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-
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:
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:
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.”
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.