Zantac Lawsuit

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

Monday, December 31, 2012

Obama Shuns Public Opinion on Psychiatric Drugs

If you are landing on my blog for the first time you'll probably have arrived here via a search engine, chances are you typed in "Paxil withdrawal" or "Seroxat side effects". In fact many visitors arrive here using the search terms Paxil or Seroxat combined with words such as "aggression", "mood swings", "suicidal thoughts", etc.

The recent Connecticut school shootings highlighted, for me at least, just how dangerous psychiatric drugs can be. It also highlighted how the public in general perceive 'mental illness'.

Adam Lanza, it is believed, shot and killed 27 people, 20 of whom were children, this before turning the gun on himself in an act of suicide.

This, obviously, outraged the public and comments on websites, forums and social networking sites were littered with opinion about Lanza's state of mind. "Nutter", "Crazy", "Madman", "Evil" all being examples of words used to describe Lanza.

Sure, I'd agree with most of the above descriptions but I wouldn't/couldn't just leave it there.

What made Lanza crazy?

Sunday, December 30, 2012

Glaxo Finish in 26th Position... But Spin Victory

Back in November I wrote how GlaxoSmithKline had been shortlisted for Britain's most admired company. When I learned that they had been shortlisted I wrote a brief email to the editor of the Management Today, who were offering the award. In a nutshell, I aired my disgust at their nomination, citing Glaxo's various violations over the years.

Management Today never replied.

No surprise then that Glaxo were blowing their own trumpet on their Facebook page early in December after they had learned that they had won the most admired company in the Health & Household category. [Fig 1]

Fig 1

The Health & Household award was a sub-category and the reason why Glaxo felt the need to cover themselves in garlands on their Facebook page was probably due to the fact that they finished in 26th position overall. Now there's some spin for you, huh?

Thursday, December 27, 2012

"Remarkable efficacy of Paxil" - Endorsed for Kids by the JAACAP

Okay, the JAACAP [Journal of the American Academy of Child and Adolescent Psychiatry] aren't exactly endorsing Paxil for kids but, in my opinion, they are doing the next best thing.

GlaxoSmithKline's... [Strike that]... Sally Laden's published study, in which eminent psychiatrists pretended they had wrote, Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial, has been the subject of much debate over the years. When it was flagged as being incorrect the pretend authors defended it. When it was proven to be incorrect the pretend authors went all quiet on us.

Now, we have a piece of literature purportedly written by the likes of Martin Keller, Neal Ryan and Karen Wagner to name but a few, that still causes controversy, this time from the publishers of the said piece, the Journal of the American Academy of Child and Adolescent Psychiatry.  I've Previously wrote about one of the more lesser known authors, Stan Kutcher. [Links at foot of post]

Monday, December 17, 2012

School Shootings and the Psychiatric Medication Link

The recent news of yet another school shooting saddened us all. I was moved by President Obama's speech to the public that has appeared and been viewed many times on YouTube.

There's a lot of speculation surrounding Adam Lanza, the perpetrator of the recent massacre in Connecticut. Stories are surfacing that he had some form of personality disorder. If true, then the likelihood is that Lanza may have been on psychiatric medication. Of course, this is just speculation. Lanza, according to his aunt, has since been described as a "quiet, nice kid," 

There is, however, a link to the majority of school shootings and psychiatric medication. The pro-pill brigade refuse to lay blame on the medications, opting instead for the 'illness' that caused these people to become hostile and murderous.

One thing is for sure, the link, however small you may think it is, has to be investigated.

SSRi Stories is a website that has collated many stories over the years. To gauge the link between psychiatric medication and school shootings one can see that there is a problem that needs some serious investigation.

SSRi Stories starts with an incident in 1988 where Laurie Wasserman Dann "walked into a second grade classroom at Hubbard Woods School in Winnetka, Illinois carrying three pistols and began shooting children, killing an eight-year-old boy - Nicholas Corwin - and wounding five others before fleeing. She entered a nearby house where she shot and wounded a 20-year-old man before killing herself. "

Dann was taking the antidepressant Anafranil [clomipramine] for Obsessive Compulsive Disorder.

Tuesday, December 04, 2012

More Paxil Birth Defect Woes for Glaxo

It would appear that GlaxoSmithKline have some sort of sick fetish for courtrooms or battling against consumers who complain about their antidepressant, Paxil [Known as Seroxat in Europe and Aropax in the southern hemisphere]

It's just been announced that Canada has been given the green light to attempt to seek justice for its first national class action lawsuit against GlaxoSmithKline, the manufacturer of Paxil, which is alleged to have caused birth defects in children born to women who took it during pregnancy.

