Part 2 Of Bob Fiddaman’s Posts On Peter Humphrey’s Recently Filed Lawsuit Against GlaxoSmithKline…


http://fiddaman.blogspot.ie/2016/11/chinawhys-vs-gsk-claims-part-2.html

Sunday, November 20, 2016

ChinaWhys Vs GSK – The Claims – Part 2

Following on from the first parter, Lawsuit Alleges GSK’s Witty Lied to the Media – Part I, today sees part 2 (The claims of ChinaWhys against GSK) – Part 3 (Coming later this week) will focus on the incarceration of Peter Humphrey and his wife, Yu Yinzeng and also the rehiring of accused whistleblower, Vivian Shi)

Here is what Peter Humphrey and his wife, Yu Yinzeng, of ChinaWhys, are alleging…

 – Between 2010-2013 GSK spent nearly $225 million on planning and travel services. Approx 44% of the sampled invoices were inflated and approximately 12% were for events that did not occur.

 – GSK set up a special “crisis management” team in order to bribe a Chinese regulators with money and gifts. A GSK executive attempted to bribe a Chinese investigator with an IPad and a lavish dinner. All bribes were approved by the head of Chinese operations, Mark Reilly.

 – GSK planned to suppress evidence of its illegal bribery activities.

 – As far back as 2008, GSK China deliberately falsified its books and records in order to conceal its illegal practices in China. These included, bribery and promotion of drugs for purposes that have not been approved by the Chinese authorities.

 – GSK paid a patient RMB 50,000, who nearly died after being given Lamictal off-label. Despite having knowledge of Lamictal caussing near death in this patient, GSK still told its reps to promote the use of Lamictal for off-label purposes.

 – GSK targeted ‘persuasive doctors’ in attempts to influence purchasing descions at their hospitals. GSK are to said to have forged a connection with these doctors by taking them to expensive lunches and dinners and also giving them gifts and cash.

 – GSK paid between 500 and 1,000 doctors to go on an all-expenses paid holiday to locations such as Brazil, India, Israel, Greece, Japan and Hungary. GSK covered all costs, including cash to cover meals and sight-seeing excursions. These were disgusied by GSK as “Conference trips.”

 – Head of Chinese operations, Mark Reilly, reeived a bribe in the form of ‘sexual relations’ in return for passing business on to China Comfort Travel, a travel agency who organised ‘conference sevices’ for GSK.

 – GSK paid doctors based on their prescription numbers.

 – GSK’s senior legal counsel, Jennifer Huang, asked private investigator, Peter Humphrey, to investigate the Public Security Bureau and to prepare an analysis of the Chinese political regime. Huang told Humphrey that she wanted to find out who’s who regarding the team who were investigating GSK.

 – Humphrey became concerned that GSK were trying to obstruct the investigation and declined to investigate state secrets.

 – Humphrey was also asked, by GSK, to look into the Ministry of Public Security, the Economic Crimes Investigation Department regarding the relationship between them and  the Public Security Bureau. Humphrey, once again, declined.

 – Head of Chinese operations, Mark Reilly, told Humphrey that the alleged whistleblower, Vivian Shi was “coming after him.” (Humphrey).  Reilly then fled China the following day.

 – GSK China told its employees to “destroy all non-compliant promtional maeterials and gifts.” They also implemented a new email system and deleted emails that were more than a year old. They claimed this was to “reduce unnecessarily legal costs.”



Bob Fiddaman.

Back Stories from the Fiddaman Blog

Glaxo – The Sex Tape Scandal

GSK’s Mark Reilly Accused of Running a “massive bribery network”

I’m Just a Blogger – Here’s GSK Served on Prawn Crackers

GSK Hiked Product Prices to Fund Bribery Scam

GSK’s Sales Reps Want Their Money Back

GSK’s Private Investigator [The Video]

Peter Humphrey’s 2012 Presentation – Pharma Bribery

GSK’s Chinese Whispers and David Cameron

“GSK were really cagey”, Claims Whitehall Official.

Glaxo Hire Ropes & Gray to Delve Into its Chinese Operations.

