Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Wednesday, September 30, 2015

GSK Vs Ronnie Biggs







Two criminals, both British - lets look at their respective rap sheets.

Ronnie Biggs



1945
9 Feb
Biggs’ first court appearance at Lambeth Juvenile Court at the age of 15. The charge is stealing a pen refill and eraser of 1/2d value from a shop display.

8 June
Second appearance at Lambeth Juvenile Court for stealing four radio valves and an eggcup. Bound over for 12 months and find £1. Discharged

16 Nov
Third appearance at Lambeth Juvenile Court for stealing his brother’s watch. Bound over for a further 12 months and fined £1.

1949
17 Feb
First prison sentence – sentenced to six months for shop breaking, housebreaking, stealing and using a false ID card. Dishonourable discharge from the RAF.

28 July
Sentenced to three months in Wormwood Scrubs at the North London Magistrates Court for ‘taking and driving away a motor vehicle’.

30 Nov
Sentenced to Borstal training after being found guilty at Essex Quarter Sessions for shop breaking and stealing.

1950
21 Mar
On trial at the Old Bailey for the first time for robbery of jewellery and money, and being armed with an offensive weapon. Sentenced to three years and six months.

1953
24 Mar - Found guilty at Country of London Sessions for garage breaking and stealing a motorcar.
30 Mar - Found guilty at Buckinghamshire Quarter Sessions for house breaking and stealing a bottle of sherry valued at 18 shillings.
Concurrent sentences of three years from Country of London Sessions and four years from Buckinghamshire Quarter Sessions.

1958
1 April
Sentenced to 12 months at Dorset Quarter Sessions for ‘taking and driving away a motor vehicle’.

25 April
18 months added to sentence by Surrey Appeals under probation order for stealing paint and a bike in 1956.

1964
16 April
Biggs sentenced to concurrent sentences of 30 years and 25 years for his part in the Great Train Robbery.



GlaxoSmithKline



1992
September 18
SMITHKLINE AND ROHM & HAAS TO CLEAN UP TOXIC SITE - both agreed to reimburse the United States for past cleanup costs absorbed by the E.P.A. totaling $250,000 - No prison sentence

1996
February 10
Drug Makers Settle Suit on Price Fixing
Fifteen big drug companies formally agreed yesterday to pay more than $408 million to settle a class action lawsuit charging them with conspiring to illegally fix prices that they charged to thousands of independent pharmacies.

In the settlement, which is subject to approval by a Federal district judge in Chicago, the 15 companies agreed to pay more than $388 million in cash. One of the defendants, SmithKline Beecham P.L.C. of London, agreed to supply the plaintiffs with a generic version of cimetidine, SmithKline's Tagamet brand ulcer treatment, valued at $20 million, as well as $30 million in cash. -  - No prison sentence

September 7
SmithKline Beecham in Settlement With U.S.
In the latest big settlement by a clinical laboratory company of Federal Medicare fraud charges, SmithKline Beecham P.L.C. expects to pay the Government about $300 million this year, without admitting any wrongdoing. - No prison sentence

2001
February 8
5 Drug Makers Use Material With Possible Mad Cow Link
For the last eight years, the Food and Drug Administration has repeatedly asked pharmaceutical companies not to use materials from cattle raised in countries where there is a risk of mad cow disease. All five vaccine makers, which include GlaxoSmithKline, Aventis and American Home Products, have now agreed to stop using the suspect materials, which include blood, fetal calf serum and meat broth. - No prison sentence

June 8
Jury Awards $6.4 Million In Killings Tied to Drug
A Wyoming jury has awarded $6.4 million to the family of a man who killed three relatives and himself after taking the antidepressant Paxil, an antidepressant made by SmithKline - No prison sentence.

2003
January 24
Asthma Drug Health Risks Are Suspected
GlaxoSmithKline said yesterday that Serevent, one of its popular asthma drugs, might pose a risk of death and serious asthma-related illness in some patients. -  No prison sentence

2004
February 7
DRUG MAKER AGREES TO PAY $175 MILLION IN LAWSUIT 
GlaxoSmithKline, the drug maker, agreed to pay $175 million to settle a lawsuit contending that it blocked cheaper generic forms of its Relafen arthritis medicine, in violation of antitrust laws in the United States. -  No prison sentence

July 9
GLAXO TO PAY $92 MILLION TO SETTLE PATENT LAWSUITS - Published: July 9, 2004
GlaxoSmithKline, the drug maker, has agreed to pay $92 million to settle lawsuits accusing it of misusing patents to thwart generic competition to the antibiotic Augmentin  - No prison sentence

2005
September 20
Glaxo Settles U.S. Fraud Charges
GlaxoSmithKline PLC will pay $150 million to settle claims it overcharged the government for two anti-nausea drugs, and prosecutors say they're looking into 150 cases of drug price fraud. - No prison sentence

2006
August 11
Glaxo reaches $70 million settlement over price-fixing claims

Pharmaceutical giant GlaxoSmithKline announced yesterday that it had agreed to pay $70 million (£36.9 million) to settle a number of civil lawsuits filed in the US which accused the company of pricefixing. - No prison sentence

September 12,
GlaxoSmithKline to Settle Tax Dispute With U.S.

GlaxoSmithKline, Europe's biggest drug maker, said Monday that it would pay $3.1 billion to settle a tax dispute with the United States government that was set to go to trial next year.  - No prison sentence

2007
March 27
Schoolgirls bust Glaxo for lying about Ribena vitamin C 

Two fourteen-year-old students busted Glaxo for lying about the Vitamin C content of the Ribena drink. Glaxo fined  NZ$217,500.  - No prison sentence

Musical interlude. The charges featured in this video resulted in no prison sentences




2012
July 2
Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.  - No prison sentence

2014
Sept 14
In the strongest signal yet, a Chinese court on Friday imposed a fine of nearly $500 million on the British pharmaceutical giant GlaxoSmithKline for bribery. Chinese authorities accused Glaxo of bribing hospitals and doctors, channeling illicit kickbacks through travel agencies and pharmaceutical industry associations — a scheme that brought the company higher drug prices and illegal revenue of more than $150 million. In a rare move, authorities also prosecuted the foreign-born executive who ran Glaxo’s Chinese unit. After a one-day trial held in secrecy, the court sentenced Glaxo’s British former country manager, Mark Reilly, and four other company managers to potential prison terms of up to four years. The sentences were suspended

2015
Sept 16
Global drug giant GSK 'published a flawed study which led to millions of children being wrongly prescribed dangerous antidepressants'
A global drugs giant published a flawed study which led to millions of children being prescribed potentially dangerous pills, new research reveals. GlaxoSmithKline misled doctors and the public into thinking their antidepressants were safe and effective, even though there was no evidence to back this up. - No prison sentence


British criminals, GlaxoSmithKline are currently partners with Global charity, 'Save the Children'.

