Throughout the past decade, GlaxoSmithKline has faced 50,000 lawsuits over its Type 2 diabetes drug Avandia. The lawsuits often allege the drugmaker failed to disclose that the popular drug may significantly increase the risk of heart attack and heart-related death.The drug’s maker, GlaxoSmithKline, has set aside $3.4 billion to settle individuals’ lawsuits over the drug and has paid another $90 million to 37 states and the District of Columbia after Attorneys General sued the company over its marketing of Avandia.
*Please seek the advice of a medical professional before discontinuing the use of this drug…..”
Interesting article (above) which mentions GSK’s 50,000 lawsuits over its heart-attack causing Diabetes drug- Avandia. Avandia has been dogged by controversy for a long time, however it’s interesting to see the figures in terms of lawsuits for drug damage because of it. I often wonder what the CEO’s of GSK (and the executives in general) think of these kinds of figures? Do they think that 50,000 people damaged is an acceptable number? Is it collateral damage to them? or do they not give a damn at all and barely give these things a second thought. Personally I think only a sociopath could ignore these kinds of things and collect the paycheck while people die or get harmed from defective dodgy drugs like Seroxat and Avandia.
50,000 lawsuits is a lot for one drug- however there has been similar numbers with GSK’s SSRI drug- Paxil/Seroxat, and other drugs such as Myodil, Pandemrix, Cervarix- etc – which have all been dogged by controversy and legal actions- some ongoing. Disturbingly too, 50,00 lawsuits is the tip of the iceberg in terms of damage – as many people cannot afford to bring pharmaceutical companies to court- or often times- they are dead from the drug so recourse is an impossibility.
How many people have GSK harmed, or killed, since its inception as a company over 100 years ago?
You won’t see that figure in their promotional brochures
And you certainly won’t hear the CEO’s talk about that either..
“…Pharmaceutical maker GlaxoSmithKline will not get a chance to undo a jury’s verdict, finding it owes $3 million to the widow of a Chicago lawyer who committed suicide, allegedly after taking a generic equivalent of GSK’s anti-depressant drug, Paxil….”
Great news for those of us who have been blogging about all things GSK/Paxil and Seroxat related for the past decade or more. It’s good to see the truth finally emerge about the dangers of GSK’s Seroxat/Paxil SSRI ‘antidepressant’.
Wendy Dolin should be very proud. This lawsuit will help bring awareness of akathisia – a horrible side effect which I and many others endured from Paxil and other SSRI’s. It will save lives..
Lawsuit Over a Suicide Points to a Risk of Antidepressants
The last dinner Wendy Dolin had with her husband, Stewart, he was so agitated that he was jiggling his leg under the table and could barely sit still. He had recently started a new antidepressant but still felt very anxious. “I don’t get it, Wen,” he said.
The next day, Mr. Dolin, a 57-year-old Chicago lawyer, paced up and down a train platform for several minutes and then threw himself in front of an oncoming train.
Ms. Dolin soon became convinced that the drug her husband had started taking five days before his death — paroxetine, the generic form of Paxil — played a role in his suicide by triggering a side effect called akathisia, a state of acute physical and psychological agitation. Sufferers have described feeling as if they were “jumping out of their skin.”
The distress of akathisia may explain the heightened risk of suicide in some patients, some psychiatrists believe. The symptoms are so distressing, a drug company scientist wrote in the Journal of Psychopharmacology, that patients may feel “death is a welcome result.”
Ms. Dolin sued the original manufacturer of Paxil, GlaxoSmithKline, claiming the company had not sufficiently warned of the risks associated with the drug. In April, a jury awarded Ms. Dolin $3 million in damages.
The case is a rare instance in which a lawsuit over a suicide involving antidepressants actually went to trial; many such cases are either dismissed or settled out of court, said Brent Wisner, of the law firm Baum Hedlund Aristei Goldman, which represented Ms. Dolin.
The verdict is also unusual because Glaxo, which has asked the court to overturn the verdict or to grant a new trial, no longer sells Paxil in the United States and did not manufacture the generic form of the medication Mr. Dolin was taking. The company argues that it should not be held liable for a pill it did not make.
Concerns about safety have long dogged antidepressants, though many doctors and patients consider the medications lifesavers.
