Welcome to Troy

April, 8, 2014 | 9 Comments


  1. I’m a bit confused. Does AbbVie’s agreement to withdraw the lawsuit itself contain a Trojan horse? If so, what is the exact nature of the beast they are smuggling in? AbbVie itself has put out a press release making a claim something like this … “we weren’t defeated, we simply negotiated a satisfactory settlement.” Apparently the EMA did agree to redact a few bits of those controversial study reports before releasing them. However, the EMA has flatly rejected this idea of a “settlement”, saying the redactions were minimal. My impression was that AbbVie was just doing what all corporations do when they lose in court – spin it so it looks like they got what they wanted, for a reasonable price. But maybe they took more ground than I realize?

    Or are you just saying, like Malcolm X, that we can’t chase away the wolf howling at the front door, only to let the fox sneak in the back door? (To Malcolm the wolf was the reactionary politicians in DC, and the fox was their so-called liberal colleagues. In this case, AbbVie has been playing the wolf while the leading fox is GSK with its “responsible data sharing” schemes.)

    In that case, let’s be on guard – but those who are celebrating are not necessarily fools. We won one battle – just one, and probably not the Big One – in a long war. But I can’t see that we’d have been better off if we had just let AbbVie gobble up whatever it wanted.

  2. I missed any mention of the recent announcement in the New York Times by Dr. Harlan M. Krumholz: “LAST week, Johnson & Johnson announced that it was making all of its clinical trial data available to scientists around the world. It has hired my group, Yale University Open Data Access Project, or YODA, to fully oversee the release of the data.” It is not clear whether the raw data of all J&J clinical trials will be made available. Will they be? Or will they be subject to the kind of restricted access that you describe in this post about the GSK “release of data”?

  3. I have struggled a bit with this. I was celebrating AllTrials and Goldacres Bad Pharma as significant moves in the right direction. I never really understood how any of this could be a bad thing when it comes to the safety of our medicines. And a year ago I would have been celebrating the AbbVie outcome too. But that has changed now and I realise my support for all trials was for my own selfish reasons.

    I was sick of being called a conspiracy theorist, stupid, paranoid and all the rest. All trials and Bad Pharma made my views more mainstream, which helped me a lot with my family, friends and colleagues. All of a sudden I wasn’t nuts in their eyes, I was ahead of the game. It also helped when I next visited my Doctor, as the facts I put to her some 4 years previous (facts she denied) were now out in the open and appeared to be widely accepted.

    But now the whole thing just seems like a case of history repeating. A way of reinforcing or reinvigorating the role of RCTs in decision making, keeping control firmly in the hands of the people who have enough money to run these trials. All these public cases are being used to appease the growing body of dissenters while simultaneously ensuring that industry keep control over the all important data. Meanwhile the position of RCT’s being the gold standard of evidence gets a massive boost with all the new transparency going about. Sorted!

    I see the whole pharma transparency play as similar to what’s happening with the long awaited report on Iraq in the UK. Why is Tony Blair so eager to see a report that should be damning of his actions? That might be because the report keeps the real information secret, with only this independent panel being able to see it on our behalf. They will no doubt water that down for the public so it causes no more than a bit of mild outrage, and we all go away happy thinking the truth is out. Our government was a little bit naughty but no more than that. Nothing criminal. Job done, move along please, nothing more to see here.

    My take on this whole transparency situation is a little more ‘Hero’ than Trojan Horse. As in the 2002 film with Jet Li. With Big Pharma as the Qin Dynasty, Andrew Witty as King Qin Shi Huang, Goldacre and all trials as the Namesless warrior and the BMJ, Cochrane and the EMA as the assassins Long Sky, Snow and Sword.

    The question is, was the nameless warrior a genuine assassin intent on revenge for the other territories of China, who in the end was convinced by the wise King Qin that uniting under Qin was best for everyone and would bring peace and prosperity to all the land? Or was the namesless warrior part of the Qin establishment from the beginning and just played his part an ingenious plot to bring down the dangerous assassins and crush the dissent once and for all?

    Is Ben Goldacre the modern version of this story – is our hero a hero?

    • AllTrials have done a huge amount to bring these issues to wider awareness and this is wonderful But now is the time of greatest peril. Having done so much good, is there a risk of being outmaneuvered by GSK and other companies. It would be more reassuring to feel that Alltrials were aware of this risk.

      In the story Hero – the protagonist is a Hero one way or the other. Not such a good story for Naivety to land us all in a mess.

  4. It appears that the drug companies have had the luxury of distorting clinical trial data for such a long time that they think it’s a right guaranteed in the Magna Carta. One can’t help but conclude that AbbVie withdrew their suit after extracting this agreement with the EMA to keep Clinical Trial data in the fog. And the only reason to do that is to be able to continue to distort it ad infinitum…

  5. Dear Dr. Healy,

    – About Humira: https://www.psoriasis.com/ – “Get the right dermatologist”
    Re: here is data – (anyone can look and see) – undisclosed liaisons between industry (pharmacological & non-pharmacological technologies) and specific medical professions and careers (e.g., click URL below).


    There are other types of data (i.e., we can look and see)

    The number of unpublished trials is larger than 50% in most of my estimates (ClinicalTrials.gov & WHO ICTRP) – raw data is available for independent scrutiny (anyone can look and see, and perform corroborative analysis).


