InjuryBoard Blog Network – September 29, 2011

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Read More:

• Drug companies pay $25 million to Illinois doctors [Deborah L. Shelton at Chicago Tribune]
• Doctor-drugmaker ties: Psychiatrist Dr. Michael Reinstein received nearly $500,000 from antipsychotic drug’s manufacturer [Christina Jewett and Same Roe at Chicago Tribune]
• Dollars for Doctors [ProPublica]

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• How Seroquel, a Risky Antipsychotic, Became a “General Purpose” Mental Health Drug (1)
• Once Again Psychiatrists Top the List of Top Prescribers—And Are Heavily Funded by Pharma (0)
• Antipsychotic Drug Seroquel— Diabetes Lawsuits Hurt AstraZeneca Profits (0)
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Note from CCHR:  While the FDA and its Pediatric advisory panel sit around pondering if one antipsychotic drug is more likely to cause diabetes in children than another while continuing their stall tactic of  “let’s study it some more ” routine, we’d like to point out the simple solution:  Considering that  antipsychotic drugs are already documented by international drug regulatory agencies to cause not only diabetes but obesity, psychosis, blood clots, heart problems, cardiac events, seizures, toxicity, confusion, coma and stroke (and that’s just in kids) as well as brain atrophy (meaning they actually shrink brains); considering there is no medical test to prove any child has a brain malfunction, chemical imbalance or any physical condition requiring the administration of these lethal drugs—and considering these drugs are literally killing kids that have nothing medically wrong with them in the first place— Do the job you are paid by U.S. Taxpayers to do and BAN their use on children.   Period.

GAITHERSBURG, Maryland (Reuters) – U.S. pediatric health advisers on Thursday urged drug regulators to continue studying weight gain and other side-effects of antipsychotic drugs as they are increasingly taken by children.

Significant numbers of U.S. children are receiving drugs to tame aggression, attention deficit disorder and other mental problems, even though there is little conclusive data to show exactly how the medications work or whether they damage kids’ health.

Similar to the recommendations the panel has made in previous years, it voted 16-1 to support the U.S. Food and Drug Administration’s routine safety monitoring of the new generation of antipsychotics.

But the panel did so with a caveat that the agency specifically look at how to clarify the drugs’ labels to highlight concerns about their impact on children, namely the risks of weight gain and diabetes.

“There is serious concern that children may be at a higher risk for serious adverse effects and we just don’t have sufficient data to answer that question,” said Dr. Jonathan Mink, a child neurology expert from the University of Rochester Medical Center.

Dr. Jeffrey Wagener, a pediatric pulmonologist from the University of Colorado Medical School, was the one adviser to vote “no” out of concern that wouldn’t get regulators closer to dealing with the risks of using antipsychotics in children.

“I don’t see how the FDA is responding to the December 8, 2009 request by this committee in a thorough fashion,” he said. “It’s taken them two years to not respond to that that we need to be more than in the observational role.”

The FDA in the next month to six weeks will release a revised label for Abilify, a drug sold by Bristol-Myers Squibb Co and Otsuka Pharmaceutical and approved to treat schizophrenia in adolescents, bipolar disorder in children 10 to 17 years old and irritability associated with autism in those as young as six.

“We ask that with this upcoming revision that you carefully consider the language around pediatric use and adverse events,” said Dr. Geoffrey Rosenthal, the committee’s chair and director of Pediatric and Congenital Heart Center at the University of Maryland Medical Center.

Abilify’s new label will detail the drug’s latest clinical trials, warn of metabolic concerns and remind doctors to monitor weight and symptoms of diabetes in all patients, said Dr. Thomas Laughren, FDA’s psychiatry products chief. The pediatric section of the label would contain a reference to those warnings, he said..

Such revisions, which are already incorporated into Johnson & Johnson’s antipsychotic medication Invega Sustenna, are being considered for other similar drugs on a case by case basis, Laughren said.