GSK CHINA – Bribery was Rife 13 Years Ago

Witty Plays Down China Scandal

Witty Witty Bang Wang. The Glaxo Gangbang…Allegedly

Book Your Holidays With GSK Travel

Andrew Witty… I know narrrrrrrrthing

The Penny Drops for GSK’s Private Investigator.

GSK China Bought Patient’s Silence for $9,000

Lawsuit Alleges GSK’s Witty Lied to the Media – Part I

Dr David Healy… “Study 329 Trick, Treat or Treximet”…


http://davidhealy.org/study-329-trick-treat-or-treximet/

Study 329 Trick, Treat or Treximet

October, 31, 2016 | 21 Comments

Seroxat/Paxil Study 329 : Republic to Empire


Science-with-a-conscience-111

“….I asked Rob whether his company would have launched an internal damage limitation exercise like GSK/SKB did around the Panorama programs about paroxetine: Of course he said – and that it would have probably been successful. Employees would have been reassured that the company – their company- would never have deliberately harmed children. Success of the exercise would have been sustained partly through loyalty to the company but mainly because no one could afford to think too closely about whether it was true. Ask too many questions and you would be out on your ear with no chance of getting a reference for a future job…”

Sally McGregor 2016- Dr David Healy’s Blog.

This is an interesting blog post by Sally McGregor, on Prof Healy’s blog.

Basically it seems that Sally is aiming to give readers a view from the other side of the pharma fence (so to speak). Regular readers will know very well what side of the fence, I’m on.

In her post, Sally explains the state (and mind set) of the industry at the time- and she puts into context -how bad stuff like Seroxat study 329, or the Zyprexa scandal, happens..

And effectively how unethical decisions from the top, trickle down, leading to harm to consumers…

I’m not quite sure I completely go along with the view from this perspective (for reasons which I will explain later) however it’s an interesting and insightful read nonetheless and well worth reading…

 


 

http://davidhealy.org/study-329-republic-to-empire/

Study 329: Republic to Empire

March, 16, 2016 | 1 Comment

Bob Fiddaman Nails Andrew Witty’s Cavalier Attitude About GSK’s Unethical Behavior


“There have been warnings about paroxetine for a long time,” including a 2007 Food and Drug Administration advisory on the risk of increased suicidality when anti-depressants like paroxetine or imipramine are used to treat people age 18 to 24, according to Dr Jon Jureidini of the University of Adelaide in Australia. The authors of the 2001 study did not report this side effect, although the evidence was there, said Dr Jureidini, a co-author of the re-analysis.

“A broad community of people around the world have raised concerns,” he told Reuters news agency.

“Mistakes were made”…. thousands of kids killed themselves because of Seroxat…

All in a day’s work for  GSK’s CEO Andrew Witty..

Minor inconveniences on the road to hoarding his millions it seems…

What’s a few thousand dead kids?

As long as there’s no dent in profits.. that’s the bottom line isn’t it Witty?


http://fiddaman.blogspot.co.uk/2015/10/andrew-witty-art-of-deflection.html

Wednesday, October 28, 2015

Andrew Witty: The Art of Deflection.

Sir Witty should have been a politician. Very adept at answering a question…with a question.

Here’s a recent interview with Evan Davis, Presenter, Newsnight, BBC

Skip to 29.40. Transcript for this section is below video.

Transcript. 29.40

Evan Davis
I’m going to open it to the floor in a second, because we do want to leave half the session for the audience to ask questions. I’ll just finish with kind of a general reflection, because it is interesting, and it’s nice when you talk about the drugs and what they cure, what the treatments are. Don’t you find it very interesting that the pharmaceutical industry has a bad reputation? We read about the China corruption, we read about profits, we read about profiteering. It is an industry that saves lives, no one can dispute that. It’s an industry that produces pills that are completely transforming for people’s welfare. Yet, it’s actually not a terribly popular industry. I just wonder if you can explain that paradox. Is it that you’ve done bad things and that’s been recognized, or is there somehow something the public don’t understand about the industry that makes them feel negative about it? Or am I wrong in thinking there’s a slight [indiscernible] around it?

