Thursday, July 29, 2010

Lawsuits Needed Against Prescribing Quacks

Evelyn Pringle April 24, 2009

On April 21, 2009, the Miami Herald reported that a 7-year-old boy in Florida, Gabriel Myers, had committed suicide by hanging himself with a detachable shower head in a bathroom of the foster care home he was placed in three weeks earlier.

All total, the Herald found the child had been given the ADHD drug Vyvanse, the antidepressant Lexapro, the atypical antipsychotic, Zyprexa, and Symbyax, a drug that contains both Prozac and Zyprexa.

The most appalling part of this story is that Dr Sohail Punjwani, the shrink who was supposedly treating Gabriel, told the Herald that he did not even recall the boy.

That being the case, it probably would have been senseless to inquire about what mental disorders the doctor was allegedly treating. According to the Herald:

"Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children.

"The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children."

Reports in the media indicate that any behavioral changes observed in Gabriel would directly correlate with events involving sexual abuse, neglect, and abandonment, none of which could be erased with pills. Being the shrink could not even remember the child he obviously was not providing therapy to help him deal with these painful issues.

Every drug he was given can cause children to become suicidal. For instance, according to the report, “Child Suicides In Florida Associated With Use Of Psychotropic Drugs,” by records researcher, Ken Kramer, of the 252 cases of suicide in Florida by children under the age of 18 between 2000 and 2004, thirty-six were on ADHD drugs.

Conshohocken, Pennsylvania attorney, Derek Braslow, has handled wrongful death cases involving ADHD drug related suicides, including one suicide by a 15-year-old girl, diagnosed with ADHD by a counselor who sent a recommendation to the family doctor to prescribe Concerta.

"The story of the girl's suicide should be required reading for every pediatrician and child psychiatrist in the country," Braslow advises.

"These drugs do one of two things to children and teenagers," he says. "They either turn them into zombies, making them passive and non-responsive, or turn them into hyper-focused, anxious kids who can't sleep or eat and become consumed with minor typical issues like friendships, boyfriends and school."

According to Dr David Healy, the psychopharmacology expert from the UK, and author of the new book, Mania: A Short History of Bipolar Disorder, Zyprexa has the highest suicide rate in clinical trial subjects of any drug in clinical trial history.

Antidepressants such as Lexapro and Prozac carry black box warnings of an increased risk of suicide. Symbyax provides a double whammy by combining Prozac and Zyprexa.

Fifteen years ago, Dr Healy published a paper stating, "the volume of case reports and other studies is sufficient to demonstrate that antidepressants and antipsychotics may induce suicidal ideation in certain individuals under certain conditions."

Children all over the US have become profit receptacles for the psycho-pharmaceutical industry. A new study by the Agency for Healthcare Research and Quality found the treatment and care of children with mental disorders for the year 2006, to be the highest expenditure of any condition, with a price tag of $8.9 billion. Everyday childhood physical injuries like broken bones and such did not even come close to mental disorders with a cost of $6.1 billion.

The psychiatric drug makers have doctors in every field of medicine profiting by writing prescriptions during office calls that require a few minutes time. Hard telling how much the shrink was making off Gabriel, the patient he could not recall; but the price for Vyvanse at on December 14, 2008, was $385 for ninety 50mg capsules. Lexapro cost $237 for ninety 10mg tablets. The price for Zyprexa was $1,195 for ninety 10mg tablets in April 2009.

A year's worth of these three drugs, if purchased at, would total $21,804.

Big Pharma CEOs are laughing all the way to the bank. In 2007, Sidney Taurel, the CEO of Zyprexa and Symbyax maker Eli Lilly, took home a salary, bonus, and compensation package worth $13 million, according to Fierce Pharma.

Doctors in Florida are notoroious for feeding young children psychiatric drugs, likely competing for the top prescribers in the nation with physicians in Texas and Ohio.

An October 2007 report by researchers at Florida University titled: The Use of Antipsychotic Medications with Children: A Comprehensive and Current View, studied Medicaid fee for service claims data for the period from July 2002 to December 2005.
Children were classified into age groups of 0-5, 6-12, and 13-18 years old. The researchers reviewed data on the diagnoses given to children who were prescribed atypical antipsychotics, and noted the following observations:

"First, antipsychotics are used to treat a wide variety of disorders in youth. Second, a small minority of children received antipsychotic medications for the treatment of psychosis. Third, antipsychotics are relatively infrequently used for the treatment of aggression among children with autism (An FDA approved use for risperidone) since only 6-8% of antipsychotic recipients are diagnosed as autistic. Fourth, antipsychotics are frequently used for the treatment of disruptive behaviors in youth."

Under the heading, "Diagnoses of Children Receiving Antipsychotic Medications," the authors wrote:

"The analyses of the diagnoses of children receiving antipsychotics reveal that the medications are used to treat a broad spectrum of disorders. Some of these disorders, for example, attention deficit hyperactivity disorder (ADHD) and major depression, clearly do not call for antipsychotic treatment."

