Posts Tagged ‘Antidepressant’

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Prozac is now a defense for murder, writes Australian Member of Parliament Martin Whitely

Wednesday, December 21st, 2011

For the first time in criminal history, a murder was attributed to an anti-depressant drug. (Photo Credit -The Daily Telegraph)

Perth Now – December 21, 2011

FIRST it was ADHD drugs, then organ donation, now WA Labor MP Martin Whitely is hoping to get some action on the fatal risks of antidepressant drugs, such as Prozac, to children.

Anti-depressant manufacturers warn that products such as Prozac should not be given to children, because of the potentially tragic consequences, but they are prescribed every day to Australian kids.

Some anti-depressants, prescribed to help lift people out of a depressive state, actually have the opposite effect and make things worse.

This is what happened, with fatal results, in the case of a 16-year-old boy in Canada who stabbed a friend to death.

For the first time in criminal history, a murder was attributed to an anti-depressant drug.

In the finding, handed down on the 16th of September 2011, a Canadian Judge said a 16-year-old boy, who stabbed his brother’s friend in the stomach, would not have committed the offence had he not been treated with the drug Prozac (a brand of Fluoxetine).

The judge accepted the evidence of psychiatrist, Dr Peter Breggin, who told the court the boy’s symptoms were consistent with a Prozac-Induced Mood Disorder with Manic Features.

In delivering his decision the judge stated, “his basic normalcy now further confirms he no longer poses a risk of violence to anyone and that his mental deterioration and resulting violence would not have taken place without exposure to Prozac”.

The boy, who had no history of violence, had been taking Prozac for three months, during which his parents observed a marked deterioration in his behaviour and mood, which included acts of violence and self-harm where previously no such signs existed.

His alarmed parents returned to his doctor for advice, but instead of taking him off Prozac or reducing his dosage, his doctor increased the dose, obviously believing more of what appeared to be causing these dangerous behaviours, would solve the problem.

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) and is approved for use in Australia for the treatment of depression, obsessive compulsive disorder and premenstrual dysphoric disorder.

However, it is routinely prescribed ‘off label’ for a range of other conditions including panic and eating disorders.

Australian Government Department of Health and Ageing figures revealed that in the 2008 financial year, 110,848 Australians received Fluoxetine scripts that were subsidised via the Pharmaceutical Benefits Scheme.

Concerns about possible aggression and manic side effects of Prozac were first raised in Australia in the New South Wales parliament in 1995, just five years after the release of the drug in Australia.

Since 2007, the US Food and Drug Administration has labelled SSRI antidepressants including Prozac with the highest possible ‘black box’ warning stating:

“All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric.”

The US Black Box warning was followed by similar warnings in Australia. The evidence that led to these warnings came from, ‘pooled analyses of short-term placebo-controlled trials of anti-depressant drugs (SSRIs and others)’ which ‘showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents [by 100%], and young adults ages 18-24 (by 50 per cent) with major depressive disorder (MDD) and other psychiatric disorders.’ The fact that SSRI antidepressants like Prozac are supposed to manage severe depression in young people but increase the risk of suicidality poses obvious questions.

Over a 10 year period, up until 30 June 2011, more than 40 adverse events of self-harm and violence, including suicides, homicides and suicidal or homicidal ideation, for Fluoxetine were reported to the Australian Therapeutic Drugs Administration (examples are listed below).

Hundreds of reports were recorded by the TGA for other antidepressants however, it is impossible to know the true number of actual events, as the voluntary nature of the reporting system means only a fraction of actual incidents gets reported.

Despite the fact that the manufacturers advise that Prozac and other SSRI antidepressants are ‘not recommended for use in children and adolescents under 18 years of age’ they are frequently prescribed ‘off label’ to even very young children.

Data provided by the Commonwealth Department of Health revealed that in the 2007-8 financial year 3,752 Australian children 15-years-old or younger (863 were 10 or younger, 117 were six or younger) were prescribed Pharmaceutical Benefits Scheme-funded Fluoxetine.

Furthermore all the expense and risks of adverse side effects may be for little or no benefit. The efficacy of antidepressants are being questioned – with some high profile, mainstream critics, arguing that placebos are just as effective and much safer in treating moderate depression.

One such critic, Marcia Angell, MD, Senior Lecturer on Social Medicine at Harvard Medical School and former Editor-in-Chief of The New England Journal of Medicine, contends; ‘that clinical trials have failed to find antidepressants effective at all in mild to moderate depression; that many psychiatric drugs have devastating adverse effects, especially in children and when used long-term; and that despite the risks and uncertain benefits, use of psychiatric drugs is soaring and the heavy reliance on drugs diverts resources better spent on improving treatment’.

In summary, taxpayers are subsidising the ‘off label’ use by children and adolescents of antidepressants, with questionable efficacy, that double their risk of suicidality. This invites some obvious questions: Is this the best way to spend our taxes? And more importantly, is this the best way to help troubled young people?

