Study 329: By the Standards of the Time

October, 7, 2015 | 25 Comments


  1. Just so hard to read, so upsetting. We are mere souls to make money from… We are not treated as people, just revenue raising.
    Thank you so, so much for Since its release, there is now an Australian lawyer willing to help…. before, there was no help for any of this, no lawyers would even try.
    So I thank you all, keep battling that disorder called Pharmaceutical Corruption and Greed Disorder….. so that so many of us, may never ever, have our lives, or our childrens lives, destroyed because of it.

  2. Excellent article and yet another example of my reasons for throwing out “evidence-based medicine.” It’s not only in psychiatry that we have no valid evidence. There seems to be a trend perhaps initiated by such events as 329 etc. to be, at the very least, careless about the demands of research.
    What about the studies that produce vital but “negative” results? My own experience with this phenomenon occurred in the late 80s. The teaching hospital in which I worked was one site for a double blind study of an antipsychotic from Sweden that was supposed to be better than Haldol and have fewer adverse effects. We were to obtain 30 elderly patients, currently on Haldol, put them through a washout and then enter them into the drug/placebo study. We had 18 months in which to do this. The study went nowhere because every single patient, washed out from Haldol, improved dramatically. That should have been published.
    My experience as a whistleblower, I must confess, made me, for a time, reluctant to say anything about fraudulent research. One’s life can be made an utter misery. The need for exposure, thank goodness, eventually overcomes the need for self preservation, at least in some.

    • Spoken like a geriatrician–a specialty developed from the experience that so many elders are overmedicated with complex regimens that are completely without systematic rationale management. Kudos!

  3. Anyone believe this?

    “New unconventional sources of data are changing the way pharmaceutical companies research and market their products, industry insiders reported here at the Health 2.0 Fall Conference 2015.

    One year of social media postings yields more information on adverse events than the entire US Food and Drug Administration (FDA) database, said Greg Powell, director of the GlaxoSmithKline global safety program.

    “People are posting information about our products,” Powell said. “Should we listen? Of course.”

    That formation overhead is a flight of pigs.

    • I believe they are watching social media closely, formally and informally.

      My blog post about Noven, which makes 5 drugs (all with black box warnings, and none for anything life-threatening, caught on in Orlando and Miami, where Noven has facilities. I don’t know what they could do in response other than hang it up, go to confession and devote themselves to good works.

      But I don’t know that they’ll use the data for patient benefit.

  4. Excellent and so disturbing.
    This work, as all of the work connected to the “revisions” of Study 329, deserves an international and distinguished award – everyone connected to it so dedicated, honest, ethical.
    Thank you.
    I remember reading that the “clinical trial” that got Zyprexa approved for children was done on a handful of children in Russia.
    Just horrifying.

  5. Even if those academics who put their name to the original Study 329 paper in 2001 really believe that they were just doing what everyone else in their field were doing at the time, this doesn’t justify no apology or no retraction. The facts are- kids were harmed because of the promotion of Seroxat/Paxil off the backs of this study. The ‘everyone else was doing it’ argument just doesn’t wash with me…

  6. Somehow I would suspect this to be the case with research that originates out of america. The finance and handing out funds to researchers who are known beforehand to be “favorable” and “willing” to achieve the obvious goals. That pretty much sums up my preconsieved idea of what modern U.S. commercialism is all about.

    But when this is used as a step to have this drug approved all over the World, then I become less understanding of its obvious flaws.

    Most of us outside america have bought in to the idea of the “land of hope and Dreams”.
    I even thought that the american judicial system with Product liability suits kept us safe over here in europe. But thats not the case. And even worse, we trust the americans, “the good guys”, in almost all areas of modern society.

    But the article above, becomes to me, just an example of how it’s “OK” in america to do business with economical motives at the expense of human suffering.

    Where is the Jonas Salk-type of doctor, risking almost his own Life to find an anti-depressant, an anti-depressant that actually relieves people from anxiety and depression, and with very few and ACCEPTABLE side-effects?

    I’m not naive enough to Think I could find such doctor, but could atleast some of the researcher show some empathic and compassionate sides to their fellow humans?

