Medicines save and improve lives, can also cause great harm if inappropriately deployed. To decide which drugs are safe, and which might work in which circumstances, regulators, doctors and scientists need access to all the results from all trials conducted on all drugs that are in use – but this data is all-too-often missing as a result of commercial practices that put millions of lives at risk. A new campaign seeks to bring this largely hidden scandal in medical science, revealed in Dr. Ben Goldacre’s book Bad Pharma, to an end – and with it the needless harm and loss of life that occurs as a result of missing data. This campaign should be music to Liberal Democrat ears, based as it is on values of transparency and freedom of information – it even has implications for Westminster and Brussels politics!
From the simplest painkiller to the most sophisticated drugs based on complex science, all medicines must undergo clinical trials before being approved for use. Such trials are subject to a hugely complex array of regulation, varying in jurisdiction from the European Union to individual hospitals, all of which is designed to ensure that only safe, effective and ethical treatments are approved for doctors to prescribe. Having painstakingly set up and conducted a trial, investigators gather data on safety and efficacy, analyse the results, and are expected to publish them for others to see.
Yet despite the enormously complicated regulation, including attempts to secure registration of trials and publication of data, far too many results never see the light of day. The picture that emerges from what evidence does get published is heavily skewed towards studies with positive outcomes. This obfuscation means that large amounts of data on experiments carried out on humans – let’s be clear about what clinical trials really are – remains hidden in company vaults or on hard drives at regulatory authorities, hidden from those making everyday prescription decisions.
Regulators like the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) need trial data to decide which drugs are safe for anybody, anywhere to use; national authorities like NICE and healthcare commissioners need to know which drugs are cost-effective; and doctors need to know whether approved drugs would be right for the patient they’re treating today. And all of these people don’t just need trial data – crucially they need all trial data from every trial/study ever conducted on all drugs in use, because data that’s missing will distort their decisions and cost lives.
So what’s to be done? Ben’s book helpfully lists dozens of actions needed at all levels from the supra-national to the local – and an important first step is imminent. In February the European Parliament will change how the EMA works, but the proposed regulations need to be bolstered to require all trials to be registered on a publicly accessible database, and all data from those trials to be published in full. There’s a Parliamentary Select Committee enquiry already underway. By signing the AllTrials.net petition (set up as a collaboration between Bad Science, Sense About Science, BMJ, James Lind Initiative and Centre for Evidence-based Medicine), you can call upon governments, regulators and the pharmaceutical industry to stop the damage caused by hidden data on clinical trials.
* Prateek Buch is Director of the Social Liberal Forum and serves on the Liberal Democrat Federal Policy Committee