    The exact percentage it’s also uncertain.

    – “around half” is probably underestimation according to data:
    Tamsulosin >75% unpublished
    Dabigatran >80% unpublished
    Agomelatine >80% unpublished
    Liraglutide: 68.5% – three times as likely to be disseminated (3.1 to be specific) & sample sizes doesn’t make any sense.

    But one thing I am almost certain: it is above 50% of unpublished trials.

    We can actually look and see deep inside some clinical trial registries (e.g., RE-LY clinical trial – JUPITER trial with rosuvastatin – antidepressants).

    Probably (almost certain about this) the terms “drug regulatory agencies” (e.g., INVIMA – Colombia) and some centers for the evaluation of healthcare technologies (e.g., IETS – Colombia) are a euphemism.

    “self-regulation is a myth not likely to be realized outside utopia” – Dr. Charles D. May, 1961.

    Probably (almost certain about this too) the real regulators are those who expose practices of the wrongdoings and do it despite the potential consequences of facing attacks aimed to suppress ideas threatening vested interests.


    Jorge R.

    P.S. I read with interest the title of your post “Welcome to Troy”, I say: welcome to chaos (there are other types of data).



    • Jorge

      Many thanks for this – I hope many will explore these links and would encourage you to add them as a comment to another more recent post also just to increase the chances of people becoming aware of them.

      The only point I’m confused about is the access to data point – there is no access to clinical trial data. Published articles represent something about the data but without access to the data and in the case of the SSRIs and suicide in children the published claims were diametrically opposite to what the data showed.


  6. Dear David,

    Thank you too, for all of your writings, as well as for replying to my comment.

    Regarding the question of clinical trial data access:

    Clinical trial data have variable levels of accessibility:

    – Study results (but not their raw data – data of industry-sponsored studies is not open at all: it’s locked up behind a lot of bureaucratic requirements and excuses).
    – Historical changes in the study registry.
    – Publications (sometimes interesting things can be found comparing their results and methods).
    – Competing interests of authors.
    – Other possibilities…

    It mainly depends on the condition and the intervention.

    For example,

    1. Antidepressants and suicide in children.

    A. ClinicalTrials.gov = 10 studies with results (outcome: suicide; intervention: antidepressants; age group: children) – the results of these studies can be also downloaded (*.xml).

    We can look and see – data can be also matched with the results of publications – inconsistencies can be documented.


    Database: https://docs.google.com/spreadsheets/d/13qRAv_QaJTYWQFYWoThO1AQwZMlyIuAI8qvrjg7yny4/edit#gid=2033799350

    Largest patient enrollment (n=2272): NCT00605865 – observational – sertraline – unpublished.

    Completed suicide † 1
    # participants affected / at risk 1/2157 (0.05%)

    “Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

    Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.”

    Study results (NCT00605865) database – please look and see.

    URL: https://clinicaltrials.gov/ct2/show/NCT00605865
    Database: results can be downloaded and archived in a database
    Study History: https://clinicaltrials.gov/archive/NCT00605865
    PubMed matches = zero – http://www.ncbi.nlm.nih.gov/pubmed/?term=NCT00605865
    Google Scholar matches = zero — https://scholar.google.com.co/scholar?hl=en&q=NCT00605865&btnG=&lr=lang_en&as_sdt=1%2C5&as_sdtp=


    – We can see on “the surface” but depth scrutiny is not possible because patient anonymized raw data is not available – I believe that the BMJ Open Data campaign is more coherent in that aspect than AllTrials – but both (I think) are mistakenly relying on clinical trials as the best level of evidence that we can get.

    – I believe (almost certain about this – I am working on the paper for peer-review) that clinical trials are not the highest level of evidence.



    – Other sources of data are also very valuable (e.g., I used the data of quetiapine on RxISK.org in this post – quetiapine / Mark Markingson case – URL below)


    – It’s possible to get some valuable information scrutinizing all of the remaining nine studies (antidepressants, children, suicide, available results) and comparing their data with those of the publications or documents reviewed by drug regulatory agencies (e.g., FDA and EMA).

    B. We can look – but we cannot see:

    Two (n=2) studies without results:


    C. There is still pending to take a look to WHO ICTRP (more data there – as well in the individual registries – eg. EudraCT).

    D. It’s like being a little more certain about the uncertainties related to unpublished studies of clinical trials (I also believe that data of observational studies and reports of adverse events – pharmacovigilance – could be equally important to trials). Nonetheless, it’s impossible to know all the hidden data (trials, observational studies, and pharmacovigilance reports) there is evidence of studies unregistered but published (violating the requirements of the ICJME) – http://www.bmj.com/content/348/bmj.g1888/rr/762419

    but the question should be: what about unregistered and unpublished studies?
    It’s like we cannot look and neither see – it’s like the dark matter in the space.

    Finally, it’s also possible analyze the quality of reporting of these studies, using criteria such as the CONSORT for trials or the STROBE for observational studies, this information could be also very valuable.

    I am aware of the Maudsley debate about psychiatric drugs, unfortunately, I cannot be there physically (but hopefully I will be there virtually) http://www.kcl.ac.uk/ioppn/news/events/2015/may/52nd-Maudsley-Debate.aspx


    Jorge R.

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