Pharmaceutical Rape is not a Metaphor

January, 18, 2016 | 41 Comments

Comments

  1. Hi Laurie Just confused, sorry as to the actual aim of this article. Is it for general discussion only? The first bit, jacking up prices, if you are the only producer/drug dealer/patent owner for a drug is not new, and not just Shkreli. He thankfully, just brought it some publicity. gw pharmaceuticals, sells sativex, a cannabis medicine. It is the only company legally allowed to sell this cannabis tincture, in UK. You can grow, make your own oils, more to your own tailored condition, for about $10 a month. This is illegal. You can buy same on-line good stuff,grown by other medicinal cannabis users for $50 a month………. To buy the same product, legally, ie sativex costs $1,000 a month. I call this pharma greed, and the stupidity of patents. Even drugs coming in to Australia, AIDs medication, has been seized, it costs about $50 a month from overseas “”black market””, to buy the patent stuff costs $1,000………….. who can afford this? Certainly not the sick, mostly sick due to pharma stuff ups to start with.
    As for drugs killing and maiming, allowing this is pure corruption. Study329.org showed even the most horrifically bad drugs, due to corruption, and fraud, end up with a bland “”safe and effective”” tag. And a 14 billion profit, from the outright murder…..
    Drugs such as zoloft in pregnancy, cause baby deformities, and deaths.
    I dont call this rape, I call this corruption. When these deaths are reported to places such as TGA, the reports are effectively “”binned””.
    This is out and out corruption.
    So basically there are many issues in your article, but confused what you wish to focus on?
    I dont see the value in creating new words, it is a bit like everything is a “”war”” just add, in front, drug, terrorist, muslim, religious…………. now everything is “”rape”” just add in front sexual, birth, pharmacy…………….. I do think it makes these words meaningless. Just my opinion………….

    • Agree with ang. “Rape” has become like “war against” – ubiquitous and meaningless. I know several women who have been raped, some as political prisoners in South America. Also confused as to the aim of this article.

    • I didn’t choose the picture of Shkreli, but maybe it does speak to the overall pharmaceutical rape culture. I see the jacking up of prices as a separate issue from harms to individuals and like you, Ang, I call this greed.

      I chose the word rape to describe pharmaceutical harm because of the many parallels to sexual rape; the point is not to get hung up on a word, but to look at the phenomenon. I absolutely think it is every person’s right to choose their own words, and in this case “corruption” didn’t cut it for me. The word corruption is too far removed from the victim — it seems more about money and hides the reality of the damage to individuals (at least in my view).

      The aim of the article is to provide a different framework from which to think about pharmaceutical harms. Feminists have, in years past, used other frameworks (comparisons with lynching, terrorism) to facilitate a better understanding of how rape affects individuals. To my knowledge, no one claimed this minimized the plight of people who were victims of those crimes. To the contrary, when similar issues are illuminated, they can be better understood.

    • I doubt your figures on the costs of medical grade cannabis are accurate, unless UK costs are vastly different than BC Bud, my cannabis prescription costs ~$1000 per month, assuming I could afford to get it filled, Sativex cost ~$900 per month but is covered for certain conditions here in Canada, as is cannabis to select classes of people.

    • There is an underlying unifying issue in the article that I recognize – and that is the reclaiming and voicing of the power of communication within a psuedo-culture that has been conditioned NOT to recognize it as communication – because it is already invested in issues of the denial and control of an imposed narrative upon communication, as its identity.
      I don’t feel to use the term rape in this context – but I see that the imposition or assertion of a deceit or coercive force is NOT a true willingness of communication and indicates a fear or hatred OF relationship itself.
      So the ‘power’ that is enacted on the sacrifice of relational (Life) is not true power but a deceit of un-owned fear, rage and associated sense of Life-denial.
      I agree that ‘war on is a false framing by which futility and tragedy of perpetual war is guaranteed. (to paraphrase your sentiment!).

      I feel to join with you in valuing our own individual responsibility for the language we use – so as to wake up from being conformed by it’s shifting and indeterminate usage and be definite as to what we are voicing – regardless whether we uncover new information that revises anything we have said. Then we are extending our presence rather than ‘just’ voicing opinion. There’s a different ring to presence than a presentation couched in ‘acceptable’ forms. If you don’t feel the communication of integrity when living your own – as best you have of it – then be ware! But this is not our cultural conditioning – is it! – We are generally told to ‘trust’ and conform to – and not challenge or question.

  2. Interesting.

    We then, of course, can take this a step further by throwing aiding and abetting or accessory to rape into the pot.

    To be convicted as an accessory to a crime, the person must possess an awareness of the crime, either before or after its commission. (Source – Crime Overview Aiding And Abetting Or Accessory – http://www.legalinfo.com/content/criminal-law/crime-overview-aiding-and-abetting-or-accessory.html

    MHRA, FDA, Keller, Benbow?

    I’m not suggesting that the aforementioned are guilty but it’s worth investigating, right?

    Then what of the original 329 authors – they can argue that they didn’t know (at the time) that they were being duped but now, after seeing all the new evidence, they still remain silent about the crime, save for the buck-passing of company spokespersons and Keller.

    Rape is one of those taboo words, a bit like the word ‘cunt’. A lot of people cringe upon hearing the words. Pharma won’t like having that word associated with them, neither will those mentioned above. But used in the correct context as DH seems to be doing here then we have a way to show the public that what pharma are doing is, indeed, akin to rape.

    DH is correct, “It is an offense that results in an invasive violation of bodily autonomy for the victim” – whatever way you slice it.

