I wrote this in the Guardian: denialism over clinical trial results being withheld

January 6th, 2014 by Ben Goldacre in bad science | 9 Comments »

I wrote this piece in the Guardian on clinical trial results being withheld, and the staggering denialism from diverse players including industry, the Royal Colleges, the MHRA, David Cameron, and more. This denialism has slowed progress on the issue, and cost lives. It’s my view, frankly, that people should be sacked – and presidents dismissed – over the appalling ESHLSG debacle, which gave false reassurance on vitally important matters of patient safety. The public, quite reasonably, expect better of medical leaders, especially when technical matters are entrusted to their care. Perhaps I’m wrong. In any case: the tide has turned, the public are watching, the professions are finally fully on side. We must celebrate that and move forward: now is the time to act. Here is a link to my piece, and here is the final two paragraphs.

www.theguardian.com/commentisfree/2014/jan/05/scandal-drugs-trials-withheld-doctors-tamiflu

 

The final frontier is delay and denialism at the Medicines and Healthcare Products Regulatory Agency, the Department of Health and the government. David Cameron, when asked about missing trial results and Tamiflu, at prime minister’s questions, explained that he took this problem seriously, and suggested new EU legislation will fix it. This is untrue. New EU legislation – which the industry have been lobbying desperately against – only requires better sharing for trials starting after 2014. Even if it passes, this will do nothing to improve the evidence base for the decisions made in clinics around the world today. The overwhelming majority of treatments prescribed by doctors right now – the everyday drugs for blood pressure, cholesterol, ulcers and more that are taken by millions – all came on the market over the past two decades, not the past seven days. That is the era of evidence that patients need.

Government should ride the wave we have created, and act. There has been more progress on trials transparency in the past 12 months than in the past 25 years. Proposals from industry and regulators are riddled with loopholes so huge they exempt the vast majority of trials on the medicines we use today: but these loopholes are finally being called out.The net is tightening for those who belittle this problem, or pretend it has been fixed, and it’s almost painful to see how easy it was for patients and doctors to have such an impact. We should have acted sooner, but we have an unprecedented opportunity for change. Anyone undermining the case for transparency will find themselves on the wrong side of patients and the wrong side of history. Medicine relies on evidence: future generations will look back on us tolerating withheld results in the same way we look back on medieval blood-letting.

 


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9 Responses



  1. Alex said,

    January 6, 2014 at 6:32 pm

    I’d be interested in knowing what other medications have suffered withheld trials information. Is it possible that a whole raft of currently prescribed and taken medications have been put to market and into people’s medication programmes without all the evidence being properly made available?

  2. EKCarpenter said,

    January 6, 2014 at 10:17 pm

    I’d suggest you read Bad Pharma, Alex. The answer is yes, absolutely.

  3. adzcliff said,

    January 7, 2014 at 9:46 am

    Bad Science (book, column and blog) and Bad Pharma have been a huge influence on me, and I dare say I’d be in a very different place with my critical thinking abilities and interests had they not existed. As a mental health professional who has also been heavily influenced by the more scientifically-minded of the Critical Psychiatry community (which was where I first stumbled across Big Pharma controversies), I slightly live in wait of a Goldacre analysis of the reliability, validity and utility of psychiatric diagnosis and drug treatment. I think I know where I stand at the moment, but I dare say I’d stand somewhere slightly different following a Goldacre take on this debate. Whether it exists (I don’t think it does) or will ever come, who knows, but there, I’ve said it…

  4. ellieban said,

    January 9, 2014 at 2:55 pm

    Adzcliff,

    I am a design student right at the start of a 6 month project with an idea to design a tool that could deliver exactly what you seem to be after (a prescribing tool that would deliver an analysis of drug efficacy for the drugs already in use today based not on trials but on real patient outcome data – sidestepping entirely the issue of missing negative data for old drugs, at least). I need to do research and development on the tool with real clinicians, would you (or anyone else reading this) consider talking to me about your specific needs?

  5. Ben Goldacre said,

    January 9, 2014 at 3:00 pm

    hi ellieban,

    just observing existing data will give dangerously misleading information on the risks and benefits of treatments, that’s why we need randomised trials embedded in routine clinical care, as described in ch 5 of Bad Pharma, and this BMJ paper we wrote:

    www.bmj.com/content/344/bmj.e55

  6. adzcliff said,

    January 10, 2014 at 6:06 pm

    Thanks Ellieban

    It sounds like an interesting project. I think I’ve been persuaded by the likes of Joanna Moncrieff when she outlines how no psychiatric drug has been showed to target a specific psychiatry pathology (assuming these complaints even exist as discrete ‘pathologies’), rather their action on the nervous system is more crude and global. I also like her analogy with alcohol, where we can accept that alcohol (at certain doses) has helpful anxiolytic properties without having to accept it provides a targeted treatment for a specific biological disorder. (As opposed to the insulin/diabetes analogy, where this is exactly what goes on.) However, of course alcohol’s crude/global effects also bring side-effects, which is why most of us have an opinion on how we prefer to use it. Likewise, certain psychiatric drugs, at certain doses, alongside other psychosocial strategies, may or may not be helpful depending on individuals’ unique recovery needs – which is where I think quality-of-life provides a much more valid lens that simple ‘symptom reduction’. Granny and eggs?

    Ta.

  7. Christian Kleineidam said,

    January 14, 2014 at 12:58 pm

    @ellieban:

    The problem isn’t really about tools to gather data. There already plenty of push for centralized health data storage.

    It about data ownership and what who is allowed to do what with data.

    If you allow the tool to interact live with all “real patient outcome data” you are likely to compromise the anonymity of the patients.

  8. brdrake said,

    February 12, 2014 at 10:36 pm

    I am currently enrolled in a Science of Medicine class at my University and our reading was your book Bad Science. This book has only clarified with me many hunches I already had about the Medical/Pharmaceutical world. The privileges the large industries are taking are destroying the foundation of science. With poor elimination of bias, excluding results from the general public and an overall lack of morals, science is being undermined. The very simple basis of science is qualitative and quantitative analysis of the things we observe. Your book has exposed to the world the truths that corporations are trying to hide, the people they are harming in the process, and how they are slowly destroying the realm of science. Thank you for taking your time to give so many a better understanding of the world that we live in, I look forward to my continued studies of science and the “bad” side of it!

  9. sproggit said,

    February 23, 2014 at 2:09 pm

    This is an interesting, insightful and helpful piece, the kind of journalism sadly lacking from UK shores for many years. Thank you for publishing it.

    Reading your explanation, the one thing I find difficult to understand is how this can be complicated? The UK taxpayer, through the UK government, is spending hundreds of millions of pounds on what is essentially snake oil, by virtue of the fact that the vendor is refusing to offer full disclosure of the results of clinincal trials…

    How can this possibly be allowed in any sane world?

    The management of the NHS and the relevent *elected* Ministers have a duty of care to their public to ensure not only the welfare of patients sent for treatment, but that monies spent on medicine procure drugs that *actually work*.

    All it would take to solve this problem would be for governments to agree that no public funds shall be paid to private pharmaceutical companies without *full and unredacted disclosure* of trial results, made available to the medical profession.

    Without that, how can any Minister testify that they *aren’t* authorising the spending of hundreds of millions in taxpayer contributions on snake oil?

    Did we pass the limit of accountability and nobody think to tell us?

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