RIP Tom Petty..


Another great artist leaves us for the great gig in the sky..

Adios Tom..

 

 

 

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Paxil Birth Defect Cases In The US Press Ahead..


http://chicago-land.legalexaminer.com/fda-prescription-drugs/us-supreme-court-refuses-to-restrict-personal-jurisdiction-in-landmark-paxil-case/

US Supreme Court Refuses to Restrict Personal Jurisdiction in Landmark Paxil Case


Today, the U.S. Supreme Court allowed to stand an appellate court decision stating that a product manufacturer is subject to personal jurisdiction for product-related claims in a state where development or testing occurred, dealing a huge blow to the well-funded big pharma legal teams who may well now find themselves defending their drugs and medical devices in all fifty states.

The U.S. Supreme Court denied cert on M.M. ex rel. Meyers v. GlaxoSmithKline LLC, letting stand an Illinois appellate court case that held that GlaxoSmithKline, a UK company with U.S. headquarters in Philadelphia, would need to defend itself in Illinois state court for catastrophic birth defect injuries resulting from pregnant mothers’ use of its anti-depressant, Paxil.  The Meyers case alleges the drug injured eight minor plaintiffs from six states, including Illinois.  The Illinois Supreme Court had already refused to hear GSK’s appeal from the appellate decision.  Unsatisfied, GSK appealed to the U.S. Supreme Court, which refused to upset the decision of the Illinois appellate court.

The Illinois appellate court previously found that Illinois had personal jurisdiction over GSK based on the defendant’s substantial in-state contacts, namely its contracts with 17 Illinois physicians to participate in 18 to 21 clinical trials on Paxil in Illinois as part of multicenter studies, and the fact that the plaintiffs’ claims arose from the defendant’s acts or omissions related to those trials.

Clinical studies involve research using participants (humans) to evaluate the health outcomes of a particular drug, device, procedure, or behavior.  Generally, these clinical studies are performed by investigators funded by drug companies that are required to submit studies to the Food and Drug Administration.  The principal investigators are generally medical doctors who may be part of a hospital, university, clinic, or general practitioner’s office.  These studies generally happen in all 50 states, and the data are usually consolidated and submitted to the FDA.  Drug companies often also publish results in medical journals.

Today, the U.S. Supreme Court chose to let that case stand by denying the defendant’s petition for a writ of certiorari, which is a written request for the U.S. Supreme Court to review a lower court’s ruling.  The denial of a petition for a writ of certiorari by the U.S. Supreme Court means the decision of the lower court stands as the final decision.

The plaintiffs in Meyers are represented by TorHoerman Law. Robert Peck of the Center for Constitutional Litigation also represented the Plaintiffs before the U.S. Supreme Court. TorHoerman Law partner Ken Brennan wrote the successful Illinois appellate brief.  Brennan says,

“While industry does not like the result, the result makes perfect sense with respect to clinical trials from which the plaintiffs’ claims arise.  Drug manufacturers treat multi-center clinical trial data as a unitary whole and aggregate the data collected in various states to reach statistically significant conclusions.  The portions of the clinical trials that occur in a particular state, however small, cannot be separated from the rest.  And, because inadequate clinical trials naturally lead to inadequate warnings, failure to warn claims arise from or relate to those trials.”

The fact that the claims made in the case arise from or relate to those trials provides a basis for the lawsuit to be heard in the state where the trials occur.

The Meyers decision undermines previous industry efforts to limit personal jurisdiction to drug manufacturers’ preferred jurisdictions under the Daimler AG v. Baumann and BMS v. Superior Court of California cases, both decided by the U.S. Supreme Court.  Since the U.S. Supreme Court chose not to hear the Meyers case, it left open the opportunity for plaintiffs alleging injuries that arise out of or relate to clinical trial data to sue manufacturers in the states where the trials occurred.  Meyers restores some degree of fairness to consumers injured by drug manufacturers.

