Study 329 is probably the most famous clinical trial ever. It is one of the few to attract a Fraud action and is certainly the only one with a $3 Billion fine linked to it. See A Milestone in Drug Safety.
The study began recruiting adolescents to Paxil, imipramine or placebo in 1994 and finished up in 1998. Later in 1998, SmithKline Beecham, the marketers of Paxil (they hadn’t discovered it), acknowledged in an internal document that the study had shown that Paxil didn’t work for children. This lack of benefit was something they were not inclined to share with the outside world. Instead they decided then they would pick the good bits out of the study and publish these.
The good bits led to a publication in 2001 – Keller and 21 others – in the Journal of the American Association of Child and Adolescent Psychiatry, which boasted that it was the journal with the highest impact factor in child psychiatry.
The authorship line was KoL-to-die-for-country.
At the time most of us were still innocent. Few would have guessed that no one on the authorship line might have had any meaningful input to the paper. Few would have guessed that none of the “authors” except perhaps the company personnel had seen the data.
The real author in the sense that most people in the street would recognize as authorship was Sally Laden. The study made Sally perhaps the most famous medical writer ever. But even she had not seen the data.
This is a woman who concedes that “There are some data that no spin can overcome”. Not having access to the data may make it easier in tricky cases.
The Keller and 21 others paper was published in July 2001. A month previously the Tobin trial in Cheyenne Wyoming returned a verdict against GSK (formerly SKB) and Paxil in a multiple homicide-suicide case.
The Tobin verdict and the facts that GSK was then the biggest pharmaceutical company in the world, and was notionally based in Britain, and that Paxil was the biggest selling antidepressant in the world, engaged BBC’s leading investigative program, Panorama.
Up till then, in 50 years, Panorama had never repeated a topic but they made four programs about Paxil – Seroxat,
All the programs are available on Study329.org along with their transcripts.
At the heart of these programs was Shelley Jofre who showed that you don’t need medical expertise to sift the wheat from the chaff of most medical studies. She read the Keller paper within weeks of its publication and immediately smelt a rat.
The rest is a history that will reach a major landmark around September 14th when BMJ publish Restoring Study 329, a year after it was submitted to them and two years after work started on the Restoration.
The Panorama programs are now available on Study329.org.
As is The Famous Grouse lecture which covers the History of 329 and the Black Box Warnings.
Yet more will be added over the next few weeks.
The BMJ paper, when published, will sit there alongside the Keller and 21 others paper.
Mickey Nardo – 1boringoldman – one of the authors of the Restoration will be have a series of posts linked to the publication outlining how and why we cannot afford to glaze over when experts mention clinical trials – RCTs. We need to grab our chance for a Shelley Jofre moment with both hands. His posts will in addition be reproduced here.
The posts here and later on RxISK.org are available for comment and there is a contact us button on Study329.org.
Copyright © Data Based Medicine Americas Ltd.
It is said that the love of money is the root of all evil.
Here we see the face of it.
I really do feel like this will be a huge step towards the truth. One day history will look back at study 329 and I hope it will be with disbelief that a company could get away with what they did. I hope in the future it would be impossible for them to get away with it.
Thank you David to you and your colleagues for all the work you have and are doing to make this possible.
We need #AllData now more than ever!
This week the press has been full of the debate over FDA’s approval of flibanserin (to be sold as “Addyi”) for “hypoactive female desire disorder.” This has given some brilliant publicity to Addyi of course, but it also highlights how many more people now distrust the “research” they’re offered and want to read the fine print.
This particular fine print has already disclosed quite a bit … Lots of people found the main benefit of Addyi — an increase in “sexually satisfying events” from 2.7 to 4.5 per month, versus 2.7 to 3.7 on placebo — kind of underwhelming. It now appears that this was found in a study where the subjects reported their results in a monthly questionnaire. A study that used a daily diary found flibanserin no better than placebo. It’s only looking back, you see, that you realize what a good time you had.
None of it seemed to justify the side effects which were fairly common and included dizziness, drowsiness and possible fainting spells from low blood pressure. The drug co study admitted those effects are sharply increased with alcohol, so that women using Addyi must be instructed not to drink.