Andrew Witty
No, clearly – first of all, I think we are, slightly alongside any big industry, or any big institution, there is a bit of that. We are big companies, we’re global. Again, like any big organization, you’re vulnerable to your weakest link in the organization. So if something goes wrong, particularly in today’s social media world – I often think about what it must have been like to run a global company in the 1970s, where you had to wait for the ship to arrive to find out what happened on the other side of the world. Today, the Wall Street Journal calls you before you’ve even heard about something inside your own company. So I do think there is a certain phenomena where – and you see that across many, you look at it in politics, you look at it in newspapers. The hacking stories, all things like that. So I think it’s a bit of that. I do think – let’s be honest, nobody wakes up in the morning hoping that they’re going to need a drug from GSK. You don’t wake up in the morning thinking, actually, if it’s a really good day, I might be diagnosed to be ill and I might need a drug. So we’re not aspirational in that sense. So you start by saying, actually, I’ve got some bad news, because I’ve been told I’m not very well. They then said: we might have some good news, because there’s something we can help you with. Then in some countries, I have to pay for it. Or in Britain, you might go to the doctor and they say: actually, I’d like to give you this, but NICE have said I can’t. So then there’s a whole series of reasonably negative concepts around pricing. So there’s a bit of that. Then you’ve got – actually, we do occasionally make mistakes. Things go wrong. We have inevitably – of course, we go through all the processes with the regulators to get a drug to be as safe and effective as it can possibly be. But the reality is, every time a human takes a drug, it’s like a clinical trial. You don’t really know what’s going to happen. Everybody can react a different way. So on the one hand, what is the story of the drug industry? The story of the drug industry is wonder drugs. On the other hand, it’s danger drugs. Those are the two extremes that we have. It’s kind of unavoidable.

Evan Davis
But you’re saying there are bad apples, and it goes wrong. Is that right, or is it – for example, in the China case. Was it that there was a bad apple and it went wrong, or was it that that was normal behaviour in certain markets, and it just got called out in that particular case?

Andrew Witty
For obvious reasons, I’m not going to get into all the details of that.

Evan Davis
Was that behaviour actually something, or was it just a slight extension of behaviour that is normal?

Andrew Witty
I think the bigger question is, where do you want to go forward?

Evan Davis
No, but just answer that one.

Andrew Witty
There’s no doubt, if you ask the more general question – so there have been concerns over the years of, is the drug industry transparent enough? What’s the relationship of the drug industry with doctors? All of those are kind of concerns – let’s call them concerns or reasons for anxiety, whatever they are. Sometimes they’ve spiked up into real issues. What we’ve really tried to do, and we’re beginning to see some other companies, I think, following a similar direction, is we’ve said: you know what? We get that. We get that transparency is a cause of concern. People are worried that something is being hidden. We didn’t think there was but people – perception is everything, right? So what did we do? We came out and said: we will publish every single bit of clinical data we have in the company. We are the only company to do that at this point. Every single thing. If a researcher wants to know exactly what the data was on patient number – all anonymized, but on Patient 1002, in Clinical Trial 87, from 2002, we will give them that information. All the way through, we’ll do that. We’ve said we will stop all payments to physicians to speak on behalf of the company. It’s a perfectly legal practice, everything the company has done – but we stopped it all.

Evan Davis
But this is a recognition – there is a lot you’ve done to present these things differently. But it is a recognition that it was pretty dysfunctional before, isn’t it? Because publishing data, to me, honestly, doesn’t seem like a great achievement. It just seems to me that that’s what you should be doing with data. Not bribing doctors seems like a thing you would do.

Andrew Witty
I wouldn’t say it’s bribing doctors – it’s perfectly legal to pay. If you went to a physician and said, would you expect to be paid for speaking on behalf of somebody, they will probably say yes. Actually, in most countries in the world, it’s perfectly legal. However, there are risks it can be abused. People can make mistakes. And there are risks that there is a misperception. Just to your point on publication, do you think academics are mandated to publish their data? Do you think universities publish all their failed studies? They don’t, but we do.