TorHoerman Law founder Tor Hoerman released the following statement in response to the Supreme Court’s refusal to hear the Meyers appeal:

“Four years ago, lawyers for GSK told me that they would not pay these children and their families.  We told GSK that we would file these cases in Cook County.  The lawyers told us we were crazy, that they would tie us up in the appellate courts and we would be in litigation for years.  I promised GSK that day that we would pursue these cases for these deserving families until a court told we could no longer do so.  Well, GSK has kept its promise, and we will keep ours.  The highest court in the land told them they have to litigate in Cook County.  What will they do now?  The right thing?  We shall see.  GSK and our clients can rest assured that Ken Brennan and the lawyers at THL will not quit on these cases.”

 

References:

https://clinicaltrials.gov/ct2/about-studies/learn

Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (which curtailed general jurisdiction) and Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773, 198 L. Ed. 2d 395 (2017)

M.M. ex rel. Meyers v. GlaxoSmithKline LLC, 2016 IL App (1st) 151909, 61 N.E.3d 1026, appeal denied sub nom. M.M. v. GlaxoSmithKline LLC, 65 N.E.3d 842 (Ill. 2016)

GSK’s Statement About Their Dodgy Cervarix Vaccine “Patient safety is always GSK’s first priority”…


Do you really believe that ‘patient safety’ is GSK’s first priority?

I would say that Profits are GSK’s first priority…

Take a look at Whistleblower Greg Thorpe’s Department of Justice Complaint from 5 years or so ago (link below) and then decide whether you think ‘patient safety’ is always GSK’s first priority…

https://truthman30.wordpress.com/2015/08/28/whistleblower-greg-thorpes-7th-ammended-complaint/

 


http://www.dailymail.co.uk/health/article-4909164/Teen-died-HPV-jab-experts-brand-vaccine-useless.html

 

 

Teenager died in her sleep weeks after being given HPV vaccine as experts reveal the lives of thousands of girls have been destroyed by the controversial jab

  • Jasmin Soriat, 19, showed neurological symptoms after having a second HPV jab
  • The teen from Vienna suffered respiratory failure three weeks later
  • Pathologist said the vaccine could have been the cause of her death
  • British teenager Ruby Shallom is also included in the documentary, her family say she was left paralysed  after having the jab
  • The stories of both girls are included in a new documentary in which doctors claim the HPV virus does not even cause cancer 

A teenage girl died in her sleep weeks after being given the controversial human papillomavirus (HPV) vaccine, a new documentary has claimed.

Jasmin Soriat, 19, a student from Vienna, suffered neurological symptoms after having a second dose of the injection and suffered respiratory failure three weeks later.

A pathologist who examined her body has said the vaccine could have been the cause of her death.

Jasmin’s story is one of ‘hundreds of documented deaths following the HPV vaccine’ according to claims in a new three-part documentary, titled Sacrificial Virgins.

Thousands of girls around the world have suffered adverse reactions, often developing chronic fatigue syndrome.

The family of British teenager Ruby Shallom from Bracknell, Berkshire, also claim she was left paralysed in three limbs after having the HPV jab.

She also appears in the documentary and reveals: ‘The only limb that works now is my left arm… I still go out and see my friends but the pain and fatigue makes it hard.’

However health officials across the globe have always strongly denied there are such devastating effects and say there is not enough evidence.

The jab is given to adolescents because the HPV virus is said to cause certain cancers – and almost all cervical forms of the disease.

But other experts have branded the vaccination ‘useless’ and argue there is no proven link between the sexually-transmitted virus and cancer.

 Scroll down for video 

Jasmin Soriat, 19, from Vienna, died from respiratory failure three weeks after having a second dose of the HPV vaccine

Jasmin Soriat, 19, from Vienna, died from respiratory failure three weeks after having a second dose of the HPV vaccine

These girls are among 'hundreds of documented deaths following the HPV vaccine', according to Joan Shenton, the narrator of documentary Sacrificial Virgins 

These girls are among ‘hundreds of documented deaths following the HPV vaccine’, according to Joan Shenton, the narrator of documentary Sacrificial Virgins 

JASMIN’S FINAL HOURS BEFORE SHE WAS FOUND LIFELESS

Jasmin was a ‘fit, happy and fun-loving’ student, according to local newspaper reports.

