Sorry not to be in regular blogging mode at the moment. Here’s a video of our evidence session to parliament, where they are running an inquiry into research integrity. I think clinical trials are the best possible way to approach this issue. Lots of things in “research integrity” are hard to capture in hard logical rules, so you end up with waffly “concordats” and rules that are applied inconsistently. With clinical trials you can make clear rules, you can measure compliance, and you can enforce compliance. There is lots of chat about this in the video below from 17:37 with me, Simon Read the rest of this entry »
Two interviews on withheld trials, NPR and ABC
Here are a couple of fairly detailed interviews I’ve done over the last two weeks, both on the problem of clinical trial results being withheld.
The first is with On The Media, an excellent NPR show, the clip is here. Read the rest of this entry »
Statins have no side effects? What our study really found, its fixable flaws, and why trials transparency matters (again).
Hi there, sorry to be absent (dayjob!). I was surprised to see a study I’m a co-author on getting some front page media play today, under the headline “Statins ‘have no side effects'”. That’s not what our paper found. But it was an interesting piece of work, with an odd result, looking at side effects in randomised trials of statins: specifically, and unusually, it compares the reports of side effects among people on statins in trials, against the reports of side effects from trial participants who were only getting a dummy placebo sugar pill. Read the rest of this entry »
My BMJ editorial: we need routine audit of missing clinical trials
I wrote this editorial in the British Medical Journal with the magnificent Carl Heneghan, director of the Centre for Evidence Based Medicine at Oxford. It’s about the Public Accounts Committee, progress on publication bias, and a suggestion for routine ongoing audit to give actionable information for decision-makers on how much information is missing. Read the rest of this entry »
Public Accounts Committee issues damning report on clinical trial results being withheld
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.
There’s also extensive commentary in our press release at AllTrials.net. Here’s my bit from that press release: Read the rest of this entry »
New super cheap edition of Bad Pharma, with extra chapter, and: Waterstones Book Club!
RIGHT. Sorry to be absent, I’m back from outer space.
NOW. There’s a new cheap edition of Bad Pharma out this month, with a new and very long extra chapter on everything that’s happened since the first edition came out. There are goodies and baddies galore, I’ll be writing about it all over the next few weeks, but if you’re impatient, there’s lots on the AllTrials website already.
Before that, Bad Pharma is Waterstones Book Club “Book of the Week“. This means it’s discounted, and out on the tables in Waterstones. More importantly, there’s a podcast discussion, and a book club reading guide. These are often great fun, and it’s worth checking out some of the others: they give suggested discussion points, this one has a piece by me on why I wrote the book, and how medical leaders have failed to address the problem of missing trials.
They also asked me to write about how I write, so there’s a splurge at the end about the huge synchronising data monster I’ve built to hoover up and organise knowledge. Your mileage, as they say, may vary.
The reading guide is here:
www.waterstones.com/wat/images/special/pdf/9780007498086_reading_guide.pdf
You can buy the new super cheap edition of Bad Pharma here:
www.waterstones.com/waterstonesweb/products/ben+goldacre/bad+pharma/9640023/
There’s a Waterstones book club podcast on Bad Pharma here:
blog.waterstones.com/2013/09/book-club-bad-pharma/
And as always: remember to sign up to www.alltrials.net, our campaign to stop clinical trial results being withheld from doctors, patients and researchers. We cannot make informed decisions about which treatment is best, as long as this information is being casually withheld. History shows that quiet backroom activity has failed to fix the problem: loud, public scrutiny is the only hope we have, and that means you.
Onward!
Head-to-Head with PhRMA on transparency in the BMJ
This week in the BMJ there’s a head-to-head on trials transparency between me and PhRMA, the pharmaceutical industry representative body in the US. My article is here, PhRMA’s is here, both articles are open access for one week (since it was press released, them’s the rules at the BMJ…) but mine is open access forever, I think, on this link.
The article from PhRMA is remarkable. Firstly, they imply that people like me, who call for all trial results to be reported, also somehow call for the reckless disclosure of individual patients’ electronic health records online. This is untrue.
More disturbing is PhRMA’s suggestion that the problem has already been fixed. For example, John Castellani says that “information on clinical trials for potential new medicines is already required by US law to be posted on ClinicalTrials.gov“. As I explain in my piece, the best available published evidence on compliance with this law comes from Prayle et al, BMJ 2012: in reality, the legislation here has been very widely ignored.
We need to fix the problem of withheld results. Doctors (and patients, and researchers, and payers, and the public) need access to all the results, of all the trials, on all the uses, of all the treatments currently being prescribed, in order to make informed decisions about which is best.
More in the articles, and for even more on why this matters for patient care, I recommend the first chapter of Bad Pharma.
Enjoy!
www.bmj.com/content/347/bmj.f1881
www.bmj.com/content/347/bmj.f1880?ijkey=KJaN2gQyuYf46yS&keytype=ref
Discussing AllTrials on the BBC Daily Politics today
I’m on the BBC2 show Daily Politics today at 12:40pm with Grant Shapps and Andy Burnham, discussing the alltrials.net campaign, and the problem of trial results being withheld from doctors, researchers, and patients. Here’s a brief film they made on the subject. Read the rest of this entry »
Here’s me and Fiona Godlee (BMJ) giving evidence to Public Accounts Committee on withheld Tamiflu trials
In December last year a group of MPs including Sarah Wollaston, David Davis, Julian Huppert and Adam Afriyie wrote to Margaret Hodge, chair of the Public Accounts Committee, asking for an inquiry into Tamiflu. Specifically, they asked about the way that vitally important information on clinical trials around Tamiflu have been withheld from doctors and researchers. That signatory list – I’m thinking of Afriyie, Huppert, and Wollaston in particular – is an important reminder that we benefit from having people in parliament with professional experience of medicine and science. Read the rest of this entry »
My evidence to the Science and Tech Select Committee inquiry on missing trial data
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 »