One box of chocolates for the first person to tell me how many times Witty deflects the questions put to him.

**Footnote

GSK were forced to be transparent, they didn’t just decide one day that they were going to be the first pharmaceutical company to “open it’s doors” (Halfway)

This from the Department of Justice/GSK agreement

“Among other things, the CIA also requires GSK to implement and maintain transparency in its research practices and publication policies and to follow specified policies in its contracts with various health care payors.”

Also…

“Moving forward, GSK will be subject to stringent requirements under its corporate integrity agreement with HHS-OIG; this agreement is designed to increase accountability and transparency and prevent future fraud and abuse.”

I think the bigger question is why did Witty fail to mention that his company were forced to be more transparent.

I’ll leave the last words to Witty…

“It’s a perfectly legal practice, everything the company has done…”

Bob Fiddaman.

Original video here.

Dr Malcolm Kendrick On Seroxat : Where The Hell Is The Outrage?


Study 329 – where the hell is the outrage?

To quote from the BMJ ‘No correction, no retraction, no apology, no comment…’

Study 329 was started in 1994 by Smith Kline Beecham, which shortly become part of the larger conglomerate Glaxo Smith Kline (GSK). Study 329 looked at the use of paroxetine, an anti-depressant, in adolescents with depression.

Following this study paroxetine was promoted and marketed heavily by GSK as demonstrating, in the words of GKS marketing materials: ‘REMARKABLE Efficacy and safety’. Over two million prescriptions were then written for children and adolescents in the US.

However, in 2002 the FDA considered study 329 to be a ‘failed trial.’ In 2003 the UK recommended that paroxetine should not be used in children and adolescents with depression because it increased the risk of self-harm and potentially suicidal behaviour.

In 2004 the FDA placed a black box warning on all antidepressants in adolescents and children stating that they increased the risk of suicidal thinking and suicidal behaviour in these groups. In 2102 GSK finally agreed to pay £2Bn for fraudulently promoting paroxetine.

But the story does not end here. A group of researchers, who had been heavily critical of this trial, finally managed to get hold of the raw data and carried out a re-analysis under the restoring invisible and abandoned trials (RIAT) initiative. Yes, this saga has been a long one.

The reanalysis was recently published in the BMJ with sadly predictable results. The primary conclusion was that ‘Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was increase in harms in both groups.’

This is in stark contrast to the original trial results. When it was first published it appeared to demonstrate very clearly that paroxetine was both safe and effective in adolescents with depression. According to GSK it demonstrated ‘.remarkable efficacy and safety’ However, using exactly the same trial data, reanalysed by independent researchers, we now find that paroxetine was both useless and damaging.

So, what has been the consequences for those involved in the initial trial and the writing up thereof? For those who read the BMJ, you will know that I am now quoting verbatim here:

  • Despite subsequent FDA and MHRA warning about increased risks of suicidal thinking and behaviour and GSK receiving a record fine, partly for illegal off-label promotion of the drug, the original report has not been retracted or even had a correction
  • Academic and professional institutions have failed to publically address the many allegations of wrongdoing
  • None of the named authors had intervened to correct the record. An internal enquiry by the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) concluded that no further action was necessary
  • Brown University remains silent over its involvement in the study. It refuses even to confirm or deny whether any investigation took place1

I will add to this that a co-author of study 329, Karen Wagner, named eight times in the 2011 US Department of Justice complaint against GSK, is currently the president elect of the American Academy of Child and Adolescent Psychiatry – whose journal, the JAACAP, is where the original study was published.

Taking stock. What do we have? A study was done, and published, demonstrating that paroxetine was safe and effective. The trial data were heavily promoted, resulting in millions of children and adolescents being prescribed paroxetine.

The reality is that this drug was completely ineffective and increased the risk of suicide (amongst other things). This has all been known for many years. The latest re-analysis simply confirms everyone’s worst fears.

So surely someone, somewhere, got punished? No they did not. Not only that, but the original published study has not even been retracted. It still sits in the medical database. A young and innocent researcher could come across it, and reference it, and use data from it to support a grant application for a study to use antidepressants in children.