But less that one month after her last Gardasil injection, her friend discovered her lifeless body.

She died in her sleep of respiratory failure, on December 10 2007 aged just 19.

She had never had any serious illnesses or lung disease, and had never smoked.

Jasmin did not experience any previous problems after any of her normal vaccinations, her family said.

Searching for answers, her parents reconstructed her final hours of life.

A picture of a regular teenager emerged. She attended a concert then went to a fast food restaurant at midnight. She then got a taxi with her flatmate to her home in Döbling. At 2am, she had a cup of tea.

The next morning, her girlfriend came by to check up on her, but Jasmin, according to the woman, ‘must have died a few hours earlier in her sleep’.

In the three-part film, doctors have spoken out to challenge the widely-accepted theory that the HPV virus causes almost all cervical cancers in later life.

Campaigners are comparing the HPV vaccine to the thalidomide scandal, which saw a morning sickness pill given to women in 1960s and 1970s that was later withdrawn after it was linked to birth defects in infants.

Award-winning producer Joan Shenton, who narrates the documentary which is supported by the pressure groups SaneVax and the UK Association of HPV Vaccine Injured Daughters (AHVID) said: ‘In the face of growing evidence of adverse reactions and public calls for a ban, thalidomide was on the market for five years before authorities around the world called a halt.

‘During those years, manufacturers continued to sell and doctors continued to prescribe. The HPV vaccine has been on the market for longer, since 2008, and is routinely administered, often paid for by taxpayers’ money and distributed through schools and health authorities.

‘It too has severe side effects but, unlike thalidomide, the HPV vaccination is not even proven to work. Our films are intended as an urgent wake-up call.’

Pathologist: Vaccine could have killed Jasmine

Government forensic pathologist Dr Johan Missliwetz was ordered by a court to do a second autopsy on Miss Soriat as the first could not establish the cause of death.

He concluded that the vaccine could have been the cause of her demise.

The doctor, who has now taken early retirement, said: ‘I couldn’t find a reasonable cause of death but had two suspicions. One is a genetic disorder of the heart and the other one, it had to do with vaccination.’

THE 16-YEAR-OLD GIRL LEFT PARALYSED BY THE HPV VACCINE

Ruby Shallom suffered spasms and pain

Ruby Shallom suffered spasms and pain

A 16-year-old British girl left paralysed in three limbs after having the HPV jab also appears in the documentary.

Back in 2014, Ruby Shallom from Bracknell, Berkshire, was vaccinated at school to protect her against cervical cancer as part of the routine NHS programme, MailOnline reported last December.

In the new film she said: ‘The only limb that works now is my left arm… I still go out and see my friends but the pain and fatigue makes it hard.’

Weeks after having the vaccine, the keen horse-rider and runner started to suffer from stomach spasms, dizziness, pain, headaches and fatigue.

Her muscles became weaker and in May 2016 – two years after she was given the jab – she woke up with no feelings in her legs whatsoever.

She is now virtually bed bound – unable to eat, lift or dress herself, incontinent and often too weak to lift her head.

Doctors have been unable to diagnose her with anything and have dismissed it as being psychological, refusing to acknowledge any link to the jab.

When he reported his findings to the drug regulation authorities, he said he received a number of phone calls from senior members of the medical establishment.

‘There was a lot of interventions. Many professors called me up and told me I should stop talking about vaccination tests.

‘I’ve done thousands of autopsies but nobody called me. This was extraordinary.’

WHAT IS HPV?

The human papilloma virus (HPV) is the name given to a family of viruses.

There are over 100 different types of HPV, with around 40 types that affect the genital area.

Different types of HPV are classed as either high risk or low risk, depending on the conditions they can cause.

For instance, some types of HPV can cause warts or verrucas. Other types are associated with cervical cancer.

In 99 per cent of cases, cervical cancer is said to occur as a result of a history of infection with high-risk types of HPV.

