GSK’s Transparency and Access Journey

November, 4, 2013 | 10 Comments

Comments

  1. David, is the team seeking to rewrite Study 329 the same as that which published the original study “Clinical trials and drug promotion: Selective reporting of study 329″?

    I am not familiar with all the ugly details of this story, but as a scientist my skepticism is raised when I see an article on an extremely important public health issue published in a journal that I’ve never heard of, which is not indexed in Pubmed, which has an impact factor of 0.15, and which is apparently not peer reviewed. The first explanation that comes to mind is that the article was not able to pass review in a peer-reviewed publication, which does not in itself render in unreliable, but certainly raises some flags.

    Just as the industry publishes papers that present only the side of the data that it wants people to see, the literature is full of papers by critics that show only the data that supports their position, which is taken out of context, or distorted (Ben Goldacre is a particularly notable offender). On pharmalot, I critiqued a recent BMJ paper that criticized industry for non-publication of 30% of large trials completed prior to 2009. The authors stated that the size of the trials eliminated the possibility that the trials were “low interest”, and that the only possible explanation for their not being published was to hide negative data. But inspection of the first 20 unpublished trials in their list (which took me only 20 minutes) showed that most of these trials were of drugs that were not approved, and which were never marketed for any indication. My personal feeling is that BMJ would never have permitted authors to make such broad statements with such a shallow level of analysis if the conclusions had not been in support of the journal’s own position.

    Your thoughts?

    • John,

      As a co-author on the publication you mention that was published in the International Journal of Risk & Safety in Medicine (IJRSM), I can assure you this critique of the Keller et al report of study 329 was peer reviewed. The article was originally comissioned by BMJ, but when submitted for publication, the BMJ lawyers decided that it was a risk for libel in the UK. We therefore sought publication outside of the UK.

      It is very difficult to publish articles critical of industry-sponsored studies found to be guilty of scientific misconduct because many medical journals are heavily dependent on industry advertising and re-print orders, many for-profit journals exist to serve industry and finally because lawyers defending industry threaten libel actions. I think BMJ and PLos Medicine are exceptions but since they are published in England, they still face threats of libel actions. GSK has successfully blocked another publication by Jureidini and myself in the Lancet.

      The team rewriting study 329 is not the same as the co-authors on the Selective Reporting paper published in IJRSM, except for the lead author, Jon Jureidini.

      Leemon McHenry

  2. David, I apologize, my statement above that the journal I refer to in the bottom paragraph above is indeed indexed in Pubmed. This was an error on my part.

    But to follow-up on the two-way transparency issue, I thought it interesting that Dr. Juredini in the letter to the editor found here (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1939762/#!po=100.000) references his own, non-peer reviewed blog as a data source for his assertion that 19/20 antidepressant trials are unpublished. If this is true, why does he not publish the result in a journal that would subject his findings to critical review? Certainly the BMJ and other medical journals have published articles critical of the industry in the past.

    I also found it noteworthy that when one goes to the site referenced by Dr. Jureidini, only members are allowed to post comments. And the criteria for membership include “Sharing our aims”, which a skeptic might interpret as “sharing our beliefs”.

    So I guess I’m trying to drive home a point here, which is that transparency is a two way street. I appreciate your own history of openness in this regard.

    I think that irrespective of other motivations and having things to hide, this sort of behavior would make many reluctant to share primary data with any and all comers.

  3. John
    Thank you your comments. Publishing that table on the healthyskepticism website was a way of making it available to readers like you to help you to check things for yourself.
    I lack your confidence in the formal peer review process; after all the Keller study was peer reviewed.
    I do however value genuine peer review, and would be grateful for you pointing out any fault you can spot in our paper in International Journal of Risk & Safety in Medicine, or any other papers that I have published.
    Jon

    • Jon, I’m surprised and complimented that you took the time to respond. Thank you.

      Yes, I am guilty of taking some shortcuts in forming my opinions, and have not yet taken the time to dig into all of the details of this story. I should look into it in greater detail, and arguably should have done so before commenting on it.

