Children & Antidepressants:
In the early 1990s in the USA and Canada, antidepressants were increasingly
prescribed to children and adolescents without evidence of efficacy and safety.
The US FDA issued a warning in 2003 regarding SSRIs, paroxetine (Paxil) and
venlafaxine (Serotax), antidepressants similar to Prozac. The results of 3
trials involving children with depression did not show any benefit to taking
paroxetine over placebo.
In addition, suicidal thoughts, suicide attempts and episodes of self-harm
were more frequent among the paroxetine users than among those in the placebo
group. In another study involving children with social anxiety disorder, 2.4% of
the 165 children given paroxetine had suicide-related adverse events as compared
with none of 157 children given a placebo. Vanlafaxine was also ineffective and
doubled the rate of suicide. In October 2004, the US Food and Drug
Administration announced that it will require drug manufacturers to issue strong
'black box' warnings on all antidepressant medication that indicate that the
drugs may cause children and teenagers to exhibit suicidal thoughts and
behaviors.
Antidepressants are chemicals that are added to a dysfunctional chemical mix
that caused dysfunction and dysphoria in the first place. Few parents make any
effort to alter their disease-causing lifestyle and few physicians make any
effort to investigate and improve a child's chemistry overall. Psychotropic
drugs are added, mindlessly to the dysfunctional chemical mix and their effects
merge with the chemistry of food, food additives and contaminants, food allergy
and airborne neurotoxins that act on the brain.
In response to the paroxetine warnings, Garland, a child psychiatrist stated:
These developments not only raise concerns about the presumed effectiveness and
safety of SSRIs for young people, but also pose disturbing questions about
publication bias and questionable interpretation of research data on the
treatment of childhood depression. Garland points to the bias in drug trial
reporting that deceives patients and physicians in all areas of medicine. If you
add the overwhelming bias in favor of prescribing drugs to the exaggeration of
benefits of some drugs over others to the suppression of negative information
about drugs, then the use of drugs in medicine is not based on science, reliable
evidence and rational thinking, but rather is an exercise in marketing and
profiteering.
An associated press report stated that: GlaxoSmithKline PLC, which is being
sued for allegedly concealing negative information on the effects of its Paxil
anti-depressant on children, admitted this week that the drug didn't show a
benefit over a sugar pill when treating depression in children. New York
Attorney General Eliot Spitzer filed a consumer-fraud lawsuit last Wednesday
accusing Glaxo of repeated and persistent fraud for concealing details on how
well the drug works and its side effects the FDA (US) admonished Glaxo for
running a TV ad for Paxil CR, the controlled release version of Paxil, that was
false or misleading because it suggests the drug can be used by a broader range
of patients than it is actually approved for.
The aggressive marketing of drugs that affect the brain has been developed
into major social and biological determinants in the USA. This trend is also
well established in Canada and promises to become a world-wide. One of the
strategies of drug companies is to persuade physicians to prescribe drugs for
non-approved conditions. This is referred to as off-label indications.
Physicians are gate keepers in the prescription drug business and drug companies
are experts at influencing physicians prescribing practice. One of the drug
giants, Pfizer agreed to pay a $430 million settlement in the USA for criminal
wrongdoing in their marketing of the anti-epileptic drug, Neuropentin. Payne
wrote: The Park Davis unit of Pfizer had made payments to encourage physicians
to prescribe the drug in part by flying doctors to lavish resorts and paying
them to tout it to treat conditions other than those approved by the Food and
Drug Administration. Park Davis aggressively marketed Neurontin to treat
attention deficit disorder, bipolar disorder, drug and alcohol withdrawal,
migraine and restless leg syndrome. About 90% of prescriptions for Neurontin (
$2.7 billion per year) were for off-label uses.
Important drug warning: Until further information is available, Paxil
(paroxetine hydrochloride) should not be used in children and adolescents
under 18 years of age [Dear Health Care Professional Letter]. Mississauga
(ON): GlaxoSmithKline Inc.; July 2003.
Garland, E.J. Facing the Evidence: Antidepressant treatment in children
and adolescents. CMAJ. Feb 17,2004:170(4)
Clements, C. You have Got Drugs. Med Post. VOLUME 38, NO. 35, October 1,
2002
Associated Press/AP Online. Paxil Said Ineffective for Depressed Kids.
Publication date: 2004-06-16
Payne, D. Pfizer pays for marketing mistake. Medical Post. June 15 2004,
58.
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