Representative plaintiff, Faith Gibson, took Paxil during her pregnancy throughout 2004. On September [same year] her daughter, Meah Bartram, was born with a hole in the heart.

The class action, given the thumbs up by The Supreme Court of British Columbia, will see lawyers argue that GlaxoSmithKline knew or ought to have known of the risks and failed to provide adequate and timely warning to doctors and the public.

The Supreme Court green light can be viewed, in full below:

Sunday, December 02, 2012

David Healy - Saints v Sinners

Fascinating talk given by antidepressant expert, David Healy, is doing the rounds on YouTube and on various blogs sites.

Healy, who recently launched a website [Rxisk] aimed at patient adverse reaction reporting, has long sought to bring about awareness regarding pharmaceutical companies and the way clinical trials are run. He's the author of many books, his most recent, Pharmageddon, takes a meticulous look at the inside workings of the pharmaceutical industry and the way in which prescription drugs are marketed throughout the world and how this aids in the survival of some of the most richest and influential global organisations in the world today. I reviewed Pharmageddon here.

Healy was branded as a maverick when he first started speaking out against the popular antidepressants, a slur put out, more than likely by the pharmaceutical industry and those KOL's [Key Opinion Leaders] he exposed.

I've watched many talks by David Healy and although we don't agree on entirely everything, I believe SSRi's cause more harm than good, his knowledge and unique ability to reach out to the layperson should be commended.

The talk [Below] is well worth watching - it will raise a few eyebrows and will give you food for thought.

For an itemised breakdown of the one hour talk, Irish blogger and friend, Leonie Fennell, has offered a timeline on her website here. Meantime, here's the talk which was presented at the Cardiff University School of Psychology on 26th November 2012. Amongst other things Healy talks about Ghostwriting,  GlaxoSmithKline, Zoloft and antidepressant use in pregnancy.

Thursday, November 29, 2012

Mark Kramer - M.D cum Jazz Man

Mark Kramer - Jazz Pianist and Consultant to the Pharmaceutical Industry

It would appear that I and others have ruffled the feathers of Professor of Psychiatry, Mark Kramer over at the Boring Old Man website.

The author of Boring Old Man, Mickey Nardo, himself a retired psychiatrist, is, just like me, asking questions regarding some of GlaxoSmithKline's ghostwritten publications, namely 329 and 352, both Paxil studies.

This prompted a lot of debate in the comments section of his post entitled, "Paxil study 352 – what’s ghost-writing?"

What started off as a mild debate, sadly turned into a free-for-all finger pointing tirade that clearly misses the message of the original post.

Wednesday, November 28, 2012

GlaxoSmithKline's Requip and Paxil in the Dock

British pharmaceutical giant, GlaxoSmithKline, have just been ordered to pay almost €200,000 [$260,000 US] to a man who claimed that Requip [ropinirole] turned him into a sex and gambling addict.

Requip, a drug to help with Parkinson's disease, carries many side effects which can include hypersexuality and compulsive gambling, even in patients without a prior history of these behaviours [1]

Didier Jambart, writes, had suffered side effects after being administered the drug Requip in 2003 for the illness, which causes tremors, slows movement and disrupts speech.

“It’s a great day,” he said. “It’s been a seven-year battle with our limited means for recognition of the fact that GSK lied to us and shattered our lives.”

In other news, a US jury has awarded $1.5 million to the family of a man who committed suicide.

Joseph Mazella, a 51 year old high school basketball coach and teacher, had been prescribed GlaxoSmithKline's antidepressant, Paxil. Strangely, Mazella was on the medication for 10 years in which time he never once saw his prescribing physician, William Beals, M.D.

On Aug. 9, 2009 Mazella and his wife contacted Beals who magically made a diagnosis over the telephone before doubling Mazella's Paxil dosage from 20mg to 40mg and also adding Zyprexa.

Story continues here


Here we have two cases which, in essence, pretty much amount to the same in as much that two people were given psychiatric drugs that made them do things that they really had no intention of doing.

I'm currently reading Joseph Glenmullen's book, "Prozac Backlash" to try and get a better understanding of the serotonin-dopamine connection.

Glenmullen writes:

"Dopamine is a close chemical partner of serotonin. A large body of research over decades has implicated dopamine, not serotonin, in these disorders, regardless of whether or not they are caused by medications or by diseases such as Parkinsons...

