The motive behind Big Pharma's promotion of the off-label prescribing of psychotropic drugs is market expansion and unfortunately, it just so happens that children provide the richest harvest because most kids are covered by health insurance plans or Medicaid.
The various recruitment schemes include trolling for customers among infants and toddlers between the ages of 0-to-5 and there are absolutely no studies on the safety and efficacy of any psychiatric drug with this patient population.
Every single prescription for a psychiatric drug written for infants and toddlers is "off label," meaning it comes with no FDA safe dosage recommendation and is prescribed for a patient and condition other than those approved by the FDA as being safe and effective.
A group of self-proclaimed "experts" even published their own little diagnostic manual called, "Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood, Revised (DC:0-3R)." On the Zero to Three Web site, where it can be purchased, it says, the "DC: 0-3R enhances your ability to prevent, diagnose, and treat mental health problems in the earliest years by identifying and describing disorders not addressed in other classification systems and by pointing the way to effective intervention approaches."
This Zero to Three group recently told ABC News that 1 in every 40 babies is depressed, in what can only be viewed as an obvious attempt to snag new SSRI customers.
Over the past year, the FDA added new warnings to the antidepressants known as selective serotonin reuptake inhibitors (SSRIs), after studies identified risks of major congenital malformations, heart birth defects, and a life-threatening lung disorder, in infants born to women taking SSRIs. Which begs the question of how can SSRIs be considered safe for infants outside the womb if exposure causes such serious harm to infants inside the mother.
For the naive readers who think this must be a joke, this can not be possible, consider a 2004 study published in the Psychiatric Services journal that found the fastest growing segment of customers for psychiatric drugs to be preschoolers aged 0-5 years, with drug use among girls doubling, and drug use among boys rising 64%.
The drug companies are literally making a killing by funneling tax dollars through children covered by programs like Medicaid all across the nation. On April 25, 2005, the Columbus Dispatch released a report on an investigation that reviewed Medicaid records for a one month period and found doctors had prescribed sedatives and powerful, mood-altering drugs for 696 Ohio babies and toddlers between the ages of newborn and 3-years-old.
About 75% of the infants and toddlers were given Hydroxyzine, a long acting antihistamine, prescribed most often to children for its sedative effects, more than 90 were prescribed another antihistamine, and 48 children were taking anti-anxiety medication.
Twenty-seven were put on Valium, twenty-eight were prescribed SSRIs, including Paxil, Prozac and Zoloft, and 18 infants and toddlers were prescribed antipsychotics.
Down in Texas, the state Comptroller, Carole Keeton Strayhorn, instigated a study on psychiatric drug use by children in foster care that reviewed the Medicaid prescription data for 2004 and 2005, to determine whether drugs were "being prescribed to make children more submissive or to simply line the pockets of the unscrupulous and the uncaring - or both," she said.
In a May 10, 2006 press release, Ms Strayhorn announced, "A clear pattern of overmedication and potential misdiagnosis of foster children is evident."
Her study found large numbers of psychotropic drugs prescribed to children, she said, "even though, according to the Food and Drug Administration, many of these drugs are not labeled for use in children and have serious side effects such as suicidal tendencies, diabetes, and cardiac arrhythmia."
She was particularly upset that children as young as 2 were on drugs. On October 18, 2006, Ms Strayhorn told CBS News, "I found babies, 2-year olds, 3-year olds being given mind-altering drugs," and said Texas children in foster care were being drugged and were dying.
Ms Strayhorn noted her concern about the use of "atypical" antipsychotics and cited 3 children who had received 30-day prescriptions for 90 tablets (3 per day) of Zyprexa, at a cost per child of $1,559.70 a month, and said the same doctor had written the prescriptions for all three children and they were all filled at the same pharmacy.
"This potential for Medicaid fraud and the possibility of long-term health problems in these children is alarming," she stated.
