HOW HIGH ARE THE RATES OF SUICIDE AND HOMICIDE FROM "ANTIDEPRESSANTS?"
"In the agency's most recent internal review of the antidepressant studies, FDA scientist Tarek Hammad concluded in August that children taking Effexor had 8.84 times the risk of suicidal behavior or thinking compared with children taking sugar pills."
Effexor carries the words "Homicidal Ideation" on its label (This is one of the meds that Andrea Yates was on when she killed her kids. See http://www.youtube.com/watch?v=pecCbMtqjos). When will the FDA study the rate of homicide?
According to Dr. Healy's book, Let Them Eat Prozac, a person taking Zoloft is 2,000 times more likely than anyone in the general population of becoming suicidal (including suicidal thinking, not just attempts or completed suicides). How high are these rates, really? Personally I am appalled that the FDA and drug companies show such a lack of concern for patients. They have known about this since before Prozac was approved in 1987 (the same year that Postpartum Support International was founded). Here is an interesting video about the financial conflicts of interest which prevented a warning from being issued in 1991: http://www.youtube.com/watch?v=FxJomeak4V4
The black box warning came out in late 2004, the same year that I suffered my nightmare experience on Zoloft. This was the same year that Elizabeth Torlakson committed suicide on Celexa, and countless other moms killed their babies that year and since then (including Dena Schlosser of McKinney, Texas, who cut off her baby's arms). If the FDA had warned sooner, many lives would have been saved. We must warn others, because doctors and drug companies are doing a very poor job, and they consistently put profits over people.
Many of these articles were sent to us by Dr. Fred Baughman, and have his comments in brackets. You can check out his website at: www.adhdfraud.com
THE FDA AND DRUG COMPANIES FAILED TO WARN
Friends and Associates,
The following notes of the recent FDA hearings on antidepressant use in
children are provided by C Brockman.
As you will see, the consensus was for the FDA to issue a warning to
physicians and the public BEFORE their analysis is completed, which won't
happen before this summer.
The FDA has yet to follow the consensus of the advisory panel....
FDA PSYCOPHARMACOLOGIC DRUG ADVISORY COMMITTEE
OPEN PUBLIC MEETING NOTES - 2/2/4
NORMAN FOST, M.D., M.P.H.
Dr Norman Fost warned that doctors are to uphold the 'principle of first do
no harm' and that as a first response it is more important not to harm than
to fail to help. He defended this principle further by questioning the
effectiveness of the SSRI's since there is tremendous ambiguity about
whether or not kids are even being helped. He challenged the suggestion
that doctors not telling patients about harm of SSRI's but only telling them
about the benefits would put the patients at risk because people and some
doctors do not know that there is a real possibility that patients can be
made worse by SSRI's. He went on to urge the PDAC to get the message out
that the FDA has a level of concern about SSRI's while they are evaluating
MARY P. GLODE, M.D.
Dr. Mary P. Glode does not believe that the benefits of not telling patients
about SSRI adverse effects outweigh the risks of telling them even though
the patients might not want to be treated for depression with the SSRI's.
She asked what is the risk of informing versus the benefit of informing?
One benefit of informing might be that the patient would most likely be
reevaluated for other treatment.
ROBERT J. FINK, M.D.
Dr. Fink along with other committee members expressed a serious concern for
the off-label use of SSRI's and the administration of SSRI's by non-mental
health trained doctors.
P. JOAN CHESNEY, M.D.
Dr. Chesney referenced the testimony of Corey Baadsgaard when she inquired
about the medical terminology for 'waking up not knowing' what one had done
when experiencing an ADE. The committee responded that the term for that
condition is 'dissociative fugue' state. She stated, 'hostile behavior is
too much of a risk,' and recommended that the clinical trials look at
homicide as well as suicide risk factors, specifically with measures for
blood levels while on SSRI's. She further recommended that the studies look
at activation syndrome. Also, she requested that committee representation
from the medical community be expanded since there was no one on the
committee here from the American Physician Association nor from a nurses' or
JUDITH R. O'FALLON, PH.D.
As a statistician, Dr. O'Fallon emphasized that in all her years of
experience one never gets good results from bad data, except that there are
lessons learned on how to better construct a superior model for future
clinical trials so as not to make the same mistakes. There was nothing in
the original data set to evaluate ADE's if the dose was raised or lowered.
In other words, no measures for blood levels were designed into the original
model. She stated, 'Identifying harm is more important to doctors than
identifying benefits because doctors otherwise have to wing it,' and that is
a very undesirable medical practice. Furthermore, new models for clinical
trials must have placebo studies and polypharmaceutical studies.
MARK HUDAK, M.D.
Dr. Hudak questioned the validity of the data from the original clinical
trials. The concern is that, as a result of variations in measuring and
methods in obtaining the data, suicide thought and attempts were equal. He
asked, ' Is this the final plumbing (of the data)?'
ELIZABETH B. ANDREWS, PH. D.
Dr. Andrews wanted to look at 'more objective end points' since study
generalizability does not compare well. She recommended end points studying
dose titration changes and clinical trials monitoring more closely.
IRENE E. ORTIZ, M.D.
