Study 329: 50 Shades of Gray

October, 28, 2015 | 26 Comments

Comments

  1. It’s a tangled web and shows how moderation of comments, in this case from the BMJ website, can lead to yet more questions being asked.

    Incidentally, I left a comment on the RIAT study via the BMJ website – it was never published. I was given no reason. I assumed it was because I wasn’t an ‘academic’ yet the BMJ invited me to the telephone conference with some of the RIAT authors.

    Ropes & Gray have appeared on my radar, as you say, they were hired during the recent Chinagate scandal, a scandal that saw the (ahem) mastermind of that scandal, Mark Reilly, receive a suspended prison sentence. Meantime, PI’s (hired by Glaxo) Peter Humphrey and his wife, Yu Yingzeng, were incarcerated for nigh on two years (both now released)

    It would appear that the BMJ are not being transparent here and when questioned they take the classic stance – say nothing.

    • Funny you should mention that Bob! Yes, they do publish comments from non-academics. I know because I have had two letters published, both in 2014. There were also a couple of really compelling letters published re: the Study 329 re-analysis: one from a “teenage Paxil survivor” now in her late 20’s, and one from a bereaved parent.

      However, I posted one recently in support of a study I thought made some good points: a plea/demand for raw data from a group of GPs. They’d started out with a very good straightforward question: What drugs, if any, are worth taking for people in the community with mild (not disabling) Congestive Heart Failure?

      http://www.bmj.com/content/351/bmj.h5002

      None of the published studies supporting this or that drug broke down the responses according to severity of the patient’s condition — and they could get no further data or helpful responses from any of the authors. As a result, they concluded the current official guidelines are pretty close to useless. In an earnest & wonky way they made a pretty strong statement.

      So far the BMJ has not printed ANY “rapid responses” to this excellent paper. I submitted one Saturday afternoon; it’s now Wednesday afternoon. Mine was written from the point of view of a former research subject who fully supports the sharing of raw data and thinks the concerns about my “privacy” are rubbish.

      One point I raised was to question the sincerity of Pharma spokespeople sweating over the privacy issue … and at the same time churning out studies based on private insurance data, which is the most radioactive personal data any hapless American patient can offer up! And without consent of any kind that I can see. I have to wonder if the BMJ is holding up my letter because that point makes them nervous (they have printed such studies, and really crappy ones too as David points out) … or if there are other responses even more inflammatory that they’re still dithering over?

  2. Run that past me again

    Study329 is the most important analysis as to why we swallowed it and what happened to us with it, after it, evidence of malfunctioning chemicals.

    Seroxat can be lethal, we can attest to that.

    Therefore, everything about this should be broadcast to the nation and health mags should behave themselves and respond without showing up their naivety, immaturity, senseless splitting hair mentality and realise that being a parent means being a parent and not a situation whereby GlaxoSmithKline can kill them off ad infinitum….

    Does that interest anyone, or, is this being unfair to Ropes and Gray….

    He acts with his hands…..mesmerizing (!)

    He is a ‘Man with a Plan’

    Sit thru until 32 mins for lies….data transparency..followed by China….No Seroxat for Mr. Witty from Mr. Davis

    https://www.chathamhouse.org/event/corporate-leaders-series-1

    • ANNIE>>> great link, but it got me thinking about what Witty said there at the end: “universities doesn’t publish all their failed research, nor do other scientists, but we (his beloved GSK, the allmighty transparency champion) do.”

      Did he just forget to mention that other scientists or universities does not sell the Product of their failed research?
      That a scientist that fails one experiment has to continue experimenting until he has a Discovery to show the World?
      Perhaps in the hands of a real scientist, Seroxat would’ve never left the drawing board.

      Instead they start Selling seroxat, and 25 years on trying to explain what the invention of theirs is doing to the human brain……
      And their explanation is to use rigged trials as GOOD examples.

