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Topics from the book,
The Human Brain

by Stephen Gislason MD

Brain Center

Brain Drug Issues & Warnings

Some Topics from the book

Tuning into the Universe
Connected to the Environment
How Many Senses?
Misunderstanding Mind/Body
Mental Illness?
Right & Left Brain
History of Mind Drugs
Prescription Drug Abuse
Psychiatry versus Biology
Mechanisms of Brain Dysfunction
Brain Circulation & Stroke
Nutrition & Brain
Allergy and the Brain
Wheat Gluten and the Brain
Attention Deficits
Is Stress Real ?
Preventing Strokes
Self Regulation
Is Stress Real?
Amino Acids

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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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  Human Nature
The Good Person
Pieces of the Puzzle
The Sound of Music
  Surviving Human Nature
  Language and Thinking
  I and Thou
  Emotions and Feelings
  Neuroscience Notes
  Human Brain
  Children and Family
  Intelligence and Learning
  Religion for 21st Century

Further reading: Alpha Nutrition Program, Neuroscience Notes, Intelligence and Learning.

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