Posts Tagged ‘FDA’

The Psychiatric Drugging of America’s Foster Children by Psychiatrist Peter Breggin

Thursday, December 22nd, 2011

The Huffington Post – December 22, 2011

Remember that many of these children will be waking up on Christmas morning to count out their multiple mind-altering psychiatric drugs that they have been prescribed by psychiatrists and other prescribers hired by the states in which they reside and paid for by tax dollars. These kids don't need psychiatric drugs, they need human "angels" to rescue them from a system that is stacked against their well-being.

The most vulnerable among us are the littlest victims. Young children, torn from their birth families through various, often unspeakable tragedies. These children end up in state supervised foster care and too often are passed from hand to hand, house to house. There were approximately 662,000 children in foster care in the United States in 2010.

Now there is a Government Accounting Office (GAO) report confirming that foster children in five states — Florida, Massachusetts, Michigan, Oregon and Texas — are receiving shocking amounts of psychiatric drugs. In the words of ABC News, they are “being prescribed psychiatric medications at doses higher than the maximum levels approved by the Food and Drug Administration (FDA) in these five states alone. And hundreds of foster children received five or more psychiatric drugs at the same time despite absolutely no evidence supporting the simultaneous use or safety of this number of psychiatric drugs taken together.” The ABC News report shows one 7-year-old holding a bag filled with 13 psychiatric medications that she had taken.

During the FDA drug-approval process, the maximum dose of a drug is determined by giving that drug by itself without any other psychoactive substances. When two or more psychiatric drugs are given together, each at its maximum dose, toxic levels of exposure can occur. In addition, some of these children are being given higher than the FDA-approved dose of individual drugs.

One young child interviewed by ABC News described the effect of the antidepressant and antipsychotic drugs he was taking: “They made me feel like I had a thousand bricks on my head.” Another child said, “Some of the medications were for ADHD but I’m not ADHD, I’m just naughty.” A teen in foster care on multiple psychiatric drugs told ABC News she felt like a “guinea pig.”

Foster children are provided government insurance in the form of Medicaid that includes “mental health” services such as psychiatric evaluations and prescription drug coverage. Individual states administer Medicaid and the U.S. Department of Health and Human Services is responsible for overseeing the state programs.

In the states surveyed by the GAO, children in Massachusetts fared worst. Thirty-nine percent of the foster care children aged 0-17 on Medicaid were prescribed at least one psychiatric drug. By comparison, 10 percent of non-foster care children in Massachusetts were prescribed at least one psychotropic medication under Medicaid. It’s serious enough when 10 percent of non-foster care children from our poorer communities are receiving psychiatric drugs; it’s even more tragic when 39 percent of our most poor and abandoned children are being inundated with these drugs.

Other states in the GAO study had total numbers of foster care children on Medicaid being prescribed at least one psychiatric drug: Oregon — 19.7 percent; Texas — 32.2 percent; Florida — 22 percent; and Michigan — 21 percent. The statistics reported are eye-opening, and it is worthwhile to see the full GAO report. In Texas, for instance, 9.1 percent of foster care children aged 0-5 years old are on at least one psychiatric drug, and 58.2 percent of foster care children aged 13-17 years old are on at least one psychiatric drug. Massachussetts has 53.4 percent of foster care children aged 13-17 on at least one psychiatric drug, and almost 5 percent of foster children aged 0-5 are on at least one psychiatric drug.

Is this widespread psychiatric drugging medically appropriate or indicated? Absolutely not. First of all, these are young children, even infants, who have already been through extremely traumatic experiences. All of them have been taken from their homes and most of them will not have had a stable replacement home. Beyond that, one can only imagine their horrendous living conditions prior to being removed from their families of origin. These children do not need psychoactive substances — they need the best human, caring services that our society can provide. The drugs may make them temporarily more docile, but by disrupting and suppressing normal brain function and development, they add new stressors to their lives and prevent them from adapting and growing as best as possible.

ABC News reports, “Of all the psychiatric medications, antipsychotics are, by far, the most prescribed, especially for foster children. Foster children are given anti-psychotics at a rate nine times higher than children not in foster care, according to a 2010 16-state analysis by Rutgers University of nearly 300,000 foster children.”

These antipsychotic drugs — including Abilify, Risperdal, Seroquel and Zyprexa — can lead to obesity, elevated blood sugar and diabetes, pancreatitis, cardiovascular abnormalities and a disfiguring and sometimes disabling movement disorder called tardive dyskinesia. It’s been suggested they could shorten lifespan by up to 25 years in patients exposed to them for decades. Evidence is accumulating that they can also lead to shrinkage of the brain in those patients exposed to them for years.

Why are these highly-toxic drugs being given to so many children in foster care? The antipsychotic drugs can suppress the highest centers of the brain — the frontal lobes — leading to indifference and apathy, which makes the children more docile and easier to manage. The use of multiple psychiatry drugs (polydrug therapy) produces similar effects. In the extreme, these children become zombie-like.