"As reports of these side effects occuring with the Prozac group (SSRi's) have mounted, researchers have been puzzled by the question of how drugs that boost serotonin could cause side effects usually linked to dopamine.

"Working out the full details of the serotonin-dopamine connection may take decades or more. Meanwhile, we are left with the clinical reality of these serious side effects, which in some cases are devastating. The unfortunate irony is that drugs heavily promoted as correcting unproven biochemical imbalances may, in fact, be causing imbalances and brain damage."

The promotion of SSRi's such as Paxil has seen pharmaceutical companies spend billions of dollars on promoting products that they really know nothing about. Withdrawal reactions to SSRi's and reports of suicide are downplayed by pharmaceutical spokespersons and key opinion leaders, who, ironically, are paid vast amounts of dollars by pharmaceutical companies to promote the use of SSRi's.

In the six or so years I was taking Seroxat [Paxil] I did many things that I wouldn't have done if I had not taken it. I look back now and wonder if a; Seroxat induced these thoughts and b; if my brain has been damaged by long term use of Seroxat.

Will I and the millions of others who have, at some point, taken an SSRi be more prone to develop Parkinson's or Huttingdon's disease?

Only time will tell.

That's some price to pay for taking a pill that was apparently safe and effective, huh?

[1] Bostwick JM, Hecksel KA, Stevens SR, Bower JH, Ahlskog JE (2009). "Frequency of new-onset pathologic compulsive gambling or hypersexuality after drug treatment of idiopathic Parkinson disease".  [Link]

Tuesday, November 27, 2012

Glaxo Shortlisted for Britain’s Most Admired Company

Definition of ADMIRATION []

archaic : wonder
2 an object of esteem
delighted or astonished approbation

Despite Glaxo's recent plea of guilty to fraud and subsequent $3 billion fine in the US, Britain sees Glaxo as a totally different corporation.

Glaxo have been shortlisted for one of Britain's Most Admired Companies awards by Management Today, in association with the Business Standards Institution [BSI]

The awards, write Management Today, are a peer review of corporate reputation. Canvassing the opinions of 200 of the UK’s largest companies, they are the only awards of their type in the UK.

Glaxo are no strangers to receiving awards from Management Today. After being shortlisted for Britain's Most Admired Companies in the year 2000, they actually went on to win it!

Management Today claims that it aims to help managers and business leaders "succeed today, and keep succeeding tomorrow". BSI, who are also associated with the awards, claim that "for more than a century, we've been challenging mediocrity and complacency to help our clients across the world embed excellence into the way they work…so they perform better, reduce risk and achieve sustainable growth.

On hearing the news of Glaxo's nomination I wrote to the editor of the Management Today website.

Dear Sir/Madam,

Sunday, November 25, 2012

GSK, Avandia and Jack the Ripper

I always love it when GSK attempt to cover themselves in garlands, particularly after being fined $3 billion for, amongst other things, marketing deathly drugs to children.

The Washington Post recently ran an article entitled, "As drug industry’s influence over research grows, so does the potential for bias." The article was heavily critical of Glaxo's bias when it came to reporting all the facts in clinical trials.

The Washington Post article centred around a 2006 report that compared three diabetes drugs, one of which was Glaxo's Avandia. The reported concluded:

"We now have clear evidence from a large international study that the initial use of [Avandia] is more effective than standard therapies" - Lawson Macartney, Senior Vice President of GlaxoSmithKline

What Macartney failed to add was the trial, according to the Washington Post,  "had been funded by GlaxoSmithKline, and each of the 11 authors had received money from the company. Four were employees and held company stock. The other seven were academic experts who had received grants or consultant fees from the firm."

The article, to date, has prompted 645 reader comments, the majority of which are highly critical of GlaxoSmithKline.

So, in a massive PR [Yawn] exercise, Glaxo have responded with the usual roll-out of  "we don't do this anymore". 

Jack the Ripper [presumed dead] was a notorious unidentified serial killer during the late 1800's. His murdering spree, which some believe to be 5 women, involved the mutilation of his victims.

Can you imagine if, during the late 1800's, Jack admitted these killings and issued a press release stating that he was a good man now and didn't kill any more? Furthermore, can you imagine if Jack had been caught by the investigative police force at the time and fined rather than imprisoned for his crimes?

Jack the Ripper was a deplorable man [could have been a woman, although I doubt it] who carried out heinous acts against vulnerable women. Could we, as a nation of sane mind been forgiving if Jack had publicly announced that he had turned over a new leaf?

