by Daniel J. Murphy, DC, FACO
Last year, a disturbing article appeared in the Journal of the American Medical Association, titled: Trends in the Prescribing of Psychotropic Medications to Preschoolers.1 The authors assessed the prevalence of psychotropic medication use in preschool-aged youths over a 5-year span. The authors specifically looked at three major psychotropic drug classes (stimulants, antidepressants, and neuroleptics) and two leading psychotherapeutic medications (methylphenidate and clonidine). Methylphenidate is best known by its brand name, RITALIN.
The study revealed that 11.1% of children were taking RITALIN, which represented 90% of stimulant medications prescribed to children.
Importantly, RITALIN use increased dramatically in the 2 to 4 year old group, an increase between 1.7- to 3.1-fold increase, depending upon the group being assessed. The predominance of this increase is in the use of these medications ?off-label.? This means that these medications are being used for signs and symptoms for which the drug has not been established to help. It is an ?anecdotal? application.
In the article, the authors note:
?The prevalence of psychotropic medication treatment for children and adolescents with emotional and behavioral disorders has significantly increased in the United States during the last few decades, particularly in the last 15 years.?
?The 5 through 14-year-old age group has experienced a great increase in stimulant treatment for attention-deficit/hyperactivity disorder (ADHD), and the 15 through 19-year-old age group has had sizable increases in the use of antidepressant medications.?
The concern for children younger than 5 years old is because of the off-label (unlabeled) use of these medications. Off-label use means use for ?treatment indications with little or no proven efficacy.?
A psychiatric newsletter reported that 3000 prescriptions for fluoxetine hydrochloride (Prozac) were written for children aged younger than 1 year in 1994.
Stimulants were the leading treatment among those 2 through 4 years old, followed by antidepressants. Methylphenidate [RITALIN] prevalence represented 90% of the stimulant treatment.
?The rate of psychotropic medication prescribed for preschoolers in the MWM program increased substantially from 1991-1995. The increase was greatest for clonidine (28.2-fold), stimulants (3.0-fold), and antidepressants (2.2-fold).?
RITALIN use was most prominent for those aged 5 through 14 years.
?The largest methylphenidate [RITALIN] increase (311%) was among 15 through 19-year-olds, whereas the 2 through 4-year-olds, like the 5- through 14-year-olds, had a smaller but still substantial increase (169% to 176%).?
?There was a greater proportional increase in preschool-aged girls receiving methylphenidate [RITALIN] from 1991 through 1995.?
?The use of SSRI [Prozac, Paxil, Zoloft] antidepressants increased dramatically at the Medicaid sites.?
?Antidepressant use increased, particularly through off-label use, in the preschool-aged group.?
?Overall, there were large increases for all study medications (except the neuroleptics). These findings are remarkable in light of the limited knowledge base that underlies psychotropic medication use in very young children. Controlled clinical studies to evaluate the efficacy and safety of psychotropic medications for preschoolers are rare.?
?Efficacy data are essentially lacking for clonidine and the SSRIs [Prozac, Paxil] and methylphenidate`s [RITALIN] adverse effects for preschool children are more pronounced than for older youths.?
?The vast majority of psychotropic medications prescribed for preschoolers are being used off-label.?
?Stimulant treatment in preschoolers increased approximately 3-fold during the early 1990s.? This pattern of increased use is consistent with an ADHD diagnosis. Hypothesized reasons for the overall increased stimulant use include:
(1) a larger pool of eligible youths because of expanded diagnostic criteria for ADHD since 1980.
(2) more girls being treated for ADHD.
(3) greater acceptance of biological treatments for a behavioral disorder.
?Preschoolers` use of methylphenidate [RITALIN] showed increases similar to those of 5 through 14-year-olds, suggesting that the expanded use of this medication for attentional disorders in US youths extends even to the very young.? ?It is notable that the largest gains in use occurred among high schoolÐaged students, 15 through 19-year-olds.?
The authors imply that the reason for greater psychotropic medication prevalence in Medicaid program populations as compared to HMO populations is because Medicaid coverage pays for these medications with an ADHD diagnosis. This suggests that our government is partly to blame for the problem of increasing psychotropic medication use in our children. Apparently, if the government, we the people, will pay for these drugs, medical doctors will prescribe them.
The possibility of adverse effects on the developing brain cannot be ruled out. Subtle changes to the developing personality may occur as a result of a psychotropic drug`s impact on brain neurotransmitters.
