Death By Paxil @ Euchred

 
PSYCHIATRIC FASCISM

For almost 150 years, psychiatry has been masquerading as a medical science and as a branch of medicine.  It is not and never was a science or a type of health care.  Modern psychiatry is driven by unproved empirical assumptions, medical biases, and pseudo-scientific opinions.  There are no scientifically established, independently proven facts in psychiatry.  Psychiatry, in fact, has no laws or testable hypotheses and no coherent and comprehensive theory.  Psychiatry conspicuously lacks scientific proof or evidence to support its news-media-parroted claims of “mental illness” or “disorders”.

After about seventy years of psychiatric practices and research, there is still no diagnostic test for schizophrenia or any of the other three hundred so-called mental disorders listed in the current edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is essentially a list of class-driven moral judgements of allegedly abnormal behaviour, published and propagandized by the American Psychiatric Association.  The DSM is the official bible of organized psychiatry.  The DSM is the equivalent of the Malleus Maleficarum in the middle ages, which Spanish inquisitors used to identify, target, stigmatize and burn witches and heretics.  Today’s witches, heretics, and scapegoats are labeled mentally ill or schizophrenic.

Hospital psychiatry with its emphasis on the control of inmate behaviour through high risk behaviour modification programs, biological “treatments”, physical and mechanical restraints, locked doors and wards, and seclusion/isolation rooms, have always exhibited several fascist elements.  I want to focus on three: fear, force and fraud.  These are the guiding principles and policies used to control citizens and groups in the population whom government leaders and other authorities, including the police and so-called mental health experts, have judged to be dissident, problematic or difficult to control.  Hospital psychiatry is very similar to the prison system.  In the prison or correctional system psychiatrists have been used as consultants to design dangerous, unethical behaviour modification programs and to conduct high risk drug experiments on prisoners.  Both the psychiatric system and the prison system systematically use fear, force and fraud for the purpose of social control and punishment - not for purposes of treatment or rehabilitation, both of which are euphemisms.  It is or should be obvious that forced treatment is in fact punishment.  It is frequently cruel and usual and should therefore be banned in the United States under that nation’s Eighth constitutional amendment.  Virtually all treatments in psychiatric facilities are forced or administered without informed consent.  They are administered against the “patient’s” (the prisoner’s) will or with consent obtained by threatening the “patient” with worse consequences, or with consent obtained by keeping the “patient” unaware of important information about serious risks and alternatives.  Informed consent in psychiatry is a cruel sham.  It doesn’t exist.

Fear/Terror - “Terror acts powerfully upon the body through the medium of the mind and should be employed in the cure of madness.  Fear accompanied with pain and the sense of shame has sometimes cured the disease”.  That was written almost two centuries ago in 1818 by Dr. Benjamin Rush, father of American psychiatry, and the first president of the APA, whose face still appears on the official seal of the American Psychiatric Association.  Dr. Rush advocated and practiced terror by designing and using the straitjacket, the tranquilizer chair and “fear of death” on numerous inmates in 19th century lunatic asylums.  Rush once had his son locked up in an insane asylum - some father!

Fear is a powerful motivator in enforcing conformity, obedience and making people submit to authority.  Historically, inducing and manipulating fear or masked terror has always been a key policy and practice in all fascist regimes, such as Italy under Mussolini, Nazi Germany under Hitler, and the Soviet Union under Stalin - in fact, under any dictatorship.  The threat of punishment, torture and the threat of being killed is enough to cause fear, panic, and terror if most of us.  We do as we’re told or else.

As used in psychiatry, fear or terror is more selective but is widespread and powerful.  In the institution, psychiatry frequently resorts to blackmail to control the more “uncontrollable” and difficult or non-compliant patient.  Psychiatrists and other therapists threaten their patients with longer incarceration, higher doses of forced neuroleptics or “antidepressants”, and/or threatened transfers to more severe maximum security institutions if they misbehave, fail to follow doctors’ orders, refuse to take their “medication”, refuse to follow institutional rules, or annoy their captors in other ways.  Generally aimed at captive populations of involuntary patients, these threats typically strike fear in many of them, and psychiatrists know it.  For example, some years ago, several patients and former patients of Queen Street Mental Health Centre, Toronto’s notorious mental hospital or psycho-prison, told me and other activist-critics that psychiatrists have threatened, if they didn’t calm down or control themselves, to transfer them to Penetang, the Oakridge division of Penetanguishene Mental Health Centre, a maximum security behaviour modification facility in Ontario, known for its harsh and brutal environment.  Penetang was and still is recognized as punishment, one of the most barbaric psycho-prisons in Canada.  It should have been shut down years ago, especially after a scathing report about many of its abuses by psychiatrist Steven Harper.

Threatening patients with physical restraints or solitary confinement is also extremely effective in arousing fear or panic in patients.  On virtually every psychiatric ward or unit, there is a place, euphemistically called “The Quiet Room”, a barren and forbidden cell-like room, with a mattress or sink, usually no toilet or blankets.  While languishing the quiet room, patients are sometimes further restrained by leather cuffs, two-point and four-point restraints, tightly wrapped around their wrists and/or ankles so they can barely move, for hours at a time.  The mere threat of loss of freedom, involuntary committal, or being locked up in a psychiatric ward or institution against your will, and without any trial or public hearing, is enough to frighten most of us.  In virtually every province and territory in Canada, these are the main criteria or reasons for being locked up or committed to a psychiatric institution: judgement of mental illness or disorder; judgement of threatening to physically hurt yourself or another person; judgement of being unable to look after yourself.  Note that these criteria are subjective moral judgements of dissident behaviour based on observation and opinion, not medical or scientific facts.  Despite the fact that mental illness or mental disorder, which in my opinion is a metaphor for dissidence, has never been officially classified as a medical disease or illness, only physicians are legally authorized to make these non-medical and fateful judgements.

In Ontario, any doctor can sign a committal form which forces an individual to be locked up in any psychiatric facility for the first 72 hours for observation and assessment.  Two other doctors can sign a form authorizing an individual’s imprisonment for another 2-4 weeks.  During the last few years, approximately 50% of thousands of people treated in Ontario’s nine psychiatric hospitals were involuntarily committed.