Infection with other types of HPV is linked to genital warts, skin warts and verrucas, vaginal cancer or vulval cancer, anal cancer or cancer of the penis, some cancers of the head and neck and laryngeal papillomas (warts on the voice box or vocal cords).

Why do the establishment vaccinate against HPV?

HPV infection – which is spread through close skin-to-skin contact, often during sexual activity – is extremely common. Up to eight out of 10 people will be infected with the virus at some point in their lives, according to Cancer Research UK.

It usually causes no symptoms at all and for most people, the body will clear the infection on its own. But for some it stays around for a long time and is believed to cause cancer, for reasons not fully understood.

According to the World Health Organization (WHO), virtually all cervical cancer cases (99 percent) are linked to genital infection with HPV.

It says both HPV vaccines – Cervarix and Gardasil – are ‘highly efficacious’ in preventing infection with virus types 16 and 18, which are together responsible for approximately 70 per cent of cervical cancer cases globally.

Fragments of HPV have been found in cancer cells in studies, hence the theory why the virus causes cancer.

But one of the film’s key arguments is that the presence of HPV in cancer cells does not mean HPV actually causes the cancer.

No proof HPV causes cancer 

Professor Peter Duesberg argues cervical cancers are not caused by HPV

Professor Peter Duesberg argues cervical cancers are not caused by HPV

In the film, Peter Duesberg, a professor of molecular biology the respected University of California, Berkeley said that scientific studies have found that cervical cancers are not caused by the HPV virus.

The academic, who wrote a controversial research paper arguing that HIV does not cause AIDS, said that they prove HPV cannot be found anywhere in the tumour or tumour cells.

‘The [HPV] vaccine should be stopped until it’s proved that it protects against cancer… It has the highest number of side-effects ever of any vaccine,’ he argued.

‘In the US, it has more side-effects reported than all other vaccines combined.

‘Since there is no scientific evidence that it will do anything else than occasionally cause warts, which will be eliminated by the immune system, there is no need for vaccination against this virus.’

He claims the vaccine won’t be properly investigated because GPs and pharmaceutical companies benefit financially. 

Dr Christian Fiala, who specialises in obstetrics and gynaecology in Vienna, also agrees there is no evidence that the HPV vaccine reduces the rate cervical cancer.

‘No-one has shown that the HPV vaccine actually reduces the rate of cervical cancer,’ he said.

‘As long as we have no proof that cervical cancer is caused by HPV, it is fundamentally useless to vaccinate against HPV because the chances are the cancer will occur whether there is HPV or not.’

Previous studies  

An article published in 2015 in the journal Clinical Rheumatology warned that chronic pain conditions are ‘more frequent after HPV vaccination’.

Researcher Dr Manuel Martinez-Lavin warned that fibromyalgia – which causes widespread pain – and a nervous system condition called postural tachycardia syndrome (PoTS), seem to be linked to the jabs.

Symptoms of PoTS include fainting, dizziness, inability to concentrate and fatigue. The condition can be long-term or even permanent

Ruby Shallom, 16, who was left paralysed in three limbs after having the HPV vaccination, features in the new documentary

Ruby Shallom, 16, who was left paralysed in three limbs after having the HPV vaccination, features in the new documentary

Another study, in the European Journal of Neurology examined the cases of six young women who had developed PoTS within weeks of receiving HPV jabs. It, too, suggested there may be a link.

In the US, France, Spain and Denmark, more than 250 court cases are being mounted over HPV vaccinations. Damages have been won in the US and France.

The Japanese government withdrew its recommendation for the HPV vaccine in 2013, after highly publicised cases of alleged adverse events in girls who had been vaccinated.

Officials stick to their stance 

Yet health authorities around the world, including the World Health Organization, have recently extensively reviewed the vaccine and have concluded it is safe.

The UK medicines watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA) and Public Health England said the HPV jab is the most effective way to protect against cervical cancer, which kills 900 UK women each year.

Officials estimate that around 400 lives are saved each year as a result of vaccinating girls before they become infected.