There are many critics of GlaxoSmithKline, I remember one blogger many years ago using the abbreviation GSK to form Global Serial Killers - He [could have been a she, although I doubt it] was pretty much on the money.

Let's take a look at Glaxo's response to the Washington Post article.

Let's also take a look at how Jack would have made a similar statement.

Friday, November 23, 2012

GlaxoSmithKline - You're An Embarrassment

In the words of Suggs, lead vocalist with Brit Ska/Pop band, Madness, "You're An Embarrassment."

Our uncle he don't wanna know he says
"We are a disgrace to the human race", he says
"How can you show your face
When you're a disgrace to the human race?"

No commitment, you're an embarrassment
Yes, an embarrassment, a living endorsement
The intention that you have booked
Was an intention that was overlooked

Now watch the video.

Thursday, November 22, 2012

Glaxo's Paxil 352 Bipolar Trial - Ghostwritten

Who you gonna jail?

Anyone familiar with GlaxoSmithKline and Paxil will know all about the Paxil 329 study that  they [Glaxo] hired a PR firm to draft and, later, persuaded key thought leaders, mainly child psychiatrists to endorse and promote at any given opportunity. The 329 study has been dissected by many who are in agreement that it's a piece of fraud. Read more about the Paxil 329 study here and here.

Not content with one study doing the rounds in various journals and pediatric clinics Glaxo, in their infinite wisdom, hired the services, once again, of a ghostwriting team to pimp out the paroxetine 352 bipolar trial.

Sunday, November 18, 2012

Rxisky Business - The Importance of Being Earnest

I've always wanted to use film titles as a title for a post, the above, Rxisky Business - The Importance of Being Earnest, kills two birds with one stone and, if I say so myself, is pleasing on the eye.

So, what am I trying to say here and why have I misspelled the word 'Risky'?

Well, this post is about the importance of filing adverse reactions to prescription drugs on RXISK.ORG, a reporting system with a difference in as much that they actually follow through the reports you send to them.

So, why report to RXISK opposed to the FDA, MHRA, TGA or Medsafe?

Wednesday, November 14, 2012

GSK Off-Label Promotion Continues

The GlaxoSmithKline Definition of 'Era'

Definition of Era:

A period of time characterized by particular circumstances, events, or personagesThe Free Dictionary

A period of time that includes the present - GlaxoSmithKline

When GSK's CEO, Andrew Witty, claimed a few months ago that his company had turned the corner and were now operating by playing by the rules and regulations there were many that were convinced - there were many who gave Witty the benefit of the doubt.

There were many that turned a blind eye to Witty's involvement during the 'era' that he blamed on GSK's plea of guilty and subsequent $3 billion fine.

To be honest, I don't trust Andrew Witty, I don't trust any executive that works, or has worked for GlaxoSmithKline. Here we have a company who think nothing of giving drugs to children when they know that the drug could possibly kill those children. How could anyone trust a company who does that? How could anyone trust a company's CEO when he tells them it does not go on anymore and it was all part of an 'era' at GSK?

Well, the proof, as they say, is in the pudding.

Thursday, November 08, 2012

GSK: "...accept that we operate differently today"

GSK's Deirdre Connolly

Deirdre Connolly, President - North America Pharmaceuticals, GlaxoSmithKline, delivered a speech to the Pharmaceutical Regulatory and Compliance Congress on November 5, the crux of which was a plea for people to start trusting GlaxoSmithKline again.


Connolly, speaking at the 13th annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, opened the gates to criticism when she told the audience, “We need those we serve, and those who make sure we conduct our business appropriately, to accept that we've changed … Continue to hold us accountable, but accept that we operate differently today.” 

Continue to hold us accountable?

Okay. Thanks for that D. I, for one, shall try my hardest.

Once again, and just like Glaxo CEO, we see the blaming of an era at GSK, implying that the current compliance protocol is robust and that they, GSK, are transparent. To be transparent one would have to give reasons why - Glaxo, on two occasions now, have covered themselves in garlands for opening their doors to show how transparent they are. What they don't tell us is that they were more than likely forced to open their doors as part of agreements and settlements with DA's and Department of Justice.

If, as Connolly suggests, “Trust is a two-way street,” then maybe she could start by retracting the study at the centre of many cases against her company.

Monday, October 29, 2012

Health Canada Under Fire

Health Canada, the "independent" body of regulators who monitor the safety of drugs, have recently come under fire for failing to monitor the safety of drugs dished out to millions of Canadians every year.

I've highlighted Health Canada many times on this blog. They, just like other global medicine regulators, are about as useful as a waterproof teabag when it comes to safeguarding the public.

