FDA Waffles Over Antidepressants Causing Suicides
According to an article in the New York Times, officials of the FDA are now acknowledging that antidepressants do cause children and teenagers to become suicidal, but the FDA is not taking the steps it should - ban the drugs for use in children, as the UK has already done.
The major preoccupation seems to be that if antidepressants are removed or carry strong warnings, there is nothing left to do. The article states that "...several speakers noted that clinicians would have almost nothing to offer depressed teenagers and children if antidepressants were banned."
This shows how locked in we are on an exclusively pharmaceutical paradigm for health and that it might be time to open up to a new view of the problem. Nutritional approaches are not even considered, although they seem to be eminently successful. In Canada, such an approach is being pioneered by Truehope Nutritional Support, a group that proposes to help sufferers with a specifically formulated nutritional supplement.
So foreign is this thought to health authorities that the Truehope was raided at gunpoint and told that they may not sell their product saying it might help sufferers of mental illness.
Another example of nutritional intervention on "mental illness", in this case ADHD, dates back to the discovery of kryptopyroles in urin. In his book "Nutrition and Mental Illness: An Orthomolecular Approach to Balancing Body Chemistry", Carl C. Pfeiffer describes the symptoms of patients with elevated urinary kryptopyroles as: "progressive loss of ambition, decreased school grades, poor concentration, poor memory, fatigue, hyperactivity, anxiety, depression, psychosis, migraine headaches, diminished sexual potency, personality changes, irritability, rages, moodiness, convulsions and uncontrolled excitement".
According to a recent article in the German magazine raum&zeit, kryptopyrroluria was documented more than a century ago. Irvine and O'Reilly improved the methods of analysis and they found in the early 60's that kryptopyroles could be found in 11% of healthy people. The percentage for mentally retarded children was 24%, but it increased in psychiatric patients to 42% and in schizophrenics to 52%.
Apparently, the substance is harmless in itself; however, it tends to attach itself to both B6 and zinc and to pull these substances out of the body through the urine, causing deficiencies of both. The remedy: supplementation with these nutrients in higher doses than generally considered necessary.
One might wonder whether health authorities are so beholden to pharma interests that they are blind to the fact that biochemical balance and good nutrition are necessary preconditions for good health. While these officials normally do pay lip service to nutrition, when it comes to effectively doing something about bad health by nutritional intervention, something kicks in that does not allow them to see the potentially life saving effects of supplements. Could it be money or is it just that health education has been under pharmaceutical monopolistic control for almost a century now? I would say it might be a combination of both.
Read the recent NYT article here:
September 14, 2004
F.D.A. Links Drugs to Being Suicidal
By GARDINER HARRIS
BETHESDA, Md., Sept. 13 - Top officials of the Food and Drug Administration acknowledged for the first time on Monday that antidepressants appeared to lead some children and teenagers to become suicidal.Dr. Robert Temple, director of the F.D.A.'s office of medical policy, said after an emotional public hearing here that analyses of 15 clinical trials, some of which were hidden for years from the public by the drug companies that sponsored them, showed a consistent link with suicidal behavior.
"I think that we now all believe that there is an increase in suicidal thinking and action that is consistent across all the drugs,'' Dr. Temple said, summarizing the agency's presentation to a special advisory committee. "This looks like it's a true bill.''
The acknowledgement, made after the hearing, comes a year after the agency suppressed the conclusions of its own drug-safety analyst, Dr. Andrew Mosholder, who first found a link between the drugs and suicide in teenagers and children. Agency officials wrote in internal memorandums that Dr. Mosholder's analysis was unreliable, and they hired researchers at Columbia University to re-analyze the same data. That study recently reached conclusions nearly identical to Dr. Mosholder's.
The testimony came before an advisory committee of 31 independent experts that the F.D.A. has charged with making a recommendation about the labeling and use of antidepressants in children and teenagers.
Family members of suicide victims at the hearing angrily denounced agency officials for the delay in admitting the risk of antidepressants in children. The British health authorities decided in December to ban the use of most antidepressants in children and teenagers.
Mathy Milling Downing of Laytonsville, Md., whose 12-year-old daughter hanged herself in January, said: "Candace's death was entirely avoidable had we been given the appropriate warnings. "The blood of these children is on your hands.''
Agency officials said that they had no regrets about the months of study. "I don't think the data were at that time reliable,'' Dr. Temple said. "Scaring people needlessly" or overdoing a warning is worrisome, he added.
The most popular pills are Zoloft, made by Pfizer; Paxil, made by GlaxoSmithKline; and Prozac, made by Eli Lilly & Company. In 2002, nearly 11 million children and teenagers were prescribed antidepressants.
