Study 329: MK, HK, SK, GSK & History

September, 21, 2015 | 23 Comments


  1. Explaining the nature, effects and possible adverse effects of medications seems to be, fundamentally, attached to the principle of informed consent. At present, it appears that a person harmed by a drug has no legal recourse by way of showing a lack of informed consent. For example, if what was proposed was a surgical procedure and informed consent was not obtained but the procedure was done and caused damage, there may well be a cause of action for medical battery. This is the intentional violation of a patient’s right to direct their own medical treatments. Doctors must obtain a patient’s informed consent when rendering non-emergency treatment. If medical treatment is performed without the patient’s consent or against their will, the patient may have a claim for medical battery, even if the doctor did not intend to cause any harm. In a medical battery claim, however, there is generally no need to prove injury or negligence but in all battery cases, it is necessary to prove that the medical personnel engaged in unauthorized touching, contact or handling of the victim.
    This does not seem to be applicable to the uninformed consumption of a medication, so what recourse for damages does the patient have? The main point of dispute in most medical battery claims is whether the patient agreed to the treatment or whether they refused it but, in order to make an informed decision, one must have honest and clear data on which to base that decision.
    Dr Healy: “While there is something to be said for a Learned Intermediary in medical extremis, when a person’s judgment may be compromised, there is much less to be said for having a third party make a judgment call that requires you to accept risks they would not personally accept, for benefits that are unlikely.”
    I would suggest that the uninformed patient is the typical patient. Where is the protection against harm?

  2. An excellent post …… which should be made MANDATORY reading for all GPs and medical students – if only, somehow, this could be done! What a magnitude of human suffering could be prevented!

  3. This post NAILS IT.

    I like Bernard Carroll’s tone when he says:

    “It may have seemed like a win-win arrangement but some of these listed authors I am sure wish they had never consented to be so trusting.”

    While it’s tempting to castigate Keller and the other so-called authors of Study 329, I think it’s critically important they not be scapegoated. The case being made by the RIAT Study 329 is that science is done this way in all of medicine and that fact should be the take home message.

    All of this has been like watching a picture develop and I get overwhelmed thinking about so many other pharmaceuticals that have been in use for decades yet need to be subject to major reanalysis. Ove mentioned something on your last post that I also think is particularly urgent:

    “Is Keller aware of that ALL doctors (99,8%) use data from RCT’s to say: “that is an anecdote because RCT’s did not show that”?”

    How many people have had the experience of telling doctor after doctor what they have experienced on a drug only to be told, “no it’s not the drug because, science.” In a world where Science Trumps Everything, the source of much patient suffering has been made literally invisible to doctors (and therefore to all of society) as science has fallen into the hands of these profit-driven corporations.

    Dr. Healy, I hope your comrades are listening to you because most of us, as survivors, have been made painfully aware that we are too low in the medical caste system for our words to be counted. That you listen to the likes of us is truly revolutionary and gives us dignity when others treat our input as valueless.

    I am grateful to any doctor or professional who recognizes their moral obligation to pick up this torch because ironically, while they are the ones the system has conditioned to NOT LISTEN TO PATIENTS, they possess the social capital necessary to shed light on the extent to which Western medicine is hemorrhaging.

  4. There’s a heap of injustice and abuse of power here. I just want to explain one small corner of it for readers who are not familiar with older anti-depressants like imipramine (Tofranil). The kids in this study were randomly put on Paxil, Tofranil or placebo. Studies had already confirmed what many docs knew from practice: Tofranil was NOT effective for relieving teen depression.

    I was briefly on Tofranil in my early 20’s, back in the Jurassic era, and also took Elavil. Both are older antidepressants called tricyclics with a different mode of action than SSRIs like Paxil. They actually are more helpful for severe depression than SSRIs, but come with side effects many patients find hard to handle–especially sedation. Tofranil made me so “dopey” I refused to take it after the first week. I took Elavil for longer. It did help, but I wondered if part of the benefit was to make me too foggy to feel anything as strong as actual despair.