The threat or fact of losing your freedom being locked up in a psychiatric facility for days or months at a time is terrifying.  The minimal or non-existent advocacy currently provided in Ontario makes the right to appeal or protest a sham, and this serves to heighten people’s fear and despair.  The mere threat of forced psychiatric treatment as well as the treatment itself can be terrorizing - e.g., electroshock, also called electro-convulsive therapy (ECT), but more accurately called electro-convulsive brainwashing by shock survivor critics such as Leonard Frank.  My close friend Mel told me of being dragged by several aids along the hallway to a hospital shockroom.  I can imagine his terror and the terror of others who suffered the same fate.  I suffered a similar terror when I was forcibly subjected to over 50 subcoma insulin shocks in the 1950s.  To the surprise of many people, this barbaric brain-damaging and memory destroying treatment not only exists, but is expanding in Canada and the United States.  Its main targets are women and the elderly, particularly elderly women.

There is also the threat of psychiatric drugs, euphemistically called “medication”.  These chemicals such as minor tranquilizers, antidepressants and the anti-psychotics such as Haldol, Modicate, Thorazine, and the so-called mood modifier Lithium, are not natural substances but are manufactured poisons, aptly called neurotoxins by psychiatrist and psychiatry critic Peter Breggin in several of his books and Joseph Glenmullen, a clinical instructor in psychiatry at Harvard Medical School, in his book Prozac Backlash.  These chemicals have no scientifically proven medical value or benefit.  What they do is control or subdue any problematic or disturbing behaviour, mood and emotion.  These toxins, particularly neuroleptics like Haldol, Modicate, Chlorpromazine, are so disabling, powerful and fearsome that many psychiatric survivors and other critics call them chemical lobotomies or chemical straitjackets.  These drugs have many serious and disabling effects, called “side effects” to minimize how they are perceived, such as trembling, uncontrollable shaking or movement of the hands or other parts of the body (which occur in the neurological disorder such as Parkinsonism or tardive dyskenisia), powerful muscular cramps, blurred vision, restless pacing, nightmares, sudden outbursts of anger, agitation, memory loss, fainting, blood disorders, seizures, and sudden death.  These so-called side effects are the drugs’ intended effects.  This fear of psychiatric drugs is compounded by ignorance and uncertainty, because psychiatrists and other doctors fail to inform patients of the drugs’ horrific effects.

Without the use or threat of force, fascism could not exist.  Machiavelli, Mussolini, Hitler knew this.  All dictators, would-be dictators, and bullies know this basic fact.  And this is the case with psychiatry.  Without the use and threat of force, institutional psychiatry would die.  Lots of psychiatrists would be out of a job.  I wish that would happen! Psychiatry gets its authority and power to force, imprison, involuntarily commit, and treat individuals against their will from the state.

Mental health legislation gives psychiatrists and other physicians the power to involuntarily commit any person they “believe”, after only minutes of examination, to be dangerous to themselves or others.  This is problematic.  The Mental Health Act wrongly assumes that doctors can predict dangerous and violent behaviour, which they cannot do.  It is worth emphasizing that Ontario’s Mental Health Act, as with other mental health acts across Canada and the United States, legally sanction the state to use force to detain or imprison people for days, weeks or months at a time.  Unfortunately, there has never been a public outcry or protest over the fact that people judged or assumed to be crazy or dangerous, but not charged with any crime, can nevertheless be locked up without a trial or the legal rights accorded to people charged with crimes such as murder or rape.  This is prevention detention, which is illegal in Canada and other so-called democratic countries, but it is legal and a common practice in all police states and totalitarian countries.  I know of no lawsuit challenge to involuntary committal as preventive detention and therefore as unconstitutional.

In institutional psychiatry in fascist states, forced treatment is the rule, not the exception.  Forced treatment and tortuous terminal medical experiments inflicted on thousands of Jews, gypsies, political prisoners, women and children, were carried out in death camps during World War II throughout Nazi Germany.  There is now irrefutable, documentary evidence that it was the German psychiatrists, particularly prominent professors of psychiatry, and psychiatry department heads, who were chiefly responsible for initiating and administering the infamous T4 program, which involved the mass murder of over 200,000 mental patients and thousands of sick and disabled children and adults during the holocaust.  The term euthanasia and mercy death to describe this murderous program is a cruel euphemism.

Much of biological psychiatry, which is largely based on unproved assumptions about the biological and genetic causes of schizophrenia and other mental disorders, can be traced back to the racist, eugenics-driven psychiatrist in Nazi Germany, Ernst Rudin, who propagated the myth that schizophrenia is a genetic disease.  He, along with hundreds of other psychiatrists in the T4 program of mass murder of psychiatric patients, is still cited in some psychiatric journal articles, as documented by researcher-activist Lenny Lapon in his brilliant book, Mass Murderers in White Coats: Psychiatric Genocide in Nazi Germany.  He states that several German psychiatrists from the Nazi era emigrated to the United States and Canada and succeeded in indoctrinating many of his colleagues in his biological, genetic and racist theories of mental illness.  Heinz Layman who emigrated to Canada in 1937, is chiefly responsible for introducing Thorazine or Chlorpromazine, and propagated the use of psychiatric drugs in Canada.

We now have an epidemic of brain damage caused by psychiatric drugs, partly due to Layman and all the other doctors he taught.  In one 1954 journal article, Layman admitted that Thorazine was a “pharmacological substitute for lobotomy”.  Despite publicly acknowledging this alarming fact, it never stopped Layman from using it on many “schizophrenic” patients in Montreal’s Douglas Hospital.  Layman also persuaded Ewen Cameron to administer chlorpromazine and many other drugs and massive amounts of electroshock.  Chlorpromazine, considered an experimental drug at the time, was widely used on many patients during Cameron’s infamous brainwashing experiments at the Allan Memorial Institute in the 1950s and 1960s.

There was no informed consent then, and there is none now.  During the Nazi years, the doctors didn’t seek permission.  According to Nazi ideology, these were “useless eaters”, “subhumans”.  This is a mindset that still rules in biological psychiatry throughout North America.  Another legacy of psychiatry in Nazi Germany is the widespread acceptance and justification of abuse to break the will of non-compliant or rebellious patients.  Physical or mechanical restraints such as straps, ropes, belts, handcuffs and solitary confinement are used in psychiatric institutions not to treat or protect but to punish people for dissident or rebellious behaviour.  It is this naked display of force and threats against patients by hospital staff which resembles the awesome brutality of German psychiatric staff during the holocaust.

Fraud: A very apt quote by Leonard Roy Frank, author of Influencing Minds is “Mystification is psychiatry’s defense against the danger of being found out”.  Many of the labels or diagnoses used by psychiatrists do not refer to real psychiatric problems or to actual illnesses.  Psychiatry professor Thomas Szasz has exposed the fraud and the myth of the concept of mental illness in many books, starting with his classic The Myth of Mental Illness.  This misrepresentation one of the greatest scientific scandals in our scientific age.  The code words that are now used in biological psychiatry such as anti-depressants do not assist people with overcoming depression or get at the causes of depression.  The term “Quiet Room” is a fraudulent code for solitary confinement.  The word “medication” is also a misleading euphemism and misrepresentation for toxic substances to which many of us have been subjected.