* A sample from the Adverse Drug Reactions Committee (ADRAC) adverse event reports for Fluoxetine Hydrochloride:

  • A 54 year old woman attempted suicide. She was also suffering from mania and a confusional state.
  • A 36 year old woman “attempted suicide”.
  • A 36 year old woman was admitted to intensive care in a coma following a suicide attempt.
  • A 51 year old woman “had sudden urge to murder someone”.
  • A 37 year old woman was admitted to a psychiatric hospital suffering from “suicidal ideation, nausea, trembling, feelings of despair, anxiety, paranoia and fear”.
  • A 16 year old boy suffering from agitation and auditory hallucinations heard voices “telling him to kill his mother, father, sister and himself”.
  • A 45 year old man “became obsessively suicidal and cut his throat” 3/7 days after Prozac was stopped.
  • A 17 year old girl “became manic half an hour after commencing antidepressant.”
  • A 40 year old patient “experienced trembling, cramps, heard voices and had suicidal ideation.”
  • A patient of unrecorded gender and age experienced “homicidal and suicidal ideation.”
  • A patient of unrecorded gender and age attempted suicide after experiencing suicidal ideation.
  • A 44 year old patient “experienced akathisia, suicidal ideation and suicide attempt.”
  • A patient of unrecorded gender and age experienced “suicidal violence” and “aggression.”
  • A patient of unrecorded gender and age experienced “suicidal ideation.”
  • A patient of unrecorded gender and age experienced “suicidal ideation and “suicide attempt.”
  • A 50 year old patient experienced “suicidal ideation, suicide attempt and akathisia.”
  • A 37 year old patient attempted suicide.
  • A patient of unrecorded gender and age experienced “suicidal ideation and suicide attempt.”
  • A patient of unrecorded gender and age made a suicide attempt and was violent.
  • A 16 year old girl “attempted to hang herself with television cord from curtain rail in hospital bedroom. Nurse said she found her at the last moment.”
  • A 16year old girl “ingested 40 Panadol tablets. Also frequent self-harming.”
  • A 16 year old girl “attempted suicide by ingestion of 80 Panadol, 20 Panadeine, 7 Olanzapine.”
  • A 29 year old patient “developed acute suicidal akathisia” and made a suicide attempt.
  • A 73 year old patient “experienced homicidal ideation and made a suicide attempt.”
  • A 60 year old woman “experienced suicidal ideation, suicide attempt and homicidal ideation – she attempted to kill her parents.”
  • A 69 year old patient “experienced suicidal ideation and was very anxious.”
  • A 16 year old girl attempted to “strangle herself with and IPod cord in the bathroom of the hospital. Agitation. She ran around crying and banging her fists of the walls and windows begging to be let out. … it lasted about 10 minutes before I could settle her.”
  • A patient of unrecorded gender and age “took a fistful of sleeping pills.”
  • A 35 year old patient “murdered his wife whilst on Prozac. He had also experienced suicidal thoughts.”
  • A female patient of unrecorded age “became seriously depressed, complained of headaches, and clenching jaw, was unable to sleep and started to self-harm. She began to have suicidal thoughts, was hyperventilating, agoraphobic, had five suicide attempts, was confused, tearful, phobic, aggressive, experienced akathisia and suspected serotonin syndrome. She experienced weird dreams, was impulsive, light headed, had numbness and tingling limbs and committed suicide by hanging on 11 September 2000 on the second attempt.”
  • A 50 year old woman “became more depressed whilst taking Prozac. She wanted to throw herself off a train or bus, had difficulty sleeping, was pacing and restless, had voice hallucinations, would look in the mirror and see a different person, had murderous thoughts, stiff legs, was hot a lot, felt she was in a delirium, could not concentrate, was angry, had numbness in her hands and pins and needles a lot in her body.”
  • A 19 year old male “had thoughts about killing himself which made him violent, tried to hit someone else, tried to hit a security guard with feelings of killing and tried to do physical damage. Tried to hurt himself and had thoughts of hurting other people. He was walking faster than normal. Experienced aggression, insomnia and was feeling high on Prozac. Also felt anxious and put on more than 20kg.”
  • A male of unreported age “experienced severe depression, cognitive impairment and was acutely suicidal.”
  • A 16 year old girl was “cutting herself, throwing herself against the walls while an inpatient”. She “intentionally overdosed on Fluroxetine” and “developed severe levels of aggression and violence.”
  • A 14 year old boy experienced “suicidal ideation.”
  • A female of unreported age “experienced suicidal ideation”.
  • A 16 year old girl experienced “excessive bleeding, psychosis, high blood pressure, severe diarrhea, sweating, tremors, violent, aggressive and suicidal behavior, serotonin syndrome.”
  • A 14 year old male experienced “severely increased suicidal ideation in two days with high level of intent and plan to jump in front of train. Previously no suicidal ideation and settled spontaneously within four days of ceasing Fluoxetine”.
  • A female patient experienced a “sudden and marked increase in hostility and verbal abuse of others and describes intrusive suicidal ideation. Seems agitated and restless”.
  • A 32 year old woman experienced “audio hallucinations, bright and blurred vision, made everything sound louder, constipation, increased suicidal thoughts and increased anxiety”

http://www.perthnow.com.au/news/western-australia/prozac-is-now-a-defence-for-murder/story-e6frg13u-1226227796937

Note from CCHR International:  CCHR is the only organization to have decrypted the US FDAs Medwatch reports on adverse reactions to psychiatric drugs and compiled them in an easy to search database.    This database is provided here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

CCHR has also compiled all international drug warnings and studies on psychiatric drugs here http://www.cchrint.org/psychdrugdangers/drug_warnings.php

 

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Antidepressant tied to heart risk

Friday, August 26th, 2011

Health24
August 25, 2011

High doses of the popular antidepressant Celexa (known as Cipramil in South Africa) can cause potentially fatal abnormal heart rhythms and should no longer be prescribed to patients, the US Food and Drug Administration has said.

Doses of Celexa (citalopram hydrobromide) greater than 40 milligrams a day can cause changes in the electrical activity of the heart, which can lead to abnormal heart rhythms, including a potentially deadly arrhythmia known as Torsade de Pointes, according to the agency.