Yesterday The Star ran with the headline, 'Health Canada brushes off reports of serious side effects'. The article, written by David Bruser and Jesse McLean, heavily featured the story of Brennan McCartney, the 18 year old who killed himself just 4 days after being prescribed the powerful SSRi Lexapro [known as Cipralex in Canada] - Back story here.

Like many before her, Brennan's mother, Nancy, was shocked to find that the medication given to her son could actually induce suicide. This was learned after the event because the warnings about this adverse reaction are seen as a minor risk by Health Canada.

Sunday, October 28, 2012

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.

Thursday, October 25, 2012

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"

Monday, October 22, 2012

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.

Wednesday, October 17, 2012

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?

Friday, October 12, 2012

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.

Tuesday, October 09, 2012

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.

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.

Friday, August 31, 2012

Brain Scan Bedlam From Leading Psychiatrist

A recent article that appeared on the Bloomberg Business Week website had me in a complete state of apoplexy [pass me the Paxil] so comical so that I nearly chewed off the side of the couch arm.

The antidepressant market... or those that find unique ways to push the poison pills, are always on the lookout for innovative ways to sell their wares. None more so than the latest from the school of the ridiculous and the latest scam offering patients a safety procedure before they take their drugs, like every good little person should.

Thee companies, namely, CNS Response Inc. (CNSO), AssureRx Health Inc. and Brain Resource Ltd. (BRRZY), are rolling out the latest in bio-technology. You are just going to love this...

The brain scan, offered by CNS, apparently works by matching electrical activity that’s recorded in the brain. From this, it is claimed, a medication can be prescribed that is just right for you.

"If a number of people with similar brain waves do well on the same medicine, then that drug will probably work for the new patient as well", CNS Chief Executive Officer George Carpenter said.

Oh yippie!

The article also quotes Mark Schiller, a San Francisco-based psychiatrist.

“I’ve had a number of patients tell me it’s really been life changing.

“They’ve been in treatment for God knows how many years, never got the right medication, and suddenly we got the right medication and they’re no longer suicidal.”

Wait a minute, is Schiller actually saying that the previous meds these people were on made them suicidal?

One thing Schiller definitely isn't saying is that he is director of medical affairs for CNS Response, Inc which provides the technology he is referring to.

Schiller practices out of the MindTherapy Clinic in California, his specialties include, addiction, adoption, anxiety or fears, attention deficit (ADHD), child or adolescent depression, divorce, domestic abuse, domestic violence, eating disorders, infertility, life coaching, loss or grief, obsessive-compulsive (OCD), relationship issues, substance abuse, trauma and PTSD, dissociative disorders, impulse control disorders, personality disorders and psychosis.

So, pretty much all bases covered then.

That's nice!

With more and more people speaking out against these drugs and with lawsuits being filed all over America it's hardly surprising that some white-coated organisation has come up with a a pre-cursor to a remedy... that isn't really a remedy at all.

The chemical imbalance theory has been debunked - now we have the electrical activity that’s recorded in the brain to target the pill pushers.

Psych: I've recorded your electrical activity and Prozac or Paxil just isn't for you. Counting the electrical impulses and adding a multiplication of 7, because there's 7 days in a week, I recommend that you take Celexa because others with the same electrical pattern as you are also on it.

Patient: Thanks God.

Psych: Oh, I'm not God...I'm just second to him.

Hubble, bubble, toil and trouble.

Whatever next?

Gotta fly, need to contact someone who can  reupholster the arm of my couch.

The wacky article can be seen in full HERE.




Friday, August 24, 2012

Plea For MHRA and EMA to Get Their House in Order

Bravo to Patrick H for starting this petition. It takes courage and resilience to stand up for what you believe in. Too many people sit around and wait for others to act, whilst others criticize those for standing up to be counted. Respect Patrick.

This from the online petition:

To the UK’s MHRA and EU’s EMA: The drugs on our shelves and those recommended by our doctors should first do no harm. As concerned citizens we call on you to put safety first and implement the reforms below:

1) Investigate and act against pharmaceutical companies employing illegal marketing activities by appointing an independent watchdog not funded by the drug industry who can be freely contacted by patients and by doctors witnessing bribery and encouragement to prescribe a drug ‘off label’- for a condition it has no licence to treat - by pharmaceutical representatives.

2) Tighten up requirements for licensing new drugs to include a thorough assessment of benefits versus risks, as well as withdrawal effects.

3) Record and minute meetings to be made publicly available, including representation from consumer groups.