Total Prison sentences (in years) handed out to Ronnie Biggs = 86 years 9 months
Total Prison sentences (in years) handed out to GlaxoSmithKline employees = 4 years (Suspended)


Bob Fiddaman







Tuesday, September 29, 2015

MHRA: Follow-Up Rate at a Price







I've been at loggerheads with the British drug regulator, the MHRA, for many years. I saw a window of opportunity a few years ago when I was (finally) given the chance to sit with their (then) CEO, Kent Woods, to discuss the struggles patients were having when trying to withdraw from SSRi- type medications. (Notes on that meeting can be viewed here) Any such meetings with them these days would be kinda frowned upon by me - their current CEO being the former World Safety Officer for GlaxoSmithKline - Safety and GlaxoSmithKline, two words, combined, that just don't sit right with me. I don't wish to sit at the same table as him or anyone connected with GSK for that matter, well, not unless they have some sort of apology to offer me. (See here)

Some months after my meeting with Kent Woods I finally gave up communicating with the MHRA. The final correspondence between myself and Kent Woods is detailed in my book, The evidence, however, is clear: the Seroxat scandal. (US - UK) - In a nutshell, the MHRA did not agree with a US Court's findings that Seroxat, known as Paxil in the US, is a tearatogen (an agent or factor that causes malformation of an embryo.)

From time to time I still send in Freedom of Information requests to the MHRA, it's all very formal, no name-calling or accusations that they are limp-wristed and incompetent.

A recent request sent in to them has been going back-and-forth - apparently my wording confused them in an original request of mine so I had to wait almost two months for their reply.

My question was, I thought, pretty straight forward but I amended it for their ease.

Please provide total number of yellow cards and total number of full investigations into the alleged adverse reaction for the following years... 2011 to date (where full investigation = how many of the affected persons, or the affected persons health care professionals, did the MHRA contact to see what happened to them or to discuss with them the adverse drug reaction)

Basically, I want to see if the MHRA ever contact any person who sends in a report of an adverse reaction, after all, the patient is the one suffering here.

It's worthy to note also that the MHRA list the number of reports sent in by patients, healthcare professionals on their website. They will list, for example, the number of reported fatalities sent in via their yellow card reporting system but, and here's the crunch, they don't provide information as to whether their team of investigators have actually discussed the adverse reaction with the patient or doctor. They also claim that just because xxx fatalities have been reported with drugs x,y and z, it does not necessarily mean that drugs x,y and z caused the deaths. How, then, can they know for sure that, for example, a suicide has been caused by a drug? Leaving the public, and doctors, second guessing just adds to the woeful way the Yellow Card Reporting System is run.

Anyway, here is their reply - looks like I need to pay money up front - £600 (minimum)







So, let's just get this straight. Me (a patient) is asking for information that, I feel, is important - in as much that I wish to try and find out if the MHRA investigative team actually respond to patients or doctors on a personal level. An example here would be a yellow-card report sent in by the family of a suicide victim, or indeed the victim's doctor - I just want to know if the MHRA would, during their investigation, contact the family to ask questions about their loved one taking his/her life and if this victim displayed suicidal thinking before he/she had taken the drug.

It seems the MHRA are avoiding the question and putting other excuses in place. (Just an opinion of mine so no need to label me vexatious)

  • It is important to note that each report is different and not every report requires follow up. 
  • Some reporters request they do not wish to be contacted again by the MHRA 
  • The MHRA determine which cases should be followed up, on a case by case basis. 

I understand that my request would take up many man hours so I sent back the following to them. It's short and sweet and yet, my lack of confidence in the MHRA tells me that they may further stonewall me with their next reply.

Dear MHRA,
I'm somewhat bemused by your answer but, I guess, I will have to take it on trust that you are not trying to pull the wool over my eyes.
Simple question as a follow-up to your reply...
Do the MHRA actually follow up any Yellow Card Report sent in by the original reporter, ie; do they,or have they, ever contacted the patient who sent in the original yellow card?

This simple question, one would think, could be answered in the blink of an eye. However, it appears that I may now have to wait a further 21 working days for a reply that I suspect will be decorated with bricks and mortar.

I hope they prove me wrong.

That will be a first!

It's simple. How many reports have the MHRA followed up by speaking with the original reporter?

I'd draw a picture for them but art was never really my thing, I draw horses that resemble hedgehogs and even my stick-men have deformities.

If the answer to the question embarrasses the MHRA, ie they don't ever follow-up with the original reporter, then why don't they just say so instead of, seemingly, putting up these stonewalls?



Bob Fiddaman















Sunday, September 27, 2015

Save The Children







Some people ask me why I'm, seemingly, hellbent on causing GlaxoSmithKline grief. I would have thought it was plainly obvious given their sombre history where kids are concerned.

The recent RIAT findings that showed (clearly) how this British pharmaceutical company hid important patient information in an effort to make money should have embarrassed GlaxoSmithKline bosses, it should have embarrassed every single person that works for GlaxoSmithKline (past and present) - more importantly this new information should have made your average person angry - sadly, there are still people who read the headlines, shrug their shoulders, and continue posting photos of their dinner on Facebook or a photo or video of a cute cat or dog. The marketing of Paxil to kids doesn't seem to bother them because... well, because it happened to other children and adolescents and not theirs. This attitude is akin to people turning their cheeks when Hitler went on his journey - "Ah well, it won't affect us, we ain't Jewish, it's not our problem."

I have a beef with apathetic attitudes, moreover I have a beef with the people with these attitudes.

I understand that everyone of us have our own agendas, I just can't fathom out what some people's agendas are?


Then there are the organizations who receive funding from GlaxoSmithKline, of which there are many.

In a perverse twist of fate we have the aptly named 'Save The Children' charity who proudly boast...

"Save the Children works in 120 countries. We save children’s lives. We fight for their rights. We help them fulfil their potential."

I have to take my hat off to any charity that puts children first and I salute Save The Children for all that they do regarding the protection of children.

Here's what I don't get...

In 2013, GSK and Save the Children formed an ambitious and strategic global partnership. At the time of joining forces, GSK CEO, Andrew Witty, had this to say...


“A partnership of this scale gives us an opportunity to do something amazing – to save the lives of one million children, and to transform the lives of millions more. At GSK we are motivated by developing innovative life-saving medicines and getting them to the people that need them.
“By joining forces with Save the Children, we can amplify these efforts to create a new momentum for change and stop children dying from preventable diseases. I hope this partnership inspires GSK employees and sets a new standard for how companies and NGOs can work together towards a shared goal.”

GlaxoSmithKline, along with the 22 original authors of the JAACAP paper, potentially put thousands of children and adolescents at risk of suicide (potential figures here)

Would it have made us all be more vocal if the risk would have been death by poisoning? Is the suicide thing debatable because the majority of us think that kids who kill themselves are mentally ill and it has nothing to do with medication inducing suicide?

How can a charity, who aim to save children's lives team up with a pharmaceutical company who did/do exactly the opposite?

With this in mind, I wrote the following to Save The Children (I have also wrote to a number of other children's charities who are affiliated with Glaxo.)



