Restoring Study 329: Letter to BMJ Jan 2016

May, 6, 2016 | 13 Comments

Comments

  1. A couple of months ago, I was seeing Dr. David N. Hall here at Cheshire Medical Center – Dartmouth-Hitchcock-Keene(CMC/DHK)(Keene, N.H.). I asked Dr. Hall if he’d heard of “Study 329”. He hadn’t. He HAS NOW. I gave him a 3-page printout of a good over-view article on Study 329. A few days later, CMC/DHK emailed me a “termination of medical services” notice. In other words, CMC/DHK is denying me medical care, because I am an activist against MEDICAL FRAUD. It’s called “retaliation”. Spread the news – let EVERYBODY know.

  2. The silence speaks volumes! Best of all, it lets the rest of us draw whatever conclusions we like about herr non-reply. Seems to me as if Dr. Fiona Goodlee’s bread is rather thickly buttered by someone – I wonder who? – and she’d like to make sure it stays that way thank you very much! I find this behaviour – of not replying to a formal request or explanation etc. – a perfect example of bad manners which seems to be on the increase in high places. There again, if we now draw the wrong conclusions about what has gone on, then she only has herself to blame.

  3. Affectations of W1A, the Head of Values at the BBC and the Head of Better..

    a funny spoof..

    http://i.dailymail.co.uk/i/pix/2014/01/24/article-2545481-1AEC506D00000578-792_306x603.jpg

    1. Relationship with GlaxoSmithKline

    http://www.zoominfo.com/p/Elizabeth-Loder/5968676

    Consultant
    GlaxoSmithKline plc

    2. John M Loder

    https://www.linkedin.com/in/john-m-loder-1410b014

    https://www.ropesgray.com/johnloder/

    3. Published Statement

    GlaxoSmithKline’s leadership on data disclosure efforts stand out.

    Dear Fiona,

    You asked me to respond to Dr. Jureidini’s accusations of conflict of interest regarding connections to GSK. These were 1) that my hospital, Brigham and Women’s, receives research money from GSK; 2) that my husband is a partner in the law firm Ropes & Gray, which has done work for GSK and thus he profits directly from this connection; and 3) that I have made public statements favorable to GSK products.

    “The efforts of industry, too, must be acknowledged, says Loder. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out.

    http://medicalxpress.com/news/2015-07-bmj-policy-clinical-trials.html

    “Others lay at least some of the blame with the medical journals that publish drug trial data.
    In response, the BMJ has promised to devote an entire issue to the topic next year.

    BMJ Editors Dr Fiona Godlee and Dr Elizabeth Loder said: “It is time to demonstrate a shared commitment to set the record straight.”

    http://www.bbc.co.uk/news/health-11521873

    1. Elizabeth Loder, acting head of research ,
    2. Trish Groves, deputy editor and editor in chief, BMJ Open

    The efforts of industry, too, must be acknowledged, some of which caught many people by surprise. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out.6 7

    http://www.bmj.com/content/350/bmj.h2373

    Global Legal Post

    http://www.globallegalpost.com/big-stories/ropes–gray-start-work-on-gsk-investigation-42674924/

    GSK In-house Lawyer Charged by Feds

    http://amlawdaily.typepad.com/amlawdaily/2010/11/ropesgsk.html

    On the basis of this advice I therefore intend to take no further action on this matter.
    Thank you again for raising it.

    All best wishes, Fiona

  4. Con Flicks and Interest

    Then there were six……
    https://pbs.twimg.com/media/A7LxmL-CUAAJc0l.png

    Then there was one.
    https://pbs.twimg.com/media/ChmUQOeXAAAegDq.jpg

    Then
    http://www.madinamerica.com/2016/05/the-fda-is-hiding-reports-linking-psych-drugs-to-homicides/

    Doing their jobs properly would make David Healy Redundant and Study329 Irrelevant and Jon Juredini Quiet

    “Study 329 will be an object of study for years to come, and it is important that the full story be available.

    GSK ‏@GSK May 6
    .@EFPIA disclosure code means more transparency in the pharma doctor rel’ship. We’re going beyond #pharmadisclosure

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

    Repetition with Murray Stewart

    https://pbs.twimg.com/media-preview/728574326023323649/4PXXuOgU.jpg

    http://davidhealy.org/not-so-bad-pharma/

    http://davidhealy.org/not-so-bad-pharma/#comments

    “Now it is unfair to say that if Ben Goldacre didn’t exist, Andrew Witty, the CEO of GlaxoSmithKline, might have had to invent him.

  5. Medical Kidnap: Get Out of Jail Free Report

    Johanna says:
    May 10, 2016 at 7:16 pm

    http://www.huffingtonpost.co.uk/dr-aseem-malhotra/great-statin-con_b_9607316.html

    “What is most extraordinary, however is that he has referred the editor of the BMJ, Fiona Godlee to the committee on publication ethics for the journal’s handling of an article by Harvard Medical School Lecturer John Abramson that questioned the benefits of statins in a low risk population and suggested that up to 20% of patients suffer side effects. An independent panel had already unanimously ruled that the paper didn’t require his previous calls for retraction. If found guilty this could result in her being fired.