Ever since they were linked to an increase in suicidal behaviors in young people more than a decade ago, all antidepressants, including Paxil, have carried a “black box” warning label, reviewed and approved by the Food and Drug Administration, saying that they increase the risk of suicidal thinking and behavior in children, teens and young adults under age 25.
The warning labels also stipulate that the suicide risk has not been seen in short-term studies in anyone over age 24, but urges close monitoring of all patients initiating drug treatment.
“The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm or suicidal thinking in adult populations,” Frances DeFranco, a company spokeswoman, said in an email. “Any suicide is a tragedy, and a reminder that depression and other mental illnesses can be fatal.”
Ms. Dolin’s lawsuit, however, has lifted the curtain on data from early clinical trials of Paxil, renewing concerns that older adults, who use antidepressants in far greater numbers than young people, may also be at greater risk of self-harm when taking the drugs.
The documents indicate that several suicides and suicide attempts in early clinical trials that were attributed to patients on a placebo — and which made Paxil look safer by comparison — should not have been counted, and that an F.D.A. reviewer later told the company as much. Glaxo eventually reanalyzed its data, and in 2006 enhanced the warning on Paxil, cautioning that among adults of all ages with major depressive disorder, “the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo” — 6.7 times higher.
But that label was replaced a year later, in June 2007, by the F.D.A.-mandated warning now carried on all antidepressants, which says only that the increased risk has been seen among people under age 25.
A Delicate Risk Calculation
Some 325 million prescriptions for antidepressants were filled last year in the United States, including 15 million for Paxil and paroxetine, according to IMS Health, a health care information company.
But while one in 10 Americans aged 12 and older has filled an antidepressant prescription, one in seven adults aged 40 and over has done so, including nearly one in five middle-aged women, according to the National Center for Health Statistics.
Many psychiatrists say the benefits of antidepressants far outweigh the risks, even for younger patients, and that the drugs are highly effective and generally well tolerated. Several prominent experts have been critical of what they say is excessive attention to the dangers, which they say could potentially dissuade people who could benefit from treatment from accessing care.
The issue is complicated by the fact that depression and other mental illnesses can themselves lead to suicide.
“Antidepressants prevent more suicides than they cause, probably by a large multiple,” said Dr. Peter Kramer, a psychiatrist and clinical professor emeritus at Brown University and the author of several books about antidepressants, including “Listening to Prozac.”
Dr. Kramer, who was not involved in the Dolin litigation, said he urges patients to contact him right away if they have a bad reaction during the first weeks after starting treatment with the drugs — and especially in the first five days.
“When I put people on medication for the first time, I say we’re going to be very cautious in the early going,” he said.
The prescribing information on antidepressants specifically warns that patients should be monitored for symptoms like anxiety, agitation, panic attacks, mania and akathisia. “There is concern that such symptoms may represent precursors to emerging suicidality,” the labels say, especially if they were “abrupt in onset” or “not part of the patient’s presenting symptoms.”
Akathisia is, by definition, a drug-induced syndrome. The word comes from Greek and means “not to sit,” referring to an inability to sit still. Akathisia is characterized by anxiety, restlessness and a compulsion to move or walk about; patients may pace back and forth, or fidget endlessly in their chairs.
It may develop when a patient, adult or younger, begins treatment, but it can also emerge when the dosage of the drug is increased, decreased or discontinued. Patients who have tolerated a drug in the past may develop akathisia when they start a new course of treatment, experts say.
Akathisia is a fairly common and well-known side effect of antipsychotic medications, commonly used to treat disorders like schizophrenia but increasingly given for a variety of mental health complaints, including depression. But the association with antidepressants is not as well recognized, experts say, and incidence rates are hard to pin down.
A group of psychopharmacologists who reviewed over 100 studies found the reported rate of what they broadly called “jitteriness/anxiety syndrome” — which they defined as a worsening of anxiety, agitation and irritability — ranged from 4 percent to 65 percent among patients initiating treatment with selective serotonin reuptake inhibitors, or S.S.R.I.s, the popular class of antidepressants to which Paxil belongs.
Psychiatrists linked S.S.R.I.-induced akathisia to suicidal behavior in a 1991 paper describing three patients who survived violent suicidal attempts — including jumping off the roofs of buildings and off a cliff — shortly after they had started fluoxetine or had the dose increased.
The patients were removed from the drug, but then agreed to try another course of treatment with fluoxetine under close observation. All three became extremely agitated and had a recurrence of suicidal thoughts.