The new generation of antipsychotic medications has raised a wave of concerns as they are increasingly being prescribed for a host of uses and for younger and younger patients, with little conclusive research addressing their impact on children and sometimes with little evidence they work.

Newer antipsychotics include J&J’s Risperdal, known generically as risperidone; Eli Lilly & Co’s Zyprexa or olanzapine; AstraZeneca’s Seroquel or quetiapine; and Abilify, known generically as aripiprazole.

U.S. researchers have found that the drugs’ use in children increased by 65 percent from 2002 to 2009, primarily through prescriptions for teenagers.

From fall 2009 to spring of this year, 1.9 million prescriptions of Abilify alone were dispensed to patients under 18, including even 875 prescriptions for toddlers younger than 2, according to FDA research.

Most commonly, the prescriptions were for bipolar disorder in teenagers and preschoolers, and for affective psychoses in children between the ages of seven and 12.

Advisers also voted unanimously to require the FDA to show them label revisions and report back in the next year or 18 months on progress in designing more studies of the drugs in children.

http://www.fox43.com/lifestyle/sns-rt-us-usa-fda-antipsychotictre78l77l-20110922,0,216106.story

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Drug Trial Scrapped Amid Outcry

The Age
By Jill Stark
August 21, 2011

FORMER Australian of the Year Patrick McGorry has aborted a controversial trial of antipsychotic drugs on children as young as 15 who are “at risk” of psychosis, amid complaints the study was unethical.

The Sunday Age can reveal 13 local and international experts lodged a formal complaint calling for the trial not to go ahead due to concerns children who had not yet been diagnosed with a psychotic illness would be unnecessarily given drugs with potentially dangerous side effects.

Quetiapine, sold as Seroquel, has been linked to weight gain and its manufacturer AstraZeneca, which was to fund the trial, last month paid $US647 million ($A623 million) to settle a lawsuit in the US, alleging there was insufficient warning the drug may cause diabetes.

Professor McGorry, one of the Prime Minister’s key mental health advisers, planned to conduct the trial at Orygen Youth Health in Parkville, listing it on the Australian New Zealand Clinical Trials Registry last March. It was to investigate whether the drug would decrease or delay the risk of people aged between 15 and 40 with early signs of mental illness developing a psychotic disorder such as schizophrenia.

Last month, psychiatrists, psychologists and researchers from Australia, Britain and the US lodged a complaint with the ethics committee of Melbourne Health, the umbrella health service that includes Orygen.

They argued there was little evidence onset of psychosis can be prevented and it was potentially dangerous to use antipsychotics on people who merely have risk factors for a psychotic illness. They said there was evidence that up to 80 per cent would never develop a disorder.

Professor McGorry insists the decision to scrap the trial was made in June and is unrelated to the complaint, which he said he was only alerted to just over a week ago.

He maintained the trial received ethics approval in July last year but was abandoned due to “feasibility issues” with recruiting participants in European and American sites, which were to form the international arm of the study. He said Orygen had to choose between investing in the drug trial or pursuing another trial using fish oil, which had proven to be useful as an early intervention treatment for schizophrenia in a smaller study. He opted for fish oil because it had less potential for side effects than antipsychotics.

Melbourne Health confirmed the complaint will still be considered by its research ethics committee in September. Yesterday the trial was listed as “prospective” on the clinical trials registry but Professor McGorry said it was being removed.

Earlier this month The Sunday Age revealed a growing backlash against the government’s mental health reforms, with Professor McGorry’s peers claiming his youth early intervention model had been “massively oversold”.

Associate Professor Geoff Stuart of La Trobe University’s school of psychological sciences, who signed the complaint, said questions remained about the trial.

“If these feasibility obstacles can be overcome in future [would] Professor McGorry embark on such a trial again? He was willing to endorse a trial which was exploring the use of antipsychotic medication in an at-risk group. There’s a major ethical issue about medicating four people to supposedly save the fifth when you’re not saving them anyway, you’re just masking their symptoms. We’re talking about kids as young as 15 who could get a full dose of antipsychotics and they’re not psychotic.”

