Chewable Ritalin for the Kiddies

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In case your hyperactive kid does not enjoy swallowing pills, Pfizer has now made it much easier. The FDA has approved an extended release formulation of methylphenidate (Ritalin) to be marketed as QuilliChew ER for children aged six and over.

Recently, the American Council's Dr. Josh Bloom reported that a study out of Denmark concluded there was no strong evidence to support the belief that methylphenidate works well for kids with attention-deficit hyperactivity disorder (ADHD). Dr. Bloom was referring to a Cochrane Review that included 185 randomized controlled trials that included 12,000 children between three and 18 years of age.

In another study, which looked specifically at the impact of ADHD medication on childrens' academic performance in the classroom, found that in 43 randomized controlled trials involving 2,110 participants drug treatment allowed children to complete their schoolwork 15 percent faster than the comparison group on placebo, or those receiving no treatment. Medications for ADHD also allowed 14 percent more children to stay on task in the classroom, signifying improved behavior.

It is challenging to definitively say whether these medications do or don t work. For every study showing improvement, there's another study that shows no significant improvement.

Because ADHD medications are stimulant drugs, chemically there is a potential for misuse or abuse. A Swedish study specifically looked at whether long-term use of stimulant medications for the treatment of ADHD contributed to substance abuse by these patients later in life. What the researchers found, paradoxically, was that not only was there no increased risk of substance abuse among individuals prescribed ADHD medication, there was a degree of protection conferred from substance abuse.

Additionally, in a population-based survey that included 443,041 respondents from 2002-2009 by the National Survey on Drug Use and Health, researchers found that in nonmedical users of prescription stimulants abuse of other illicit substances often preceded use of stimulant medications. That indicated non-medical use of ADHD medications is not an initiating factor for abusing other drugs.

The story, however, becomes more concerning when looking at college campuses, where it was estimated that 17 percent of students misused stimulant medications. The primary reason for misuse is for academic purposes, given that medications like methylphenidate and amphetamine salts have the capacity to make even the most mundane subjects riveting. Meanwhile the most common source for obtaining these medications was from peers with prescriptions.

From an academic perspective, stimulant medications are the perfect drugs. It comes in a pill (definitely better than smoking or snorting), keeps students awake for hours, provides laser-sharp focus, decreases appetite (and guards against the freshman fifteen) and again, somehow has the ability to make boring subjects seem entertaining. Compare that to methamphetamine, cocaine, crack -- or insert drug of choice here -- drugs that can can be easily abused, or used to the point of addiction.

Over nearly two decades starting in the early 1990 s, there has been nearly a ten-fold increase -- the National Institute on Drug Abuse cites an eight-fold rise, but the figures it presents indicate the bump is higher -- in the number of total prescriptions for stimulants. In 1991, there were four million prescriptions written; 18 years later that number jumped to 39 million. Part of that increase is attributed to diagnostic criteria to determine what constitutes ADHD. There are also an inordinate number of people who falsify their symptoms to get a prescription for these medications.

In a culture where prescription drug abuse is rampant -- currently it ranks second among illicit drug users -- there has to be recognition among the healthcare profession that an gigantic increase in stimulant drug prescriptions is problematic.

Whether the formulation allows pills to be chewed, released immediately or extended is all well and good ("bravo" Pfizer) but something about stimulant medications doesn t settle well. Given the tendency for abuse and re-sale, and the lack of strong evidence of its efficacy in combatting ADHD, this new formulation aimed at younger patients may not be just what the doctor ordered.