The risk of suicide among patients given the pills is very small. If 100 children and teenagers are given antidepressants, 2 or 3 will become suicidal who otherwise would not have had they been given placebos, agency officials said. None of the children in the trials committed suicide, but some thought about or attempted suicide, researchers found.
In March, the agency required antidepressant manufacturers to include on labels a warning that therapy with antidepressants could lead some patients, both adults and children, to become suicidal. The committee must decide whether this warning is strong enough or whether the drugs should be banned for children. The advisory committee is expected to make a decision on Tuesday. The F.D.A. normally follows recommendations of its advisory committees.
It is a complex task. Most studies of the drugs have failed to show that they have any effect on depression in children and teenagers. But the drugs have proven effective in adults, and studies suggest that teenage suicide rates have dropped in countries where use of antidepressants is widespread. A large study of depressed teenagers conducted by the National Institute of Mental Health recently found that Prozac was far more effective in treating depression in children and teenagers than was talk therapy.
Several speakers noted that clinicians would have almost nothing to offer depressed teenagers and children if antidepressants were banned. Suicide is the third leading cause of death among teenagers, trailing only homicide and accidents. Without treatment, many more teenagers will die, several experts said. If the committee suggests an even stronger warning, some patients will resist therapy and could perhaps die, some speakers said.
The issue has roiled the agency and is likely to transform the way the drug industry markets its products. Committees in both the House and Senate have begun investigations following disclosures that Dr. Mosholder's analysis had been suppressed.
The New York State attorney general Eliot Spitzer, filed suit against GlaxoSmithKline, charging the drug maker with fraud for failing to disclose the results of clinical trials of Paxil that found no benefit while promoting the drug to physicians. The company settled the suit this summer by promising to disclose the results of all of its clinical trials of its marketed products dating back to 2000.
Editors of the nation's top medical journals have said they will not to accept for publication trials that have not been publicly registered, and legislation is expected to be offered in both the House and the Senate requiring the disclosure of the results of all major drug tests on humans.
For some bereaved parents, Monday's hearing was a chance to take drug makers and the F.D.A. to task.
Mark and Cheryl Miller of Overland Park, Kan.,, told the committee that their 13-year-old son, Matthew, had committed suicide seven months ago while taking Zoloft.
"Why haven't parents like Cheryl and myself and countless others been told the truth?'' Mr. Miller asked.
But others said that antidepressants had helped millions. Dr. Suzanne Vogel-Sibilia of Beaver, Pa., said that she had brought her 15-year-old son, Tony, to the hearing to represent what she said were the vast majority of patients who had been helped by the drugs.
"Please help me preserve my future," Tony told the committee. "Don't take away my medication."
Claims that antidepressants cause patients to become acutely suicidal have been made since 1991, just three years after Prozac was introduced. But drug makers and regulators long dismissed these claims, saying they were anecdotal reports without any basis in rigorous clinical trials.
Then last year, GlaxoSmithKline announced that tests of Paxil had found that teenagers and children who took the pill were more likely to become suicidal than those given placebos. The announcement was quickly followed by a similar one from Wyeth, the maker of Effexor, another antidepressant. Suddenly, the anecdotal reports were being confirmed by clinical trials.
Still, just how the drugs may lead some people to become suicidal remains the subject of fierce debate. Many of those at the hearing said that the pills had brought a change in the personalities of their friends and relatives. Alice Erber said that Paxil caused her 21-year-old son, Jake Steinberg, to throw himself in June from the 24th floor of a Manhattan office building.
"If he had not taken Paxil, he would be alive today,'' Ms. Erber said.
But Dr. Temple speculated that some people taking the pills become suicidal because they are actually getting better. As their depression improves, he said, they gain the energy to act on suicidal thoughts that their illness had suppressed.
"I think the work is cut out for us tomorrow,'' Dr. Wayne Goodman, chairman of the advisory committee, said at the end of Monday's hearing.
Also interesting in this context: A complaint filed in April 2005 by Charles Medawar of Social Audit in the UK, regarding the overuse and lack of evidence of efficacy of SSRI inhibitors.See http://www.socialaudit.org.uk/6050420.htm#Regulation
See also related articles:
FDA suppressed antidepressant risks, panel says
The Discovery of Kryptopyrrole and its Importance in Diagnosis of Biochemical Imbalances in Schizophrenia and in Criminal Behavior - Journal of Orthomolecular Medicine: The Discovery of Kryptopyrrole and its Importance. Vol. 10, No. 1, 1995
Pyroluria: Hidden Cause of Schizophrenia, Bipolar, Depression, and
Anxiety Symptoms - by Woody McGinnis, M.D.Antidepressants Linked to Withdrawals in Newborns, Study Says
Feb. 4 (Bloomberg) -- GlaxoSmithKline Plc's Paxil, Eli Lilly & Co.'s Prozac and other antidepressants may cause convulsions and other withdrawal symptoms in newborns whose mothers took the drugs during pregnancy, according to a study in the Lancet medical journal.Investigator Exposes Pharma Corruption - Loses Job
Health Canada: Causing Deaths by Withholding Information on Drug Dangers
Pharma makers withhold suicide data in drug studies
Drugs do not work - in most cases
Drugs and Doctors May be the Leading Cause of Death in U.S.