Professor McGorry acknowledged the evidence suggested antipsychotics were not effective as a first-line treatment for the at-risk group. But he said the risks had been exaggerated and he would consider a similar trial on patients for whom other treatments had failed. “I wrote the guidelines which said do not use antipsychotics in ultra-high risk patients, so I’ve never been supportive of it in clinical practice … [but] we should have the freedom to research all available options for this population,” he said.

The controversy over the aborted trial largely centres on “psychosis risk syndrome”, a condition that some mental health advocates want formally recognised. But critics say that could lead to young people being wrongly labelled, stigmatised and medicated for symptoms that may be temporary. They also fear that while Professor McGorry says his Early Psychosis Prevention and Intervention Centres prescribe drugs only to those who have experienced a psychotic episode, his willingness to medicate an at-risk group could mean the criteria will broaden. Professor McGorry insists this will not happen.

Early intervention What is it?

EARLY intervention is based on identifying and treating psychosis in its early stages to prevent patients developing full-blown psychotic illnesses such as schizophrenia.

Patrick McGorry’s Early Psychosis Prevention and Intervention Centres (EPPIC) treat young people who have experienced a psychotic episode with treatments such as psychotherapy, family therapy, medication or a combination. He says early treatment significantly improves the chance of recovery and reduces long-term impairment. But diagnosing psychotic disorders is difficult and McGorry’s critics say there is no reliable diagnostic tool to predict if someone will develop a psychotic illness and there is insufficient evidence intervention can prevent it.

Critics say up to 80 per cent of those with ”psychosis risk syndrome” – which refers to people who only have risk factors such as a family history or a deterioration in mental health – never develop an illness. They fear early intervention will lead to many patients being wrongly labelled as psychotic and medicated unnecessarily.

A recently released literature review by The Cochrane Collaboration found there was insufficient evidence that early intervention could prevent psychosis and that any benefits were not long term. Professor McGorry said it used flawed methodology.

http://www.theage.com.au/national/drug-trial-scrapped-amid-outcry-20110820-1j3vy.html?from=age_sb

August 21, 2011

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NaturalNews – August 16, 2011

by Monica G. Young

Click image to visit CCHRInt's Psychiatric Drug Side Effects Search Engine

What irony. Detroit mother, Maryanne Godboldo, was just charged with child neglect for refusing to obey a Child Protective Services order to give her daughter Risperdal, a powerful psychoactive drug. Meanwhile federal and multiple state prosecutors are suing Johnson & Johnson for deceptively marketing the drug – including mismarketing its use on children – and hiding dangerous adverse effects. J&J now faces a potential $1 billion in damages.

Having earlier observed the drug’s dreadful effects on her child, Maryanne was correctly pursuing holistic treatment for the child instead when the legal battle began. The jury’s ruling, now handed down against the mother, is not only a travesty of justice, but a reflection of psychopharma’s vast propaganda machine. (http://www.naturalnews.com/033295_p…)

Fortunately not everyone is fooled. The US Department of Justice (DOJ) has been investigating J&J for years in regards Risperdal – its sales practices, pay-offs to doctors to promote the drug, and failures to disclose harmful effects. The pharma giant has now tentatively agreed to settle a misdemeanor criminal charge, however the DOJ and US attorney’s office are pursuing additional criminal actions.

The government plans to join civil lawsuits filed by company whistleblowers, aiming to recover millions of dollars paid for prescriptions via government health programs like Medicare and Medicaid.

Already multimillions in fines have been levied against J&J for this powerful antipsychotic which is widely prescribed not only for schizophrenia but mood and anxiety disorders, dementia and other unapproved uses.

