To: Janet Woodcock; Mark McClellan MD; Robert Temple; Thomas Laughren;
Cc: Thomas Insel MD; Warren Rumble; Rosemary Roberts; Nora Volkow MD;
Benedetto Vitiello MD; James Scully MD; Judith Rapoport MD; Laurence
Greenhill; Xavier Castellanos
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Contact: Vera Hassner Sharav
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"
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
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
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
How can the FDA approve drugs that are prescribed over a period of years
safety has NOT been tested adequately? Doesn't the law imply that an
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
seek FDA marketing approval. But who else benefits from trials that are
NOT to reveal adverse effects that only become apparent after 6 months or a
The answer is the stakeholders in the medical / industrial complex--doctors,
professional organizations, academic and government research
except the vulnerable children who are made to ingest drugs whose safety no
vouch for. Little children have become commodities for the enrichment of
powerful stakeholders--all of whom receive public support in one form or
The concluding paragraph in the TIME report demonstrates how the profession
cynically shifted responsibility to parents. The stakeholders--and
FDA has ensured that parents know nothing about the potential harm for their
and know nothing about the false advertisements and market manipulations
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
most powerful medicine a suffering child needs is the educated instincts of
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
from taking too few. "Like every other choice you make for your kids," says
"you make right ones and wrong ones." When the health of a child's mind is
line, getting it wrong is something that no parent wants."
On February 2, 2004 the FDA is convening a public meeting of two advisory
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
then in the US.
Did the SSRI drug manufacturers submit the evidence to the FDA as required
If so, Why did FDA officials ignore evidence of life-threatening harm for
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
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
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
xxxxx cut xxxxxxxx
"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,
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
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.