4) Enforce pharmaceutical companies to publish their trial data, without hiding adverse effects, on their website for free access.

5) Take patient reported adverse reactions seriously and encourage patients who have had adverse effects to share them on the website so other patients and doctors are informed.

Why this is important

The profit-hungry drug company GlaxoSmithKline has been peddling a diabetes drug they knew was causing heart attacks without informing doctors or patients of the risk. Regulators in the EU knew about the dangers but failed to act fast enough, putting lives unnecessarily at risk. Previously, UK regulators knew about anti- depressants causing suicide but took over ten years to do anything about it. The same complacency is happening again with new anti-depressants and other drugs.

Earlier this month GSK pleaded guilty to criminal charges relating to anti-depressant and diabetes drug frauds and agreed to pay a $3 billion fine. That brings total fines against big pharma in the US in the last four years to almost $10 billion! But no fines in the UK or EU. Why do we put up with it?

A massive push from thousands of people right now will add to pressure from the media and force regulators to act faster and more decisively against dangerous drugs. As a citizen of the UK I need to know that my family and I are safe and that drug companies put patients before profits. But drug companies will only do the right thing if regulators force them.

Let’s join together in a gigantic outcry for the UK’s Medicines and Healthcare products Regulation Agency and EU’s European Medicines Agency to put safety first. Sign the petition!


I truly hope the petition will make the MHRA stand up and listen. I suspect they will, as usual, pretend to listen then do absolutely nothing about the issues raised. They are limp-wristed and powerless and claim to be the best regulator in the world. To be the best of a truly awful bunch is not something I'd be proud of.

The MHRA are in bed with the pharmaceutical industry, they are not just sleeping with them they are performing all sorts of kinky sex acts. Just follow the money trail folks, case in point being these 4 articles I wrote back in 2010.

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money




Tuesday, August 21, 2012

No Free Lunch at GSK

So, I was browsing the the Cafepharma message boards and it appears that Witty has cracked the whip at GSK.

Disgruntled reps are complaining that they have received news that they can no longer have more than two lunches with doctor's in the space of a month, furthermore, they cannot bring doctor's staff any foodstuffs.

Dang it, no more doughnuts for the, already heavy, receptionist.

This got me thinking.

What if Witty really did start to crack the whip at GSK, maybe his memo would look something like this...


Dress Code:

1. You are advised to come to work dressed as a gopher. Costumes can be hired from the Department of Justice Department for a small fee.

2. You cannot wear anything from the 80's or 90's - they are both era's that we wish to forget about.

3. We have a range of product memorabilia, including t-shirts, that you can purchase for a small fee. Unfortunately we have no adult sizes as these product placement shirts were not intended for adult use.

XX Small - "I Just Took My Paxil" T-Shirts - 200,000 in stock

XX Small - "We Love Karen Wagner" T-Shirts [Paxil logo on back]- 200,000 in stock

XX Small - "Keller Is Da Daddy" T-Shirts - [Paxil logo on back] - 200,000 in stock

Kiddy Lunchboxes [Paxil Logo on Lid] - 200,000 in stock

Mr Men Series, Vol 9 - "Mr Grumpy Gets Better" - [Mentions Paxil] 200,000 in stock

Fake Dog Turds [Paxil 329 Limited Edition, signed by Sally K. Laden] ONLY 99 LEFT!

Paxil Rope - 12 LEFT

Paxil Razor Blades - 4 LEFT

Benbow Bear - A true to life talking teddy bear. Just pull the chord and hear, "These drugs are  not addictive", "Dr Healy has been proved to be wrong on every single occasion", "The evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased rate of self harm", "Generally these symptoms are mild to moderate", "The information in the patient leaflet and in the information we supply to doctors, is based on fact", "I think patients have nothing to fear from taking Seroxat", "I utterly refute any allegations we are sitting on data", and "We take the safety of our medicines extremely seriously".

Sick Days: 
We will no longer accept a doctor's statement as proof of sickness. If you are able to go to the doctor, you are able to come to work, unless you are involved in an internal dispute with the company, in which case you shall remain on sick leave without pay. Any doctor's statement as proof of being fit to work will not be accepted.

Bereavement Leave:
The drugs you promote for off-label prescriptions, are known to cause death in the populations they are not indicated for. By now you should be used to death. Any friend, family member or pet that dies... suck it up and deal with it. We don't pay you to have a conscience.  

Toilet Breaks:
Will only be permitted if you ingest ALLI, our failed dietry supplement. Batches of ALLI can be ordered for $2 on Ebay or for $160 from one of our executives.