In June, a South Carolina judge demanded the company pay $327 million to the state for deceptively marketing Risperdal and concealing its dangers. The judge called J&J’s practices “detestable.” Last October, a Louisiana jury ordered the company to ante up $257.7 million for misleading claims about the drug’s safety.

Recently, Massachusetts Attorney General joined the fight, filing a lawsuit against J&J for illegal marketing and failing to disclose “an increased risk of death” connected with the drug.

In Texas the Attorney General Office has joined forces with whistleblowers, with a jury trial scheduled for this fall. This lawsuit alleges that Janssen, J&J’s pharmaceutical division, intentionally marketed Risperdal for use on children even though it was only approved for adult schizophrenia. The suit also involves a company scheme to boost prescriptions by paying hundreds of thousands of dollars to “experts” to evaluate and recommend the drug state-wide and nationally. Awarded damages are anticipated to be much larger than in South Carolina or Louisiana. Texas has paid more than $500 million for the drug since it was first brought to the market.

Attorneys general in about 40 other states have shown interest in suing the company.

Users speak out – beware of this drug!

(Note from CCHRInt –search Risperdal or antipsychotic drug side effects in CCHR’s Psychiatric Drug Database here http://www.cchrint.org/psychdrugdangers/drug_warnings.php – simply type in Risperdal  in the Red Search box or choose it from the drop down menu)

Risperdal’s documented “side effects” include huge weight gain, diabetes, lethargy, muscular tics, breast development in males, and many more.

Below are just a few sample statements made online by individuals from their experience with this so-called “medication” (the root word of medicate means “to heal”):

“Basically I lost the drive for everything. Total shut down to my outgoing personality. Massive weight gain.”

“Tardive dyskinesia [involuntary movement disorder], diabetes, gained 100 pounds in the first year, was a zombie… I was put on this nightmare drug when I was six. I was forced to take it against my will, and it ruined my life… This is a horrible, HORRIBLE drug, and should be banned.”

“Apathy, not talking, just staring, sleeping constantly, tongue movements, loss of sexual function. This is a very BAD DRUG…a mental straight jacket. DO NOT put children on this drug!!! It’s poison.”

“I gained weight, became very tired, and of course that just led them to put me on antidepressant medications…. I have been on it since fifth grade and hardly knew what was happening to me.”

“My son has gained over 100 pounds… He was an excellent student, received a doctorate and now cannot even remember what he studied. He sleeps all day and cannot work a job. His quality of life is nil. His mouth twitches and he has no control over it… It is like taking a dose of legalized poison every day. This is a LIFE WASTED AND RUINED, a brilliant mind destroyed and tortured. As a mother, it rips out my heart every day.”

Yet per Johnson & Johnson annual reports, global Risperdal sales from 1994-2010 totaled nearly $29 billion.

http://www.naturalnews.com/033336_Risperdal_child_neglect.html

Sources for this article include:

http://www.google.com/hostednews/ap…

http://www.thefix.com/content/jj-su…

http://www.reuters.com/article/2011…

http://www.kxan.com/dpp/news/invest…

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The Fix – Aug 5, 2011

by Walter Armstrong, Deputy Editor, The Fix.

Pharmaceutical giants spend billions a year to get doctors to prescribe drugs to American kids. Johnson & Johnson even passes out Legos advertising its latest anti-psychotic, ignoring mounting evidence that the drug causes diabetes, wild weight gain, and grows breasts in boys and girls who take it. Their solution? More pills

Plastic Legos stamped "RISPERDAL" are a fixture at pediatricians' offices nationwide.

In the past decade, America’s pharmaceutical industry has knowingly marketed dozens of dangerous drugs to millions of children, a group that executives apparently view as a lucrative, untapped market for their products. Most kids have no one to look out for their interests except anxious parents who put their trust in doctors. As it turns out, that trust is often misplaced. Big Pharma spends massive amounts to entertain physicians, send them on luxury vacations and ply them with an endless supply of free products. As a result, hundreds of thousands of American kids—some as young as three years old—have become dependent on amphetamines like Adderall and a pharmacopeia of other drugs that allegedly treat depression, insomnia, aggression and other mental health disorders.