Dr. Ortiz pointed out that developing measures for blood levels alone might
give rise to flawed implications. She clarified that 'different dosages
cause different reactions which are not predictable' and therefore, we 'must
also watch behavior with more precision'.
SAMUEL D. MALDONADO, M.D. M.P.H.
Dr. Maldonado was concerned about issues of 'bad data' and wanted to know
about 'other signals' in the data.
RICHARD GORMAN, M.D. FAAP
Dr. Gorman had questions about what is found 'when we are data mining.' He
asked, 'What got one company to voluntarily label?' Dr. Laughren responded
that they 'found a signal' and that 'they are allowed to modify labeling if
it strengthens labeling'.
ANDREW C. LEON, PH. D.
Dr. Leon requested that clinical trials look at treatment emergent symptoms.
He is concerned about the changed scores from the data.
RICHARD P. MALONE, M.D.
Dr. Malone asked about the efficacy in OCD. He stated that with the high
placebo response rate, it is difficult to find an effect.
CYNTHIA R. PFEFFER, M. D.
Dr. Pfeffer wanted to look at the clinical trial data of who improved and
who did not improve in placebo trials of SSRI groups, and what are the
predictors of that. She also emphasized that it is important to determine
whether or not randomization worked in suicidality.
DANIEL S. PINE, M. D.
Dr. Pine warned that the differences in the studies' measures may have
created some inconsistencies in analysis between studies, and therefore,
there should not be a rush to judgment that the SSRI's are not beneficial to
CHARLES E. IRWIN, JR. M. D.
Dr. Irwin suggested that patients themselves seem to be more 'ahead of the
curve than clinicians' since the patients are the ones taking the
medications and since the clinicians no longer seem to be practicing a
protocol for watching and waiting when dispensing SSRI's.
Others on the committee raised concerns about the mistaken impression from
an FDA disclosure that 'Efficacy has not been established' since this phrase
leads one to assume that the studies have not been done even though they
have been done. The recommendation when using this phrase is 'to show that
the studies were done.'
MATTHEW V. RUDORFER, M. D.
Dr. Rudorfer summarized the committee's conclusions to endorse an SSRI
warning for doctors and consumers indicating the FDA's concern about SSRI's
link to suicide while further research is being conducted to measure the
connection to suicidality to see if there is a link. He further emphasized
that the warning should include language to urge doctors not to dispense
SSRI's liberally since the FDA does not yet have the data that they want and
need to determine a link. He also mentioned that akathisia, activation
syndrome and other signals should be further investigated.
December 11, 2003
British Warning on Antidepressant Use for Youth
By ERICA GOODE
British drug regulators yesterday recommended against the use of all but one of a new generation of antidepressants in the treatment of depressed children under 18.
In a letter sent to doctors and other health professionals, the government regulators said a review of data on the safety and effectiveness of the drugs, known as S.S.R.I.'s, indicated that their benefits did not outweigh their potential risks. [[[[[[[[basis of informed consent and this the case, there is no justification to prescribe]]]]]]]]]
Their effectiveness in treating depression in children, they said, has not been sufficiently demonstrated, and some drugs have been linked with suicidal thoughts and self-harm in children and adolescents [[[[[[[[[as have all sched II stimulants]]]]]]]]]]. A summary of the findings was published on the Web site of the British Medicines and Healthcare Products Regulatory Agency (www.mhra.gov.uk).
The agency, the equivalent of the Food and Drug Administration in the United States, said it was issuing a strong signal to doctors but was not barring the drugs completely because there were cases when their use might still be warranted.
The agency exempted Prozac, from Eli Lilly, but recommended against the use of six drugs: Paxil, from GlaxoSmithKline; Zoloft, from Pfizer; Effexor, from Wyeth; Celexa and Lexapro, from Forest Laboratories Inc., and Luvox, from Solvay.
The F.D.A. is investigating whether the data support a link between suicide and the S.S.R.I.'s — selective serotonin reuptake inhibitors —in children and adolescents. On Feb. 2, an advisory committee for the agency will hold public hearings on the issue. But Dr. Russell Katz, director of the division of neuropharmacological drug products, said that for many reasons, finding whether such a link exists was no easy task. "Our view at the moment is that the risk is not particularly well-understood or defined," Dr. Katz said. "It is not at all a straightforward matter to figure this out." [[[[[[[[[[[FDA now bought paid for, no longer protector of the public—my view but I have no hesitation in concluding this.]]]]]]
He said there was no indication that the British regulators had access to any studies beyond those already under review by the F.D.A. [[[[[[[[[Brits more protective of their public, FDA, US psychiatry of big pharma]]]]]]]]
In June, the American agency warned doctors that they should not prescribe Paxil for depressed children and adolescents until it had sorted out the issue. In October it issued a health advisory noting that doctors should use caution in prescribing S.S.R.I.'s to young patients and should closely monitor those taking the drugs.
Only a few of the drugs — including Prozac, Paxil and Zoloft — have been tested in large trials as a treatment for depression in young people.
One big problem for outside researchers, and for the public, is that the data that seems to show a link between the drugs and suicide is privately held by drug companies, though it has been provided to the government agencies.