“This is exactly what happened the last time I was on fluoxetine, and I feel like jumping off a cliff again,” one of the patients reportedly said. Another said she had tried to kill herself “because of these anxiety symptoms. It was not so much the depression.”
Dr. Anthony J. Rothschild, one of the study’s co-authors, has since disavowed the paper, saying it was an observation that has been disproved by subsequent drug company clinical trials.
He testified as an expert witness for Glaxo in the Dolin trial.
Akathisia symptoms so closely resemble symptoms of anxiety and depression that it may be hard for a doctor to distinguish between the underlying illness and what could be a side effect of the drug used to treat it, said Dr. Joanna Gedzior, an assistant clinical professor of psychiatry at the Fresno Medical Education Program of the University of California, San Francisco.
If a doctor thinks the patient’s condition is deteriorating, he or she may increase the dose of the medication, which could be disastrous if the drug itself is causing the problem.
“We have to be very careful about this and ask, ‘Is it something I’m giving the patient that’s causing this?’” said Dr. Gedzior, who wrote a paper on akathisia.
Doctors at Southern Illinois University School of Medicine last year described the case of a 45-year-old man who developed akathisia just days after he was put on an antidepressant but was misdiagnosed as having panic attacks. When doctors doubled his dose, he attempted suicide.
The doctors warn that akathisia “can be one of the most ambiguous clinical diagnostic presentations in all of psychiatry” and is “often underdiagnosed or misdiagnosed.”
“We know that anxiety and akathisia create a sense of hopelessness, especially if the feelings are not validated,” Dr. Gedzior said, and hopelessness can lead to suicidal thoughts. The combination of akathisia, anxiety and depression puts patients at risk of suicide, she believes.
Explaining to patients that their emotional turmoil may be caused by a drug side effect can alleviate their distress, she said. Doctors can reduce the patient’s discomfort by discontinuing the drug, or adding another prescription, such as an anti-anxiety medication.
During the Dolin trial, a therapist testified that Mr. Dolin had called to schedule a same-day session on July 14, the day before his suicide. But Mr. Dolin was unable to sit still during their meeting, shifted nervously in his chair, and could not calm down.
The therapist was so worried that she called him at work the next day — the day of his suicide — to urge him to ask his doctor for anti-anxiety medication.
Ms. Dolin is convinced her husband was not suicidal until he developed akathisia as a side effect to paroxetine. Her husband was having “one of his best years ever,” she said. The couple were high school sweethearts who had been married for 36 years, and had adult children who were thriving and a large circle of friends.
“Stewart occasionally had stress and anxiety associated with being a high-powered attorney, but he had great coping skills, and he would seek counseling and move on,” said Ms. Dolin, who has started an organization called Missd to raise awareness about the warning signs of akathisia.
“The only thing different this time was that he had started Paxil.”
How many kids were harmed from GSK’s over-hyped and over-sold Flu Vaccine – Pandemrix?
Do you think GSK’s former CEO Andrew Witty gives a second thought to the suffering of these children? or do you think the current CEO -Emma Walmsely- loses a single nights sleep over the suffering of these kids?
“…Andrew Witty, the former long-serving chief executive of UK drugmaker GlaxoSmithKline, has jumped into the biotech venture-capital sector and been hired by a former industry mentor to join Hatteras Venture Partners. Sir Andrew becomes a venture partner at US-based Hatteras. Separately, GSK’s ex-research and development head Moncef Slaoui has joined European venture firm Medicxi. “We are thrilled to welcome Andrew to Hatteras Venture Partners. He brings unparalleled strategic insights and extensive industry experience to the firm and to our portfolio of emerging companies,” said Bob Ingram, general partner of Hatteras….”
Lawyers acting for families who say their children suffered significant health problems following a controversial swine flu vaccine are due in court next month as part an effort to force the State to release crucial documents.
The Health Service Executive (HSE) has now identified 300,000 documents relevant to the case and the Department of Health has 465,000 which need to be examined.
The vaccine, called Pandemrix, has been linked to the sleep disorder narcolepsy. Lawyers for both sides will appear in the High Court on October 5.
The State indemnified the vaccine’s manufacturer, GlaxoSmithKline (GSK), against potential lawsuits. Other European countries did likewise, amid global fears of a swine flu pandemic in 2009.