    The Tofranil Kids in Study 329 were put on a dose the investigators knew was much higher than the average adult patient would get. They must have been completely miserable. They also were exposed to other risks such as cardiac arrhythmias, and I believe several left the study early due to “cardiac problems.” This was an unreasonable risk to take, even with healthy young people.

    The only possible reason to do this was to artificially make Paxil look as good as possible. In that way it was both an abuse of the young people in the study, and an abuse of millions of other patients who were sold an inflated belief in Paxil as a “wonder drug.”

    • Brilliant points being made here…

      Fully agree on the point about informed consent in regards to the violation to the body and mind from not being warned of side effects… Seroxat is the poster-child for it. Thalidomide is the only thing comparable Seroxat in terms of public outcry and controversy, however with the SSRI’s this is a class problem, and of course the RIAT study on Paroxetine opens cans of worms way beyond one drug. I’m so glad that Healy, Doshi, Nardo, and the others, had the tenacity, and courage, to open those cans of worms…

      Furthermore, it’s utterly horrifying to read about how these kids were treated in the study itself, then to know how it was marketed (mostly off label) to hundreds of thousands of youngsters, and well … we know the rest… utterly shameful..

      However, as was pointed out- we must not scapegoat the authors, that’s what GSK would want. Yes there has to be accountability of course and they played a part, as did drug reps, marketing departments, the regulators and psychiatrists on the pay roll, but in my opinion it”s GSK who should hold the most accountability here..

      They are the Godfather and Kingpin behind the scam itself…

  5. This is the question we all ask ourselves on a daily basis.

    Having experienced the experience from a top law firm who advertise ‘have a claim of medical negligence, then we will talk for you’ and having it dismissed because a GP, legal budgerigar, could not find fault with the ‘service’ I was given and actually said that she could not see how my doctors could have done anything differently (squawk)…it was all copy and paste…a report, it was not.

    I won an award from the British Overseas Development Agency, for report writing for my textile company, of £2,000. Not to me, you understand, for my company.

    I know how to write reports.

    All this wonderful back ground that David has given us, which has taken him, and, his, colleagues, years in the making, might give grounds for a Serious Legal Challenge to a Pharmaceutical Company, but, it doesn’t stop our doctors and psychiatrists pulling fast ones, which, they, know, they are doing….we are not represented by anyone against their duplicitous work…and we either need a Class Action Against the Doctor, living near you, or, we need a healthy dose of realism from Government Agencies, who, as, far, as, I, can, read, it, have no place in this provision.

    The work David and Team have done, which, is on our behalf, really should eventually lead to a whirlpool of patient complaints about Doctors.

    If anyone can think how to resolve this particular issue, I would love to hear it……

    • If there is evidence that a person is biased in some manner that would affect the reliability of her claims, then an Argument from Authority based on that person is likely to be fallacious. Even if the claim is actually true, the fact that the expert is biased weakens the argument. This is because there would be reason to believe that the expert might not be making the claim because he has carefully considered it using his expertise. Rather, there would be reason to believe that the claim is being made because of the expert’s bias or prejudice.
    • If a person makes a claim about some subject outside of his area(s) of expertise, then the person is not an expert in that context. Hence, the claim in question is not backed by the required degree of expertise and is not reliable. It is very important to remember that because of the vast scope of human knowledge and skill it is simply not possible for one person to be an expert on everything. Hence, experts will only be true experts in respect to certain subject areas. In most other areas they will have little or no expertise.

    The Data was Not Spoken from where we sit with our doctors

    … As with most scientific papers, Keller and colleagues convey an impression that “the data have spoken.” This authoritative stance is possible only in the absence of access to the data. When the data become accessible to others, it becomes clear that scientific authorship is provisional rather than authoritative.

    A cad em micks

    Someone needs to do the right thing by the Paxil 12….well said…but, its not just 12, is it?

    Today, that is…..