Even for those who have the data, determining if a link exists is complicated, Dr. Katz and other experts said, because it is not always clear that the patients described as suicidal actually are. For example, experts say, some teenagers may cut or harm themselves but do not intend to commit suicide.
There are no reliable estimates of how many American children and teenagers are on antidepressants, but studies indicate the number has risen sharply over the past decade. Experts on the British agency's advisory committee estimated that 40,000 Britons under 18 were taking such drugs, with about half taking Prozac.
The British agency exempted Prozac, the regulators said, because studies have shown it to be effective for treating depression in children and adolescents.
Some experts said the British action was extreme.
"I think they're really overreacting," said Dr. Jeffrey A. Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina. "This is really going way too far, and in the process doing more harm than good."
Dr. David Shaffer, a professor of psychiatry and pediatrics at Columbia University who sent a letter on the issue at Pfizer's request to the British drug agency, said he had concluded that there was insufficient data to restrict the use of the drugs in adolescents. "The bottom line is that suicidal ideation and suicide attempts are very common in depressed kids," he said.
Dr. David Healy, of the University of Wales College of Medicine, who has been outspoken about the need for more unbiased testing of antidepressants, said the British agency had not addressed larger questions about the drugs.
"The issue isn't necessarily that these drugs should be banned for children," he said. "The question is, `What is the safest way they can be used?' "
Other researchers said the British action was helpful in calling attention to the unanswered questions about the effectiveness and safety of antidepressants for children.
"Right now there is a large question of whether the standard of treatment for children diagnosed with depression" should be the inhibitors, said Dr. Julie Magno Zito, associate professor of pharmacy and medicine at the University of Maryland.
Alison Langley, a spokeswoman for the British agency, said the recommendation was issued because the drugs "don't work in the majority of cases for children under 18 with depressive illnesses."
Although the regulators cautioned doctors that the S.S.R.I.'s should not be prescribed "as new therapy," they added that if a child was already taking one of the drugs and doing well, "the normal completion of the planned treatment course should be considered as an option in the management of the illness."
They also said that the drugs might still be appropriate for some children — those who cannot tolerate Prozac, for example — and cautioned only that in such cases the medication should be prescribed and supervised by a specialist rather than by a general practitioner.
In addition, the regulators noted that their recommendation did not apply to the use of Luvox and Zoloft for children and adolescents who suffered from obsessive-compulsive disorder, citing research that demonstrated the effectiveness of the two drugs for the condition.
Children and adolescents who are currently taking the drugs, the regulators cautioned, should not stop taking them abruptly or change their treatment without medical supervision.
[[[[[[[[[[at best, the risk benefit ratio remains unknown. I believe the suicidal ideation and risk and suspect it is there for prozac as well. ]]]]]]]]]
Heather Timmons contributed reporting from London for this article.
Lawsuits - Only Weapon Available Against Giant Big Pharma Pushers
Evelyn Pringle 7/10/06
Over the past several years, new studies have shown the new generation of psychiatric drugs to be not only extremely dangerous but also ineffective, and the majority of these medications in fact now carry black box warnings about a number of life-threatening side effects associated with their use.
The drugs include selective serotonin reuptake inhibitors antidepressants (SSRIs), like Paxil, Prozac, Zoloft, and Effexor, and the atypical antipsychotics, that include Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify.
Hidden studies dating back to before many of the drugs were even FDA approved have also surfaced, many as a result of litigation, that demonstrate that Big Pharma knew all about the problems with the drugs, but concealed the adverse event reports, and only allowed the findings from positive clinical trials to become public.
GlaxoSmithKline has now lost several lawsuits because it knowingly concealed years of negative information about the serious adverse reactions to Paxil
In one lawsuit it was shown that GSK deliberately misled both physicians and patients to believe that Paxil was not addictive and had no withdrawal reactions with a question and answer pamphlet distributed to doctors' offices to be disseminated to patients, in which GSK asks the question: "Is Paxil addictive?"
And, in response, the pamphlet states: "Paxil has been studied both in short-and-long-term use and is not associated with dependence or addiction."
By the time the lawsuit was filed on August 21, 2001, the plaintiffs' attorneys had been individually contacted by approximately 500 Paxil withdrawal victims.
As a result of GSK‘s fraudulent marketing of Paxil as non-addictive, the Las Angeles based Baum Hedlund law firm won a major settlement in this class action filed on behalf of patients who got hooked on the drug, and in many instances, found they were unable to stop taking it.
The documents that surfaced during litigation showed that since before Paxil was approved, GSK had known about the withdrawal affects from it own clinical trials and from many others conducted by prominent scientists, in addition to receiving thousands of complaints by individuals who used Paxil.
According to the lawsuit’s complaint, “GSK’s motive of deliberately failing to advise physicians and the public of the adverse effects that can lead to withdrawal problems (and that it knew a percentage of users of the drug inevitably would experience) was for financial gain and its fear that, if properly labeled the drug, Paxil would lose its share of the SSRI market.”