      And it’s still up to ME to bring forward evidence that they know this is a harmful drug.
      They have all the Money, but they can’t still produce a single shred of evidence that their Product is safe, other than hoaxed scientific jibberish.
      //Ove 2015

      • Bob and Ove

        Seek and ye will find….it is mind boggling that Evan Davis, with all the publicity, failed to bring up the portfolio of psychiatric medication.

        Not only that, but, as a Newsnight Presenter, he, either, does not keep abreast of the Newspapers or he would rather keep his nose out of a possible Diplomatic Row.

        Great Blog, Bob.

        • Yes Annie – wouldn’t it be interesting to know what went on beforehand as, not only did Evan Davis not mention psychiatric meds., but neither did any of the questions! I doubt that it was a true reflection of audience participation. Maybe they’d been thoroughly checked out before entering – just incase there was a ‘conflict of interest!

  3. “…and you (bunch of troublemakers) as the paper’s authors…”.

    We will force you to tone it down, or better still just go away; but if you persist, we will have to publish it, as we cannot be seen to be scared of a very powerful corporation, even though, from then onwards, we will be changing our underwear every time the phone rings…

    The word craven springs to mind.

    Sightly off topic, from today’s Lancet Psychiatry:

    “Biomarkers are urgently needed…” (yet again, so that we can reverse-engineer them onto our DSM/ICD books of nonsense. So if you have any spare ones lying around in your garage or your shed, please give generously to these needy academic psychiatrists).

    “Development of drugs for the treatment of the clinical symptoms and cognitive deficits of schizophrenia is unsatisfactory, with many initially promising compounds not showing beneficial effects in clinical studies. Experimental model systems of schizophrenia combined with well-validated biomarkers are urgently needed to provide early indicators of effectiveness. Herein, we argue that experimentally controlled sleep deprivation represents a translational model system that can be studied in combination with neurocognitive biomarkers. Specifically, we review data on the psychotomimetic effects of sleep deprivation in healthy human beings and provide evidence of the psychosis-like deficits in translational inhibitory biomarkers—prepulse inhibition and antisaccades—that occur after sleep deprivation. These data support the use of the sleep deprivation model in combination with biomarkers with excellent psychometric properties and well-characterised neural mechanisms, such as prepulse inhibition and antisaccades, to substantially advance development of drugs with antipsychotic or pro-cognitive effects”.

    I have no idea what all of this bulls*** means, but I do know that I become intensely psychotic if I am sleep-deprived, and I suspect that I will then prepulse my inhibitions and translate my antisaccades, just like anyone else. But they won’t be trying any of their antipsychotics on me…stuff like this would be funny, if it didn’t have drug companies waiting in the wings to capitalise on it.

    I’ve just signed up for a PhD in Dan Brown literature…

    Walter

    • Jee-zus H. Christ! Yes, it’s true–sleep deprivation is a pretty damned reliable way to produce psychosis. No matter what your “biomarkers” may be. So is solitary confinement. Ain’t it great, then, that people who are susceptible to psychosis get treated with so many drugs that can cause … insomnia? (And then thrown into seclusion when they’re just too disruptive?) This is true of some of the anti-psychotics, and even more so with antidepressants.

      Actually, for those who want to study psychosis, the classic way to produce it has been with amphetamines. Ah, but now amphetamines are therapeutic aren’t they? More and more of us are born with an amphetamine deficiency! I know docs who regard the very notion of Adderall addiction as some sort of New Age alt-medicine hysteria. So even in the lab, I guess, they couldn’t bear to use a Medicine to make the subjects crazy.

  4. And just when this Little Miss Muffet was growing comfortable with the notion that BMJ was exceptional as a medical journal not corrupted by industry, along comes the spider . . .

  5. wow…

    The greedy nefarious tentacles of Bi Pharma have all but strangled the very idea of ethics out of medicine altogether…

    Big Pharma has a huge influence upon how the ethics work (or don’t work) in medicine, academia, the psychiatric profession, the regulators, universities, some patient groups, and health-care in general…

    However, dodgy though this is, and it is undoubtedly so..

