Support the Petition to the FDA to Protect Children from Exposure to Dangerous Adult Psychiatric Drugs
Attorney Stephen Sheller has petitioned the U.S. Food and Drug Administration stating that:
We presently represent hundreds of individuals who have suffered serious harm, including gynecomastia and prolactin-related injuries as a result of their ingestion of the second-generation atypical anti-psychotic medications Risperdal® (risperidone) marketed by Ortho-McNeil-Janssen Pharmaceuticals, Inc., formerly Janssen Pharmaceutical, Inc., a subsidiary of Johnson & Johnson (hereinafter "J&J").
We hereby petition the Food and Drug Administration (hereinafter "FDA"), pursuant to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§352, 321 and 21 C.F.R. §§10.30 and 7.45 to immediately revoke the pediatric indication forRisperdal®, all generic versions of risperidone, and Invega (an extended release and injectable medication which includes the same primary active metabolite as Risperdal) unless and until the long-term safety of the drug can be demonstrated, or in the alternative to immediately require that labeling for Risperdal® and all generic versions of risperidone include a black box warning on the lack of sufficient safety data.
You can support this petition! Ask the FDA to revoke approval of Risperdal and other similar antipsychotic drugs for children and adolescents. Do this by "commenting" on Attorney Sheller's petition. Laypersons and professionals may comment. Public and professional input will help encourage the FDA to do the right thing for all our children. Go here to comment.
Drug Companies Drive the Psychiatric Drugging of Children
by Peter R Breggin MD, with Ginger Breggin
Johnson & Johnson, the company that makes the antipsychotic drug Risperdal, has tentatively agreed to a settlement of $2.2 billion to resolve a federal investigation into the company's marketing practices. Although details are not fully finalized, this includes "a roughly $400 million criminal fine for the illegal promotion of the antipsychotic Risperdal," according to the Wall Street Journal. It's been well documented that Johnson & Johnson confidentially paid psychiatrists such as Harvard's Joseph Biederman to promote adult drugs such as the powerful antipsychotic drug Risperdal for children. The company has even ghost-written at least one of the Harvard professor's "scientific" articles.
Another recent DOJ settlement with drug company GlaxoSmithKline resulted in Glaxo's agreement to pay $3 billion in criminal and civil fines. As I wrote in an earlier Huffington Post blog:
In one of the most egregious examples of fraudulent marketing, "In the case of Paxil, prosecutors claim GlaxoSmithKline employed several tactics aimed at promoting the use of the drug in children, including helping to publish a medical journal article that misreported data from a clinical trial," [according to the New York Times].
Glaxo manipulated and rewrote this study, which was rejected by the FDA for failing to show efficacy. The Glaxo rewrite made it appear as though the drug was useful for adolescent depression even though the FDA had not approved Paxil for adolescents. The company then got almost two dozen well-known researchers and "experts" to put their names on the article as if they had written it.
GlaxoSmithKline also secretly paid about $500,000 to psychiatrist Charles Nemeroff, while he was a professor at Emory University, to promote Paxil. Glaxo even ghostwrote a psychopharmacology textbook for family doctors, who write many prescriptions for children, which was "coauthored" by Nemeroff and psychiatrist Alan Schatzberg. Nemeroff was sanctioned for failing to report the Glaxo payments he received while at Emory. But he's landed on his feet running, now chairing the psychiatry department at the Miller School of Medicine at the University of Miami.
None of these drug-company-bought psychiatrists has suffered serious consequences. Biederman remains a star at Harvard and Nemeroff recently received a new $2 million federal grant from the National Institute of Mental Health. These influential psychiatrists are just two out of many doctors who have been investigated for extensive financial relationships with drug companies. Read more here.
Psychiatrist Stuart Shipko, MD from Pasadena, CA , a member of the Center for the Study of Empathic Therapy Advisory Board, has let us know that drug company Eli Lilly has now changed the label on Prozac to include sexual dysfunction that persists after stopping the drug. The label says: "Symptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment". Here is a link to the 2011 Prozac product label.
by Peter R. Breggin, MD
...The title of the research paper actually tells the story: "Electroconvulsive therapy reduces frontal cortical connectivity in severe depressive disorder." The specific area is the "dorsolateral prefrontal cortical region." This is the same area assaulted by surgical lobotomy. It contains nerve trunks connecting the rest of the brain with the frontal lobes -- the seat of our capacity to be thoughtful, insightful, loving, and creative. Think of what it takes to be a person; all of that requires the unimpaired functioning and connectivity of the frontal lobes of your brain.