MHRA received 3,972 ‘Yellow Cards’ – a scheme where doctors and the public can report side-effects of drugs – between 2010 and 2013. More than 940 were categorised as serious.

The manufacturers of one of the HPV jabs, Cervarix, insists the benefits of vaccination outweigh any risks associated with its use (stock photo)

The manufacturers of one of the HPV jabs, Cervarix, insists the benefits of vaccination outweigh any risks associated with its use (stock photo)

Yet Dr Ian Hudson, MHRA chief executive, wrote to Richard Benyon, the Conservative MP for Newbury, saying: ‘The fact that we have received more reports for HPV vaccine than other vaccines does not in itself raise any particular concerns.’

A spokesperson for GSK, manufacturers of Cervarix, previously told Good Health: ‘Patient safety is always GSK’s first priority. A vaccine is only ever approved for the public if clinical trials show the benefits of vaccination outweigh any risks associated with its use.

‘Governments globally scrutinise clinical trial data through independent medicines review agencies before vaccines can be approved for use. We remain confident in the favourable benefit-risk profile of Cervarix to help prevent cervical cancer.’

Freda Birrell, who heads the pressure group AHVID said the campaign against the jab is growing.

She said: ‘I’d like to see our politicians listen, I’d like to see them recognise that what’s been happening can not be a coincidence.’ 

Glaxo’s 6.2 Million Payout In 200 Paxil Induced Baby Defect Cases In Canada..


How many babies did Paxil/Seroxat deform world-wide since it was licensed 20 years ago?

 

Do you think Emma Walmsley ever gives a second thought to those babies? or their suffering?


 

https://www.thestar.com/business/2017/03/01/bc-firm-reaches-62m-paxil-settlement-in-class-action-against-glaxosmithkline.html

 

VANCOUVER—A proposed settlement has been reached in a lawsuit filed by a woman who alleges her daughter suffered a birth defect after she was prescribed the anti-depressant Paxil during pregnancy.

Rosenberg Law, a Vancouver firm that filed the class-action lawsuit involving about 50 mothers and their children, says it has reached a $6.2-million settlement with GlaxoSmithKline Inc.

In a statement on Wednesday, the pharmaceutical company says it has agreed in principle to settle the lawsuit but it does not admit to any liability or wrongdoing as part of the agreement, which must still be approved by the Supreme Court of British Columbia.

Read more:Using antidepressants early in pregnancy may raise birth defects risk

Faith Gibson of British Columbia was named as the representative plaintiff in the suit after her daughter Meah Bartram was born with a hole in her heart in 2005.

Gibson’s initial statement of claim filed in B.C. Supreme Court in 2012 alleged that Paxil increased the risks of damage to the heart and lungs of newborns, who it contends were unable to breath properly due to constricted blood vessels.

GlaxoSmithKline says patient safety is its “highest concern” and it continues to believe that it provided accurate and updated information on Paxil to regulators, and also communicated safety information to regulatory agencies, the scientific community and health-care professionals.

The company says it agreed to the proposed settlement “to avoid the time and expense associated with the trial and the subsequent steps in the class-action proceeding.”

“We continue to be of the view that the scientific evidence does not establish that exposure to Paxil during pregnancy causes cardiovascular birth defects.”

Rosenberg Law says as many as 200 children in Canada could benefit from the settlement.

In a decision released in 2013 upholding the class-action lawsuit, the B.C. Court of Appeal said the company sent a letter to health professionals in September 2005 that referred to preliminary results about a study that showed an increased incidence of cardiovascular defects in babies born to women who took Paxil during the first trimester of pregnancy.

Gibson’s daughter was born about two weeks before the company sent the letter to doctors.

In February 2006, the company amended the product label to outline the potential problems that might arise.

The plaintiffs alleged in court that the company knew or ought to have known of the risk before then.

 


 

GlaxoSmithKline’s 50,000 Avandia Lawsuits…


https://www.drugwatch.com/avandia/litigation/

Avandia Lawsuits and Settlements

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…..”

https://medslawsuit.com/drug-injuries/avandia-lawsuit/


 

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..

