Posts Tagged ‘drug warnings’

FDA Needs to Ban Antipsychotic Drug Use on Kids

Friday, September 23rd, 2011

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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How Did These Babies Die? Question unites grieving families

Tuesday, August 2nd, 2011
BC LocalNews.com – August 1, 2011
by Jeremy Deutsch

Matthew Schultz was only 2.5 hours old when he died on Feb. 21, 2009. A coroner’s report stated there was no anatomical or toxicological cause of death, which was deemed “natural”. Another baby, Greyson Rawkins, was only two months old when he died on March 23 of this year. A coroner’s report found Greyson died of sudden unexplained death in infancy and his death was ruled undetermined. However, the mothers of both babies were taking Effexor while carrying and believe the antidepressant drug may be connected to the deaths of their children. And, as KTW learned, there are widespread medical warnings about pregnant women taking antidepressants.

Two hours is not a lot of time, but for little Matthew Schultz, it was his entire life.

One moment, Amery Schultz held Matthew in his arms. The next moment, his child was dead.

As the Merritt family struggled to deal with their grief, two years later and 45 minutes away in Kamloops, another family would be shattered by the sudden loss of a newborn.

Greyson Maxwell Rawkins was found one morning by his mother, cold and unresponsive.

The two-month old was dead.

Unlike most sudden-infant deaths, which go largely unexplained, both families believe they know exactly what killed their sons — an antidepressant called Effexor.

Matthew was born on February 21, 2009, at 2:21 a.m. at Royal Inland Hospital.

Right from birth, the newborn had poor colouring  and trouble breathing.

Schultz said he and wife Christiane argued with medical staff at the hospital about Matthew’s symptoms, only to be told they was normal.

An hour later, alone in the hospital room, Amery held Matthew in his arms.

He was gently rocking his fifth child to sleep and noted the baby’s lips were a bit purple.

Matthew fell asleep in his father’s lap.

Moments later, a nurse came into the room and noticed the new born was pale and unresponsive.

Matthew was in complete respiratory and cardiac arrest.

Medical staff were unable to revive him and he was pronounced dead an hour later.

“Losing your child — you can’t explain it,” Amery said.

“It tears a hole in your heart that will never heal.”

The B.C. Coroners Service listed Matthew’s death as natural — as far as the coroner was concerned, it was a case of sudden infant death syndrome (SIDS).

However, the Schultzes were not convinced.

The couple started to do their own research and were dismayed by what they found.

Christiane had been taking the antidepressant Effexor, also known by its clinical name venlafaxine, for years prior to Matthew’s birth and during pregnancy.

Three previous children were also exposed to the drug.

Unbeknownst to the couple, venlafaxine had been under a Health Canada warning since 2004.

The government agency had advised that newborns may be adversely affected when pregnant women take a specific group of antidepressants during the third trimester of pregnancy.

The list included venlafaxine.

The Schultzes said their family doctor never told them about the possible risks of taking the drug during pregnancy.

“I asked every pregnancy, ‘Should I get off of these?’” Christiane said.

“But I was told, ‘No, they’re fine, they’re perfectly safe.’”

Convinced Effexor contributed to Matthew’s death, the family awaited the final report from the coroner, hoping to get some answers as to the cause of their son’s death.

They were also hoping the coroner would make recommendations so other families wouldn’t suffer through a similar loss.

But the report, which the Schultzes received on the two-year anniversary of Matthew’s short life and death, surprised and angered the family.

It made no recommendations and found no cause of death.

According to the coroner’s report, a detailed autopsy on Matthew showed no anatomic cause of death, but the possibility was raised of venlafaxine exposure being a contributing factor.

Brain-tissue samples were sent to a research facility in the U.S. for examination to determine if there was an underlying susceptibility to the class of antidepressants.

But the report noted it was unclear how prenatal exposure to Effexor might have contributed to Matthew’s death, if at all.

The report concluded the significance of the exposure to venlafaxine in utero is unknown and made no recommendations.

“At best, I can’t bring my son back,” Amery said.

“But to call his death natural, certainly it’s not.”

He argued the coroners office has ignored what he considers overwhelming evidence the drug played a role in his son’s death.

The report itself listed exposure to venlafaxine under the category of other conditions contributing to death.

Physician and coroner Karla Pederson, with the B.C. Coroner’s Service, looked over the results of the report and is satisfied the office went to great lengths to find the cause of death.