Dear Sir/Madam,
Whom may I speak with regarding your affiliation with British pharmaceutical giant, GlaxoSmithKline?
As you will probably know by now, a new study that was recently published in the British Medical Journal (BMJ) has shown that GlaxoSmithKline knowingly withheld vital patient information back from regulators and the public regarding it's best selling antidepressant Seroxat, known by the brand name of Paxil in the United States. The new findings have urged the associate editor of The BMJ to write a scathing feature on GlaxoSmithKline - this is unheard of in medical journals.
The clinical trial, known as Study 329, originally showed that adolescents/children, across the world, were at no harm in taking Seroxat, when in actual fact, there were 12 adolescents in the original study who suffered suicidal feelings whilst on Glaxo's drug.
Glaxo never informed the people they should have and, for the past 14 years, academics have been calling for the retraction of this fraudulent study. GlaxoSmithKline, despite new evidence showing how they hid the data, have declined to remove the study, a study that is still used by healthcare professionals when deciding whether or not to prescribe children Seroxat off-label.
It makes a mockery of your affiliation with them. On one hand you are running an organisation that is trying to help save children, on the other hand you are affiliating yourselves with a company who put children at risk, and continue to do so.
The new study and the background can be found here - http://study329.org/
I strongly urge you to inform yourselves and reassess your allegiance with GlaxoSmithKline.
If this is just about receiving funding from GlaxoSmithKline to help your cause then you may wish to find out exactly how much money they have made over the years regarding the sale of paroxetine (generic name) to children and adolescents.
I don't expect for one minute that you will respond to this email but as a matter of conscience I urge you to, at the very least, read the new study and the history of this whole sordid affair that has put children and adolescents at high risk of suicidal thoughts and, in some cases, completed suicide.
Regards
Bob Fiddaman

--

Those of you on Facebook, Twitter, Instagram and the other countless social media websites who wish to carry on burying your heads in the sand and ignoring what Glaxo have done here, that's fine - just leave it to the people who have been affected by pharmaceutical greed. Glaxo aren't the only company who have caused heartache for parents, husbands, wives, brother, sisters and friends of those who have died as a result of unsafe antidepressants (short video below with just a handful of instances) - Hey, they are other people's loved ones so it really doesn't matter - just continue with your fluffy bunny, dog and cat pictures on Facebook.

I often wonder if I am wrong to do what I do and if I should just, like the millions of others on Facebook, just bury my head in the sand and use my status profile to tell people that I have just ordered a chicken madras or egg foo yung for my tea... then proceed to post a photo of it on to my wall when it arrives.

Such apathetic attitudes of the general public make it easier for the likes of GlaxoSmithKline and the charities that align themselves with them.

We ALL have a part to play in protecting children, whatever our life agendas, whether or not those children are our own.

The irony of it all is that this rant of mine will be 'liked' on Facebook, people on my friend list (not all of them) will see it appear on my wall and they will instantly 'like' it without actually clicking on the link to read it - hey, it must be likable because that Fiddaman guy is having a pop at GSK again.

I created this blog almost 10 years ago - I wanted to get to the bottom of the whole Seroxat/Paxil debacle because I had taken it and suffered the horrific withdrawal effects from it. When I learned that this antidepressant, and other SSRIs were actually causing kids to kill themselves (adults too) I changed direction - this wasn't just about me, it was about others less fortunate than me. I suffered horrendous side effects but I lived to tell the tale, others were less fortunate than I.

This is for them, it's also for the Facebook Fluffy Bunny Brigade. 


Enjoy your chicken madras.


**Update - Save The Children Respond** - Here




Bob Fiddaman.






Saturday, September 26, 2015

GSK: What on Earth Were They Thinking?




As the latest outing of GSK's Study 329 simmers and the finger of blame from Glaxo's point of view is aimed at technology, whilst the original authors of the JAACAP article point their fingers in the direction of, well, um, everyone but themselves, I thought I'd take a trip down memory lane.

Thank goodness for this old blog of mine.

Back in 2013, I wrote about a 2008 study I had stumbled across. The study, sponsored by GlaxoSmithKline, was carried out in Japan. They wanted to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily.

The target population?

7-17 year-olds!

I kid you not.

Here's the original post of mine. Pay particular attention to Glaxo's recruitment poster. One has to ask why, after the failure of study 329 and 377, Glaxo wanted to trial paroxetine out in more kids.

Here's the 2013 blog post of mine...


Why Was the Japanese Paxil Pediatric Study Terminated?

By Bob Fiddaman

September 18, 2013



Regular readers of this blog will know how I broke the news back in 2009 regarding GlaxoSmithKline's attempts to push Paxil [known as Seroxat in UK] on kids in Japan.

I was so outraged at this that I wrote to the Japanese Embassy and the Japanese Ministry of Health, more or less to give them a detailed view of how GSK had previously claimed Paxil was safe for kids to take...when in actual fact they knew that it wasn't.

I never heard back from either one of them.

I also contacted GlaxoSmithKline in 2010, you can see the email I sent to them (link at foot of this post).

In 2008, one year before I broke the news, Glaxo were recruiting kids for a clinical study. I say Glaxo, they, in actual fact were sponsoring the study.

The study was designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily.

Oral paroxetine is a sickly orange syrup, I've been on it myself. It was the only safe way to taper from this highly addictive antidepressant.

And just who were being used as the guinea pigs in Japan?

One look at the inclusion study criteria would have showed you.

Ages Eligible for Study:7 Years to 17 Years.

Yup, that's right folks. Despite being dragged through numerous courts in the US where evidence was shown that Glaxo manipulated previous clinical trials in children, here they were again back in 2008 recruiting more kids.

A marketing campaign went out in the form of a poster... which I just happened to obtain from a source at Medwatcher Japan. Medwatcher were also furious at this particular clinical trial involving kids and Paxil.



If a picture paints a thousand words, eh?


Well, folks... **drum roll** - the trial has been terminated.

**Cue a spectacular display of fireworks**

According to GSK's clinical trial database the study was terminated in 2011. They give no reasons as to why this study was terminated.

What we do know is that 56 kids were enrolled. 29 were in the Paxil group whilst the remaining 27 were in the placebo group.

The study results claimed that there were 3 reports of suicidal ideation in the placebo group but none in the Paxil group. [More about this later]

The subjects enrolled had to have a diagnosis of a depressive disorder before being allowed into the study.

So, it would appear that 3 of the kids taking placebo had suicidal ideation. Not one report in the Paxil group. Glaxo must have loved this.

Unfortunately for the Glaxo sponsored trial, Paxil didn't really show much efficacy.

Open the Outcome Measures on the Clinical Trials website and it tells us how Paxil failed.

Paxil didn't reduce the depression scores of the children sufficiently to be considered effective and the primary purpose of this study was efficacy. In this study all participants had to have a depression score of 45 or greater to be included. A 50% reduction on the CDRS-R is required to consider children have responded to treatment.

So, not only did Paxil not reach the standard for efficacy but in comparison to, let's say, fluoxetine, it would be seen to be less effective.

In the Fluoxetine studies [1] [2] the average decrease was 28.9%. In this Japanese study, the decrease was only 16.9% therefore the kids would not be considered to have responded to Paxil treatment.

No wonder the study was terminated, right?

It would appear that GlaxoSmithKline didn't want to expose the fact that Paxil is less effective than that of their competitor.

Another interesting finding from the Japanese study was the participants only had to have been free from any antidepressant for 1 week prior to the trial commencement.

