Irish watchdog failed
to bark
The Irish Medicines Board is failing to protect public health through its refusal to issue a warning on the dangers of SSRIs to adults as well as children.
Basil Miller investigates
STORY>>
'More therapists,
less drugs'
Tony Blair's health strategy chief wants 10,000 more therapists to avoid needless SSRI prescribing
STORY>>
Profs: SSRIs need suicide warning
Scientists say suicide risk requires warnings for adults
STORY>>
FDA warns on SSRI adult suicide risk
The US regulator has placed 'Black Box' warnings for adults on all SSRIs
STORY>>
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Leading US psychiatrist Peter Breggin has warned that Ireland and Europe should be very careful not to follow the United States into the “hell” of relying entirely on powerful psychoactive drugs to treat psychological problems.
In a thoughtful, wide-ranging interview for wellbeingfoundation.com, Dr Breggin warned that Europe “usually ends up where the United States is in these matters, and where we are is a disaster”. In the US, he said, a growing number of ordinary human difficulties are being labelled as ‘illnesses' and subjected to what he called ‘toxic psychiatry'.
Breggin was keynote speaker at a conference in Dublin on Saturday 21 October on the theme of 'Healing Depression Without Drugs or Electric Shocks'.
The author of ‘Toxic Psychiatry' and other bestsellers addressed the conference in Dublin's Burlington Hotel on the question ‘Is Psychiatry Doing More Harm Than Good?'. Dr Breggin has been a life-long campaigner against psychiatric abuses and ineffective treatments and for patients' rights. He has done an enormous amount to expose the inefficacy of orthodox psychiatric treatment and campaigns tirelessly for the rights of those suffering mental difficulties.
Dr Breggin was joined on the platform by Dr Pat Bracken, clinical director of mental health services in West Cork, himself a wise voice on these matters and a supporter of patients' rights, and by Dr Aine Tubridy and Dr Michael Corry. The day also featured a specially-made documentary film, Soul Interrupted, and a play, Across The Dark Wave, performed by the Open Heart Company, questioning the validity of psychiatry's stance on depression.
Dr Breggin insisted that electro-convulsive therapy (ECT) should be banned outright because of the brain damage it causes to subjects. “ECT makes as much sense as having a horse kick you in the head,” he said. “It injures the brain — it's that simple.”
The biological approach in psychiatry, in tandem with the giant drug companies, had achieved near-total dominance in treatment in the US, he said. The result was that the incidence of many conditions such as depression was increasing and people were not being healed. “Instead they are condemned to take these toxic cocktails of drugs, in many cases for life, with further disability the result and even greater difficulties placed in the way of recovery,” he stated.
The drug companies, he said, are now campaigning to extend the use of their products to general anxiety, sadness, even pre-menstrual tension and other everyday difficulties, and into the child population. He urged the government and health authorities not to put the Irish people in the same situation. “I think you have a wonderful opportunity to rethink the psychiatric approach before it is too late,” he said in the interview for the website of the Wellbeing Foundation, published on Monday, October 9.
“It would be wonderful to see ECT banned in Ireland,” said Dr Breggin. “It's time to turn around this notion that damaging the brain with psychiatric treatment, whether ECT or drugs, is a solution to life's unhappiness, stress, and suffering. We have to completely junk the biomedical model. We have to completely junk using drugs and ECT. We have to get down to the basics of what people struggle with, in terms of a spiritual, philosophical, economic and psychological understanding of every person who comes to us for help.”
A full report of the conference will be posted on www.wellbeingfoundation.com in the coming weeks.
READ INTERVIEW>>
Dublin: 23 October 2006
Birth defects red flag for Seroxat
Australian authorities have warned that pregnant women taking Seroxat (paroxetine, sold in the US and other countries as Paxil) are at double the risk of having a birth defect in their unborn child. The Australian regulatory agency, Therapeutic Goods Administration (TGA — equivalent to the IMB), has reclassified Seroxat from a grade C to a grade D drug , one that should be avoided during pregnancy.
The new warnings for Paxil and other SSRIs are spelled out as follows: "Details from a preliminary analysis of GlaxoSmithKline data showed a higher incidence of congenital malformations, particularly ventricular septal defects, in babies born to women taking the drug. Babies of women taking paroxetine in the first trimester of pregnancy were 2.2 times more likely to be born with a congenital malformation and 2.08 times more likely to have a cardiovascular malformation than those born to women taking other antidepressants, the data showed.
"A second population-based Danish study found a 60% increase in cardiac abnormalities among babies of mothers taking SSRIs."