    Thanks for Background….increasingly hypnotic

  6. What about the adults who became suicidal trying to get off this drug .. what were they told….adults in their forties like myself who had never been suicidal or depressed before.
    Well in trying to get answers i was told i had an underlying depression …that was news to me so when i immediately replied that is not right I was referred to a psychiatrist. Being totally ignorant as to my plight i asked Dr Simon Bainbridge on secondment from the UK if he was aware of any issues or problems with people getting off paroxetine. He replied, “If there were problems then people would be suing the drug companies,” At the time i interpreted that as a ‘no there are no problems.’
    I was then over the next few years of suffering an emotional and psychological hell – protracted ssri withdrawal, to come to the conclusion, after a little of my own research, that Bainbridge was a man who clearly had his initials round the wrong way !

    Question: Am i the only one to be uninformed of an enduring horror story scripted by a doctor and arrogantly dismissed like this.
    Answer: What do you think?

  7. So my wife had to attend a funeral on Friday – one that brought chills to her soul. It was the younger brother of a friend since school, a friend who had supported her though her darkest times on antidepressants.

    He broke up with his girlfriend a while back, and his mild OCD symptoms got worse. He went to see a psychiatrist and was prescribed antidepressants. He was sectioned some weeks later. He injured himself escaping, and tried on his own to stop the medication that he said was making him worse. They found him eventually. Some weeks later when he was calmer and compliant, he was released into the custody of his parents. Last week, he wrestled the car keys from his dad, and proceeded to drive the car into a wall at high speed. Now he is dead.

    We watched this all unfold from a distance over the past year or so completely unable to affect the outcome.There was nothing we could do other than for Claire to pass on some of what we had learned to his sister. As the situation progressed, the things that took place raised all sorts of red flags that made us believe that he was in this trap for life, or at least for as long as he could hold on to life. Sadly, he couldn’t hold on for long.

    For Claire it was hard. She saw someone that was going through what she went through, but because of an extremely unlikely turn of events, she made it and they didn’t. This has to stop.
    Lets hope the Restoring of Study 329 is the start of something because this really has to stop.

    • I think this is a very important point, Neil, has brought up. A tragic tale, Neil.

      What do we do under these circumstances?

      I have a new friend, bright, breezy, and very clever; an Open University tutor.

      She has immense personal problems with an errant husband, a policeman who was siphoning off monies in their joint account. They are separated and share the children and she escapes to the Caravan Park, with one, two or three children in tow.

      We recently socialised and she mentioned she had been given Sertraline. Hmmmm

      She volunteered these words “my doctor is lovely and supportive and has become a real help to me. She said that my body was so ravaged from lack of Serotonin over the years, from stress, that these pills would normalise my Serotonin and go a long way to help with my stress levels.”

      I said, actually, that is not scientifically proven.

      As she launched into drinking a second bottle of wine, and became somewhat animated, I really was at a loss…I didn’t feel that I should push the point as I became aware that she might develop hostile feelings towards me…..

      Just don’t suddenly stop taking them, I said.

      No worries, she said. Everyone knows you have to taper and my doctor told me I am on the lowest dose, one 100 mg. and one 50 mg. daily.

      I worry for her and feel that all I can do, if I become a true friend, is just to watch how it goes…but, I am completely aware that this isn’t enough, on my part…..

      • There is little you can do. I was barely able to affect the outcome for the mother of my children, never mind someone outside of my immediate circle.

        But it’s like watching a car crash in slow motion. You can see this persons life being destroyed, and you know what would likely turn that situation around yet there is nothing you can do and no one you can tell that would believe you.

        I expect I am going to have to get used to that feeling more and more as the years go by.

  8. The evolution of the Learned Intermediary doctrine is indeed a problem today. How many lawsuits have failed because the plaintiff was caused irreparable loss (e.g. death of a loved one from drug-induced suicide), but the doctor admitted that s/he had been warned, but did not see any need to pass along that warning, or did not really comprehend or believe it. Since the doctor was warned, because of Learned Intermediary a legal action for failure to warn could not succeed, even though the patient and his/her family had no clue.

    Yes this post should be mandatory reading and not just for doctors, because the main point that sticks with me is that drug companies should be like car companies: if the brakes are faulty, tell the people who own the cars. Make a public announcement.

    Of course, that would tend to undermine marketing messages. From the consumer perspective, all the more reason to demand it.