This article was followed by this editorial.2
Psychotropic Drug Use in Very Young Children
In The USA, 1% to 1.5% of all children 2 to 4 years old are receiving stimulants, antidepressants, or antipsychotic medications. The ?prevalence of neuropsychopharmacologic interventions in this age group increased substantially during the last decade.?
One study shows a 3-fold increase in methylphenidate [RITALIN] prescriptions in Canada and a 10-fold increase in the prescription of selective serotonin reuptake inhibitors [Prozac, Paxil] in the United States for children 5 years old and younger between 1993 and 1997.
?It should be emphasized that most of the drugs prescribed involve off-label use because efficacy of psychotropic drugs has not been demonstrated in very young children.? In fact, methylphenidate [RITALIN], the most commonly prescribed drug in these studies, ?carries a warning against its use in children younger than 6 years.? ?Furthermore, the validity and reliability of the diagnoses of attention-deficit/hyperactivity disorder, mood disorders, and schizophrenia in very young children have not been demonstrated.? There is virtually no clinical research on the consequences of pharmacologic treatment of behavioral disturbances of very young children.
?Early childhood is a time of tremendous change for the human brain. Visual processing, language, and motor skills are acquired during this sensitive period. The cortical synaptic density reaches its maximum at the age of 3 years and is substantially modified by pruning during the next 7 years. At the same time, the cerebral metabolic rate peaks between 3 and 4 years of age.?
?Studies in experimental animals indicate that the aminergic systems that are the target of action of these psychotropic medications play an important role in neurogenesis, neuron migration, axonal outgrowth, and synaptogenesis.?
?Perinatal treatment of rats with an antipsychotic drug results in a long-standing abnormality in dopamine receptor function and altered levels of dopamine and norepinephrine in adulthood. Thus, it would seem prudent to carry out much more extensive studies to determine the long-term consequences of the use of psychotropic drugs at this early stage of childhood.?
?Given that there is no empirical evidence to support psychotropic drug treatment in very young children and that there are valid concerns that such treatment could have deleterious effects on the developing brain, the reasons for these troubling changes in practice need to be identified.?
?It appears that behaviorally disturbed children are now increasingly subjected to quick and inexpensive pharmacologic fixes as opposed to informed, multimodal therapy associated with optimal outcomes.?
This ?disturbing prescription practices suggest a growing crisis.?
In a 1999 interview with Peter R. Breggin, M.D., Director of the International Center for the Study of Psychiatry and Psychology and associate faculty at The Johns Hopkins University Department of Counseling, and author of Talking Back to Ritalin (Common Courage Press, 1998),3 additional disturbing information is presented, including:
Could the over diagnosis of ADD and ADHD and prescribing of Ritalin be a cause of the violence we are seeing in our schools today? This drug is not a mild stimulant and kids are getting hooked on it by the millions. Studies show that lab monkeys react to Ritalin in the same way they react to cocaine and other research animals prefer it to cocaine.
It`s easy to see why ADD diagnoses have exploded since the beginning of the decade. It was in 1991 that children labeled ADD could first qualify for special education services in public schools. The drug makes children do what their parents and teachers cannot get them to do without it: sit down, shut up, keep still, pay attention. Since compliance is the goal, five times more boys are given the drug than girls and subsequently medicated when in the past these same children would simply have been said to have ants in their pants. The reality of the use of this powerful drug is used as an excuse to make life easier for the adults around them.
Ritalin decreases blood flow to the brain, and routinely causes other gross malfunctions in the developing brain of the child. America`s children are being exposed to a ?prescription epidemic? of dangerous, addictive stimulant drugs such as Ritalin and Adderall.
?Ritalin does not correct biochemical imbalancesÑit causes them,? Dr. Breggin says, adding that there is some evidence that it can cause permanent damage to the child`s brain and its function.
Pediatricians, parents, and teachers are not aware of these hazards because a large body of research demonstrating the ill effects of this drug has been ignored and suppressed in order to encourage the sale of the drug. The damaging effects of the drug can include:
(A) Decreased blood flow to the brain, an effect recently shown to be caused by cocaine where it is associated with impaired thinking ability and memory loss.
(B) Disruption of growth hormone, leading to suppression of growth in the body and brain of the child Permanent neurological tics, including Tourette`s Syndrome.
(C) Addiction and abuse, including withdrawal reactions.
(D) Psychosis (mania), depression, insomnia, agitation, and social withdrawal.
(E) Possible shrinkage (atrophy) or other permanent physical abnormalities in the brain.
(F) Worsening of the very symptoms the drug is supposed to improve including hyperactivity and inattention.