    What’s even worse is- those who are under this influence are in complete denial about it..
    That’s the real danger..
    The worms in the can don’t even realize that they are the worms in a can..
    And the can is literally crawling…

  6. What is it with these People in Power – does the very post of ‘a very important person’ turn their heads so much that common decency does not apply anymore? I refer to the notion that, on receiving a letter or email that you disagree with, it’s acceptable to ignore it. Where I come from, the least you should do is reply to it. Ok, maybe the recipient won’t necessarily like the reply but getting an acknowledgement of the fact that you had written in the first place is a good feeling in itself – after all, we’re each of us allowed an opinion and have the right to express it.
    Soon after Restoring Study 329 was published, I wrote to several MPs and Lords drawing their attention to its importance etc. and wishing to know how they intended bringing the contents to the notice of the public in general. I added a paragraph about the heavy cost of medications to the NHS, the unnecessary suffering by so many people of all ages and the cost of this to the Welfare system.
    I did this because I felt a sense of duty to do so as a mark of respect to all who have suffered by the hands of the ‘big pharma’ companies and in support of those who try so hard to make things better in that field. ‘Surely’, I thought, ‘the least they can do, on receipt of their letters, is acknowledge the fact.’ Guess how many ‘acknowledgements’ or replies came? ONE – and that was from our own MP! Feeling that it’s ‘safer’ to do nothing shouldn’t be an option in my book.

  7. The *support group* for transgressors of their oath is exceedingly fascinating. Especially, I notice, in the area of secrecy, which brings in the common human dominator. Perhaps, on a purely subconscious level, the web operates as one entity that conceals the evidence of harm as an essential component for its survival.

    If such a web is obscenely wealthy, the law of attraction will supply it with enough unwitting lemmings to form the foundation for a global economy!

  8. Pharma has infected every nook and cranny of health care. From the top to the bottom it’s soiled and corrupt.
    I was sitting in a hospital waiting room not long ago waiting for my son to come out from his appointment. Waiting to see if his visual field defect had worsened. The defect that appeared on SSRIS. I was staring at a poster on the wall. It was telling patients they shouldn’t use willpower to stop smoking as they would ultimately fail. They should use drugs. At the bottom of the poster sat proudly alongside the NHS logo was the Pfizer logo. Pfizer the reason my son was in the consulting room.

    • Lisa,

      Pfizer can’t prescribe their wizbang drugs. Like many health care professionals who reach out to doctors, from the prominent academic KOLs to those in our backyards, seeking a rational strategy for reclaiming the integrity of medical practice, I receive no responses. I’m sure I am barking up the right tree. what gives?

      I am not the least bit surprised nor am I interested in the tried and true tactics of fraudulent business practices. What is alarming and deeply fascinating is the silence from what one would hope is the majority of doctors whom, one would expect, are outraged by the absence of science in their literature, and more importantly in the guidelines for treatment, that have replaced medical expertise.

      Hoping this is just the calm before the storm — and that a new day is about to dawn.

    • LISA>>> The other day I had one of my 6-months checks with my psychiatrist.
      Beneath her desk, tucked away against the wall, was a small paper bag. Like the ones you see in womens accesories stores (for make-up and whatever)
      This one was Bright White, with string handles, like woven strings.

      On the side it said: “helping brave people get braver, and well, SHIRE”

      (SHIRE, is big pharma, perhaps less known than others)

      (the quote isn’t Word for Word, but very similar)

      Could it have been a hotel-weekend?
      Fancy drinks?
      “Networking”?
      “Speeches”?
      Further education?

      Oh I wish I knew what came in that obvious giftbag!

