None of these drugs, except Ritalin and others in its stimulant class, have been tested in more than a few dozen children for more than about two or three months. Even Ritalin, which has been around for decades, has been studied no longer than 18 months for its effectiveness or safety. Until recently, the pharmaceutical industry has had little incentive to test drugs in kids -- the market wasn't large enough and pediatric drug studies pose additional ethical hurdles.

But drug companies became very interested in drug trials involving children about two years ago, when the government agreed to extend exclusive patents on drugs for six months if the companies facilitated testing in children. About two years after the extension, however, the FDA, still not satisfied with the amount of pediatric testing being done, introduced an administrative mandate that required drug companies to test previously approved drugs frequently used in children. The move brought three thinly veiled "citizen suits" funded by the drug industry that challenged the FDA's authority. When the FDA backed down under this pressure, child advocacy groups -- including the American Academy of Pediatrics and the American Academy of Child and Adolescent Psychiatrists -- expressed outrage. The FDA finally reinstituted the mandate, with the apparent public approval of the Bush administration.

Now Sens. Hillary Clinton, (D-N.Y.), Christopher Dodd (D-Conn.), and Mike DeWine (R-Ohio) are sponsoring legislation to make the testing mandatory for drugs that are regularly prescribed for children.

But this proposal doesn't go far enough. At the moment, doctors and their patients learn only in a haphazard fashion about the side effects that develop with a drug's long-term use. There are no requirements for what is called post-marketing surveillance -- for any drug -- despite repeated calls for such a procedure from medical and patient advocacy groups.

Drug companies aggressively oppose this kind of thorough follow-up on drugs, not only because it is expensive, but because they don't really want to find out whether their drugs continue to work over time or if long-term side effects develop. Currently, that kind of research is a job for the country's trial lawyers. But this de facto "system" of monitoring the effects of drugs requires many casualties before an adverse outcome is discovered or established in the medical and popular literature.

At the heart of this debate is the recent surge in the use of psychiatric drugs to treat children. So many children are taking these medications that the need for more testing and follow-up is suddenly crucial. Unfortunately, the alternative -- effective non-drug interventions for the treatment of children's behavioral issues -- has been overlooked.

Specific psychotherapeutic approaches to the treatment of behavioral issues in children -- ADHD, anxiety and obsessive compulsive disorder -- have been shown to eliminate or decrease the need for drugs. But the pharmaceutical industry, with its control of psychiatric research funding, influence in the media, and direct advertising to patients, has no interest in the promotion of these approaches. The problem? Psychosocial treatments like family therapy and special education do not generate stock dividends or equity, and they are less available than drugs.

If other interventions were more widely available and aggressively promoted, it is possible that Shaina Dunkle's apparently mild ADHD symptoms, diagnosed by her school psychologist, could have been managed without medication. Yes, some children who do receive non-drug help can still benefit from taking a psychiatric medication. But Shaina's parents say they never would have given desipramine to their daughter had they known more about it. They trusted the doctor; they believed the drug to be safe.

The extensive prescription of these medications for children, without adequate testing for safety and effectiveness in children constitutes a hidden time bomb that could explode with still more casualties. Catastrophic side effects, like the one that killed Shaina Dunkle, may be rare, but they become predictable when we treat so many children with so many drugs. We need to know more, much more. And until we do, it is imperative that we give adequate consideration to treatments that do not involve drugs whose full effects we don't completely understand.

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