Report Says 195,000 Deaths Due to Hospital Error
FDA urges stronger warning on antidepressants
Jason Hidalgo RENO GAZETTE-JOURNAL
An advisory panel recommended the use of a "black box" warning on antidepressant drug labels Tuesday, citing the increased risk of suicidal behavior in children taking such medications.Doctors Say They Will Cut Antidepressant Use
By GARDINER HARRIS - September 16, 2004
Psychiatrists, pediatricians and family practice doctors said in interviews that they would restrict their use of antidepressants in the wake of a federal advisory committee's decision that the medicines should contain severe warnings about the risks of suicide.WALL STREET JOURNAL - September 28, 2004
FDA to Probe Antidepressant Risks for Adults - After Planning Warning for Kids, Agency to Re-Examine Evidence Suggesting No Danger of SuicideDrugs licensing flaws exposed - Special report: Pfizer advised on how to get antidepressant approved by member of body deciding on application - By Sarah Boseley Monday October 4, 2004 - The Guardian
See also a statement by Vera Sharav, President, AHRP
September 11, 2004
(Alliance for Human Research Protection)Antidepressants and suicide-related risks for children
The FDA bears responsibility for a credibility crisis in medicine. The FDA has allied itself with the pharmaceutical industry, adopted that industry’s culture of arrogance and concealment of evidence—even as children’s life-safety were put on the line. The hazardous side-effects of SSRI antidepressants were concealed for 25 years with FDA’s tacit approval—lest the truth impede industry’s mega-profit goals. Indeed, FDA’s limited review of selective evidence, its reliance on information supplied by psychiatrists with financial conflicts of interest, and the invited presentations by Pfizer and Eli Lilly, are calculated to minimize the scope of the problem.
The Alliance for Human Research Protection will convene a press briefing at which five independent experts will review scientific and clinical evidence, shedding light on what was known 20 years ago, what is known and not known today about the safety and efficacy of antidepressant drugs.
The issues to be addressed at the press briefing, and the documented evidence presented, will not be explored by the FDA advisory committee meeting—inasmuch as independent analysts were excluded from the discussion. All critical analyses and reports from outside independent experts have been excluded from the committee deliberations—much as Dr. Mosholder’s report and recommendations were suppressed for six months—until it was made public by The Alliance for Human Protection who posted it on its website in July.
The five independent expert presenters are:
Peter Mansfield, MD, University of Adelaide (Australia), Director of Healthy Skepticism will discuss the illusion of potency in light of the meta-analyses in the British Medical Journal (which he co-authored) and the Lancet--Peter Breggin, MD, a child psychiatrist, with a sub-specialty in clinical psychopharmacology, who was among the first to recognize adverse antidepressant drug reactions—Lawrence Diller, MD, a pediatrician and family therapist who has evaluated and treated more than 2,500 children--Stefan Kreuszewski, MD, a clinical and academic psychiatrist, and Associate Medical Director of Physicians' Health Programs, Pennsylvania Medical Society, who will discuss the impact of over-prescribing SSRIs for children in state custody-- David Healy, MD, Director of the North Wales Department of Psychological Medicine and Visiting Professor, University of Toronto, who in large measure has brought pressure to bear on the FDA to examine the pediatric data. Dr Healy will shed light on FDA’s asymmetric standards for evaluating efficacy and safety, and will present newly uncovered documents.
Children’s lives have been been put on the line by concealed hazardous side-effects of SSRI antidepressants. The FDA lent its support to the least forthcoming drug manufacturers--even exerting pressure on companies that were willing to disclose suicide-related risks on their antidepressant drugs labels. FDA officials forced Wyeth and Forest to toe the line.
Following the independent experts’ presentations, questions from members of the press will be answered. Families will also share experiences that show the chilling reality of the life-threatening consequences of SSRI antidepressant drug use in children and adolescents.
posted by Sepp Hasslberger on Wednesday September 15 2004
updated on Wednesday December 8 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2004/09/15/fda_waffles_over_antidepressants_causing_suicides.htm
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