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    GlaxoSmithKline Embraces Clinical Trial Data Sharing - Is That A Good Thing?
    By News Staff | July 11th 2013 11:45 AM | 5 comments | Print | E-mail | Track Comments

    Scientists and policy makers need all the evidence to make informed decisions about medicines but drug research is an area where privacy concerns and transparency are in conflict.


    Like all areas of research, trials with positive results are likely to be published but even then half of all trials for the treatments being used today have gone unpublished. Government officials have seen the studies but not the wide community, with some exceptions.  GlaxoSmithKline, the world's fourth largest drug company, has committed to share all Clinical Study Reports going back to the foundation of the company, as part of the AllTrials campaign.  

    There is legislation mandating greater transparency, such as the U.S. law requiring trial results for potential new medicines to be posted on ClinicalTrials.gov.

    Since 80% of the medicines prescribed this year came onto the market more than a decade ago, Ben Goldacre, blogger, author and research fellow at the London School of Hygiene and Tropical Medicine, calls for trials from the past to be fully disclosed.

    Opponents disagree. 

    John Castellani, President of the Pharmaceutical Research and Manufacturers of America (PhRMA), says mandatory disclosure could affect patient privacy, stifle discovery, and allow competitors or unscrupulous actors to use the information.  Threats to patient privacy "will jeopardize patient willingness to participate in clinical trials, which would delay the availability of new therapies.

    "The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information," he writes.

    Rather than forcing the issue and allowing too much privacy he says industry is "engaged in a dynamic ongoing process to improve on all aspects of clinical trials" ans that should take its course.


    Are regulators not enough?

    Would science and medicine be improved if the public, trial lawyers and anti-medicine activists had access to all trial data, or would it lead to more promotion of fear and doubt by advocacy groups exploiting lack of knowledge to advance an agenda? Goldacre sides with more transparency, saying there is greater chance of  "real and unnecessary risks" when only regulators see all the information on trials - because problems with evidence are also identified by academics and doctors working outside of regulatory bodies.

    He says that Clinical Study Reports – long documents held by regulators and companies on the full methods and results of trials – should be shared publicly, with information about individual patients redacted where necessary. He says that 1.6 million pages of this material have already been shared by the European Medicines Agency (EMA). 

    On the issue of patient privacy, he does not call for individual patient records from trials to be published openly, but does point to several examples of "sensible and cautious sharing of [these] detailed datasets" among professionals.

    The problem of missing trials "is one of the greatest ethical and practical problems facing medicine today," writes Goldacre. "The AllTrials movement is driving the solution forwards: patients need industry to engage constructively with this widespread consensus, on the practical details – urgently – so that we can all move on."

    Castellani disagrees. Mandatory public disclosure of clinical trial information, without appropriate scientific and clinical context, could undermine patient trust and confidence in the safety and effectiveness of approved medicines, he writes.

    He also raises concerns over disclosure of intellectual property, confidential commercial information, and proprietary scientific methods found in clinical trials, saying this "could stifle discovery and open the possibility of competitors or unscrupulous actors using the information for their own products in other markets or countries."

    He outlines the huge investment and "considerable risk" involved in the search for new treatments, and concludes that "only a carefully balanced regulatory and competitive environment can foster the future investments in this research necessary to produce new treatments to benefit current and future patients."

    Comments

    "Castellani disagrees. Mandatory public disclosure of clinical trial information, without appropriate scientific and clinical context, could undermine patient trust and confidence in the safety and effectiveness of approved medicines, he writes."

    This is completely correct. If there would not have been an information by Mad-in-America (see there) about the design of some studies, concernig the negative symptoms and how psychaitric drugs effect them, may be, I would still beleave, that neuroleptica are good for me. But they aren't! Well, it's me, who is interested in Neuro-biology, that only finds a reenforcement of his opinoin in the criticism of Mad in America of drugs in negative symptoms of schizophrenia, but how about the whole lot of psychiatrist, that believe in the published abstracts? No, laking of compliance because of reading the whole study is good for the patient!

    "safety and confidence", propably You think about the "placebo effect"? How thoughts and emotions do cure? No, Sir, I disagree. But I see, that a lot of people do behave in this way. So make a study an propagate it, and all people believe in it, and we have a fine medicine, by the power of thoughts and emotions? Sorry, that contradicts, besides all more or less prooved marginal effects (my god, yes, quantum), my experience.

    Gerhard Adam
    Would science and medicine be improved if the public, trial lawyers and anti-medicine activists had access to all trial data, or would it lead to more promotion of fear and doubt by advocacy groups exploiting lack of knowledge to advance an agenda?
    Oh yeah, instead of advertisers and promoters that have no problem making promises on television for prescription drugs that viewers aren't actually allowed to get without a doctor's permission.

    Sorry, but that argument was lost the moment pharmaceuticals began advertising.

    Why is it that those most opposed to a "nanny state" have no problem with "nanny corporations"?

    BTW, lest it be lost in the commentary, what GlaxoSmithKline is doing is a very good thing.
    Mundus vult decipi
    Hank
    That's what Ben says and I generally agree - obviously I am a fan of open data. But we have created an anti-science schism never before witnessed in history and it can't be dumped at the feet of corporations. A whole lot of people have access to information they once did not have, and it has made the Internet a haven for people who find just enough to be wrong.
    Gerhard Adam
    So what?  People have always been wrong, and it's only ever been a small subset of people that understood some of the more complex issues.  Science is hardly unique in that regard.  Most people don't understand the basis of foreign policy or economics or any number of other things on which they have to make decisions.

    More importantly, the people that are "the opposition" still don't have any authority or decision-making capability.  These people are not the problem.

    If we are to focus on the problem, then let's deal with the spineless politicians and corporate officers that want to bow down before anything that might be a tiny bit controversial or require them to provide some transparency.  Those are the people that are to blame for not taking on the responsibilities and making some of the hard decisions that need to be made.

    That's why I applaud this move to transparency.  So what if people protest or want to ban things.  Perhaps if there are enough radical ideas proposed it just might dawn on the populace to elect people that can actually govern.  Until then, they are getting exactly what they voted for.  When all anyone cares about are single-issue politics, then don't be surprised when the morons in office don't lead or govern.

    Mundus vult decipi