Patients at high risk for changes in the electrical activity of the heart include those with pre-existing heart conditions (including congestive heart failure) and those prone to low levels of potassium and magnesium in the blood, the FDA said.

Read entire article:  http://www.health24.com/news/Depression/1-903,65865.asp

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Interview with “Psychiatryland” Author, Phillip Sinaikin, MD

Monday, July 25th, 2011

Scoop News – July 25, 20011

By Martha Rosenberg

"Psychiatry mimics science but is not a real science. The symptoms it treats are subjective and have not been demonstrated and cannot be demonstrated at the cellular level."

Phillip Sinaikin, MD, is a Florida psychiatrist who has been in practice for 25 years. His new book focuses on excesses and industry influence in the field of psychiatry.

Rosenberg: Your new book, Psychiatryland, traces how deception, conflicts of interest, medical enabling and direct-to-consumer advertising have resulted in millions being on psychiatric drugs they don’t need. One patient you describe has legitimate mourning and grief work to do after his wife leaves him for his own cousin. But his grief is pathologized into “bipolar disorder” by the system, including his own mother.

 Sinaikin: By the time I saw this patient, he was on Wellbutrin and another antidepressant, the mood stabilizers Eskaltih and Keppra, the antipyschotic Abilify, the tranquilizer Klonopin and Adderall for ADD. Calling grief a psychiatric disorder deflates and dishonors the spiritual dimension of loss and grief and the sadness which is a marker of the lost love. By the time this patient came under my care (three years after the loss of his wife) his “case” had become such a jumbled, incomprehensible and irrational mess of overdiagnosis and overmedication that the only word I can use to describe it is CRIMINAL.

Rosenberg: Can you explain the popularity of such drug cocktails? The drugs haven’t been tested together so the patient is a guinea pig. And their total cost can exceed $1000 per month, often shuttled onto taxpayers because the people are considered disabled under federal entitlement programs.

Sinaikin: Psychiatry mimics science but is not a real science. The symptoms it treats are subjective and have not been demonstrated and cannot be demonstrated at the cellular level. That gives psychiatrists free reign to just experiment and symptom chase, often insanely chasing the side effects and negative interactions of the current drug regimen with more and more drugs. Polypharmacy is also a way psychiatrists can distinguish themselves in an increasingly competitive market. No one believes you need a specialist for one drug — any primary care physician can give you Zoloft — but for multi-drug therapy you do. If you don’t write a prescription as a psychiatrist, you won’t work these days. It is like being a pacifist and having no choice but working in a bullet factory.

Rosenberg: A lot of this trial-and error polypharmacy is buttressed by the concept of “treatment resistance” and “Prozac poop-out.”

Sinaikin: I write in the book that an antidepressant not working anymore is no different than getting used to anything that used to thrill us. We buy our dream house with two bedrooms and a garage and after a while it doesn’t make us happy anymore and we are eyeing the house with three bedrooms and a pool. Another example, of course, is falling in and out of love.

Rosenberg: You document in Psychiatryland the creation of new diseases to sell drugs including adults now diagnosed with childhood disorders like ADD and children with adult disorders like bipolar and depression.

Sinaikin: One scientific article I read about the new childhood disorders sounds like a satire. Two well-respected “thought leaders” in psychiatry were debating the underlying pathology of a three-year-old girl who ran out in traffic. The first doctor believed her dangerous behavior was indicative of an Oppositional-Defiant disorder. The other doctor argued her impulsive act represented grandiose delusions where this girl believed she was special and cars could not harm her. She was, therefore, bipolar.

Rosenberg: Another shocker in your book is how everyday drug and alcohol addicts were recast as having psychiatric conditions for money.

Sinaikin: The insurance companies told the rehabs they would no longer pay for inpatient rehab for heroin, cocaine or alcohol unless there was also another Axis 1 psychiatric disorder like bipolar disorder or major depression. I was working in a drug treatment facility when the change happened. Since addicts typically complain of anxiety and depression, a completely understandable emotional response to their toxic lifestyles, it was “no problem” to add a new label and throw a few psychiatric drugs at their now relabeled “dual diagnosis.” Of course the central tenet of recovery, taking personal responsibility, was buried by the new victim narrative of self-medicating a previously undiagnosed mental illness.

Rosenberg: Treating addiction with psychiatric drugs before or instead of seeking a higher power is antithetical to the 12 Steps of Alcoholics Anonymous.

Sinaikin: As I say throughout my book, human beings are indescribably complex. There are times when the dual-diagnosis concept is necessary and helpful but clearly not applicable to 100% of the cases of addiction as it is now applied. I believe that the 12 Step model is an ideal model of recovery. Patients can have the help whenever they are truly ready, not just when someone decides to foist it on them. Most importantly, the addicts helping other addicts are doing it to facilitate their own recovery and not for ulterior motives such as money. Amazingly, in a world gone profit crazy 12 Step recovery programs are still free. I conceptualize the 12 Steps as a distillation of the spiritual principles world’s great religions but no one is forced to believe in anything including God.

Rosenberg: Given conflicts of interest at the American Psychiatric Association, which drives psychiatric diagnoses, in the FDA drug approval process itself and the legions of doctors willing to huckster for pharma as thought leaders or Key Opinion Leaders (KOLs), do you see any hope of rescuing people from Psychiatryland?

