Anti-depressants are a placebo.
Not.
A September 2004 Food and Drug Administration hearing found that more than two-thirds of studies of antidepressants given to depressed children showed that they were
no more effective than placebo, or sugar pills, and that only the positive trials were published by the
pharmaceutical industry. The lack of effectiveness of antidepressants
has been known by the Food and Drug Administration since at least 2000
when, according to the Food and Drug Administration Background Comments on Pediatric Depression, Robert Temple of the Food and Drug
Administration Office of Drug Evaluation acknowledged the 'preponderance
of negative studies of antidepressants in pediatric populations'. The
Surgeon General's report said of stimulant medication like Ritalin,
`However, psychostimulants do not appear to achieve long-term changes in outcomes such as peer relationships, social or academic skills, or
school achievement.'.
The Food and Drug Administration finally acknowledged by issuing
its most severe Black Box Warnings in September 2004, that the newer
antidepressants are related to
suicidal thoughts and actions in children
and that this data was hidden for years. A confirmatory review of that
data published in 2006 by Columbia University's department of
psychiatry, which is also the originator of the TeenScreen instrument,
found that `in children and adolescents (aged 6-18 years),
antidepressant drug treatment was significantly associated with suicide
attempts . . . and suicide deaths. . . . '. The Food and Drug
Administration had over
2000 reports of completed suicides from 1987 to 1995 for the drug Prozac alone, which by the agency's own calculations represent but a fraction of the suicides. Prozac is the only such drug approved by the Food and Drug Administration for use in children.
Other possible side effects of psychiatric medication used in children include mania, violence, dependence, weight gain, and insomnia from the newer antidepressants; cardiac toxicity including lethal arrhythmias from the older antidepressants; growth suppression, psychosis, and violence from stimulants; and diabetes from the newer anti-psychotic medications.
Parents are already being coerced to put their children on psychiatric medications and some children are dying because of it. Universal or mandatory mental health screening and the accompanying treatments recommended by the President's New Freedom Commission on Mental Health will only increase that problem. Across the country, Patricia Weathers, the Carroll Family, the Johnston Family, and the Salazar Family were all charged or threatened with child abuse charges for refusing or taking their children off of psychiatric medications.
~~
As an expert witness, Healy used his access to Pfizer's
clinical-trial data to reanalyze the company's results. He found that
volunteers on Zoloft had twice the risk of suicide as those taking placebos.
However, adding insult to injury, the miscarriage of justice was cemented in 2004 when the Supreme Court refused to hear the Miller appeal-just as the FDA issued a requirement for "Black Box" label warnings about the risk that Dr. Healy was prevented from testifying about in front of a jury. In 2006, GlaxoSmithKline sent warning letters to physicians acknowledging not a two-fold increased risk, but a six-fold risk of suicidal behavior in adults taking Paxil. FDA's subsequent analysis of the adult data confirmed the increased risk in adults.
http://www.thenation.com/docprem.mhtml? ... 6&s=yeomanThe lawsuit filed on behalf of Ray Badyna, specifically cites an article
published in 2000, on a study funded in part by Prozac maker Eli Lilly, and
Paxil maker SmithKlineBeecham, that found the incident of deliberate self-harm by patients taking SSRIs to be 5.5 times higher than persons taking tricyclic antidepressants.
Recently a document became public that clearly shows the manipulation of
study results in articles published on Pfizer's Zoloft (sertraline), by the
medical communications agency, Current Medical Directions in 1998.
The CMD published 6 articles on Zoloft use with children but all total,
only 1 article mentions one suicidal act. However, according to Dr David Healy, one of the world's leading authorities on SSRIs, and author of "Let Them Eat Prozac," and "The Antidepressant Era," there were 6 suicidal acts.
He says, the rate of
suicidality in children taking Zoloft was in fact 9%,
but Pfizer got away with not publishing these negative findings by only
reporting side effects that occurred at a rate of 10% or higher.As far as the benefits of Zoloft, a study in the Journal of American
Medical Association in April 2002, compared the effectiveness of Zoloft, St
John's Wort, and a placebo and reported that
placebo patients had the highest rate of remission of symptoms at 31.9%, and Zoloft's 24.8% rate of remission was barely better than the 23.9% of St John's Wort.
The kinds of suicides that experts say are SSRI-induced are extremely
violent, totally unexpected and impulsive. Notes are seldom left and many
suicide attempt survivors recall a strange out of body like experience.