The newer antidepressant drugs such as Prozac, Paxil, Zoloft, Cymbalta, Lexapro, Wellbutrin, Effexor and Pristiq and have been shown to cause an increase in suicidal behavior in children. In addition, as the FDA-approved label and medication guides for these drugs confirm, they also can cause a general worsening of the individual’s condition, including depression, anxiety, hostility, aggression, impulsivity and mania. Many studies also suggest that a high percentage of children are driven into abnormal mental states by these drugs. When a child develops any one of these adverse reactions they are likely to have additional psychiatric drugs added to their drug cocktail rather than being carefully withdrawn from the offending substances.

As ABC News documented with one mother, parents or foster parents who object to the prescriptions of mind-altering psychiatric drugs for their young children are likely to be threatened with removal of the child from their care. In a separate case in Detroit, a child who was on Medicaid due to physical disability was taken off her mind-altering psychiatric drug by her mother when she displayed adverse effects.

The prescribing clinic called child welfare services and reported the mother. Welfare services removed the child from her mother’s care for a time. Fortunately, this child was later returned by court order to her mother and criminal charges against the mother were dismissed.

But word gets around. Complain about your child being placed on drugs and social services may intervene.

A mother in Millbrook, NY, was charged with medical neglect for not continuing her 4th grade son on a cocktail of psychiatric medications that was making him angry and listless. Off the drugs his energy returned and his mood improved, but public school officials kicked the boy out of school and reported the mother. The mother prevailed and was exonerated of “medical neglect” charges. Her son attended a private school and thrived. He is now a grown man and responsible citizen. His mother explained, “Kids don’t need drugs, they need individualized education and better family life. The priorities are all screwed up.”

In two of the ABC news foster care cases, the clinics that were authorized to deliver services to the children were also promoting themselves as being research facilities for “CNS Conditions” (central nervous system conditions, a misnomer for psychiatric conditions.) As research facilities those clinics have ties with pharmaceutical companies.

And what about the drug companies? Are they doing all they can to prevent the inappropriate use of their products? To the contrary, several of the largest drug companies have paid billions to settle claims they illegally marketed antipsychotics to children and other off-label populations, such as the elderly.

What is being done to these children should be viewed as chemical battery and child abuse. The misguided parents and foster parents are not the perpetrators. The psychopharmaceutical complex is the perpetrator, including the drug companies, the federal government and organized medicine and psychiatry.

The drugging of America’s children raise many issues including parental rights, children’s rights, child safety, off-label prescribing of the drugs and fraud and malpractice on the part of the researchers, psychiatrists and other prescribers. Most tragic is the silence! The stifled voices of victimized children and the self-serving silence of health professionals throughout the country who fail to take a public stand against the escalating drugging of our children.

Drugging traumatized foster children shoves them under society’s rug and is in no way therapeutic for the child. There are humane and effective approaches to helping our most vulnerable children. First, they need to be protected from predatory psychiatrists and other prescribers. Second, they need improved social services that could keep many of them in their homes or provide better assistance, training and supervision to improved foster care homes. When they inevitably become emotionally distressed and at times behaviorally disturbing, they do not need chemical readjustments of their brains — they need better attention from adults in the form of improved home-life or foster care, improved educational opportunities and psychosocial therapies aimed at helping them overcome and move beyond the trauma and stress they have endured and continue to endure as children and youth.

Sure, it’s easier to give them drugs. But has anybody noticed — it doesn’t help them in the long run. Exposure to psychiatric drugs in childhood is dangerous and over time can be damaging, disabling and even deadly.

No agencies and no associations — not NIMH, the American Medical Association, the American Psychiatric Association, the American Psychological Association, and the many other mental health associations — are willing to call a halt to the massive tidal wave of mind altering psychiatric drugs being thrown at America’s children. Several states, including Florida, Louisiana and New York have expelled “high prescribing” doctors from Medicaid but this is like nipping off the top of the iceberg. The primary problem remains: Placing children on psychiatric drugs instead of offering genuine help.

Dr. Robert Nelson, M.D., Ph.D. of the FDA Office of Pediatric Therapeutics, squirmed when challenged by Diane Sawyer in the ABC foster child series, but said the FDA had no plans to strengthen their warnings about psychiatric drugs and children.

The GAO, while courageously illuminating the great number of foster children on psychiatric drugs as well as the seriousness of children being exposed to multiple psychiatric drugs, falls far short of calling for the curtailment of the drugging of American children.

Twenty-five years ago, a tiny fraction of children were prescribed psychiatric medications, and that was largely confined to stimulants. In the early 1990s we were blowing the whistle on the increasing attention psychiatry was paying to children. I wrote an op-ed piece in the Wall Street Journal in 1989 and spoke frequently through the media about how children being blamed and diagnosed for problems in families, schools and in society. From 1990 to 1995 the increased prescribing of psychotropic drugs for preschoolers had begun.