Sinaikin: The system is unbelievably bad and even worse than it looks. But, I think a goal that could be achieved would be a repeal of direct-to-consumer advertising. Patients now come into my office asking me if they have ADD or bipolar disorder or if they can have Cymbalta. When I began practicing psychiatry, long before direct-to-consumer advertising, this would never have happened.

Psychiatryland

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Pharma-Funded Psychiatrists Behind Bogus Child ‘Bi-Polar’ Epidemic- Disciplined for Conflicts of Interest

Friday, July 22nd, 2011

Harvard Psychiatrists Disciplined for Conflicts of Interest

Alliance for Human Research Protection – July 21, 2011

by Vera Sherav

Psychiatrist Joseph Biederman was funded millions by Pharma while promoting child "bipolar" disorder

The primary promoters–inventors, one might say– of diagnosing children with “bipolar” disorder, who for over a decade, aggressively promoted the biopolar diagnosis and use of antipsychotics in children, were disciplined by Harvard University and its affiliated Massachusetts General Hospital.

An investigation, prompted by Sen. Charles Grassely, was conducted by Harvard University-affiliated Massachusetts General Hospital. It concluded (earlier this month) that psychiatrist Joseph Biederman and two of his proteges, Thomas Spencer and Timothy Wilens -each of who failed to disclose millions of dollars they had each received from the makers of antipsychotics, the drugs they promoted for the treatment of bipolar in children–had indeed violated the University’s/ and hospital’s conflict of interest reporting  standards.

The three wrote a mea culpa letter stating “we want to offer our sincere apologies…” acknowledging “our mistakes…”

However, no mention was made anywhere about the profound consequences of these psychiatritsts’ commercially-driven clinical recommendations. No mention about the corruption of the scientific literature, about clinical practice that deviated from the Hippocratic Oath, “First, do no harm,” nor was any mention made about the harm suffered by children whose doctors were misled about the safety and efficacy of highly toxic drugs.

Child psychiatrists and pediatricians throughout the US were guided by these exceedingly influential Harvard psychiatrists.

As Sen. Chuck Grassley noted in 2008 in the Congressional Record, “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. {But] They have also taken millions of dollars from the drug companies.”

The companies that paid them millions include: Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

The Senator brought public attention–and to Harvard University administrators’ attention–the financial conflicts of interest, “Out of concern about the relationship between this money and their research.”

Indeed, documents uncovered during litigation confirmed that the research was scientifically corrupt and commercially-driven. The New York Times reported that Dr. Biederman promised Johnson a& Johnson that a study (yet to be conducted) in preschool children who would be given the company’s antipsychotic, Risperdal (risperidone) “will support the safety and effectiveness of Risperdal in this age group.”

“The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.”

Another of Biederman’s Harvard ignoble disciples was Jeff Bostic, who is also at Massachusetts General Hospital. He was named in a 2009 lawsuit joined by the US Department of Justice alleging Forest Laboratories promoted its antidepressants for pediatric use without FDA approval and paid kickbacks to docs to encourage prescriptions. He received $750,000 in payments for giving talks on using these drugs in children.

Strangely, the National Institute for Mental Health, which had awarded thse psychiatrists millions of dollars at taxpayers expense. It appears that NIMH officials did not see fit to even conduct an investigation into the corruption of science and violation of federal regulations. This demonstrates a lack of professional and moral integrity at the NIMH whose administrators think nothing about the misappropriation of public money for commercially-driven, junk research.

http://www.ahrp.org/cms/content/view/828/9/

Backstory from Pharmalot:

Pharmalot

Harvard Docs Disciplined For Conflicts Of Interest

By Ed Silverman // July 2nd, 2011 // 9:03 am

Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments.

In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”

And what is their punishment? They must refrain from “all industry-sponsored outside activities” for one year; for two years after the ban ends, they must obtain permission from the med school and the hospital before engaging in any of these activities and they must report back afterward; they must undergo certain training and they face delays before being considered for promotion or advancement (you can read their letter here).

The hospital had this to say: “A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues (read the statement). And a Harvard Med School spokesman sent us this: “We confirm that the review of their compliance with the Harvard Medical School Policy on Conflicts of Interest and Commitment has concluded, and appropriate actions have been taken.” He added that the conflicts policy was revised last year.

The sanctions result from a long-standing controversy over the explosive use of antipsychotics in children. Biederman, in particular (see photo), had been one of the most influential researchers in child psychiatry. Although his studies were small and often financed by drugmakers, his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.

For more than a decade, Biederman and his colleagues aggressively promoted the diagnosis and use of antipsychotics to treat childhood bipolar disorder, a problem that once was largely believed to be confined to adults. But the docs maintained this was underdiagnosed in kids and the meds could be used for treatment, even though they had not been approved for most pediatric use at the time. Meanwhile, the relationships with drugmakers were never properly disclosed (back story).

And for years, payments they received from drugmakers were not thoroughly reported to university officials. Yet, millions of dollars in NIH grants, which were administered by the hospital, were awarded to the docs at the same time they were receiving money from various drugmakers that make and sell antipsychotics and antidepressants. Which ones? Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

At one point, Biederman pushed J&J to fund a research center at MassGen that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use. He was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH rules forbid researchers from running trials with drugmakers if they receive more than $10,000 from a company that makes the drug (back story).

