Study 329: The final chapter coming soon
Arguably the most controversial drug study ever, Study 329, published in July 2001:
- Concluded that paroxetine was a safe and effective medication for treating major depression in adolescents;
- Is still widely cited in the medical literature, providing physicians with assurance about the usefulness of paroxetine;
- Was criticized by a few alert and concerned journalists and academics. Their voices were buried by a tsunami of positive marketing and promotion by vested interests;
- Resulted in a successful New York state fraud lawsuit against GSK;
- Resulted in 2012 in the biggest fine in corporate history – $3 Billion; and
- Remains unretracted.
Paroxetine Names Around the World
In June, 2013 Peter Doshi and colleagues published “Restoring invisible and abandoned trials: a call for people to publish the findings” in the British Journal of Medicine (BMJ).
They referred to this proposed protocol as RIAT, and described its purpose as follows:
Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond.
A team of researchers undertook to re-analyze the original data and publish a new analysis under the RIAT protocol.
In August, 2015, after a year and seven drafts, BMJ notified the team that their submission would be published in September, 2015. This will be the first ever trial with two completely different takes on the same data.
This new study, Restoring Study 329: Efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression: restoration of a randomised controlled trial, should shock all who care about integrity in drug safety. Find out the inside story when a new site, Restoring Study 329, goes live.
Thank you.
This is thrilling that the shroud of secrecy will be lifted on the efficacy and harms of Paroxetine in the treatment of adolescents and may be throws some light on some of us who were not adolescents.
Thank you.
Annie
Never has the term “Bated breath” been more apt.
For me at least.
Wonderful news, now I know why GKS got fined 3 billion………. I am spreading the good news, I await the report.
I hope the research damage is so substantial that it’s off the market in 24 hours. That wouldn’t be fast enough.
I haven’t quite surmised how one topples a criminal activity but I’m thinking about it since I started reading Truthman30’s work on Paxil. I never can remember the UK name for it…the med is such a fraud, they have to make up 109 aliases for it. See above.
Thank you, Dr. Healy, it’s nice to know someone else is shining light on this topic….it’s a life or death manner..and needs to be addressed. Hats off to you!!!
Perhaps this will be a first step in giving some integrity to the shady world of prescription drug labelling. However, I don’t believe the “game” will change until those in the pharmaceutical and academic medical world who collude in providing false, misleading, and too little information about same are sent to prison for their crimes. Should this finally start to happen, the picture should clear up a bit more.
I look forward to reading what may be the real truth about Paxil.
Wow just wow. This is a huge step on the way forward ! The Truth !!
This is fantastic news.
Staking my life on their believing this. Have used up all my words. Borrowed time. They won’t believe me.
I can hardly believe what I have just read! Let’s hope that the report, when published, will be all that is being expected of it. It is high time that something positive happened in the context of this drug. To all of you who have suffered as a result of being prescribed this menace – good luck and I hope that the truth will go a little way towards your stories being believed at last. At least it may protect the next generation from its evils. ( I know it has worked for many thousands of patients – they are the lucky ones; our thoughts today are with the unlucky ones who deserve no less than the TRUTH – such a pity that a cure for their present pains can’t come with it1 We must also remember the many who are no longer with us due to this drug.) I am sure that we will be kept well informed of the date of publishing. I wonder if the World Press will be as quick to inform?
I must admit that I am still reeling and find myself having horrid thoughts about it all being a scam or a setup to provoke!
Congratulations to all concerned in this – and a special thank you too to you David, for without your diligence I have no doubt that we would not have such good news.
Champagne at the ready everybody – no, sparkling water would be more appropriate actually.
It will be interesting to see the reaction when (if) the BMJ publishes this version of Study 329. Personally I think GSK (and those who colluded with them in their Paxil/Seroxat Scam) have blood on their hands. It’s corporate manslaughter (and it’s corporate manslaughter of children in order to make a buck out of their suffering). The Seroxat scandal is still as scandalous as ever…
I remain cautiously optimistic. I doubt we will see anything lifechanging as long as scientists depend on “drug-money” (manufacturers wallet pays for science)
BTW, it’s been a couple of weeks now since the theory of Serotonin got “busted”, but doctor hasn’t mentioned it to me yet….
(Sweden will probably be last to jump aboard any new science..)
I really dislike living in the shadow of Seroxat.
….one of the biggest challenges of trials transparency. …
Today at 7:33 AM
Dear AllTrials supporter
In the recent judicial review against the Health Research Authority (HRA), the UK’s ethical approval body for clinical trials, a clinical trials company tried to challenge the HRA’s attempts to monitor whether applicants are registering all their trials. Despite the Court’s judgment – that the HRA has a clear legal right to monitor researchers’ compliance with all their legal and ethical obligations – we cannot ignore the fact that there are people who want to undermine that progress. There is a danger that politicians and others will see this backward view as significant and representative of industry.