In Tennessee, a study in the August 3, 2004, Archives of Pediatric Adolescent Medicine, found that over a 5 year period, the number of preschool children covered by Medicaid who were not psychotic but were prescribed antipsychotics had increased 61%.
Moreover, the drugging of infants and toddlers for profit is not likely to end any time soon. On May 5, 2006, a study discussed by United Press International, said investigators from the Duke University, detected signs of depression, anxiety and other mental illnesses in one in 10 of the 307 children they studied between the ages of 2-to-5, which is about the same as with older children, they said, and not much lower than the rate in adults.
In light of the drastic rise in the sales of drugs that will follow this blatant customer recruitment net, its important to mention that UPI said the research was funded in part by the "pharmaceutical giant Pfizer."
Its not as if the drug makers need to convince more doctors to drug kids. A report by Gardiner Harris in the November 23, 2006, New York Times, states that last year in the US, about 1.6 million children and teens, including roughly 280,000 kids under the age of 10, were given at least 2 psychiatric drugs at the same time, according to an analysis by Medco Health Solutions, conducted for the Times.
In his report, Mr Harris discusses the case of 3-year-old Fate Riske, from Fond du Lac, Wisconsin, who takes 2 antipsychotics plus a sleeping medicine to control what her mother, Elizabeth Klein-Riske, told Mr Harris were "hours-long tantrums, a desire to watch the same movies repeatedly and an insistence on eating the meat, cheese and bread in her sandwiches separately."
A major side effect of the new "atypical" antipsychotics is obesity and the Times reports that 3-year-old Fate's weight has gone from 30 pounds to 48 in just five months.
Prescribing multiple psychiatric drugs at the same time is apparently common among children covered by private health plans as well. The Time's analysis found that more than 500,000 children were prescribed at least 3 drugs at the same time and more than 160,000 got at least 4 drugs together.
According to Mr Harris, "doctors routinely pair stimulants with antidepressants, antipsychotics and anticonvulsants even though some of these medications can cause serious side effects, have few proven pediatric psychiatric benefits and lack clear evidence about how they interact or influence mental and physical development."
In fact, between 2001 and 2005 the use of new "atypical" antipsychotics with children increased 73%, Medco determined. Yet in September 2005, a major government study determined that the far more expensive atypicals were neither more effective nor safer than the old antipsychotics that cost pennies a day that doctors rarely prescribed any more.
The drugs prescribed for ADHD can hardly be considered safe and harmless either. In September 2005, the FDA announced that Strattera, touted as the only non-stimulant ADHD drug, had been found to increase the risk of suicidal behavior in some children, and told Eli Lilly to add a Black Box warning to the drug's label.
On February 9, 2006, with a vote of 8 to 7, members of the FDA's Drug Safety and Risk Management Advisory Committee called for a Black Box warnings on the labels of ADHD stimulants drugs about the risks of stoke, heart attacks and deaths.
In their interviews with the press at the time, FDA panelists cited 25 deaths in the US between 1999-2003, among stimulant users, but 51 deaths were found to be listed in an agency staff report.
Neurologist, Dr Fred Baughman, author of, "The ADHD Fraud: How Psychiatry Makes Patients of Normal Children," used the Freedom of Information Act, and found 186 deaths among users of ADHD drugs in the MedWatch database between 1990 and 2000.
According to Dr Grace Jackson, MD, author of, Rethinking Psychiatric Drugs: A Guide for Informed Consent, "given the fact that a mere 1% of all adverse events are believed to be filed with the FDA under the nation's voluntary reporting system, the true scope of stimulant lethality is much larger than the regulatory agency concedes."
A report on the use of ADHD drugs titled, "Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data," by Kate Gelperin, MD, MPH, Medical Epidemiologist and Kate Phelan, RPh, Safety Evaluator, of the FDA, was presented in March 2006, to the FDA's Pediatric Advisory Committee.
The Summary of the Report states, "The most important finding of this review is that signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors, at usual doses of any of the drugs currently used to treat ADHD."
