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 firstname.lastname@example.org 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)
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