  6. Just maybe matters such as Study 329 are beginning to permeate into the broader medical profession…

    “All in the mind”, R4 this afternoon, there is an apparent crisis in UK psychiatry, with 100 senior posts presently not filled. Apparently, most doctors have no wish to sit next to a psychiatrist at a party… Sir Si was interviewed, and he said “I don’t want to sit next to a psychiatrist neither, as they just want to talk sh** “.

    His choice of final word caught me by surprise, as I thought he was about to be really honest about what his chemically-obsessed colleagues might discuss…

    Sir Si also said (optimistically) that from this year onwards, half of all medical students would have to spend time in a psychiatric environment. I’ll be platting sawdust if that results in all those empty posts being taken up…

    Walter

  7. Your comment Walter is sadly true. I have just mostly met psychiatrists in the system who just don’t get it or see it and will go on to talk a load of old rubbish.

    In fact I’ve been laughed at sneered at (very unprofessional) but I have learnt not to bite back, your only give yourself a headache.

    I once heard a hospital Dr years ago say “A lot of psychiatrists are just failed medical students that couldn’t make it in med school) so chose either psychiatry or dermatology. It’s sad comments are made like that because they should all be as good as the best Dr,s out there.

    I have met some very bad ones unfortunately and think it’s those who give the proffesion a bad name.

    The last one I saw was hissing through her teeth looking like she wanted to knock me out for saying Ssris can cause intense alcohol cravings. I wanted to explain to her but she was too angry and didn’t look like she wanted to listen so I didn’t bother.

    That is part of the problem not wanting to listen.

    • I’m interested in your comment that many psychiatrists don’t seem to listen, and some laugh at you in an unprofessional way. Also, today on the BBC Breakfast show, Mental Health First Aid programme is being taught to hairdressers so that they can listen to customers if they feel low and want help. All this is giving the impression that if you are feeling suicidal and can talk about it and be referred for professional help, it is ready and waiting out there for you. Our son died, but had been rubbished and humiliated in front of a Home Treatment team by an NHS psychiatrist who also works as a Head Trainer in NLP (neurolinguistic programming) who told him he might as well stop taking his Venlafaxine AT ONCE as he didn’t consider him to be depressed ( no suggestion of tailing it off, also advised to stop Zopliclone at once). He got terrible withdrawal symptoms, reported feeling dreadfully much worse head pain and anxiety, and was shouted at in front of the team for being attention seeking. The psychiatrist wouldn’t listen to us or him about his 11 year history of struggle with OCD and anxiety after first taking RoAccutane, the acne drug, when he was 21. The psychiatrist then put him on Olanzapine, Sertralne was added, and he experienced such voids in his thinking that he ended his life. The psychiatrist would not listen to us at all. He told our son he would probably end his life but would rather he did it in hospital than out in the community, but he was withdrawing treatment anyway ‘because he had not co-operated’, presumably because he said he felt so suicidal. So no hospital care was being offered, and in a way we were relieved because this man had been up before the GMC over safety issues and a death in his hospital some time before. We feel NLP is being used, even covertly, for a quick fix to get immediate results, which can be dire, and then when deaths occur, it is denied that it was used. You cannot suddenly stop a drug like Venlafaxine because hypnotically you feel you know best what is wrong with a patient after 2 short meetings with him, and then rubbish him for reporting feeling terrible. This man we feel should not be practising psychiatry in the NHS, or even in his several private practices. Our son explained how suicidal he felt, but was derided for it. I don’t think his experience is unique.

  8. w-n-m-f-w/

    http://1boringoldman.com/index.php/2014/09/19/weep-no-more-for-witty/

    “if you try to publish criticism of a fraudulent article, what you’re going to find is that you are certainly not getting published in one of the high-impact medical journals, like BMJ

    http://www.madinamerica.com/2016/05/researchers-deconstruct-ghostwritten-industry-trial-for-antidepressant/

    “a considerable conflict of interest when it comes to editorial decisions on critical manuscripts submitted to the journals.

    “a pilot that can’t trust the instruments on his airplane

    http://1boringoldman.com/index.php/2016/05/14/this-tawdry-era/

    ”yet the authors had one hell of a time getting it published

    “persisted until they found a journal that would accept the article as it should’ve been written.

    ………………”insure that all this dedicated work is rewarded with a wide readership, one that helps us move closer to putting this tawdry era behind us…

    w.n.m.f.w…. http://1boringoldman.com/index.php/2013/07/28/a-closing-argument/


    Johanna
    July 29, 2013 | 7:11 PM

    I ran across this joint statement on “responsible” data-sharing practices from PhRMA and its European cousin EFPIA. It is a real piece of poop, of course … we will share data only with “responsible” parties in a “responsible” format. In other words, we are committed to telling you everything we think you need to know. Trust us.

