GSK - Flying the Flag of Hypocrisy

GSK - Flying the Flag of Hypocrisy

Hypocrisy is the state of promoting or administering virtues, moral or religious beliefs, principles, etc., that one does not actually have or is also guilty of violating. Hypocrisy often involves the deception of others and thus can be considered a kind of lie [1]

Irish blogger, Leonie Fennell, recently highlighted the Irish media [RTE] accepting awards from GlaxoSmithKline for, of all things, a TV program about the history of clinical trials with children!

Perversely, Glaxo Ireland proudly announce on their webpage that, "The purpose of the GSK Irish Medical Media Awards is to recognise the important contribution of Irish medical and consumer healthcare journalists. Here in Ireland, we’re extremely fortunate to have a strong, independent media that can, and does, challenge pre-conceptions, ask the hard questions and push for answers."

Aidan Lynch, Vice President and General Manager of GlaxoSmithKline Pharmaceuticals Ireland, presented winners with their awards.

MHRA: Breckenridge to Step Aside

Alasdair Breckenridge to Step Aside as Chairman of MHRA

Better late than never but I guess it had to happen given the length of time Breckenridge has held the position of Chairman of the MHRA and, of course, his age.

Alasdair Breckenridge is to step aside as Chairman of the MHRA. His end of his term in office will cease on 31 December 2012. [Link]

[Insert Applause]

[Insert firework display]

[Insert ticker-tape]

Breckenridge will be best remembered by victims of GlaxoSmithKline's Seroxat for his stuttering performance on BBC TV's Panorama. [See video below post]

Breckenridge, who, before taking his role of Chairman at the MHRA, used to be employed by SmithKline Beecham, who later went on to be the entity we now all know as GlaxoSmithKline.

Much has been said about Breckenridge on this and many other blogs. To be honest I actually don't know what role he played at the MHRA - Yup, we all know the title [Chairman] but it's hard to see what he actually contributed to the business. Maybe he was just dead-wood and the MHRA's CEO, Kent Woods, kindly found him a position within the agency, "Sit down, close the door and talk to nobody about Glaxo or Seroxat"

In Defence of Glaxo: Stephen Whitehead Speaks Out

ABPI CEO, Stephen Whitehead

Friend and fellow advocate RC over at Seroxat Secrets alerted my attention to a recent post in the New Statesman where the wheels of PR have kicked in and underplayed Glaxo's history of abhorrent behaviour.

The Association of the British Pharmaceutical Industry's CEO, Stephen Whitehead, felt the need to contact the New Statesman after a review by Helen Lewis of Ben Goldacre's new book, Bad Pharma: How drug companies mislead doctors and harm patients. 

I've not read Goldacre's book yet, ordering from Amazon when one lives in New Zealand is like waiting for a bus that never arrives. I will, however, obtain a copy at some point.

What's striking about Whitehead's letter to the New Statesman is his defence of British company GlaxoSmithKline, let's not forget that Glaxo are not American or a Japanese corporation, they are British so any actions, be they good or bad, blemish the the Union Jack flag.

Whitehead, just like Glaxo CEO, Andrew Witty, blames nobody but a bygone era, further adding that pharmaceutical companies being fined "...are all examples from the US and simply not relevant to the UK market."

Oh gee, and there was me thinking that Glaxo's cancerous corruption was worldwide, what was I ever thinking? Thanks for putting me straight on that one Mr Whitehead.

Mimicking Depression: The Wrong Diagnosis

A lot has been said on the use of antidepressants and whether they are safe and effective in those that use them.

The majority of healthcare professionals who prescribe these medications on a daily basis seem to think that antidepressants have a place in today's society. The majority prescribe them because they have been told, and are still told, that they are safe and effective.

Of course, your average GP doesn't just think that the evidence that these drugs work is based around the clinical trials, spokespersons of pharmaceutical companies and thought leaders. They, apparently, see the results first hand. Depressed Joe feels a whole lot better because of the Prozac that Dr Jones prescribed him 2 months ago. The change in Joe is enough for his Dr to believe that the Prozac is working. The placebo effect rarely enters the mind of Joe or Dr Jones.

I find the history of marketing antidepressant medication fascinating in as much that it is rarely questioned by the masses, even if it was questioned by your average layperson it's, more often than not, met with a shrug of the shoulders and an 'Ah well' attitude.

It couldn't happen to me, right? I'd never allow myself to become depressed, to take an antidepressant people must be weak, why don't they just get a grip of themselves?

Attitudes like this may have there place but the genius of pharma marketing is that they are very convincing but always driven by profit.

15 Good Reasons Not to Trust Andrew Witty and GSK

Glaxo CEO, Andrew Witty

GSK Head, Andrew Witty and his recent announcement about transparency could possibly be believed if one were inclined to be gullable. See here, Glaxo's Murky Transparency Claim

He blamed the recent $3 billion guilty plea for off-label promotion of GSK drugs that not only harmed but killed people on an era. See here, GlaxoSmithKline: The Andrew Witty "Era"

Do we, as consumers, really think Andrew Witty is being sincere with his latest offering? He, as recent as last year, refused to meet with Janice Simmons, founder of the Seroxat User Group, to discuss the 15,000 emails she has amassed from patients who are struggling to withdraw from his company's antidepressant, Seroxat. See here, **Exclusive - GSK's Andrew Witty in Patient Aftercare Snub

Witty's backroom staff and predecessor's have also made promises and outrageous statements in the past.

Glaxo, and indeed other pharmaceutical companies, are always telling doctor's and patients about the benefit vs risk of taking their antidepressant medications.

Like Witty, I'm coming up with my own benefit vs risk ratio. Can he, or indeed his company, GSK, be trusted to deliver the goods this time around?

Glaxo's Murky Transparency Claim

Glaxo head, Andrew Witty, is in the news - this time he's bigging-up his company for being transparent.

Many of the mainstream press are carrying the story, "All Hail Sir Andrew". Critics are viewing this by asking their own questions, one such critic being Mickey Nardo, who, by his own admission, is one boring old man with time on his hands.

Mickey, a retired psychiatrist, raises some good points in a post here, he writes:

I don’t want to join the voices that find something wrong not matter what changes are made. So long as pharmaceutical manufacturers remain private business enterprises, we can expect the to act like other businesses in a capitalistic society. But at a time like this when GSK is making a change in policy towards something that needs fixing as badly as this does, I think it behooves us to go over it with a fine tooth comb to make sure it conforms to the needed change rather than represents another attempt at deceit. With GSK, we’ve earned the right to use that word [deceit] freely. I’ve already mentioned the issue of "panel of experts" as a potential conduit for deceit. But there’s something else.

Health Canada Bury Heads in Sand over Champix Suicides

Unsurprisingly, the Canadian medicines regulator, Health Canada, are burying their heads in the sand regarding the reported suicides that surround the smoking cessation drug, Champix, also known as Chantix [Varenicline]

Canadian newspaper, The Star, is reporting that their own "investigation has found 24 Canadians taking Champix to quit smoking have killed themselves since it hit the market here in 2007, putting it among the leading suspected causes of reported suicides linked to prescription drugs."

The investigation also found that there was no indication Health Canada has investigated individual cases of psychiatric side effects since it looked into 14 cases of aggression, depression and suicidal thoughts from 2007, adding, Health Canada did a “systematic review” to see if Champix caused psychiatric reactions in 14 cases from 2007, the year the drug came out here.

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.

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.

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.

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman. Global outlets HERE 

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.

LISTEN HERE


Back stories:

The Thalidomide Apology and the SmithKline Suppression

GSK's Paralympic Irony




Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman. Global outlets HERE 

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.