    Great post.

    • I completely agree with your comment that the word ‘rape’ has been ‘a taboo word’ in polite society – tending to shock upon its utterance. Surely, to awaken the general public to the dreadful goings on, the use of ‘tamer’ words would be useless. Anyone who has suffered, in the way that Joanne describes, has surely been violated to a degree that no other word should need to be considered in its stead.
      There is an awful lot in this post – have already read it through twice; maybe Laurie’s idea is to make us think broadly about these issues. Personally, I feel that maybe it’s time to share such ideas with a wider audience – the public, generally, have very little knowledge (and even less comprehension) of the ridiculous waste of human potential that happens daily in our midst. Maybe each one of us should aim to share whatever knowledge we have – whether it be personal experience or otherwise – with as many ‘untouched’ friends or neighbours as possible in the hope that, by doing so, we may prevent one more human being from becoming a severely injured individual. Like with most things, the usual feeling is ‘it could never happen to me’ – we all know how easily it can and with what devastating results.

    • “Acccessory to a crime” would thus also include the executives at Eli Lilly and Astra Zeneca (see the internal documents of each – for Zyprexa and Seroquel) who made the decisions they did to hide potentially lethal side effects.

    • Bob, very apt what you say there re “aiding and abetting…”

      The further I look into what I argue is gross over-vaccination of children (and companion animals) with a multitude of lucrative vaccine products, the more appalled I become by those who facilitate this process, and who fail to blow the whistle on this exploitation. They’re even making it compulsory now…

      The bodily autonomy of citizens, and particularly pre-citizens, i.e. children, is being captured by Big Pharma. And we are being sold right down the river by those who should protect us from abuse, i.e. the ‘doctors’, and ‘the professors’, and ‘the regulators’, and ‘our political representatives’.

      Our rights are being trashed, and we are being subjected to the ‘tyranny of experts’. This is happening in Australia right now and most people are oblivious to the threat.

      Increasing vaccination of adults is on the cards, maybe people will wake up then?

      In the meantime anyone who challenges vaccination policy is subject to attack, consider for example Judy Wilyman and her PhD thesis challenging vaccination policy in Australia: http://www.abc.net.au/news/2016-01-13/wilyman-phd/7086346

      Also see my letter to the Editor-in-Chief of The Australian newspaper (i.e. Murdoch media) on this matter: http://over-vaccination.net/

      It seems the Sciences were hijacked long ago by vested interests, perhaps the Humanities were the last bastion of academic freedom? For how much longer I wonder…

      Be warned, people who challenge the status quo are in danger, our ‘liberal democracies’ are a sham.

    • I would very much like to go after Keller, Thase, Nemeroff and a few others. I’ll take Thase, the man who put Effexor on the map, according to Dr. Carlat. He played a role in Brintellix too, and that stuff just devastates people, especially the still-sleeping who had such high hopes for it. They vomit all day and it so much at night they can’t sleep. Massive headaches and crying jags. It’s so pronounced and ubiquitous it cannot have been absent in the trials. Keller and Nemeroff trialled nefazodone, the drug so lethal that Europe banned it and the make stopped selling it in the US. FDA has no problem with it, of course. The generic is still made and you can fill a prescription for it. The physical side effects in the study I read were so numerous and God-awful it was almost ridiculous. And the whole gang was in on the Effexor maintenance studies that conflated withdrawal with relapse…

      When there are a handful a drugs and dozen studies that were handled just as fraudulently as paroxetine was, they’ll be nailed to the wall. Maybe we can’t analyze the data, but we can lobby for access to it.

  3. I often use the word “killed” when applied to my family member who is dead of the (hidden by Eli Lilly) side effects of Zyprexa (profound hyperglycemia) and occasionally use the word “murdered” – which makes clearer the premeditation involved. But “rape”? Well, why not…a twisted act no matter what name is given to it.

    The companies themselves, the FDA, and the medical profession go out of their way to avoid the truth of it, twisting words with the help of public relations experts. So I like the idea of doing the same, painting what has and continues to be done by these actors with the darkest of brushes.

    One day, perhaps, justice will be done. In the meantime keeping the pressure on by whatever means is an essential thing.

  4. The result of pharmaceutical ‘rape’ is often ECT ‘rape’ – and there is a difference – many of the forced victims go kicking and screaming.

    • Out of the two, I think I would prefer to go ‘kicking and screaming’ rather than oblivious to the possible damage the ‘kinder’ treatment offers. Transparency needs to be established as a human right in all cases. With a ‘choice’ we can choose; with only a ‘temptation to try’ we can easily be lured in the wrong direction.

  5. “We are looking for images to illustrate the series and would welcome any cartoons or other images that are germane to themes below.

    The first image here is Martin Shkreli”

    I like images and have posted quite a few over the last few years of this blog.