What is to be done?

It is time for state attorney generals to launch full-scale investigations into the practices of these Medicaid psychiatrists. When appropriate, they should be charged with battery and with fraud, and sued for malpractice. But the psychiatrists are largely responding to the campaigns conducted by the psychopharmaceutical complex.The entire system, from the drug companies and insurance companies to the medical and psychiatric associations, and also the researchers and universities, need to be investigated for participating in this widespread medical abuse of children.

This Christmas, as many of us gather around a Christmas tree watching the children in our families wake up with shining eyes and happy laughter… remember. Remember that there were approximately 662,000 children in foster care in the United States in 2010.

Remember that many of these children will be waking up on Christmas morning to count out their multiple mind-altering psychiatric drugs that they have been prescribed by psychiatrists and other prescribers hired by the states in which they reside and paid for by tax dollars. These kids don’t need psychiatric drugs, they need human “angels” to rescue them from a system that is stacked against their well-being.

Only an outraged citizenry will change this. Write your Congressional representatives and senators. Write your state representatives and senators. Write your state attorney general’s office requesting a full investigation in your state of the crisis with foster children and psychiatric drugs. If you are a parent or a foster parent being pressured to keep your child on psychiatric drugs, call your local paper, referencing the ABC News investigation. If you are a reporter, plan a local series on this issue. If you are a teacher, a social worker or professional in the Medicaid system, consider becoming a whistleblower against the chemical assault of these children. If you are a medical professional learn how to help children safely taper off their psychiatric drugs while assisting their families in obtaining more useful services. Always remember that withdrawal from psychiatric drugs can be hazardous and needs to be done carefully with experienced clinical supervision.

It’s the Christmas season. Let’s not forget the kids who are so drugged their eyes cannot sparkle anymore. Become one of their real-life angels.

Peter R. Breggin, M.D. is a Harvard-trained psychiatrist and former full-time consultant with NIMH who is in private practice in Ithaca, New York. Dr. Breggin is the author of more than twenty books including the bestseller Talking Back to Prozac and the medical book Brain-Disabling Treatments in Psychiatry, Second Edition. His most recent book is Medication Madness, the Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime. He is also the author of dozens of peer-reviewed scientific articles, many in the field of psychopharmacology. On April 13-15, 2012 in Syracuse, New York, the annual conference of Dr. Breggin’s 501c3 nonprofit international organization, The Center for the Study of Empathic Therapy, will present a panel of lawyers, experts, survivors and families concerning antidepressant-induced violence and crime. Conference information is available on www.EmpathicTherapy.org.

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ABC World News: Study Shows U.S. Government Fails to Oversee Treatment of Foster Children With Mind-Altering Drugs

Wednesday, November 30th, 2011

By DR. MARK ABDELMALEK, BRINDA ADHIKARI, SARAH KOCH, JOSEPH DIAZ and CLAIRE WEINRAUB

Watch the year-long investigation tonight on “World News with Diane Sawyer” at 6:30 p.m. ET

Children in foster care are more likely to take multiple antipsychotic medications for longer periods of time than any other group of children. (Fuse/Getty Images)

“I was almost despondent to believe that the kids under the age of one, babies under the age of one were receiving this kind of medication.” —US Senator Thomas Carper.

The federal government has not done enough to oversee the treatment of America’s foster children with powerful mind-altering drugs, according to a Government Accountability Office (GAO) report to be released Thursday.

ABC News was given exclusive access to the GAO report, which capped off a nationwide yearlong investigation by ABC News on the overuse of the most powerful mind-altering drugs on many of the country’s nearly 425,000 foster children.

The GAO’s report, based on a two-year-long investigation, looked at five states — Florida, Massachusetts, Michigan, Oregon and Texas. Thousands of foster children were being prescribed psychiatric medications at doses higher than the maximum levels approved by the Food and Drug Administration (FDA) in these five states alone. And hundreds of foster children received five or more psychiatric drugs at the same time despite absolutely no evidence supporting the simultaneous use or safety of this number of psychiatric drugs taken together.

GAO Key Findings:

Overall, the GAO looked at nearly 100,000 foster children in the five states and found that nearly one-third of foster children were prescribed at least one psychiatric drug.

The GAO found foster children were prescribed psychotropic drugs at rates up to nearly five times higher than non-foster children, with foster children in Texas being the most likely to receive the medications compared to foster children in the other four states.

Watch the year-long investigation tonight on “World News with Diane Sawyer” at 6:30 p.m. ET

Although the actual percentages of children who received five or more psychiatric drugs at the same time were low in the five states included in the GAO report, the chances of a foster child compared to a non-foster child being given five or more psychiatric drugs at the same time were alarming.

In Texas, foster children were 53 times more likely to be prescribed five or more psychiatric medications at the same time than non-foster children. In Massachusetts, they were 19 times more likely. In Michigan, the number was 15 times. It was 13 times in Oregon. And in Florida, foster children were nearly four times as likely to be given five or more psychotropic medications at the same time compared to non-foster children.

