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Zypexa Warnings for Children Reviewed by FDA

FDA To Review Zyprexa Warnings For Children

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Pringle: Pharmaceutical Hustlers Part 2 (SSRI Pushers)

Pharmaceutical Industry Hustlers – Part II

Pushers of SSRI Antidepressants

To gain approval for treating children, all a drug company has to do is submit two positive studies to the FDA to prove a medication is safe and effective for kids. However, after 20 years of feeding the new generation of antidepressants to tens of thousands of kids in clinical trials, the only one ever approved is Prozac.

Collectively, these antidepressants are referred to as SSRI’s (selective serotonin reuptake inhibitors) and include Paxil, Zoloft, Celexa and Lexapro. When the term SSRIs is used, it often refers to their chemical cousins Effexor, Wellbutrin and Cymbalta as well.

The drug companies, “by their sheer economic clout,” have become the single most dominant influence in our healthcare system, and the “ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence,” says Dr Lawrence Diller, a behavioral-developmental pediatrician and author of, “The Last Normal Child,” in the July 13, 2008, San Francisco Chronicle.

“In this climate,” he explains, “drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than non-drug (e.g., parenting and education) approaches.”

That is why we are seeing famous (or infamous) Newsweek cover boys – like a 10-year-old “who has taken 38 psychiatric medications in his short, unhappy life,” he says.

Dr Joseph Glenmullen, author of “Prozac Backlash,” testified at a hearing before the US House Energy and Commerce Committee on February 10, 2005, and explained how important lawsuits have been in unearthing the internal company documents, which reveal the antidepressant-induced suicidality risk. Both the FDA and the pharmaceutical industry knew about this side effect over a decade ago, he said.

Dr Glenmullen noted that the FDA failed to adequately educate doctors and the public and called it a “most dangerous scenario” when neither the doctor nor the patient knows how to recognize antidepressant-induced suicidality.

He pointed out that only Prozac was FDA approved for depressed children, and all other antidepressants studied had failed to demonstrate they were more effective than placebo. He faulted the FDA for failing to require drug manufacturers to tell doctors in the labels that the drugs had been studied and failed to show efficacy.

He noted that one million American children were on antidepressants for everything from shyness to school anxiety to headaches to attention deficit disorder. “How can the FDA allow this to happen when it has acknowledged that the drugs can make children suicidal?” he asked.

“Family doctors write 70% of prescriptions for antidepressants and know little about how to diagnose and treat antidepressant-induced suicidality,” he pointed out.

Once the FDA approves a drug, doctors can prescribe it for any purpose, a practice called off-label prescribing. “Many doctors prescribe many medications off label for children, but none do it as frequently as child psychiatrists,” says Dr Diller.

He advises that none of the psychiatric drugs have been studied for more than two or three months regarding long-term safety or effectiveness with children, with the exception of stimulants used for ADHD. Drug companies oppose this kind of thorough follow-up on drugs “not only because it is expensive, but because they don’t really want to find out whether their drugs continue to work over time or if long-term side effects develop,” he states in the paper, “A Prescription for Disaster,” published by Salon.com on May 23, 2002.

“Currently, that kind of research is a job for the country’s trial lawyers,” he writes.

“But this de facto system of monitoring the effects of drugs requires many casualties before an adverse outcome is discovered or established in the medical and popular literature,” Dr Diller points out.

Highly Paid Hustlers in motion

The “failure of clinical trials to provide safety information about the effects of long-term use is at the heart of the debate about the legitimacy of prescribing psychotropic drugs for children,” according to Vera Hassner Sharav, President of the Alliance for Human Research Protection in the 2003 paper, “Children in Clinical Research: A Conflict of Moral Values,” published in the American Journal of Bioethics.

No SSRI was approved for children before 2003. However, by “the early 1990’s, it didn’t matter that they were not officially approved for use in children: they were commonly given to children as young as 6 years old,” says Professor Jonathan Leo in the 2006 paper, “The SSRI Trials in Children: Disturbing Implications for Academic Medicine.”

He points out that “the child psychiatry profession fully endorsed the use of these drugs well before the FDA approved them, and, in an even odder twist,” he says, “the profession endorsed the use of them well before any of the major studies in children were even published.”

“It appears that one reason for doing the studies in the first place was to justify already well-accepted prescribing patterns,” according to Professor Leo.

“If a trend is created ‘because everyone else is doing it’ then it appears that the child psychiatry profession’s use of these drugs in the late 1990’s more closely resembled a trend instead of a logical scientific undertaking,” he explains.

The first major studies claiming SSRI’s were safe and effective for children began to appear in the late 1990’s. In all the published studies, papers and poster presentations used at medical seminars, conferences and other events to expand the “well-accepted prescribing patterns,” to doctors in every field of medicine, there are the names of the same “Highly-Paid Hustlers,” also known as “key opinion leaders,” because they are supposedly so highly respected by their peers.