However, that might not be the half of it: Apparently their study of Addyi-Alcohol Interactions was carried out on just 25 people, and 22 of them were men! Which is pretty funny given that the drug company had loudly complained that the FDA wouldn’t give their product a fair chance because it was indifferent to women’s health needs …
Who knows what else we might find out if we could see the actual data?
And I want all the academics backing me up, publicly!
Not as in vouching that I am a fully normal person, which I am, but vouching that Seroxat/Paxil can harm me but still leave me a “normal person” beneath the layer of Chemicals.
Since my trail of behaviour is so strongly contrasted between ON and OFF Seroxat, all I can do is to tell authorities to take that into serious account.
But, oh yes, ‘authorities’ are part of the ‘revolving doors’ here in Sweden too. So, once a pharmaceutical marketer, is now the head of overseeing adverse events for “lakemedelsverket”, the government branch for overseeing Pharmaceuticals. But it’s populated with former pharmaceutical Company employees. And most of them own their fancy sunset-facing villa in the Stockholm archipelago.
But me I’m still smart enough to see that not even professors and academics can change the public opinion on me – but can I please get some help explaining to my Lovely parents? They still stand by me, despite the many questions they must have. (Unlike Leoni and others, they still have their son here, but still can’t understand what the H happened to him…)
And lastly, can you tell I’m angry? Feels good to announce that I don’t get more angry than this, though virtually tortured by Seroxat for 15 years, the pill now makes me somewhat accepting about the situation – I “care-less”.
My parents are facing this without the numbing of any pill, they hurt more than me.
Your comments always get to my heart because the things you say remind me of my son.
My son was lucky to be found not guilty and didnt go to prison … I say lucky not because he wasnt not guilty but because fate led me to someone who’s expertise helped us prove he was not guilty.
I know you were not so lucky and spent time in prison. My sons court case was terrible it dragged on for a year and all the time I had this terrible dread because he was facing up to 8 years in prison if they did not think the drug withdrawal had any influence on him.
It still makes me feel physically sick to think of how he was that dreadful day he commited his crime and the image of him locked in the perspex box handcuffed in court the morning after his arrest will haunt me forever. Its something I had never imagined I would see. It doesnt haunt him because he cant remember it.
He has said some terrible things to me and been selfish, nasty and arrogant but I still love him because I know thats not my son. I know thats what the drug did to him. He has improved and I see glimpses of the old him and that gives me hope.
I stand by him because although its made my life hell I love him and good or bad times I wouldnt want to be without him and Im sure your parents ( who sound wonderful) feel the same.
All the best to you Ove.
Thank you Lisa.
My parents stand by me, they help me with more than I can ask for, in very dire times too. But I haven’t been able to tell them just how much has been ruined by Seroxat. I have mentioned bits here and there, but some things would just sound strange to them. They know all my strange behaviours, but how can I tell them this pill causes them when Swedish society says they’re harmless?
I wish so deeply we had a professor like D. Healy here in sweden, who could make a video or some other statement, without the need for subtitles. Who could show that I’m not just making this stuff up.
My parents are calm and collected people, worked their whole Life and now enjoy retirement. I’m afraid they won’t see the truth unravel.
I’ve read about you and your son too, and I Believe I answered you one time with: “never doubt for a second that the drugs made your son ill”
All youtubevideos are in English, since all the critics are ‘foreign’, and mum and dad don’t speak it that well..
Yes you did answer me and it has helped me greatly in understanding whats happened to my son by reading your comments Ove.
I hope one day your parents will get the information that shows them what harm this drug did to you. It must be very hard for you and them.
I know whats happened to my son has affected our relationship. Its very hard, when these drugs go wrong they wreck the lives of the victim and all those who love them and are close to them.
As it stands right now, my only way to restoration (google translate) (to redeem my good name) is if I open up a lawsuit on GSK. My chances to win are extremely slim, but I would gain some credibility as it would open some peoples Eyes that there are serious questions to be asked about Seroxat.
Most of people involved will deny, but through the Court I could show I’m not alone.
I know my parents would begin to comprehend by then, if they saw all the pieces come together. How I lost my interest in my long time girlfriend, and how I lost my interest for Life itself. My inability to get emotionally involved, how I shrank my World in to my 2-room appartment.
