Study 329 has just gone live. The Restoring Study 329 article with its appendices, data, history, accompanying feature by Peter Doshi and editorial by David Henry can be found on the Restoring Study 329 site Study329.org.
Here are the key findings at present.
Efficacy
Harms
Background
At present
The note above says “Here are the key findings at present”. You can download most of the key data from Study329.org. We expect others, even GSK, will be able to improve on some aspects of what we have done – suggest refinements to the coding perhaps – or fill in details of the history of this study.
There will be more to come from the 329 Team here and in other settings, along with responses from Keller and colleagues and others.
Many thanks J. Jureidini “et al”.
It’s 3:25am and I’ve read each line on BMJ website.
Transparency is the Word. I wish for many to follow. There must be many Young and eager scientists out there who could undertake the task of re-analyzing many more old
published RCT’s
Some of the graphs caught my attention, but especially the one who showed the difference in adverse-events using different methods of reporting. The original with the “CSR” didn’t list any advers-event under “psychiatric”.
To me, that is in itself mysterious, since the evaluated drugs are intended for “psychiatric use”. Thus effects labeled as “psychiatric” should be more frequent?
Also the remarks on how “use of statistic analysis” can be used to obscure events.
For the future: how do I get access to read responses to your publication?
Will responses be available on BMJ-site?
I saw the responses-link, none yet, but I hope I can get to see what other scientists says about this, good or bad…
Godspeed folks
Ove
We will make sure all responses on BMJ appear on Study329.org also
David
Well done! That just about sums up the whole fraudulent trial, what more can anyone say………… good god, if I had been given the true information before my medicated nightmare…………….. RIP ALL THOSE LITTLE ANGELS, murdered by a drug company.
Can you put this is a form I can easily send to friends, via facebook. This hopefully goes viral very quickly.
Well done, to all involved, dedication and determination, you all deserve medals, but we all know this is unlikely to happen in our lifetimes.
Wat nu?
Exactly….looking forward to all things Study329…
Thank you, all.
#alltrials
Twitter
1. 3h
Roelien den Ouden @RoeliendenOuden
Wat Ben Goldacre al beschreef in (het uitstekende) Bad Pharma: GSK hield deze info bewust achter. Wat nu? #AllTrials https://twitter.com/nrc/status/644292666184855552 …
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o
o
2. 6h
Dr Kit Byatt @Laconic_doc
Good news: GSK in #AllTrials & released data; Bad news: data shows parox has higher suicide risk rate than claimed https://twitter.com/bmj_company/status/644278368175677440 …
A full list of names of this medication in alphabetical order would be very helpful…. It was the first drug to send me nuts (Given it to help me sleep), in Australia is/was called Aropax. I can not find this name on your picture for the study….
Found the fb button thankyou……………. if that was there before, I apologise, call it tunnel vision, couldn’t get my eyes off those charts. I would like to buy a copy of BMJ, is this possible? thankyou amigos!
Well done!
I was waiting for this. Thank you, David!
It is so nice to read all these details in a published article in the BMJ!
I hope this paper has the power to convince many, many scientists to be sceptical about published data and “milestone-drugs”.
I’m sure it was a lot of work. There’s just one critic: Why did you miss Shelley Jofre? Without her name it looks like the scientific community corrected itself.
And last but not least: is this an outstanding article or just the first article in a series of articles where the heros are revealing the true facts about other “famous” studys?
Peter
Thanks for mentioning Shelley. She features in a big way on the Study329.org site. Without her input it is unlikely that anything would have happened.
David
Yes, she is featured a lot on the study329-site and you are always mentioning her. That is not the point.
I was just trying to think like an “ordinary” psychiatrists who does not read anything else, than the BMJ.
In this article I am missing a note on Panorama and Jofre.
But anyhow my congratulations to your team! Great work!!!!
Peter
I just wanted to say, on behalf of all of us who have suffered dreadfully as a result of the misuse of these so called ‘wonder drugs’, based on fraudulent scientific reporting and a cover-up which just beggars belief, – a huge ‘thank you’ to all the team. The amount of sheer hard work to get this far is simply staggering.
Thank you too, to everyone who has made this possible – including all those behind the scenes, and pig-headed activists everywhere, who have hung on in there for 15 years without giving up.
Very best wishes to all of you
Sally
Amazing achievement.
In the words of Ben Goldacre..
“Historic”..
But truly historic though..
(I can’t do cartwheels like Ben as I don’t have the ability with post-Seroxat balance problems)
🙂
But seriously, well Done to David Healy, and the others- truly remarkable achievement..
Revisiting this really put me in a dark place. Today, whilst mulling over the week leading up to the launch of this important study, I actually welled up and then blubbered.
There were a catalogue of errors in the original study, it would be nice to say that they were unforeseen, truth is, the evidence was there, it always was – the 22 plus Laden should be utterly ashamed of themselves for not asking for it – they’ve had 14 years to right a wrong and still, even after the RIAT findings, they remain silent or ignorant to the real facts.
It’s a great day for science that is tinged with great sadness for families and loved ones who have had to endure losing loved ones to this suicide pill.