Anyone who's anyone will know that one week off an antidepressant is hardly a time to get the champagne corks popping and decorate rooms with bunting and balloons. Any number of these participants could have been suffering withdrawal even before they were entered into the Japanese trial. Any of these patients suffering withdrawal, which remember can mimic depression, would have had immediate relief if they were selected for the Paxil arm of the trial. As the phases of the trial progressed they would have, obviously, reaped the benefits of Paxil but not for their apparent depression, their benefits from Paxil would have merely meant they would not be going through withdrawal anymore.

Take the three patients from the placebo arm of the study who, according to the results, suffered suicidal ideation, and we may just find that these three were also taking antidepressants a week or so before they entered the Japanese study.

Could their suicidal ideation have been caused by the withdrawal effects of the medication they were taking prior to the Japanese study?

Glaxo pretty much shot themselves in the foot with this study, a study that should never have taken place given the findings of the Paxil 329 study.

So, once the Japanese trial was over did the sponsors, GlaxoSmithKline, do any follow-up to see if these kids were okay? The doses used in the study were between 10mg and 40mg, the latter being enough to put a horse into a coma.

The withdrawal phase of the Japanese study lasted three weeks. Two weeks later the participants were contacted to see how they were.

Can you imagine a 7 year old child on 40mg of Paxil a day just having three weeks to taper? Even if the 7 year old was on a lower dose it's still mind-boggling how one adult human could give someone so young a pill known to increase suicidal thoughts, known to increase completion of suicide.

What on earth were GlaxoSmithKline thinking by using kids in a study for Paxil?

The Japanese public, particularly the children and adolescents, just don't know what a lucky escape they've had from this truly awful abomination of an antidepressant.


Bob Fiddaman


[1] Psychometric Properties of the Children's Depression Rating Scale–Revised in Adolescents - J Child Adolesc Psychopharmacol. 2010 December; 20(6): 513–516.
[2] Early Prediction of Acute Antidepressant Treatment Response and Remission in Pediatric Major Depressive Disorder - J Am Acad Child Adolesc Psychiatry. 2009 January; 48(1): 71.

Back stories:


Friday, April 03, 2009 - Japan/GSK - 329 All Over Again!

Friday, April 03, 2009 - Email to Ministry of Health - Japan


Friday, September 24, 2010 - HEY, GLAXO!... LEAVE THOSE KIDS ALONE


Wednesday, May 18, 2011 - GSK Japan, Paxil Study in Kids Update





Wednesday, September 23, 2015

Seroxat - Project 1059 Laden With Withdrawal Problems






GlaxoSmithKline are defending allegations that it's antidepressant, Seroxat, known as Paxil in the US, causes severe withdrawal reactions when patients have tried to taper of of it. They have settled similar allegations in the US with over 3,000 claimants, all of whom went on to sign confidentiality agreements - the official line of that particular case was that it was "resolved."

Later this year sees GlaxoSmithKline defend the same allegations, this time in the UK. The case has been running for 8 years plus and at no time have GlaxoSmithKline, via their representative lawyers, Addleshaw Goddard, made any offer of settlement to the 105 plaintiffs in the case.

So, there's a kind of stale-mate. 105 claimants allege they suffered severe withdrawal reactions when trying to wean themselves from Seroxat - Glaxo have maintained that "We believe the product is not defective and that there is therefore no merit in this litigation."

No merit?

Let's go back in time, to the year 2000.

James Ballenger, MD, was chair of the Medical University of South Carolina’s Department of Psychiatry, and he had been carrying out a long-term panic disorder study in 2000, Seroxat was the choice of drug. The study was cancelled by GlaxoSmithKline (then SmithKline Beecham) after they learned that Ballenger's findings had found something that they wanted to keep quiet - Severe withdrawal effects in adults that take them!


"There are some data that no amount of spin will fix."

As with most clinical studies, Glaxo had, just like they did in Study 329, hired a ghostwriter to draft the positive results from Ballenger's study.

Once again, just as in Glaxo's infamous 329 study, Sally K. Laden was handed the job of turning bad into good. Sadly, for Glaxo at least, even Laden couldn't spin the results of Ballenger's study, (known as "project 1059")

Internal emails between Laden and Daniel Burnham of SmithKline Beecham show Burnham write the following...

"The issue of discontinuation sx [side effects] vs. relapse is obviously a concern of the J Clinical Psychiatry reviewers... Thus we have decided to terminate further work on this manuscript."

The industry prefer to call withdrawal issues "discontinuation problems".

What is striking about this correspondence is Laden's response to Burnham...

“We understand your reasons for cancelling this project. There are some data that no amount of spin will fix, and these certainly fall into this category.”

This, to me at least, suggests that Laden was familiar with spinning poor results into bad.

Laden then told her bosses at Scientific Therapeutics Information, Inc. (STI)...

“Yes, Virginia, there is a God. SB cancelled our project 1059 (long term panic disorder study). Reason: the side effect data was terribly unfavorable to our favorite antidepressant. And we hate when that happens!”

Definition of 'terribly' -  very, extremely, hugely, intensely, immensely, dreadfully, incredibly, extraordinarily, seriously.


In a 2012 interview with investigative journalist Dyan Neary, Ballenger said...


“What that study in retrospect probably showed for the first time was that there’s withdrawal from the medicine…your body might miss it.”


Hmm, dependency anyone?

Question we really should be asking here is why didn't GlaxoSmithKline, when they knew of the severe withdrawal problems, carry out their own study into these problems raised in Ballenger's study? Why did they sit on this information? Myself, and others, would then not have had to endure the horrific withdrawal problems - had myself, and others, had previously know about these "terrible" side effects, we would never had taken Seroxat.

The prosecution rests, m'lud.

Here's the emails. (Click to enlarge)






Something for Glaxo's UK lawyers, Addleshaw Goddard, to mull over, perhaps.


Bob Fiddaman.



Competing interests

I am one of the 105 claimants in the UK group action.







Monday, September 21, 2015

Alastair Benbow: The Devil is in the Details





First off, I'm not a mathematician. Maths, or if you're American, math, is another language to me, in fact, for me at least, it would be easier to learn Chinese than it would to grasp maths. I was the kid at the back of the classroom who still counted on his fingers underneath the table, out of view of those who were better at numbers than I.

I was going through some of the archives and recent media articles regarding the original 329 study.

There were 275 subjects in the 8 week trial, 12 of whom had suicidal thoughts (in the paroxetine arm)

12 suicidal thoughts out of 275 subjects = 4.363636363636364%

Okay, out of the 275 subjects, 90 were on paroxetine. The table below is based on efficacy results for 90 patients. The actual figure of adverse events was based on 93 patients but I'm keeping the figure at 90 for ease.



12 suicidal thoughts out of 90 subjects = 133.33333333333334 (Roughly 13%)

Given there were approximately 2 millions prescriptions for paroxetine written for adolescents one year after the study was published in the JAACAP this means, if I have my maths correct, that...

133.33333333333334 of two million = 266,666





In 2003, GSK's then Head of Psychiatry, Alastair Benbow (pictured above) went on national television and claimed that, "less than a small class size would have these suicidal thoughts." (video below - 1 minute 21 seconds, Alastair Benbow

Benbow's 'small class size' is a classroom, therefore, that can fit 266,666. pupils. What school did Benbow attend?