Reacting to this news, Dr Ann Blake Tracy, director of the International Coalition for Drug Awareness, commented: "Let me remind you that when you hear a warning about one drug in a class of drugs that are designed to work in the same way, do not ever think that just because the drug you are taking is spelled differently and has a different chemical makeup that the result may be different. The thing is, the drug works in the same manner — the end result is the same, not different. And the definition of stupidity is doing the same thing over and over again and expecting a different result.
"Every time I see doctors switch a patient reacting to one SSRI antidepressant to another SSRI, and then another and yet another, as they so often do, I wonder why they think they are going to get a different response. It is insane! So, when you hear a warning on one of these drugs, expect sooner or later to hear similar warnings on the other antidepressants.
"Red flags going up on one of them should be a red flag for the others in the same class that work in a similar way. Paxil (Seroxat) may have raised red flags first because it has a stronger effect on the reuptake of serotonin, but over time you will get the same effect with one not as strong. Because Celexa and Lexapro act even more powerfully on serotonin reuptake that should make them potentially more deadly in producing side effects, yet notice here that the doctor they have interviewed to defend the antidepressants has suggested that these drugs are safer.
"Also, please note that this agency has warned that Effexor should be avoided during pregnancy due to the severe withdrawal symptoms the baby suffers. Other warnings are also listed, about withdrawal symptoms in babies produced by the other antidepressants."
Dr Tracy's final comments relate to the original story in Australian Doctor, First trimester antidepressant risk
Dublin, Ireland: September 19 2005
Blair man: ‘10,000 more therapists'
A prominent adviser to British prime minister Tony Blair says that thousands of people are needlessly on prescriptions for antidepressants due to the lack of trained therapists who could be far more effective in treating depression.
Professor Richard Layer, the Labour peer who wrote the Downing Street strategy paper ‘Mental Health: Britain's biggest social problem?', calls for 10,000 new therapists to be trained to deal with the problem and get people off the drugs. Delivering the inaugural Sainsbury Centre for Mental Health lecture in London on Monday 12 September, Layer said: "The NHS needs 10,000 more people trained to deliver psychological therapies if it is to tackle Britain's biggest social problem. At present there are more mentally ill people on invalidity benefit than the total number of unemployed people. At any one time there are one million people suffering from clinical depression, and another 4 million suffering from clinical anxiety states. For these groups, the depressed and the fearful, there is almost nothing except a few minutes with the GP and some pills."
Layard wants to see a new network of over 250 psychological treatment centres to provide talk therapies such as psychotherapy and cognitive behaviour therapy for a million people a year. According to the NHS, such therapies are "of equal effectiveness to anti-depressants" and should be freely available. "Yet only one in 10 patients got to see a therapist because there are so few available," said Layard. "This leads to unnecessary personal suffering and a huge economic cost, including £10bn a year on incapacity benefits. This is totally unsatisfactory. If people have any persistent physical illness like asthma, blood pressure or skin disease, they automatically see a specialist. But not so if they suffer the torment of mental illness."
Under his plan, the typical psychological treatment centre would have about 20 staff. Half would be clinical psychologists and half therapists, who might be mental health nurses or social workers with two years extra training. The basic course of treatment would provide patients with 10 sessions.
The scheme was unlikely to cost the NHS more than drug treatments in the long run, although there would be substantial training costs in the early years. "The savings to employers and the benefits system would be enormous, measured in hundreds of millions of pounds, if not more," government mental health spokesman Louis Appleby said.
Stories: ‘Mental illness is now our biggest social problem'
Call for more therapists to end Prozac nation
Dublin, Ireland: September 19 2005
Profs: SSRIs need suicide warning
There were seven suicide attempts among people taking Seroxat, compared to one among those given a placebo, in trials covering almost 1,500 patients taking either Seroxat or a placebo, according to new research by four Norwegian scientists. The result was significant even though the number taking Seroxat, 916, was greater than those on placebo, 550, the scientists said.
The data, they wrote, when added to the information from trials of the other drugs of the class, "strongly suggests that the use of SSRIs is connected with increasing intensity of suicidal attempts per year". They say there is a strong case for concluding that there is an increased risk of suicide attempts in adults taking antidepressants.
"The two meta-analyses and our contribution taken together make a strong case for the conclusion, at least with a short time perspective, that adults taking antidepressants have an increased risk of suicide attempts. We also conclude that the recommendation of restrictions on the use of paroxetine for children and adolescents recently conveyed by regulatory agencies should be extended to include usage by adults."