But in June 2008, US Senator Chuck Grassley made a far-reaching statement before Congress that pulled the curtain back on the money involved. The statement is memorialized in the Congressional Record. Referring to the three docs, he said “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

“Out of concern about the relationship between this money and their research, I asked Harvard and Mass General Hospital last October to send me the conflict of interest forms that these doctors had submitted to their institutions. Universities often require faculty to fill these forms out so that we can know if the doctors have a conflict of interest. The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”

How much were they making? At first, maybe a couple of hundred thousand dollars combined. But at his behest, the med school and hospital asked the docs to take a second look. “And this is when things got interesting. Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.

“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” And as Grassley then noted, there was still more money that went unreported (to read the Congressional record, click here and then check the box for 2008 and type in the name ‘Biederman’ in the search box. Then click on ‘payments to physicians’ to read the complete statement and the chart showing payments to each doc).

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Paxil and Prozac Linked to Risk of Heart Birth Defects

Monday, June 27th, 2011

AboutLawSuits.com – June 27, 2011

According to Finnish researchers, doctors should avoid prescribing Paxil or Prozac to pregnant women, due to the potential risk of heart birth defects.

In a study published in Obstetrics & Gynecology medical journal, researchers found that side effects of Prozac and Paxil use during pregnancy may increase the risk of women giving birth to children with congenital heart defects. Both drugs belong to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Researchers looked at national data from Finland on 635,583 births occurring between 1996 and 2006, and found that 31 out of every 10,000 women who took Paxil during pregnancy gave birth to children with right ventricular outflow tract defects that affect blood flow from the right chambers of the heart to the rest of the body, more than four times the frequency of births among women who did not take Paxil. For those who took Prozac, 105 babies born out of every 10,000 had isolated ventrical septal defects; a hole between the left and right sides of the heart, which was more than double the rate of babies born to women who did not take the drug.

The researchers also found that women who took any SSRI antidepressant during pregnancy were more than twice as likely to give birth to a child with a neural tube defect; 22 out of every 10,000 newborns, as compared to 9 out of every 10,000 newborns born to women who did not take any SSRI during pregnancy.

SSRIs are a relatively new class of antidepressants, which help reduce symptoms of depression by preventing certain nerve cells in the brain from re-absorbing the chemical serotonin. These drugs are commonly used by millions of Americans with depression.

Although the drugs have been found to cause fewer side effects than older anti-depressants, research has shown that users of the drugs could also face an increased risk of suicides, and use during pregnancy has been linked to a risk of birth defects, especially among users of Paxil.

Prozac (fluoxetine) is marketed by Eli Lilly and is approved for the treatment of depression, obsessive-compulsive disorder (OCD) and other psychiatric problems. In 2007 there were more than 22 million Prozac prescriptions in the United States.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.

In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.

The company reportedly agreed to settle hundreds of Paxil heart birth defect lawsuits last year. The Paxil lawsuits were filed by parents who say that the use of the antidepressant during pregnancy caused persistent pulmonary hypertension in newborns (PPHN) and other birth defects. The lawsuits claimed that the company failed to warn consumers and doctors that use of Paxil during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claimed that the company purposefully hid test results that would have revealed the side effects of Paxil and misled doctors.

http://www.aboutlawsuits.com/paxil-prozac-birth-defect-study-19139/

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Beware the ghost(writer)s of medical research

Friday, June 17th, 2011

The One Click Group – June 16, 2011

By Dr. Marc-André Gagnon
 and Dr. Sergio Sismondo
 Expert Advisors – EvidenceNetwork.ca

The medical research world has been concerned about the problem of ghostwriting for more than a decade.

The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

How ghostwriting feeds Big Pharma profits

Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.

Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key ones did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck – the AustralasSian Journal of Joint and Bone Medicine – and perhaps 10 other fake journals for Merck and other Big Pharma companies.

In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called “Case Study Publication for Peer-Review”, or CASPPER, a playful reference to the “friendly ghost”. Such strategies are not exceptions; they are now the norm in the industry. Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies’ capacity to influence medical knowledge and create market share and market niches for their products.

A call for Evidence-Based medicine

In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive.

Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebo, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights – and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.

Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck’s internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized” – “seek them out and destroy them where they live,” reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

Corporate science

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones – and sometimes through outright fraud.

As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

http://www.theoneclickgroup.co.uk/news.php?id=6349#newspost

Dr. Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr. Sergio Sismondo is professor of Philosophy and Sociology at Queen’s University. His current research is on the pharmaceutical industry’s relationships with academic medicine and practicing physicians.

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Ending a Midlife Affair with Meds by Paulina Porizkova

Monday, May 23rd, 2011

“My affair with an antidepressant reinforced what I already knew: I’m not one for affairs. I’d rather fight tooth and nail to keep and restore what I have than take a break from it. But that is so much easier said than done with a Klonopin in my pocket.”

Huffington Post   May 18 2011

by Paulia Porizkova – Supermodel


I felt guilty. I felt unnatural. I felt ashamed. Finally, I broke down and confessed my dirty little secret to a girlfriend and found that she not only knew what I was talking about, but she was doing it, too. And the more I opened up about it, the more I found that I was not alone. Women in their late 30s and 40s were all having the same affair.

With an antidepressant.

I started taking Lexapro after my anxiety attacks came back and, for all intents and purposes, practically crippled me. I’ve always had anxiety attacks, or panic attacks as some know them, but after years of learning how to deal with them, I thought I had them under control. While my kids were little, the anxiety attacks even subsided to the point where they hardly bothered me. But at the stroke of 40, they came back worse than ever.

I couldn’t get in a car, a bus and certainly not an elevator without panic overwhelming me: a crippling, terrifying sense of dread. I couldn’t draw a proper breath, my heart pounded and heat flashed through my body, making me break out in sweat. To top it off, my PMS symptoms of frustration, depression and irritability stretched two to three weeks instead of the typical one.