  9. Dr. Healy,

    VW stocks plummeted +25% yesterday and the company will pay BILLIONS of Euros for cheating emissions for diesel engines. Yet, all is quiet on the Pharma Front.

    • Yes, interesting isn’t it; goods count for more than human lives of course – we must not forget that! When I heard that story on the news, it struck me how similar it was to the Study 329 outcome but oh so different in the reaction to the news. Anyone heard mention of GSK or Study 329 in any news programmes in the UK since the publication? – I certainly haven’t. Let’s bombard Parliament with letters now and see if we can wake them up to our news. Letters I suggest, not e-mails, – if enough of us write, then at least the delivery postman might begin to wonder what is going on even if our messages fall on deaf ears! Seriously though, alone I am one, and maybe the only one that will have sent a letter to my actual MP, but I am sure that between us all we would cover a good few individuals in the House. Jeremy Corbyn ( whatever our feelings regarding that post) has started a trend of asking questions from the public in PMQ time so he may be the very chap to turn to with our plight. Actually, the Labour party has recently appointed a minister for mental health (not sure if that is actual title but roughly so) – she, yes SHE , had an article in the Sunday Express last Sunday which I have kept so she will get a letter too. Am also writing to a Welsh Lord as well as to my son’s MP who was, until May’s election, a local GP – so he certainly needs a copy, especially as, at present, he seems to like the sound of his own voice by all accounts; maybe he’ll be glad of a new topic to share with Dave C( who actually has more than enough on his own plate at the moment it seems!).
      The reality of all this, surely, is – we are the ones who have suffered either personally or by watching a loved one suffer; the experts have done their work and dedicated hours and hours of their time to it – isn’t it now in our hands to do all that we can to further their work? Without our “evidence” their hard work could go to waste – it would simply be another report without a human face to it – and that should not be allowed to happen. As David has reminded us, this goes way beyond the Seroxat issue – it is a light for the majority of us who are popping pills in the dark,without a clue of what is really in them nor of what harm we may be causing to ourselves and, in the process, creating a great wealth in all the wrong places. I shall be waiting to hear a newsflash in the near future regarding a bottleneck at Downing Street as Royal Mail vans queue up to deliver sack after sack of mail addressed to both Houses of Parliament!!! Any cartoonists among us? – bet you could create a good one there!

      • The difference is money. It is financially advantageous to the global economy and for that matter, the car industry, if the world rejects diesel cars. Just like it was financially advantageous for the world to reject gas guzzling petrol cars about 10 – 15 years ago, just like it was financially advantageous when we changed from leaded fuel about 15 years before that…. and just like it will be in ten or 15 years time when we change from small petrol cars to whatever…. electric or hydrogen maybe. Then some time after that there will be a scandal about fuel cells or batteries and we will all change again.

        In the long run, even VW share holders who stick it out will probably still be winners, as all the so called green diesel cars that people bought because of government tax incentives and scrappage allowances given for their old petrol cars, are now replaced with little turbo charged petrols that are much cheaper to manufacture but won’t be any cheaper to buy. Someone’s got to build them, and that creates growth.

        The only time you will ever here that Surely big pharma is just the same… the only time you will find out if a drug is dangerous, is if they have something more profitable to replace it in the pipeline. The scandal then drives everyone to the new product.

  10. I think it will blow over as probably most other car manufacturers are doing the same thing.

    Once a VW lover, always a VW lover.

    Three Billion $ in fines blew over for GlaxoSmithKline.

    When most people swallow their Seroxat, unless they are up to speed, reading the finance pages is the last thing they do.

  11. Volkswagen is nothing compared to this: politicians, public bodies and even the mainstream media do not want to grapple with the systematic deceit that they have perpetuated which have wrecked and destroyed countless lives, of which the Paxil story is only the tiniest tip eof the iceberg (grievous and terrible though its consequences are). For them the new Pandora’s Box would be lifting lid on all the harms that have been inflicted on ordinary citizens (even on themselves and their own families). Will anybody ever be called on to answer for this? Instead, it would not surprise me if some new honour was not soon bestowed on Sir Andrew Witty to re-assure everyone that GSK lies at heart of the social and political order, and can do no wrong. Can a CH or an Earldom be far off?