“We are not making a presumption that we know what caused the death of this child, because we do not know,” she said.

When asked if the coroners service is concerned about the use of antidepressants during pregnancy, Pederson noted the drugs are used by thousands, if not millions, of pregnant women around the world without resulting in infant death.

Greyson Rawkins was born on Jan. 24, 2011, at RIH.

Like Matthew Schultz, little Greyson had trouble breathing at birth and spent five days in the hospital before he could go home for the first time.

“He was just different from my first,” said Greyson’s mother, Nicole Rawkins, who noted her second child weighed less and slept much more than her daughter, Layla, now three years old.

During her entire pregnancy, Rawkins said she was taking a prescribed 450-milligram daily dose of Effexor to help her depression.

It was more than five times the amount she took during her first pregnancy.

The 31-year-old Rawkins was also taking another drug called Seroquel, between 100 and 150 milligrams a day, which is used to treat bipolar depression.

She said her doctor never told her of the risks.

After two months, though, Greyson appeared to be doing well.

That was until the evening of March 22 of this year.

Rawkins put Greyson to sleep in his bassinet, in the same room with her and her boyfriend.

But the two-month old was being fussy, so mom brought him into her bed for nursing.

They fell asleep, with Greyson lying on the edge of the bed with his mom.

At around 4 a.m., Greyson’s older sister decided to climb into bed, while Rawkins’ boyfriend moved to a couch.

Five hours later, Rawkins awoke to find her son cold and unresponsive.

“I shook him a bit, but he was floppy,” she recalled.

Emergency services was dispatched, but it was too late.

Greyson was dead.

Rawkins thought she had accidently killed her baby, but that wasn’t the case.

A coroner’s report released at the end of June listed the death as undetermined and classified it as SIDS.

As in the Schultzes’ case, the autopsy noted Effexor and Seroquel as risk factors for SIDS in the case, but added it could not be determined by a pathological exam.

An autopsy on Greyson also stated the respiratory complications at birth were considered likely secondary to withdrawal effects from utero exposure to venlafaxine.

Despite the findings, Rawkins said the blame in Greyson’s death has fallen on her shoulders.

“I wasn’t allowed to grieve because everyone was watching me,” she said.

After getting in contact with the Schultz family and sharing their stories, Rawkins is also certain the antidepressants she had taken for months played a role in Greyson’s death.

The two mothers have been carrying around their own guilt because they unwittingly exposed their children to the drug.

“Every day I look at them and I did that to them because I didn’t look up the safety of the drug,” said Christiane.

“Every day is guilt.”

http://www.bclocalnews.com/news/126547313.html

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Note to Press Re: Arizona Shooting—Before Touting Pharma’s “More Mental Health Treatment Needed” Line – Try Asking The Right Questions

Wednesday, January 12th, 2011

By CCHR International

10 recent massacres were committed by those under the influence of psychiatric drugs resulting in 54 dead and 105 wounded

Every single time there is a school shooting, or some senseless massacre, the press are quick to start touting the need for more mental health treatment to “prevent” these tragedies—well before the facts of the case have been investigated. In fact, most of the press don’t appear as interested in bringing the facts to light as they are in making “recommendations” based on assumptions and calling for more mental health services/treatments.   How one can make recommendations before finding out what actually occurred seems illogical to us, and we’re hoping we’re not the only ones.   What also seems illogical is the lack of direct questioning and demand for answers given the facts already known about prior massacres/shootings, such as:  The majority of those who committed such acts had already undergone mental health “treatment,”  and were already on psychiatric drugs.   Drugs documented by international drug regulatory agencies to cause violence, mania, psychosis, hallucinations, suicide and even homicidal ideation.

In the case of prior massacres/shootings, what has repeatedly occurred is that when the facts finally came out,  due solely to the efforts of those few  determined investigative reporters (such as Fox National News reporter Douglas Kennedy), and it was revealed that the shooter had been under the influence of psychiatric drugs, or in withdrawal from them,  most of the press were quick to counter the drug/violence connection by featuring some Pharma mouthpiece touting the “there is no evidence that these drugs cause violent or homicidal behavior” line.

Really?    No evidence? There have been 22 International Drug Regulatory Agency Warnings on psychiatric drugs causing violence, mania, psychosis and even homicidal ideation.   These warnings have been issued by drug regulatory agencies in the United States,  the European Union, Japan,  The United Kingdom, Australia and Canada.