    Not being a clairvoyant as to the next four articles, I could proffer:

    Silent Knight – Pill Crusher

    http://cdnimages.opentip.com/full/MDL/MDL-NONSK0100.jpg

    The Doctor – Apples

    https://greenmetropolis.files.wordpress.com/2007/12/an-apple-or-four-a-day-keeps-the-doctor-away.jpg

    Practically speaking – Florence

    http://izquotes.com/quotes-pictures/quote-apprehension-uncertainty-waiting-expectation-fear-of-surprise-do-a-patient-more-harm-than-any-florence-nightingale-368197.jpg

    Only because of Germane – and, for, Bob

    http://s3.amazonaws.com/stripgenerator/strip/73/62/27/00/00/full.png

  6. Just possibly this article was too wide ranging but I was glad to be introduced to the term “tone police” although I was already too acquainted with the reality – I seem to have had a major row here with a lady called Deirdre some months ago. Admittedly, we often get pressure on the Age of Autism website to tone down references to “Nazis” or particularly the use of the word “holocaust” from our own side: sometimes the comparisons are trite but how do you convey the seriousness of what is going on when above 1 in 30 children are suffering neurological injury by iatrogenic or environmental means and the rate has been steadily increasing for 35 years or more, and we just go on making the toxic brew worse. If you sustain long term physical/mental damage from an unwarranted medication it is bullying to be told you cannot use the word rape (which historically is a word which has a complex of connotations and not just one). The volence isn’t any better for being hidden.

  7. I think this ‘pharmaceutical rape’ term is very accurate.

    “A pharmaceutical product is introduced into one’s body that causes harm — something one did not consent to — something that one had a legal right to more information about so that a different choice could have been made. Most often, it involves trusting and having that trust violated.”

    Then you have the analogy to some of the horror stories out of Africa where perpetrators having raped their victims leave them barbarically physically impaired (genital mutilated) so they can never function in this area ever again.
    Isnt this what occurs with PSSD.

    Then there was the horrific withdrawal that went on daily for 2-3 years once drug free.
    In one of my complaint letters to medical authorities 3.5 years ago i described it with this exact analogy, referring to it as being, emotionally and psychologically ‘raped’ daily.

  8. Read this (with great interest) as Laurie laying the groundwork for the posts to follow – defining and explaining the words used. I guess as a result of the furore sparked by the term ‘pharmaceutical rape’ in a previous blog?

    Problem is, ‘rape’ is such a hot word – entirely appropriate for the sense I have when I read the internal memos from Eli Lilly about the fact that olanzapine causes diabetes: they knew, I took the stuff for years, I got diabetes – and feel violated. ‘Rape’ seems completely correct. And no one has sole rights over a word – it’s not the property of victims of sexual violation.

    But – because its a highly charged word – its use can alienate people with less understanding of the issues. I wouldn’t read Breggin’s Toxic Psychiatry for years (still haven’t, for other reasons) because I didn’t see ‘psychiatry’ as inherently poisonous – it seemed far too strong a word, and put me off. ‘Rape’ is fine here, where we understand the issues but maybe we have to tread softly with those who don’t see themselves as having been raped?

    For some reason I haven’t quite worked out – I get a flavour of the problems that bedevilled the feminist movement in the 1970s (and the old Labour party). I hated ‘consciousness raising’ meetings, because there was an edge of self righteous exclusivity about them – and because they mostly turned nasty in the end. Women rounded on other women for not being sufficiently radical, daring to admit that they quite liked cooking and sex…and interminable pointless arguments about whether men could ever be victims of ‘sexism’. Activists have to be very careful to keep their own houses in order: be inclusive, respectful and open – not least, because invaluable energy gets wasted in bickering for hours over one tiny detail.

    Look forward to the next instalments.

  9. Seroxat – Never As Bad As It Looks…controversially ‘raping’ my/our/your experience?

    Image 1.

    http://www.badscience.net/2005/09/never-as-bad-as-it-looks/#more-171

    Never as bad as it looks
    September 1st, 2005 by Ben Goldacre in bad science, hate mail, letters, scare stories, statistics, times, water | 15 Comments »

    Ben Goldacre
    Thursday September 1, 2005
    The Guardian

    • “One of Britain’s most widely prescribed antidepressants has been linked to a seven-fold increase in suicide attempts.” Hold the front page! Oh hang on, it’s on the front page of the Times already. “An analysis of trials for Seroxat involving more than 1,500 patients found seven suicide attempts among those taking the drug and only one among those taking a placebo.” Step up once more Nigel Hawkes, health editor of the Times: step up here and read the academic paper. Methods section. First paragraph. “Paroxetine [Seroxat] treatment made up 190.7 patient years altogether and placebo 73.3 patient years.” The Seroxat group was almost three times as big as the placebo one. Does that make a sevenfold increase? Fingers only now, no calculators. But perhaps this was an innocent journalist, taking a press statement at its word. As a student of irrationality, Bad Science likes to study the origins of peculiar beliefs. The idea of a sevenfold increase wasn’t in the paper, because I read it. And it wasn’t in the press release (you know how we disapprove of science by press release) because I read that too. No. We can only assume Hawkes conjured it up by himself.
    • And now with great regret I must announce that Penta Water, clustered molecule kings, worthy Bad Science adversaries and originators of my second best-ever hate mail have ceased trading. From http://www.teampenta.co.uk: “Regarding future stocks of Penta Water, we have been told by the US manufacturer that no further supplies from the US will be dispatched, pending an enquiry raised by Trading Standards (Labelling and Bottled Water Regulations, 1999).” They will be missed.
    • I say second best-ever hate mail because I received another gem today. Enjoy: “Who is this smug arrogant little shit, Ben Goldarse? He has only to read the following two pages of the supplement his crap appears in to find some extremely bad science -of the stupid competing boys kind. Then there was, for example, the shameless witchhunting of Benveniste just a few years back by the science establishment mafia in France. And a closer inspection of Newton’s so-called Laws of Motion reveals they are no more than a circular self-referential description posing as an explanation. So who’s kidding who here? How about getting a grown up science writer? Nothing personal, but there’s truth and there’s lies. There’s knowing and there’s ignorance. There’s real science and there’s prejudiced dogma. From a truth-seeking scientist.” Bravo!

    http://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-3-14

    Image 2.

    http://davidhealy.org/study-329-big-risk/

  10. Rebecca Riley was the same age as my youngest daughter. My little girl trusts and relies on adults and authority figures every day of her life. I was watching her sing along to one of her favourite TV shows and it got me thinking about Rebecca and how the big people she relied on so utterly betrayed her.