If this were not all completely and absolutely one hundred per-cent fact, you might think we have a possible plot line for a dystopian novel here. A story of terrible corruption where large corporations can distort data through one hundred and eighty degrees, and get away with a fine. A world where bent researchers promote research that results in more children committing suicide, and then move on positions of greater power and authority – with no censure from anyone. To become presidents of major medical societies, for example.

Frankly I don’t think I would dare to write a novel with a plot so completely outrageous. Surely someone, somewhere, would be punished for this behaviour. Surely the paper would be retracted. Surely a co-author of such a study would not be in line for a prestigious position. Surely the public would rise up in outrage.

In truth, it seems, nothing is going to happen at all. I must dig out 1984 and read it again, just to depress myself even further.

1: BMJ 2015;351:h4629

AllTrials Is A Red Herring… We Need Access To ALL DATA…


For the red herrings see here

Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.

Erm no Ian, today’s GSK  (2014) were recently caught bribing hundreds of Chinese doctors and fined 500 Million dollars last year.  You fail to mention this very recent moral indiscretion.

GlaxoSmithKline Found Guilty of Bribery in China

U.K. Drug Maker Handed Largest Ever Corporate Fine in China

This fine was hardly a sign of moral leadership Ian, so don’t be ridiculous..

In regards to GSK’s scientific leadership, while giving the access to data for study 329 is undoubtedly a good thing, the fact that GSK hid it for so long (and promoted Paxil/Seroxat off label to doctors/kids which resulted in kids killing themselves) is not. I am shocked that you would try to spin this as somehow good PR for GSK . Study 329 was abhorrent, Seroxat is a disgrace.

Seriously, what planet are you on Ian?

Where is GSK’s apology for all this carnage?

Publicity from Study 329 contributed to paroxetine being prescribed to “hundreds of thousands” of adolescents, Jureidini said.

Dr David Healy’s  new post, ‘Data Wars‘, raises some very important points in regards to the ‘data transparency debate’.

I have long been suspicious of Alltrials, Ben Goldacre, Simon Wessely, Sense About Science and the various other ‘movers, shakers and consensus makers’ in this debate, and I’ve written several posts about them explaining why:

See these posts of mine for further details-

https://truthman30.wordpress.com/2014/08/15/whats-the-real-story-simon-wessely/

https://truthman30.wordpress.com/2013/11/19/ben-goldacre-bad-pharma/

Call me suspicious by nature, and perhaps I am, however when you’ve been writing, and researching, about GSK’s various unethical shenanigans (for almost 9 years now) you tend to sense when something isn’t quite right. Couple that with a horrendous time on Seroxat, then finding out afterwards that it all could have been prevented if the whole psych/pharma system wasn’t so corrupt, and throw in my sheer determination -for over a decade now- to expose every corner of the Seroxat Scandal, and you end up down some very strange rabbit holes indeed.

The recent expose (restoration of Seroxat Study 329) by the RIAT team, published in the BMJ, caused quite a stir online. Not only did it make headline news, but the responses on social media could warrant many studies in themselves. Paxil/Seroxat harmed many people. These are not ‘anecdotes’, these are people’s lives-

See these posts for details of the impact of Paroxetine world-wide:

https://truthman30.wordpress.com/2015/09/22/i-knew-that-shit-was-poison-12-people-describe-their-young-lives-on-paxil-seroxataropax/

https://truthman30.wordpress.com/2015/09/19/social-media-discusses-paxil-seroxat/

The real world affects of Seroxat (Paroxetine/Aropax/Paxil) have been horrendous for those who were unfortunate enough to have been prescribed it. I’ve known that Seroxat is a dangerous drug since I was first prescribed it in 1998. It was only after I came off it, in late 2001 or thereabouts, that I discovered (courtesy of the BBC through their Panorama programme- “The Secrets of Seroxat‘ documentary) that the problems with Seroxat (of increases in suicide, self harm, akathisia, murder, aggression, withdrawal, dependence etc) were worldwide problems. There was some solace in finding this out from the BBC Seroxat series, however I won’t get those lost Seroxat years back. I won’t get my health back that I lost either, nonetheless an apology from GSK for almost killing me with their drug, lying in PIL’s, and corrupting doctors, would be nice though- but I won’t hold my breath. I was collateral damage, and harm to people like me is factored into GSK’s cost of doing business. To GSK, my life was disposable, so it’s insulting for me when I see people like Ben Goldacre and Sense About Science collude with sociopathic companies like GSK.