A big hearty congratulations to the RIAT team and all those who worked tirelessly behind the scenes to get the truth out.
Pages and Pages and Pages on Ben Goldacre of Alltrials Fame from whom I would very much like a Retraction of GSK in their Promotional Materials for Alltrials and who totally missed the point as to why they were the first company to sign up
With thanks in advance
https://twitter.com/search?f=images&vertical=default&q=%23alltrials%20-MyalgicEncephal
Egg on face or custard pie in face…let AllYour Supporters decide….
Congratulations David Healy and Our Riot Teams
Explore:
http://www.gsk.com/en-gb/media/social-media/
No, thanks
At last the truth is out. It is very refreshing to read that the facts actually tell the same story as all the young sufferers have repeated over and over again – no longer can doctors hide behind their dis-belief of all these facts. We need this news out in all areas now – to professionals and laymen alike – while it is still fresh, otherwise I fear that it will soon be forgotten about by the majority of people. Have just sent a note to a local freelance journalist here in North Wales checking that the local press knows about the news and its great importance. I wonder if Panorama are planning another programme to share this news? Congratulations and many thanks to all concerned in this fantastic article. I have a feeling that you still have much to share with us when the time is right!
Thank you to the team involved in Restoring Study 329.
Question: Given GSKs orchestrated litany of lies in respect of children do you think they may have used the same behaviour template for the adult study as well?
Answer ” What do you think?
Well, the saying goes – “once a liar, always a liar”! – it will be very hard for us to believe otherwise really won’t it, especially as we all know of so many lives that have been damaged that were not “children or adolescents” at the time of being prescribed the drug. Truth is that we need to move on – we now KNOW the truth, it is as we had suspected for so long, the stories from the past are now THE TRUTH. Beyond that , the past cannot be changed. I am sure that the wish of families of surviving sufferers is – let history not repeat itself. Hopefully, care of the surviving sufferers will now be improved – agreement on the cause of their problems is a leap forward in this direction but to me the main point of yesterday’s news is to make sure that tomorrow’s news is better – in other words, that no more “children and adolescents” should ever have to suffer like the ones from our immediate past. Through their suffering will come a better future for all – as I feel quite sure that those beyond being “children and adolescents” WILL benefit from the fact that the truth is now having its rightful place. In my opinion, it is our duty to broadcast this news as far and wide as we as individuals can do – that is the only way to keep it fresh in people’s minds – for that, surely, is showing respect and gratitude to David and the rest of the team for the incredible amount of work that they have done to give us this heartening news .
Dr David Healy and co-authors: On this day, you drew a line in the sand and said ‘No More’. For many years, the cynic in me told me there were no more heroes. How wrong I was.
This is your day; and this is yours:
https://www.youtube.com/watch?v=YYjBQKIOb-w
Thank you.
Walter
All of the studies………… I was a victim of Aropax, but that has only been one of many….. I would like to see a revisit of studies done on Effexor, the relationship killer, life destroyer………. only thing with Effexor, is you actually think you are sane, while on it. All of these drugs are evil, and more evil the fact they said the older drugs were dangerous, all the time, the newer drugs were not only more dangerous, but more addictive………… addictive in such an insidious way, you don’t crave them, but if you don’t take them, once addicted, you go mad………………. http://www.survivingantdepressants.com tells all the truths the doctors don’t.
Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.
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.”
http://www.alltrials.net/news/new-research-on-old-data/
Annie, I know! I almost posted that here last night but it was just so insane I had to close my laptop.
Yes, clearly having the prefix ‘Sir’ before your name enables you to see the bigger issues, and to be able to ignore and dismiss the silly anecdotal trivia, such as Chinagate and the ongoing SFO investigation. Along with the Sirs, and Dr Goldacre, we can all happily cartwheel down the street, chasing a muck cart (GSK); but thinking we are following a wedding.
Alltrials looks set to become the latest incarnation of the patient organisation – yet another smokescreen for Big Pharma. Reading ‘Sirs’ statement, you would think that GSK had actually funded the 329 reanalysis. Pathetic pandering…
Walter
Does this mean its not good for children or als for grown ups ?
This means there is a problem for all drugs for all indications (cardiac, osteoporosis, contraceptive etc) and for all ages.
DH
But does it also mean that paxil is not working for depression only for adolescents or also for adults ? Thankx david healy !
I have just watch the programme ‘In pills we trust’. Quite an eye opener. I have been on paxil for at least 15 years and must say I must be one of the people that it is suitable for. I battled since childhood with anxiety that eventually developed into debilitating panic attacks. My GP put me on paxil and my life changed dramatically for the better. Social anxiety also eased up as a bonus side effect. I did not consult the doctor for social anxiety but it was something I had always had problems with. I am current on half a tablet a day..with a few side effects which are livable. There is a history of mental illness in my family..my sibling and father succumbed to alcohol and drug adictions. They may have been alive today if they had sought appropriate treatment rather than ‘self medicating’. That all said it is shocking to see how greed has resulted in manipulated data and over prescribing. The withdrawal symptoms are aweful, i did come of the meds a few years ago but went back on again as my old symptoms reappeared. My heart goes out to patients affected and to the GPs that genuinely thought they were helping their clients.