    The song my daughter was singing is from a Disney show called Doc McStuffins…It goes like this.

    The Doc is in and She’ll fix you up.
    if your a toy then your in luck.
    it’s ok don’t be afraid the Doc really knows her stuff.

    Doo Doo Doo you know it’s good for you
    The doc is gonna help you feel better
    Oh Oh Oh it’s the place to go
    when you feel a little under the weather
    Let Doc McStuffins do her thing
    to get you right back in the swing
    Doc McStuffins Doc McStuffins
    Come and let the visit begin
    the doc is in.
    Doc McStuffins Doc McStuffins
    Come and let the visit begin
    the Doc is in…

    This was followed a little later in the episode by…

    Oooo

    Do what the doctor
    Do what the doctor
    Do what the doctor says

    Do what the doctor
    Do what the doctor
    Do what the doctor says

    Listen up
    Follow doctors orders

    Step right up
    We’re so ready for ya

    She’s the one
    To help you get better
    And stay that way
    If you

    Do what the doctor
    Do what the doctor
    Do what the doctor says

    Do what the doctor
    Do what the doctor
    Do what the doctor says

    Listening to my daughter singing these songs, and then reading about little Rebecca got me so angry. The contrast between these songs and the experience of this little girl was just too much to take. And I bet that so called Doctor is proud of his achievements, his social standing and his trinkets and possessions.

    What happened to that little girl is abuse of the highest order. There are no words that can properly describe it. Rape is inadequate, but not near as inadequate as ‘corruption’.

    Use whatever words you want. Whatever words you feel describe or illustrate your message best. Making people aware in as many ways as possible is what matters. New words, old words, any words, any form of communication you are capable of. If the intention behind your message is genuine, then people who genuinely listen will understand what you are saying. There is no point worrying about the others.

  11. Well, Martin Keller and the other doctors who collaborated with GSK on “Study 329” have finally come out with a rebuttal of the RIAT study! Have not had a chance to dig in yet, but look forward to a response from David & his crew.

    But I was startled by Dr. Gabrielle Carlson’s attached statement of her current conflicts of interest: participation in a Pfizer study of an undisclosed antidepressant, and a GSK study of using Lamictal to prevent relapses in bipolar disorder:

    “Stony Brook was a site in the two projects. The studies were industry-sponsored, FDA requested trials over which the company had complete control.

    We merely supplied patients.”

    It seems to have a bearing on the definition of pharmaceutical rape – and even more on the question of who is the rapist? Not to mention what’s left of medical ethics in the clinical trials biz. Dr. Carlson seems to be saying that she cooperated so completely with the drug company that she can no longer be held responsible for anything that was done, or anything that was reported afterwards. But in that case, how was she a doctor – and how was anyone in the study her “patient”?

    I fervently hope no one emerged from either study feeling like a rape survivor. But if they did, maybe we need a whole new vocabulary for Dr. Carlson’s role, and that of SUNY-Stony Brook.

  12. Language is not a fixed thing, neither are words, phrases or definitions. Language and meanings change and evolve as society and culture changes and evolves. I think that pharmaceutical ‘rape’ is the most apt phrase I have heard which applies to what happened to me and my experience of being prescribed Seroxat (Paxil). It in no way refers to ‘sexual rape’, and I don’t know why people would be offended by the phrasing and the use of the word ‘rape’ in this context. The word ‘rape’ is often used in other contexts such as the ‘rape’ of the land or the ‘rape of the Earth’- in the context of pillaging, exploitation, violation and extermination of species, etc etc.

    When you are prescribed a drug like Seroxat you’re body, mind and soul is violated. The after effects can linger psychologically for years, if not decades, or even a lifetime. This is pharmaceutical rape, no doubt about it.

  13. Very saddened and angered to hear Joanne’s story.

    Also language and metaphor, as said, is vital to the traumatised and the rendered wordless, especially to those rendered wordless at the time or in the long term by the damage…

    David Healy has provided the affected with perfect, meaningful, metaphors for the state of the present open air bedlam industry, on how serious adverse effects can be and the difficulties of a clinical setting for both patients and doctors. Along with those given by patients themselves. And I’m always impressed and edified at where words continually fail me by everyone’s comments. .

    And I’m glad, having read initial the post on ‘pharmaceutical rape’, that Laurie was not silenced or intimidated on the non metaphor. Having thought about it since, it is appropriate in its actual definition. Not to be allowed to use the word ‘rape’ (and for the potentially offended, I too know the difference in terms of how the word is more commonly used), re-trivialises, re-traumatises, reinforces the silencing. In terms of those who would castigate, it causes ‘offense’. And distracts from the actual aim.

    As mentioned by commentators on the publication of the initial post – the child who hangs themselves? The non-violent, peaceful man or woman never warned and/or unaware they are under serious threat to self who kills, or who endures monstrous thoughts of harming their loved ones. Violence done begetting physical violence.