The complaint alleges that GSK over-promoted Paxil in order to increase sales at the expense of revealing the truth about the addictive and dependency nature of Paxil and fraudulently conveyed to all health care providers in the US that Paxil's side effects were only "mild," when in fact GSK knew the drug's withdrawal effects were severe.
It also claims that GSK fraudulently conveyed to health care providers in the US that a British study involving 13,741 patients found that all SSRI's exhibited a similar rate of withdrawal reactions, when in fact GSK knew that the study found Paxil to have the highest rate of withdrawal reactions of any SSRIs. [[[[[[[including Prozac]]]]]]]]
Over the last several years, evidence has surfaced that also proves that GSK concealed negative information and studies that demonstrated that Paxil drastically increases the risk of suicide and self-harm, especially with children.
A report by psychiatrist, Dr Peter Breggin, a court certified expert and author of numerous books on psychiatric drugs, written years earlier when he served as an expert witness in a Paxil lawsuit, reveals how GSK not only concealed negative studies, but also manipulated data about Paxil-induced suicidality so that actual suicide attempts in clinical trials were underreported, while attempts by subjects taking a placebo were inflated.
The report also notes how GSK hid the events related to akathisia (agitation with hyperactivity) and stimulation, which Dr Breggin says, are known risk factors for suicidality and violence.
Excerpts from the report were recently published by Dr Breggin, in the Spring 2006 issue of Ethical Human Psychology and Psychiatry, Vol 8.
His original report was attached to a July 21, 2001, affidavit submitted in the California case of Lacuzong v GSK, filed by the widow of a man who drowned the couple's 2 children, before drowning himself in a bathtub, after taking Paxil for only three days.
After the Lacuzong case was resolved, at GSK’s insistence, the report was sealed under a protective order. However, in the more recent case against the company, Moffett v Glaxo SmithKline, in Mississippi the protective order was lifted and the report was entered in the public record. Dr Breggin has also made it available on his web site at www.breggin.com.
“The publication of a previously sealed report is rare,” he says, “the first in my experience.”
According to Dr Breggin, drug companies settle almost all lawsuits out of court in order to seal incriminating scientific data. “This deprives the FDA, medical profession and public of critical information on drug safety and efficacy,“ he says.
He wants the laws changed so that they require drug makers to publish all of the safety and efficacy information they generate regarding their products.
In March, 2006, Baum Hedlund’s leading SSRI attorney, Karen Barth Menzies, filed another class action lawsuit against GSK, in federal court in the company’s hometown of Philadelphia, this time on behalf of patients under the age of 18, who attempted suicide while on Paxil, and on behalf of the family members of children who committed suicide while taking the drug.
Its important to note that Paxil has never been approved by the FDA for any use with children, and so therefore, every prescription written for the children involved in this lawsuit was for off-label use.
One suicide in the case involves 11-year-old Trevor Blain who was prescribed Paxil for "separation anxiety disorder" by his pediatrician in October 2000, and immediately began having trouble sleeping and exhibited angry outbursts. His family knew nothing about the connection between Paxil and these adverse events and so Trevor continued to take the drug.
In early November 2000, Trevor hanged himself with his dog's leash in the family laundry room and although he initially survived the suicide attempt, he remained in a coma for several weeks before he died on December 7, 2000.
Another plaintiff in the case, is 17-year-old Tonya Brooks whose family doctor diagnosed her with "social anxiety disorder" and prescribed Paxil in 2004. While taking the drug, Tonya became agitated, aggressive and had difficulty sleeping.
She first attempted suicide by taking an overdose of Paxil and sleeping pills. After surviving the first attempt, 2 days later Tonya gouged a hole in her leg with a pair of scissors and was hospitalized for several days.
Recounting the horror when she found her daughter sprawled on the bathroom floor after her second suicide attempt, with blood everywhere, Tonya's mother, Cheryl Brooks, says, "no parent should have to go through what we did."
According to Attorney Menzies, this is another case where GSK concealed information to protect profits. "Through our Paxil litigation," Ms Menzies states, "we've obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children."
"That's about as reprehensible as you can get," she adds.
"Governmental regulators around the world have now analyzed the actual data from the clinical trials, not GSK's version of it," she notes, "and have found an increased risk of suicidality."
"We wanted to make sure the rights of all of these kids," she says, "are protected by filing this lawsuit."
Pfizer's SSRI, Zoloft is no better than Paxil. There were also clear indications of probable suicidality risk in clinical trials on this drug long before it was approved.
For instance, in a "healthy volunteer" Zoloft study conducted by Ian Hindmarch in 1983 in which 12 volunteers were randomized to either a placebo or Zoloft, every volunteer but one, who took Zoloft dropped out within days, due to severe agitation, after making comments such as “I was running like a machine inside” and “I have never felt as bad as this in my life”
In 2003, the Journal of the American Medical Association published the results of 2 trials on children treated with Lustral (Zoloft) in which 17 children who were given the drug were pulled out of the trial because of side effects, compared with five children who received a placebo, and only 10% more children improved on Zoloft than on a placebo.
And yet the authors of the study wrote: "the results of this pooled analysis demonstrate that sertraline (Lustral) is an effective and well-tolerated short-term treatment for children and adolescents with major depressive disorder."