The fact that none of these powerful mood-altering medications have been approved by the FDA to treat children under 10 has posed no obstacle to the industry’s marketing masterminds. They’ve waved off objections by some some doctors who wonder how these complex drugs will affect the vulnerable brains and bodies of their young patients. Other experts have warned that children exposed to this multi-molecular barrage on their central nervous systems could potentially be at much higher risk of becoming adults who are addicted to chemicals, prescription and otherwise. But thanks to a billion-dollar advertising campaign, millions of kids across the nation are now taking pills to control a long  litany of “behavioral problems.”

Luckily, Johnson and Johnson is not getting off scot-free. Last week, Massachusetts Attorney General Martha Coakely announced that the state was suing the world’s biggest pharmaceutical firm, Johnson & Johnson, for illegally promoting Risperdal, an “atypical anti-psychotic”,  for off-label treatment of childhood schizophrenia, bipolar disorder, autism, hyperactivity and attention deficit disorder, depression and anxiety, sleep disorders, anger management, mood enhancement or stabilization. As BNet’s Placebo Effect blog recently reported, the list of maladies is grotesquely long. J&J, which prides itself on its high-minded credo of “always putting patients first,” began moving its new drug into this new market as soon as Risperdal won approval in adults—even though the FDA explicitly forbid it from doing so, for the simple reason that the firm had never done a single test of the drug in children who suffered from these or any other conditions.

Though Risperdal was marketed as a less dangerous—if not more effective—alternative to older “typical” anti-psychotics, it quickly became apparent that the drug had many worrisome side effects in adults, including the rapid onset of diabetes and alarming weight gains. But despite a growing weight of evidence about the drugs, J&J only stepped up its promotion of the drug for children—aiming for more conditions and in ever-younger kids—no doubt to squeeze as many profits as possible out of this lemon before the FDA ordered them to stamp a warning on the label or withdraw it from the market altogether.

Unsurprisingly, teens and kids started developing symptoms of drug-induced diabetes and weight gain. Several also developed a bizarre condition called galactorrhea, in which milk flows spontaneously from the nipples of your breasts—girls and boys alike—a happening that is likely to drive even the most balanced teen around the bend. What may be even more bizarre, when doctors alerted J&J sales reps to this side effect, sales reps relayed the warning to their managers, who advised the sales reps to tell the doctors (in a frankly illegal reversal of medical protocol) that rather than take the kids off Risperdal, they could be treated with yet another drug.

The Massachusetts case is the third of about 10 state lawsuits in which jurors will be asked to pass judgment on whether J&J’s Risperdal promotional practices constitute medical fraud. Class-action suits by patients (or parents) claiming injury are also in the works. The Obama administration has shown some guts in not simply allowing the giant drug makers to settle such lawsuits for giant fees ($2 billion is not unusual, however ho-hum to pharma) but in holding individual company executives personally liable for the criminal activity.

In fact this code of misconduct is what we have come to expect from the pharmaceutical industry: Always put profits first, break the law now, pay the fine years later. Given the high-risk nature of drug development—a novel compound costs close to $1 billion and a decade to get to market—Big Pharma has tried all manner of dark arts to increase its odds. Criminal activity, once largely limited to the sales divisions, has overtaken the entire endeavor. Clinical trials that produce negative data—including health risks—are hidden from the FDA. Early signals of serious side effects are covered up, as are promised follow-up studies upon which approval is conditioned. Like other industries, pharma and its lobbyists have regulators and Congress by the balls.

