This is very odd indeed. Westminster, one of the most expensive public schools in the UK, is holding a fund-raising auction. In this auction, you can buy an internship at Imperial College’s Institute of Biomedical Engineering, on the promise that this will look great on your CV. Read the rest of this entry »
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):
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.
I couldn’t be any happier. This is huge, and internationally huge. GSK have made a commitment to post CSRs online. 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.
If you’re a US podcaster or blogger and you want to chat about bad behaviour in the pharma industry then do please email the three of us (Brian.Gittis@fsgbooks.com email@example.com firstname.lastname@example.org).
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 email@example.com for Canada, and Brian.Gittis@fsgbooks.com for the US. Do also cc me, firstname.lastname@example.org, and we’ll try to fit it in around the various bits of other work while I’m out there.
You can buy the US edition of Bad Pharma here.
Sun 17th Feb 7:30pm
Powell’s Bookstore, 1005 West Burnside.
Talk, Q&A, and signing
Mon 18th Feb 7:30pm
Town Hall, downstairs, enter on Seneca Street
Talk, Q&A, and signing:
NEW YORK CITY, NY
Thurs 21st Feb 7:00pm
Talk, Q&A, and signing
NYC Skeptics at University Settlement, 184 Eldridge Street
Friday, 15th Feb, 7:30pm
Massey College lecture, free and open to the public.
Thursday 14th Feb, 6pm-8pm
Pub talk organised by @julia, free, open to all
Excellent to see the UK House Of Commons Health Select Committee making such a clear statement about the ongoing problem of missing trial results, which the ABPI have laughably claimed is “historic“.
They call upon NICE, the GMC and the pharmaceutical industry to address the problem, and they also take a very strong clear position: that withholding the results of clinical trials should be neither legal nor ethical. Read the rest of this entry »
Here’s a documentary I made for BBC Radio 4 (with producer Rami Tzabar) about evidence based social policy, and why we should do more randomised trials in government. It’s good fun, 40 minutes, with contributions from Dean Karlan (who wrote this book and is behind all these excellent trials on reducing poverty), Prof Sheila Bird, Jonathan Portes from NIESR (his excellent blog here), the man they call GOD, and many more.
It’s also Radio 4 documentary of the week (woo!) which means you can download it as an mp3. The link is live for another 5 days, and it works for some countries outside the UK too.
And now that it’s expired on iPlayer, you can listen to it on FigShare here:
If you’re interested in reading more evidence based policy, I highly recommend this Cabinet Office paper that I co-authored a few months ago, downloadable for free online. As explained here, it’s brief, and very much designed to be the Ladybird Book of RCTs in Government. If you want more on the uses for randomised trials in criminal justice, I wrote this in the British Medical Journal with Sheila Bird and John Strang in 2011 (sorry it’s not open access, I’ll try to fix that soon). More to come on this topic soon. Read the rest of this entry »
Just catching up on posting some overdue entries, I’ll do a roundup of progress on the hidden trial data problem in a while. Firstly, briefly, here’s an interview I did with the members’ journal of the Institute for Clinical Research (the people who design and run clinical trials). It’s a good, constructive discussion, mostly covering publication bias and missing data. Shortly afterwards, the ICR issued a position statement on transparency and hidden data, which is (partially!) good. Read the rest of this entry »
Briefly: the ABPI have engaged in an energetic personal smear campaign, as predicted at the end of Bad Pharma. I’ll think about posting the details from leaked and external ABPI documents at some stage. I’m posting some correspondence today because the CEO and President of the ABPI have both falsely claimed to MPs and journalists that I’ve refused to meet them over many years. This is silly and untrue, especially when the ABPI have also specifically stated in public that they are refusing to engage with my concerns. Both Stephen Whitehead (CEO) and Deepak Khanna (President) have failed to provide any explanation of why they’ve made these false claims, or give a full list of the people they’ve misled, so regrettably I’m posting my letter to them here. Read the rest of this entry »
Sorry to have been absent, I’ve been working away on several projects behind the scenes, on which much (much!) more shortly.
I’m extremely pleased to say that the Commons Science and Technology Select Committee have just announced that they will now conduct a formal inquiry into missing trial data. Full details are posted below, and a briefing on the basics of this ongoing problem can be found at the bottom of this post.
I will post more on this, and the wider campaign, shortly, but before I run to a meeting, I should tell you one story that explains why I think this inquiry is important.
Two weeks ago the European Medicines Agency held a meeting on transparency and clinical trials (I was on the panel). During the discussion, a lawyer working for a drug company stood up and said, quite simply: we pay for this data to be collected, we should be able to control how it is used. There was no sharp intake of breath at this comment, in a room full of 200 regulators, researchers, industry representatives, and doctors.