And consider that just last week, TIME Magazine reported on a study from the Institute for Safe Medication Practices that  “based on data from the FDA’s Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.”  And out of the Top 10, 8 were psychiatric drugs.

From Time Magazine: “When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

The Top 10 included  the Antidepressants Pristiq, Effexor, Luvox, Paxil, Prozac, ADHD Drugs, Strattera and the Anti-Anxiety drug,  Halcion.

Now, to be perfectly clear, we’re not saying for a fact that Loughner was taking  psychiatric drugs at the time of the shooting, or in the past, which studies show can cause long-term  damage long after an individual has stopped taking them.   We’re saying, why aren’t the press finding out?   Consider that 10 recent massacres were committed by those under the influence of psychiatric drugs documented to cause mania, psychosis, violence and even homicide, resulting in 54 dead and 105 wounded—and those are just the ones we know about. In several cases, medical records were sealed or autopsy reports not made public or, in some cases, toxicology tests were either not done to test for psychiatric drugs, or not disclosed to the public.   But let’s just consider what we do  know about the mental health “treatment” of those who committed these acts of violence:

  • Dekalb, Illinois – February 14, 2008: 27-year-old Steven Kazmierczak shot and killed five people and wounded 16 others before killing himself in a Northern Illinois University auditorium. According to his girlfriend, he had recently been taking Prozac, Xanax and Ambien. Toxicology results showed that he still had trace amount of Xanax in his system.
  • Omaha, Nebraska – December 5, 2007: 19-year-old Robert Hawkins killed eight people and wounded five before committing suicide in an Omaha mall.  Hawkins’ friend told CNN that the gunman was on antidepressants, and autopsy results confirmed he was under the influence of the “anti-anxiety” drug Valium.

  • Jokela, Finland – November 7, 2007: 18-year-old Finnish gunman Pekka-Eric Auvinen had been taking antidepressants before he killed eight people and wounded a dozen more at Jokela High School in southern Finland, then committed suicide.

  • Cleveland, Ohio – October 10, 2007: 14-year-old Asa Coon stormed through his school with a gun in each hand, shooting and wounding four before taking his own life.  Court records show Coon had been placed on the antidepressant Trazodone.

  • Blacksburg, Virginia – April 16, 2007: 23-year-old Seung Hui Cho shot to death 32 students and faculty of Virginia Tech, wounding 17 more, and then killing himself.  He had received prior mental health treatment, however his mental health records remained sealed.

  • Red Lake, Minnesota – March 2005: 16-year-old Jeff Weise, on Prozac, shot and killed his grandparents, then went to his school on the Red Lake Indian Reservation where he shot dead 7 students and a teacher, and wounded 7 before killing himself.

  • Greenbush, New York – February 2004: 16-year-old Jon Romano strolled into his high school in east Greenbush and opened fire with a shotgun.  Special education teacher Michael Bennett was hit in the leg.  Romano had been taking “medication for depression”.

  • El Cajon, California – March 22, 2001: 18-year-old Jason Hoffman, on the antidepressants Celexa and Effexor, opened fire on his classmates, wounding three students and two teachers at Granite Hills High School.

  • Williamsport, Pennsylvania – March 7, 2001: 14-year-old Elizabeth Bush was taking the antidepressant Prozac when she shot at fellow students, wounding one.

  • Conyers, Georgia – May 20, 1999: 15-year-old T.J. Solomon was being treated with antidepressants when he opened fire on and wounded six of his classmates.

  • Columbine, Colorado – April 20, 1999: 18-year-old Eric Harris and his accomplice, Dylan Klebold, killed 12 students and a teacher and wounded 26 others before killing themselves.  Harris was on the antidepressant Luvox.  Klebold’s medical records remain sealed.

  • Notus, Idaho – April 16, 1999: 15-year-old Shawn Cooper fired two shotgun rounds in his school, narrowly missing students.  He was taking a prescribed SSRI antidepressant and Ritalin.

  • Springfield, Oregon – May 21, 1998: 15-year-old Kip Kinkel murdered his parents and then proceeded to school where he opened fire on students in the cafeteria, killing two and wounding 22.  Kinkel had been taking the antidepressant Prozac.

So, given the fact that these shooters were on psychiatric drugs, given the fact that 22 international drug regulatory agencies warn these drugs can cause violence, mania, psychosis, suicide and even homicide, given the fact that a major study was just released confirming these drugs put people at greater risk of becoming violent,  here are the questions we think deserve to be answered.