Okay, so two million prescriptions does not necessarily mean two million adolescents. The two million prescriptions may have been repeat prescriptions to individuals. So, lets say the number of individuals written a prescription is between 200,000 and 2,000,000











Whatever way you slice it, Alastair Benbow must have gone to an awfully big school!

To put this into some sort of perspective, America de Cali, a Columbian football team, play their homes games at the Pascual Guerrero stadium which holds some 33,000 spectators. So, if 250,000 individuals were given prescriptions for paroxetine one year after the JAACAP review by Keller et al had been published, Benbow's small classroom would have looked something like this...




If 500,000 individuals were handed out prescriptions for paroxetine then Benbow's small sized classroom would have resembled this (Kingdome, Seattle - now demolished)







Okay, let's give Benbow the benefit of the doubt here and say that just 175,000 individuals took paroxetine one year after the JAACAP review.

That would give us (excuse the Devil numbers) a class size of 16,666 pupils.

In other words, Benbow's small sized class could be compared to the Nilson Nelson Gymnasium in Brazil (pic below)



Furthermore, and once again cutting Benbow some slack, let's say just 87,500 took paroxetine one year after the JAACAP review - that would still give us a pretty large classroom,   - 8,333 pupils.

An averaged sized class (not small sized class) in the US was between 19 and 26 pupils in 2011/12. (Source)

Remember, Benbow claimed that, "less than a small class size would have these suicidal thoughts."

What exactly is less than small? English language and usage may be worth looking at to understand what Benbow was actually saying. (Smaller vs. less vs. lesser) Maybe it was yet more coding from GSK (see http://study329.org/) for explanation of "emotional lability"

Maybe Benbow was talking about the 12 patients who had suicidal thoughts that the restoration team found... or maybe he was talking about the 6 that Keller et al found?**

Either way, it was an extremely poor choice of words to use. Perhaps Benbow should have used the same criteria I've used here, although going on national television and saying something like, "We believe that between 8,000 and 266,000 would have had these suicidal thoughts one year after our study was reviewed and published" , wouldn't really have gone down too well with GSK executives, or, indeed, their shareholders.

Truth is over two million prescriptions were written for children/adolescents one year after the Keller study was published. It is unknown how many children/adolescents were individually prescribed paroxetine, it's believed to be, as I mentioned, between 200,000 and 2,000,000. Even if the figures are less we still see a potential for thousands of adolescents and children that may have been at risk of suicidal thinking. One also has to take into account that these figures are based on US prescriptions only. Add to it prescriptions written for adolescents and children in other countries and we have stadiums bursting at the rafters!

Maybe a more striking headline regarding the recent restoration study findings should have been 'Between 8,000 and a quarter of a million kids put at risk one year after flawed paroxetine data published.'

The interview with Benbow (below) is from 2003, some two years after the Keller paper was published.






As I said, at the top of this post, I'm not a mathematician so I may be totally wrong with these figures. When Benbow said , "less than a small class size would have these suicidal thoughts", I took it as maybe 10, or 20 at the most. Truth of the matter is, in an 8 week clinical trial 12 patients, who were taking paroxetine, suffered suicidal thinking - that figure may be higher because none of the 90 (93) patients given paroxetine in the 8 week trial were followed up, in other words, more may have had suicidal thinking after the 8 week period. The patients who dropped out before or at the 8 week point weren’t properly followed up – who knows what the story was behind the patients reported as just being ‘lost to follow up’ or ‘consent withdrawn’ for example.

Some patients did go on to take part in a 6 month continuation phase and these were followed up at various points, but this data has never been published.

If any statistician stumbles on this post of mine they may be able to clear things up for me?



**Keller et al only classed 5 of 6 as serious adverse events (suicidal ideation/gestures)





Bob Fiddaman

Related

















Friday, September 18, 2015

329: The Aftermath - Karma Chameleon






It's been almost two days now since the publication of the damning 329 restoration study in the British Medical Journal (BMJ) and, as I suspected, no apology has been forthcoming from either GlaxoSmithKline, any other the original study 329 authors or the The Journal of the American Academy of Child & Adolescent Psychiatry's (JAACAP)

What we have seen, however, is a couple of quotes from spokespersons. GSK's Bernadette Murdoch and lead author of the original 329 study, Martin Keller - they make interesting reading, even though they are small musings.

First off, Bernadette Murdoch, Communications Director for GlaxoSmithKline Australasia.

On responding to the restoration study, Murdoch told ABC Australia, "We did provide an unprecedented level of data to the research team. In relation to the findings from the team's analysis, they do appear to be in line with the longstanding view that these medicines, anti-depressants like paroxetine, are not suitable for children. This is widely known and clear warnings have been placed on the product label for more than a decade."

Before offering you her small quote on the original study, let's just try and analyse her above quote. I'm no psychologist, these are just my thoughts.

"We did provide an unprecedented level of data to the research team."

This is true. In fact GSK provided over 77,000 pages of raw data to the restoration team. What Murdoch failed to mention was GSK made it difficult for the team, so difficult in fact that the restoration authors called this process of research the "periscope."

This from the authors...

"This restoring invisible and abandoned trials (RIAT) exercise proved to be extremely demanding of resources. We have logged over 250,000 words of email correspondence among the team over two years. The single screen remote desktop interface (that we called the “periscope”) proved to be an enormous challenge. The efficacy analysis required that multiple spreadsheet tables were open simultaneously, with much copying, pasting, and cross checking, and the space was highly restrictive. Gaining access to the case report forms required extensive correspondence with GSK. Although GSK ultimately provided case report forms, they were even harder to manage, given that we could see only one page at a time. It required about a thousand hours to examine only a third of the case report forms. Being unable to print them was a considerable handicap."

"In relation to the findings from the team's analysis, they do appear to be in line with the longstanding view that these medicines, anti-depressants like paroxetine, are not suitable for children."

Deflection, deflection, deflection. Here Murdoch, probably guided by GSK's attorneys, tries to let the reader know that all antidepressants, not just Paxil, are not suitable for children. She is telling us something that we already know yet, at the same time, letting the reader know that GSK are a good company and would not ever allow drugs that are not meant for children onto the market. GSK did not voluntarily offer this information, they were forced to do so after regulators found that they were lying in their original 329 study.

"This is widely known and clear warnings have been placed on the product label for more than a decade."

Again, this appears as if Murdoch is trying to undermine the restoration study, it's almost like "Oh hum, tell us something we don't know." She wants the public to know that, for almost a decade, her company have been warning the public about the dangers of paroxetine in children and adolescents. This, however, does not detract from the fact that her company tried to gain a licence for paroxetine use in children and adolescents even though they knew that..

A: It didn't work;

B: It was dangerous.


Speaking about the original 329 study (the fraudulent one) Murdoch offered this...