In the section titled, "Prescribers of Antipsychotic Medications," the authors reported that "very young children were the least likely to be prescribed an antipsychotic by a psychiatrist and the most likely to be treated by a primary care physician."

"It is likely that some of these young children never come to the attention of psychiatric specialists," they said. "Over the 3.5 years of the study, involvement of child psychiatrist with these children, as measured by percentages of scripts written, declined while primary care involvement increased."

"The large number of general practice physicians writing small numbers of scripts is of concern in that there may not have either sufficient training or experience to assure quality prescribing practices," the authors warned.

The report noted that the "use of antipsychotic medications with children 0-5 is of concern," and stated:

"The guidelines developed by the program indicate this practice is generally "not recommended" while recognizing that disruptive aggression in autism is now an FDA indicated use. Only 8% of the young children receiving antipsychotic treatment had a diagnosis of autism.

"ADHD was the most frequently used diagnosis for children 0-5 years on antipsychotic medication. Affective disorder is the next most frequently appearing diagnosis despite Florida's expert panel's assertion that the diagnosis is of questionable validity for children under 6 years old."

In checking the definition of "Affective Disorder," the Gale Encyclopedia of Neurological Disorders, states: "Major depressive disorder, bipolar disorders, and anxiety disorders are the most common affective disorders."

For the period of July 2005 to December 2005, the Florida report shows the following prescriptions and diagnoses for the 0-5 age group, including the alarming diagnosis of schizophrenia for 115 infants and toddlers: ADHD 1372, Affective Disorders (other) 255, Other not specified 249, Autism 211, Conduct Disorder 179, Adjustment Disorder 102, Major Depression 25, Anxiety Disorder 22, Tourettes Disorder 10, and Depressive Disorder 9.

For children in Gabriel's age group of 6-12, the report shows the following, including 474 children diagnosed with schizophrenia: ADHD 5197, Affective Disorders (other) 1553, Conduct Disorder 963, Other not specified 548, Major Depression 537, Autism 445, Adjustment Disorder 449, Anxiety Disorder 224, Depressive Disorder 202, and Tourettes Disorder 55.

The practice of stigmatizing kids as young as infants and toddlers for life with a diagnosis of schizophrenia in order to justify prescribing the expensive antipsychotics is despicable. Dr Healy reviewed the number of Florida children diagnosed with schizophrenia and compared the data to children diagnosed with schizophrenia in North Wales. The current rate of treatment for schizophrenia in 0-15 year olds is four per million in North Wales, he found.

"Florida has a population of 18.25 million so it should have 73 persons with this illness in the 0-15 group," he says. "But it appears you have 1,409 on antipsychotics - 20 fold higher."

Since April 2008, Florida has required doctors to obtain prior approval to prescribe antipsychotics to children on Medicaid under the age of six. On March 29, 2009, the St Petersburg Times reported the process had lowered the number of kids on the drugs and compared the number of prescriptions for children five and under for the period of May to December 2008, to the same period in 2007.

Apparently a decrease in mental disorders among infants and toddlers magically occurred between 2007 and 2008, because the antipsychotic prescriptions were as follows:

2007: Below age one - 23, one year-olds - 39, two year-olds - 103, three year-olds - 315, four year-olds - 886, and five year-olds - 1,801.

2008: Below age one - 0, one year-olds 5, two year-olds 26, three year-olds 107, four year-olds 268, and five year-olds 437.

Going after the drug companies has done little to curb the illegal peddling of psychiatric drugs to children. Lilly paid over a billion this year to settle fraud charges over the off-label marketing of Zyprexa, and several more fraud lawsuits are still pending. Johnson & Johnson and AstraZeneca are also facing fraud charges over the off-label marketing of Risperdal and Seroquel.

Forest Laboratories was similarly charged recently for marketing Lexapro and Celexa off-label to kids. GlaxoSmithKline paid a couple million in 2004 to settle charges related to illegally peddling Paxil to children. In recent SEC filings, Glaxo registered a $400 million charge to settle an investigation of the off-label marketing of unnamed products.

In other lawsuits, Glaxo was ordered to reimburse families and third party payors for the cost of off-label prescriptions of Paxil to children. Glaxo also has several Paxil related suicide trials coming up this year.

Thus far, Lilly has paid over a billion to settle out of court with roughly 30,000 people over Zyprexa injuries. Thousands of Risperdal and Seroquel lawsuits have been filed against Johnson & Johnson and AstraZeneca by person injured as well.

Florida has supposedly been monitoring the prescribing habits of doctors with children for the past several years. Gabriel's shrink was already on a list that the Florida Agency for Health Care Administration had red-flagged as having "problematic" prescribing practices with children since 2006, according to the Miami Herald.

It's obvious that the only action that might slow the profit driven drugging of helpless children in this country is a steady filing of highly publicized lawsuits against the prescribing quacks all over the US.

A class action against the group of shrinks most responsible for convincing doctors throughout the nation to prescribe cocktails of psychiatric drugs to children, titled "Joseph Biederman et al," might do wonders as well.

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