Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Saturday, September 22, 2012

Who Cares About Sweden Trilogy - The SSRi Swindle

A great set of videos to watch regarding the dangers of SSRi's.

"Who Cares About Sweden" released by ARTIMUS Film SVB AB will make you angry, sad, frustrated and all the other emotions one faces when realization sets in about how we, as consumers, have been duped by the pharmaceutical industry and the field of psychiatry.

Thursday, September 06, 2012

Former GSK Head Launches "The Year of the Brain"

Former GSK Head of Psychiatry Alastair Benbow

Alastair Benbow. Now there's a name.

Benbow and I go back a long way, well my criticisms of him do. He knows who I am, which, I guess, is quite flattering considering I'm just a former Seroxat patient with a gripe against his former employers, GlaxoSmithKline.

Wednesday, September 05, 2012

Marty "Bling Bling" Keller Retires from Brown Uni

Lead author of the now infamous Paxil 329 paper, Martin Keller, has, it seems, retired from his position at Brown University. This will no doubt free up some time for the hard working child shrink so he can sit on more pharmaceutical advisory boards [for a fee] or attend more symposiums [for a fee] or maybe give after-dinner speeches [for a fee].

Keller, along with the study he is supposed to have wrote, became infamous around the time GlaxoSmithKline were trying to push their antidepressant, Paxil, on children and adolescents.

Paxil, known as Seroxat in Europe and Aropax in Australia and NZ, was never meant for children and adolescents but Glaxo pushed it on this population regardless.

The study, "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression", has caused much controversy over the years. In a nutshell, it's a piece of fraud and lists Martin Keller as the lead author. The study itself was penned by Sally Laden, a ghostwriter hired by GlaxoSmithKline. Laden miraculously turned three poor Paxil clinical trials into one good one. In truth, children and adolescents would have had a better chance of survival in a clinical trial for Russian roulette.

Calls for Keller to be removed from Brown Uni have been loud. Brown Uni have stood by their man as much as the Journal where the ghostwritten study appeared all those years ago.

I'm not the first to slam this study, many have done it before me, Leemon McHenry, John Juriedini, Evie Pringle, Shelley Jofre, Alison Bass, to name but a few. For what its worth, I even added my two penneth for the study to be retracted.

Many continue to dissect it, One Boring Old Man author being one such advocate.

What I do know is that this study has been responsible for persuading doctor's around the world to prescribe Paxil to children and adolescents 'off-label'. This sits perfectly well with Keller et al and the editor of the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP]. It would appear that having a misleading piece of literature which, in essence promotes an unsafe drug to children and adolescents doesn't really bother GlaxoSmithKline either, if it did surely they would have asked for its retraction. Why would they though, it would be an admittance of fraud.

Sara Carlin and Sharise Gatchell are just two examples of what can happen to children on Paxil. They both hanged themselves. The 329 study showed there was an increase in suicide for Sara and Sharise's age group, an increase that was hidden by GlaxoSmithKline.

For those unfamiliar with the whole fraud behind Glaxo's study it's easily explained in the half hour documentary aired by BBC TV's Panorama team, the fourth investigation into Paxil. [Video below]

GlaxoSmithKline have been let off the hook on numerous occasions. Their role in the 329 study should never be forgotten. Keller and all those other key opinion leaders who added their names to the study should, along with ghostwriter Sally Laden, be utterly ashamed that the influence of their names has caused so much heartache for families bereaved by suicide.

Those who added their names to the study are listed below. Not one of them, to my knowledge, has apologised for their part in influencing doctor's in prescribing Paxil to children and adolescents. They can argue that they didn't know but they have each had more than enough time to retract their names from the study or, at the very least, speak out about how it... or they was manipulated by GSK.

Martin B. Keller

Neal D. Ryan

Michael Strober

Rachel G. Klein

Stan P. Kutcher

Boris Birmaher

Owen R. Hagino

Harold Koplewicz

Gabrielle A. Carlson

Gregory N. Clarke

Graham J. Emslie

David Feinberg

Barbara Geller

Vivek Kusumakar

George Papatheodorou

William H. Sack

Michael Sweeney

Karen Dineen Wagner

Elizabeth B. Weller

Nancy C. Winter

Rosemary Oakes

James P. McCafferty

News of Keller's retirement can be seen on the blogs of Alison Bass and Ed Silverman

BBC Panorama documentary about the fraudulent study is below.



Tuesday, September 04, 2012

Frances Kelsey - Thank You

Frances Kelsey, prevented thalidomide from entering the market in the United States

A fascinating interview with the women who was responsible in stopping the drug, thalidomide, being widely prescribed in the United States.

Frances Kelsey was the reviewer for the U.S. Food and Drug Administration [FDA] who refused to authorize thalidomide for market because she had concerns about the drug's safety.

Kelsey, against all odds, stood up to be counted. She knew there was something wrong with the drug and she stood firm in not allowing herself to be manipulated by the company that was trying to push it on American citizens.

The FDA needs more people with a conscience, with ethics.