The data was available even before Seroxat was first licensed in 1990, the Norwegian researchers found. The findings are likely to be seized on by lawyers attempting to win damages against the drug's manufacturer, GlaxoSmithKline, in the US and in Britain. The mental health charity Mind said the results were "extremely worrying" and confirmed what it had been arguing for years. "By ignoring what mental health service users themselves have said about the medication and its effects, the drugs regulators may well have caused lives to be lost," said Sophie Corlett, policy director of the charity.
Campaigners, including Mind, say the drug should be withdrawn from sale, but GSK and the Medicines and Healthcare products Regulatory Agency (MHRA) have defended it, arguing that its benefits outweighed the risks. Sales of paroxetine have fallen sharply in Britain in the past three years after concerns about it were highlighted by campaigners. Corlett said: "This study would seem to be an extremely worrying addition to growing evidence raising serious concerns over the safety of paroxetine. Mind's own research has revealed that 50% of the people who contacted us to report a reaction to Seroxat had experienced feelings of wanting to self-harm or commit suicide, and 58% of these people said they had not experienced these feelings before they started taking Seroxat."
[Stories & sources: Drug 'can trigger suicide in adults', Guardian, 22 August 2005]>>
[Seroxat linked to suicide attempts among adults, Independent, 22 August 2005]>>
[Top-selling drug linked to increased suicide risk, Times, 22 August 2005]>>
[Research: Suicide attempts in clinical trials with paroxetine randomised against placebo]>>
[Seroxat and the risk of suicide, UK National Electronic Library for Health, 24 August 2005]>>
[Seroxat Users Group info pack]>>
Dublin, Ireland: September 19 2005
O'Mahony calls for quick action by IMB
Cork nurse Nuria O'Mahony, who has been demanding reform of the medicines regulatory regime in Ireland, and especially for stricter warnings on antidepressants, has welcomed the FDA's action. Demanding immediate action by the Irish Medicines Board and the Department of Health to protect the public, the founder of the Holistic Action Group said in a statement on 3 July that her requests to the IMB and the Minister for Health, Mary Harney, had so far been ignored.
Here's the full text:
"After losing my husband to antidepressant induced suicide in 2003 and obtaining an open verdict during the inquest into his death, I am pleased to welcome the warning released by the FDA on 30 June 2005 including all adults on their antidepressant warning.
I have been campaigning for this kind of warning to be released in Ireland for the last 18 months. After many correspondences with the Irish Medicines Board, the Minister for Health, Mary Harney, and her predecessor Micheál Martin, Opposition members, independent Senators and including the EMEA (the European medicines agency) and European Commission I have been IGNORED and no action has been taken.
"I regret that many people's lives could have been saved if only the regulatory bodies listened to the consumers and it was a bit more critical of the data provided (or not) by the pharmaceuticals and scrutinised this data on the best interest of the patient, not the pharmaceuticals.
"The experience of consumers must be central to a modern system for the licensing and regulation of prescription drugs and that reports of adverse reactions by consumers must be given at least as equal weight by the regulator as the clinical trials data supplied by pharmaceutical companies. The clinical trials data cannot be called scientific if it is not all available for independent scrutiny to support the findings. This is in the best interest of consumers.
"Today I am demanding immediate action to remedy this misconceived, chaotic situation surrounding antidepressants today in Ireland, especially the family of the SSRIs. The recent EMEA warning regarding paroxetine (Seroxat) only goes up to the age of 30, and it does not go as far as their American counterparts have gone, to all adults, suggesting the possibility of an increased risk for suicidal behaviour in adults treated with antidepressant medications.
This kind of warning is necessary to save lives. There are not similar warnings for the rest of the SSRIs regarding the adult population in Ireland.
"The longer it takes for such a warning to be issued in Ireland the longer the Irish people are going to continue to suffer with preventable drug-induced problems that could end up in suicide, as in the case of my husband. It is important for doctors to realise that following the National Institute of Clinical Excellence (NICE) guidelines in the treatment of depression is in the best interest of the patient and it would spare up to 67% of depressed people (on antidepressants) suffering with mild depression from going on these tablets unnecessarily, which causes more harm than good. This is in the best interest of mildly depressed people in Ireland, and it is confirmed in the NICE guidelines which recommend that antidepressants should not be prescribed to mildly depressed patients.
"Suicidal and aggressive adverse effects can happen to anyone who takes these drugs, regardless of the reason for the prescription. For 15 years the pharmaceutical companies have been blaming the patients and the "disease" for the violence and suicides. Doctors and family members must now be made aware that the drug itself can make patients become aggressive and suicidal.
"I call for the appropriate necessary warning to be released in Ireland as soon as possible, in order to save lives."