      • Ove,

        These glamour gift bags are also given to nurses who attend “free” gourmet dinners hosted by pharma–All that is required of the nurses is submission of an evaluation form, confirming their attendance at the mini lecture given by a pharma rep. – the reward? free continuing education units ! Why would a nurse choose any other forum for professional enhancement/education?

        I can only speak for myself, as a nurse who has a fair collection of pharma souvenirs, and certificates of CEU– enough to paper the walls of a banquet hall. Something very rotten was happening to my patients (nearly all children/adolescents), and not a single MD, pharma rep. or medical management administrator invested their time and energy to get to the root of the problems–that patients exhibited–ONLY AFTER TAKING PSYCH DRUGS.

        Speaking only for myself, the only logical course was seeking information outside of the Harvard network– Between the HMS Conway Medical library and Google, I had a gold mine of info in less time than it took to force me to resign. Bob Whitaker used the Conway library, BTW– and like me, he has a *no trespass* order from HMS. (Conway, consMedical School, right next door to Boston Children’s Hospital)

        So, you see, it does not take a great deal of effort, or even an inordinate amount of education going into these matters–Seems like all that is required is CONCERN– or for me, frantic worry over something of primary importance– for me, children. Patients suffering adverse effects do this sort of sleuthing all the time–.

        So, rather than wondering what is on your psychiatrist’s pharma emblazoned glamour bag, I would worry what is in her head, and look for evidence of a conscience or a heart…

        Considering the bare minimum required of providers of cookie cutter sham medicine, — you could be daft and lazy and still make a handsome profit practicing market based medicine.

        I’d like to see the scammers having to make their full living wage off of pharmas hand outs–. I think it is a crime that the patient has to pay to be disregarded– and or waste their precious health care insurance –supporting these sloths — no matter how glamorous they look!

        • My guess is that what happens in Boston, is replicated here (small Town, nowhere, nowhere, Sweden) on a slight smaller scale.

          Of course I agree that nurses get further education, and even a gift bag to some degree, they aren’t paid good enough to start with. But Physicians are paid very well. Any influence on a physician, (GP, Psychiatrist, MD) is a bribe and fraudulent behaviour. At least there should be a fine for that.

          Well, if you have seen how the Children comes in second to the professionals careers and earnings, then I can easily see why you are so Active on this site and others.

          And perhaps info isn’t hard to come by, if you know where to look, but I feel so alone in my quest for information. To some degree it is still a daunting task for me, that I had never pictured was likely to be needed for me. I trusted my representatives and government to keep my Pharmaceuticals corruption free.

          Pharmaceuticals and what is considered good nutricious food, I thought were two areas where corruption did not occur.

          No, I won’t waste time trying to find a heart, nor her mind, of my psychiatrist. The “grin” she showed me, when I told her that tapering off Paxil was too hard for me, was enough to understand her imagined superiority….

          • Ove,

            In the field of psychiatry, I learned all I needed to know– just a bit after I really needed to know it–.

            Here’s a bit of advice from a wizard in ” HarryPotter”-

            “Never trust information you get from anything– unless you can see where it keeps it’s brain.”

            So until we know–where *they* are keeping their brains—we are pretty much on our own. And better off, I think.

            🙂 Katie

  9. Mr W (ill) Power…..nice comment, Lisa

    The Globals are Inter Twining……. ….continued execution…

    https://twitter.com/hashtag/GSKQ315?src=hash

    ben goldacre ‏@bengoldacre 14 hrs14 hours ago
    My sky broadband has gone down and… All the broadband port settings are… blank. I am a defeated nerd.

    GSK ‏@GSK 11 hrs11 hours ago
    Who says bigger is better? We’re working w/ @Pfizer to make portable mini pill-making pods that are faster & cheaper http://ow.ly/TZA5G

    http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_collaboration_with_gsk_on_next_generation_design_of_portable_continuous_miniature_and_modular_pcmm_oral_solid_dose_development_and_manufacturing_units?linkId=18339928

    • Pods | Define Pods at Dictionary.com
    dictionary.reference.com/browse/pods

    High speed air thrusts the pods from one location to the final destination, continuously giving them little bursts along the way.