This drug has also been linked to severe violent behavior in children. On January 26, 2006, a psychologist on Court TV announced that 14-year-old, Cody Posey, was on Zoloft when he killed his parents and sister. He started taking the drug on April 20, 2004, and committed the murders on July 5, 2004.
Cody's father was the range manager for well-known TV reporter Sam Donaldson.
As for the granddaddy of SSRIs, Eli Lilly’s Prozac, the first to be approved back in 1987, within one decade of the drug's arrival on the market, there were 39,000 adverse event reports submitted to the FDA's Medwatch, according to award-winning investigative reporter, Robert Whitaker. And that number is said to represent only about 1% of the actual number of adverse events, he reminds people.
"So, if we get 39,000 adverse event reports about Prozac," Mr Whitaker said in an interview for Street Spirit in August 2005, "the number of people who have actually suffered such problems is estimated to be 100 times as many, or roughly four million people."
"There were more adverse event reports received about Prozac in its first two years on the market," he told Street Spirit, "than had been reported on the leading tricyclic antidepressant in 20 years."
"This makes Prozac the most complained about drug in America, by far," he said.
Linda Hurcombe, an American citizen who resides in the UK, lost her 19-year-old daughter, Caitlin, to suicide as a result of Prozac.
She describes how 8 years ago, her "undepressed daughter saw an ad for antidepressants on television while visiting the US."
"Caitlin decided she wanted this pill," Ms Hurcombe explains, "because she was nervous about final exams and had heard at the university too that Prozac made you lose weight and feel great."
Caitlin got a prescription from the doctor, she said, with no problem.
"After 63 days on this medication," Ms Hurcombe says, "during which time her behavior descended into chaos, Caitlin hanged herself from a beam in the guest bedroom of our home."
Ms Hurcombe has written a book titled, "Losing a Child," and says, most shockingly, during the research for the book, "I have found that Caitlin was just one of thousands whose lives have been snuffed out in a similar manner."
On February 2, 2004, investigative reporter, Kelly O'Meara, wrote an article that reported on the first clinical trial of its kind, by Dr David Healy, director of the North Wales Department of Psychological Medicine at the University of Wales, in which Prozac was given to a volunteer group of mentally healthy adults.
The study determined, apparently just as in the case of Ms Hurcombe's "undepressed" daughter, that even mentally healthy adults were adversely affected by the drug.
According to Ms O'Meara, between one in 20, and one in 10, people in the study on Prozac experienced akathisia, "whereby they become mentally restless or manic and lose all inhibitions about their actions."
"People don't care about the consequences as you'd normally expect," Dr Healy explains, "they're not bothered about contemplating something they would usually be scared of."
He said the study showed that: "We can make healthy volunteers belligerent, fearful, suicidal, and even pose a risk to others."
Kelly O'Meara's coverage of the adverse effects of psychiatric drugs is virtually unmatched by any other journalist in the US. During her 6-year stint with the Washington Times' Insight magazine, she wrote more than two dozen investigative articles about the link between SSRIs and the bizarre, violent acts committed by patients taking the drugs, which include the majority of children involved in school shootings in the US.
Her new book, "Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill," is about informed consent. "The people need and deserve the whole truth about their psychiatric diagnosis," Ms O'Meara advises, "and the mind-altering drugs that are prescribed as treatment."
Experts say the book is a must read for patients considering whether to take psychiatric drugs. The “chemical imbalance in the brain” theory that drug maker’s tell patients they have when marketing the drugs, is debunked in the book by some of the nation’s leading experts, and according to Ms O'Meara, the drug companies themselves have been forced to admit that they do not understand how the drugs work in the human brain during the treatment of an alleged mental illness.
"In fact," she says, "a test that measures a person’s brain chemicals does not exist."
"Never in the history of the world has science discovered what the correct brain chemical levels are for any living person," Ms O'Meara explains, "making it impossible to know if these naturally occurring chemicals are out of balance."
"If confirmable proof of a chemical imbalance were required prior to filling a prescription for any antidepressants," she says, "not a single prescription would be written because to date the only known method of determining chemical levels in the brain is during autopsy."
Over the last decade the drug companies have conned doctors into writing millions of prescriptions to children for these SSRIs, under the guise of protecting them from suicide, and yet the suicide rates for kids during this time period have remained statistically unchanged, with boys varying by at most one suicide up or down, and the rate for girls not moving an inch, according to a review of statistics put out by the Department of Health and Human Services.
Even though the atypical antipsychotics are not FDA approved for any use with children, and their package inserts specifically state that their safety and effectiveness with children have not been established, Big Pharma has doctors prescribing them off-label to children of all ages for a long list of so-called mental disorders.
According to a study in the March-April 2006, Ambulatory Pediatrics journal, between 1995 and 2002, the rate of children receiving antipsychotics increased five-fold, to an estimated 2.5 million, or an increase from 8.6 prescriptions for every 1,000 children in the mid-1990s, to nearly 40 in every 1,000 in 2002.
A recent review by USA Today of the FDA’s adverse reporting system from 2000 to 2004, found at least 45 deaths in children under 18 listing atypicals as the "primary suspect." There were also an additional 1,328 reports of other side effects, including many that were life-threatening.