I’ve tried to show that institutional, coercive psychiatry has a fascist history and that biological psychiatry as practiced today in psychiatric facilities in Canada and the United States is still based on fear, force and fraud.  Psychiatry does not deserve public or government support.  We must work to abolish psychiatry.  We must also continue working to create self-help advocacy groups, more drop-in centers, and more affordable, supportive housing in our communities.  We need to create our own alternatives to the monstrous and evil mental health system.  By doing this, we empower ourselves.  This is our work, our challenge, and our hope.

Dear Sirs/Madam,
 
I have taken the unusual step in copying in both your CEO, Kent Woods and your Head of Pharmacovigilance Risk Management, Sarah Morgan. I have also blind copied interested parties in on this particular request as I feel any response you may give may put their minds at ease that we are being protected from harmful drugs.
 
What I am about to present to you is something that you may or may not already be aware of. If you are already aware then I would find it very strange as to why no public announcement has been made by the MHRA regarding the issue I am about to present to you.
 
This is more applicable to Sarah as she is the Head of Pharmacovigilance Risk Management and, as such, the responsibility falls, in the main, on her shoulders, for alerting the powers that be and, to an extent, the British public about serious matters that may arise regarding prescription drugs that may be harmful to a populous of those taking them [however small that populous may be]
 
Attached is a study ‘ Polymorphisms in the CYP 2D6 Gene: Association with Plasma Concentrations of Fluoxetine and Paroxetine’, by Corinne Charlier, PhD, Franck Broly, PhD, Michel Lhermitte, Emmanuel Pinto, Marc Ansseau, and Guy Plomteux.
 
Sarah will be in a much better position than I, and probably to anyone else at the MHRA, to offer her evaluation of the study.
 
I have met with both Sarah and Kent at a meeting last September where the issue of SSRi withdrawal was discussed. As yet, nothing has materialised from that meeting with regard to informing doctors, the BNF and to arrange a meeting with Dr. David Healy. I know these things take time but as each hour passes more and more consumers of these products are going through needless suffering. I am in no position to speed up the process, that, ladies and gentlemen, lays solely on you.
 
I digress.
 
As you will see from the attached PDF, there is a far more serious problem that needs to be brought to the table and addressed immediately.
 
The paper throws light on what happens to patients when they are prescribed a dose over 20mg of paroxetine. It’s a given that anything over 20mg of paroxetine is not beneficial to a patient, yet we all know that this is still happening throughout the UK.
 
Please correct me if I am wrong with the following:
 
Paroxetine uses a liver enzyme called 2D6 – to reduce the drug so that the body can clear it. If drugs are  not cleared properly – with each dose taken the drug concentration in the blood will continue to increase to toxic levels. The thing that makes paroxetine quite unique and unsafe is that whilst it needs this 2D6 enzyme for metabolic reduction and clearance – it also acts as a inhibitor of production of the enzyme, basically, it shuts down the livers ability to produce the enzyme so that it cannot further metabolise the drug.
 
I take it that we all agree that there is no further clinical benefit in doses above 20 mg of paroxetine – there is also much greater increase for adverse reactions as the body cannot deal with or eliminate this increase in paroxetine drug quickly enough. For people who already have a genetic deficiency in production of 2D6 (about 8-10% of the white population)  i.e.; their liver cannot/does not produce the enzyme – the drug is basically a death sentence for 8-10% of the white population.
 
 
My question to you all is thus:
 
What do the MHRA plan to do to warn people?
 
Regards

12 RECENT SCHOOL/TEEN SHOOTERS UNDER THE INFLUENCE OF

PSYCHIATRIC DRUGS

Resulting in 54 Killed

And 105 Wounded

* Dekalb, Illinois – February 14, 2008: 27-year-old Steven Kazmierczak shot and

killed five people and wounded 16 others before killing himself in a Northern

Illinois University auditorium. According to his girlfriend, he had recently been

taking Prozac, Xanax and Ambien. Toxicology results showed that he still had

trace amount of Xanax in his system.

* Omaha, Nebraska – December 5, 2007: 19-year-old Robert Hawkins killed

eight people and wounded five before committing suicide in an Omaha mall.

Hawkins’ friend told CNN that the gunman was on antidepressants, and autopsy

results confirmed he was under the influence of the “anti-anxiety” drug Valium.

* Jokela, Finland – November 7, 2007: 18-year-old Finnish gunman Pekka-Eric

Auvinen had been taking antidepressants before he killed eight people and

wounded a dozen more at Jokela High School in southern Finland, then

committed suicide.

* Cleveland, Ohio – October 10, 2007: 14-year-old Asa Coon stormed through

his school with a gun in each hand, shooting and wounding four before taking

his own life. Court records show Coon had been placed on the antidepressant

Trazodone.

* Blacksburg, Virginia – April 16, 2007: The psychiatric drug history of Seung-Hui

Cho in the Virginia Tech Massacre was never made public. Initial reports stated

that “depression medication” was found among Cho’s belongings. But neither

his toxicology reports, nor his recent medical history were ever released to find

out whether Cho had been in withdrawal from psychiatric medication. (33 were

killed and 29 injured, but this was not included in the total of dead and wounded

cited above.)

* Red Lake, Minnesota – March 2005: 16-year-old Jeff Weise, on Prozac, shot

and killed his grandparents, then went to his school on the Red Lake Indian

Reservation where he shot dead 7 students and a teacher, and wounded 7

before killing himself.

* Greenbush, New York – February 2004: 16-year-old Jon Romano strolled into

his high school in east Greenbush and opened fire with a shotgun. Special

education teacher Michael Bennett was hit in the leg. Romano had been taking

“medication for depression”.

* El Cajon, California – March 22, 2001: 18-year-old Jason Hoffman, on the

antidepressants Celexa and Effexor, opened fire on his classmates, wounding

three students and two teachers at Granite Hills High School.

* Williamsport, Pennsylvania – March 7, 2000: 14-year-old Elizabeth Bush was

taking the antidepressant Prozac when she shot at fellow students, wounding

one.

* Conyers, Georgia – May 20, 1999: 15-year-old T.J. Solomon was being treated

with antidepressants when he opened fire on and wounded six of his classmates.

* Columbine, Colorado – April 20, 1999: 18-year-old Eric Harris and his

accomplice, Dylan Klebold, killed 12 students and a teacher and wounded 26

others before killing themselves. Harris was on the antidepressant Luvox.