1) Court records show that a case against Jared Loughner was dismissed on Dec. 9, 2008, after he completed some type of diversion program.    What was the diversion program?  Did it include mental health treatment or do the case notes include any information about any prior mental health treatment  Loughner may have undergone?  Such was the case of Columbine shooter Eric Harris’s “diversion program”, where case notes dated 4/16/98 revealed that “Eric has been having difficulty with his medication for depression.  A few nights ago he was unable to concentrate and felt restless.  He went to the doctor and the doctor is changing his medication.”

* Further note to press: Sometimes finding the psychiatric drug connection requires a bit more due diligence than just asking the question; case in point,  following the Columbine massacre, the Coroner’s office initially reported no drugs were found in Eric Harris’ tox reports.   Following this, an investigative reporter found that Harris was rejected from the military and psychiatric drug use was suspected as the cause for the rejection.   When this became known,  the coroner’s office seemed to find that  Harris did in fact have the antidepressant Luvox in his system.

2) The Wall Street Journal reported, “One high-school pal said Loughner had become suicidal”.  Considering the FDA has issued black box warnings that antidepressants can cause suicidal ideation (as can other psychiatric drugs) was Loughner already under the influence of these drugs?

3) The press has reported that Loughner was “barred from campus pending a psychological evaluation.”  So what happened?  Did he get one?  Was he ever in mental health treatment, or prescribed a psychiatric drug? Ever?

As a final note:  Whether or not Loughner was yet another in the long list of shooters under the influence of drugs documented to cause mania, psychosis, hallucinations, aggressive behavior, suicidal and homicidal ideation—Given the international drug regulatory agency warnings & studies, the just released Institute for Safe Medication Practices study, this much we know for certain; the  last thing we need is more kids on psychiatric drugs.    And given what we already know about the risks of these drugs, any recommendation for more mental health treatment, meaning more people and more kids put on these drugs, is not only negligent, but considering the possible repercussions, criminal.

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Psychiatrist Asks, “Why Are People So Divided When It Comes To Children’s Mental Health?” We’ve Got the Answer…

Tuesday, December 7th, 2010

20 million kids are being prescribed dangerous mind-altering drugs

By CCHR

Today’s Huffington Post features an article from psychiatrist Harold Koplewicz, frequently seen in the press leading the cheer for more psychiatric diagnosing and drugging of children.   In today’s article, Koplewicz makes a plea to ‘Stop the Stigma’ which is preventing children from being diagnosed mentally ill.   Pretty catchy slogan isn’t it? “Stop the Stigma.”  It ought to be, it’s a brilliant marketing campaign, brought to you by Big Pharma, via the National Alliance on Mental Illness (NAMI), a group that  masquerades as a “patient’s rights group for the mentally ill”  but receives tens of millions in Pharma funding.

But here’s the real rub—What entity is most responsible for stigmatizing millions of children? What group has pathologized childhood behavior and repackaged a list of behaviors into a “disease” called ADHD?  Psychiatry and Pharma.   You can’t be a kid anymore.  If you display child-like behaviors you can be  branded mentally ill for life. And its not just us saying this.  Consider that the former Chairman of the American Psychiatric Association’s DSM task force,  psychiatrist Allen Frances, stated “Our country is in the midst of a fifteen year ‘epidemic’ of Attention Deficit Disorder (ADD). There are six potential causes for the skyrocketing rates of ADD—but only five have been real contributors. The most obvious explanation is by far the least likely – that the prevalence of attention deficit problems in the general population has actually increased in the last 15 years. Human nature is remarkably constant and slow to change, while diagnostic fads come and go with great rapidity. We don’t have more attention deficit than ever before-we just label more attentional problems as mental disorder.”

He  also talked about “stigma,” but sourced the industry creating it—psychiatry: “The ‘epidemic’ of childhood Bipolar Disorder has created a public health dilemma” and that it is  “based on much hype and very little scientific evidence. The label Bipolar Disorder also carries considerable stigma, implying that the child will have a lifelong illness requiring lifetime treatment.”

Exactly.

The title of Dr. Koplewicz’s article is “Why Are People So Divided When It Comes to Children’s Mental Health?” so we’d like to answer that question, as it’s pretty simple —Some of us are for children’s rights and putting their best interests above all else, while others are for Psycho/Pharma and putting their best interests above all else.