Initially part of GAO’s investigation, Maryland was later excluded from GAO’s analysis “due to the unreliability of their foster care data” according to the report, a problem ABC News learned many states face.

Foster children were also more than nine times more likely than non-foster children to be prescribed drugs for which there was no FDA-recommended dose for their age.

For the most vulnerable foster children, those less than 1 year old, foster children were nearly twice as likely to be prescribed a psychiatric drug compared to non-foster children.

When Sen. Thomas Carper, D-Del., lead requestor of the GAO report, first learned of the report’s findings, he said, “I was almost despondent to believe that the kids under the age of one, babies under the age of one were receiving this kind of medication.”

ABC News has reviewed dozens of medical studies published in recent years that echo GAO’s findings — research showing foster children receive psychiatric medications up to 13 times more often than kids in the general population.

In some parts of the country, as many as half of foster kids are on one or more psychiatric medications. This, compared to just 4 percent of kids in the general population.

http://abcnews.go.com/US/study-shows-foster-children-high-rates-prescription-psychiatric/story?id=15058380#.Tta8ymrjWSo

 

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Time Magazine: Why Are So Many Foster Care Children Taking Antipsychotics?

Wednesday, November 30th, 2011

11/29/2011 by Maia Szalavitz

More than 8% of children in foster care have received antipsychotic medication, and just over one quarter of those in foster care who also receive disability benefits take these drugs, according to a recent studyin the journal Pediatrics.

The question is why? Children in foster care have typically been neglected or abused — indeed, simply removing a young child from his or her parents, even abusive ones, is in itself traumatic — so, not surprisingly, kids in foster care are more likely to suffer from psychiatric and behavioral problems than those who have stable families. Previous data suggest that foster-care children are about twice as likely as those outside the system to receive psychiatric medications.

Whether these problems are leading to higher rates of antipsychotic use, however, is not clear. “I think we have clinicians facing some very challenging situations,” says Susan dosReis, associate professor at the University of Maryland School of Pharmacy and lead author of the study. “But we don’t have information as to why the prescribers decided on these medications for [these particular] youths.”

The numbers suggest that the influence of pharmaceutical company marketing cannot be overlooked. Ninety-nine percent of youth receiving antipsychotic medications in the study were given atypical antipsychotics — the newer generation of these drugs, which are expensive and mostly unavailable in generic form and have been heavily advertised.

All of the major manufacturers of these drugs have been fined by the Food and Drug Administration for illegal marketing practices — in part, for marketing the drugs for unapproved use in children — with some convicted of criminal charges.

Eli Lilly, which manufactures the atypical antipsychotic Zyprexa, paid out $1.42 billion in 2009 — $615 million of that to settle criminal charges. The charges against Lilly involved selling Zyprexa to doctors for use in children, despite the fact that it was not approved for this age group.

Bristol Myers Squibb paid $515 million in 2007 to settle charges that it also illegally pushed its antipsychotic Abilify to child psychiatrists. Pfizer paid out $301 million in a similar case related to its drug Geodon. AstraZeneca paid out $520 million to settle charges over the drug Seroquel. In all of these cases, the drugs were sold for unapproved use in youth.

Read the rest of the article here

Watch one foster kid’s story:

 

 

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Addiction Specialist Says It’s Easier to Withdraw Patients from Heroin than from Xanax

Monday, November 14th, 2011

KNTV – November 14, 2011

"It's so much easier to take people off heroin. I'd rather take 100 people off heroin than one person of Xanax because I know they'll have a year of withdrawal," says addiction specialist Dr. Jerry Callaway.

Also known as Alprazolam, it’s the 11th most prescribed drug in the United States, but you often don’t need a doctor to get it.

22-year-old “Nick” is a recovering Xanax addict.

In addition to getting them at parties, he says he also would get prescriptions for hundreds of Xanax pills from doctors.

“All you have to do is walk into a doctor’s office and say you have anxiety, at least that’s what I did and it was written to me,” he says.

Nick says he knew he had to kick the drug when he took Xanax, blacked out while driving and seriously injured three people.

“It’s sobering to know my actions caused innocent people great bodily injury,” he now says.

Doctors warn weaning off the drug has serious risks too.

“It’s so much easier to take people off heroin. I’d rather take 100 people off heroin than one person of Xanax because I know they’ll have a year of withdrawal,” says addiction specialist Dr. Jerry Callaway.

A spokeswoman for Pfizer, the manufacturer of Xanax says, “When prescribed and taken as indicated Xanax has a well established safety profile and is an important treatment option that has benefitted millions of patients.”

Between 2004 and 2008 the Centers for Disease Control reported an 89 percent increase in the number of emergency room visits nationwide related to the non-medical use of Xanax and other drugs in its class.

According to drug site which reviews the FDA’s adverse events data base, people using Xanax reported more than 11,000 adverse events between 2004 and march of this year.