    Although veering, perhaps dangerously, from the brilliant definition, not even in its most severe state (unimaginable), for me – younger and with no clue – there was also an ‘evil’ element or character to the anxiety and akathisia or the psychic assault. I’m sure I was not the only one, unaware of the word ‘akathasia’, under perceived/real threat and perceived persecution, who talked to ‘it’ (if not a specific he or she), asked ‘it’ to stop? Please. No consent, it was an invasive violation of bodily autonomy, almost a state of utter possession – over which the victim has no control. And is blamed on the victim and/or the victim completely blames themselves.

    (Bizarrely, in my case, after and despite a horrendous experience with Seroxat after prescription in 1997 at twenty one, in almost twenty years, not once – even after 2006 – were warnings ever given by any doctor on more SSRI prescriptions or regarding withdrawal; no recognition of the initial damage (‘Bipolar’), no support, no treatment plan, no monitoring. Tapering advice, on approx. follow up 8 drugs, was afforded only once!).

    There would be nothing but coverage of pharmaceutical harms and the public health crisis in the media if all affected patients could recognise and did report, and these reports were properly passed on. Most people also trust and depend on their doctors/psychiatrists to educate them – and to report.

    As indicated by Sally, in the dog pile knee jerk reactions, it’s may often be the case that some of those more aware, still just can’t make the mental leap – socially, culturally, or in terms of the actual prevalence of adverse effects and how severe they could be. An extraordinary leap – even for those who may have experienced milder adverse effects on the continuum. Awful when the affected, in whatever way, or when those who may suffer from depression/mental illnesses in general, rush to invalidate each other’s experiences.

    Less Jesus style, more Martin Luther King, they should be forgiven for they know not what they do. Could I have made the mental leap, imagined? I doubt it. For all I have been put through, I still couldn’t put myself in the drug induced state or, dare I say it, the mental rape of Donald Schell or young Matt Miller (or that of the pharmaceutical company and their lawyer for that matter– truly ‘subhuman’).

    Power to Laurie and all risking so much to raise awareness. An awakening was long needed – on so many levels…And though the new definition is meant to challenge the accepted societal assumptions about pharmaceutical harms, their prevalence, causes and consequences for the greater good – including the good of doctors – try telling that to your GP or psychiatrist.

    For the first time in almost twenty years I finally brought up the subject of withdrawal myself when back with a psychiatrist (and, without giving the drug low down, big brave girl, brought academic literature for discussion in case enduring withdrawal symptoms would at least be considered).

    Dismissed!

  14. Doctor Rape is Not a Metaphor……

    Re: Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. Response from the authors of the original Study 329

    18 January 2016

    Martin B Keller
    psychiatrist
    Boris Birmaher, M.D., Gabrielle A. Carlson, MD, Gregory N. Clarke, Ph.D., Graham J. Emslie, M.D., Harold Koplewicz, M.D., Stan Kutcher, M.D., Neal Ryan, M.D., William H. Sack, M.D., Michael Strober, Ph.D.
    attn: Martin B Keller, MD, 700 Butler Drive, Blumer 120, Providence, RI 02906, USA

    http://www.bmj.com/content/351/bmj.h4320/rr-27

    http://www.bmj.com/content/351/bmj.h4320/rapid-responses

    Dear Mr. Kline..

    http://2spl8q29vbqd3lm23j2qv8ck.wpengine.netdna-cdn.com/wp-content/uploads/2015/09/Paxil-Approvable.pdf

  15. Rapid-

    http://www.bmj.com/content/351/bmj.h4320/rapid-responses

    20 January 2016

    Peter Doshi
    associate editor

    Tom Jefferson
    The BMJ
    Baltimore, Maryland, USA

    Response to Keller et al. re: RIAT

    In their letter [1], Keller and co-authors of the Study 329 report published in Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001[2] challenge the validity of the 2015 re-analysis published in The BMJ by Le Noury et al. [3], in part because of “substantial problems with RIATT [sic] methodology.” Keller et al. note that the RIAT approach lacks detailed protocols or other documents explaining RIAT methodology, and consider this problematic.

    As lead and senior authors of the Restoring Invisible and Abandoned Trials (RIAT) declaration [4], we disagree with Keller et al.’s criticism, and use this opportunity to explain our position.

    RIAT is a conceptual framework for bringing corrective action to the scientific literature by publishing unpublished trials and re-publishing published-but-misreported clinical trials. The 2015 publication by Le Noury et al. used the RIAT framework to republish Study 329. The basis for this was the misreporting of the study by Keller et al. in their 2001 publication in JAACAP.[2] This publication was a key piece of evidence in the US Department of Justice criminal lawsuit against GlaxoSmithKline which ultimately settled for US $3 billion in 2012.[5] Other researchers have used the RIAT framework to publish an unpublished trial on colorectal surgery.[6,7]

    The RIAT declaration [4] outlines a number of steps that “restorative authors” (here, Le Noury et al.) should use to enable an ethical primary publication of a clinical trial. A key one is that RIAT papers must report the clinical trial according to the original protocol of the original trial. Any analyses conducted that were not pre-specified in the original protocol must be clearly marked as such. (We wrote: “RIAT analyses should follow the analyses specified in the protocol (including any specified in amendments). Any other analyses are discouraged, but if done must be clearly noted as exploratory and not prespecified. At the same time, RIAT authors may wish to critically appraise the trials they report. This can be useful, but the critique should be clearly identifiable and placed in the discussion section.”[4])
    PD served as one of the formal peer reviewers for the Le Noury paper and as far as he can tell, the authors followed this guidance.