My doctor, fully aware of my dislike for medication of any kind (please, I had two kids all natural, I could take some pain!) suggested that I deserved a break from anxiety. Rebooting the system, he called it. He also fully supported the idea that I begin talk therapy, but in the meantime, he offered me the following analogy: you can build a house with your hands, or you could use power-tools. Either way, you’re building a house, right?

I had just gotten kicked off of “Dancing with the Stars” (as the first contestant) and my ego traveled back to ninth grade, when I was the least popular kid in school and just couldn’t figure out what I had done wrong to be so disliked. But I had to get over myself, quick. I had children who needed me. I had a husband who needed me. I also had my novel (that took me five years to write) to finally promote. This was no time to sink under!

I knew that unless I did something drastic (far more drastic than my new and intense exercise routine and healthy diet-plus-vitamins, but less drastic then running away from home and my life, screaming, blinded by tears and rain, down, say, Fifth Ave), I would at the very least alienate all my friends, my children and my husband.

Lexapro it was.

At first, the stuff didn’t seem to work. It wasn’t until a few months into treatment that I realized what had happened. My world had quieted. The constant buzz of anxiety became noticeable only by its absence. It was like spending your entire life in a room buzzing with fluorescents, and then, one day, they stop. I wasn’t even quite sure what to do with this silence, how to live in it.

When I had to have a physical for insurance on “America’s Next Top Model,” I truthfully wrote down the only medication I took, Lexapro. Writing was admitting it, and I did so with a fair bit of trepidation. Unfortunately, this was promptly broadcast all over the “ANTM” production set. It seems I couldn’t be properly insured on a TV set if I was taking an antidepressant. I had just started taking it, and this reaction was exactly what I had feared. I was judged crazy. Unstable. It was almost enough to get me to stop it before it had even had a chance to work. Fortunately, the woman in charge of all this paperwork laughed and admitted that she was also taking said medication — weren’t we all? The production could just write a waiver taking their chances with crazy ol’ me. And they did.

As I got braver and dared to speak more openly about what I perceived as a terrible weakness, my girlfriends, one by one, stepped up and admitted that they were also on antidepressants. At one point, I found myself at a girls-night-out dinner and discovered all eight of us were on assorted antidepressants! One girlfriend took it because she was depressed. One took it because she got too angry. One also suffered from anxiety attacks. The reasons were diverse, but what we had in common were our age ranges and being married with children.

This shocked me. It also got me wondering. What was going on here? Was this a sort of universal malaise that hit peri-menopausal women? Without antidepressants, would we all be quietly suffering, or exercising like maniacs, having sexual affairs, turning to alcohol or drugs? Was this the female equivalent of a male midlife crisis — Botox and antidepressants instead of the fast car and young chick?

I spent two years with my lover Lexapro; the two most mellow years of my life. My immediate frustrations were comforted, my resentments muffled, my anxiety calmed; I was wrapped in a thick, warm comforter, insulated against the sharp pangs that came with living.

But I was also insulated against or from fun things like my creativity and sexuality. I used to joke to my friends that after 24 years with my husband, we were, sexually speaking, a finely tuned precision engine. But now it felt as though I was being touched through a barrier, or, in this instance, a thick and cumbersome rug. After a while, it seemed like being intimate was just too much work for too little pay.

And as for creativity, well, with my new sense of peace, I found I had no need to actually say anything. This, for a writer, is akin to a cook who has no appetite. Sure, it’s possible to work, but the results will be uninspired at best. I no longer bothered to fight with my girlfriends, or husband; I could just shrug and walk away from situations that previously had me in endless knots analyzing and discussing. And so, for two years, I learned nothing new. I felt emotionally Botoxed. Who was I under the blankets? What did I really feel like? I began to wonder and to want me back, even at the steep price of misery.

I decided that this affair had all the drawbacks of an affair: the sexual distancing from my husband, the guilt, the lies; and the benefit — silence from the fluorescents — didn’t seem worth the price.

The weaning was predictably unpleasant, three weeks of being tired and shaky from wrangling with awful dreams. And then anxiety came creeping back: the clamminess, the suddenly speeding heart, the heat flashes, the disorientation. But this time, I also became aware of something I may have previously neglected under the loud hum of anxiety, or failed to identify, or perhaps simply didn’t have: depression. It could have been circumstantial: after all, with my career at crossroads, my children no longer needing me every minute and my face and body beginning to cave under the demands of gravity, I had something to be a little down about.

I upped my exercise routine to every day. I could finally understand the drug addicts who had cleaned up but wrestled with the urge to use every day. With the drug, I didn’t feel like me, but without it, I also didn’t feel like me — at least not the me I remembered, the one I wanted to be. My kids got to know a whole other side of mommy: an irrational, frustrated, weepy woman who had previously been tightly leashed and only let out when I was alone. I felt sorry for myself and then terribly guilty because I had absolutely no right to feel sorry for myself. The world seemed to be too heavy to carry by myself, but I could not ask for help, because I had never needed help before and didn’t know how to ask. There were moments of sunshine, though. And I could feel its warmth and take pleasure in it rather than just noticing it.

The years since have been categorized by a fair deal of misery and soul-searching — but also learning. I am on some sort of an accelerated life comprehension program I didn’t sign up for, but nevertheless must process. This got me thinking: could it be possible that these feelings are growing pains? Perhaps they are necessary to cross to the other side where peace and confidence of age will finally triumph. After all, it’s not only teenagers who have to adjust to changing hormones, and most of us can still remember the misery.