Lunch Break:

No more free lunches for doctor's and their staff.

No more vouchers for Wing's Chinese restaurants, the Gringo's Mexican chain etc.

Glaxo Foodles will be available for all reps [for a small fee] along with a carton of Ribena [Vitamin D extracted due to carton staying in sun for too long]

Thank you for your loyalty to our company. If you have any issues regarding compliance then please forward them to our compliance department and we will make sure your grievances are heard... Be prepared to lose your job though. Nobody likes a smart ass!

Sir Witty.

Friday, August 17, 2012

GSK's Paralympic Irony

The GSK Facebook page is proudly boasting the following message:

"We're supporting London 2012 to help ensure the Olympic and Paralympic Games are the cleanest possible. To see the journey of an athlete's sample watch this video"

The GSK Facebook posse then highlight a video in which they basically blow their own trumpet about how good they are at what they do.

What GSK fail to tell its 49,761 Facebook followers is that they have just been implicated in a lawsuit in the US for their part in distributing doses of thalidomide to physicians for human trial, along with Sanofi Aventis.

The complaint alleges GSK's predecessor Smith Kline & French conducted a clinical trial on at least 875 people, which including pregnant women, in 1956 and 1957 in the U.S. as it pondered over a licensing agreement for the drug with Gruenenthal, which made thalidomide.

Sanofi predecessor Richardson-Merrell are alleged to have distributed more than 2.5 million thalidomide tablets to about 20,000 patients.

Research suggests that a pregnant woman participating in the Smith Kline & French trial delivered a malformed baby. Smith Kline decided not to market the thalidomide drug but, at the same time, never let the public know about its clinical trial results.

One can only assume that if Smith Kline did release information from its thalidomide clinical trial then maybe, just maybe, it would have rang alarm bells and the distribution of the drug may have been slowed, or better still, halted in its tracks.

Kevin Colgan, a spokesperson for GSK stated:

“GSK intends to vigorously defend itself against this lawsuit and the others filed previously. 

“This lawsuit involves events dating back over 50 years by a predecessor company, Smith Kline French, that no longer exists. Moreover, the plaintiffs’ complaint is replete with scientific inaccuracies and factual misstatements.”

The case, Valerie Spence et al. v. Avantor Performance Materials, case number 120800665, was filed August 9, 2012 in the Pennsylvania Eastern District Court.

Meantime, GSK's Facebook page continues to cover itself in garlands, one striking comment sums them up:

As with the Olympic Games, antidoping testing will also be carried out at our laboratory for the Paralympic Games with every athlete that wins a medal and up to 50% of all competitors being tested. Approximately 5000 tests were carried out during the Olympic Games and a further 1250 will be conducted during the Paralympic Games.

No problem in releasing these test results then, huh?




Saturday, August 11, 2012

Paxil - Multiple Symptoms, One Solution

So, we all know how Glaxo failed to show the efficacy and safety of Paxil use in kids, we all know how they buried data and hired a ghostwriter to dupe doctor's, journal editor's and parents of kids. Basically, a suicide link was seen in the clinical trials, Glaxo covered it up. We all know how Glaxo reps were given carte blanche by executives at Glaxo to pay doctor's large sums of money, carefully disguised as preceptorship's and/or fees for attending and sitting on advisory boards. All this on top of the lavish weekend breaks for doctor's and, in some instances, their partners.

That's business, eh folks?

The following is a letter from the FDA's Division of Drug Marketing, Advertising and Communications [DDMAC] to GlaxoSmithKline warning them about their promotional activities regarding Paxil and children.

Remember, Glaxo had not got a licence for Paxil in children, none the less they saw fit to push it on them in the despicable way.

Basically, Glaxo distributed a T-shirt during a Health Fair function at the Children's Advocacy Center of Brevard in Brevard, Florida. The front of the T-shirt saw the logo and name of the Children's Advocacy Center, while the back of the T-shirt saw the claim "Multiple Symptoms, One Solution" followed by the Paxil logo.

Here's the letter, courtesy of the Drug Industry Document Archive, from the FDA to Eloise R. Scott, D.V.M. Associate Director, U.S. Regulatory Affairs at Glaxo, formerly Smithktine Beecham Pharmaceuticals.




Friday, August 10, 2012

Email to Editor of JAACAP - Re Paxil 329

Below is an email I've sent to the editor of the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP]

It follows on from the recent abhorrent behaviour of British pharmaceutical company, GlaxoSmithKline and their agreement to plead guilty with regard to the way they knowingly misbranded Paxil and knowingly falsified a ghostwritten study [329] for the sole purpose of making money from a product that had a propensity to induce suicide in children and adolescents.