They include, but are not limited to, Drs Joseph Biederman, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer and Karen Wagner.

Dr Biederman and the gang at Harvard almost single-handedly instigated the epidemic in the off-label prescribing of drug cocktails to children, of 2, 3 or even 4 drugs at a time, in combinations that have never been tested on animals much less humans. The mental illness always known as “manic-depression” was now “bipolar disorder,” and in the mid-90’s, Dr Biederman, and a few more “opinion leaders” started claiming that a great number of children were afflicted, possibly even as early as in the womb, some said.

“Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States’ most influential doctor when it comes to determining whether their children are normal or mentally ill,” says Dr Diller, in an article entitled, “Are Our Leading Pediatricians Drug Industry Shills?” in the July 13, 2008, San Francisco Chronicle.

“Biederman and his team,” Dr Diller writes, “are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs.”

“The science of children’s psychiatric medications is so primitive and Biederman’s influence so great,” he says, “that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs.”

“This happens in the absence of a drug trial of any kind – instead,” Dr Diller notes, “the decision is based upon word of mouth among the 7,000 child psychiatrists in America.”

”That’s why Iowa Sen. Charles Grassley’s recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic,” he says.

“If true,” Dr Diller notes, “this scandal is yet one more stake in the heart of American academic medicine’s credibility with frontline doctors like him, and more importantly, with the parents of the children he deals with every day.”

Until the “bipolar” profiteering scheme was set in place by publishing a couple bogus studies and then passing them around to doctors all over the country at medical seminars and conventions, manic-depression was unheard of in children. It still is in other counties.

Most parents are not aware of the life-long consequences of a childhood mental-illness diagnosis. Children with medical records showing treatment become ineligible for a wide range of occupations. An early diagnosis can also make it difficult to obtain health insurance for life.

In the age of computerized recordkeeping, there can be no deleting of this damning information. Just as there is no scientific way to prove that anyone has a mental disorder, there is no way to disprove it either. Once diagnosed, a child will never escape the label.

Dr Emslie was busy pumping out new marketing tools last year, this time in the form of a treatment guideline to promote the off-label use of psychiatric drugs to toddlers. However, the “respectable” medical journals continue to publish this kind of trash.

He is the first author on a December 2007 paper in the Journal of the American Academy of Child & Adolescent Psychiatry that reviewed the developmental considerations related to preschool psycho-pharmacological treatment, presenting current evidence bases for specific disorders in early childhood and described the recommended algorithms for medication use in 3- to 6-year-olds.

This “Preschool Psychopharmacology Working Group” claims it was developed to review existing literature and to develop recommendations to guide clinicians considering psycho-pharmacological treatment in very young children. “The purpose of this effort,” the authors note, “is to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications.”

Not one single psychiatric drug is approved for children under 6; not alone and not together with any other. Yet the Group says it has established algorithms for the treatment of ADHD, disruptive behavior disorders, major depressive disorder, bipolar disorder, anxiety disorders, posttraumatic stress disorder, obsessive-compulsive disorder, pervasive developmental disorders (such as autism) and primary sleep disorders.

On May 5, 2006, United Press International reported on a Duke University study where investigators studied 307 children between the ages of 2 and 5 and claimed they detected signs of depression, anxiety and other mental illnesses. The rate was about the same as with older children and not much lower than within adults, they said. UPI made sure to mention that the research was funded in part by the “pharmaceutical giant Pfizer.”

Judging by the results of this “study,” the “Hustlers” recruited another 30 toddlers as potential customers for daily drug cocktails in one sweep. Notably missing from all the above lists of “disorders” is a condition that could account for half of the stigmatizing labels in one age group, commonly known throughout time as the “Terrible Twos.”

Sad aftermath

Of all the harmful actions of modern psychiatry, the mass diagnosing and drugging of children is the most appalling with the most serious consequences for the future of individual lives and for society, says Dr Peter Breggin, author of the new book, “Medication Madness.”

Many children who end up seeking help from Dr Breggin are already on four or five drugs at one time. He says millions of children are growing up with “drug-intoxicated brains.”

Not only do these medications suppress spontaneity and volition, he warns, but the psychiatric approach teaches children that they cannot, without medication, learn to manage their own behavior. In effect, the children are taught that they cannot exercise and develop self-determination, autonomy or free will, he explains.

Pennsylvania psychiatrist Dr Stefan Kruszewski also warns that “young children who are medicated do not learn to adapt and develop coping strategies as they move through the developmental stages of childhood.”

“They rely on a false belief that drugs can solve problems,” he says, “rather than relying on their own innate creative potential or the help of family, friends, and schooling.”