And I’m starting to wonder whether antidepressants can often be the emotional equivalent of plastic surgery. With them, we can stave off the anguish of change; we can take breaks from the afflictions of living. But is it also possible that through the serendipitous use of these brand new staver-’off’ers, we will ultimately pay a price: the price of going through life anesthetized and smooth with all the self-awareness of a slug?

I will never cease to be grateful to live in a time where knowledge has made it possible for people to no longer suffer. But would that knowledge exist without a little suffering? I’m certainly not an anti-medicine crusader — in most cases modern medicine saves lives. There must be a large percentage of people for whom an antidepressant makes the difference between life and death, or at the very least, the difference between a life worth living and a life to be endured.

But I also think that those who try to take the shortcuts — the pill to lose weight, the pill to be happy, the pill to be smart, to sleep, to be awake, are just running up their tab. And there may not be a pill when you’re presented with the bill. Which you will. (Sorry for the trite rhyming, I couldn’t resist.)

My affair with an antidepressant reinforced what I already knew: I’m not one for affairs. I’d rather fight tooth and nail to keep and restore what I have than take a break from it. But that is so much easier said than done with a Klonopin in my pocket.

http://www.huffingtonpost.com/paulina-porizkova/ending-a-midlife-affair-with-meds_b_862442.html

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The Problem With Rehab: Medicalizing Drug Addiction

Sunday, May 22nd, 2011

ABC News

by STEFAN P. KRUSZEWSKI, M.D.

"clients are continuing to rely heavily on pills to combat their anxieties, mood changes and addiction. "

In my specialty as an addiction  psychiatrist, I have often advocated for residential treatment when unremitting drug and alcohol problems persist because other, less intensive, services have failed. That may soon change.

Over the past two years, I’ve witnessed a worrisome trend: the medicalization of addictions. Some of this makes no sense to me. Let me explain.

There have always been drug treatments for acute detoxification of drug and alcohol problems. The drugs have changed over the years, but the concept of providing a brief period of drug stabilization to prevent seizures or delirium or to mitigate psychosis has gone one unabated.

For instance, barbiturates were once used to minimize alcoholic delirium, but the barbiturates were replaced by benzodiazepines and, although still commonly in use, the benzodiazepines have been more recently supplanted or co-administered with anti-seizure drugs, like valproex or gabapentin. The endpoint has largely been the same: we will stabilize the patient over an acute period of rapidly changing health conditions (sweating, diarrhea, pulse, blood pressure, temperature, pain) and, once the detoxification has been successfully completed and the patient is comfortable and alert, we will begin a process of education and behavioral health techniques to foster a hoped-for drug free recovery state.

That is changing, however, in certain facilities in ways that I believe are destructive and counter-productive.

Two cases serve as illustration: I’m asked to review the medical necessity and reimbursement for care provided in a high profile and nationally-acclaimed drug rehab. The case is of a 20-year-old male from the northeastern United States who is addicted to a drug, methadone (an opioid agonist replacement medicine) and alprazolam, a benzodiazepine anti-anxiety drug. He enters treatment and spends 29 days in rehab, where he is provided buprenorphine (a partial opioid agonist replacement drug for opioid dependence) in decremented detox and maintenance for the duration of his stay and clonazepam (used as a substitute for his alprazelom addiction). He is discharged with the recommendation and prescription to return home and continue methadone and clonazepam.

That’s worth repeating. The patient is discharged to continue the same addictive drug for which he was admitted and a longer-acting (and still habit-forming) benzodiazepine drug to replace his other anti-anxiety medication. And with a price-tag of nearly $40,000.

Separately, I’m asked to review, for medically necessity and reimbursement purposes, the care of a 53-year-old woman. Like the young man in the above synopsis, she enters a world-class drug rehab in Florida, but this time for alcoholism. At the time of admission, she is also taking an SSRI antidepressant and a benzodiazepine anti-anxiety drug.

She spends 27 days in the facility. At various times during her admission, not unlike many individuals being weaned off alcohol, she complains of mood fluctuations, anxiety, sleeplessness and body aches. At the time of discharge, she has been taking — and she is recommended to continue to take — seven drugs: citalopram, an SSRI antidepressant; bupropion, an SNRI antidepressant; a small dose of an antipsychotic, aripiprazole, to augment the antidepressant effects of her two different antidepressants; a small dose of thyroid supplement, thyroxine, to do the same; gabapentin, an antiseizure medicine and clonazepam, both prescribed to decrease her anxiety; and carisoprodol, a centrally-acting anti-muscle spasm drug to minimize her musculoskeletal discomfort.

Capsulizing the above: A woman with alcohol dependence on one drug for depression is treated in rehab for almost a month (at a cost of a little more than $45,000) and is discharged on seven drugs, including not one, but two (clonazepam and carisoprodol) with significant habit-forming and addiction-enhancing characteristics.

Message to substance providers: We have a problem. Although addiction experts may justify these “treatments” because education and solace is provided to the patients, I believe that this mocks the purpose of (the very important and necessary) addiction treatment. There is little, if any, harm reduction, because the clients are prescribed the same or other addictive compounds during and after rehab. The clients are also prescribed new drugs, particular in the latter case of the alcoholic woman, whose potential for drug-drug interactions and future adverse events cannot be accurately predicted.

The clients are receiving expensive inpatient care for services and treatment that could easily be managed in cheaper and less-acute-care outpatient settings, like intensive outpatient or partial hospital programs. And, most importantly, the clients are continuing to rely heavily on pills to combat their anxieties, mood changes and addiction.