That’s the short version.  Here is a bit more detailed answer;

Point 1) Millions of children have been stigmatized with bogus psychiatric “labels” that are based solely on opinion, and not one shred of medical evidence that there’s anything physically wrong with them.  No blood tests, brain scans, X-rays, MRIs or any proof whatsoever they are “mentally ill” and require drugs euphemistically being called “medicine.”    Unlike real medical diseases which are discovered in labs, psychiatric diagnoses are invented by psychiatrists in committee, by  the following “scientific” process;  Cluster a number of behaviors into a nice little package, give it a name and add “disorder” on the tail end of it,  then take a vote.  Majority wins.   That’s about it. And that’s why mental disorders can be here one day and gone the next, because of majority opinion — namely, psychiatry’s.   So while psychiatrists talk about the “amazing progress” they’ve made, and how “close” they’ve come to proving mental disorders are “real medical conditions,” we’d like to point out the obvious—they haven’t.   They couldn’t prove mental disorders were physical/medical conditions 50 years ago, and can’t prove it today despite billions in government funding.    No progress.  Whatsoever.   Zippo.  Nada.    So understandably, Dr. Koplewicz,, as people become more educated about this ludicrous subjective process of disorders made to order, they are concerned about the lack of real science to psychiatric “diagnoses” particularly where their children are concerned.

Point 2) The majority of psychiatrists within the American Psychiatric Association that “decide” on what will and will not be a mental “disorder” are funded by Pharma.  That’s called a Conflict of Interest.  A serious, egregious conflict of interest.  No “conspiracy” here Dr. Kopelwicz, just some facts about your colleagues and their incentives for developing more mental disorders.

Point 3) Due to these subjective, invented mental disorders,  20 million children are currently taking mind-altering, life-threatening drugs, acknowledged by international drug regulatory agencies to cause future drug dependence, stunted growth, mania, psychosis, violence, aggression, hallucinations, heart attack, stroke, sudden death and suicidal ideation.  All international studies and warnings on psychiatric drugs along with all the reports filed with the U.S. FDA’s Medwatch by doctors, pharmacists and healthcare providers reporting suicidal ideation and death from psychiatric drugs given to toddlers, young children and teenagers can be found here:  http://www.cchrint.org/psychdrugdangers/

Point 4) While Koplewicz has the audacity to call the “over-drugging” of children “a myth”,  consider that the Government Accountability Office has launched a federal investigation into the massive increase of drugging children in foster care.  “The investigators will attempt to account for estimates in the hundreds of millions of dollars of possible fraud arising from prescriptions for drugs explicitly barred from Medicaid coverage.  The GAO is collecting data from six states to search for patterns of abuse.  According to a number of foster care experts who spoke with Politics Daily, children in foster care, who are typically concurrently enrolled in Medicaid, are three or four more times as likely to be on psychotropic medications than other children on Medicaid. Alarmingly, many of these drugs are medically prohibited for minors and dangerous to the children taking them.”

Point 5) Senate investigations this past year revealed that some of the “leading” psychiatrists touting the wonders of diagnosing and drugging kids, and largely responsible for massive increases in kids unnecessarily placed on dangerous psychiatric drugs, were on Pharma’s payroll, and failed to disclose this.  Psychiatrists such as Joseph Biederman, who was being paid millions of dollars by the Pharmaceutical companies while skewing the results of drug trials to show false benefits for kids, in order the launch a nationwide campaign to get children diagnosed as “bi-polar.”

And he’s not the only one: Here are some of the “leading” psychiatrists exposed by Senate investigations:

Melissa DelBello, Associate Professor of Psychiatry and Pediatrics at the University of Cincinnati, was exposed in 2007 by the Senate Finance Committee for concealing $180,000 she received from AstraZeneca in 2003 and 2004.  DelBello’s studies of the antipsychotic Seroquel, made by AstraZeneca, in children helped to fuel the widespread pediatric use of antipsychotic drugs.

In 2008, Joseph Biederman, a leading Harvard child psychiatrist whose work helped fuel an explosion in the use of powerful antipsychotic drugs in children, was exposed for withholding earning at least $1.6 million in consulting fees from drug makers between 2000 and 2007.