"A substantial proportion of psychosis-related cases were reported to occur in children age ten years or less, a population in which hallucinations are not common," it stated.
"The occurrence of such symptoms in young children," the authors wrote, "may be particularly traumatic and undesirable, both to the child and the parents."
"The predominance in young children of hallucinations, both visual and tactile," it said, "involving insects, snakes and worms is striking, and deserves further evaluation."
However, years of documented deaths and injuries do not seem to have any adverse effect on the sale of these drugs. In 2004, twenty-three million prescriptions for ADHD drugs were written for children in the US, according to the July 1, 2005 New York Times. On August 24, 2006, Rueters News reported that in 2005, ADHD drug sales in the US reached nearly $3 billion.
In the US, a Black Box warning was added to the labels of all SSRIs about the increased suicide risk with children in October 2004. On December 9, 2004, ABC's Prime Time Live revealed that at least 100 children in the US had committed suicide while taking SSRIs and that many others had attempted suicide.
The following year, according to a study reported at a meeting of the American Academy of Child and Adolescent Psychiatry, SSRI use with children declined, with the greatest decrease being with patients younger than 9. Most specifically, there was a 17.8% drop in use for children younger than 4, who were already on SSRIs, and there was a 14.4% decrease in new prescriptions written for children younger than 4.
However, corresponding with the decrease in SSRI use, the study discussed by Mr Harris in the Times, found that doctors are now prescribing combinations of antipsychotics and anticonvulsants for children more often.
According to Dr Baughman, the problem with this practice is not just the prescribing of multiple drugs for children without any scientific basis. "When there is no demonstrable disease to target," he says, "there is no scientific justification for giving even a single pill."
Barry Turner, Lecturer in Law at Leeds Law School in the UK, has spent years researching psychopathy and often speaks on the dangers of "pathologising" children's behavior and prescribing SSRIs to kids. As an academic lawyer, he has for a number of years also been involved in litigation related to the marketing and promotional activities of drug makers.
According to Mr Turner, SSRI's are dangerous when used with children because they are disinhibitors, and block out guilt, fear, empathy and the ability to face difficulties. The drug makers themselves, he says, have accepted this disinhibitory effect and have even used it as an explanation for teenage suicides.
"Those who grow up disinhibited," he explains, "become what is known as psychopathic."
"Psychopaths," he states, "are unable to benefit from guilt, fear or empathy and as a result they pray on victims without inhibition."
Most serial killers, rapists and serial arsonists, he says, are classic psychopaths. True psychopaths are rare and Big Pharma has always ignored them because they are believed to be untreatable so there is no profit to be made off psychopaths, he adds.
Mr Turner is most outraged over the revelation that American doctors are feeding SSRIs to infants. "Babies do not suffer from depression," he says, "which is a multi-factorial issue based on life experiences as much as any other cause."
"Even if SSRI's were not toxic to the babies metabolism, which of course they are," he states, "these drugs will severely interfere in the process by which an infant becomes a human being."
"Complex psychological processes are at work in a baby that no-one, not even the most bloody arrogant psychiatrist have any ideas about," he says. "Disrupting those processes will generate a monster, a totally distorted development."
"As these children grow into adolescents and adults," he advises, "the normal stages of development will be hideously distorted."
"Instead of maybe developing 'depression,' they will definitely develop deep and untreatable personality disorders," he warns. "Real, manufactured disorders."
Mr Turner says drug companies are manufacturing a small army of artificial psychopaths by disrupting the developing brains of infants. "Giving SSRI's to babies will create monsters that no psychiatrist will be able to control," he warns.
He says ADHD drugs are also creating psychopaths, "not because it is real, but because children are being brainwashed into believing they are sick, so it becomes a self fulfilling prophecy."
"If this lunacy does not stop," Mr Turner warns, "the US will have a societal catastrophe on its hands that will make the Wall Street Crash look like a walk in the park."
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Drug Makers Trolling for Infants and Toddlers
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