Problem? Relying on pills got them to rehab in the first place. So what’s the point of attending and paying for — or charging a commercial insurance carrier, Medicare or Medicaid, or any other third-party payer — for an expensive retreat that leaves you in virtually the same mental place, or worse, than you started? Not that much.

Dr. Stefan Kruszewski is an addiction psychiatrist and CEO of Kruszewski & Associates, a Harrisburg, Pa., company that focuses on health care and financial fraud.

http://abcnews.go.com/ad/gmaintroad.html?goback=http://abcnews.go.com/Health/MindMoodNews/addiction-treatment-medicalization-wrong-approach/story?id=13642451

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Wellbutrin – To Promote or Not Promote… That is the Question

Friday, May 6th, 2011

Seroxat Sufferers – Stand Up and Be Counted
By Bob Fiddaman
May 6, 2011

Did they or didn’t they?

Lauren Stevens, the Glaxo associate general counsel, who is charged with one count of obstructing an official proceeding, one count of falsifying documents before a federal agency and four counts of making false statements to the FDA, has heard evidence given to a jury by James Millar, GSK vice president of strategic pricing, contracting and marketing.

Millar had originally refused to testify but prosecutors persuaded the US District Judge [Roger W. Titus] to order him to give his testimony.

Millar was head of GSK’s marketing for Wellbutrin and remained insistent that GSK’s promotion of its product was as an antidepressant that carried low risk of weight gain and sexual dysfunction.

GSK have claimed that they worked with doctors to stop the promotion of Wellbutrin for off label use.

In 2002, writes Law 360′s Christopher Norton, “GSK became aware that the company’s two top promotional-speaker doctors were using slides in their presentations including information for off-label uses of the drug, but swiftly took steps to bring the pair into compliance with all regulations.”

Those top two doctors were named as Psychiatrist James Hudziak and physician James Pradko, they were both the most highly paid doctors in GSK’s Wellbutrin promotional stable.

It was Millar who, alongside others at GSK, worked with doctors that GSK, claimed, paid to promote the drug in an effort to ensure the physicians removed any mention of off-label uses from their presentations, especially in the wake of new regulations that began to roll out around 2002, he told the jury, writes Christopher Norton for Law360.

It is alleged that Lauren Stevens lied to the FDA when they sought information from GSK about whether or not they promoted Wellbutrin for weight loss. It’s also alleged that Stevens knew GSK had sponsored programs that promoted Wellbutrin as a weight loss drug. Stevens is also alleged to have known that GSK had paid many doctors to promote Wellbutrin to other doctors which included “off-label” use.

Millar claims that he was sent to monitor Psychiatrist James Hudziak after concerns were raised about his potential use of off-label slides, slides he used at presentations. Millar was apparently able to make Hudziak change the presentation and got him to start using a “company approved” slide kit.

Stevens has claimed that she concealed slides from the FDA showing that GSK was promoting Wellbutrin for illegal unapproved use, she has also claimed that she was advised by a company lawyer to do so.

So, we have GSK saying they did everything in their power to stop doctors promoting the illegal, unapproved use of Wellbutrin… yet we have Stevens, as part of her defence, claiming she concealed slides that showed GSK was promoting Wellbutrin for illegal unapproved use. Not only that – she was told to do so by one of GSK’s lawyers!

The mind boggles at how this company operate.

It seems that Stevens, the former Glaxo associate general counsel, is now turning against the very same people she used to work for. You go girl.

The case against Stevens continues.

Her re-indictment can be viewed HERE

Read article here:  http://fiddaman.blogspot.com/2011/05/wellbutrin-to-promote-or-not.html

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Autopsy of Florida School Board Shooter Shows Antidepressant in His System

Thursday, April 14th, 2011

The Walton Sun – April 14, 2011
By S. Bradly Calhoun

10 recent massacres were committed by those under the influence of psychiatric drugs resulting in 54 dead and 105 wounded

PANAMA CITY — The man who held the Bay District School Board hostage before killing himself last year had an antidepressant, acetaminophen and foot fungus medication in his system, his autopsy revealed. The report on Clay Duke was released Wednesday by the Bay County medical examiner’s office.

Duke, 56, killed himself Dec. 14 after firing several shots at school board members during a public meeting. Duke was brought down by three bullets from Mike Jones, the district’s chief of safety.

A toxicology report revealed that at the time of Duke’s death, he had atropine, a drug commonly used in emergency rooms to resuscitate dying patients; acetaminophen; Terbinafine, used to fight fungal infections in fingers and toes; and Citalopram, an antidepressant found in Celexa, in his system.

Forest Laboratories Inc., which makes Celexa, notes on its website the company urges patients to “call a health care provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression, new or worse anxiety, feeling very agitated or restless, panic attacks, trouble sleeping (insomnia), new or worse irritability, acting aggressive, being angry, or violent, acting on dangerous impulses, an extreme increase in activity and talking (mania), other unusual changes in behavior or mood.”

Attempts to contact officials with Forest Laboratories were unsuccessful Wednesday.

To read international studies and drug regulatory warnings on psychiatric drugs click here and use the red search box with the following terms; violence;mania; homicidal; psychosis; http://www.cchrint.org/psychdrugdangers/drug_warnings.php

To see what doctors, pharmacists, health care providers and others have reported on the antidepressant Celexa click here and simply chose Celexa from the drop down menu Drug Name/Drug Class http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

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