Frances Kelsey prevented a disaster. In her honour the FDA have now established 'The Frances Kelsey Award', which is given to an FDA staff member annually.

Kelsey is now 98, the interview with her [below] is one that we, as patient advocates, should listen to.

One for the sisterhood.


Back stories:

The Thalidomide Apology and the SmithKline Suppression

GSK's Paralympic Irony



Sunday, September 02, 2012

The Thalidomide Apology and the SmithKline Suppression

What was the role of GSK's predecessors in the  thalidomide scandal?

Many people, particularly those affected by the thalidomide disaster, are just not satisfied with Gruenenthal, the German manufacturer of the drug who, after 50 years, have just issued an apology via their CEO, Harald Stock.

It's a surprising move considering Gruenenthal are the subject of litigation, also surprising because pharmaceutical companies don't often admit to their mistakes, let alone make a public apology.

So, what happened all those years ago?

Well, court documents are alleging that Gruenenthal knew that their sedative, thalidomide, marketed in Germany as Contergan caused harm to the fetus as early as 1956 but never revealed that risk. Five years later the drug was withdrawn from the market after it was learned that babies were being born with foreshortened and distorted limbs, including curved spines, malformations to the eyes, ears and genitals, which were sometimes missing and malformations to the intestines, kidneys and hearts. One of the more common birth defects was a complete absence of the anus.

Not to be deterred by such trivial adverse events, they went ahead and gave it the all clear.

The lawsuit, also states that Gruenenthal were a Nazi led company whose motto was "succeed at any cost". At the time, Gruenenthal's director of their research and development group was Dr Heinrich Muckter. Two years before this role Muckter was a medical scientist for the army of the Third Reich. The lawsuit states:

"Specifically, he was the medical officer [Stabsarzt] to the Superior Command of the German Occupation Forces occupying Krakau, Poland, with the additional ominous title of 'Director for the Institute of Spotted Fever and Virus Research'. Given the role that military medicine played in the objectives and methods of the Nazi occupation of Krakau, Muckter's work there involved the science of killing rather than healing."

If this wasn't in black and white on a court documernt we'd be correct to assume this was some sort of Hollywood horror movie. Documents are provided at the end of this post.

I'll move on from the Nazi link, I once got threatened by GlaxoSmithKline's lawyers for referring to their head of psychiatry, Alistair Benbow, as a former Nazi dictator - far be it for me to draw comparisons.

The Apology

The apology by Harald Stock on behalf of Gruenenthal is cold, so cold that it chills to the bone. Gruenenthal have kept this suppression under wraps for 50 years, in fact, in 1972 they settled a lawsuit in Germany, a settlement where they accepted no liability, they just paid out plaintiffs and kept quiet.

It's always been said that it takes a brave person to apologize and, I guess, in this instance Stock was on a hiding to nothing. No apology would be seen as cruel whilst an open apology would show how transparent Gruenenthal were, particularly if it could be shown that they had learned from their mistakes. It's also classic deflection of blame, new CEO means 'not my fault, it was the fault of my predecessors.'

Enter the blame of the 'era'

Just like GlaxoSmithKline's CEO, Andrew Witty, did about a month ago, apart from apologizing, Gruenethal blamed this tragedy on an era. "...the suffering that occurred with Contergan 50 years ago happened in a world that is completely different from today"

Great detective work Mr Stock.

We have computers, phones that we can take out with us, more TV channels than we could possibly watch and we can even send men to the moon and robots to Mars.

An apology quickly followed by a reason for that apology is not an apology at all. It's a disgraceful act of depravity that, sadly, we, as onlookers, just shrug our shoulders at and go about our daily routines of uploading fluffy bunny pictures to our Facebook buddies or typing out our 140 characters to Twitter.

There should be global outrage about this latest stunt by a pharmaceutical company, alas we are all too busy to spare a thought for the families affected, we are all too busy to stand up with them and demand that criminal charges be sought and that those responsible be imprisoned for life for their part in covering up this utterly abhorrent scandal.

The role of GlaxoSmithKline

The lawsuit has also implicated British pharmaceutical giant GlaxoSmithKline for it's role in keeping the birth defects behind close doors. Glaxo, who were known back then as SmithKline and French, [SKF] are alleged to have carried out clinical trials of thalidomide on 875 women, some of whom were pregnant. During the trials it is alleged that two women gave birth to babies who were deformed.

SKF decided not to market thalidomide, a wise move. They also, the suit alleges, decided not to inform anyone that two women had given birth to deformed babies during their own clinical trials. SKB, cites the suit, had a legal duty and a common law duty to report these findings, at least, to Gruenethal. They also had a legal duty to report their findings to US Congress. When asked for results SKB told Congress that all the results had been submitted to Gruenethal.

Quite why SKB never told Gruenthal or indeed the public remains a mystery.

To date Andrew Witty, head of SKB's succsessor GSK, has issued no apology.

Andrew Witty was knighted in the 2012 New Year Honours for services to the economy and the UK pharmaceutical industry.

Here's those documents that should, but probably won't, see Andrew Witty blame another era of the company he is head of.

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