The Food and Drug Administration's pediatric advisory committee earlier this week not surprisingly failed to support an earlier recommendation to affix black-box warning labels of sudden death on bottles of Ritalin, the FDA's most severe action short of banning the use of the drug for attention deficit hyperactivity disorder (ADHD). There were moments at Wednesday's hearing that looked staged, and as if they were intended to get a different verdict from a friendlier jury.
The pediatricians obliged, in contrast to last month's renegade activist panel of cardiologists, led by Steven Nissen, who was also instrumental in bringing to light the Vioxx scandal.
That advisory committee's warning recommendation shocked FDA officials and reopened a Pandora's box of concerns about side effects and overuse of Ritalin. The real dangers from Ritalin, however, were not even mentioned by the committee members. That is the growing concern among frontline doctors, like me, of increasing signs of prescription-stimulant abuse by teenagers and college students.
In my own practice, many teenagers and young adults have told me they had already tried a stimulant, usually Adderall, which is an amphetamine, on their own. They liked the effects and wondered if they had ADHD? One high-school senior told me he had been able to buy or trade for Adderall for the last two years, taking the pills before important exams, like the SAT, and for big projects. He never saw a doctor until meeting with me.
My two sons, one a freshman in college and the other a high-school senior, report the wide availability of these drugs at their schools, especially around exam time.
So what's the problem here? Do all these kids have ADHD because they think they do better by taking these drugs? Not true. It has been known for decades that these medications will improve anyone's performance on repetitive and boring tasks. It is not as clear whether they improve test-taking abilities, but the high interest in the illegal use of these drugs suggests, at least "on the street," the belief that they do.
Until two weeks ago, my concerns about prescription-stimulant abuse were based only on rumor and anecdote. Now, the first hard data come from a study funded, not surprisingly by Eli Lilly, the maker of Strattera, the only nonstimulant approved for the treatment of ADHD (but also vetted by the officials at the Drug Enforcement Administration). The study, published in the journal Drug and Alcohol Dependence, uses a government survey of 54,000 people from 2002 and projects that, nationwide, 21 million individuals have misused a prescription stimulant at least once. Some 3 million have abused only prescription stimulants, and 75,000 young people between the ages of 12 and 25 meet psychiatric criteria for addiction and drug abuse. Since 2002, rates of prescription stimulants to adults have continued to rise, suggesting that this number of 75,000 may be higher today.
With the suggested black-box warning, the committee clearly wanted to get the nation's attention, not only about the cardiovascular risks of the prescription stimulants, which include other well-known drugs such as Adderall and Concerta, but also to alert everyone to their potential overuse in children. The panel kept referring to a study where 1-in-10 11-year-old boys around the country take Ritalin or its equivalent.
The possibility of dying from Ritalin is extremely small for a child without a pre-existing heart condition (on the order of 0.0002 percent). However, 75,000 prescription-stimulant addicts dwarf the number of children who died taking the drug. It also represents a real, not an hypothetical, risk such as that for heart attack and stroke, which so worried the FDA cardiovascular committee.
Of those who casually misused Ritalin, according to this survey, 1 in 10 went on to develop tolerance and addiction to the drug. If one recalls the graffiti on the walls of San Francisco's Haight-Ashbury in the 1960s that read "Speed Kills," the concerns about a 10 percent-addiction rate are indeed chilling.
There have been three previous waves of doctor-prescribed stimulant abuse since World War II, the last being Dexedrine for weight reduction in the 1970s. In every previous case, American society, through congressional hearings and state laws, decided that the overall harm of prescription stimulants to the society was greater than the good they provided.
With the case of ADHD, the decision may have to be bifurcated. Ritalin has had a 70-year history of safety with preteens. No kid under the age of 13 has ever become addicted. But if history is a guide, the real risk from Ritalin to our country will be for Johnny's older brother doing this drug on his own, illegally, while away at college. The safe use of these drugs in young adults and teenagers will require much stricter legal controls on prescribing. Unfortunately, it will likely take increasing drug-abuse casualties and young people's deaths to mobilize the necessary public pressure to make that change.