Monday, July 26, 2010

Drug Makers Trolling for Infants and Toddlers - November 26, 2006

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Drug Makers Trolling for Infants and Toddlers

First published November 26, 2006

The underlying motive behind Big Pharma's promotion of the off-label prescribing is market expansion and unfortunately, children provide the richest harvest because most kids are covered by private 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.

However, a group of self-proclaimed "experts" has published their own diagnostic manual called, "Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood, Revised (DC:0-3R)."

It can be purchased on the Zero to Three Web site, where 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.

The FDA has added new warnings to 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 readers who think this must be a joke, that this can not possible be, consider a 2004 study published in the Psychiatric Services journal that found the fastest growing customers base for psychiatric drugs to be preschoolers aged 0-5 years, with drug use among girls doubling, and drug use among boys rising 64%.

All across the country, drug companies are literally making a killing by funneling tax dollars through children covered by public health care programs like Medicaid.

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 being drugged. 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."

A report by Gardiner Harris in the November 23, 2006, New York Times, states that 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 in 2005, 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 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.

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."

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."

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