To me, this shows that we have become detached from reality, through the abstractions of evidence, and how we have failed to focus on the needs of patients. It is one thing to talk about controlling data in technical meetings. But I doubt any one of the people responsible for creating and perpetuating a situation where trial data is routinely withheld could walk up to a patient and say: “we think we should be allowed to withhold vital evidence about whether that pill works or not, from you, the person swallowing it.”
That’s why I think this inquiry is potentially very important. This problem has persisted, because lot of people – some of them in positions of great responsibility, as we shall see – have worked very hard to shut down any legitimate public discussion of its existence.
I think transparency is a win for academia, and for industry. I also think, with the rise of open data and transparency in government and elsewhere, it’s an inevitability. So I’m sad to see them resisting it so aggressively, and I hope they can change.
Committee to inquire into clinical trials and disclosure of data
Clinical trials in the UK are regulated by the Clinical Trials Directive which was transposed into UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004. In December 2011, the Health Research Authority was created to protect and promote the interests of patients and the public in health research. In July 2012, the European Commission produced proposals to revise the Clinical Trials Directive.
Transparency and disclosure of clinical trial data have been topical recently, in part due to the recently published book Bad Pharma, by Dr Ben Goldacre. It highlighted that pharmaceutical companies are entitled to conduct numerous clinical trials on a new drug but publish selectively, thus skewing the evidence base available for doctors and patients seeking to make informed decisions.
Terms of Reference
The Committee seeks written submissions on the following matters:
1. Do the European Commission’s proposed revisions to the Clinical Trials Directive address the main barriers to conducting clinical trials in the UK and EU?
2. What is the role of the Health Research Authority (HRA) in relation to clinical trials and how effective has it been to date?
3. What evidence is there that pharmaceutical companies withhold clinical trial data and what impact does this have on public health?
4. How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?
5. Can lessons about transparency and disclosure of clinical data be learned from other countries?
Submitting written evidence
As part of a scheme to promote paperless working and maximise efficiency, the Committee is encouraging written submissions for this inquiry to be sent by email to email@example.com and marked ‘Clinical Trials’.
The Committee invites written submissions on these issues by noon on Friday 22 February 2013.
Each submission should:
a) be no more than 3,000 words in length
b) be in Word format with as little use of colour or logos as possible
c) have numbered paragraphs
d) include a declaration of interests.
If you need to send a paper copy please send it to:
Science and Technology Committee
House of Commons
London SW1P 3JA
Please note that:
• Material already published elsewhere should not form the basis of a submission, but may be referred to within a proposed memorandum, in which case a hard copy of the published work should be included.
• Memoranda submitted must be kept confidential until published by the Committee, unless publication by the person or organisation submitting it is specifically authorised.
• Once submitted, evidence is the property of the Committee. The Committee normally, though not always, chooses to make public the written evidence it receives, by publishing it on the internet (where it will be searchable), by printing it or by making it available through the Parliamentary Archives. If there is any information you believe to be sensitive you should highlight it and explain what harm you believe would result from its disclosure. The Committee will take this into account in deciding whether to publish or further disclose the evidence.
• Select Committees are unable to investigate individual cases.
More information on submitting evidence to Select Committees may be found on the parliamentary website at:www.parliament.uk/get-involved/have-your-say/take-part-in-committee-inquiries/witness/
Andrew Miller (Labour, Ellesmere Port and Neston) (Chair)
Caroline Dinenage (Conservative, Gosport)
Jim Dowd (Labour, Lewisham West and Penge)
Stephen Metcalfe (Conservative, South Basildon and East Thurrock)
David Morris (Conservative, Morecambe and Lunesdale)
Stephen Mosley (Conservative, City of Chester)
Pamela Nash (Labour, Airdrie and Shotts)
Sarah Newton (Conservative, Truro and Falmouth)
Graham Stringer (Labour, Blackley and Broughton)
Hywel Williams (Plaid Cymru, Arfon)
Roger Williams (Liberal Democrat, Brecon and Radnorshire)
Specific Committee information: firstname.lastname@example.org / 020 7219 2793
Media information: Nick Davies email@example.com / 020 7219 3297
Committee website: www.parliament.uk/science
Watch committees and parliamentary debates online: www.parliamentlive.tv
Publications / Reports / Reference Material: Copies of all select committee reports are available from the Parliamentary Bookshop (12 Bridge St, Westminster, 020 7219 3890) or the Stationery Office (0845 7023474). Committee reports, press releases, evidence transcripts, Bills; research papers, a directory of MPs, plus Hansard (from 8am daily) and much more, can be found onwww.parliament.uk.