Publicly at least anyhow..

 

GSK Loses Its Appeal Against Wendy Dolin..


“…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….”

http://cookcountyrecord.com/stories/511217908-judge-no-need-for-new-trial-3m-verdict-vs-gsk-over-lawyer-s-suicide-should-stand

 

 

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

Photo

Wendy Dolin’s husband, Stewart, killed himself in 2010, and she believes the antidepressant he had begun taking, a generic form of Paxil, was responsible. In April, a jury awarded her $3 million. Credit Whitten Sabbatini for The New York Times

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.

Photo

Wendy and Stewart Dolin on vacation in Aspen, Colo., in 2006. Ms. Dolin’s lawsuit raised questions about the risk of suicide in adults taking antidepressants.

“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.

Suicide Data Incorrectly Reported in Drug Trials, Suit Claimed

Paxil was approved following large clinical trials. But two suicides recorded in the placebo group should not have been counted, an F.D.A. reviewer wrote. Read more »

“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.

Photo

A photograph from the wedding of Wendy and Stewart Dolin in 1974. Mr. Dolin went on to a successful, if stressful, career as a high-powered attorney. Credit via Wendy Dolin

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.”

“…Negligence is alleged against the State and GSK in administering an untested vaccine and/or a defective product…”


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?

Or are both too busy counting the millions they reaped, and continue to reap, from their careers in one of the most corrupt pharmaceutical companies on the planet?

“…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….”

https://www.ft.com/content/adfadcdc-9d49-11e7-8cd4-932067fbf946

 


http://www.independent.ie/irish-news/health/parents-distraught-over-delay-in-getting-vaccine-documents-36114969.html

 

Parents ‘distraught’ over delay in getting vaccine documents

Michael Boylan. Picture: Collins 1
Michael Boylan. Picture: Collins
Martina Devlin

Martina Devlin

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.

Read More: Foetal damage ‘is a hidden phenomenon in Ireland’

Mr Boylan said the State refuses to accept it owes a duty of care to the children who received the vaccine.

Progress has been painfully slow and parents are completely distraught.” he said.

He says the Department of Health’s stance is causing delays in dealing with the issue of compensation and agreeing a care package for those affected.

In a statement, the Department of Health told the Irish Independent that the vaccine was bought by the State in response to a pandemic alert from the World Health Organisation.

 

It said complying with the discovery order “is not a trivial or quick process” and eight staff were now compiling documents. A discovery order was made last November.

 

“Vaccination of children was prioritised as the rates of influenza were highest in those groups at that time,” said the Department of Health.

It noted that 29 people died from swine flu, all but two of whom were in “at risk” groups. Those judged to be at risk included the elderly, those with underlying medical conditions and children.

 

A Government-commissioned report later found a 13 to 14-fold increase in the incidence of narcolepsy, which causes drowsiness, among children vaccinated with Pandemrix.

The swine flu risk turned out to be less severe than feared at the time and the public vaccination campaign ended in March 2010.

Negligence is alleged against the State and GSK in administering an untested vaccine and/or a defective product.

Irish Girl With HPV Vaccine Induced Disabilty Asks Maker Of Vaccine ‘Do You Feel Guilty?”…


http://www.irishmirror.ie/news/irish-news/health-news/irish-teens-health-deteriorates-after-7906349

“….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..


https://www.japantimes.co.jp/news/2017/02/13/national/crime-legal/suit-opens-tokyo-court-cervical-cancer-vaccine-side-effects/

“…..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…”

 


 

Someone From GSK London Has Been Reading…


GSK1

 

Hello, whoever you are?

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…

https://truthman30.wordpress.com/2017/08/19/gsk-whistleblower-greg-thorpe-also-has-reservations-about-the-serious-fraud-office-investigation-into-gsk/

Bob Fiddaman Discusses The Seroxat Scandal On James Moore’s MadInAmerica Podcast Series..