But it’s the corruption of the medical profession by the pharmaceutical industry that has proved most insidious, and nothing illustrates the perilous consequences better than J&J’s illegal marketing of Risperdal to kids. Making 100,000 sales calls on psychiatrists and pediatricians, the company lined the pockets of willing MDs employing familiar pharma ploys, from the small-change items like lavishing free samples, free lunches and—this may be a first—even free colorful plastic Lego blocks printed with the word RISPERDAL for children to play with in the waiting room, to the big-ticket items such as “educational” meetings at fancy resorts and “advisory board” soirees at the Four Seasons. The company even paid certain leading specialists hundreds of thousands of dollars a year to conduct J&J-designed trials and sign their name to J&J-written studies published in the top medical journals—providing a “scientific” spin to the promotional materials. In this amorphous manner, a professional consensus emerged that the atypical anti-psychotics were effective in very young children for attacks of rage, poor impulse control, defiant and oppositional behavior—the transient, irrational, sometimes frightening “acting out” that sends overworked adults around the bend.

By means of this closed circle or deceit and kickbacks, J&J beat out the competition to grab 50 percent of the pediatric market for anti-psychotics. And although many other psychiatrists and pediatricians were arguing that anti-psychotics should never be given to children under 10 in the first place, the white wall of silence in the medical profession generally prevents doctors from becoming whistleblowers unless prodded by investigative news reporting.

Everybody was profiting, it seemed, except for the kids.

Consider Kyle Warren, who as an 18-month-old Louisiana toddler began taking Risperdal prescribed by a pediatrician on the J&J payroll (plastic RISPERDAL Legos and all). Kyle suffered from frequent temper tantrums, and his mother, Brandy Warren, then 22, was a new mother on Medicaid and, as she told the New York Times, “at my wit’s end.” But like any good mother, Brandy kept on searching for the right diagnosis and the right treatment, going from doctor to doctor and amassing a contradictory set of assessments, such as autism, psychosis, schizophrenia, bipolar disorder, and attention deficit hyperactivity disorder. By the time he was age three, Kyle’s daily pill regimen resembled that of someone very old or very sick, including Risperdal, the antidepressant Prozac, uppers for ADHD and downers for insomnia. He was sedated, he drooled, and he was ballooning with fat from the side effects of the Risperdal—but, look Ma, no more temper tantrums!

read the rest of the article here: http://www.thefix.com/content/jj-sued-illegal-promotion-drugs-kids?page=all

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By CCHR Int
June 23, 2011

At just 6 years of age, still grieving over the death of the only mother he’d ever known, his foster mother, Giovan Bazan received the first of many psychiatric “diagnoses” and drugs that would plague him for the next twelve years of his life. Moved from foster home to  foster home, orphanages and other modes of state care, Giovan was stigmatized with a plethora of psychiatric diagnoses and drugs until the age of 18, when he could finally make his own medical decisions and quit. Now a child advocate working part time at the Division of Family and Children Services (DFCS) in Georgia, Giovan is on a mission: To get a full-time job with DFCS and help enact laws to combat the wholesale labeling and drugging of foster children. In the video below, Giovan tells his story and why he decided to fight back against the abuse of kids in foster care.

(Story continues below)

Foster kids—often removed from family homes because of abuse—are further abused when they are prescribed psychotropic drugs under state care. Many of these children are on cocktails of prescribed drugs, including antipsychotics and antidepressants with documented side effects of diabetes, stroke, mania, psychosis, tumors, coma, suicide and death.

Yet, the rates with which these children are being given drugs has been increasing. The antipsychotic use rate among foster kids increased by 5.6% between 2004 and 2007 (from 11.7 percent to 12.4 percent). Another study in Pediatrics, revealed that youth in foster care covered by Medicaid insurance receive psychotropic medication at a rate more than 3 times that of Medicaid-insured youth who qualify by low family income.

Only half of state child welfare systems have a policy to review usage of these drugs, and those are weak policies at that.

The psychiatric drugging of foster kids has caused so much concern nationally that in July 2010, the Government Accountability Office (GAO) started an investigation into the use of these drugs in foster care, as they are widely used in dangerous combinations, and for so-called “off-label” uses to treat symptoms for which they have not been medically approved. The GAO is looking into the estimated hundreds of millions of dollars of fraud arising from this and is collecting and analyzing data from Florida, Maryland, Massachusetts, Minnesota, Oregon and Texas.