Alan Schatzberg, president-elect of the APA, and Professor and Department of Psychiatry Chair of Stanford University was also investigated in 2008 by the Senate Finance Committee.  Schatzberg was forced to step down as principal investigator in an NIH funded research project into a drug called Mifeprestone, to treat “psychotic depression.” Senate investigators found that Schatzberg failed to report $4.8 million worth of stock in Corcept Therapeutics, a drug company which he co-founded and acted as lead researcher on a drug development project for until he was forced to surrender that role after being exposed.

A Senate investigation found Charles Nemeroff, Professor of Psychiatry and Behavioral Sciences and Chairman of Psychiatry and Behavioral Sciences, Emory University School of Medicine had concealed $2.8 million he earned from drug companies. He was forced to step down as Chairman of Psychiatry and Behavioral Sciences at Emory due to being exposed for his hidden pharmaceutical pay and attempted cover up.

In December 2009, Sen. Charles Grassley filed a complaint about Fernando Mendez-Villamil to federal authorities for his excessive prescribing of antipsychotics to children that were not approved by the FDA.  This cost taxpayers $43 million over six years.  Mendez-Villamil is apparently also currently under investigation by the Medicaid program.  Mid 2009, the Florida Agency for Health Care Administration reported that that Mendez Villamil is the top Medicaid prescriber of mental health drugs in the state—for all ages.  It was calculated that he wrote more than 150 prescriptions a day, seven days a week for six years

So to summarize, we don’t have an epidemic of mentally ill children, we have an epidemic of psychiatry stigmatizing children with mental disorders that cannot be medically/scientifically proven to exist.  We have an epidemic of children prescribed dangerous and potentially lethal psychiatric drugs, including infants and toddlers.  And we have the real source of stigmatization—the Psychiatric/Pharmaceutical industry.

To read Koplewicz’s article, click here

http://www.huffingtonpost.com/dr-harold-koplewicz/mental-health-being-openminded_b_791706.html

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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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CCHR Int Releases New Psychiatric Drug Search Engine—310 International Drug Regulatory Warnings & Studies & 194,000 Adverse Psychiatric Drug Reaction Reports

Monday, March 29th, 2010

By CCHR Int
March 29, 2010

Psychiatric drugs sales generate $80 billion per year with Big Pharma spending $4.7  billion per year on TV and print ads, and $1 billion per year on internet advertising.

As a result the number of people worldwide taking psychiatric drugs has skyrocketed to 100 million (20 million of them children) with documented side effects of worsening depression, mania, psychosis, violence, suicidal and homicidal ideation, birth defects, diabetes, heart attack, stroke and sudden death – to name but a few.

International drug regulatory warnings have increased by 400% in the last 10 years, yet the general public has nowhere to go to find this information online in an easy to search, concise format.

Until now.

CCHR International, the world’s leading mental health watchdog, has created a free public search engine featuring:

  • 160 psychiatric drug warnings from international drug regulatory agencies.
  • 150 drug studies from international medical journals.
  • 194,558 adverse reaction reports on psychiatric drugs filed with the FDA between 2004-2008 from doctors, pharmacists, other health care providers, consumers and lawyers.

People can search international drug regulatory warnings, or studies, or both. They can search by the brand name of a drug (such as Prozac, Zoloft, Ritalin, Seroquel) or by drug class (such as antipsychotic, stimulant, antidepressant) or by type of side effect  or by country issuing the study/warning.  All information is summarized and easy to read.

CCHR International has also decrypted the FDA’s Adverse Drug Reaction reports which include psychiatric drug side effects reported to the FDAs Medwatch program.  This lists who reported the side effect (Doctor, Pharmacist etc) the side effect of the drug and also the age range.

Any medical term that appears in the search results can be defined simply by double clicking the word, and a small bubble will appear defining the word.

No other mental health watchdog or government agency is offering this service to the public.  This is the world’s only searchable online psychiatric drug database containing all international studies, warnings and FDA adverse reaction reports on psychiatric drugs in existence.

You can try out the new Psychiatric Drug Search Engine here: http://www.cchrint.org/psychdrugdangers/

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National Alliance on Mental Illness (NAMI) – A Pharma front group

Thursday, October 22nd, 2009

The Citizens Commission on Human Rights (CCHR) states it is no wonder that the National Alliance on Mental Illness (NAMI), a group that claims to be an advocacy organization for people with “mental illness,” opposed the black box warnings on antidepressants causing suicide for under 18 year olds in 2004, and black box warnings on ADHD drugs causing heart attack, stroke and sudden death in children in 2006, when you look at their biggest source of funding: Pharma.