Klebold’s autopsy reports were never released.

* Notus, Idaho – April 16, 1999: 15-year-old Shawn Cooper fired two shotgun

rounds in his school, narrowly missing students. He was taking a prescribed

SSRI antidepressant and Ritalin.

* Springfield, Oregon – May 21, 1998: 15-year-old Kip Kinkel murdered his

parents and then proceeded to school where he opened fire on students in the

cafeteria, killing two and wounding 22. Kinkel had been taking the

antidepressant Prozac.

“Gardasil had three times the number of Emergency Room visits - more than 5,000. Reports of side effects were up to 30 times higher with Gardasil”

CBS) There are new concerns about Gardasil, the vaccine that prevents a virus that caused cervical cancer. It’s approved for girls as young as nine. And five million have received it since it was approved two years ago. The FDA and its maker insist it’s safe. But CBS News investigative correspondent Sharyl Attkisson has exclusive information on some very serious side effects.

Read More Here

http://fiddaman.blogspot.com/2009/02/new-worries-about-gardasil-safety.html

Major Reality Check

When the pain reliever Vioxx was withdrawn from the market last fall after the announcement that it increased patients’ risk of heart attacks and strokes, millions of Americans panicked. The sometimes-sensationalized headlines didn’t help: People wondered, Should I trust my doctor? Could a medication that I thought would help me actually kill me? Is our drug safety system broken?

Suddenly, ads for the drug were replaced with ads looking for Vioxx “victims.” Law firms across the nation began recruiting anyone who had ever taken the drug as plaintiffs for class-action suits. Merck, the company that developed the drug, could be liable for billions of dollars, making it one of the costliest liability cases ever. No surprise, then, that Merck’s stock plummeted 40 percent in just six weeks.

But the real cost was even greater: Not only did patients stop taking Vioxx but, doctors say, many people stopped taking their other medicines, too — sometimes putting their health at serious risk.

Vioxx was the first pebble in the pharmaceutical rock slide. Soon, accusations about a spate of other drugs were making headlines, including all COX-2 inhibitors which, like Vioxx, relieve pain. The charges didn’t stop there. The FDA was accused of simply rubber-stamping new drugs; drug companies were blamed for hiding information about unsafe products; and the efficacy of clinical trials that did not reveal how large numbers of people would react was questioned. But one question that was rarely asked could determine whether or not pharmaceutical companies continue to develop and produce breakthrough medications that can save or extend lives and help people live without pain. The question: Do Americans expect drugs to be risk-free? And, if someone suffers a bad reaction, will lawyers rather than doctors be the first people we call?

Panic Over Pills: Overreaction?
During the ten-year period between 1994 and 2004, the FDA approved 321 completely new drugs (this doesn’t include approvals for changes to existing medicines), bringing the total to more than 10,000 drug products on the market. During that same period, eight drugs were withdrawn for reasons of safety, such as the diet drug fenfluramine (fen-phen, associated with heart-valve disease) and the allergy drug Seldane (linked to heart arrhythmias). But the Vioxx recall created a shock wave for the American consumer like no other. Many people had come to depend on their “meds,” and they expected them to be safe, too, especially when they cost so much. Prescription drugs account for, some say, the fastest growing segment (about one-tenth) of all health expenditures, with some specialty drugs costing hundreds of dollars per dose.

“With Vioxx, the real shock and outrage came when there was a suggestion that people in authority may have known about these harmful side effects and not shared them with doctors or the public,” says Anne Woodbury, chief health advocate for the Center for Health Transformation, a think tank founded by Newt Gingrich. It made people question their faith in the pharmaceutical industry, federal regulators and physicians: those we trust to make sure our drugs are safe. Before, taking a newly prescribed pill with a slug of water was as routine as brushing your teeth. For many people, this is no longer the case.

“Now patients and doctors are going to ask themselves: Could this new drug be another Vioxx?,” says Jerry Avorn, MD, a professor of medicine at Harvard Medical School and the author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.

People have reason to worry. In clinical trial data submitted to the FDA, Vioxx showed no connection to heart problems. The drug was approved in May 1999. But after Vioxx hit the market and grew in popularity, heart problems were revealed — lots of them. Tens of thousands of people may have been affected, and Merck was accused of hiding that information.

“The system is not perfect,” comments Marianne J. Legato, MD, professor of clinical medicine at Columbia University College of Physicians and Surgeons in New York City. “Sometimes a company may not want to show data that are negative till they really know what’s going on. But it’s ridiculous to suggest that they would suppress things willy-nilly, because if a drug is going to cause severe side effects, it’s not in their best interest to hide that.”

Read more

http://www.rd.com/your-america-inspiring-people-and-stories/the-safety-of-prescription-drugs/article28463.html

Another great article found in Readers Digest.

A doctor blows the whistle on a dangerous new drug that wrongfully received FDA approval.

The well-dressed woman in the waiting room was yellow, recalls John Hanson, MD — a clear sign of jaundice. That was puzzling: One month earlier, in March 2005, Vivienne Wardley (not her real name), 51, had been in excellent shape except for a cold. A health-conscious woman, Wardley avoided prescription drugs and drank moderately. But tests showed that she needed an emergency liver transplant. And when Dr. Hanson, a gastroenterologist in Charlotte, North Carolina, examined her liver, he was startled. It was only a third of its normal size and showed massive tissue death.
What could have attacked Wardley’s liver so quickly? The doctor remembered another patient his partner had treated in February. Usually healthy, Ramiro Pulquero, 26, walked into the Carolinas Medical Center in Charlotte jaundiced, feverish and vomiting blood. He died three days later. The autopsy showed that his liver, like Wardley’s, had suffered tissue death.

Dr. Hanson soon learned that both patients had taken Ketek, a new antibiotic, for their minor respiratory infections. Strangely, they’d been on the pills for just five days before their livers failed. At that same hospital, another patient suffered liver damage after three days on Ketek; luckily, he recovered after stopping the drug.

Wanting to sound the alarm, Dr. Hanson and his colleagues published an online report in January 2006 in the Annals of Internal Medicine, a journal widely read by physicians. Dr. Hanson’s phone started ringing the moment the story appeared. Most callers were doctors who’d seen similar cases. Another call was from the FDA: David Ross, MD, a medical reviewer who had tried, unsuccessfully, to stop Ketek’s approval. “I thought there was a problem with this,” he told Dr. Hanson. “I’m really glad you wrote this paper.”

Dr. Ross knew something that Dr. Hanson didn’t. “The company submitted fabricated data, the FDA knew it, and they approved the drug anyway,” Dr. Ross says. Many of the patients in Ketek’s clinical trial, in fact, didn’t exist — a point an FDA higher-up had ordered him not to tell the agency panel that was considering whether to approve the drug.