For more information on the psychiatric drugging of children, watch these videos:

Psychiatry—Labeling Kids with Bogus ‘Mental Disorders’

Drugging Our Children—Side Effects

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Note from CCHR: There are a lot more serious documented side effects to antipsychotics  than simply weight gain for kids—such as, diabetes,  stroke, tumors,  seizures, coma and heart problems to name a few.  These warnings/studies are summarized in our psychiatric drug database – simply search antipsychotics in under 18-year-olds – here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

Parent Dish – June 21, 2011

Children can experience dramatic weight gain and insulin resistance just weeks after taking the drugs for the first time. Credit: Getty Images

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The Miami Herald – May 28, 2011

By Fred Grimm

They’re children of the new Florida ethic. Zombie kids warehoused on the cheap in the state’s juvenile lock-ups. Kept quiet, manageable and addled senseless by great dollops of anti-psychotic drugs.

A relatively small percentage of young inmates pumped full of pills actually suffer from the serious psychiatric disorders that the FDA allows to be treated by these powerful drugs. But adult doses of anti-psychotic drugs have a tranquilizing effect on teenage prisoners. Prescribing anti-psychotics for so many rowdy kids may be a reckless medical practice, but in an era of budget cuts and staffing shortages, it makes for smart economics.

Florida fairly inundates juvenile offenders with this stuff.

The Palm Beach Post reported last week that the Florida Department of Juvenile Justice has been buying twice as many doses of the powerful anti-psychotic Seroquel as it does ibuprofen. As if the state anticipated more outbreaks of schizophrenia than headaches or minor muscle pain.

The Post found that Florida purchased 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs during a two-year period for the boys and girls who occupy the 2,300 beds in state-run residential facilities. (Most of the state’s juvenile offenders are held in jails operated by for-profit contractors. Records revealing the quantity of medications that private companies pour down their prisoners’ gullets were not available.)

Such drugs, meant for adults, are known to send children into suicidal despair, along with risking heart problems, weight gain, diabetes and facial tics. Yet, the DJJ and its contract psychiatrists push them willynilly onto their young wards.

It’s not as if state officials have been unaware of the risks facing children prescribed “off label” uses (unapproved by the FDA) of these pharmaceuticals. Even as the state doled out Seroquel like candy to kids in DJJ jails, the Florida Attorney General’s office was entering into a lawsuit with 36 other states against drug manufacturer AstraZeneca for promoting dangerous, off-label uses of Seroquel for treating both the young and the elderly. (AstraZeneca agreed to settle the lawsuit in March for $68.5 million and to stop marketing the drug for unauthorized uses.)

It was as if the schizophrenics most in need of Seroquel were roaming the halls of government, not the juvenile jails.

“This is the face of all these budget cuts; what happens when you eliminate social workers and prison guards,” said Broward Public Defender Howard Finkelstein. He suspects that DJJ has compensated for the staff shortages at state lockups by pumping “the most powerful drugs known to man into children who have not been diagnosed for psychiatric problems.”

Finkelstein says he assigned two of his staff attorneys last week to visit juvenile lock-ups and investigate what he calls the “zombification” of young offenders who had been represented by his office.

Florida Attorney General Pam Bondi opened her own investigation last week. Bondi’s staff attorneys are interested in the Post’s report that psychiatrists prescribing off-label uses of such astounding quantities of the profitable anti-psychotics for DJJ prisoners (at taxpayer expense) had been greased by drug manufacturers with some $250,000 in gifts and speaking fees.

The DJJ drug scandal seems all the more maddening considering that it follows a similar uproar just two years ago after the suicide of a seven-year-old Margate foster child. Young Gabriel Myers had been given adult dosages of three anti-psychotics before he hung himself.