    We and our co-authors specifically intended RIAT to be a living concept, open to suggestions for improvement. While Keller et al. express concern over a lack of “detailed methodology” for RIAT, they do not cite the RIAT declaration [4] nor mention any details of what is actually lacking in the current process. We invite them to read the RIAT declaration.
    We welcome all thoughts on how to ensure the most robust RIAT papers possible.

    Peter Doshi and Tom Jefferson

    References:

    [1] Keller M, Birmaher B, Carlson GA, Clarke GN, Emslie GJ, Koplewicz H, et al. Re: Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. Response from the authors of the original Study 329 [Internet]. 2016 [cited 2016 Jan 20]. Available from: http://www.bmj.com/content/351/bmj.h4320/rr-27

    [2] Keller MB, Ryan ND, Strober M, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 2001;40:762-72. http://www.ncbi.nlm.nih.gov/pubmed/11437014

    [3] Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. The BMJ. 2015 Sep 16;351:h4320. http://www.bmj.com/content/351/bmj.h4320

    [4] Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ 2013;346:f2865. http://www.bmj.com/cgi/doi/10.1136/bmj.f2865

    [5] Doshi P. No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility. The BMJ. 2015 Sep 16;351:h4629. http://www.bmj.com/content/351/bmj.h4629

    [6] Treasure T, Monson K, Fiorentino F, Russell C. The CEA Second-Look Trial: a randomised controlled trial of carcinoembryonic antigen prompted reoperation for recurrent colorectal cancer. BMJ Open. 2014 May 1;4(5):e004385. http://bmjopen.bmj.com/content/4/5/e004385

    [7] Treasure T, Monson K, Fiorentino F, Russell C. Operating to remove recurrent colorectal cancer: have we got it right? BMJ. 2014 May 13;348(may13 2):g2085. http://www.bmj.com/content/348/bmj.g2085

    Competing interests: We are the first and senior authors of the RIAT declaration, which was coauthored by David Healy, who is part of the group that reanalysed Study 329. PD served as one of the formal peer reviewer for the reanalysis manuscript and provided the Jureidini team with unpaid advice on the RIAT process before the paper was submitted and while it was under review. PD is also a graduate of Brown University, where Professor Keller is Professor Emeritus of Psychiatry and Human Behavior. PD initiated an inquiry in 2012 that resulted in additional information from clinical study reports of Study 329 and eight other studies being posted on GSK’s website. In addition, PD received €1500 from the European Respiratory Society in support of his travel to the society’s September 2012 annual congress in Vienna, where he gave an invited talk on oseltamivir. PD and TJ were co-recipients of a UK National Institute for Health Research grant (HTA – 10/80/01 Update and amalgamation of two Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children: http://www.nets.nihr.ac.uk/projects/hta/108001). This review relied on clinical study reports provided by GSK for zanamivir. TJ receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, Rome. TJ is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 pharmaceutical products. In 2011-2013, TJ acted as an expert witness in a litigation case related to oseltamivir phosphate; Tamiflu [Roche] and in a labour case on influenza vaccines in healthcare workers in Canada. In 1997-99 TJ acted as a consultant for Roche, in 2001-2 for GSK, and in 2003 for Sanofi-Synthelabo for pleconaril (an anti-rhinoviral, which did not get approval from the Food and Drug Administration). TJ was a consultant for IMS Health in 2013, and in 2014 was retained as a scientific adviser to a legal team acting on the drug Tamiflu (oseltamivir, Roche). In 2014-15 TJ was a member of two advisory boards for Boerhinger and is in receipt of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. TJ has a potential financial conflict of interest in the investigation of the drug oseltamivir. TJ is acting as an expert witness in a legal case involving the drug oseltamivir (Roche). TJ is a member of an Independent Data Monitoring Committee for a Sanofi Pasteur clinical trial.

  16. I would say it’s an accurate description of what I saw happen. Other words spring to mind as well when I think of what happened to my son, grevious bodily harm, assault kidnap ( of his personality ) he was mentally and physically battered by side effects and they stole him.

    • Well said Lisa! Just wondering how your son, himself, describes what he went through? Our son has recently said, more than once, “you could say that Seroxat killed me really couldn’t you?. The person I am now is not the person that I was before” – I think that says it all. Thankfully, he still has the determination to continue with different suggestions that may help to give him a ‘life’ rather than an ‘existence’ – basically, to have the energy and ‘freedom of mind’ to do more than lie on his bed.

      • As Anne said, you both sound like devoted parents.

        Your sons are very lucky in that respect. I have some experience with Seroxat but not as a child.

        Sorry to hear about your sons, one ‘stolen’ by side effects, the other ‘killed’ – I know the enormity of what they are trying to articulate and I couldn’t attempt it as an adult (or young adult) – and not for many years.

        When it came to children, no debate, on the Bill Cosby of drugs, it was pharmaceutical rape.

        Mary, I also have little memory of my time on the drug; subconscious protection or memory wipe – probably, or at least in my case (I became ‘manic’), a bit of both. I think paroxetine in itself, as far as I’ve read, could also affect memory, cognition and IQ.

        • Thanks Dee. Our son was not a child actually, he was 22. He was living independently, was engaged to be married, was completing an Advanced GNVQ in Health & Social Care, had been interviewed at Lancaster Uni. for a Social Work course. He became anxious about completing his GNVQ, went to his GP, was put on an SSRI – overdosed within 3 days, changed to another SSRI – major problem with suicidal thoughts in first few days, put on Seroxat and, as the saying goes, all hell was let loose. Suffice to say that none of us have lived through anything that comes near the ‘hell’ of his 3 months on it. Thankfully, 2 young psychiatrists at the local psych. unit saw his condition for what it was and it was removed ‘cold turkey’.
          His determination to recover is as strong today as it has ever been – we are now about 13 years down the line and the only part of his ‘old life’ that remains is the fact that he can, again, now live semi-independently. Is it any wonder that his comment describes the experience as a ‘killing’?