But I would get overrun by media. Me, who almost can’t go to the grocery store as it is….
I would get overrun by the Corporate solicitors of GSK, who couldn’t care less if the truth comes out 25 years from now. By then they all had their upscaled lives allready, and i would likely not be around anymore to claim i was right from the start…
But I’m glad to have Healys blog, to see him poke his finger in their side saying: “you can fool alot of people most of the time, but you can’t fool all of us all the time..”
And I really appreciate yours and Annies comments.
“If no-one else pads our backs, let’s pad our own”
Re: a video or some other statement, without the need for subtitles. Please see “Who Cares In Sweden” “Det handlar alltså om forskare och experter som för egen vinnings skull (ekonomiskt eller på annat sätt) talar för en ökad användning av mediciner” http://www.whocaresinsweden.com/sv/ Hope it is helpful.
I would only add to that, that it is particularly unfair, in this day and age, for you to have a life of a guilt trip.
You know, that Seroxat has impaired your life, considerably, and, you know, deep down, that as Lisa said your parents love you very much.
Why should your parents carry this weight, as well as yourself, when, all over the world parents are carrying terrible burdens of loss of their children, children in a smog of drug induced distress and adults in distress, too.
We feel your pain, Ove, you describe it so well and I hope you can take something from us who are behind you and we hope that one day, may be not just yet, you will wake up and be the hugely considerate son that you sound like you are.
Just try to take one day at a time. Don’t try and force anything that isn’t ready to be there and most of all be kind to yourself and then, hopefully, for you, the rest of your life will become a thoughtful and less painful experience.
We only get one life and no matter what has happened with Seroxat, we are all still here and may be one day we will be better at counting our blessings.
I think we are all shocked and may be getting some more shocks when a lot more is revealed, but, at least we are in the right place, here, and for that I am truly grateful.
It is also good that you are speaking so lucidly and no doubt we will continue to hear from you and I look forward to that. Also, Lisa, a relief to hear the outcome and hope things only get better from now on…..
We are getting to know each other quite well now and thank you to David for allowing us to do that as support is so critical for us.
We have spent too long with this and introspection was never anything I used to do, but, it’s quite difficult not to with something so seriously awry as this.
Most comments have more common sense than anything I have ever heard whilst travelling through The Seroxat Experience and you have certainly wound up in the right place.
Those lost years and the way I kicked Seroxat is not to be recommended, and, it is fair to say that I had to spend years unravelling it all, in my head, from the brainwashing that I was indeed someone who should not be alive.
I could cope with GSK and their machinations but it was almost impossible to cope with the doctors and their machinations.
I can thank my mother and my child who never lost confidence in me and when it was all over I had to do all that I could for them to forget about it which I did.
The Headmaster who refused my child her standard grade exams because of Seroxat, was a terrible situation for her and it was surprising that she didn’t say lets not bother but she had studied at ‘home’ by herself so off she went and passed brilliantly as I knew she would.
We could not do highers as there was too much coursework, so University was out of the question. As it turned out, I think she was better off not going,
She is an exceptionally quick learner and she can turn her hand to anything and this isn’t taught at learning establishments.
The lack of understanding can follow you around for decades and it came from the first moment of Seroxat and for decades I just wished the persecution would stop.
How easy it is for some doctors to behave badly and then make it all ten times worse.
You would not believe the way I was spoken to from the first minute I brought their attention to ‘withdrawal’ symptoms and pushed around and pushed around until there was almost nothing left.
This is not just nor fair nor acceptable behaviour.
If Seroxat had not been prescribed badly, negligently and without my consent then none of this ‘bullying’ would have happened. That is as true as I can make it.
I could ride off into the sunset; however, I think it is worth seeing through to the end of this chapter.
When I was in Kent from Scotland, back on Seroxat, looking at the tv schedule, was Panorama.
This programme knocked my socks off.
I had just been through terrible abuse from doctors, two hospitals as emergency admittance, and, when we watched this programme, me and mum, just looked at each other with eyes like saucers…my doctors had not watched the Programme and despite my protestations the dose was doubled by one psychiatrist whilst the other one prepared me the year long liquid withdrawal programme.
It didn’t end there, as the liquid stopped and the abuse started again from the surgery.