    In the United States, at the moment, a Centers for Disease Control scientist, William W Thompson, is appealing to Congress to be allowed to give evidence that he and the other authors of a 2004 paper suppressed data involving two sub-groups to give the MMR vaccine a clean bill of health over autism – one was a subgroup of population (African Americans) and one was a diagnostic subgroup (isolated autism) [1]. This has be going on for over a year: the politicians are not anxious to hear it, the mainstream media (soaked in pharmaceutical advertising) are not anxious to report it (or if the do they pour ill-informed scorn), and the agencies were captured a long time ago.

    What we do not see so far with pharmaceutical industry – even where fraud and professional intimidation are by common consent exposed – are any consequences to the perpetrators. For the shareholders a fine is only a commercial risk. Suing a manufacturer is also only a theoretical possibility in the United Kingdom as things stand (and vaccine manufacturers are immunised from prosecution in the United States). When is anyone going to be sacked, or shame-facedly resign? When is anyone going to be prosecuted for state sanctioned grievous bodily harm, or mass-killing?

    [1] Kevin Barry, Vaccine Whistleblower, Exposing Autism Research Fraud at the CDC, Foreword Robert F KennedyJr, JD,LLM, Preface Dr Boyd Haley. Skyhorse 2015

    • Very precise recounting of the well trodden path that has led squarely to this horrific “Aha!” moment. It is clear that Jerome Burne is on target regarding the leaks in our “American” system of prestigious academics and regulatory agencies that are letting this scandalous BS (Paxil Study 329) pass through to greener pastures.

      I can’t argue against Burne’s trepidation over yet another made-in-America tool. This is the tool that will craft a vehicle to provide a smooth ride over the carnage of this latest episode of plundering by the monster. A covert maneuver in the guise of legislation called “The 21st Century Cures Act”, would, according to Burne’s reporting , “… severely weaken the FDA’s already ineffective regulatory scheme for medical devices.” So, obviously America is not to be counted on in the realm od prioritizing the protection of patients, when there is money to be made by getting drugs and medical devices on the market even sooner than the fast track we already have. Now America will surpass this fiasco, creating disaster making history by approaching the speed of light…and so on. He laments the effects this will have on patient safety in the UK, which is a purely rational concern. Burne instructs his fellow citizens to hang their hopes on the political leadership of a man not yet elected–, Jeremy Corbin.

      This candidate, according to Burne promotes a re-nationalization campaign, and would naturally apply much needed legislative muscle to separate the industry that makes and sells medical treatments from the process of testing them for safety and efficacy. A publicly run program to test new treatments? One that is not *yet* owned and staffed by the monster?

      Interesting to note in the comments that follow the article, a proposition made for deterring the monster’s penchant for criminal behavior. Criminal prosecution directly addresses the problem, but seems farthest from the minds of those writing out their outrage over the RIAT team article published recently by the BMJ.

      The U.S. and the U.K. are separated in a myriad of ways, but our citizens are united in their predicament, share the exact same risks of harm and a worsening fate… if this monster remains on the loose. Why, then, aren’t there signs of efforts to create a strong alliance toward a common goal that benefits all of us, such as has been demonstrated by the RIAT team? Nationalism or nationalisation rather misses the point of the findings of this global group of like minded scientists, doesn’t it?

      I think it is very difficult for anyone who holds a position that allows them to directly and immediately communicate current events to the public, to sit with and ponder the implications of the loaded history behind Paxil Study 329. This is the kind of news that could incite panic because it rips the very fabric of our security blankets. Brings too much, too close to home. We accepted that medicine/health care is a for-profit business. No longer patients, we are consumers, and as such a market. But this is, after all, a business that depends on the services of a special group, qualified by a special professional license. Won’t they always prioritize their actions around serving the best interests and protecting their patients from harmful medical practices –and a [hard to imagine] band of cold, calculating thugs that will label our casualties, “collateral damage” in the free market?
      To my recollection, it has been the group self identified as “psychiatric survivors” that has given testimony to the unfathomable — doctors exploiting vulnerable, suffering people for profit. Far short of calling them victims of crimes against humanity, the same sort of journalists who are detracting their readers from the full ramifications of the scandalous evidence brought to light by this recently published article by the BMJ, were not so long ago, minimizing all of the early warning signs shared in the personal stories of psychiatric survivors.