“Psychiatry was once plagued by ‘boundary violations,’ where physicians exploited the dependence of their patients,” Dr David Healy explains in the 2006 paper, “The Latest Mania: Selling Bipolar Disorder.” But he says:

“All the indications are that we are now in a new era of drug-related boundary violations. There is perhaps nowhere in medicine where this is more obvious than in the case of bipolar disorders, with adults treated with bizarre cocktails and children put on some of the most lethal drugs in medicine.”

“The extensive prescription of these medications for children,” Dr Diller warns, “without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties.”

“Catastrophic side effects may be rare,” he says, “but they become predictable when we treat so many children with so many drugs.”

“There is nothing more despicable than a doctor knowingly telling normal children they are mentally ill for profit,” says Dr Fred Baughman, author of, “ADHD Fraud – How Psychiatry Makes Patients of Normal Children.”

“Because the children made into ‘patients’ are normal to begin with,” Dr Baughman contends, “those who treat them with psychiatric drugs are guilty not of an iatrogenic medical mistake, but a willful for-profit poisoning.”

“What should we call it when children die pursuant to a fraudulent diagnosis,” he asks. “First degree murder? Second degree murder? Justifiable homicide? Manslaughter?”

In an expert report recently submitted in litigation involving a Paxil-induced suicide by a 13-year-old boy, Dr Glenmullen discusses a case where that question begs to be answered when he tells the court: “It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today.”

There are many families suffering all over the country as a result of the drugging-children-for-profit schemes set in place by the Highly-Paid Hustlers. “For us it has been four and a half years without resolution or closure,” says Mathy Milling Downing, whose daughter Candace hung herself in January 2004 after being prescribed Zoloft at age 12 because she was nervous when taking tests at school.

“Every day hurts,” Mathy says. “One never gets over the loss.” Prior to her death, the Downings saw no signs of Candace being depressed or suicidal.

They were not told to watch for signs of suicide. The doctor did not inform them that Zoloft was not approved for children, and they were assured that Zoloft was safe.

The Downings would later learn that their daughter’s physician was on Pfizer’s payroll. “Although we realize that Candace’s doctor only made about $12,000 acting as a Pfizer consultant, it’s not the amount that bothers us,” Mathy says.

“It’s the medical compromise. It’s the lack of informed consent. It’s placing economical gain above the well-being of an innocent child and a trusting family,” she states.

“I just want to know when ‘Greed before Need’ will diminish and doctors will once again place a patient’s well-being first,” she says, “before financial gain.”

“What has happened to the Hippocratic Oath that doctors are supposed to take?” Mathy wants to know.

Rough estimates

In “Let Them Eat Prozac,” Dr Healy discusses how he reached his estimates for the high number of suicides and suicide attempts that could be attributed to Prozac alone. An April 2000 paper in the Archives of Psychiatry looked at the rates for suicide attempts on newer antidepressants compared to placebo and reported SSRI rates higher than placebo.

These figures made it possible for him to estimate how many people had made suicide attempts. “If ten per thousand make an attempt on Prozac and five per thousand or less do so on placebo or other antidepressants, and if (as is conventionally estimated) 40 million people worldwide have had Prozac,” he writes, “then there will have been 200,000 more suicide attempts on Prozac than had Prozac not been used.”

“Conventional wisdom is that there is one suicide for every ten attempts,” he explains. “These would give 20,000 suicides over and above the number who would have committed suicide if they had been left untreated or been treated with older agents.”

Dr Healy then accessed the FDA’s Adverse Event Database to look at suicides reported and found there were over 2,000 as of October 1999. “The FDA estimated their database picked up only between one and ten per cent of serious adverse events,” he writes.

“This gives a spread between 20,000 and 200,000 suicides on Prozac,” he concludes.

There is no way to know how many people have suffered needlessly because the drugmakers lied about the suicide risk for so many years. According to Dr Healy, aside from the need to save lives, if emergent suicide linked to a drug is not correctly attributed to treatment, patients suffer a long-lasting injury to their self-esteem and self-confidence as a consequence.

“If patients have engaged in actual suicidal acts as a result of treatment and the connection to treatment is not made, given that prior suicide attempts appear to increase the risk of future successful suicides, it appears possible that the risk of a future successful suicide has been increased accordingly,” he warns in a June 2003 briefing paper on “Antidepressants and Suicide.”

Evelyn Pringle
epringle05@yahoo.com

(Written as part of the Paxil Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman’s Pharmaceutical Litigation Department www.baumhedlundlaw.com)

Filed under: antidepressants, Baum Hedlund, Charles Grassley, Congress, Preschool Psychopharmacology Working Group, , , , , , , , , , , , , ,

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