"These studies were conducted in the '90s, many years ago when computer systems were very different. A lot of the notes were handwritten. It's important to remember that when a medicine is approved for use, it's not just the pharmaceutical company that makes that decision. There are lots of checks and balances in between, so a regulator uses all of the data that's available on a medicine before recommending it for use for a patient,"

In essence, it appears, that Murdoch is saying, "It's not just our fault". It's almost like an admittance of guilt. We were less than fruitful with the truth but it was the job of the regulators to try and catch us out, they didn't, so they must also take the blame. In using the line, "These studies were conducted in the '90s, many years ago when computer systems were very different. A lot of the notes were handwritten," it appears Murdoch is blaming technology - ie; the RIAT team had better technology than what we did so they found stuff that we didn't...because our computers back then were not as sophisticated as what they are today.

It's interesting to note that no apology was offered by Murdoch. It's basically a rebuttal and a deflection on a calamitous scale.

Original Study 329 Lead Author Martin Keller.

This guy is priceless.



Keller, pictured above, is quoted in The Journal of Higher Education, the No. 1 source of news, information, and jobs for college and university faculty members and administrators.

Here's what he had to say...

"The 2001 results faithfully represented the best effort of the authors at the time, and that any misrepresentation of his article to help sell Paxil was the responsibility of Glaxo. Nothing was ever pinned on any of us," despite various trials and investigations, and when I say that, I’m not telling you we’re like the great escape artists, that we’re Houdinis and we did something wrong and we got away with the crime of the century. Don’t you think if there was really something wrong, some university or agency or something would have pinned something on us?"

So, it appears that Keller here is speaking on behalf of all of the original 329 authors (22 in all)

Interestingly, he lays the blame at the feet of GlaxoSmithKline, the same company who have, according to court documents, paid Keller on a number of occasions, although he denies that he, or any of the other 21 authors were paid to put their name to the 2001 JAACAP article. Keller, according to investigative journalist, Alison Bass, has in fact  "received $500,000 annually from pharmaceutical companies that manufacture the antidepressant drugs that he lauded in a series of medical research reports." ~ Boston Globe  10/04/99

It's a bizarre stance and one of complete denial. "...any misrepresentation of his article to help sell Paxil was the responsibility of Glaxo."

Key word here is 'responsibility' and Keller, it appears, seems to be shirking his. The responsibility was on Keller and his team to make sure that they read the raw data, or, at the very least, asked for the raw data.

It's a merry-go-round of buck passing akin to kids being asked, who spilled the milk?

Keller goes further, in a two page letter sent to Retraction Watch, a group of individuals that strive for celerity as much as accuracy. The letter is signed by Keller and 8 of the original article authors.

David Healy, who was one of the co-authors of the restoration study has responded to Keller here.



The letter, missing the signature of, amongst others, Karen Wagner, is regarding the science behind the two studies. I'll leave that to the experts. What I do find interesting is the claim by Keller et al that the article wasn't ghostwritten. It's just one paragraph but uses an interesting choice of words...

“Restoring Study 329” asserts that this paper was ghostwritten, citing an early publication by one of the coauthors of that article. There was absolutely nothing about the process involved in the drafting, revision, or completion of our paper that constitutes “ghostwriting”. This study was initiated by academic investigators, undertaken as an academic / industry partnership, and the resulting report was authored mainly by the academic investigators with industry collaboration. "

 Not ghostwritten?

**Insert laughter here**

Here's Keller's letter to Sally K. Laden, the ghostwriter who worked for STI, the PR firm Glaxo hired to write the findings on their study.



"Dear Sally, you did a superb job with this.... enclosed are some rather minor changes from me, Neal and Mike."

I'm quite surprised Keller has opened up a discussion regarding the new restoration study. He's been quiet for many years regarding payments that have been made to him and his former University, Brown, in Rhode Island. By opening discussion about the new study leaves him open to questions about money he was paid but never declared, something he has remained tight-lipped about since news broke of his faux pas.

Furthermore, is Martin Keller really qualified to spot suicidal beahviour in adolescents/children, indeed, does Keller actually know the difference between males and females, come to think of it, do GlaxoSmithKline?

Alison Bass, Pulitzer Prize nominee and author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial. She wrote on her blog back in 2008...

A memo from Keller to the IRBs at Brown and two of its affiliated hospitals, Butler and Bradley. In January 30, 1995, Keller reports (fig 1) that a teenage girl, patient #70 in study 329, ingested 82 Tylenol pills on January 19 and was hospitalized at St. Ann's Hospital. She was discontinued from the study at the end of January and coded as noncompliant according to another memo (fig 2) from Keller to Brown's IRB. Yet according to the GlaxoSmithKline's final report, (fig 3) patient #70 in the same study was a 12-year-old boy enrolled in the trial on February, 22, 1995 and withdrawn on March 24 after suffering from chest pains. This patient had been randomized to the imipramine arm of study 329.



fig 1








fig 2




fig 3




Quite remarkable. Paxil, it seems, can now give you chameleon qualities!


To date, neither GlaxoSmithKline or any of the 22 authors of the original study, or indeed, Sally K. Laden, have apologized.


Bob Fiddaman.


Back Story

Reanalysis of Glaxo's 329 Study Goes Public

Also see

RIAT Study in the media









Wednesday, September 16, 2015

Reanalysis of Glaxo's 329 Study Goes Public







It's been a long time coming, 14 years give or take.

Today sees the publication of a damning reanalysis of GlaxoSmithKline's infamous Study 329, a study, or a review of which, that was first published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001.


BACKGROUND

The study made claims that paroxetine (Paxil, Seroxat, Aropax) was a safe and effective medication for treating major depression in adolescents and has, for the past 14 years, been widely cited in the medical literature, providing physicians with assurances about the usefulness, and safety, of paroxetine in this patient population.

Despite many calls for its retraction it remains unretracted and still provides false and misleading information to physicians and, in many cases, parents, who read it.

Let's take a look at the findings of the original study...

"Paroxetine is generally well tolerated and effective for major depression in adolescents."

Initially, the study looked plausible, after all, it had the backing of high ranking child psychiatrists who had, so we were led to believe, trawled through the data and supported the claim that paroxetine was safe and effective for children and adolescents.**

The new groundbreaking study published today shows how the claims and subsequent support of the claims were misleading and, in actual fact, false.

The reanalysis, Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence - Joanna Le Noury (Lead author), John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude, concludes that...

"Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs."


More on this new study and commentary from me, further down this post of mine.


With an initial study that made claims of safety and efficacy doctors and patients were led to believe that there would be no problems ingesting paroxetine and that it would make a lot of troubled children and teenagers well. Behind the scenes the pediatric Paxil machine was turning its wheels. GlaxoSmithKline, the company that sponsored the original study and manufactured the pill, had learned, some three years previous to the original publication, that the study did not show efficacy in this patient population but they had spent a lot of time and money trying to gain a licence in children and unfavourable results would mean losing out to a lucrative market.  Internal company memos, sent to senior management set the stall. It showed how they, with silence and denial could convince doctors and journals to play along with the claim that Paxil was safe and effective.

One has to ask why they would do this. One can only arrive at the answer that Glaxo did it for the profit, nothing more, nothing less. In fact, it's a good question to ask Glaxo officials - Why did they claim a study drug was safe and effective when they knew that it wasn't?

How do we know this?

Well, a company email surfaced via litigation in the US. It was dated Oct 14, 1998 and told senior management that...