They include 83 deaths, 107 completed suicides and 100 comas.

Addiction experts also say you might be surprised whose abusing Xanax.

“It might be a stay-at-home mom or a working mom, and in an attempt deal with the overwhelm of that they go to the doctor, they talk to them about the anxiety, they talk about the overwhelm the doctor prescribes them Xanax and next thing you know now they’re addicted to it,” says treatment center director Lori Johnson.

The FDA does require a warning to patients that Xanax can become addictive, but there is a petition asking them to add a stronger and more visible safety alert.

“I think it’s overdue,” Dr. Callaway says.

Nick, who has now gone six months without Xanax, has a warning of his own for those considering experimenting with the drug.

“At all costs stay away from it. There’s nothing good about it, nothing good can come out of Xanax,” he says.

http://www.ksdk.com/news/article/285646/9/Xanax-building-dangerous-reputation

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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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New Study Confirms: Millions of kids misdiagnosed with ADHD and drugged

Tuesday, September 20th, 2011

September 20, 2011

New Study published in American Journal of Family Therapy confirms millions of normal kids misdiagnosed with ADHD & drugged.

by CCHR Int—A new study published today in the American Journal of Family Therapy has found that millions of children have been misdiagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and wrongly prescribed amphetamine-like drugs categorized by  the U.S. Drug Enforcement Administration (DEA) in the same class of highly addictive drugs as cocaine, opium and morphine.

The study conducted by researchers at the New England Center for Pediatric Psychology and the Rhode Island College Department of Special Education found that of the “over 5 million children who are now being treated with ADHD medication, a majority may be suffering from Faux-ADHD, a disorder linked to irregular bedtimes” and that a majority of the children diagnosed ADHD may be unnecessarily medicated.    Now while we at CCHR applaud any study on the issue of “ADHD” which is not  ghost written by Big Pharma or those with a vested interest in drugging kids, we would like to pose two simple questions regarding this latest study:

1)  If there is such as thing as  “Faux-ADHD” what exactly is “real” ADHD?    There are no blood tests, brain scans, x-rays or genetic abnormalities that can prove any child has a “real” condition of ADHD.   Therefore any diagnoses of ADHD is “Faux.”   The criteria for an ADHD diagnoses  rests entirely on a checklist of behaviors,  including such “abnormal” child behavior as:

  • “runs about or climbs excessively in situations when it is not appropriate”
  • ” is often “on the go”
  • “acts as if driven by a motor”
  •  ”blurts out answers”
  •  ”is easily distracted”
  • ” loses pencils or toys”
  • “often doesn’t seem to listen”

2)  Given the diagnoses itself is not a medical condition, what child being prescribed drugs isn’t being “unnecessarily medicated?”   ADHD drugs are classified by the DEA as schedule ll drugs because they are as highly addictive as cocaine, morphine and opium.  ADHD drugs such as Ritalin, Concerta and Adderall are documented by the FDA and international drug regulatory agencies to cause hallucinations, mania, psychosis, drug dependence,  stunted growth, insomnia,  heart attack, suicidal ideation and sudden death.  Normal children are simply being drugged.  Not medicated.  Drugged.

The fact is that any child diagnosed with ADHD has been misdiagnosed.  Any child placed on cocaine–like ADHD drugs is being unnecessarily drugged.  The diagnoses of ADHD in any circumstances is a Faux-diagnoses, serving only the psychiatric pharmaceutical industries and fueling their $4.8 billion a year ADHD drug empire.

 

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Antidepressant tied to heart risk

Friday, August 26th, 2011

Health24
August 25, 2011

High doses of the popular antidepressant Celexa (known as Cipramil in South Africa) can cause potentially fatal abnormal heart rhythms and should no longer be prescribed to patients, the US Food and Drug Administration has said.

Doses of Celexa (citalopram hydrobromide) greater than 40 milligrams a day can cause changes in the electrical activity of the heart, which can lead to abnormal heart rhythms, including a potentially deadly arrhythmia known as Torsade de Pointes, according to the agency.

Patients at high risk for changes in the electrical activity of the heart include those with pre-existing heart conditions (including congestive heart failure) and those prone to low levels of potassium and magnesium in the blood, the FDA said.

Read entire article:  http://www.health24.com/news/Depression/1-903,65865.asp

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Why Drug Companies Are Shy About Sharing On Facebook

Tuesday, August 23rd, 2011

NPR – August 22, 2011
by Nancy Shute

Drug firms fear that being "liked" on Facebook could get them in trouble with the FDA. iStock photo

People love how Facebooklets them comment on and share other people’s posts. But the idea of sharing on social media has got drug companies scared. When Facebook told drugmakers that they had to start allowing comments on their Facebook pages, some of those pages started disappearing.

“Take On Depression” suddenly disappeared. “ADHD Moms” vanished, too. So did “Epilepsy Advocate.” In the past, drug companies had been reluctant to create Facebook pages without a guarantee that they’d be closed to public comments — a unique accommodation on Facebook’s part. But that accommodation ended last week.

