October 26

NY Times Whitewashes Ritalin Experiment in Preschool Kids

NY Times Whitewashes Ritalin Experiment in Preschool Kids

Sat, 16 Nov 2002

A story in The New York Times magazine about a controversial government sponsored drug experiment avoids examining the tough issues. Instead, it describes the growing pains of an apparently normal 4 year old boy, Sam, whose parents enrolled him into the Preschool ADHD Study (PATS) in response to an advertisement in The New York Daily News: “Is your preschooler just too active?”

The Times story fails to address the ethical issues that the experiment raises:

FIRST: children as young as 3 years old, are being used in an experiment designed to test their body’s tolerance of a psychostimulant drug at increasingly higher doses. The drug, Ritalin, affects both their developing brains and their central nervous system. Indeed, the Times states: “During a high-dose week, Sam developed a tic –a common and disconcerting side effect.”

The Times mentions the most prevalent adverse side effects such as involuntary tics, weight loss, and insomnia, but fails to mention that Ritalin is often a gateway drug to abuse, or that no one even claims to know whether long term use of the drug will permanently alter brain development–especially in such young children. NIMH has never conducted long-term safety studies. Why? Are they afraid of the likely findings?

SECOND: young children are knowingly introduced to drug dependency: Dr. Steven Hyman, former director of NIMH, an expert on the mechanism of psychotropic drugs, is quoted in the Times story, but was not asked about his own research findings. In his scientific articles he refers to psychostimulant drugs–such as Ritalin, amphetamine, and cocaine– as addictive drugs of abuse.

In an important (much cited) 1996 article in the American Journal of Psychiatry [vol. 153:151-162], Dr. Hyman explained that psychotropic drugs– including psychostimulants–create “perturbations in neurotransmitter function.” Furthermore, he noted, repeated perturbations “produc[e] adaptations that lead to substantial and long-lasting alterations in neural function.” The neural adaptation to psychostimulant drugs, according to Dr. Hyman, is addiction.

Indeed, evidence demonstrates that older school children abuse Ritalin and traffic in Ritalin.

Furthermore, Ritalin has been recently found to be more potent than cocaine: A report in the Journal of the American Medical Association about Dr Nora Volkow’s finding, states that a typical dose of Ritalin given to children ( 0.5 mg/kg) blocked 70% of dopamine transporters. Dr Volkow told JAMA: “the data clearly show that the notion that ritalin is a weak stimulant is completely incorrect.” The 3 year old children in the PATS experiment are started at 1.25 mg a day increased to as much as 7.5 mg three times a day! Vastag B, “Pay Attention: Ritalin Acts Much Like Cocaine,” JAMA, August 22/29, 2001, Vol. 286 No. 8,

OTHER KEY FACTS NOT DISCLOSED TO READERS OF THE NY TIMES: The researchers conducting the PATS study (and other pediatric drug trials testing psychiatric drugs) received grants and honoraria from the drug companies that will ultimately be the beneficiaries of the experiment. The experiment is designed to yield favorable findings for prescribing psychoactive drugs to young children.

Indeed, Dr. William Pelham Jr., director of the Center for children and Families (NYS University, Buffalo) who offers a training program that avoids drugs told the Times reporter: “I bet you 100,000 bucks I could tell you the results of that trial… The results will be that kids need medication because parent training is not enough. I think that’s dangerous. It’s going to send a message to people that young children need medication.”

The saddest part of the Times story is the ending, as Sam’s personality and imagination seem to have been submerged. Sam recites the characteristics that he has been taught comprise the “ideal”: “I have a child,” he said, in his serious, earnest way. “His name is Billy. He just turned 3. He knows all his alphabets. He knows at school when recess time is on. He knows when the bell rings, and they’re going out. He listens to his teachers. He cleans up when he’s supposed to.”



Preschool Meds



On a warm, breezy Friday in September, a parade of mothers in minivans arrived at a preschool in suburban Connecticut to drop off a collection of 4-year-olds. Among the young students was Sam G., a sturdy, big-eared boy with cheeks that flush easily and a personality that has earned him a reputation, politely speaking, as a handful.

Like most 4-year-old boys, Sam loves things that move — trains, planes and trucks, especially fire trucks — and is usually on the move himself. When he enters a room, his clear blue eyes dart about, as though he cannot take in the sights fast enough. His knees and elbows are perpetually scraped. When his teachers read stories aloud, Sam often wanders about.

This particular Friday was no exception. It was Bring-Your-Stuffed-Animal-to-School Day, and Sam burst through the door carrying a two-foot-tall black-and-white cow he calls Moo. Surveying the scene, he paused momentarily and then, as if someone had lighted a fuse underneath him, thrust his arms forward and began zipping around the room, the cow acting as his shield. During the next two hours, Sam tried to open the childproof window locks; he got into fights in the sandbox and repeatedly stood in the center of the room, swinging the cow by its tail. When his teacher finally put the animal on the shelf ”for a nap,” Sam burst into tears.

Time was, Sam’s rambunctiousness would have been chalked up to childhood or, more precisely, boyhood. Today, Sam has a diagnosis — attention deficit hyperactivity disorder, and a potential treatment: methylphenidate, a drug better known by its brand name, Ritalin. Sam has been taking the drug, in various doses that are interspersed with dummy pills, since July as part of the three-year Preschool A.D.H.D. Treatment Study, known as PATS. This unusual clinical trial is financed by the National Institute of Mental Health and overseen by the New York State Psychiatric Institute in Manhattan. The institute, which is affiliated with Columbia Presbyterian Medical Center, is one of six academic medical centers around the country that have been recruiting children since January 2001. The aim is to enroll 314 children by February. Results are expected sometime in 2004.

The research may be the most controversial medical experiment the federal government has ever conducted in children: a study of the safety and effectiveness of generic Ritalin in preschoolers, ages 3 to 5. Experimenting on children is always delicate, especially when the children are barely out of diapers. Ritalin, marketed to help hyperactive students focus in school, is a stimulant, and though it is generally considered safe, scientists acknowledge they do not understand how it affects young children’s developing brains. The drug is not approved for children under age 6. But doctors increasingly prescribe it to them ”off label” — a worrisome trend, yet hardly surprising in an era when 3-year-olds are expected to know their numbers and 5-year-olds are being taught to read.

”We have an obsession with performance in our country,” says Lawrence Diller, a behavioral pediatrician in Walnut Creek, Calif., and the author of two books on A.D.H.D. ”We have a universal performance enhancer in Ritalin. It helps anyone, child or adult, A.D.H.D. or not, to perform better. It was inevitable that there would be this drift down to the 3- to 5-year-old set.”


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