TIME – Medicating Young Minds with Mood / Behavior Altering Drugs

Sat, 1 Nov 2003

A TIME magazine cover story (excerpt below) looks at the inordinate popularity of prescribing mood altering psychotropic drugs for children begins to raise troubling questions about the specter of doing long-term harm to children.

Doctors prescribing these drugs claim the unaccounted increase in children being diagnosed and prescribed psychotropic drugs is “better diagnosis and detection.” But that claim is not borne out by any new empirically verifiable diagnostic tool. In fact, diagnosis of children with psychiatric disorders is entirely subjective–there are no objective markers or tests, merely check lists.

To understand the huge increase in the number of children on psychotropic drugs, one needs to examine the financial interests of those who promote the practice of such prescribing. Among the professional organizations that have pushed for widespread use of psychotropic drugs in treating “troubled” children– without demonstrating the existence of an actual mental illness for which the drugs prescribed have proven to be safe and effective–is the American Academy of Child and Adolescent Psychiatry. TIME fails to note, however, that the Academy is funded by–and therefore under the influence of–the manufacturers of psychotropic drugs.

TIME reporters note: “There is a lot of money to be made in developing the next Prozac, but there is less profit if you test it for longer than the law demands.” Indeed, that’s because a longer trial period would reveal those long-term adverse effects and hurt the marketing of the drugs.

Incredibly, TIME reports, “The Food and Drug Administration (FDA) doesn’t require long-term studies that follow patients over decades. Its only requirement is toxicity trials that span six to eight weeks. In an effort to entice companies to conduct lengthier studies, the agency now grants an extension of six months of exclusive marketing rights to any company engaging in studies of a drug’s effects on a minimum of 100 children for more than six months.”

But taxpayers pay the FDA to ensure that only safe and effective drugs are approved. How can the FDA approve drugs that are prescribed over a period of years when their safety has NOT been tested adequately? Doesn’t the law imply that an approved drug has been shown to be safe and effective for longer than a mini-trial? TIME reporters figured out that short drug trials benefit drug manufacturers who seek FDA marketing approval. But who else benefits from trials that are designed NOT to reveal adverse effects that only become apparent after 6 months or a year?

The answer is the stakeholders in the medical / industrial complex–doctors, professional organizations, academic and government research institutions–everyone except the vulnerable children who are made to ingest drugs whose safety no one can vouch for. Little children have become commodities for the enrichment of these powerful stakeholders–all of whom receive public support in one form or another.

The concluding paragraph in the TIME report demonstrates how the profession has cynically shifted responsibility to parents. The stakeholders–and especially the FDA has ensured that parents know nothing about the potential harm for their children, and know nothing about the false advertisements and market manipulations that mislead them into believing their children need or will be helped by these drugs:

“…the heaviest lifting will, as always, be left to the family. Perhaps the most powerful medicine a suffering child needs is the educated instincts of a well-informed parent – one who has taken the time to study up on all the pharmaceutical and nonpharmaceutical options and pick the right ones. There will always be dangers associated with taking too many drugs – and also dangers from taking too few. “Like every other choice you make for your kids,” says Chang, “you make right ones and wrong ones.” When the health of a child’s mind is on the line, getting it wrong is something that no parent wants.”

On February 2, 2004 the FDA is convening a public meeting of two advisory committees to discuss documented evidence from company controlled clinical trials linking SSRI antidepressant drugs to an increased risk of suicidal and homicidal acts by children. The previously concealed evidence was made public in June 2003, first in Britain, then in the US.

Did the SSRI drug manufacturers submit the evidence to the FDA as required by law? If so, Why did FDA officials ignore evidence of life-threatening harm for children?

http://www.time.com/time/covers/1101031103/story.htmlTIME

Sunday, Oct. 26, 2003

Medicating Young Minds
Drugs have become increasingly popular for treating kids with mood and behavior problems. But how will that affect them in the long run?
By JEFFREY KLUGER

EXCERPT:

Getting by is hard enough in middle school. it’s harder still when you’ve got other things on your mind – and Andrea Okeson, 13, had plenty to distract her. There were the constant stomach pains to consider; there was the nervousness, the distractibility, the overwhelming need to be alone. And, of course, there was the business of repeatedly checking the locks on the doors. All these things grew, inexplicably, to consume Andrea, until by the time she was through with the eighth grade, she seemed pretty much through with everything else too. “Andrea,” said a teacher to her one day, “you look like death.”

