Pringle: Drug Makers Trolling for Infants and Toddlers News

[Guest guest]

Drug Makers Trolling for Infants and Toddlers News

December 21, 2006

By Pringle

http://www.lawyersandsettlements.com/articles/drug-prescription.html

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 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 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, Klein-Riske, told Mr

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 , " 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 , 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 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 , 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 , 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 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 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 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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