      As a scientist in the industry I’ve spent my career doing what I regard as good and worthwhile things. I’ve worked on projects in cancer, cytomegalovirus retinitis (in the pre-protease inhibitor era), multi-drug resistant bacterial infections, disease-modifying therapies for Alzheimer’s disease, and AIDS. I’m currently seeking funding for some ideas for treating dengue.

      I recognize that the commercial side of the industry has done some truly awful things. But in my experience, many critics of the industry engage in the same data cherry picking, data distortion, and conveniently shallow data analysis that the industry has in many cases been guilty of. For this reason I’ve broadly adopted the same skepticism toward papers by industry critics that I’m sure you have adopted for all papers coming out of industry. I place little weight on the conclusions drawn unless I re-analyze the data for myself, and I don’t have time to do that for each and every paper. I’ve reached a range of different conclusions on the occasions that I have taken the time to do this.

      I don’t mean to convey any disrespect when I say this.

      It’s good to interact with you and with David here and discuss issues honestly and respectfully. Maybe what we need is more of this. David and I are so far apart on the issues that I have trouble sometimes grasping what his basic assumptions are. But maybe with time we will both learn some new things.

      How about if you open up your website to comments by non-members? Who knows, I might stop by….

  4. This comment is posted on behalf of Graham Dukes, and addresses the issue of the responsibility of a company to people injured in a trial.

    First I must reject the suggestion that the International Journal of Risk and Safety in Medicine is not peer reviewed or does not feature in authoritative bibliographies. I was founding editor of this Journal and both I and my successor have consistently used expert peer review; the Journal also features in most bibliographic systems.

    Second on the question of a company’s responsibility for subjects injured in its trials, I have published on this on various occasions and summarized my conclusions in several books:

    Dukes & Swartz (1988): Responsibility for Drug-Induced Injury. (Elsevier). In Chapter 16 ((Clinical Investigation of Drugs) there is long sub-section entitled “The Responsibilities of the Sponsor”.

    These are said to include “a duty to ensure publication at least of the principal results, irrespective of whether these are favourable to the product or not”. There is also an account of a case (anonymized on the advice of the publisher’s lawyers!) in which a firm chose to dismiss a fatality involving an elderly patient during a trial as being “co-incidental”, and did not report it to the regulatory authorities; the effect was later found to be a characteristic of the drug and led to its withdrawal from the market.

    This text does not go into the issue of compensation for injury during trials.

    The Law and Ethics of the Pharmaceutical Industry. (Elsevier, 2006). Here there is a long section on “The Responsibilities of the sponsor” in clinical trials, pp. 298-301.

    On the injury issue it includes the following text:
    “It has long been considered that there is a moral obligation to compensate any participant who suffers injury (Childress 1976). There is also a broader belief that a sponsor should provide insurance to cover loss or injury on the part of the investigator, the institution and the participants, where such loss or injury is a consequence of their involvement in the trial.

    The Association of the British Pharmaceutical Industry has long recommended compensation in such cases (ABPI 1994) and within the European Union national legislation now makes such insurance compulsory for patients or volunteers.

    Sponsors and their insurers have on occasion seen fit to pay claims relating to a non-drug related injury, e.g. to a healthy volunteer patient who was injured when his bed collapsed, and another who incurred a nosocomial infection while in hospital for the study.” (p.301)

  5. Transparency means getting everything about a piece of research out in public view for independent review and analysis by others–everything . . . the good, the bad, and the ugly. There will usually for room for disagreements. But putting out something but not everything blocks unfettered discourse and the opportunity to test for the truth of things in dispute. The first canon of empirical science is the “intersubjectivity principle,” which, simply put, means that two observers using the same means can look at and agree on what is being observed. Another canon of empirical science, the “replicability principle,” is dependent on the first. Commercial interests and politics have created world where it is possible for the FDA to regulate the practice of quasi-science in which the fundamental canons of empirical science are ignored. By “quasi” I mean “not.” In the US, this state of affairs is legislatively-induced madness. Were it not so, we would not be having this exchange of views.

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