Other life-long physical adverse effects of these drugs are beginning to emerge in children. The Children's Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with atypical drugs, according to Robert F Kennedy Jr vs the Medical Elite, by Mark Sircus Ac, OMD, on June 22, 2005.
"The most studied adverse effect of the newer generation of antipsychotics,” he notes, “is their association with hyperglycemia, in some cases leading to ketoacidosis, coma, or death.”
“Many of these drugs carry black box warning to alert MD's about the dangers of diabetes," according to Mr Sircus.
Psychiatrist, Dr Stefan Kruszewski, also says the atypicals substantially increase the risk of other serious physical illnesses such as heart attack, hypertension, and stroke.
For the past 30 years, Dr Breggin, has served as a medical expert in lawsuits involving psychiatric drugs and has testified in cases involving tardive dyskinesia.
All antipsychotics also now carry a warning about the extremely serious condition of tardive dyskinesia. According to Dr Breggin, the condition is a drug-induced movement disorder that is usually irreversible and there are no adequate treatments for the disorder.
“Tardive dyskinesia often looks so "strange" or "bizarre," Dr Breggin says, “that it is mistaken for a mental illness rather than a neurological disorder.”
The abnormal movements, he says, can afflict any muscle group of the body and can impair the ability to walk, speak, breathe and swallow.
“It is highly variable in expression and severity,” according to Dr Breggin. One variety involves painful spasms of muscles, he says, that can literally torture the victim, and another involves an agonizing inner agitation that drives people to move their arms or legs, or to pace.
“Some cases,” he advises, “are painful, disfiguring, exhausting and ultimately disabling.”
Dr Breggin has served as an expert in a half dozen tardive dyskinesia cases that resulted in verdicts for the plaintiffs including several cases in which Risperdal caused tardive dyskinesia in children, where the drug was prescribed to control behaviors that were in fact, he says, caused by stimulant ADHD drugs that the child was already taking.
According to Dr Breggin, tardive dyskinesia occurs at a cumulative rate of 4-7% per year in otherwise healthy patients treated with antipsychotics and after only a few years, 20% or more of patients will be afflicted. In older patients, he says, the rate is even higher.
Overall, according to estimates by a 20-year career FDA scientist and researcher, Dr David Graham, the use of atypicals antipsychotics increases the annual death rate in the US by more than 12,000 people a year.
They are approved for a very limited number of psychiatric disorders but once again, drug makers have found way to get doctors to prescribe them off-label for a multitude of unapproved illnesses for age groups that they were never intended..
The off-label prescribing of these drugs is so out of control that according to a July 7, 2006 report by Decision Resources, Inc, a leading research and advisory firm on pharmaceutical and healthcare issues, antipsychotics represented the fourth-highest-ranking class of drugs in worldwide sales in 2005, and two of the top ten drugs in sales are atypicals.
But the icing on the cake as to the absurdity of their widespread use, come from a government study published in the September 22, 2005, New England Journal of Medicine, that determined that the new atypicals are only barely more effective than no drugs at all.
Another increasingly popular class of dangerous drugs being over-prescribed to children of all ages are the ADHD medications, commonly known as “speed“ to addicts. Information released by the FDA in February 2006, showed that between 1999 and 2003, seventy-eight million prescriptions were written for ADHD drugs for children ranging in age from one to 18.
On March 14, 2006, the FDA posted a review on its web site of reported adverse events between January 2000, and June 30, 2005, that found nearly 1,000 reports of psychosis or mania possibly linked to ADHD drugs. Psychosis is defined as a mental disorder characterized by the inability to distinguish real and imaginary events.
"The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD," according to a March 3, 2006, memo from 2 members of the agency's ADHD psychiatric review team.
The FDA also disclosed reports of 25 deaths in children and adults between 1999 and 2003, and 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia.
Yet experts say that the FDA is stalling at best, and refusing at worst, to add appropriate warnings to the labels of ADHD drugs to alert all the parents of the ever growing number of children being placed on these drugs, about their numerous life-threatening adverse effects, that experts predict, would no doubt result in a decrease in use.
Psychiatrist, Dr Grace Jackson, author of, “Rethinking Psychiatric Drugs: A Guide for Informed Consent,” says that “whether by ignorance or design, the regulators remain oblivious to the evidence-based limitations of the prescription pad: at least 40% of all children fail to tolerate or respond to stimulant therapy; about twice as many respond at least as well to non-pharmacological interventions.”
“The long term outcomes for medicated children,” she notes, “demonstrate diminishing returns over time, persistent suppression of growth (about 1 cm per year), and artificial behavioral improvements which dissipate when treatment is withdrawn."
“The connection between stimulants, cardiovascular disability, and death,” Dr Jackson says, “has long been documented in the medical literature, but physicians and government regulators have refused to acknowledge the hazards associated with prescriptions.”
Dr Breggin, warns that all stimulant drugs can cause “a continuum of stimulation, including agitation and irritability, anger, hostility, disinhibition, hypomania and mania.”
The stimulant or activation syndrome, he advises, was observed decades ago with stimulant drugs such as amphetamines, Adderall, and Dexedrine, and methylphenidates such as Ritalin and Concerta.
