The UK House of Commons Science and Technology Select Committee are currently looking at the problem of clinical trial results being withheld from doctors and patients (partly, the committee says, in response to Bad Pharma, which is heartening). A clear, thoughtful report and policy recommendations from this committee could be an important step towards fixing these problems.
I gave oral evidence this week on a panel with Roche, GSK, and the ABPI (who have previously tried to pretend that all the issues in Bad Pharma were “historic” and “long addressed”). I’ve posted the video below, and I’ve posted my written evidence underneath that. First is my submission addressing the specific questions posed by the Committee, and then my appendix, giving background on the problem of withheld trial results. Read the rest of this entry »
I was on Newsnight this evening, discussing the measles outbreak in Swansea, and how we can get people vaccinated with MMR when they’ve previously refused. In my view: prevention is better than cure, it’s hard to reverse a scare story once the toothpaste is out of the tube, and we must innoculate ourselves against future vaccine scares, because they will come. That’s why services like Behind The Headlines are important. Here’s the video:
At the end, Jeremy Paxman seemed (endearingly) amazed to hear that vaccine scares respect local cultural boundaries. Here’s what I was discussing, in an extract from my first book Bad Science (this bit’s from pages 292-4 of the red paperback):
I made a film for The One Show on BBC1, which goes out tonight. It’s about “publication bias“: the problem of clinical trial results being withheld from doctors and patients. (I also get to go into an awesome underground bunker where documents are stored…).
I was asked by Michael Gove (Secretary of State for Education) and the Department for Education to look at how to improve the use of evidence in schools. I think there are huge, positive opportunities for teachers here, that go way beyond just doing a few more trials: there is a need for a coherent “information architecture” that supports evidence based practice. I was asked to write something that explains what this would look like, specifically for teachers. Pasted below is the briefing note from DfE press office, and then the text of what I wrote for them, which came out this week. You can also download a PDF from the DfE website here. Read the rest of this entry »
We rely on clinical trials in medicine, but companies and researchers are able to withhold results wherever it suits them: this breaks evidence based medicine. The best available systematic review evidence estimates that around half of all trials for the treatments we use today have not been published: you can read the details on this problem, and the flawed efforts to remedy it, here.
We decided that something needed to be done, and so we set up www.alltrials.net, with Sense About Science, the BMJ, Sir Iain Chalmers (co-founder of Cochrane) and the Centre for Evidence Based Medicine in Oxford. Since then the campaign has snowballed. We have been joined by groups as diverse as MRC, the Wellcome Trust, IQWiG (the German NICE), NPA (the US doctors body) and many more. Read the rest of this entry »
GSK have just this minute announced that they are signing up to the alltrials.net campaign.
This will be written in a hurry. Briefly: the results of clinical trials have been routinely withheld from doctors and patients throughout medicine, and this problem has not been fixed. The www.alltrials.net campaign is asking for all trials to be registered, for all summary results to be reported, and for full Clinical Study Reports to be made publicly available. CSRs are important, because it is now clear that brief summaries about trials (such as academic journal articles) can be incomplete or misleading. Last Friday I met with Andrew Witty, the head of GSK, to discuss these concerns, and it was clear that they’ve spent a lot of time thinking about these issues.
There is a new EU Clinical Trials Regulation currently passing through parliament in Brussels. It is currently in draft form, and riddled with holes: essentially it allows companies and researchers to withhold trial results, and play fast and loose with analyses. These problems are best documented in the BMJ by one of the co-founders of Cochrane:
The EU lead legislator (or “rapporteur”) on this bill is Glenis Willmott. She is a Labour MEP from the UK, and well-known to those in public health for her battles with the tobacco industry in Europe. Patients around the world are very fortunate that she has been chosen for this positon on clinical trials, and I am very pleased to say that her office have just this afternoon issued a press release on trials transparency. It is very clear that she will be working hard to fix this broken legislation, and her initial report on the draft Regulation demonstrates a clear recognition of problems that have been neglected for too long. Read the rest of this entry »
Bad Pharma is out in the US and Canada on 5th Feb, which is extremely good news (sorry about the delay, floods and hurricanes apparently..). I’ll be doing a few public lectures in various places, alongside media stuff and other things, there’s a list of open ones below.
Also: in the UK I’ve done a gazillion talks, and the most fun things always come from random people. So if from the list below it looks like I’m passing through your town and you want me to do a talk in your university, a pub, or an event, or you think there’s someone I should meet, a campaigner, an academic, a journalist, then please contact firstname.lastname@example.org for Canada, and Brian.Gittis@fsgbooks.com for the US. Do also cc me, email@example.com, and we’ll try to fit it in around the various bits of other work while I’m out there.
I am very pleased to announce the launch of a prominent campaign for access to all trial results, which we have launched this week at www.alltrials.net, with myself, Sense About Science, Sir Iain Chalmers from the James Lind Initiative (previously co-founder of Cochrane), Dr Fiona Godlee (Editor in Chief of the BMJ), and Dr Carl Heneghan (Director of the Centre for Evidence Based Medicine at Oxford).