    I notice GSK is a member of both organizations. Is this GSK’s policy on data sharing as well? If so, I think it poses a real question for the AllTrials group and particularly those who have expressed enthusiasm for GSK’s data sharing initiative. (I like a number of things Ben Goldacre has done but I am really puzzled as to why he wants to “do cartwheels” over GSK’s offerings in this field so far. And I fear he and AllTrials could get manipulated into total irrelevancy, or worse, if they get too trusting.)

    So I hope they ask GSK: Are you standing behind this Orwellian piece of poop issued by your trade associations? If not, please stand up and say so. And if so, what the heck does it mean that you also “endorse” AllTrials?

    http://study329.org/wp-content/uploads/2015/01/KraustoJureidiniMay32013.pdf

    http://study329.org/correspondence-with-gsk/

  9. Ben Switching..

    http://1boringoldman.com/index.php/2016/05/15/captain-ben-and-his-crew/

    RIAT author compares COMPare to Errol Flynn..

    The BMJ/Alltrials partnership and a twelve month hurdle for Study329 to be published and then retracted

    I guess the hills of Georgia are not alive to the hills of british medical journals interests and the hills of GlaxoSmithInCline..the first pharmaceutical co to sign up as they never stop telling the world

    http://www.alltrials.net/supporters/organisations/gsk-statement/

    Q: Was RIAT a squashbuckling doddle?

    Q: Was it welcomed with Open Arms?

    Q: Was GlaxoSmithKline guilty/not guilty of suppressing data?

    Captain Blood
    Romance

    “Swashbuckling saga about a 17th Century *Irish Doctor* who’s unjustly charged with treason”

    “After he treats wounded English rebels, physician Peter Blood is arrested and sentenced to slavery in Jamaica.
    There he catches the eye of the governor’s daughter, *who buys him*.”

    Kudos where it’s due; for half a story :

    http://compare-trials.org/blog/are-your-results-unusual-or-how-often-are-outcomes-switched/

    “ You need look no further than the classic example of study 329

    “But the trial report in the academic journal

    We hope that the journals will engage, and we hope you will help us, to help them, to do the right thing!

    (Dr) Kamal Mahtani, (Dr) Ben Goldacre.

    Curiouser
    and curiouser..

  10. “Share This Story, Choose Your Platform!”

    http://www.alltrials.net/news/publishers-announce-new-way-to-link-clinical-trials-with-publications/

    Share This Story, Choose Your ….Form!

    “Dr David Healy, professor of psychiatry at the University of Bangor, and director of the patient drug safety group RxISK, says serious fluoroquinolone side-effects have been reported since they were introduced.

    ‘Their use was justified on the grounds that they were really strong antibiotics that could be reserved to treat serious infections,’ he says. ‘They were then used for everything, including trivial infections and even to prevent infections.

    ‘The problem is most members of the public regard these antibiotics as safe, and don’t connect their symptoms with them. But they’re not safe – all of them are tricky, and fluoroquinolones have the worst side-effects.’

    http://www.dailymail.co.uk/health/article-3593515/Antibiotics-got-rid-chest-infection-Jane-says-destroyed-health.html

    Data Based Medicine Retweeted

    Harlan Krumholz ‎@hmkyale

    .@US_FDA: ‘serious side effects of fluoroquinolones generally outweigh benefits’ [why did it take so long]

    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500665.htm

  11. There is without question that the advent of some drugs have liberated many from would be incarceration which is greatly appreciated. However, in the long term, it is probable that some adverse effects can be discovered and need to be dealt with honestly.
    There has been a sea change in psychiatry as a result but there still remains a huge area of misunderstanding, both by pharmaceuticals and practicing doctors. It seems to me that people don’t know whether the blurb is accurate and what is the proper dose to administer. On top of that like thalidomide the outcome of some drugs may be completely unexpected despite genuine good intentions and all the knowledge available.
    Therefore, it seems it is important for everyone to be aware of the problems in trying to modify the behaviour of the mind and emotions. Patients cannot know precisely what is happening because there are, I suggest, too many complicated feelings and symptoms.
    Things can go on for a long time before they are reported so it is difficult to pin-point the cause. Eventually, new facts and research may produce a better understanding and change accepted practice and wisdom. This can involve a long time scale in communicating this to everyone involved in prescribing and treating people who have serious mental health issues. Improvements are thus not immediate or well disseminated through medical practitioners. Therefore, it is imperative for everyone to be aware of the possibility of the need to revise possible negative outcomes and quickly react to bona fide findings. It seems there are many areas where there could be improvements in treatments if the existing shortcomings could be addressed. Clearly, despite great efforts there is much cause for being critical and a need for open mindedness. Do not spoil huge advances that have been made by trying to not have to rethink some apparent flagship enterprises. It is a complex area and it deserves maximum observation and care.

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