“I don’t believe spending time on these issues in front of the advisory committee will be productive,” the supervisor wrote in a January 2003 e-mail.

The “issues” were mind-boggling. The physician who enrolled the most patients in the study, an Alabama weight-loss doctor, allegedly forged scores of signatures, enrolling “volunteers” every few minutes.

By the time of the FDA review, she was under criminal investigation. (She’s now in federal prison.) Another key researcher had been put on probation by the California medical board for gross negligence. He was arrested shortly after the study ended, when police, called to his home on a domestic violence complaint, found him with a bag of cocaine and waving a loaded gun at imaginary people. The study was so riddled with fraud and error that FDA reviewers decided it was useless.

Yet Dr. Ross says he was told to divulge nothing about those problems to the advisory board, which recommended that the drug be approved. Later, he says, he was pressured to soften his report about Ketek’s liver toxicity to give higher-ups, as he was told, “wiggle room” to okay it.

Six million Americans have now used the drug, including hundreds of infants in a clinical trial designed to test Ketek’s effectiveness against ear infections. “How does one justify balancing the risk of fatal liver failure against one day less of ear pain?” one FDA scientist, Rosemary Johann-Liang, MD, protested — to no avail — in a memo to her superiors. Most ear infections clear up in a few days on their own, she says.

The agency says the controversy is overblown. “There was enough good, solid scientific data to make that decision,” says FDA spokeswoman Julie Zawisza, pointing to what appeared to be a history of safe use of Ketek in other countries. Ketek has now been linked to 18 deaths and at least 134 cases of liver damage, according to an independent analysis using FDA data. The real toll, some researchers say, may be far greater.

In December 2006, after Dr. Ross stood up at an FDA advisory board hearing and told an astonished audience about the saga of the drug, the panel urged the agency to strictly limit its use. Last February, one day before a Congressional committee began probing the FDA’s handling of Ketek, agency officials abruptly rescinded its use for bronchitis and sinusitis and placed a strong “black box” warning on its label. By that point, Ketek’s maker, Sanofi-Aventis, had already suspended its study on ear infections.

Last October the FDA sent a warning letter to Sanofi-Aventis, accusing the company of knowingly presenting compromised data to the agency, a charge the company denies. “We were not aware of the fraud,” says spokeswoman Melissa Feltmann. “It was not until the FDA’s criminal investigators uncovered it that we became aware of it.”

The question remains, What did the FDA and the drugmaker know about the fake safety data, and when?

Congressmen John Dingell and Bart Stupak, both Michigan Democrats, are investigating that mystery right now in Congressional hearings.

Luckily, Vivienne Wardley recovered. But “unfortunately,” Stupak says, “the truth comes too late for some victims.”

What You Can Do

• Don’t give up on medical research.
“Never before have we had so many scientific advances that need to be evaluated,” says John Gallin, MD, director of the National Institutes of Health Clinical Center in Bethesda, Maryland. But there’s a serious shortage of volunteers to help test the potential breakthroughs in the more than 50,000 clinical trials currently under way around the world. Some studies do come with risks; others don’t. Many volunteers say they see enrolling in a clinical trial as a kind of civic duty — with the potential to do good for all mankind.

• Be wary of new drugs.
All medicines come with risks. When a doctor prescribes one, he’s making a judgment call that its benefits outweigh its dangers. But with newly approved drugs, the risks are not always well understood at first. That’s why Drummond Rennie, MD, of the University of California, San Francisco, advises sticking to meds that have been on the market for at least four or five years: “I never, ever take a new drug.

I want to see reports on the toxic effects after many thousands of people have taken it.” The exception: A patient with a life-threatening condition may be more willing to accept risks. Check your meds at medlineplus.gov.

• Report your side effects.
As a consumer, you can (and should) report adverse reactions to drugs and medical devices directly to the FDA. You can submit a form online at www.fda.gov/medwatch or call 800-FDA-1088.

• Pony up.
Urge your representatives to support increased funding for the FDA. Visit strengthenfda.org to find contact information and to learn what the Alliance for a Stronger FDA (with more than 100 nonprofit, consumer and industry groups, as well as former FDA commissioners and Secretaries of Health) is doing to improve the agency that is entrusted with America’s health.

I found this while in the waiting room of a local hospital, last week.  I read the entire thing three times.  It’s a really great article.

It was published in Readers Digest, April 2008. 

Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days. And despite mounting concerns about the safety of Chinese-made drugs, the agency had only enough field inspectors last year to check a mere 13 of the 714 Chinese factories that produce medicines for U.S. consumers.

Many of the nation’s leading doctors, scientists and lawmakers now agree that the FDA is in crisis. Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slowly to remedy them. Insiders say it’s woefully underfunded, dangerously understaffed and fractured by bitter internal tensions. Instead of depending on the FDA, Americans are doubting it — and for good reason.

The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy — and, post-9/11, sniff out any food-borne terrorist plot. Yet the agency’s annual funding, $2 billion, is about what Fairfax County, Virginia, pays for its public schools.

“Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected?” asks former associate commissioner William Hubbard. “Dream on.”

A chilling new report commissioned by the FDA’s own advisory Science Board describes an organization nearly out of control. “We were shocked at the appalling state of science at the FDA,” says Garret FitzGerald, MD, chairman of the pharmacology department at the University of Pennsylvania School of Medicine and an advisor on the report. “The analogy is Katrina. But we have to fix this before the hurricane hits.”

Drug safety is perhaps the greatest concern. The respected Institute of Medicine, created in 1970 by the National Academy of Sciences, recently labeled the FDA’s drug branch “dysfunctional,” saying it muzzles scientific dissent, inadequately monitors drug safety and relies too heavily on drug company dollars.

Even the department’s champions are worried. “I don’t think the FDA is at a collapse point yet, but it’s getting close,” says Hubbard, who retired in 2005 after 26 years at the agency. “In some places, regulation is so weak that there’s nothing left.”

The agency’s most recent difficulties began in 2004, when officials came under fire for silencing a staff scientist who had concluded that antidepressants could increase suicidal behavior in teens. That same year, the FDA was criticized for not acting quickly to take the painkiller Vioxx off the market after it was shown to increase the risk of heart attack and stroke.

“Every generation has required some health disaster to reform the FDA,” says David Graham, MD, a drug safety expert who has worked at the agency for 24 years. Today, he says, that window of opportunity has been pried open by debacles such as Vioxx. Former FDA commissioner David Kessler, MD, agrees: “These are the times when things get fixed.”

