Fixing flaws in science must be professionalised. By me in the Journal of Clinical Epidemiology.

July 10th, 2015 by Ben Goldacre in bad science | 6 Comments »

Me and a dozen other academics all just wrote basically the same thing about Open Science in the Journal Of Clinical Epidemiology. After the technical bits, me and Tracey get our tank out. That’s for a reason: publishing academic papers about structural problems in science is a necessary condition for change, but it’s not sufficient. We don’t need any more cohort studies on the global public health problem of publication bias; we need action, of which the AllTrials.net campaign is just one example (and as part of that, we do still need many more audits giving performance figures on individual companies, researchers and institutions, as I explain here). We have a paper coming shortly on the methods and strategies of the AllTrials campaign that I hope will shed a little more light on this, because policy change for public health is a professional activity, not a hobby. Where academics are sneery about implementation, problems go unsolved, and patients are harmed.

Ironically all these papers on Open Science are behind an academic paywall. The full final text of our paper is posted below. If you’re an academic and you’ve ever wondered whether you’re allowed to do this, but felt overwhelmed by complex terms and conditions, you can check every academic journal’s blanket policy very easily here.

And lastly, if you’re in a hurry: the last two paragraphs are the money shot. Enjoy.

 

Fixing flaws in science must be professionalised. Read the rest of this entry »

My new book is out today. Here is the introduction. Hooray!

October 23rd, 2014 by Ben Goldacre in book, ITYFIABMCTT, onanism | 14 Comments »

whooo wil buuuuy my loverly neeeew boooook whooo wil buuuuy my loverly boooook My new book is out today: a collection of columns, journalism and essays, but also some of my more colourful government reports, academic papers, and more.

It looks lovely.

Here is the introduction.

Hooray!

……  Amazon …………………..

…………………. Audible ………

……….  Waterstones  ……….

….. Kindle   ……………………..

……….   Local  ………………….

…….. Harper Collins  ………..

Introduction

This is a collection of my most fun fights: but the fighting is just an excuse. There’s nothing complicated about science, and people can understand anything, if they’re sufficiently motivated. Coincidentally, people like fights. That’s why I’ve spent the last ten years lashing science to mockery: it’s the cleanest way I know to help people see the joy of statistics, and the fascinating ways that evidence Read the rest of this entry »

I wrote this in the Guardian: denialism over clinical trial results being withheld

January 6th, 2014 by Ben Goldacre in bad science | 11 Comments »

I wrote this piece in the Guardian on clinical trial results being withheld, and the staggering denialism from diverse players including industry, the Royal Colleges, the MHRA, David Cameron, and more. This denialism has slowed progress on the issue, and cost lives. It’s my view, frankly, that people should be sacked – and presidents dismissed – over the appalling ESHLSG debacle, which gave false reassurance on vitally important matters of patient safety. The public, quite reasonably, expect better of medical leaders, especially when technical matters are entrusted to their care. Perhaps I’m wrong. In any case: the tide has turned, the public are watching, the professions are finally fully on side. We must celebrate that and move forward: now is the time to act. Here is a link to my piece, and here is the final two paragraphs.

Read the rest of this entry »

Public Accounts Committee issues damning report on clinical trial results being withheld

January 3rd, 2014 by Ben Goldacre in alltrials campaign, badpharma | 1 Comment »

Screenshot 2014-01-03 21.55.17MPs 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 »

Why – and how – I wrote Bad Pharma

October 8th, 2013 by Ben Goldacre in bad science | 21 Comments »

This is my piece for Waterstones Book Club, where I was asked to write about why – and how – I wrote Bad Pharma. The full book club caboodle is here, and you can buy the book here.

Here it is… Read the rest of this entry »

Win. Parliamentary Sci Tech Committee announces official inquiry into missing trial data.

December 13th, 2012 by Ben Goldacre in bad science | 2 Comments »

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.

www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/news/121213-clinical-trials-inquiry-announced/

Committee to inquire into clinical trials and disclosure of data

13 December 2012

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 scitechcom@parliament.uk 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:
The Clerk
Science and Technology Committee
House of Commons
7 Millbank
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/

 

FURTHER INFORMATION

Committee Membership:
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:  scitechcom@parliament.uk / 020 7219 2793
Media information: Nick Davies  daviesnick@parliament.uk / 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.

GSK have promised to share all trial data: should we trust them?

October 11th, 2012 by Ben Goldacre in big pharma | 1 Comment »

Briefly: today, several people have asked for my response to this story in the Guardian, celebrating GSK’s promise for more transparency on their trial data. Read the rest of this entry »

The ABPI claims that all the problems in my book are “historical”. This claim is simply untrue.

October 11th, 2012 by Ben Goldacre in big pharma | 21 Comments »

My book Bad Pharma documents serious ongoing problems in the pharmaceutical industry. In particular, I show how vitally important information from clinical trials is still being withheld from doctors and patients, right now, today; and that patients experience avoidable suffering and death as a consequence. There is no nicer way to express that reality, and this ongoing problem of missing data is meticulously documented in the book, because it is widely discussed in the medical literature.

I am very sorry to say that the ABPI, the UK pharmaceutical industry PR group, has now responded, and their only response has been to flatly deny what is plainly and provably true. Here is their press release, Read the rest of this entry »

Here’s the foreword to my new book.

September 25th, 2012 by Ben Goldacre in bad science | 19 Comments »

My new book Bad Pharma is out today. It describes how drug companies harm patients, around the world, by distorting evidence on an industrial scale. More  than that, it shows how doctors, academics, and regulators have all failed to fix these problems. Bad practices have been perpetuated, because the public have not understood the true scale of the disaster. If this book is not ignored, it will make certain current public positions from industry, and from regulators, untenable. That will be the beginning of fixing the problem, and for the rest, I need your help.

But first, with kind permission of the publishers, here’s the introduction. I hope you like it.

Read the rest of this entry »

New edition of “Testing Treatments”, best pop science book on Evidence Based Medicine ever.

October 18th, 2011 by Ben Goldacre in great popularisers of science, methods | 6 Comments »

People often ask if there’s one good book that is accessible to all, about how evidence based medicine works. The answer is undoubtedly “Testing Treatments“. I name-check it to death in Bad Science, I learnt a huge amount from it, and it’s just come out in a new edition. You can (generously!) download the full text as a PDF for free here, and there are translations in various languages for free on that page too. I recommend getting a paper copy (they’re lovely and it’s very readable) here, there’s a proper Kindle edition here, and the publisher page is here. Meanwhile a website version with extra resources is coming shortly.

I genuinely, truly, cannot recommend this awesome book highly enough for its clarity, depth, and humanity.  My foreword for the new edition is pasted below. Read the rest of this entry »