In addition, Dr Breggin brings up an all too common situation with children who are recruited by the mental health industry. "As the child's emotional control breaks down due to medication effects, mood stabilizers may be added," he explains.
"Eventually, these children end up on four or five psychiatric drugs at once and a diagnosis of bipolar disorder by the age of eight or ten," he warns.
According to pediatric neurologist, Dr Fred Baughman, another well-known expert and author of the new book, “ADHD Fraud, How Psychiatry Makes Patients Out of Normal Children,” in addition to the deaths listed by the FDA between 1999-2003, in persons using ADHD drugs, the MedWatch database also contains 186 more deaths between 1990 and 2000.
According to Dr Baughman, drugging kids has become rampant. "Its happening all across country,” he says, “not by thousands but tens of thousands, picking most on the disenfranchized, powerless.”
"These children become for-profit receptacles for psychiatric drugs," he warns, "which will undoubtedly alter their bodies and brains."
Dr Baughman’s alarming prediction is apparently becoming a reality. According to a study by Medco Health Solutions, a managed-care firm, there was an 85% increase in the use of sleeping pills among children between 2002 and 2004 and about 15% of the children who took sleeping pills were also taking ADHD drugs. Since stimulant drugs cause insomnia, experts say, the sleeping pills are obviously being used to counteract their side effects.
Due to the fact that only between 1% and 10% of all adverse drug reactions are ever reported to the FDA, experts point out that the actual combined number of deaths and serious injuries associated with psychiatric drugs each year is much, much higher than FDA statistics indicate.
Interviews and court and legal documents from Breggin, Menzies, Baughman, Jackson, Hurcomb, and O’Meara.
FDA web site.
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Contact: Vera Hassner Sharav
GlaxoSmithKline, Britain's biggest pharmaceutical company
will change the label in the UK to reflect the severe
withdrawal that its antidepressant drug, Seroxat (Paxil in US)
generates in many patients. In Britain, the package
label will no longer claim that the Seroxat is not addictive.
The change comes as a result of thousands of complaints
received by the BBC following its October documentary on Panorama.
See transcript at:
On May 11 (Mother's Day), the BBC will present a follow-up to
that documentary which elicited phenomenal viewer response.
The BBC said it received 67,000 phone calls and 1,400 emails.
Among the responders to the October expose were families who
reported 16 suicides, 11 of them in the past two years,
that they say have never been reported to the UK Medicines
and Healthcare products Regulatory Agency (MHRA).
The agency said it knows of only seven suicides of people on
Seroxat over the past two years.
In the U.S. the Food and Drug Administration (FDA) acknowledges
that it receives only 1% to 10% reports of adverse drug effects
suffered by patients. Doctors--many of who receive financial
inducements from drug companies, simply don't report adverse drug
When will the FDA act to protect the American public by requiring
drug companies to disclose fully the severe side effects induced
by their drugs? Psychoactive drugs such as the SSRI antidepressants,
the 'atypical' antipsychotics, and the psychostimulants such as,
methylphenidate (Ritalin). To varying degrees they all induce severe
physical and behavioral adverse side effects--including addiction.
The SSRIs and antipsychotics induce extreme restlessness (akathisia)
which leads some people--including children--to become violent.
GPs accused of not reporting Seroxat suicides
Sarah Boseley, health editor
Friday May 9, 2003
At least 16 suicides of people who took the
antidepressant Seroxat have gone unreported by their
doctors in the past few years, it will be revealed
this weekend, raising serious questions about the
monitoring capabilities of the medicines regulator.
Concerns that Seroxat and others in the SSRI
(selective serotonin re-uptake inhibitor) class, such
as Prozac, could tip a minority towards suicide have
been raised for a while.
In the US, two years ago, a jury awarded a family
pounds 4.6m damages after concluding that the drug,
known there as Paxil, caused Donald Schell to kill his
wife, daughter, baby granddaughter and then himself.
The medicines and healthcare products regulatory
agency, part of the Department of Health, collects
reports from doctors on any side-effects or adverse
reactions that might be linked to a prescription
medicine. Neither patients nor their relatives can
fill out a "yellow card" - recording problems - and
not every doctor participates in the scheme as it is
The BBC's Panorama programme Emails from the Edge will
reveal on Sunday that the phenomenal response - 67,000
phone calls and 1,400 emails - to its October
documentary on Seroxat threw up reports of 16
suicides, 11 of them in the past two years, that have
never been reported to the MHRA, as far as relatives
are aware. The agency knows of only seven suicides of
people on Seroxat over the past two years.
"In retrospect, when it is fully conceded that the
drug can cause problems, this is going to look like a
very serious failure," said David Healy, director of
the North Wales department of psychological medicine,
who has taken evidence to the agency linking suicides
to this class of drug.
He added: "Doctors have been getting the mantra from
the drug companies for 12 years that it is the disease
[causing the suicide] and not the drug. It does
provide a nice way out for GPs who just don't want to
contemplate the possibility that a drug they prescribe
could cause death."
