Clinical trial data for all drugs in current use | BMJ

"The drug industry does many good things. It produces medicines that can improve health and save lives. It creates jobs and stimulates economic growth. Sadly it does bad things too. Persistently and systematically over decades it has withheld and misreported data from clinical trials.1 As a result, a whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money. Such wilful distortion is scientific misconduct.2 It is not something we can forgive because of the good things drug companies do. As Ben Goldacre says in the introduction to his new book Bad Pharma, 'Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale. But that does not allow them to hide data, mislead doctors, and harm patients.' Hats off then to GlaxoSmithKline, which announced last month that it would allow access to anonymised patient level data from its clinical trials.4 An independent panel will assess all requests, and the company’s chief executive officer, Andrew Witty, says access will be granted on the basis of a reasonable scientific question, a protocol, and a commitment from the researchers to publish their results. Trial data collected since 2007 will be placed on a password protected website. Earlier data, not yet available in standard digitised formats, will be made available on “an ad hoc basis.” Whether researchers will find it as easy to get past the panel as Witty suggests we will have to wait and see. It will be particularly important to know how many requests are turned down and for what reasons. And amid the plaudits, a moment of doubt. Surely what this apparently brave and benevolent action really serves to highlight is the rank absurdity of the current situation. Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made? How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? ... Goldacre’s book makes it clear that the reasons are complex and there are no simple solutions. But there is no doubt that medical journals could do more. Rather than no longer publishing industry funded trials, as some have suggested, they could leverage their power and publish only where there is a commitment to make the relevant anonymised patient level data available on reasonable request. The International Committee of Medical Journal Editors has so far declined to take such a step. The BMJ will require this commitment for all clinical trials of drugs and devices—whether industry funded or not—from January 2013..."