It was like I was living in a parallel universe with all these doctors approaching me from totally different angles and I found it impossible to follow.
I called the helpline after the second programme.
Annie>>> I also love how it Comforts you to hear of others with similar experiences.
But I really dislike how “others” look down on me and the experiences I share with them.
You know as well as many in here that we are not “entitled” to deem our experiences as adverse events, we need “others” (Like David H or your psychiatrist) to strength with certificates that our experiences are due to the pill. Even though every fibre in my body and mind seperate myself from ANY form of violence.
(Other adverse events are easier to attribute the pill, but my violent outburst sent me to prison….)
But even other adverse events gets challanged beyond reason.
Now don’t get me wrong, I would love justice for us all, but when I wasn’t given it I doubt others will.
I’m no “superhuman”, just average in almost all aspects, but without even a trace of violence.
And if psychiatry aren’t ballsy enough to come Clean to me, there are sure others out there with worse background that will certainly not be told the truth.
And I hate the feeling of “dis-empowering”, I’m looked upon with distrust.
So sometimes when I read your stories I get this gut-wrenching feeling of how you get treated the same way, mistrust.
Perhaps we all should laugh a bit of how we follow dr. Healy like ducklings or his “disciples”.
I guess we just hang on to our only “trump card” in this very poorly shuffled deck.
Let’s stick together ’til the tide turns// Ove
Thank you Annie. This blog has become all our salvation I think. Its the only place where I truly feel that people understand what my family has been through and that does give me a lot of comfort.
I cannot imagine that the grandees of the RCPsych will allow this reassessment of paedocidal Study 329 to go through, without putting up some sort of defence on behalf of their ‘brethren’ in the U.S.
Maybe as a ripost, it would be worth compiling a list of Keller et al, and putting against each of their names the ‘benefits’ which each has recieved over the years from GSK, because that information contains the root of the problem.
Many thanks to all who have worked to keep this blatant evidence of corporate corruption in the spotlight over the years,
For Ove…on Sunday
Who Cares in Sweden was one of my most important viewings
Watch thirteen minutes and David talks towards the end of this part
Those 3 episodes of WCIS was my first Contact with what the rest of the World Thinks about Paxil/Seroxat.
It was 2 years ago now.
Since then I have brought actual science papers to my psychiatrist, she still won’t listen. (Those science papers found through Paxil-progress and other forums, links on truthman30’s homepage and so on…)
Sweden is a very open and free society, and that is what the title of the video “spins” on. In reality, psychiatry here is even more hierarchial than most western countries. And some of the “professors” at the very top was featured in the video.
The DSM is followed to the letter here.
What I really love about WCIS is that many of the interviewees strikes me as very calm, collected and intelligent people. And that gives it credibility.
It’s also narrated in Swedish, with subtitles when needed.
Since then I have brought actual science papers to my psychiatrist, she still won’t listen. (Those science papers found through Paxil-progress and other forums, links on truthman30’s homepage and so on…)
Speaking for me….this is what I am looking forward to:
Study329.org Study329.org Study329.org Study329.org Study329.org
annie, thank you for your informative comments and links. I wonder if a ground swell of public outcries for criminal prosecution based on Study329.org is a way to galvanize essential points of yours and many others that have been disregarded by *psychiatry*?
I know you follow 1boringoldman. and madinamerica . There is a strong foundation being laid for the grassroots action that could turn the tide.
The young man who displayed unstinting courage and unparalleled expertise in rallying the power of *the people*, Aaron Swartz, is gone, but his methods were well documented. The time is right for displaying the full power of the internet and our freedom to connect.