The Gabriel Myers Task Force, made up of child advocates, state officials, political leaders and judges from across the state, spent a year investigating whether the Florida Department of Children and Families had administered dangerous drugs as “chemical restraints” for troublesome foster children.

Foster kids, as it turned out, weren’t the only victims of the on-the-cheap ethic. But don’t think of children reduced to zombies. Think of all the money we save on prison guards.

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BNET
By Jim Edwards
May 27, 2011

In 2008, the FDA declared that powerful antipsychotics such as AstraZeneca (AZN)’s Seroquel were being over-prescribed and started a monitoring initiative to curb their use. It hasn’t worked, judging by an analysis of the FDA’s adverse event database by the Institute for Safe Medication Practices.

Seroquel is only approved for schizophrenia, mania and bipolar disorders. It’s a powerful drug that has serious side effects if taken for a long time: It’s associated with weight gain and diabetes, among other problems.

Yet the ISMP found that 47 percent of all adverse events linked to Seroquel since 2004 occurred when the drug was being used for unapproved or “off-label” purposes, such as depression. 21 percent of adverse events are linked to off-label use of Seroquel in depression — a condition for which there are plenty of other available drugs — and 26 percent of events occur with other off-label uses:

The ISMP said:

the adverse event data show quetiapine [Seroquel] has become a general purpose psychiatric drug with most reported injuries occurring outside its core indication for treatment of the most severe mental disorders, schizophrenia and psychosis.

In the off label category more than half the cases were for sleep disorders and insomnia. The next largest group was anxiety, and the remainder was divided among many other medical uses including autism, panic attack, headache, restlessness, nervousness, dementia and agitation.

The report is yet another in a series of publications from a variety of sources that suggest some psychiatric doctors are abusing their patients with Seroquel. In addition to the FDA’s 2008 declaration, consider:

• Florida’s Department of Juvenile Justice — which houses kids with criminal records — buys twice as much Seroquel as ibuprofen.
• The military’s spending on Seroquel increased sevenfold since 2001as veterans’ doctors prescribed it for insomnia and post-traumatic stress disorder.
• Seroquel isn’t approved for children under age 13 but there are plenty of researchers studying it in kids anyway.

Injuries from Seroquel’s side effects can be severe and permanent. In addition to diabetes they include suicidal/self-injurious behavior, and neurological movement disorders such as tardive dyskinesia, dystonia and parkinsonism.

AstraZeneca’s role in promoting Seroquel for off-label uses is well documented. The company has paid $1.5 billion in legal costs and settlements for its mismarketing of the drug ($520 million to the Department of Justice; another $743 million in legal costs in unresolved cases through March 2011; and $198 million in civil settlements.)

So doctors have no excuse. The FDA — which has almost no jurisdiction over physicians — and the courts have performed their roles. It’s time for the medical profession to take responsibility for the damage it is causing and cut down on its dispensing of Seroquel.

Read article here:  http://www.bnet.com/blog/drug-business/how-seroquel-a-risky-antipsychotic-became-a-8220general-purpose-8221-mental-health-drug/8545

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BNET
By Jim Edwards
March 25, 2011

One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”

Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded at CourtroomView Network.)

In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk:

But J&J began trying to figure out whether the “dear doctor letter” could actually be used to promote Risperdal, which executives believed was not as risky as similar drugs. SVP/R&D Scott Reines had seen a previous “dear doctor letter” from Eli Lilly that had used the same sleight of hand, and he asked a colleague, “how much commercial liability would we incur if we sent a similar letter about Risperdal”?:

When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:

The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”

Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J …  [and] no competent person would have let [the 'dear doctor letter'] go out”:

J&J faces up to $36 million in fines as a result.

Read article here:  http://www.bnet.com/blog/drug-business/internal-j-j-emails-detail-8220ugly-8221-chapter-in-mismarketing-of-antipsychotics/7743

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