  7. Thanks Johanna, the research must have taken hours and hours of your time. Can’t say I’m happy after reading it but truly appreciate your thoroughness and easy writing style. As for Study 329 not doing very much wrong by the standards of the time – maybe they should look at what is now happening, in the UK, to individuals who thought that their behaviour wasn’t very wrong ‘by the standards of the time’ as far as respecting children is concerned! To me, ‘evil’ has always been ‘evil’ irrespective of time; being caught out does not increase the intensity one iota.

  8. Is there a prize that we can nominate you for? Great exposition of the seamy underside of the clinical trials industry!

  9. Great high standards of reporting, Johanna.

    By the Standards of the Time is such an appropriate title for your piece/peace..

    Whether the Standards of that Time is the get out clause of today; and we all have to be sycophantic, is another matter, where Sir Andrew said on his piece in the FT, video, on Minions, ending with:

    “Its not like you have been hired as a mercenary or a hired gun…you grew up with it”

    FT: “Andrew, thanks very much”

    I thought that was such an interesting voluntary use of words, as, no one had accused him of being a mercenary….if I had said something like that to a psychiatrist, it could have landed me in hot water..

    It seems that summarising your research, we have limitless bodies who are mercenary, whose only raison d’être
    is to push the boundaries of acceptance and for who’s good?

    I suppose, in the end, it depends on the scale of the fallout and who is counting the bodies?

    Thank you, Johanna.

  10. Some really highly relevant (and pretty shocking) news, courtesy of Carl Elliott and Leigh Turner, the two Minnesota professors largely responsible for getting to the bottom of Dan Markingson’s death:

    The Univ. of Minnesota has just announced a new policy: It will prohibit recruiting patients into research studies while they are on involuntary 72-hour holds. This is how Markingson ended up in the study that cost him his life. The U. is quite proud of this policy apparently, describing it as going “above and beyond.”

    However, they’ve refused calls to reveal how many patients have been recruited in this way, or to answer other questions about their psych research. In one case that came to light last year, a man alleged he was told he could get his substantial hospital bill written off if he entered a drug study.

    If a big university psych department felt free to engage in this conduct until just recently, I don’t like to think what’s going on at the private behavioral-health enterprises …

    • I was flabbergasted at that UM announcement–not that they were stopping, but that they had been doing it at all.

      Your article above it what the other commentors say it is, by the way. Excellent and worth prizes.

  11. “Modern psychiatry is suffering a moral decline under the psycho-pharmceutical complex.”
    Breggin 1991, Toxic Psychiatry p 382.

    Not a lot has changed really. Its the same old same old.

    I feel like i have just been given a tour of the inner workings of an organized crime syndicate or terrorist group creating horror stories.
    Then i pinch myself and i remember that these are people who have promised to;
    First do no harm!

    I’m sure Pinel would turn in his grave if he read this.

    Here is the most ridiculously, comically, outrageously, unbelievable thing i have heard all year!
    ” Our lead author, Dr. Gary Sachs, reported no drug-company research funding in 2014, and a mere $4,713.20 in personal payments! ”
    Sachs you don’t moonlight as a stand-up comedian as well do you?
    No Nothing to declare !………..Gary let me remind you … you are not working at the airport!

    • Yes, let some American journalist dig some in this dr. Sachs’s finances.
      Perhaps we would find a fancy house, car, boat???
      Maybe there are “uncertainties” to “what” have financed them?
      Order some prints from IRS, if you could do that in America, we can here..
      Any Citizen in Sweden can look at the earnings from any other Swedish Citizen at least 5 years back.

      If he is supposed to be without financial ties, then he surely would hand out proof without a hassle?

  12. Great sleuthing, Johanna and timely , too.

    I wonder how much longer it will take the medical community to attempt to reclaim some of its integrity. –Hope it is before RCT data is completely fabricated, which, of course has always been within the realm of possibility–

    Promises, promises— those who are suffering the most, need to demand accountability. I rather hope doctors will lead the way on this–

  13. I have A funeral to go to. I have to go as its my step son. But ang wrote first comment.. about having a lawyer in AUSTRALIA I would like to know who that Lawyer is as I’m loosing my life to antidepressants as are some friends of mine including my son…. Thankyou for this wonderful article….I had many suicide attempts on Paxil..I.was out of my mind driven to drink….and tried to kill my Amazing partner….I’m surprised my son and Partner survived this. If it wasn’t for
    David Healy I would be a lost loner There is more but another Time would be more appropriate
    Thankyou once again. Mrs K J Powell .