I find this extremely disturbing.

Alltrials is a redherring, so is Ben Goldacre’s  transparency agenda. Simon Wessely is too, as are Sense About Science.

I don’t trust any of these people/organizations. I don’t believe patients should either.

Why do I say that?

Well, hundred thousands of kids were likely put at risk from GSK’s promotion of their dangerous Seroxat/Paxil drug off label. Many high profile psychiatrists put their names to the ghost written study 329 and subsequently- the lives of hundreds of thousands of kids were put at unnecessary risk. They were prescribed a drug (Seroxat/Paxil) which has been shown to be harmful. Many died and many were damaged, plus we haven’t even begun to assess the damage to the adults who were prescribed Seroxat.

I was one of those adults. I am one of those people who suffered. What is going to be done?

Where is the outcry about Seroxat killing kids from people like Prof Simon Wessely? (the head of the UK college of Psychiatry).

Where is the utter condemnation from people Dr Ben Goldacre? (A supposed patient advocate).

Where is the press release from Sense About Science castigating GSK for this disgraceful crime?

Where are their statements expressing their utter disgust at this flagrant abuse of vulnerable people? (Depressed people prescribed Seroxat).

They’re simply not there… none of these people/organizations have condemned this scandal.

Instead what we have are organizations like Alltrials basically congratulating GSK (for giving access to a study which was fraudulent in the first place) and helping GSK spin this abhorrent Seroxat study 329 scandal into something positive (quite how they can justify this is beyond me). Notice how Alltrials fail to condemn GSK for putting kids at risk, but how they try to spin this as GSK somehow being the good guys for providing the patient level data to David Healy and the RIAT team.

What Alltrials also fail to draw attention to is- the fact that the process itself was close to impossible (it also took years), and it was through sheer determination and tenacity on behalf of the RIAT team that they got to study the data never mind the pain staking process of attempting to analyze it. Furthermore, what Alltrials also don’t mention is- the RIAT process and Rxisk are looking for the Data – Access to all the data, not just the registering of trials. What use are the trial results and what use are the trials themselves without the data which makes them? We need access to all the data. Alltrials isn’t looking for this- that’s why I don’t trust them.

Alltrials is a red herring, so are Sense About Science-  and along with the true extent of Seroxat harming kids (and adults) that’s what the RIAT team has also just exposed…

See David Healy’s Data Wars for more:

http://davidhealy.org/study-329-data-wars/

Sense about Science

Simon Wessely and Clare Gerrada are the power couple of British Medicine.  He is the current President of the Royal College of Psychiatrists, and she is a recent President of the College of General Practitioners.  When faced with questions about over-prescribing of antidepressants by GPs, she is quick to insist that GPs rarely treat distress and that almost all prescribing is for genuine illness and the drugs work well.  He gives similar messages in respect of psychiatry.

Sense about Science began in Britain 15 years ago with donations from Corporations in the Risk Management Business – from Monsanto through Nuclear Power to Pharma. These donations have vanished from sight now, replaced by endorsements from all major UK universities and journals like The BMJ and support from Charitable Foundations.

SAS’s stated mission would have appealed to someone like SW who had come under attack from a lot of fringe groups in the 1990s for taking a balanced data-driven approach to Chronic Fatigue Syndrome (M.E.).

But SAS has now become a node to handle any messages in the media that might hurt the interests of a company or corporate sector – such as anything to do with vaccination or my recent editorial on So Long and Thanks for all the Serotonin.  BMJ sent this article (as they send all articles) to SAS who got in touch with SW to rustle up statements from Jeff Lieberman types which can be disseminated widely to the media either for citing or as a means to close down stories:

You might not want to take Healy’s work seriously in the light of what these senior figures in the field are saying.