      • He can’t remember a lot of it. The week that led up to his arrest is still blank nearly 2 years later apart from odd little bits. He said to me that what he can remember is as if it’s a film and he knows he’s in it but he doesn’t feel it. For months he said he felt like he was a passenger in a car and someone else was driving.
        As you know he is through the worst thanks to DH and moving on with his life. Perhaps it’s best if he doesn’t remember a lot of it … I wish I didn’t.

  17. Dear Commenters

    RIAT has plenty to say about Seroxat.

    Patient Persecution, at this level, are Very Serious Offences, but, only if it is proven.

    It was like a ‘feeding frenzy’ at the zoo, spawned by the illicit and the complicit; and to think, I paid in to their salaries and pensions…

    So, what was the point of all that?

    Sons of Seroxat, if you value your life at all, get out of bed in the morning, stay out of bed without ruminating.

    Lisa and Mary, would it not be helpful to suggest your sons put a pen to keyboard and tell it for themselves so we can listen to their thoughts.

    Just a suggestion to ruminate over as you are both clearly devoted parents doing their best…..under the circumstances and not being the person you were is not such a bad thing if things didn’t go your way…..there comes a point when too much introspection becomes ‘victimhood’ and that is not something I was prepared for or wanted to be.

    Buckling under this pressure is not easy but they have the rest of their lives ahead of them and being young need to make that gigantic step and it might be cathartic for them to do so?

    What do you think?

    Are Psychiatrists and Parents too close to the problem and could someone else drop in?

  18. Annie, I take your point – what suits one doesn’t necessarily suit another though. Our son has put his story on the Rxisk discussion page; it wasn’t easy for him as he has very little memory of his time on Seroxat. Whether his lack of memory is his subconscious protecting him or that it was so traumatic that memories of the time failed to be formed, I don’t know – what I do know is that being put on all sorts of other drugs ever since has hampered rather than supported his recovery to such a degree that anything he tries, he fails at. Also unfortunate is the fact that the majority of those who have supported him over the years deny the Seroxat link – he’s been told, on one occasion, that he ‘has all the answers and just get on with it’ and another time ‘you’ve got to do it – these psychological things are just a nuisance’ – such comments are hurtful and unhelpful.
    He doesn’t pity himself in any way – his comment just states a fact as he sees it. He bears no malice towards the GP who prescribed the Seroxat nor towards anyone else involved in the chain of events during his 3 months on Seroxat.
    His choice of tech. communication is through MIND and their Ele-friends social network.
    I would agree with you that we,as parents, (we,actually, are not his birth parents – he was a foster child of ours) are quite possibly too close to the problem inasmuch as their pain has become our pain, BUT I PITY ANYONE WHO HAS HAD TO GO THROUGH THIS TYPE OF EXPERIENCE WITHOUT THE BACKUP OF CLOSE FAMILY MEMBERS.

  19. This was one of many fatal errors made by a brand new woman gp in our rural practice.

    Not only disregarding written advice by a psychiatrist, but, not asking me if we lived alone. She had never met me before and advised cold turkey with dramatic results.

    The irony – given Seroxat for an impending financial crisis, which is not a psychiatric diagnosis. An airline pilot cannot fly to work 1 ½ hours from the airport, living in the sticks, and, for a ‘temporary four years’ we jacked up our financials with an apartment nr the airport. My driving licence was intact.

    What she did after that was inhumane, cruel, nasty and worrying.

    I wasn’t totally alone. I had my nine year old whose scholastic successes were doomed from that time on.

    It was unfortunate that the gp did not ask us any personal questions whatsoever and it was unfortunate that there was no support team for us.

  20. Cutting to the Chase
    Does swallowing Seroxat make you feel like a Patient Parasite..

    https://twitter.com/hashtag/IAmAResearchParasite?src=hash&ref_src=twsrc^tfw
    http://www.alltrials.net/news/international-committee-of-medical-journal-editors-proposes-individual-patient-data-sharing/
    http://www.alltrials.net/news/british-pharmacological-society-calls-for-transparency-early-in-clinical-research/

    als
    Twitter
    1. 14h
    Sense About Science @senseaboutsci
    The @britpharmsoc calls for more trial transparency early on in clinical research http://bit.ly/1RZc1mw #AllTrials pic.twitter.com/PAEIW87pdj

    2. 17h
    David Healy @DrDavidHealy
    Drug co “summaries” may tell us less than ghostwritten articles. #ICMJE is right, #Alltrials is wrong, We need IPD. http://www.medpagetoday.com/Cardiology/CardioBrief/55761
    Retweeted by Resplendent Phoenix
    3. 15h
    David Healy @DrDavidHealy
    #IAmAResearchParasite who can’t live on drug co “summaries” as we found in #Study329. Urge #AllTrials to reconsider. http://www.alltrials.net/news/international-committee-of-medical-journal-editors-proposes-individual-patient-data-sharing/
    Retweeted by Resplendent Phoenix

    This is the new revamped Patient Information Leaflet for GSK/Seroxat.

    Reduced the stats 1: 100, 1:1000, 1:10000 and in comes much of the stuff we have been talking about..