To make it clear that it is no such thing, AllTrials and the Ethical Medicines Industry Group have today sent a joint letter to the HRA, setting out why it should not be dissuaded from its path. It is published in Pharmafile today.
Monitoring compliance with regulations and good practice is one of the biggest challenges of trials transparency. Medical journals tell us that they still receive submissions from studies that have not been registered, and recent reviews have found big gaps in compliance on trial registries. The HRA had found a sensible and practical way of integrating some basic monitoring into the ethical approval process that they’re responsible for. Regulatory bodies in other countries have been considering whether it is a way forward.
We hope our letter will also make it very clear to them that AllTrials supporters, the UK biopharmaceutical industry, and the English courts have all agreed that it is.
For most of you, this is just an update. But some of you work in organisations, or have colleagues that perform an equivalent role to the HRA in other countries, overseeing, protecting and promoting the interests of patients and the public in health research. Organisations all over the world, such as the Office for Human Research Protections in the US, the Federal Institute for Drugs and Medicines in Germany, and the Brazilian National Health Surveillance Agency should all read this letter, to name just a few. If you have dealings with people at organisations such as these, can you help us to make them aware of the letter? Email me*
Best wishes
James
*Some great volunteers have been compiling a list of all the agencies across the world, which we plan to assemble and make available on AllTrials.net very soon, so any suggestions for organisations we should add would be very useful.
All I know is that I was on it (addicted to it) for 15 years. In 2007, while still on the drug, I started reporting to my now ex-boyfriend how I was having severe problems trying to realise any kind of human emotion, and was quite sexually defunct. It was full-blown in the summer of 2009, in the sense that, I was still on the drug and now not able to feel any human emotion at all, or love, or sexual. It was NOT a case of residual depressive symptomatology. My re-uptake pump was disabled for 15 years. My serotonin, which is essential in the role of assuming emotions, has been severely jeopardized. I feel nothing and I never ever sleep. I am living like a house plant.
http://www.medicaldaily.com/antidepressants-dont-just-change-your-sex-drive-they-can-affect-your-feelings-love-toward-297598
In my case, it’s permanent. There is no change whatsoever since 2009. I’m now off it, but the damage is done.
Maeve>>> I started citalopram in 1998, immediately I started losing interest in my girlfriend of 6 years (high school sweetheart, and I knew nothing of this back then). My sexual interest started going astray, from a very ’emotional’ and ‘2-sided” sex, to all about me and myself and the need to experience ‘deviants’.
Switched to Seroxat/Paxil in about the year 2000, and I broke up my relationship all together. But I stayed in touch with her for Another 5 years, and with absolutely no jealousy watched her dating others.
I have not been emotionally capable of living Close to a girl since!
The switch to Seroxat made me plunge even deeper into trying out sexual things, many of who left me disgusted of myself the SECOND I had reached climax. That meant I could not fantasize about that particular fantasy again for quite awhile, but had to try Another, and Another….
And all this for a guy whom when I was late teen/early 20’s never had thought of anything more “naughty” than perhaps to try buying some ‘Victorias secret’ for my girlfriend….
I can’t stop the pill, and I choke each day when I’m forced to take it….
Perhaps dr. David Healy could write a short note on what his thoughts are on dr. Richard Hortons piece in ‘the Lancet’?
He is of course unknown to me, but the more people with insight in science and scientific publications that oppose current situation, the better?
“What is medicine’s 5 sigma” by Horton:
http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2815%2960696-1.pdf
(this might be old news in Britain, but it just reached Swedish alternative media, barely noticed in mainstream media, just a re-written version that skewes toward Health and diet research…)
David Healy did write a short note……..
https://davidhealy.org/everyone-has-the-right-to-challenge-scientific-experts/
David_Healy says:
April 12, 2015 at 9:00 am
The issue here seems to me to be that most of the respondents are trying to grapple with the establishment’s inability to show much intelligence – where to cite Scott Fitzgerald “the test of a first rate intelligence is the ability to hold two opposing ideas in mind at the same time and still function”.
May be GSK don’t work on Saturdays….O fat um
In yesterdays Scottish Daily Mail, Glaxo deal fails to cheer traders as the share price fell to 1324.5p
It wasn’t so much the Market Report in the City and Finance Page about the multi million pound drug deal with Novartis with this MS drug, it was the extraordinary name it had that caught my eye
O fat um um ab
http://www.bloomberg.com/article/2015-08-21/afm1lDtNQjcM.html
We know about Paroxetine, but, had we heard of O fat um um ab
Unforgettable, now…I would be embarrassed to ask for my O fat um um ab
At least Seroxat and Paxil had a sort of sciency name……
“Novartis already markets O fat um um ab as a cancer drug under the brand name Arz erra rather than as a treatment for MS”
http://www.stockmarketwire.com/article/5098682/GSK-to-sell-ofatumumab-for-up-to-1bn.html