However, some countries, including Poland and Switzerland, refused to licence it, saying it was insufficiently tested.
More than 60 children may have had their auto-immune system compromised by the vaccine rolled out by as part of a public health campaign in early 2010, according to families.
Irish authorities are fighting the families “tooth and nail” over accepting liability, according to solicitor Michael Boylan, a medical negligence expert with law firm Augustus Cullen, which represents more than 60 children.
“….A devastated girl has spoke about how the HPV vaccine snatched her teenage years from her and begged the HSE not to “abandon” her.
16-year-old Rebecca Hollidge, from Carrick-On-Shannon in Co Leitrim, got the cervical cancer jab Gardasil in 2013 and her life has been turned upside down.
Rebecca now relies on a wheelchair to leave the house, is in constant pain and when she suffers a “crash” can spend up to 23-hours a day asleep….”
It’s not often that I veer into Vaccine territory. However, I couldn’t help but be struck by this video (see second one above) of an Irish girl (Rebecca Hollidge) questioning one of the people involved in the manufacturing process of the HPV vaccine Gardasil (Virologist Margaret Stanley). Rebecca was harmed by the vaccine, but despite this, she has the courage to fight the injustice that was done to her, and many other girls.
Rebecca asked Margaret, ‘do you feel guilty for promoting this vaccine’? ‘more girls end up like me’, ‘in a wheelchair’, ‘not attending school’.. ‘do you feel guilty’… “yes or no”?…
Margaret responds with… ‘no I don’t feel guilty’….
This exchange, is a perfect example of what happens when a person gets injured by a pharmaceutical product. Nobody is held to account, the victim’s reality is denied, and the manufacturers display contempt, not empathy, towards the people that they harm. The only way to access the truth about the drug is through the court system, and even then- often cases are sealed- or gagged.
What a horribly cruel and inhumane system.
Similar to Gardasil, GSK’s Cervarix, has caused damage to many thousands of girls world-wide, and of course GSK deny it. Just like they deny the harm from Seroxat, Avandia, Pandemrix, Myodil, Tafenoquine and god knows what else…
It’s all about profits for the Pharmaceutical industry- the patient harmed is just road-kill to them…
How the corporate executives, and everyone else on the Pharma’s payroll, can turn a blind eye to the suffering of those who get harmed or injured is beyond me..
Their big paychecks must balance their consciences somehow..
“…..Erina Sonoda, a 20-year-old college student, said she started to suffer strong menstrual pain after receiving the second of three recommended shots of the Cervarix vaccine, and the pain spread to other parts of her body after the third vaccination.
Due to agonizing pain, Sonoda said she has difficulty walking without a cane and often must use a wheelchair.
“I felt acute pain as if someone was squashing my internal organs. … Such conditions have only gotten worse,” Sonoda told the court while sitting in a wheelchair.
“I received the shots because the government recommended it,” she said. “I want the government to take seriously its responsibility for causing us (to suffer from) such symptoms.”
Since last July, a total of 119 plaintiffs have filed similar suits with courts in Tokyo, Nagoya, Osaka and Fukuoka, according to Masumi Minaguchi, a lawyer representing the women.
The government and the drugmakers — GlaxoSmithKline PLC and Merck Sharp & Dohme Corp., who make the HPV vaccines Cervarix and Gardasil, respectively — sought Monday to dismiss the compensation claims.
Representatives of the drugmakers said the safety and effectiveness of the medicines against cervical cancer have been scientifically confirmed and denied there is any link between the alleged side effects and the vaccines…”
I’m glad that someone from GSK’s HQ in London has been reading about Greg Thorpe’s comments on various blog posts on my blog. I wonder how they can sleep at night whilst working for such an abhorrent company…
He is a rockstar of the movement to expose the truth about psychiatric drugs, to many he is a hero and to some, he is an uncompromising agitator. His blog has been viewed over 2 million times and he is respected by many and also well known by the pharmaceutical regulators and many of the pharmaceutical manufacturers too.
I was keen to ask Bobby about his own experiences of the mental health system, his research and campaigning over the years and his relationships with the UK and US pharmaceutical regulatory bodies.
A blog dedicated to the study of complex relationships in pharmacology; with a medicolegal perspective. “Journalism is printing what someone else does not want printed: everything else is public relations.” ― George Orwell | CC-0