Oliver Sacks dies in New York aged 82
There are some great people and there are some great people
annie, I share you admiration for Dr. Sacks. He has left us a valuable legacy. I don’t want to assume that you had a less than favorable reaction to my suggesting that we could benefit from Aaron Swartz’s legacy. I mean, I really don’t get what you meant by posting link to his tribute then saying;
“There are some great people and there are some great people”
Not knowing exactly what you meant, it does strike me that there is a big difference in the legacy these two left. Dr. Sacks is definitely a unique physician in his approach to understanding anomalies — something I wish would be emulated widely by all medical professionals, researchers included. Aaron Swartz was also a very gifted, unique computer genius, in that he scorned using his *magic powers* for making himself a ton of money, instead, using them for greater good. But, the victory he ignited to overturn the SOPA bill was a demonstration of the power we all have. He clearly articulated the message that the internet and our freedom to connect for a common cause, brought out the best in hundreds of thousands of regular people. It was a very unique demonstration of the power of the 99%. And he set this victory in motion while under federal indictment –
The finer points of his case, which basically was a radical approach to challenging JStor, one of a few corporations that limited public access to scientific journal articles ( due to a law that entitles them to assume ownership of the copyright on every article published in any scientific journal, BTW); the details of the case against M.I.T. and the Massachusetts State & the Federal Prosecutor, require some research, which I would not expect most people would want to undertake. However, the most outspoken and most highly esteemed professional, criticizing the inhumane process that led to felony indictment for which Aaron was facing up to 35 years in prison and $100,000,000 in fines, was and is Larry Lessig, who assisted the work of Robert Whitaker and Lisa Cosgrove and wrote the forward to their book, “Psychiatry Under the Influence” – a scholarly approach to indicting psychiatry as a corrupt institution incapable of reforming itself.
Forward “Psychiatry Under the Influence” by Larry Lessig
I continued to pursue the truth about the tragic death/suicide of Aaron Swartz (Jan 11.2013) and was astounded by the points of connection between his life, his mission and those I already hold in high regard for their courageous efforts to expose the corruption in psychiatry. I fully believe that making the criminal behavior of Psychiatry/Pharma a political issue, and strategizing the role of the internet, would have been a cause Aaron Swartz would have taken to heart. The network he helped create and then mobilized in 2012 to defeat SOPA has continued to grow and continues to honor his legacy.
I just wanted to point out that there is a path to follow for making Study329.org a pivotal moment– something greater than validation for the many who have suffered and continue to suffer from this scourge–, though I am not minimizing the tremendous positive impact this will have for those who deserve to be vindicated. But– Now, there is Documented evidence of willful debit, fraud– and the mayhem that followed years of psychiatry discounting what Mickey Nardo now claims is evidence that is so obvious to anyone who knows to look for it; documented evidence is forthcoming. We can play a major role in how it is disseminated to the public. We can assume a leading role in crafting the take home message. We can do together, what even the most noble, credentialed, humanitarian experts cannot do alone.
We can be as great as the best of ’em 😉
Comment from Laurie Oakley
Katie, I love these connections.
It seems that key in defeating SOPA was getting it across to the public that the legislation was something that would end up affecting internet freedom for everyone. That is perhaps what made a broad base of support possible.
I think key for us getting a broad base of support is for it to be made clear that what happened with Study 329 carries over into all of medicine, that powerful moneyed interests are affecting entire healthcare systems, and not just psychiatry.
A lot of people can and do ignore abuses in psychiatry yet their ears may perk up when they realize these kinds of commercial influences permeate the areas of medicine that affect them/everyone. Connecting this to what people are already recognizing/facing with economic pressures, police repression, etc. This type of framing might help us build that broader base.
I’m also wondering whether criminal proceedings in regard to company practices will end up changing medical culture or whether effects might be limited to corporate and/or regulatory culture? The minds of doctors are so firmly entrenched in the status quo that it might (also) take something directed at them to wake them up. What any of that might look like I do not know. I did write up a petition a while back and can share w/you if you’d like:). Was thinking we (in US) might need a new govt before going to the trouble.
Thinking out loud with a FRIED brain. So grateful this conversation is happening.
Thanks, Laurie, you have eloquently articulated the connection possibilities.
Crafting the basic take home message(s) for the public is key. This *news* effects us all. In that sense, the messages should be varied and unique. What I love most about the 20-30’s activists is their ability to resonate with the mainstream– masters of marketing strategies. You may have noted how Aaron Swartz immediately began to translate the take home message into simple phrasings– like, SOPA was “Internet Black Listing” –He used strong, provocative language that captured the attention of a wide audience, then swung into detailed public education specific to the group he was addressing. He made the point early on in his political activism career that with the internet we all have a voice–the question is : Who will be heard? Amongst the youth who were already poised for a strong anti-SOPA campaign, were some very good artists and writers. There was an advertising campaign- pictures, visual art,– must have been totally inspiring because the big guns on the internet used a visual of “black listing”– e.g; Google, Wikipedia went BLACK – the phone lines into congress “literally melted”. A turning point that demonstrated how well the public alert/education campaign had been run.