“As you will know, the results of the studies were disappointing in that we did not reach statistical significance on the primary end points and thus the data do not support a label claim for the treatment of Adolescent Depression.”
So, how did we get from this to this?

 “This ‘cutting edge,’ landmark study is the first to compare efficacy of an SSRI and a TCA with placebo in the treatment of major depression in adolescents. Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression.”
Well, it has to do with not being fruitful with the truth. The study results were sent to a PR firm who, after reading through them came to the conclusion that paroxetine was indeed safe and effective. Here's the rub though, Glaxo only provided the PR firm with a summary of the study, roughly 200 pages. The actual study results (raw data) was over 77,000 pages long. Neither the PR firm or the authors who added their names to the study actually saw the raw data, more importantly, nae bizarrely, neither the PR firm or the original study authors asked to see the raw data. One has to ask why?

Glaxo didn't want the negative results leaking out to doctors, the public or their sales staff so they, once again internally, sent out the following to senior management..

“TARGET
To effectively manage the dissemination of these data in order to minimize any potential negative commercial impact…. It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.”

It worked as, one year after the JAACAP article went public, some two million American children and adolescents were prescribed Paxil. That figure is America only - add to it the number of children and adolescents elsewhere in the world that have been prescribed it and you will see why this was a lucrative market for GlaxoSmithKline.

The subsequent marketing of Paxil by its sales representatives to physicians is discussed on pages 11-12. United States of America Vs GlaxoSmithKline.



RESTORING STUDY 329

In as much as proving that the original 329 study was deeply flawed and misleading, the restoration (reanalysis) shows severe problems with the way studies are accepted by medical journals and also highlights how study authors merely put their names to ghostwritten reviews, in this case Glaxo hired a PR firm (1 & 2) to draft the misleading evidence that Paroxetine was generally well tolerated and effective for major depression in adolescents, despite evidence to the contrary, evidence that, allegedly, the PR firm did not see.

The "authors" of the original review, unlike the authors of  'Restoring Study 329' didn't actually get to see the raw data and signed off the review (passed it off as their own clinical findings) - it's akin to structural engineer inspectors taking it as gospel that a building is safe because the builders told them so.

Restoring Study 329 also showed significant increases in the paroxetine and imipramine arms, including serious, severe, and suicide related adverse events, all of which became apparent when the data were made available for reanalysis.

One has to ask some serious questions here about the original 329 authors, all of whom have, over the past 14 years, refused to retract their names from the study.

In an accompanying feature in the British Medical Journal (BMJ) Peter Doshi associate editor, The BMJ, writes...

"The first draft of the manuscript ultimately published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) was not written by any of the 22 named authors but by an outside medical writer hired by GSK. And the paper’s lead author, Brown University’s chief of psychiatry, Martin Keller, had been the focus of a front page investigation in the Boston Globe in 1999 that documented his under-reporting of financial ties to drug companies.
"But for those who have been calling for a retraction of the Keller paper for many years, the system has failed. None of the paper’s 22 mostly academic university authors, nor the journal’s editors, nor the academic and professional institutions they belong to, have intervened to correct the record. The paper remains without so much as an erratum, and none of its authors, many of whom are educators and prominent members of their respective professional societies, have been disciplined."


Doshi also picks up on Karen Wagner who was one of the original 329 study authors. He writes...

Karen Wagner, is a coauthor of the JAACAP paper. Wagner, a psychiatrist at the University of Texas, is also named eight times in the 2011 US Department of Justice complaint against GSK. According to the complaint, Wagner promoted paroxetine at a 1999 GSK sales force event. A GSK newsletter cited in the complaint quotes Wagner as telling the sales force that major depression was “a lethal disorder and it requires treatment.” Based on the results of Study 329, which were at the time still unpublished, “Dr Wagner said: ‘We can say that paroxetine has both efficacy and safety data for treating depression in adolescents.’”

At a telephone press conference (BMJ kindly invited me to participate) on Monday (14th Sept) Doshi spoke about the two studies. "What we have here is one paper published in 2001 saying that paroxetine is safe and effective and a new analysis that says that the drug is unsafe and ineffective, different conclusions and I think the RIAT authors have it right." (RIAT is the name given to the restoration authors - restoring invisible and abandoned trials)

On answering if criminal charges may be brought against any of those connected with the original study, Fiona Godlee, editor in chief of the BMJ, said, "I think there are movements, and this debate is ongoing, about the extent to which research and misconduct, which I think we can all agree, seems to have happened here and certainly many other instances could be the subject of criminal proceedings."

GlaxoSmithKline have had a copy of the RIAT findings since March. I asked one of the co-authors, David Healy, who was also part of the teleconference, if Glaxo had responded to it. He told me, "Not to us, that we're aware of."

RIAT author, Jon Jureidini, a child psychiatrist, also spoke of the study. "You will see from our paper that the harms associated with this drug in this trial were quite striking - twice the severe adverse events, four times the psychiatric events and high levels of suicide (events) and self harm, all of which were unclear in the previous publication." The high levels of suicide that Jureidini spoke of are  shocking. There were 11 suicidal patients in the paroxetine group compared to just one in the placebo group.


In an accompanying video (link at foot of this post) Jureidini shows how the RIAT team found more adverse events than the FDA and how Martin Keller, the lead author in the original study, under reported events, even though they had been identified by GlaxoSmithKline.

Speaking of videos, in 2003, some five years after GSK sent internal emails to senior management stating efficacy had not been proven with paroxetine, Alistair Benbow, then GSK's Head of Psychiatry, was asked on national televison if he thought paroxetine could be safe in children. He answered, "Absolutely, it could be... the evidence, however, is clear, these medicines are not linked with suicide, these medicines are not linked with an increased  rate of self-harm."

24 secs.






COMMENTARY


It's 'take a bow' time for the restoration study authors, Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, and Elia Abi-Jaoude.

This is a significant piece of history and the British Medical Journal should be applauded too for finally showing some common sense and for not bowing down to pressure from British pharmaceutical giant, GlaxoSmithKline.

I don't expect for one minute that we will get any form of apology from either GlaxoSmithKline, the original study authors or, indeed, the Journal of the American Academy of Child and Adolescent Psychiatry. They have had nigh on 14 years to make retractions to the fraudulent study and they have each, individually declined. Today's publication of the reanalysis should, however, shake the boots of the authors. What they have done here is become part of Glaxo's murky history and hopefully every single one of the authors (22 in all) will, at some point in the future, come under scrutiny from law enforcers. Fraud is fraud, whatever way you slice it and each of the 22 have, knowingly or unknowingly, been part of that fraud, a fraud that put children and adolescents at risk, a fraud that has for 14 years been part of the reason why Paxil, this non-efficacious and unsafe antidepressant with side-effects such as suicidal thinking, has found its way into the mouths of children and adolescents.

For their part in this lack of care and duty to children they will have to face tough questions from family, friends and the media. Pleading ignorance just won't cut the mustard anymore.

The universities who have stood behind these authors also need to feel shame today, they have also been part of the reason why so many kids have been put at great risk and, arguably, many kids who have gone on to complete suicide induced by Paxil.