Sense about Science has since spread to Canada, Australia and now the United States and everywhere the mission is the same.

AllTrials & AllData

SAS was a founder of AllTrials.  This sounds like AllData – the hashtag for Restoring Study 329 – but at the moment it is quite the opposite.

There has been close to radio silence from AllTrials in the face of the call for AllData, aside from one stunning press release that more or less credits GSK with the efforts to Restore Study 329.

17th September 2015

Many supporters of AllTrials will be interested in a study published in The BMJ today, a reanalysis of previously hidden clinical trial data. The new research used data from a 1990s clinical trial of the GlaxoSmithKline (GSK) antidepressant drug paroxetine. Today’s findings contradict a 14-year-old analysis of the data referred to as Study 329, which found paroxetine to be safe and effective for treating adolescents with major depression.

The new research is the first reanalysis of a drug study under the RIAT (Restoring Invisible and Abandoned Trials) initiative, which calls on companies and academic funders to publish detailed trial information for independent scrutiny. The RIAT team was able to access the original clinical trial data using GSK’s patient-level data access portal, where researchers can request access to this information.

Tracey Brown, Director, Sense About Science and co-founder of AllTrials:

“When all trials are registered and results reported, it becomes possible for researchers to work out what data are available. GSK has gone further and made its patient level data available to researchers. It is disappointing that there are still so many companies not reporting trials. Researchers, doctors, patients and, in July, their shareholders have said they want transparency about trial results. This will confirm their views.”


Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.”

Pontius Andrew?

Faced in 2012 with questions about the $3 Billion fine imposed on GSK, triggered by a sequence of events starting with Study 329 – is it just the cost of doing business? – Andrew Witty snapped back:

“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”.

Everything about Study 329 suggests that Andrew is comprehensively wrong. Corporate malfeasance happens when the system is set up so that the efforts of 100,000 well-meaning people get transformed into the worst of outcomes and it then takes the efforts of a few brave people within GSK to alert the outside world to how things are going wrong.


GSK 2 GSK1

Study 329 Is Making Headlines … This From Dr David Healy…


http://davidhealy.org/study-329/

Study 329

September, 16, 2015 | Reply

Dr David Healy : The Troubled Life of Study 329: Consequences of Failure to Retract


The Troubled Life of Study 329: Consequences of Failure to Retract

http://davidhealy.org/the-troubled-life-of-study-329-the-consequences-of-failure-to-retract/
 
September, 8, 2015 | 1 Comment

Seroxat Secrets Blog Makes A (Brief) Comeback…


Great blog..

Has been sadly missed 😦

https://seroxatsecrets.wordpress.com/2015/08/06/what-i-believe-2/#comment-86830

What I believe – 2

admin:

I’m reposting this for a couple of reasons – the first is that I haven’t written anything for a while (that’s an understatement!) and secondly, if that’s going to be the case again, I think this is the perfect post to greet anyone who may arrive here for the first time.

It still amazes me that people are still being prescribed Seroxat in 2015 – and also that so many Doctors still seem to be ignorant about the possible problems that many patients can have when the try and withdraw from this drug. That’s not to mention the problems associated with long-term use of Seroxat.

Glaxo thinks it’s all gone away…

Originally posted on seroxat secrets…:

I believe Seroxat is defective and dangerous.

I believe that Glaxo has hidden clinical trial data that shows exactly how dangerous a drug it is.

I believe that Seroxat is addictive.

I believe that Seroxat can cause anger, aggression and violence.

I believe that something must be done to help people who suffer terrible problems with withdrawal, as they desperately try to stop taking Seroxat.

I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.

I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.

I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little.

Believe me – I know what I’m talking about.