  10. Patrick Vallance on ‘The life scientific’ this morning on Radio 4. ‘All Trials’ came up, and Study 329 was briefly discussed – GSK come across as humane, far-sighted, and benevolent…wow.

    But no mention of the forthcoming whitewash (oops, I meant ‘results’) of the SFO investigation into the ‘sex tape & prostitutes’ affair of GSK China.

    At the end, when Jim Al-Khalili asked him if he now missed ‘the science’, his reply was that, on the contrary, he was now ‘immersed in science’. The man seems very bright and well-educated – how can he possibly mistake something brown, sticky and very deep for ‘science’?

    Yours perplexedly,

    Walter

    • http://www.bbc.co.uk/programmes/b06mdbnq#rsn-schedules-panel

      I’ve just listened to that episode on The Life Scientific too – here’s the link, if anyone is interested.

      My guess is that Patrick Vallance is one of GSK’s new public faces: calm, reasonable and oh so reassuring. He skirted very skilfully over the matter of study 329 – either he’s always been a smooth talker or GSK has put him through some strenuous PR media skills training.

      You wonder how he can have muddled science and dog shit – I imagine the size of the salary/perks package had a lot to do with it? A fact that was missing from his description of the dinner party when GSK made him an offer he couldn’t resist….

      • And another thing – the programme byline states:

        “Patrick Vallance is something of a rare breed: a game-keeper turned poacher; an academic who’s moved over into industry”.

        When did game-keeper come to mean someone who acts as a lackey, or serf, to the poacher? Who on earth wrote this byline? Don’t they know where academics obtain their funding? After all, Patrick made a big deal about how GSK opened up the facilities at one of their labs to academics…

        Walter

  11. Great minds and all that….I was thinking about illusions of grandeur, yesterday

    Q: When did you realise that you could rise up the ranks and become a big fish?

    A: I realised I was capable of ingesting huge swathes of scientific information and that I could talk, and talk and talk without stopping…I could talk the talk well into the night, I could keep talking….I could move my arms around like a deaf interpreter…I thought I could become powerful

    Q: I have noticed that you have not a great deal of inflexion in your lengthy talks; it seems sort of flat, have you always talked with your foot turning on its edge?

    A: My foot is not really a part of who I am, my foot is like your foot, and our feet are maybe happy feet

    Q: Are you a popular sort of person?

    A: Who isn’t popular, dressing well, clean and wholesome, well educated, what’s not to like?

    Q: I suppose you won’t want to give me a scoop today and talk about Seroxat

    A: I will talk about Seroxat long into the night, I will talk about Seroxat until the cows come home, I will talk and talk and talk…my arms and hands and fingers will show you we have helped the world overcome their diseased minds….how long have your got?

    So, great piece, Johanna, on Rx, pull the old Bone a Part……..

  12. @Rooters

    “recent disappointments”

    “after past setbacks in clinical trials”

    DRUGGED UP: GSK AND….SET OUT THEIR STALLS

    https://uk.finance.yahoo.com/news/drugged-gsk-roche-sanofi-set-070001015.html

    Mr. Brand i court……” noooooo “

    Mr. Witty feted and dated in New York

    After Large Mosquito, AW, PV, SAS

    https://twitter.com/GSK

    GSK Retweeted

    Sense About Science ‏@senseaboutsci 22 hrs22 hours ago
    Clinical trial transparency important for health and the right thing to do: @GSK on @BBCRadio4 #AllTrials from 20:09 http://bbc.in/1HosAyC

    #alltrials
    Twitter
    1. 20h
    Stephanie Wykstra @Swykstr
    “Transparency is critically important for the future of human health.” Patrick Vallance on BBC #AllTrials #opendata http://bbc.in/1KWiyVC
    Retweeted by Brent Brewington

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