Diabetes blogger Amy Tenderichthinks it’s high time the drug companies quit walling themselves off. She’s the founder of  Diabetest Mine,  an independent site. She says: “The notion that they would be able to be able to put up these Facebook pages and then close them off to comments is ridiculous.”

On her site, people with diabetes comment a lot. They share information on what drugs they’re taking, give each other advices on dosages, and tell people which drugs are working for them, and which are causing side effects. For Tenderich and others, the whole point of social media like Facebook and Twitter is to comment on other people’s posts.

But drug companies have to play by different rules. The Food and Drug Administration requires that each a drug manufacturer mentions a prescription drug, they also have to list its risks and side effects. That’s called fair balance.

“You see some of those magazine ads that are three and four pages long and you wonder why they are?” asks Tony Jewell, who supervises drugmaker AstraZeneca’s social media efforts. “It’s because we’re communicating the full risks, benefits and appropriate use of the medicine. That’s a little bit harder to do in a social media channel like Facebook and Twitter.”

One big reason companies cite for killing Facebook pages is that they wouldn’t be able to adequately police comments with inaccurate information about prescription drugs.

“So they might say, ‘Lipitor’s great at whitening your teeth,’ which it’s not approved to do,” says Jonathan Richman. That’s his example of a potentially dicey comment. He’s a group director for the Possible Worldwide ad agency in Cincinnati, and he closely follows the drug industry’s social media efforts on his Dose of Digital blog. “The question becomes, What’s Pfizer’s liability? What action could the FDA take, based on somebody else posting that?”

So far, the FDA hasn’t come down on a single drug company for allowing public comments. The only action the agency has taken against use of social media was last year, when it warnedNovartis that a Facebook “share” widget for the leukemia drug Tasignaviolated fair balance.

But the FDA also hasn’t told the companies how to use social media and still follow the “fair balance” rule. In November 2009, the agency held public hearingson how pharma companies should use social media. But the FDA has yet to issue official guidance. Jewell says that because of that, his employer and other companies are erring on the side of caution.

Tenderich says patients would benefit from a rich interaction with drug makers. She sees more and more drug company employees interacting on her site, giving advice on behalf of their employers. That’s a huge benefit for patients, she says.

The pharmaceutical companies could benefit, too, she says, by learning what problems patients are having with drugs, and how to make them better.

“They could get so much fantastic, free, very high-value feedback,” she says.

http://www.npr.org/blogs/health/2011/08/22/139859210/why-drug-companies-are-shy-about-sharing-on-facebook?ps=sh_sthdl

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Two High Ranking Senators – Grassley & Kohl – Question Use of Psych Drugs in Nursing Homes

Monday, August 15th, 2011

MedPage – August 15, 2011

Emily P. Walker

Click image to watch video: Psychiatric Abuse of the Elderly

WASHINGTON — Two high-ranking senators have urged the Centers for Medicare and Medicaid Services (CMS) to take a closer look at potential over-prescribing of atypical antipsychotics to nursing home residents.

There are eight atypical antipsychotics approved by the FDA to treat schizophrenia and/or bipolar disorder, including clozapine (Clozaril), aripiprazole (Abilify), and quetiapine (Seroquel).

Atypical antipsychotics are not approved to treat dementia, and must carry black box warnings that elderly people who take atypical antipsychotics have an increased risk of death, compared with those who take placebo pills for dementia.

Still, it’s clear that these drugs are being used in nursing homes to control behavioral problems related to dementia. A 2011 report from the Department of Health and Human Services Office of the Inspector General (OIG) found that 14% of all nursing home residents with Medicare had claims for antipsychotics and 88% of the atypical antipsychotics prescribed off-label were for dementia.

And in 2009 Elli Lilly, the makers of olanzapine (Zyprexa), pled guilty and paid $1.4 billion to the federal government for allegedly targeting doctors who worked in nursing homes and assisted living facilities to prescribe olanzapine off-label to elderly patients with dementia.

In their letter, Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wisc.), urged CMS administrator Donald Berwick, MD, to examine the issue of overuse of antipsychotics in nursing homes more closely. The letter is a follow-up to one the senators sent in May after the release of the OIG report, which the senators themselves requested.

The newest letter, sent Aug. 1, requests that CMS investigate what role pharmacy benefit managers — who manage prescription drug coverage for Medicare beneficiaries living in nursing homes — play in fueling the possible overuse of atypical antipsychotics in elderly people in long-term-care facilities.

Pharmacy benefits managers may receive rebates from drug companies for prescribing certain drugs, and CMS should look at their role in “unnecessarily increasing the use of antipsychotic drugs and to subsequently take action to address such practices and curb excess use.”

The letter also urges CMS to consider requiring that physicians, who off-label prescribe drugs with black box warnings to seniors, certify that a Part D provider will cover the drug.