Congress has begun that job. Last September, lawmakers did increase the FDA’s funding by $145 million, although only about one fourth went to the drug-review branch (more on that later) and boosted its regulatory powers. Observers hope FDA officials will use their new clout to restore the agency’s lost luster. But they say the public needs to weigh in to make sure that happens. Here, the five key problems, what’s being done to fix them and how you can help.

• Problem: Pressure From the Industry
There’s pressure to speed decisions, and there’s pressure to soft-pedal problems. That means drugs may go on the market without adequate vetting — or follow-up. Critics of the FDA like to say it’s the best agency the pharmaceutical industry can buy. That’s a political jab, and agency advocates say it’s unfair. “The extraordinary efforts of these committed staff members are the very reason further catastrophic food-and-drug events have been averted,” an otherwise scathing review by the FDA’s Science Board concluded last November.

But most agree that there’s at least a problem of perception, and perhaps more than that, caused by the growing chunk of the agency’s budget that comes directly from drug companies. Industry dollars now pay for more than half of the FDA’s drug-review budget; in five years, that proportion is expected to jump to 70 percent.

Called user fees, this $400 million a year is designed to speed decisions on applications for new drugs. “User fees seem to save taxpayers money,” says Susan Wood, PhD, the former assistant commissioner for women’s health at the FDA and now a professor of public health at George Washington University. “But they undermine public confidence in the FDA’s independence and impose time pressures that could end up costing lives.”

Faster approval of drugs, of course, is a very good thing if you need a lifesaving medicine. Many patients are clamoring for that speed. Review times have been cut from 27 months to less than a year. Vioxx was fast-tracked in just six months. But some argue that the pendulum has swung too far. “A lifesaving drug should be sped along,” says Steven Nissen, MD, chair of the department of cardiovascular medicine at the Cleveland Clinic and a frequent advisor to the FDA. “But with user fees, we’ve pressed the accelerator on all drugs, and that’s a mistake.”

Here’s the danger: “The easiest way to make those deadlines is not raise too many questions and just accept what the drug companies say about safety,” says former FDA drug reviewer David Ross, MD. Too often, Dr. Ross says, reviewers tell their FDA supervisors that a drug doesn’t work or has a major safety problem and “managers come up with contrived reasons to approve the drug anyway.” He says the standards of safety and efficacy have slipped to the point that the drug reviewers “can end up approving almost anything.”

No one can say that moving drugs more quickly from the laboratory to the pharmacy always puts Americans at risk. But there is a smoking gun: an alarming spike in adverse drug reactions reported to the FDA recently, from 267,000 in 2000 to over 471,000 in 2006. And the number of reported deaths has nearly tripled, from 5,519 to 15,107. That’s only part of the story: The agency estimates that it learns of fewer than one in ten drug reactions.

Janet Woodcock, MD, the FDA’s deputy commissioner and chief medical officer, flatly denies that user fees and sped-up approvals compromise safety. “The FDA is legendarily tough — our requirements are viewed as a really tough bar to get over.”

“The review standards have not changed one bit since the introduction of user fees,” says Alan Goldhammer, PhD, deputy vice president for the Pharmaceutical Research and Manufacturers of America, the drug industry lobby. “We’ve been careful never to compromise the independence of the FDA. Congress would not permit it.”

Nevertheless, says Dr. Woodcock, “I understand that there’s a perception problem.”

What’s Being Done
Congress slightly increased the FDA’s drug safety budget last year but accomplished that mostly by boosting user fees once again. To help offset that influence, and enable the FDA to tackle all its other responsibilities, reformers say Americans should pay 3 cents a day to fund the agency, rather than the 1.5 cents we now pay. The agency’s Science Board argues, “That’s a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world.”

• Problem: Safety of New Drugs
When the FDA approves a drug or medical device, staff scientists must, in effect, make a judgment call about its safety. They’re relying on industry studies that usually follow between 600 and 3,000 people, often for just a few months. Those small clinical trials are designed to measure a drug’s safety and effectiveness in a targeted group of patients — not the dangers the drug might pose when it’s taken by people with a wide variety of backgrounds and health conditions. “If it kills one in 2,000 people, or makes one go blind, you may not see that in the trial,” says Drummond Rennie, MD, a deputy editor of The Journal of the American Medical Association (JAMA) and a professor of medicine at the University of California, San Francisco. “You start adding that up, and that’s ten in 20,000 going blind, and that’s a lot of people.”

Those risks are revealed only after a medicine goes on sale and has been used for months or years by hundreds of thousands or even millions of people. Keeping track of those reactions is called post-market surveillance, and experts say it’s one of the most important phases of drug testing. Historically, user fees were not allowed to go toward checking the safety of drugs once they were on the market. And until now, those follow-up reports haven’t been mandatory. A 2006 report found that 65 percent of the studies that drug firms promised to conduct in recent years hadn’t even begun.

What’s Being Done
Congress authorized the FDA to spend $25 million from user fees this year to improve drug safety. But agency insiders say that’s not nearly enough. “You’ve still got a mismatch,” says Hubbard, who is now a senior advisor for the Alliance for a Stronger FDA, a group that includes seven former agency commissioners and three former Secretaries of Health and Human Services. “You still have all this effort going into getting the drugs on the market, and not much going into making sure they’re safe once they’re out there.”

On that issue, Congress got tough last year. The FDA can now require companies to trace the long-term effects of their drugs. If firms renege, they face stiff fines, up to $10 million for repeat offenses.

Another crucial reform: Companies can no longer treat the results of clinical trials as trade secrets. Until this year, a manufacturer could cherry-pick what it revealed — publishing a favorable study in a medical journal and sticking less rosy findings in a drawer. A report in the January New England Journal of Medicine revealed that one-third of antidepressant drug trials are not published, which can mislead doctors into thinking the drugs are more effective than they really are.

Here, too, Congress has drawn the line: Companies must post results of clinical trials on a public database, ClinicalTrials.gov, within one year of their completion. Independent experts should soon be able to evaluate the findings and better inform doctors and consumers about what the studies mean. Unfortunately, companies can wait three years to post summaries written for the general public.

That new measure of openness draws kudos from Dr. Woodcock, the FDA deputy commissioner. “People volunteered for those trials, and their lives may have been altered as a result,” she says. “They deserve to know that their information has contributed to society.” Having such full disclosure about a treatment or device is the only way to know what medical research means for all of us.

• Problem: Sloppy Record Keeping
For an organization whose core function is gathering and analyzing crucial facts quickly, the FDA’s partially computerized database “is like something that came off the ark,” says Dr. FitzGerald, the Penn pharmacologist and agency advisor.