A call for this fraudulent study to be retracted has previously been asked for by Jon N. Jureidini and Leemon B. McHenry, whom are both mentioned and referenced below.

I've previously called for Glaxo CEO, Andrew Witty, to contact JAACAP, seeing how it was his company that hired a ghostwriter for the article.

His limp-wristed excuse that this was part of an era just doesn't wash. If he had any morals then he would tell the journal to pull the study, although the damage has been done now and many children may have died as a result of this study being published.

More about Witty coming soon on this blog... there's some disgruntled whistleblowers out there.

Anyway, here's the email to the editor of the Journal of the American Academy of Child and Adolescent Psychiatry.

Dear Mr Martin,

I am the author of the book, The evidence, however, is clear; the Seroxat scandal, and the blog, Seroxat Sufferers. Seroxat is the UK brand name for GlaxoSmithKline's antidepressant, you will know it by its US brand name, Paxil.

The reason I am contacting you is with regard to the publication in the Journal of the American Academy of Child and Adolescent Psychiatry entitled, "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression." - Martin Keller et al.

It is my understanding that the particular study was used as a marketing tool by British pharmaceutical giants, GlaxoSmithKline, and was in fact not written by the authors, Martin Keller et al, at all but by Sally Laden, an editorial director for Scientific Therapeutics Information.

Given that this publication has been widely available since 2001 its safe to assume that many inquiring doctors, pediatrics, child psychiatrists and, in general, healthcare professionals, have used it as a guide when making a decision whether or not to prescribe Paxil off-label to children and adolescents.

It is also my understanding that the study, better known as Paxil 329, has been brought to your attention in the past by Jon N. Jureidini and Leemon B. McHenry and despite pointing out to you Paxil 329'S flaws you refused to retract it. In fact, you added that, “We have found no evidence for such errors nor any justification for retraction according to current editorial standards and scientific publication guidelines. We therefore will not proceed further with your request” [1]

I am sure you are aware of recent events regarding GlaxoSmithKline's guilty plea surrounding the illegal marketing and promotion of many of their products, one of which was Paxil.

Glaxo agreed to plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C.  331(a), 333(a)(1) & 352(a). That 'misbranded drug' was Paxil.

Transcripts of GSK's plea and settlement agreements are available on the Department of Justice website. [2]

Regarding Paxil and their guilty plea, Glaxo settled allegations that:

From 1999 to 2003, during sales calls, dinner meetings, spa programs, lavish weekend conferences to places such as Puerto Rico and Hawaii, through a false and misleading medical journal article, and through the distribution of free samples for patient use, GSK promoted Paxil to doctors for the treatment of depression and, to a lesser extent, obsessive-compulsive disorder in patients under age 18.


That they conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, GSK failed to demonstrate efficacy on the endpoints identified in the study protocols.


That they hired a contractor to write an article on one of the studies that was published in July 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). The article stated that Paxil “is generally well tolerated and effective for major depression in adolescents.” The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol.


There marketing team distributed the JAACAP article to all of the Paxil sales representatives with a cover memo that stated that Paxil had demonstrated “REMARKABLE Efficacy and Safety in the treatment of adolescent depression.” Some GSK sales representatives used the article to urge doctors to prescribe Paxil to treat patients under age 18.

Given that they have pleaded guilty one would assume that the next natural step would be for the study to be retracted. I gather the responsibility falls upon you to issue such an order.

Can you tell me if you plan to retract "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression." - Martin Keller et al, and/or issue an explanation as to why you wish to retract it?

If you plan not to retract it could you please explain why?

Could you please also state, for the record, that your position is that you can still see no evidence of errors nor any justification for retraction according to current editorial standards and scientific publication guidelines.

Meantime, I look forward to your reply and hope that you will find it in your heart to remove this fraudulent publication as a goodwill gesture to the parents of children that have killed themselves as a result of Paxil induced suicide after it was prescribed to them by doctor's, pediatrics, child psychiatrists and, in general, healthcare professionals, whom used your journal as a reference when weighing up their decisions to prescribe it to this vulnerable population.

Yours sincerely,

Bob Fiddaman.

[1] Jureidini, Jon N. and McHenry, Leemon B.(2011) 'Conflicted Medical Journals and the Failure of Trust', Accountability in Research, 18: 1, 45 — 54




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