The original study, given the thumbs up by the original 329 review authors, was also taken as gospel by doctors who referred to it when checking to see if it was safe to prescribe kids Paxil off-label. Had Glaxo had been truthful then kids such as Sara Carlin, Sharise Gatchell and Adrian Keegan, to name but a few, would probably still be alive today. The same can be said for the authors, had they had asked to see the raw data then they would have drawn the same conclusion as the restoration authors, had they had called for the study to be retracted then kids who are now in the ground would, more than likely, be above the ground and enjoying their young lives. The JAACAP also needs to hold up its hand here as do the Universities who have, it appears, backed the authors associated with them.

There are different degrees of murder and manslaughter, someone, if not all, should be held accountable here. No better place to start than the current CEO of GlaxoSmithKline, Andrew Witty. Failing a murder or manslaughter charge then why not bring those responsible to trial under The Federal Child Abuse Prevention and Treatment Act, child neglect under this law states, "An act or failure to act which presents an imminent risk of serious harm.". I think the risks have been clearly proven, don't you?  Am I wrong to suggest that those responsible should face criminal charges? Ironically, in England, the National Society for the Prevention of Cruelty to Children (NSPCC) use the tagline, "Every Childhood Is Worth Fighting For," yet I cannot find one single piece of legislation that protects children from unsafe prescription drugs, or those that market and promote these drugs. This needs to change!


GSK BOXING CLEVER

On April 26, 2013, RIAT team member, Jon Jureidini, sent Andrew Witty a letter calling for the retraction of the JAACAP 329 article (fig 1). In a cleverly drafted response (fig 2) from GSK's Head of Governance, John E. Kraus, GSK told Jureidini that they did not agree that the journal article was false and misleading, they added that the article, "accurately reflects the honestly held views of the clinical investigator authors." In essence, GSK are correct, and it is yet another example of GSK's spin.

What GSK are saying here is that the article (not the actual study) stands up to scrutiny. Of course it does! The JACCAP article was based on a summary of the actual study and the findings of the PR firm hired to write the findings of that summary. Remember, GSK omitted negative findings in the summary sent to the PR firm and ghostwriter, Sally K. Laden. (Letters obtained from http://study329.org/)



FIG 1




FIG 2


I really can't find words to describe GlaxoSmithKline's attitude. I am, for the first time since the conception of this blog, utterly dumbfounded by GlaxoSmithKline's 'shrug of the shoulders' and lack of respect for those harmed by their product approach. Glaxo will argue until they are blue in the face that it has never been proven that Sara Carlin, Sharise Gatchell, Adrian Keegan and many more killed themselves because of paroxetine induced suicide. They can say this with confidence because no subject in the original trial, as far as we know, went on to complete suicide. The truth of the matter is, since its launch, paroxetine has been implicated in many suicides. In Britain alone there have been 65 reported suicides associated with paroxetine, these are just reports sent in to the British drug regulator when family members or doctors suspect that paroxetine may have been attributed to the individual suicides. Many more are not sent in - and herein lies the problem of the original study. If a patient kills themselves whilst on paroxetine the treating physician may once again refer to the original 329 review, and what will they see?

"Paroxetine is generally well tolerated and effective for major depression in adolescents."

No mention of a suicide threat, so any of the subsequent articles about Paxil related suicides and black box warnings will be largely ignored because, at the end of the day, a doctor is going to believe the word of 22 academics rather than a tabloid newspaper or documentary.

The study published today highlights the suicide threats in the original study, the subjects who, remember were just children and adolescents, who felt suicidal whilst in the trial. Many more were self harming, a precursor to suicidal thinking - GlaxoSmithKline did not label these subjects as suicidal, instead they opted for the term "emotional lability." A code they used, one can only assume, to prevent questions being asked - to me, a layperson, the term "emotional labilty" just means the subject was unstable. In fact, the medical dictionary defines it as "a condition of excessive emotional reactions and frequent mood changes." Glaxo will, once again, argue that suicidal thinking could fall into this definition but to actually label an adverse reaction as a suicidal thought would have probably meant that the original study would not have been published and hailed as a landmark study in the treatment of depression in children and adolescents.

I guess the results of the restoration study will show the world just how abhorrent this British company are when it comes to the welfare of children and adolescents. It's not the intention of the study to show that, it's just my view. It will also show how the whole process of clinical trials are deeply flawed and one sided and how paying highly respected child psychiatrists to endorse a drug takes precedence over actually allowing those same highly respected child psychiatrists to see the actual raw data.

Two studies, two opposite outcomes...and a whole bunch of internal company memos that show how this one company knowingly managed the dissemination of the negative study results so perfectly, making a huge profit as a result and, at the same time, putting children and adolescents at risk.

Clinical trials should be about science and about rigorously checking raw data. Restoring 329 is, I believe, the very first study that has used these models.

I anticipate that  Le Noury, Nardo, Healy, Jureidini, Raven, Tufanaru, Abi-Jaoude and the BMJ will now fall under the radar of GSK and the mud-slinging will begin. That's how Glaxo operate. They do it with reps who bring it to the attention of senior management that illegal activities are occurring within the company, they do it with expert witnesses who offer evidence against their products in court rooms, an example of this can be seen here, they do it with anyone who basically questions their ethics.

The RIAT team need to be applauded, it's not been easy to wade through 77,000 pages of raw data, a task made even harder by GlaxoSmithKline when the study authors learned that they could not simply save information off Glaxo's database, they had to painstakingly do it the old-fashioned way, by using a pen and paper.

Many others need to be applauded for their efforts over the years too. Leemon McHenry and Shelley Jofre spring to mind, as do investigative journalists Evelyn Pringle and Alison Bass. The LA based law firm, Baum Hedlund have also been instrumental in getting the information out as have the infinite amount of bloggers, not forgetting, of course, the Healthy Skepticism team and the Citizen's Commission on Human Rights.

It will be interesting to see, over the coming weeks and months if any of the original authors reject the findings of the restoration study - chances are they will, likelihood is that they won't be able to tell you why they reject these new findings. Science, particularly where raw data is used, cannot be argued.

For the record, the 22 authors of the original study are:

Martin B. Keller (lead author), Neal D. Ryan, Michael Strobber, 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. Winters, Rosemary Oakes, and James P. McCafferty.

As for GlaxoSmithKline, they will do everything to minimize the fallout of this study, after all they have shareholders whom they wish to continue buying their shares. If those same shareholders had any morals they would disassociate themselves with a company who knowingly put profit before the safety of children and adolescents - then again, money blinds people - the original 329 study is crystal clear evidence of that.


Make a habit of two things: to help; or at least to do no harm. - Hippocrates




Bob Fiddaman.





** I use the term 'children and adolescents' because, to me at least, there is no definitive cross-over when a child becomes an adolescent.


Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence (BMJ 2015)  -  Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, Elia Abi-Jaoude

No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility (BMJ 2015) - Peter Doshi associate editor, The BMJ

Restoring Study 329 Website

Link to author video



Related news: Glaxo go to trial in the UK within the next 12 months where they will defend allegations that Paxil (known as Seroxat in the UK) caused severe withdrawal issues and dependency in a number of people who were prescribed it.


FOR SARA










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