MPs on the UK parliament’s Public Accounts Committee today issued one of the most damning reports ever seen on the problem of clinical trial results being withheld. Their amazement at the extent of the problem is palpable. This is a fantastic result for the campaign that started with Iain Chalmers et al many years ago, grew with the publication of Bad Pharma, and is now transformed into a vast behemoth with widespread support at AllTrials. You can read the Committee’s report in full here, and see the video of the evidence session with me and Fi Godlee from the BMJ here. I should say, I’ve been hugely impressed by the MPs I’ve come into contact with on this issue.
There has been extensive media coverage so far, some of the best (the ones that go beyond the Committee’s press release…) can be found in: the Independent, the Telegraph, the BBC, PharmaTimes and the Times (regarding that last article, I wonder if Bina Rawal of the ABPI will come to regret claiming that Richard Bacon, the deputy chair of the highly influential Public Accounts Committee, has been misleading people: the current regime at the ABPI do seem rather clumsy, more on their activities to come). Next, here is an article by David Tovey, head of Cochrane, one from Ginny Barbour, the big medical cheese at PLOS, and here is the BMJ news piece. Here’s a comment piece by Matt Ridley in the Times (caution: contains climate lols), and here’s a comment piece from me in The Guardian. There’ll be an editorial in the BMJ shortly.
Dr Ben Goldacre, author of Bad Pharma and co-founder of AllTrials: “Today’s report is a complete vindication of AllTrials’ call for all the results, of all the trials, on all the uses of all currently prescribed treatments. None of the proposed new legislation or codes of conduct come anywhere close to this simple, vital ask. Industry has claimed it is on the verge of delivering transparency for over two decades. While obfuscating and delaying, ever more results have been withheld. Some in industry now claim that results from even a decade ago may be lost and inaccessible. This is both implausible and unacceptable.
“We need urgent action from government, regulators, the GMC, and all professional bodies to ensure that the full methods and results of all trials on all currently used treatments are made available to doctors, researchers, and patients. We cannot make informed decisions about which treatment is best when vitally important information is routinely and legally kept secret. Future generations will look back at this absurd situation in the same way that we look back on mediaeval bloodletting.
“Stephen Whitehead CEO of ABPI said in February that they “would not respond” to the AllTrials petition3. It is increasingly clear that researchers, policy makers and patients will not tolerate the current situation.”
Dr Ben Goldacre, author of Bad Pharma and co-founder of AllTrials: “It is not enough that trial results are seen in secret, behind closed doors, by regulators alone: especially when, as with Tamiflu, regulators around the world disagree about the benefits of a treatment. It is also not clear that even regulators see everything. It is particularly concerning to see that the MHRA seems to have told the Committee that regulators had all the information on all trials on Tamiflu. The evidence to the Committee from the Cochrane Collaboration shows that was not the case. We are only able to see this apparent discrepancy because the evidence for Tamiflu has now been subject to half a decade of intensive investigative work by several groups around the globe. This is extremely concerning, and the problem for other treatments may be even greater.”
This Committee report is a fantastic piece of forward movement. Here’s my account of the AllTrials campaign, and the events following the publication of Bad Pharma, from the update chapter in the new edition of the book. It’s remarkable, and rather shameful, that took so long to get these issues seriously addressed. But the tide has turned.