For instance, 71-year-old Milton Cole, who was in good health and not
depressed, went to a heart doctor with chest pains. After tests failed to reveal a heart problem, the doctor gave Mr Cole free samples of Prozac, supposedly to relieve the chest pain. Thirteen days later, his wife found him hanging from a beam in a back room of their shop, according to the November 3, 2003 Miami Herald.
Dr Joseph Glenmullen, author of "Prozac Backlash," and "The Antidepressant Solution," explains that the difference between ordinary suicidality and SSRI induced suicidality can be distinguished because an activation syndrome usually accompanies SSRI suicidality, which includes akathisia and mania.
Harvard trained psychiatrist, Dr Stefan Kruszewski, agrees and says,
"Because the drugs cause predictable neurochemical changes in the central nervous system, SSRIs can also increase the risk of violence and aggressive acting out."
On March 22, 2004, the FDA issued an Advisory warning that symptoms such as akathisia, anxiety, agitation, panic attacks, insomnia, irritability,
hostility, impulsivity, hypomania, and mania had been reported in patients
taking Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor,
Serzone and Remeron and recommended close observation of patients for worsening depression or emergence of suicidality.
According to Attorney Braslow, at the time of this warning it was revealed
that Forest had added a suicide warning on Celexa sold in Europe years earlier, but in the US there was no such warning on Lexapro or Celexa.
"In addition," Mr Pogust reports, "the drug maker had previously conducted a number of European trials with both hospitalized and outpatient adolescents which
showed Celexa to be no more effective than a placebo."
In May 2005, the FDA published the alarming suicide rate for children
taking SSRIs in a Public Health Alert that stated
"1 in 50" kids on SSRIs become suicidal or have increased suicidality "DUE TO DRUG."
The next month, another FDA Advisory warned that adult patients "should be watched closely for worsening of depression and for increased suicidal thinking or behavior."
In addition to suicide, some of the most serious adverse events reported
to be associated with SSRIs in recent years, are birth defects. Many studies have determined that SSRIs are harmful to the unborn fetus. In April 2006, a study in the American Journal of Obstetrics and Gynaecology, by Canadian researchers, found
that SSRIs use during pregnancy doubled the mother's risk of delivering a stillborn infant and increased the risk of premature delivery, underweight babies, and seizures.These findings are important for doctors to know because according to a
report by CDC researchers last year in Pediatrics, preterm birth is the leading cause of infant mortality in the US, accounting for at least a third of all deaths in 2002.
The
harms to the fetus reported include a withdrawal syndrome, requiring prolonged hospital stays, respiratory support and tube feeding and a 6-fold increase in the life-threatening lung disorder, persistent pulmonary hypertension, as well as serious heart birth defects that require open heart surgery to correct.
In September 2005, studies conducted by Danish and US researchers found that the use of SSRIs in the first 3 months of pregnancy was linked to a
40% increased risk of birth defects such as cleft palate, and a 60% increase in cardiac defects. One study of 1,054 women who took SSRIs found they increased the risk of premature birth by 40%.
As a result of the rising number birth defects found to be associated with
SSRIs, drug companies are facing a slew of lawsuits. They are reportedly
especially worried about birth defect information becoming public because
medical experts estimate that tens of thousands of infants in the US have
SSRI-related birth defects, with the blame largely unknown to the parents.
Nearly 10 years ago, one of the harshest admonishments about the
over-prescribing of SSRIs came in an Editorial in the October 20, 1997, issue of Time Magazine by Candace Pert, a professor at Georgetown University Medical Center at the time, as one of the two scientists who discovered the serotonin binding process, which stated in part:
I am alarmed at the monster that Johns Hopkins neuroscientist Solomon
Snyder and I created when we discovered the simple binding assay for drug receptors 25 years ago.
Prozac and other antidepressant serotonin-receptor-active compounds may also cause cardiovascular problems in some susceptible people after long-term use, which has become common practice despite the lack of safety studies.
The public is being misinformed about the precision of these selective
serotonin-uptake inhibitors when the medical profession oversimplifies their action in the brain and ignores the body as if it exists merely to carry the head around!
"In short," she warned, "these molecules of emotion regulate every aspect
of our physiology."
Dr Healy says SSRIs continue to be over-prescribed even as researchers are finding more and more adverse events and doctors need to fully explain these side effects before prescribing the drugs so patients can make an informed choice about taking them.
Persons interested in more information on legal matters related to SSRIs
can contact the Pogust & Braslow law firm at 610-941-4204, or
http://www.pogustbraslow.com/Evelyn Pringle
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