If CMS followed the senators’ advice, Medicare payments for antipsychotics that “lack a medically-accepted indication” should be drastically reduced, the senators said.

“Taking such proactive steps will create disincentives for entities that administer pharmacy benefits to allow these practices to flourish while also providing CMS with clearer means to recoup erroneous payments,” Grassley and Kohl wrote.

A recent study found that the prescription cost for a typical antipsychotic increased from $38 to $41 between 2004 and 2008, while the price tag for an atypical antipsychotic rose from $226 to $323, the researcher found. Overall, the cost of typical antipsychotics in the U.S. was $600 million in 2008, while the cost of atypical drugs reached $9.9 billion.

That same study concluded that atypical antipsychotic use is growing, especially among seniors, and the drugs are increasingly prescribed off-label, sometimes without convincing evidence to support that use.

In 2008, 91% of the prescriptions written for atypical antipsychotics were for circumstances where the evidence for the efficacy was uncertain, the researchers found.

However, a separate study found that after the FDA issued a black box warning about the risks of using the drugs to soothe behavioral problems in dementia patients, there was a decline in prescribing the drugs to patients in the VA medical system.

http://www.medpagetoday.com/Geriatrics/Dementia/28052

 

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Twisted web of lies in Maryanne Godboldo Case: Big Pharma, multiple agencies, judge, DHS all profit from child abduction

Monday, August 15th, 2011

NaturalNews -  August 15, 2011

by Christina Luisa

There is a good chance you have heard the story of Maryanne Godboldo and how armed government agents broke down her door and attempted to kidnap her 13-year-old daughter Ariana to turn over to CPS because she refused to medicate her with a potentially dangerous and mind-altering anti-psychotic drug Risperdal (http://www.naturalnews.com/032191_C…). Maryanne had been using holistic remedies for her daughter instead, such as dance therapy.

The Detroit mother is now currently going through a criminal and custody trial because of this incident, and a variety of revealing and disturbing information is starting to come out about the involvement of Big Pharma and other parties in the twisted web of lies the case is wrapped in.

The jury presiding over the hearing was convinced to believe that Maryanne’s refusal to give her daughter the controversial drug, supposedly used to “treat” ADHD, represented a form of parental neglect. Read more here: http://www.naturalnews.com/033295_p…

Thanks to the Voice of Detroit (VOD), it is now coming to light that the New Oakland Child-Adolescent & Family Center – a private facility which reported Maryanne to CPS for taking her daughter off the drug — has paid connections with Big Pharma since at least 2004.

Pharmaceutical companies were involved all along

According to the Center’s website, Kimberly Smith — Director of Pharmaceutical Research for all its facilities since 2004 — provides “clinical support and supervision” for the Clinton Township facility. She is also the head of the Center’s Office of Recipient Rights. The website openly says that Kimberly has been coordinating Adult and Pediatric CNS (Central Nervous System) Clinical Trials for a number of big pharmaceutical companies for the last ten years.

Smith was recently contacted by VOD at her office, and she admitted that not only is she paid by the drug companies she works with, but that trials she is paid to conduct are among those carried out at New Oakland’s facilities. She refused to give further information on specific drug trials, saying the information was “private.” She claimed reports are only published after the FDA approves a drug, and that a confidentiality agreement must be signed with the company.

However, this statement is not nearly the whole truth, according to the U.S. National Institutes of Health’s website at http://ClinicalTrials.gov. The site indicates that the FDA Amendments Act of 2007 “requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices.” A clinical trial of Depakote that New Oakland recruited participants for was listed on the site while it was still ongoing.

Ms. Smith claimed that parents are required to complete a detailed form when their child participates in such a study, but said she did not have a blank copy of the form she could provide for proof.

Follow the money trail

Even beyond the New Oakland Center’s drug connections, those involved in seizing Ariana – from the judge to the DHS and various public and private agencies involved — are connected to each other in a suspiciously twisted web. All are getting big bucks for not only children they barbarically take from their families, but for clinical trials on psychiatric drugs and medical treatment — including pharmaceutical drugs — that are given to the children.

Government officials involved in the case, including Judge Lynne Pierce, Department of Human Services chief Maura Corrigan and others also have their ties to Big Pharma and the undercurrent of money funneling.

Godboldo first took her daughter to The Children’s Center in Detroit when Ariana began having significant adverse reactions to the immunizations she had been receiving. Maryanne didn’t realize at the time that the Children’s Center is one of six partners in Behavioral Health Professionals, Inc (BHPI), a non-profit based in Michigan. BHPI is the parent organization for ConsumerLink and CareLink, which network with insurance companies and refer children to the various partners and other organizations.

Amber Kozlowski — a “social worker” — testified on Aug. 5 that she was responsible for Ariana’s admission to the Hawthorn Center on March 25. There, Ariana’s prosthesis was removed in violation of her disability rights, she was re-medicated with Risperdal and other drugs and was said to become the victim of sexual abuse, as stated in a police report filed by her family.