View original

Psychiatrist and Blogger (1boringoldman) Mickey Nardo Writes About Paxil (Seroxat) Withdrawal


Posted on Thursday 20 August 2015

As I’ve mentioned before, back in the early days of SSRIs, I was lucky to have a good friend whose wife, a sophisticated Social Worker, had taken Paxil shortly after it came on the market. When she stopped, she got ill and was perceptive enough to recognize that it wasn’t anything like her “depression coming back.” It was something else. It was a withdrawal syndrome. She described it clearly back then, including “brain zaps,” just like we’ve come to know it now that it’s more recognized and well characterized. So I knew about withdrawal early, and began slow tapering off of SSRIs a long time ago with all of them [never prescribing Paxil]. When I mentioned it to colleagues, they didn’t know what I was taking about.

Today, I ran across a post from Bob Fiddaman, a long-time reference source on all things Paxil [Seroxat], linking two previous posts of his I’d missed. He’s been on the trail of some Clinical Trials of Paxil done in Yugoslavia [back when there was a Yugoslavia to do trials in].
Here’s the gist of the story. Back in 1988, SmithKline Beecham initiated a trial [called the relapse trial].
At this time, SKB were seeking approval of Paxil and the Yugoslavia trial was to show the FDA (the US drug regulator) how effective Paxil was in treating depression – they would also try to show the FDA how it was important to keep taking Paxil and not to stop… because if you did stop then you would go into relapse, in other words, SKB were trying to prove that stopping Paxil meant the patient’s original illness would return.
So, after a period on Paxil, half the patients changed to placebo, and sure enough, they got ill – interpreted as a return of the illness:
With the results they wanted, SKB then provided the FDA with apparent evidence that showed patients staying on Paxil continued to enjoy a normal, “depression free” life, but that those abandoning the drug would  suffer relapse back into a depressive state. One thing that was irksome to SKB was that they had to convince the FDA that the relapses shown in the study were not simply patients suffering withdrawal.
Bob’s source is the transcript from a suit resolved in 2002 Nguyen & Farber, plaintiffs vs. SmithKline Beecham Corporation. The transcript goes on to describe how SKB was able to essentially game Dr. Thomas Laughren into helping them convince the FDA panel that this was recurrent depression rather than withdrawal. When Bob wrote the MHRA with an FOIA request, they wrote back that they didn’t have any records. The MHRA official is a former GSK employee.
The thing that struck me in this story is that they even did the relapse trial in the first place. They must’ve known about the discontinuation syndrome early on and actually did this Clinical Trial to spin it away.

That brings up something that has nagged at me for years. I still see depression in two major categories, just as I did before I even came into psychiatry. Depression [with a capital “D”] meaning Melancholia, the Depressive Episodes of Manic Depressive Illness, Post-Partum Depression, etc. And depression [with a little “d”] as in everything else [formerly known as Neurotic Depression]. Whichever the case, depression is a time-limited condition – and medication for depression is a time limited medication. The guideline I recall from the days of the Tricyclics and MAO Inhibitors was that patients who had responded to these medicatiuons should continue them for 6 months before stopping to prevent a relapse [I have no clue how that guideline got into my mind so long ago].

I followed that practice even after the SSRIs came along. Years later, when I retired and started seeing patients in a clinic where patients had been medicated by someone else, it was apparent that the rest of the world saw things differently. Patients had been on an antidepressant for years and obviously thought it was keeping their depression away. And getting them to give it up required knowing them for a while, and withdrawing slowly as a trial. Otherwise, it was like taking away a talisman, or a comforting blanket. I’ve wondered how that idea of antidepressant as preventative-forever ever came about. Avoiding withdrawal may well be the answer…

An Anecdote: The last time I worked in the clinic, I was seeing a woman with a fairly striking anxiety syndrome, persistent since getting out of a physically abusive relationship [actually a life-threatening physically abusive relationship]. She was accompanied by her current boyfriend, a nice and supportive biker-guy with cap on backwards, tank top, and liberal signage [tatoos]. She and I were discussing medication, and he piped in. “Man, don’t give her that Paxil. Miss a dose of that stuff and you’re Jones-ing – sure enough.” I guess if a biker type in rural Georgia knows about Paxil withdrawal, it has to be a widespread problem…