One of those who contacted Panorama was Graham Aldred
from Cheshire, whose wife killed herself after 11 days
on Seroxat. Rhona, 53, suffered nightmares and then
began to behave out of character.
In a statement, the MHRA said the safety of
anti-depressants was closely monitored but it would
look at any data from the Panorama study that was made
available to it.
GPs accused of not reporting Seroxat suicides
03.05.2003: Seroxat maker abandons 'no addiction' claim
13.03.2003: Coroner calls for inquiry into Seroxat
27.07.2002: Antidepressant Seroxat tops table of drug withdrawal symptoms
28.04.2002: Seroxat: The real story
28.04.2002: Seroxat: The real story (part two)
10.07.2001: Suicide fear over anti-depressant
A-Z guide to public services and voluntary sector speak
Department of health: mental health
The Royal College of Psychiatrists
Institute of Psychiatry
Copyright © 2003 The Guardian.
Saturday May 10, 2003
Mind is critical of the Medicines and Healthcare products Regulatory Agency
for failing in its duty fully to investigate the extent to which people
experience side effects from Seroxat, including suicides that bereaved
relatives believe are directly linked to the drug (GPs accused, May 9). For
eight years Mind has campaigned for consumer reporting of side effects to
psychiatric drugs. The MHRA is extending the yellow card scheme to the
public through NHS Direct, but this is still too little too late. Whenever
Mind campaigns on the safety of drugs, and the right for patients to be
given full and unbiased information on the potential side effects, we are
criticised by some groups who say we are scare-mongering. Why should we, and
programme makers like Panorama, be silenced, when there is a real issue of
public safety at the heart of our concerns? Millions of pounds are spent
advertising psychiatric drugs, but who has the money to balance these
messages? Panorama has given us, and the many people who have experienced
horrific side effects or lost a loved one, the opportunity to get this issue
the attention it deserves. We understand that many people say they find
Seroxat beneficial, so we are not calling for an all-out ban. We are calling
on the MHRA to stop doctors prescribing it to new patients until they
undertake a full and independent review that includes the experiences of
people taking it.
Chief Executive, Mind
Seroxat maker abandons 'no addiction' claim
Firm agrees to alter leaflet to patients after complaints
Sarah Boseley, health editor
Saturday May 3, 2003
The drug company which makes Seroxat, the antidepressant which thousands of
people say they cannot give up because of severe withdrawal effects, is to
drop the claim on its patient leaflet saying the drug is not addictive.
The admission of a change of policy from GlaxoSmithKline, Britain's biggest
pharmaceutical company, comes in a BBC Panorama programme to be shown on May
Emails from the Edge examines the big response from Seroxat users to its
first investigation, in October, of its withdrawal problems.
Seroxat is a commonly prescribed antidepressant of the SSRI (selective
serotonin re-uptake inhibitor) class, to which Prozac also belongs.
Many people say it has changed their lives by lifting them out of
depression, but some experience distressing side-effects when they try to
reduce the dose and stop taking it. These effects are said to include
sensations comparable to electric shock.
Last July the Guardian revealed that Seroxat topped the league table for
complaints of side-effects made by doctors to the government's committee on
the safety of medicines under the yellow card scheme. A total of 1,281
complaints were filed - more than the combined amount for the rest of the
top 20 most cited drugs.
The watchdog group Social Audit complained at the time about the wording on
the Seroxat patient information leaflet. It states that "these tablets are
not addictive", and that withdrawal problems "are not common and not a sign
Alastair Benbow, head of European clinical psychiatry at GSK, says in the
film that the wording was poorly understood by patients. Yesterday he told
the Guardian that he accepted that the drug, like other medicines, did cause
physiological changes. "It is absolutely right, some people have symptoms
and for some those are very troubling."
But GSK is unlikely to head off the mounting criticism because it intends to
keep the advice issued in a separate information sheet to doctors which says
the drug does not cause dependence.
David Healy, director of the North Wales department of psychological
medicine, has long argued that the company should change its advice to
"If there is withdrawal, then there is physical dependence. There will be
some people who will never be able to halt this drug, there will be some for
whom halting will not be awfully difficult and some for whom it is a real
issue." The SSRIs were not like opiates such as heroin which causes drug
depmcency as opposed to physical dependency, he said. They were more
comparable to the benzodiazepines such as Valium, which is now prescribed
only with great caution because of withdrawal problems.
Charles Medawar, of Social Audit, was not impressed by GSK's move. "My
feeling is that the changes GSK proposes could and should have been made at
least five years ago and will not tell patients anything they don't know.
They are glossing over the reality. This is far too little, too late."
Sarah Venn, of the Seroxat users group which has 4,000 members, said: "We
are pleased to have this news but it doesn't address the information
provided to doctors. It doesn't go anywhere near helping patients who are on
this drug and can't get off it."
Some patients complain of doctors lacking sympathy when told about the
But Dr Benbow said GSK's "feedback" showed doctors did understand what was
meant and he could see no reason to spell out the difference between
"physical dependency" and "drug dependency".
"I think we would start to get into difficulties of definition." He said the
wording of the doctors' leaflet should only be changed "if we think there is
a clear lack of understanding [by] the doctors," he added.
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