      So, another suggested resolution to *it*, or rather, that which cannot be named, is a means for preventing *it* from continuing to do massive harm with impunity. Round about and off in the future, and totally discounting the odds against starting up a brand new, untainted, pristine agency to police the monster, this at least follows a very descriptive narrative of *it*.

  12. I like the way this commenter speaks up…in America..

    1. bpdtransformation, B.A. on September 24, 2015 at 2:03 pm said:

    Being interested in Britain’s system of mental health provision, I took a look at some of the links.

    In this – – it says, “An estimated three quarters of people with a mental illness receive no treatment”.

    To the article’s credit, it spoke about the value of psychological therapies for “mental illness” and “symptoms”. It could indeed make a big difference if more psychotherapy were provided quickly to distressed people.

    On the other hand, this article could imply that “three quarters of people without mental illness” are not receiving medications. Since the net effect of medication use is usually negative, 75% of people not getting treated could be seen as an encouraging statistic, with less damage being done in the long term.

    Then I looked at the NICE Guidelines. Unfortunately, some of the ones about mental illness stink. Here are some highlights from:

    “Schizophrenia” –

    “In both hospital and community settings, antipsychotic drugs are the primary treatment for psychosis and schizophrenia. There is well established evidence for their efficacy in both treating acute psychotic episodes and preventing relapse over time in conjunction with psychological interventions.”

    Therefore, the primary guidelines given by the British government about treatment of psychosis are bald lies to the public…. There is not well established evidence for any of the assertions above about neuroleptics…. nor should “symptom control” or even “relapse prevention” be the primary focus of any serious long-term effort to help a psychotic person.

    So I am not sure why Kinderman suggests that NICE is commissioning interventions for which there is a “good evidence base.” Rather, it sounds like NICE has been infected by the drug companies and psychiatrists.

    To be fair, I did look at some of the other NICE guidelines, and some of the information about conditions like personality disorders and depression is less distorted and more supportive in its representations.

    But, the tinge of the disease model and distortions about efficacy of medications is still bleeding all over England’s national guidelines.

    Hopefully Britain can learn from what sounds like a more humane, open, realistic attitude prevailing in Norway.

  13. The Worlds Best Kept Secret….Study 2.31…………….for mystery guest, and, why this matters…

    Sense About Science @senseaboutsci
    Thanks @SLSingh! He’s auctioning his M-209 cipher machine (that hides secrets) to help fund #AllTrials! Please share

    ben goldacre ✔ @bengoldacre
    blimey, @SLSingh auctioning off ww2 mechanical cipher machine to fund #alltrials and @GoodThinkingSoc … Thanks!

  14. My guess is these kids were treated for *unmasked bipolar disorder* .
    The same fate may well have befallen some of the kids who dropped out of the study due to *adverse reactions*, re-classified as disqualified due to new diagnosis of bipolar disorder.

    This may sound a bit off the wall to many reading here, but the casual dismissal of adverse reactions- even suicidality following SSRI prescribing to kids, is classic “it’s the disease, not the drug” rationalizing, that boosted the “kiddie” market for mood stabilizers and atypical antipsychotic drugs.

    A similar marketing strategy is the well known ADHD misdiagnosed as bipolar–. Kids diagnosed ADHD , who were adversely reacting to stimulants were also subjected to “it’s the disease, not the drug” rationalizing prescriptions for mood stabilizers and/or atypical antipsychotics. Again, the disease, was bipolar disorder.

    I don’t think the apathetic attitudes noted particularly by those who authored and sponsored study 329, can be fully appreciated without a refresher course on the wider agenda that fueled pathologizing child and adolescent temperament differences and the reification of childhood bipolar disorder.

    I also wonder how much outrage can be generated over study 329 without debunking the sham that is the cornerstone of child adolescent psychiatry in America.

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