Bob is a fearless and tireless campaigner for Seroxat sufferers, check out the podcast here

https://www.madinamerica.com/2017/09/bob-fiddaman-taking-pharmaceutical-regulators-seroxat-scandal/

Bob Fiddaman: Taking on the Pharmaceutical Regulators and the Seroxat Scandal

James Moore

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338

This week we have an interview with Bobby Fiddaman.

Bobby is a very well known author, blogger and researcher who has been writing about psychiatric drugs and the many issues involved for over 11 years.

In 2011 he released his book, ‘The Evidence, However, Is Clear…The Seroxat Scandal’ which is a powerful and explosive account of his experiences taking and withdrawing from the antidepressant Seroxat.

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.

https://html5-player.libsyn.com/embed/episode/id/5700768/height/90/width/490/theme/custom/autonext/no/thumbnail/yes/autoplay/no/preload/no/no_addthis/no/direction/forward/render-playlist/no/custom-color/000000/

In this episode we discuss:

  • How, in the late 1990s, Bobby had health problems which made working difficult and this led to low mood and a doctor prescribing Seroxat (Paxil, Aropax, Paroxetine)
  • How he felt that his moods and emotions were blunted by the drug and he recalls not feeling empathy or emotion
  • That eventually his pay was stopped and he was retired on ill health grounds but by this time his financial position was difficult and he became divorced
  • That Bobby took 21 months to wean himself off the Seroxat using a liquid form, going from 40 milligrams to 22 milligrams a day over 19 months
  • That he then quit cold turkey, against doctors advice, because he just want to get rid of the stranglehold that the drug had on him
  • How Bobby felt that his short term memory was affected by being on the drug
  • That sometimes it is harder for friends and family to experience someone going through withdrawal, because they don’t know what is happening to the person that they love
  • That these experiences promoted Bobby to write his 2011 book, ‘The Evidence, However, Is Clear…The Seroxat Scandal’
  • How Bobby stumbled across an article by the investigative journalist Evelyn Pringle and that set the ball rolling with his own blog
  • How Bobby’s blog started to cover the experiences of families who had experienced tragedy due to psychiatric drugs
  • That the blog hosts guest writers so people can tell their own story in their own words
  • How Bobby knows that the pharmaceutical manufacturers and the regulators are regular visitors to his blog
  • That Bobby has been told that his blog makes GlaxoSmithKline ‘cringe’ and this is a measure of the impact of his work
  • That Bobby feels that the manufacturers should just come clean and let the truth come out about the drugs, the clinical trials, the adverse effects and the withdrawal problems
  • That many people don’t understand that compensation and out of court settlements often just allow the truth to remain hidden
  • How Bobby was present for the entire trial between Wendy Dolin and GlaxoSmithKline and was shocked by the behaviour of GSKs attorneys
  • That the term ‘akathisia’ is not well known but is implicated in many suicides related to antidepressant and antipsychotic drugs
  • That doctors need to listen to patients to understand the wide range of effects of the drugs
  • That Bobby feels that the regulators, particularly the UK MHRA, should hang their heads in shame because they know about the problems with the drugs but do nothing in response
  • That there is an incestuous relationship between the pharmaceutical manufacturers and the regulators
  • How Bobby has had several meetings with the MHRA over the years, including meeting the CEO, but he feels that they meet to appease rather than take action in response to concerns
  • That Bobby also set up a meeting between MHRA and Dr. David Healy
  • That the regulators are totally funded by the pharmaceutical industry
  • How Bobby now highlights celebrities who promote the chemical imbalance theory of mental illness
  • That social media has had a big impact on the ability of people to get together and share experiences and make their voices heard
  • How the MHRA Yellow Card scheme is meant to work
  • How, when you start asking questions about follow up, you find that no action is taken and the database of adverse events is worthless
  • That nowhere on the labelling is a list of the benefits of antidepressant drugs
  • That in order to make the drugs safer, we should listen to patient concerns
  • That Bobby uses humour as a tool for getting the message heard
  • How Bobby would like to encourage others to write about their experiences
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