Study 329: The Data

September, 12, 2015 | 11 Comments


  1. David,

    re: ” Appendix H contains the individual patient level data in the form of Clinical / Case Report Forms (CRFs).”

    Are there sign off notations on each of these CRFs? Is the credential of each reporter known?

    What is the level of expertise required by the reporter who reviewed and evaluated the significance of the adverse effects recorded in Appendix H?

    The “periscope” you describe as the remote access portal to Appendix H bears a strong resemblance to the restricted access policies imposed by the Juvenile Court here in Boston, with regard to medical records, secured by court order at the request of attorneys representing the family of a young patient who had been declared a “ward of the state,”
    Attorneys can view the records in a monitored room in the court house for a prescribed period of time. Attorneys are allowed only legal pads and pens– no electronic devices, for making notations. To further impede this vital process, it is common practice for the medical records to be shuffled out of sequence, then stuffed into as many uncoded boxes as needed to contain up to a year’s worth of medical records. Apparently, there is no law, or established legal guidelines that prohibit such blatant attempts to impede the review process of confidential documents. Institutions who are under scrutiny must take a certain amount of delight in knowing everything == literally everything they can get away with!

  2. The”” here “” links are not working at my end……
    Amazing the lengths they will go to to hide the truth, I wonder how many documents have been rewritten, before being supplied?

  3. It will be very interesting to see this..

    If GSK’s periscope is their idea of transparency, then surely they should go back to the drawing board with Ben Goldacre and Alltrials?..

    Transparency is supposed to give easy access to information not obstruct it..

    Well done on managing to achieve a re-interpretation of this Paxil (Seroxat) study despite these major road blocks…

  4. Well done David for cutting through the lies, somehow the word lies feels impudent,it doesn’t cover the magnitude of what is being done.
    Can anyone tell me if Stewart Hosie MP is worth going to with a claim just asking on behalf of a good friend.


  5. Yeah, all this is very positive, and by the sound of it it will show pretty much the opposite of the original publication.

    Now I wish for some unity.
    Unity behind this team of Healy, Nardo, le Noury and the others.

    From who? Well, anyone who wants future (and past) studies to have access to the full raw data.

    Let academics argue over conclusions made from raw data, not over marketing-spun Words in “abstracts” or “conclusions”.

    And if something isn’t “safe and efficacious”, do not ever bring it Close to any human recipent!

  6. Thank you and your colleagues’ for your relentless pursuit of the whole truth. If this was the way Paxil clinical trial outcomes were handled in the past, was that what gave drug companies tacit approval (freedom from repercussions) to put other similar iterations of these drugs on the market? Is there no end to this? No day of reckoning? No way to compensate people for their destroyed lives? Why is Effexor still on the market? Why is Abilify marketed as a booster drug when the never, ever to begin with antidepressants’ ability to deaden emotions would wear off? Why, why, why?

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