Today’s New York Times article, “Drug Makers Are Advocacy Group’s Biggest Donors” states “A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators. The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry. Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private. But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.”

Read NY Times article here: http://www.nytimes.com/2009/10/22/health/22nami.html?_r=2

More on NAMI:

    • NAMI’s pharmaceutical funding was first exposed in the November 1999  Mother Jones article  “An influential mental health nonprofit finds its grassroots funded by Pharmaceutical millions,”  Internal documents obtained by Mother Jones found 18 drug firms gave NAMI a total of $11.72 million between 1996 and mid-1999. These include Janssen ($2.08 million), Novartis ($1.87 million), Pfizer ($1.3 million), Abbott Laboratories ($1.24 million), Wyeth-Ayerst Pharmaceuticals ($658,000), and Bristol-Myers Squibb ($613,505).  And that NAMI’s leading donor was Eli Lilly and Company, maker of Prozac, which gave $2.87 million during that period. In 1999 alone, Lilly will have delivered $1.1 million in quarterly installments, with the lion’s share going to help fund NAMI’s ‘Campaign to End Discrimination’ against the mentally ill.”

    • In a 2000 Insight Magazine article, NAMI spokesperson Bob Carolla stated, “Mental illness is a biologically based brain disorder” and deferred to the U.S. Surgeon General’s 1999 Report on Mental Health as evidence of this. Yet the author of the article, Kelly Patricia O’Meara reviewed the entire report looking for this evidence, and found, “The Surgeon General’s report does not provide a single piece of scientific data supporting mental illness as a brain disorder or disease.”

    Factually, the Surgeon General’s report admitted there is no medical proof to substantiate NAMI’s claims. The report states, “The diagnoses of mental disorders is often believed to be more difficult than diagnoses of somatic or general medical disorders since there is no definitive lesion, laboratory test or abnormality in brain tissue that can identify the illness.”

    Psychiatrist Loren Mosher, former Chief of Schizophrenic Research Studies National Institute of Mental Health (NIMH) stated, “The National Alliance for the Mentally Ill (NAMI) gets the pharmaceutical money and then says they spend it on their ‘antistigma’ campaign. They say that mental illness is a ‘brain disease.’ And it works well for the people who suffer from this to use their drugs. This is why NAMI is pushing for forced medication. It is an amazing selling job on the part of NAMI.”

    • December 18, 2003, The New York Times reported that NAMI bused scores of protestors to a hearing in Frankfort, Kentucky, took out full page ads in Kentucky newspapers, and sent angry faxes to state officials, all protesting a state panel proposal to exclude the antipsychotic drug Zyprexa from Medicaid’s list of preferred medications. According to the article, “What the advocacy groups did not say at the time was that the buses, ads and faxes were all paid for” by the manufacturer of the antipsychotic drug Zyprexa, Eli Lilly.

    In 2004, NAMI opposed the FDA issuing “black box” warnings on antidepressants about their increased risk of suicidal thoughts and behaviors in under 18-year-olds.

    In 2006, despite overwhelming evidence of serious adverse cardiac events and sudden deaths caused by ADHD drugs, NAMI took the position that the “black box” warning on ADHD drugs was “premature.”

If NAMI was truly a patient’s rights advocacy group as they purport to be, the question must be asked why they opposed legislation that forwards patients rights.

Take for example the Child Medication Safety Act, a bill that passed the House of Representatives 425-1 in 2003. The bill stated that as a condition of receiving federal funds, states develop policies and procedures that prohibit schools from requiring a child to take psychiatric drugs as a condition of attending school. NAMI reported in their Policy Alerts section of their Beginnings newsletter that summer that they were “not opposed to the intent of the bill.” However, in the same article they stated “given the bill’s stern enforcement provisions—threatening the loss of federal education funds—it’s enactment would inevitably have a chilling effect on schools across the country.” They went on to encourage people contact their Senators to “express concern” about the bill.

Despite NAMI’s efforts, the bill, hailed as a protection for parents rights, was passed in December 2004 as the Prohibition on Mandatory Medication Amendment, a bill CCHR and many other concerned groups had been strongly in support of, after numerous parents came forth stating they had been forced to have their children take psychiatric drugs as a condition of attending school, and even had been charged with medical neglect for failing to comply.

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