The web site Aaron Swartz created “Demand Progress” was a launching pad– still is. The technology that activated a very user friendly method for calling political representatives- in the house and Senate was one of Aaron’s masterpieces– I am connecting with the web site. Anyone can make contact on-line to seek guidance and assistance in publicizing Study 329 for what it really represents : The literal meaning of Medical Child Abuse; Their (children’s) PAIN, Our GSK(Pharma’s) Psychatry’s(medical profession’s) GAIN. – Phama/Doctors _ TOO BIG to assail? — a few ideas.
A visual message has to include photos of the criminals- the prestigious by line for Study 329. Additionally the ACNP Task Force (Jan 2004). (see time lines) ( the task force includes two local Boston spin doctors : William Beardslee (Connected to BCH/Harvard) and Ross Baldessarini (Harvard ). “Group Finds No Suicide-Antidepressant Link”– I know how this played out in my area– A focus for a local campaign that can be applied to the stomping ground of everyone of the other 9 Pharma KOLs who — did’t bother to write their own report? Lot’s of sketchy in this scenario. Researching the background is key- Public defamation is also key , IMO.(examples abound on You Tube)
A few tips I have gotten from my easy-to- access underground sources.
1) Connect the dots– in as many formats as possible- (visuals, graphics, narratives.)
2) Focus on the impact– statistics (how prolific the SSRI campaign for kids became– even after the evidence was shared with doctors) – number of prescriptions written, the toll of harm/deaths, profits (in the billions).
3) *Identify the “good guys”- same M.O.- photos, bios, credits. Credibility.
4) Weave in Criminal thread- (my idea ( an editorial cartoon) Lady justice- the defendants before her– GSK attorney trying to remove the blindfold “Oops! No peeking!” – simplified with several options.
5) Common theme : This is YOUR problem now– (my idea- parody of “Ask your doctor–if____ is right for you?”– “TELL your doctor ________ !!! )
6) Power of the public we are the 99.95%(Larry Lessig’s calculation ).
7) Demand Justice/ Protection under law.
Aaron points out how autonomous and creative the various groups became–. Rallied around the main points and 24/7 virtual access to each other, they succeeded in Changing Minds! This is where true power lies, IMO.
Also– thinking out loud with a fried brain– let the endorphins flow!
For those who are not familiar with Aaron Swartz and the *victory for the people* that he rallied and applied his expertise and passion to secure, here is a link to his speech on *the method*.
Anyone who wants to know how the Dark Lords in Boston destroyed this brilliant, gifted champion for fundamental human rights, here is a link to the documentary on his life:
Here in the U.S. we have investigative journalist nonpareil , Robert Whitaker, whose webzine, madinamerica is sometimes referenced here. Whitaker published a book this year “Psychiatry Under the Influence” with co-author Lisa Cosgrove– both has completed fellowships at Harvard’s Edmund J. Safra Center for Ethics, working with the law professor who helped create the lab for studying institutional corruption. This Harvard Law professor, Larry Lessig, also wrote the forward to Whitaker & Cosgrove’s book. Larry Lessig has been very outspoken in defense of Aaron Swartz, whom he had known over a decade, and who was a fellow at Harvard– studying institutional corruption at the Safra Center.
I think the documentary, “The Internet’s Own Boy”, which I linked above, is an important tutorial for the challenges we face in this battle against Goliath. The corruption discussed here and elsewhere on the internet that is powered by wealth and abject disdain for the people’s best interests, has damaged and destroyed countless lives. But this documentary has another more important, and virtually unheard of message; that WE can do something about it. Aaron’s family and his many distinguished friends and loved ones shared this message to both honor Aaron’s life and rekindle the flame that led to so many of Aaron’s unprecedented victories over institutional corruption. Granted, it is the 20 -30 something group who championed these cases, but their methods were freely shared and their work continues (this I know for sure 🙂
Counting down to Study329.org we have free access to study proven methods and connect globally. This is a golden opportunity !