for the purpose of pre-trial proceedings.

The recently unsealed documents include notes from a meeting between salesperson Nancy White and a doctor in July 2006, during which the doctor said that his patients were expressing concern about Seroquel’s links to diabetes. White reported telling the doctor that “there has been no causative effect” proven between the drug and the disease.

Yet in November 2002, AstraZeneca had issued a warning to doctors in Japan that due to dozens of reports linking Seroquel to diabetes, “causality with the drug could not be ruled out.” The company cautioned doctors not to prescribe the drugs to diabetics and to encourage all Seroquel patients to monitor their blood sugar. Just over a year later, the company issued a similar warning to doctors in the United States.

Read entire article:  http://www.naturalnews.com/029012_AstraZeneca_diabetes_drug.html

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