Nuria O'Mahony
Holistic Action Group (founder)
Nuria O'Mahony's petition for stricter drug regulation
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The FDA announced on 1 July that it has changed its stance on the risk of suicide by people taking SSRIs and other antidepressants. In a surprising reversal of its earlier refusal to admit the possibility that SSRIs (selective serotonin re-uptake inhibitors) can drive adults who take them to suicide or other forms of violent acts, the US health regulator has declared that Patient Information Leaflets (PILs) enclosed with the medication must carry a Black Box warning that suicidality is associated with taking these drugs.
The FDA's announcement is stark: "Several recent scientific publications report the possibility of an increased risk for suicidal behaviour in adults who are being treated with antidepressant medications," it begins. Black Box warnings are strong and serious warnings about the side effects of a drug which are printed in large, bold type and surrounded by a heavy black border — the black box. Used in the US and Canada, there is no equivalent here.
Previously, the only FDA warning in relation to ‘suicidality' — suicidal acts or thoughts — was for patients under the age of 18, so-called paediatric patients. That warning is now extended to the entire population. The FDA has also started a new process of evaluating the drugs for suicide and other health risks, describing it as "a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications".
"It is expected that this review will take a year or longer to complete," the FDA announcement said, adding that "adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased. Adults whose symptoms worsen while being treated with antidepressant drugs, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional."
Drug companies have been asked to hand over all data from trials they have conducted among adults, so that the FDA can evaluate them. Known trial data from among groups of young people indicate that the risk of suicidality among SSRI takers is twice as high as among those given placebos, though placebos worked almost as well as, and in many cases better than, the drugs in terms of improvement in the depression being treated.
At close of business on 4 July, neither the Irish Medicines Board website not that of the British MHRA carried any comment on the FDA's new position, nor any announcement that any change in current advice is contemplated. The European regulatory agency, the EMEA, had no comment or news release on its website either. Depressiondialogues.ie has drawn the IMB's attention to the FDA's announcement and we are awaiting comment.
The FDA's announcement is HERE>>
Not everyone believes the FDA has done enough. Dr Ann Tracy, director of the International Coalition for Drug Awareness and author of Prozac: Panacea or Pandora? Our Serotonin Nightmare, says the FDA's move goes nowhere far enough. SSRIs, she says, are extremely dangerous drugs which create and amplify dangerously aggressive states in the brain and should be banned. Other commentators are equally emphatic that the drugs constitute a health menace.
SEE Dr ANN TRACY'S COMMENTS BELOW
The drugs which are covered by the FDA's latest announcement
US brand name first, followed by Irish/British brand name where applicable, and active ingredient. Each name links to its FDA warning.
Celexa/Cipramil (citalopram)
Cymbalta (duloxetine) A new drug from Eli Lilly
Effexor/ Efexor (venlafaxine)
Lexapro / Cipralex (escitalopram)
Luvox / Faverin (fluvoxamine)
Paxil / Seroxat (paroxetine)
Prozac / Prozac (fluoxetine)
Remeron / Zisprin (mirtazapine)
Serzone (nefazodone)
Wellbutrin (bupropion)
Dr Ann Tracy says the SSRIs are dangerous drugs which should be banned
On Friday, July 1, 2005, the FDA issued strong warnings about the dangers of antidepressants and increased risk of suicide. But we need to ask if their warning has gone quite far enough and how many have needlessly lost their lives to these drug in the interim due to the lack of any warning? By way of introduction I am Ann Blake Tracy, PhD, executive director of the International Coalition for Drug Awareness. I am the author of Prozac: Panacea or Pandora? Our Serotonin Nightmare. The last 15 years of my life have been devoted full time to researching and writing about SSRI antidepressants. For 13 1/2 years I have testified and consulted as an expert witness in cases involving antidepressants. Some of the more high profile cases being: comedian Phil Hartman's murder/suicide, Columbine, Red Lake and other school shootings, the Atlanta Day Trader shooting and many other workplace violence incidents in which antidepressants were involved. In September of 1991 and again in February and September of 2004 I testified before the FDA Advisory Committee on this issue.
The simple fact is that when LSD goes into the brain it mimics the neurotransmitter serotonin. Antidepressants work by impairing one's ability to metabolise serotonin so that over time the level of serotonin begins to rise. So why are we surprised when we see those on antidepressants doing things we would expect to see from someone on LSD?