Using a functional MRI in nine patients, the authors of the study conclude, "Our results show that ECT has lasting effects on the functional architecture of the brain." The result of these lasting effects is "decrease in functional connectivity" with other parts of the brain. In other words, the frontal lobes are cut off from the rest of the brain. The authors call this "disconnectivity." Does this sound familiar? It is a "lasting" frontal lobotomy.
This new study contradicts claims by shock advocates such as psychiatrist David Healy that ECT does not cause brain damage.
The report argues that this ECT effect supports the idea that depressive patients have too much activity in their frontal lobes and are returned to normal bv damaging the offending area of the brain. Psychiatry frequently takes this position.... Read more.
New Research: Antidepressants Can Cause Long-Term Depression
(first published on Huffington Post)
by Peter R. Breggin, MD
Shortly after Prozac became the best-selling drug in the world in the early 1990s, I proposed that there was little or no evidence for efficacy, but considerable evidence that the drug would worsen depression and cause severe behavioral abnormalities. I attributed much of the problem to "compensatory changes" in neurotransmitters as the brain resists the drug effect. Since then, in a series of books and articles, I've documented antidepressant-induced clinical worsening and some of its underlying physical causes. Now the idea has gained ground in the broader research community and has recently been named "tardive dysphoria."
It has been apparent for many years that chronic exposure to SSRI antidepressants frequently makes people feel apathetic or less engaged in their lives, and ultimately more depressed. In my clinical experience, this is a frequent reason that family members encourage patients to seek help in reducing or stopping their medication. SSRI-induced apathy occurs in adults and includes cognitive and frontal lobe function losses. (See Barnhart et al., 2004; Deakin et al., 2004; Hoehn-Saric et al., 1990). It has also been identified in children. Adults with dementia are particularly susceptible to antidepressant-induced apathy.
A recent scientific study by El-Mallakh and his colleagues reviewed the antidepressant literature and concluded that any initial improvements are often followed by treatment resistance and worsening depression. They compare this problem to tardive dyskinesia, caused by antipsychotic drugs, and call it tardive dysphoria, "an active process in which a depressive picture is caused by continued administration of the antidepressant." Based on rat studies, they hypothesize that "dendrite arborization" -- an increased branching growth of nerve cells -- caused by chronic antidepressant exposure, may be the cause.
Wall Street Journal, November 16, 2011
The medicating of Americans for mental illnesses continued to grow over the past decade, with one in five adults now taking at least one psychiatric drug such as antidepressants, antipsychotics and anti-anxiety medications, according to an analysis of pharmacy-claims data.
Among the most striking findings was a big increase in the use of powerful antipsychotic drugs across all ages, as well as growth in adult use of drugs for attention-deficit hyperactivity disorder—a condition typically diagnosed in childhood. Use of ADHD drugs such as Concerta and Vyvanse tripled among those aged 20 to 44 between 2001 and 2010, and it doubled over that time among women in the 45-to-65 group, according to the report.
Overall use of psychiatric medications among adults grew 22% from 2001 to 2010. The new figures, released Wednesday, are based on prescription-drug pharmacy claims of two million U.S. insured adults and children reported by Medco Health Solutions Inc., a pharmacy-benefit manager.
America’s State of Mind Report is a Medco Health Solutions, Inc. analysis examining trends in the utilization of mental health‐related medications among the insured population. The research reviewed prescription drug claims of over two million Americans to assess the use of antidepressants, antipsychotics, attention deficit hyperactivity disorder drugs and anti‐anxiety treatments between 2001 and 2010.
The Report provides revealing insights into the utilization of mental health treatments along gender lines, age groups and geography, as well as changes that have occurred over the decade. Read the full report here.
Prozac Turned Teen into Murderer
Judge Bases Opinion on Testimony of Psychiatrist Peter R. Breggin, MD that the Antidepressant Caused a Stimulant-like Syndrome Leading to Manic-like Behavior, Suicidality and Violence
( Go to Judge's Opinion )
The headline from the Winnipeg Free Press in Canada tells the story: "Judge Agrees Prozac Made Teen a Killer." Provincial court judge Robert Heinrichs listened to expert psychiatric testimony for the defense by Peter R. Breggin, MD and weighed it against testimony for the prosecution by a Canadian psychiatrist.
On September 16, 2011 the judge issued his opinion in regard to the sixteen-year-old who stabbed his friend to death. The judge determined, "His basic normalcy now further confirms he no longer poses a risk of violence to anyone and that his mental deterioration and resulting violence would not have taken place without exposure to Prozac." Also consistent with Dr. Breggin’s lengthy report and testimony, the judge observed, "He has none of the characteristics of a perpetrator of violence. The prospects for rehabilitation are good."