    Last updated 3 November 2015

    https://www.medicines.org.uk/emc/medicine/2057

    ADVERSE EVENTS FROM PAEDIATRIC CLINICAL TRIALS
    The following adverse events were observed:
    Increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility. Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder. Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age.
    NO ONE SHOULD SWALLOW SEROXAT AND MOST OF THIS PIL(L) IS LIES

    What do you think?

    https://twitter.com/DrDavidHealy

  21. I have experience with both the devastating effects of Ciprofloxacin and psychiatric drugs and think “rape” is a perfect word to describe what happened to me and many, many others.

    I became psychotic after the use of Ciprofloxacin and have been forced to use psychiatric medication that ruined my life, my body, my brain, my soul. I was first given harmful medication without any warning or informed consent. When this medication caused psychosis I was – without having harmed anyone – violently locked up, undressed and forced on the ground, were they repeatedly put a needle in me with highly toxic, brain damaging chemicals. These chemicals made my life so bad that I want to be dead every single day. How exactly is this not comparable to rape? They violated my body and my soul.

    Not only was this rape. It was extremely organized, premeditated rape that is covered up by people in high places. People knew exactly the damage these drugs did and did not care about their victims.

  22. If you’re going to use the word “rape”, the first situation you have to talk about is forced injection. That is, literally, a rape-like situation, involving direct violence and bodily violation. After “pharmaceutical rape” is widely applied to mean psychiatric injection, you can start to argue the case for putting the lack of informed consent into the same category.

    Don’t perpetuate the myth that people only take psych drugs because they’ve been convinced to do so, that we are all “good patients”. That pushes the issue of violent injection under the rug. It defuses the power of using the word “rape”.

    “Rape” is a one-time event with long-term emotional consequences. Taking health-destroying drugs is a long-term process. Perhaps the relationship that spawns it is coercive, but it is not the same as having orderlies hold you down so a nurse can shove a needle in your buttock. Bad, yes, but not the same.

  23. I agree that the kind of forced treatment you describe is an awful violation of bodily integrity, but I do not agree that it is primary to any definition of pharmaceutical rape. Because extreme violence often dominates any discussion of rape, people generally fail to recognize the seriousness of rapes that seem milder in comparison. I intentionally made a distinction between the violence of forced treatment and the non-consent inherent in all pharmaceutical rape. Pharmaceutical rape can occur along with this one psychiatric practice, but ultimately it encompasses much more.

  24. I have been educating myself in bridging issues of integrity in observed consciousness (the only one I have 😉 with reflections in our world – of collective consciousness. There are many destructive and deceitful arenas active within a cultivated normalcy of social invisibility that include medicalisation of our consciousness, of our body; our biology – including toxic exposures and bio-technological interventions to our environment – that themselves are symptomatic of a corruption of the currency of our thinking – such that a pervasive ‘institutional’ disease embodies a distorted human consciousness – socially and culturally disposed to deny and hide the true power of communication – such that any movement to embody or give witness to a true communication – in feeling and form – will not only meet suppression but which has a conditioned inhibition against being spoken or heard.
    I appreciate this article. I support THAT we feel outrage where it is sane and healthy to feel it – and that use this to find communication rather than be baited or triggered into conditioned reaction – which is easily manipulated and used against us.
    Trust has been established with regard to a scientific and medical establishment by which we abnegate our responsibility – our voice – our consciousness of discernment – for external ‘authorities’ who likewise are conditioned to follow edicts coming from what is effectively a closed cabal of private interests that hide within our wishful worship of science as saviour, like Trojans in a wooden horse. Not that integrity in consciousness is anything but scientific in its willingness for uncovering and sharing fresh perspectives within the already true – but that dis-integrity of consciousness operates a segregative mentality – that is in a sense – held private or masked from open communication so as to engage in power over upon what would otherwise be relationship. Fantasy personae act out unconscious or denied fear and rage – with al the force of such denials.
    Sooner or later, if we value consciousness of shared and felt existence, the unseen role of denial has to be addressed and I believe that addressing it politically, socially and individually is one purpose – but that to only address the external symptoms is yet to be diverted from an inner recognition of our re-integrative sanity by a hate hidden in righteousness.
    The corruption of consciousness could be summarized as hate, justified and hidden beneath the masking appearance of righteousness. There is nothing new about the mind’s capacity to deceive. But Culture in its true sense is our sense of worth and purpose embodied – and this is always something to rediscover anew – or else we fall asleep in forms and appearances that invite and are open to ‘other’ purposes of ungrounded and un-relational fantasy to usurp.
    I didn’t know what I would write in joining with this article in spirit – but I share a willingness to find Voice – to find ways of communicating, owning and addressing, that which a loveless and dysfunctional definition of ourselves gives rise to. This calls for a pause from what and who and where our current sense of ourself operates from. For listening within rather than reaction. Perhaps only the revealing or revisiting of traumatic imprinting will allow this willingness to listen – for who ‘already knows’ has no need to listen – and so operate a mind they think their own – and yet is it their consciousness of presence or is it the mask of adaptation to a ‘loveless and fearful world’?

  25. I could not think of a better way to describe the attitude. It is indeed pharmaceutical rape. I’m a man, you’re a woman, I decide what is best for you. I’m a doctor, you’re a patient. This is the exact attitude of any GP, psychiatrist I have seen and also being told there is something wrong with me for not accepting this. Blamed for the abuse which I have had to endure by the medical profession. Yet told that this is ok and that time will heal any wound. Abuse by abuse. Olanzapine, take this! The more the better- it will numb you, you will cry. You will be my victim and you will have to come back to me for more help if you need to come off it one day.

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