For many decades now medical research has shown that impairing serotonin metabolism will produce migraines, hot flashes, pains around the heart, difficulty breathing, a worsening of bronchial complaints, tension and anxiety which appear from out of nowhere, depression, suicide - especially very violent suicide, hostility, violent crime, arson, substance abuse, psychosis, mania, organic brain disease, autism, anorexia, reckless driving, Alzheimer's, impulsive behavior with no concern for punishment, and argumentative behavior.
How anyone ever thought it would be "therapeutic" to chemically induce these reactions is beyond me. Yet, these reactions are exactly what we have witnessed in our society over the past two decades as a result of the widespread use of these drugs. Why does the FDA expect us to wait until "more definitive information" than what we already have "becomes available?"
Can you remember when over two decades ago depressed people used to slip away quietly to kill themselves rather than killing everyone around them and then themselves as they do while taking SSRI antidepressants?
A study out of the University of Southern California in 1996 looked at a group of mutant mice in an experiment that had gone terribly wrong. These genetically engineered mice were the most violent creatures they had ever witnessed. They were born lacking the MAO-A enzyme which metabolizes serotonin. As a result their brains were awash in serotonin. This excess serotonin is what the researchers determined was the cause for this extreme violence. Antidepressants produce the same end result as they inhibit the metabolism of serotonin.
These are extremely dangerous drugs that should be banned as similar drugs have been banned in the past. They should be placed in the same classification as PCP, a dissociative anesthetic.
As a society we once thought LSD and PCP to be miracle medications with large margins of safety in humans. We have never seen drugs so similar to LSD and PCP as these SSRI antidepressants. All of these drugs produce dreaming during periods of wakefulness. It is believed that the high serotonin levels over stimulate the brain stem leading to a lack of muscle paralysis during the sleep state thus allowing the patient to act out the dreams or nightmares they are having. The world witnessed that clearly in the Zoloft-induced murder-suicide of comedian Phil Hartman and his wife, Brynn. (And for those who may not be aware, the wrongful death suit for their parents was settled by Pfizer on behalf of Sean and Birgen Hartman.)
Connecticut witnessed the Prozac-induced case of Kelly Silk several years ago. This young mother attacked her family with a knife, then set the house on fire killing all but her 8 year old daughter who ran to the neighbors. As she stood bleeding and screaming for help she explained, "Help! My mommy is having a nightmare!"
Out of the mouths of babes we will understand these nightmares for what they are. She understood that this was something her mother would do ONLY in a nightmare, never in reality.
This is known as a REM Sleep Behaviour Disorder. In the past it was known mainly as a drug withdrawal state, but the largest sleep facility in the country has reported that 86% of the cases they are diagnosing are patients currently taking antidepressants.
Because this was known in the past as a condition manifesting mainly in drug withdrawal you can see how dangerous the withdrawal state from these drugs will prove to be. That is why it is so critical to make sure patients are weaned EXTREMELY slowly so as to avoid ANY chance of going into a withdrawal state.
For additional information go to www.drugawareness.org .
Below, for your information, is the FDA testimony of Mark Taylor, the first boy shot at Columbine, given in September, 2004.
Mark Taylor's testimony
September 13, 2004 to the FDA
(First boy shot at Columbine High School)
I am Mark Allen Taylor and I am a victim of the SSRI antidepressant era. I took six to thirteen bullets in the heart area in the Columbine High School shooting when Eric Harris, on Luvox, opened fire that now infamous day.
They almost had to amputate my leg and my arm. My heart missed by only one millimetre. I had three surgeries. Five years later I am still recuperating. I went through all this to realize that SSRI antidepressants are dangerous for those who take them and for all those who associate with those who take them.
I hope that my testimony today shows you that you need to take action immediately before more innocent people like me, and you, do not get hurt or die horrible deaths as a result.
As Americans we should have the right to feel safe and if you were doing your job we would be safe. Why are we worrying about terrorists in other countries when the pharmaceutical companies have proven to be our biggest terrorists by releasing these drugs on an unsuspecting public?
How are we supposed to feel safe at school, at home, on the street, at church or anywhere else if we cannot trust the FDA to do what we are paying you to do? Where were you when I and all of my classmates got shot at Columbine?
You say that antidepressants are effective. So why did they not help Eric Harris before he shot me? According to Eric they "helped" him to feel homicidal and suicidal after only six weeks on Zoloft. And then he said that dropping off Luvox cold turkey would help him "fuel the rage" he needed to shoot everyone. But he continued on Luvox and shot us all anyway.
So, why did these so called antidepressants not make him better? I will tell you why. It is because they do not work.
We should consider antidepressants to be accomplices to murder.
Dublin, Ireland: July 4, 2005