In his written opinion in the case of “Her Majesty the Queen and C.J.P” (Citation #2011 MBPC 62), Judge Heinrichs concluded, “Dr. Breggin’s explanation of the effect Prozac was having on C.J.P.’s behavior both before that day and in committing an impulsive, inexplicable violent act that day corresponds with the evidence” (p. 18). He also found, “there is clear medical and collateral evidence that the Prozac affected his behavior and judgment, thereby reducing his moral culpability” (p. 20). The judge’s complete opinion is available here. Read the rest of the story here.
by Peter R. Breggin, MD, Psychiatrist, Private Practice, Ithaca, New York
Director, the Center for the Study of Empathic Therapy, Education and Living
First published in the Huffington Post
The diagnosing of millions of children with ADHD in order to medicate them with stimulants and other psychoactive chemicals is an American tragedy, growing into a worldwide catastrophe. Never before in history has a society attempted to deal with its children by drugging a significant portion of them into conformity while failing to meet their needs in the home, school and society. The ethical scientist or physician, the concerned parent or teacher, must feel stricken with grief and dumbfounded that we have allowed the interests of powerful advocacy groups to completely override the interests of our children.
To make matters worse, on October 16, 2011 the American Academy of Pediatrics overrode the FDA and recommended that children as young as age four be diagnosed with ADHD and given the stimulant methylphenidate (e.g., Ritalin, Metadate, Focalin, Daytrana and Concerta). The scientific literature actually shows that 50% or more of children this young when give Ritalin, Focalin, Dexedrine, Adderall and other stimulants will become obviously depressed, lethargic, weepy--but more manageable. Moreover, it's been proven time and again that the stimulants stunt their growth. In addition, studies show that stimulants will permanently change their brain chemistry, cause shrinkage of brain tissue, predispose children to cocaine addiction in young adulthood, stigmatize them with a false diagnosis, and push them toward becoming permanent consumers of psychiatric drugs.
This endorsement of drugging younger children by the American Academy of Pediatrics is an outrage. While focusing on ADHD and stimulants, the endorsement will open the door to every other psychiatric drug. Those weepy children who are having adverse reactions to stimulants will have an antidepressant added to their daily drug dose. When some of them become overstimulated, sedatives will be added to the regimen. When some of them develop drug-induced hallucinations and delusions, or mania, mood stabilizers and antipsychotics will be added. These new guidelines will encourage prescribers to throw caution to the wind with toddlers, opening a Pandora’s box of drug intervention for children. Many young children will have their brains bathed with powerful and often toxic chemicals in the early years of their central nervous system development.
The scientific issues are simple enough. Read the rest of the essay here.
Dr. Peter Breggin presents the first Lifetime Empathic Therapy Award to esteemed and beloved colleague Bertram Karon, PhD
by Peter R. Breggin, MD, In The New York Times October 13, 2011
The drugging of children for A.D.H.D. has become an epidemic. More than 5 million U.S. children, or 9.5 percent, were diagnosed with A.D.H.D. as of 2007. About 2.8 million had received a prescription for a stimulant medication in 2008.
By making an A.D.H.D. diagnosis, we ignore and stop looking for what is really going on with the child.
The A.D.H.D. diagnosis does not identify a genuine biological or psychological disorder. The diagnosis, from the 2000 edition of the “Diagnostic and Statistical Manual of Mental Disorders,” is simply a list of behaviors that require attention in a classroom: hyperactivity (“fidgets,” “leaves seat,” “talks excessively”); impulsivity (“blurts out answers,” “interrupts”); and inattention (“careless mistakes,” “easily distractible,” “forgetful”). These are the spontaneous behaviors of normal children. When these behaviors become age-inappropriate, excessive or disruptive, the potential causes are limitless, including: boredom, poor teaching, inconsistent discipline at home, tiredness and underlying physical illness. Children who are suffering from bullying, abuse or stress may also display these behaviors in excess. By making an A.D.H.D. diagnosis, we ignore and stop looking for what is really going on with the child. (read more: "A Misdiagnosis Anywhere" by Peter R Breggin MD New York Times October 13, 2011)
Los Angeles Times -- Psychiatrists sharpened their interest in child mood problems several years ago in response to criticism over the number of children diagnosed with bipolar disorder — a debilitating condition in which periods of depression alternate with euphoria or elevated moods. It is considered incurable, although symptoms may be treated with drugs that carry serious side effects.
The idea that bipolar illness can begin in childhood caught hold in the last decade. The number of outpatient visits for children diagnosed with bipolar disorder mushroomed from fewer than 200,000 a year in 1995 to 800,000 in 2003, according to a 2007 study in Archives of General Psychiatry.
The study reinforced the notion that childhood bipolar disorder had become a fad diagnosis.
Read the complete story here.
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