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  FDA to debate antidepressant risk to kids
  Friday, January 30, 2004 Posted: 10:40 AM EST (1540 GMT)
  . Depression a common, but treatable, disease   

[Fred A. Baughman Jr., MD:
their headline]

[Fred A. Baughman Jr., MD:
Craig, Greg, here they are, out of the closet, now calling, the
normal, ubiquitous emotion, depression, a disease. They have been cautious,
too ashamed, to speak the word forthrightly for 2-3 decades, resorting to
"disorder" --meaning the same thing. Now here they are up front about it.
Their two-fold commission from pharma is evident here (1) invent, fortify
diseases (2) say whatever it takes to convey the safety, efficacy,
necessity of the drug/drugs, no matter what their potential to cause injury,
death. Craig, see the 1995 call of psychiatrist, Weery of New Zealand to
ban the tricyclic antidepressant, desipramine, in children as it was causing
heart deaths, only to be shouted down by US psychiatry, in particular,
Biederman of Harvard, a hired gun. --Fred ]

  WASHINGTON (AP) -- Parents of children with depression must sort through
  an emotionally charged controversy in deciding on treatment: Do popular
  adult antidepressants sometimes increase the risk of suicide when
  they're given to kids?
  British authorities last month declared a list of common antidepressants
  unsuitable for children, citing that possibility. Next week, U.S. health
  authorities open public hearings on the issue, at which parents who
  blame the drugs for children's deaths are expected to face families who
  credit the same pills for saving lives.
  It's a difficult question, as depression occurs in about 10 percent of
  youth, and depression can lead to suicide. Some 1,883 10- to
  19-year-olds killed themselves in 2001, and specialists say there are 10
  to 20 attempts for every suicide.
  Antidepressants called SSRIs, such as Paxil, Zoloft and Effexor, have
  been long used by adults, and authorities say there's no evidence of a
  suicide risk for them.
  But medicines can work differently in children, and only carefully
  controlled studies can prove if suicidal behavior is more common among
  youths taking SSRIs. The same holds for determining whether if a risk is
  proved, is the risk because the drug just did not alleviate the
  depression or had had some other effect.
  No suicides have occurred in studies encompassing 4,000 children. But
  preliminary data suggest suicidal behavior and attempts, while
  infrequent, might be two to three times greater among users of some
  SSRIs: roughly 3.2 percent among children getting the drugs compared
  with 1.5 percent among those given dummy pills.
  The possible risk was spotted after the U.S. Food and Drug
  Administration, seeing pediatric SSRI use rising, ordered research to
  see whether they work in children.
  So far, the FDA has approved just one SSRI -- Prozac -- for use in
  depressed patients under age 18, but the agency says none of the others
  are yet proven to alleviate pediatric depression.
  Lack of benefit in the face of possible risk led to Britain's warning
  that SSRIs other than Prozac are unsuitable for children. Here, FDA
  still is analyzing the research; it hopes to have recommendations by
  "Obviously there are many pediatric psychiatrists who believe in these
  drugs, but definitive advice on what to do is still pending," says Dr.
  Russell Katz, FDA's chief of neurological drugs. "Now, we can only say
  use them with caution."
  Emotional debate
  For 18-year-old Jame Tierney of Kernersville, North Carolina, that's not
  enough warning. On Monday, Jame will tell the FDA that fury and thoughts
  of suicide consumed her while taking Effexor -- an experience her family
  wants the government to pay special heed to because Jame wasn't
  depressed when she started the drug at age 14. It was prescribed for
  migraine headaches.
  A year of the starting dose induced some jitteriness. But when the
  headaches returned and the doctor doubled the dose, Jame's parents say
  their daughter went from a sweet, popular honor student to a raging
  (I think these drugs have a place even in these age groups, but my
  ability ... to use these drugs safely is going to be enhanced if they
  come with the right warnings.
  -- Dr. David Healy )
  "I hated my family, my friends and most of all myself," Jame says,
  describing screaming fits and hard-to-control impulses such as once
  lightly cutting her wrist with a razor until the pain stopped her.
  Effexor maker Wyeth Pharmaceuticals wrote doctors in August to warn that
  while a cause-and-effect isn't certain, its studies show more
  suicide-related thinking in children taking the drug than those given
  dummy pills, including a 2 percent incidence of hostility.
  The debate elicits strong emotions.
  "The aim is to do no harm. Leaving it (depression) untreated is not
  'doing no harm,"' says Dr. Graham Emslie of the University of Texas
  Southwestern Medical Center. 

[Fred A. Baughman Jr., MD:
Calling depression, however mild or
severe a disease is fraudulent and fundamentally abrogating the informed
consent rights of the patient/family]

  He co-chaired a task force of the American College of
  Neuropsychopharmacology that last week declared evidence that links
  SSRIs to suicide is too weak to justify not using them. The group points
  to evidence that suicides have dropped as SSRI use increased around the
  world, and to autopsy studies that show most suicides hadn't taken an
  anti-depressant, or the right dose, just before their deaths.
  On the other side, critics claim SSRIs sometimes cause agitation and
  urgent anxiety, called akathisia, that could make certain people
  "I think these drugs have a place even in these age groups, but my
  ability ... to use these drugs safely is going to be enhanced if they
  come with the right warnings," says Dr. David Healy, director of the
  North Wales Department of Psychological Medicine, who helped trigger
  Britain's review.
  Day-to-day, doctors and parents are caught in the middle.
  "The kids are in distress at this moment, so we have to work with the
  information currently available," says Dr. Joseph Gold, director of
  pediatric psychiatry at McLean Hospital, affiliated with Harvard Medical
  He's reassured at the apparent low incidence of problems and notes that
  older antidepressants have far more common side effects but prescribes
  the lowest possible dose.

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