Companies are required to tell the FDA about any severe reactions they learn of, and do so within 15 days if the injuries are life-threatening. And the agency operates a website called MedWatch (www.fda.gov/medwatch), where doctors (and patients) can download a form to report problems. But few physicians bother to use it. The result: Only a small fraction of adverse reactions get passed on. Even more important, the FDA doesn’t have the time or money to make sense of the information it does receive.

The agency is notified of half a million problems each year, a third of them serious, says Dr. Woodcock. Most of those reports arrive via paper fax and have to be sorted by hand. More worrisome, the FDA’s skeleton staff of 35 report analysts have only eight minutes to read even the most serious case, says Hubbard, who tracked such things as associate commissioner.

“We’ve never had enough resources to really do the job and hire the staff,” says Dr. Woodcock, who has been at the FDA for two decades. “And it’s not that we didn’t try.”

What’s Being Done
Congress has responded, telling the agency to invest several million dollars to connect to large medical-records databases run by the Veterans Health Administration, Medicare and HMOs. Using these databases will allow the FDA to better track and analyze adverse drug side effects. That means the FDA will know much sooner if a newly marketed drug needs to be relabeled or pulled off the market, even whether one medication works better than another. And thanks to Congressional intervention, the agency will now be able to make label changes quickly, without prolonged negotiations with the drug companies.

Problem: Conflicts of Interest

The FDA’s advisory boards, which vote on drugs and devices, are intended to represent a broad spectrum of physicians, researchers and patient advocates — not stockholders. But a study published in JAMA in 2006 found that in 22 percent of advisory board meetings, more than half the members had direct financial interests in the companies whose medical products they evaluated, or their rivals.

The agency says it’s doing the best it can. Because drug companies underwrite most clinical research, even at universities and hospitals, some say it’s difficult to find top medical experts with no ties to industry.

What’s Being Done
Congress has decided to roll up the red carpet. Over the next five years, the FDA will have to cut by 25 percent the number of advisory committee members with financial ties to a product under review. Consumer groups had hoped for an outright ban but say this is a step in the right direction.

• Problem: Muzzled Experts
Dr. Graham, in the FDA’s drug safety office, says that a few years ago he was ordered to soften his assessment of a drug he thought should be withdrawn because it could cause liver failure and death. “Industry is our client,” a supervisor told him.

“It may be your client,” Dr. Graham says he replied, “but it will never be mine.”

When told this story, FDA spokeswoman Julie Zawisza said, “Our client is really the public.”

Still, other agency scientists share Dr. Graham’s concerns. Drug reviewer Rosemary Johann-Liang, MD, suggested two years ago that the diabetes drug Avandia carry a black box on its label (the agency’s strongest warning), alerting patients and doctors to its cardiac risks. Instead, Dr. Johann-Liang says, her supervisors reprimanded her and deep-sixed her report.

Last August the agency did finally issue an urgent warning about the drug and placed a black box on its label. But by then Dr. Johann-Liang had resigned — and millions of Avandia prescriptions had already been filled.

Many agency staffers say they’ve felt similar pressure to soft-pedal product dangers. In a poll of 1,000 FDA scientists, conducted in 2006 by the Union of Concerned Scientists, 20 percent said agency decision makers had asked them explicitly “to provide incomplete, inaccurate or misleading information to the public, regulated industry, media or elected/senior government officials.” And 40 percent said they could not publicly express concerns about public health “without fear of retaliation.”

The tone has been set from the top. Last year Andrew von Eschenbach, MD, the FDA commissioner, told a roomful of staffers to stop making their gripes public. “If they don’t follow the team,” he said, “the first time, they’ll be spoken to; the second time, they’ll be benched; and the third time, they’ll be traded.” (FDA spokeswoman Zawisza says Dr. von Eschenbach has no desire to limit dissent.)

The tangled story of Ketek, a once-promising new antibiotic, illustrates what can happen when the agency’s scientists feel marginalized.

What’s Being Done
Last year Congress created the Office of Chief Scientist of the FDA, to give staff members a forum for debates and improve the quality of research. The new law also gives in-house staffers the right to publish their critiques in medical journals and makes sure their assessments, even if overruled, are made part of the public record.

Money alone won’t solve the FDA’s morale problem. In recent years, dozens of career scientists and senior managers have left the agency, a much higher turnover than that of the National Institutes of Health or the Centers for Disease Control and Prevention. Public trust in the agency has slid from 67 percent in 2001 to 36 percent in 2006.

Without change at the top, longtime agency watchers say, there’s no assurance that officials will get tough on industry scofflaws. In fact, from 2000 to 2005, FDA enforcement against drug, vaccine and medical device manufacturers dropped by more than 50 percent, according to a recent investigation by California Congressman Henry Waxman.

A discouraging sign: One of the first regulations the agency proposed this year is intended as a shield, according to some Congressional leaders, designed to protect drug companies from lawsuits brought by people who believe they’ve been injured by drugs or medical devices.

But having stronger tools and the right leadership could gradually restore the FDA to what it once was — a highly respected band of medical detectives, apolitical and immune to corporate pressure.

There is one bright spot on the horizon, says Jerry Avorn, MD, a professor of medicine at Harvard Medical School and an expert on the drug-approval process. “There is more public awareness of this issue than I’ve seen in 30 years,” he says. “And that can help put the agency’s many smart, dedicated people back into the driver’s seat. Because a lot of this is really not about very arcane science. It’s about common sense. And that’s what’s been missing, until now.”

If SSRI were prescribed for clinical depression and the diagnosis was carefully defined then we would not have this problem.  What is happening and has been for a long time is that doctors have exchanged clinical treatment for a prescription pad.  In addition to this pharmaceutical companies have been injecting themselves in the doctor patient relationship which has lead to an ungodly amount of abuse and where the line of actual illness and normal human emotion are no longer clearly defined and always in favor of pharma. The gray zone is vast and it is killing people in the tens of thousands.  Health Canada along with other worldwide drug regulators has allowed big pharma to convince us that normal human emotion is a bloody illness. 
 
Childhood shyness is a rite of passage from infancy to adulthood.  It is part of human development.   Pharma has created this enormous market and our kids are the intended target of this market.  They are making billions of dollars every year because parents and doctors are buying into this nonsense that is literally making our children sick, emotionless zombies.  Is that what we want?  Do we want emotionless zombies with not a care in the world running our countries a few years from now?  Think about that very carefully.  That’s what SSRI’s do.  They either steel human emotion or they induce manic like episodes, aggression and suicidal thoughts and actions.  These drugs were not intended for healthy human beings.  They were intended for people with severe and debilitating disease where natural treatments such as behavior therapy have failed.  SSRI drugs should be a last resort.  The balance of benefit and risk are far too high for these drugs to be doled out like candy.
 