According to the Voice of Detroit, Kozlowski said she works for Neighborhood Services Organization (NSO) — one of the partners of BHPI — directly while contracting with ConsumerLink for the hospital liaison part of her job. NSO’s board of directors includes executives from various health and insurance agencies, including the Detroit Medical Center, Pro Care Health Plan and the Health Alliance Plan.

The Children’s Center, which is primarily funded by the Department of Human Services, also has its own foster care division and is funded at the rate of $34 per day for foster care provision, according to state budget documents. These funds originate with the federal government and are also channeled also into various other private foster care agencies in the state.

But that’s not all – the center also receives substantial grants from Ford Motor Company, and three Ford family members sit on its board.

Corruption, lies and illegal action

After authorities seized Ariana and institutionalized her, they decided she didn’t need the medication after all, but still continued to institutionalize her for seven weeks before releasing her to an aunt. Due to Maryanne’s allegedly firing a shot when authorities tried to take her daughter, this case received special attention – but it is otherwise exactly like thousands of other cases like it in Michigan. In the Godboldo case and many others, orders to remove children are literally rubber-stamped.

Voice of Detroit also recently reported that the Interim Supervisor of Juvenile Intake for Wayne County, Vikki Kapanowski, testified at Godboldo’s juvenile court trial that these orders are actually approved by a probation officer with no law license who merely stamps the judge’s name on the order — the judge never even sees the order.

Voice of Detroit and the Detroit News also reported on testimony in Godboldo’s criminal trial revealing that the whole process of serving the illegal order was, in itself, illegal. The probation officers doing this rubber-stamping in Detroit have not been sworn, do not have law licenses and are not authorized to perform functions such as issuing these orders.

CPS has no intentions of protecting children

Everything about this case seems wrong. To begin with, Ariana was not only prescribed a dangerous drug that is restricted to individuals over the age of 18, she had to witness a standoff with a SWAT team because there was no legal court order to remove her. A caseworker lied and called Maryanne’s actions medical neglect, even though she was working out a treatment plan elsewhere with another medical doctor. Ariana was then forced to return to the same facility that she was said to have been sexually assaulted at.

Not only has CPS – an agency sworn to protect children — shown no concern about this child’s best interests in any regard, its insistence on forcing children on medications is the reason why the Godboldo family has been forced to struggle through this ridiculous and unnecessary trial.

Ariana was taken from her mother (a low-income household), who CPS assumed would not be able to afford to defend herself, and was attempted to be placed in a foster home, group home or institution without due process or any evidence to prove that intervention was even necessary to begin with. All the while, federal matching funds and Medicaid funds were being collected to do so.

This case has exposed a serious problem in the way child protection is handled in not only Detroit or in the entire state of Michigan; the sad truth is that this is how child protection is being handled in every city in the country as well. Far from protecting children, CPS frequently exploits children for private gain.

This all comes back to the disturbing truth about the corruption of the agency, and how it uses private contractors to kidnap children and take them from their homes. The private contractors working for CPS are paid up to millions of dollars in reward money a year (http://www.infowars.com/cps-warrior…). Maryanne Godboldo has now openly accused CPS of being engaged in child trafficking (http://www.naturalnews.com/032501_M…) as well as sexually molesting her daughter (listen to interviews below).

Risperdal was unlawfully marketed to children to start with

What is even more interesting about all this information is the timing of recent news reports that Johnson and Johnson has just settled with the Justice Department and agreed to plead a misdemeanor on the illegal marketing of Risperdal ((http://voiceofdetroit.net/2011/08/0…).

Forty US states are planning lawsuits against J&J for this (http://www.pharmalot.com/2011/08/jj…). Johnson and Johnson has been forced to pay millions in damages – in multiple cases – for misleading safety claims it made about Risperdal while marketing the drug, including to children.

Big Pharma’s habit of paying medical professionals to recommend, market and prescribe their products regardless of the consequences is gathering more attention in recent times, such as in the case of Risperdal.

According to one lawsuit filed against the drug company giant, the FDA told J&J in 1997 that its request to market Risperdal for children was “without any justification.” In the following years, J&J’s arsenal of pharmaceutical sales reps made thousands of sales calls to child and adolescent psychiatrists. The company informed doctors that they qualified for the drug if they had as few as one adult patient displaying minor signs of schizophrenia.

Listen to interviews with Maryanne Godboldo here:
http://naturalnews.tv/v.asp?v=8B819…
http://naturalnews.tv/v.asp?v=97774…
http://www.naturalnews.com/033295_p…

More sources/further reading:

http://voiceofdetroit.net/2011/08/0…

http://online.wsj.com/article/BT-CO…

http://www.nccprblog.org/2011/08/fo…

http://www.pharmalot.com/2011/08/jj…

http://online.wsj.com/article/BT-CO…

http://www.mentalhealthrightsyes.or…

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