The problem, though neither Andrea nor her teacher knew it, was that her adolescent brain was being tossed by the neurochemical storms of generalized anxiety, obsessive-compulsive disorder (OCD) and attention-deficit/hyperactivity disorder (ADHD) – a decidedly lousy trifecta. If that was what eighth grade was, ninth was unimaginable.

But that was then. Andrea, now 18, is a freshman at the College of St. Catherine in St. Paul, Minn., enjoying her friends and her studies and looking forward to a career in fashion merchandising, all thanks to a bit of chemical stabilizing provided by a pair of pills: Lexapro, an antidepressant, and Adderall, a relatively new anti-ADHD drug. “I feel excited about things,” Andrea says. “I feel like I got me back.”

So a little medicine fixed what ailed a child. Good news all around, right? Well, yes – and no. Lexapro is the perfect answer for anxiety all right, provided you’re willing to overlook the fact that it does its work by artificially manipulating the very chemicals responsible for feeling and thought. Adderall is the perfect answer for ADHD, provided you overlook the fact that it’s a stimulant like Dexedrine. Oh, yes, you also have to overlook the fact that the Adderall has left Andrea with such side effects as weight loss and sleeplessness, and both drugs are being poured into a young brain that has years to go before it’s finally fully formed. Still, says Andrea, “I’m just glad there were things that could be done.”

Those things – whether Lexapro or Ritalin or Prozac or something else – are being done for more and more American children. In fact, they are being done with such frequency that some people have justifiably begun to ask, Are we raising Generation Rx?

Just a few years ago, psychologists couldn’t say with certainty that kids were even capable of suffering from depression the same way adults do. Now, according to PhRMA, a pharmaceutical trade group, up to 10% of all American kids may suffer from some mental illness. Perhaps twice that many have exhibited some symptoms of depression.

Up to a million others may suffer from the alternately depressive and manic mood swings of bipolar disorder (BPD), one more condition that was thought until recently to be an affliction of adults alone. ADHD rates are exploding too. According to a Mayo Clinic study, children between 5 and 19 have at least a 7.5% chance of being found to have ADHD, which amounts to nearly 5 million kids. Other children are receiving diagnoses and medication for obsessive-compulsive disorder, social-anxiety disorder, post-traumatic stress disorder (PTSD), pathological impulsiveness, sleeplessness, phobias and more.
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“The world would be a far less interesting place if all the eccentric kids were medicated toward some golden mean. Besides, there are just too many unanswered questions about giving mind drugs to kids to feel comfortable with ever broadening usage. What worries some doctors is that if you medicate a child’s developing brain, you may be burning the village to save it. What does any kind of psychopharmacological meddling do, not just to brain chemistry but also to the acquisition of emotional skills – when, for example, antianxiety drugs are prescribed for a child who has not yet acquired the experience of managing stress without the meds? And what about side effects, from weight gain to jitteriness to flattened personality – all the things you don’t want in the social crucible of grade school and, worse, high school.

Adding to the worries is a growing body of knowledge showing just how incompletely formed a child’s brain truly is. “We now know from imaging studies that frontal lobes, which are vital to executive functions like managing feelings and thought, don’t fully mature until age 30,” says Hinshaw. That’s a lot of time for drugs to muck around with cerebral clay.

For that reason, it may not always be worth pulling the pharmacological rip cord, particularly when symptoms are relatively mild. Child psychologists point out that often nonpharmaceutical treatments can reduce or eliminate the need for drugs. Anxiety disorders such as phobias can respond well to behavioral therapy – in which patients are gently exposed to graduated levels of the very things they fear until the brain habituates to the escalating risk.

Depression too may respond to new, streamlined therapy techniques, especially cognitive therapy – a treatment aimed at helping patients reframe their view of the world so that setbacks and losses are put in less catastrophic perspective. “The therapist teaches relaxation skills and positive thinking,” says Denise Chavira, clinical psychologist at the University of California at San Diego. “It goes beyond talk therapy.” Unfortunately, medical insurance pays more readily for pills than these other treatments for adults and children.”

Copyright © 2003 Time Inc. All rights reserved.