  14. Tie this article together with what 1BOM writes on one of his lates post, how american psychiatry recruits patients to “voluntarily” join pharma-trials, while hospitalized!!!

    How should psychiatry, as a whole, distance itself from the “abuse” of old? When they to this day exploits fellow humans in the absolute worst imaginary scenario: when your mind is failing you and you seek help for it!

    I was never one of the “bullies” at school, but I was a part of the “don’t-try-to-mess-with-the-sports-Jocks-types”. And at times I was rough/tough towards people.
    But there was ONE thing I NEVER was: and that was to be in any way abusive towards any other person who could not fend for themselves!

    The psychiatrists 1BOM and Joahanna Ryan talks about here are doing just that. They gamble with that the patients won’t get any problem from the untried drug, and that they just fit like a pawn in their own scheme to find subjects to try a chemical onto.

    I mean: if a healthy, never had Medical problems type of human, volunteers for a drug trial is one thing. But if you are suffering from schizophrenia, mania, delusion and generally aren’t in any good ‘contact’ with your ‘inner self’, and seek Medical attention for such issues. Then the Medical authority, doctor, psychiatrist, professor must be absulutely flawless when his decisions almost “rule over” his patients ability to judge for himself.

    It is, without a doubt, one of the worst scenarios of ABUSE!
    Call it abuse of Power or abuse of “percieved authority” or whatever.

    Makes me Think of song lyrics:

    “Is this the best way we can grow our orchards, is this the best way we can grow our good fruits? To fall like dry leaves and rot on the top soil and be called by no name except Deportees”

    We aren’t treating fellow men very good nowadays either.

  15. Something unsettling…?

    • Sense About Science @senseaboutsci

    New head of FDA Robert Callif supports trial transparency. Companies hiding results face big fines soon… #AllTrials

    Retweeted by Shannon Brownlee

    Why Robert Califf Deserves to be FDA Commissioner – US News

    One take on why the cardiologist’s nomination spells good things for your health.
    U.S. News @usnews

    Sense About Science @senseaboutsci

    New head of FDA Robert Callif supports trial transparency. Companies hiding results face big fines soon… #AllTrials

    Retweeted by pharmagossip

    One comment……J:)

  16. OH fa’Chrissake! Can anybody really be that dumb?

    It’s not for nothing that Robert Califf has been called the “ultimate industry insider.” He spent his years at Duke building up the Duke Clinical Research Institute — a godawful hybrid thing, a Contract Research Organization grafted onto the body of a university. It played host to a huge scandal around fraudulent cancer research of the “personalized medicine” variety during his time too. Califf was not implicated in that scandal, but he sure as hell was not implicated in doing anything about it either.

    Well Sen. Bernie Sanders is not a revolutionary, and he’s not a science expert either — his view of Pharma is pretty much restricted to being scandalized at their price-gouging. But he has more sense on the issue than “Sense about Science USA”

    Bernie Sanders ‏@SenSanders 16h16 hours ago

    NEWS: Citing FDA Nominee’s Ties to Rx Industry, Sanders to Oppose New Commissioner

  17. Johanna….it is difficult to place loyalty to patients…it is difficult to place loyalty to Zen Goalacre…why?

    He sits at home playing with his Smart phone….why?

    ✔ @bengoldacre
    Amazing. @GSK support #AllTrials Amazing. Fantastic. Historic.
    Ash Paul @pash22

    @bengoldacre @GSK @trishgreenhalgh Well done Ben. As a demonstration & measure of goodwill, will they now retract their Paxil Study no 329?
    3:34 PM – 6 Feb 2013

    Jorge Ramirez @Jor_H_R

    @Firefly_fan @DrDavidHealy Yes indeed. … – #AllTrials -> What about retractions? (e.g. Study 329)
    Retweeted by wilma miles

  18. I am truly shocked but not at all surprised. Isn’t drug research and development really for the benefit of shareholders who will plough more dosh into the machine to enable more profits to generate more shareholders, dosh etc etc? Client/patient benefit is a mere side effect!

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