(G) Decreased ability to learn.
Ritalin works by producing robotic or zombie-like behavior in children. Ritalin`s lack of effectiveness has been proven by hundreds of studies but has not been revealed to doctors, teachers or parents. ?Parents and teachers and even doctors have been badly misled by drug company marketing practices,? Dr. Breggin says. ?Drug companies have targeted children as a big market likely to boost profitsÑand children are suffering as a result.?
Last Summer, an article in the lay press titled: Too Many Pills For What Ails You,4 noted:
?Shyness, once viewed as becoming in some people, is today being cast as a prevalent medical problem. Thankfully, shy people can receive relief in the form of a pill called Paxil. The medicine is an old drug being applied to a novel disease called “social anxiety disorder”.?
?Both the disease and the drug are largely the innovation of the drug`s manufacturer and its Madison Avenue advertising agency.?
?In the past, medical professionals wouldn`t dare to prescribe a powerful psychotropic drug such as Paxil to treat the benign personality traits portrayed in the drugs advertisements. Yet, the race is on to develop pills that will satisfy social needs.?
?Madison Avenue executives are hard at work recasting bothersome physical traits with memorable names and deceivingly broad descriptions to expand potential markets for dozens of new medications.? Advertisers have done the same for ?overactive bladder? and ?erectile dysfunction.? ?The aim of advertising executives is to stretch the clinical definitions to expand the market for new drugs and convince millions of new consumers that they`re affected with a condition that requires medication.?
?In a study published recently in the Journal of the American Medical Association,1 researchers reported that the use of certain psychotropic drugs such as Ritalin in 2- and 4-year-olds doubled and even tripled during the last decade.?
Experts say frustrated parents, agitated daycare workers and 10-minute pediatric visits all contribute to quick pharmacological fixes for emotional and behavioral problems.
?Attention deficit disorder? and ?hyperactive disorder? were formerly known as Ôminimal brain damage.? The pharmaceutical companies, to accommodate marketing goals, changed the names. ?These efforts have helped get 4 million extra-lively, fidgety and easily distractible kids on Ritalin and 2.5 million on antidepressants.?
?Ironically, in a country where every child from preschool onward can recite anti-drug catechisms, millions of children are legally drugged with a substance so similar to cocaine that, according to one medical journal, ÔIt takes a chemist to tell the difference`.?
The research and marketing of attention deficit disorder, an affliction that barely registered in the professional literature a decade ago, illustrates how certain normal traits can be recast as medical symptoms with the, right mix of modern medicine and savvy marketing.
The rest of the world has yet to acquire the American taste for Ritalin, as we consume 90% of the Ritalin produced.
?Probably the most important medical development of the 20th century was that economics replaced curiosity as the driving force behind research.?
Lastly, an article5 last September notes:
Fight Over Ritalin is Heading To Court
Company Accused Of Conspiring To Create A Diagnosis
?The emotional debate over whether kids are placed unnecessarily on Ritalin, the medication to treat hyperactivity, is headed to the courts.? Lawyers, including some who were involved in the successful lawsuits against big tobacco, have filed lawsuits in new Jersey and California.
?Novartis Pharmaceuticals is accused of conspiring with the American Psychiatric Association and others to create a novel medical diagnosis of attention deficit hyperactivity disorder (ADHA) and then cashing in on the fear it caused among parents.? Their definition of ADHD is ?inappropriately broad,? resulting is a criteria where ?There`s not a child in America that`s not ADHD.?
?Everybody makes money on the diagnosis: The shrinks, the drug company and the schools.?
In 1995, physicians, mainly general practitioners and pediatricians, wrote 6 million Ritalin prescriptions.
1. Julie Magno Zito, PhD; Daniel J. Safer, MD; Susan dosReis, PhD; James F. Gardner, ScM; Myde Boles, PhD; Frances Lynch, PhD; Trends in the Prescribing of Psychotropic Medications to Preschoolers, JAMA, Vol. 283 No. 8, February 23, 2000, pp. 1025-1030.
2. Joseph T. Coyle, MD; Psychotropic Drug Use in Very Young Children; JAMA, Vol. 283 No. 8, February 23, 2000.
3. Peter R. Breggin, M.D., Talking Back to Ritalin, Common Courage Press, 1998.
4. Scott Gottlieb; Too Many Pills For What Ails You; Oakland Tribune, July 30, 2000.
5. Toni Locy; Fight Over Ritalin is Heading To Court: Company Accused Of Conspiring To Create A Diagnosis; USA Today, September 15, 2000.