In July 2008 Health Canada published a press release in defense of Canada’s drug administration.  Ontario resident along with world experts insist that Canadian drug regulators are not being completely honest about their role in Canada’s drug safety. “The role of our regulators should be to protect and defend the health and safety of Canadians but when individual regulators have a financial interest in approved drugs how willing are they going to be to take their billion dollar baby off the market?” The conflicts of interest are astounding and probably contribute to the unacceptable number of people that die each year as a result of the side effects from so called “safe and effective” drugs. They have not even provided adequate warning labels on patient leaflets.  They favor pharma but try to appear as though they are concerned with safety.  Health Canada is very aware that GlaxoSmithKline is not simply promoting Paxil as a drug for depression.  They promote it for anxiety (their definition of anxiety would mean every single person needs Paxil) they are promoting is for shyness. (Their definition of shyness means we would all be on it at one time or another.  How convenient for them)  Doctors are prescribing this dangerous and toxic drug for headache, sleeping problems, PMS, situational depression which could be manage with talk therapy.  the terrible two’s…etc People have died, people are losing their jobs, being thrown into poverty and oppression and we are letting them do it.
 
SSRI drugs are addictive and getting off them is not much fun.  It’s a living hell!  Do we really want to put our kids through something like that for shyness?  These drugs are linked to 37 or so school shootings and suicide.  When journalists ask GSK or other SSRI pushers for a comment they always say “Paxil has been proven safe and effective for the treatment of depression……” the problem is these drugs are not simply prescribed for depression.  They try to manipulate the public into believing the child that took his/her own life was severely depressed to begin with.  That is absolute Crap and they know it.
 
This is not about convincing regulators that these drugs are dangerous and we are headed for disaster.  They know damn well that SSRI drugs are out of control and if they don’t they are not qualified for the positions they hold.  This is about politics and greed.  This is about waiting to see how much public pressure they can take before their hand is forced and how much money can be made in the meantime.  They don’t’ give a damn about the kids and the parents and the hell these drugs are creating.
 
Canadian citizens that read about this and dismiss it because they feel it will not or does not affect them are sadly mistaken.  This is going to affect all of us eventually.  Canadians can be fence sitters at times.  They fully expect the very few to save the millions.  Canadians need to get off their ass and become more aware, and more involved in their children’s future before it’s too late.
 
If world drug regulators have allowed this to continue for over 16 yrs and in spite of all the evidence to prove these drugs are extremely dangerous and being overprescribed …. What else is going on that we don’t know about?
 
Come on Canada… Wake up!!!

I’ve just been copied in on an email sent to Health Canada from a very concerned Canadian citizen. They have given me permission to post the email on my blog. The person’s name and email address have been redacted at their request:
http://fiddaman.blogspot.com/2009/01/concerned-canadian-citizen-email-to.html

Dear Health Canada,

It is very obvious that Paxil poses a serious threat to the life and liberty of children and adults in Canada. It seems equally as obvious that there is an overprescribing issue. Tonight I found a website created by GlaxoSmithKline. The sites intended purpose is pre-screening for shyness which they feel their drug is suited well for. I find that extremely difficult to believe. (Both the fact that shyness is a mental illness at all and that the benefits of Paxil would outweigh any risk)

I’m not going to sit here and try to convince you of Paxil’s mounting death toll and the 16 yr wake of needless suffering. I know you know about it so let’s not debate the obvious.

I did some research on the side effects of other known disasters you have pulled from the shelves such as Vioxx and Thalidomide. I am wondering why, in spite of the fact that SSRI drugs have a much higher number of reported severe side effects than either drug mentioned above; you have done very little about it.

I would suggest Paxil be removed from the shelves but someone is making far too much money for that request to be realistic.

1) When you are going to demand GlaxoSmithKline to make their warning labels more visible? I have seen the warning label and it does not stand out at all which was also reported on the evening news which focused on the senseless death of Sara Carlin and Ontario Chief Corners office. I don’t think that this is an unreasonable request especially considering a more visible label could have saved some of the Canadian lives we have already lost and will save some in the future which should be Health Canada’s main focus.

2) When can the public (Paxil addicts) expect a withdrawal program?

You, along with doctors have been made aware of how difficult it is to withdraw from Paxil. Leading experts suggest greater than 40% of users will experience severe withdrawal complications. This is hardly a number to ignore. I am also wondering how many people have been forced into poverty and live off of disability as a result of this health care disaster that is out of control and has been for many years.

After corresponding with world experts on SSRI withdrawal it is my understanding there is no withdrawal program in place and that you have never requested one in spite of how debilitating withdrawal can be and the threat to one’s life. GlaxoSmithKline suggests a two week tapering period. Experts like Dr. David Healy have regarded this as nearly an impossible challenge for patients and a very dangerous one at that. After being prescribed Paxil for PMDD (bad PMS) and spending two years getting off these drugs, I can assure you that the experts are not exaggerating. I don’t know how I survived it. A child with an uninformed doctor and ignorant parent or caregiver does not stand a chance. Don’t reply to me and tell me that Paxil is not licensed for children. It is being prescribed off label every single day for children and we both know it.

Considering the number of people taking SSRI drugs I feel strongly that these issues should have been addressed carefully long before now. It seems to me that Health Canada has demanded the bare minimum from a company guilty of tax evasion and collusion in the United States, Half a billion dollars worth of bribery in Italy, Illegal drug trials in New Jersey, ghost writing, and faced criminal charges for knowingly promoting a drug proven ineffective and extremely dangerous in children. I’m sure I have missed a few but surely you get my point. With the latter in mind it has come as a shock to me and other consumer advocate groups that GSK is planning on a second attempt at a pediatric license in Japan.

If I were to pull any one of those stunts would you continue to do business with me and bend the rules in my favor or would I be behind bars? If I were your neighbor would you trust me to watch your child?

Of course you would not trust me with your child. But you have been telling Canadians to trust GSK with their children knowing the company is promoting an unsafe drug for our most vulnerable members of society and the very people that will be running this country one day.

GlaxoSmithKline has been selling life saving drugs for a very long time. However, this does not give them a license to intentionally deceive Health Canada, Canadian doctors and consumers.

It has always been your job to protect and defend the health and safety of Canadians. I feel that in regard to Paxil, you have failed us.

I would really like a reply to this but not a cut a paste of a standard reply. I intend to report on this as it will be the focus of a paper I have been working on.

Regards,

Name redacted