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.
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 »
The GMC are focused mainly on the narrow issue of an individual doctor’s competence when seeing individual patients. But there are broader issues that have an equally important impact on patient care and public trust: failure to publish clinical trials, failure to participate in research, and imperfectly declared conflicts of interest, for example.
The Health Select Committee have an annual review with the GMC to discuss how they’re getting on. Here’s a letter I wrote to them, along with Iain Chalmers, Fiona Godlee and Trish Groves of the BMJ, and Ginny Barbour from PLoS. We suggest some actions the GMC could take to improve patient care on all these issues. Below that is the video of the committee raising our concerns with the GMC. Broadly speaking: the GMC said they’d have a think. This is forward movement, and there’s more to come next year, with the launch of something interesting, new, and fun (and currently a bit secret…). Read the rest of this entry »
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.
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 »
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…).
You can watch it here:
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 »
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).
The response so far, in a very short period of time, has been phenomenal. We have collected over 7,000 signatures already, simply from tweeting, and several extremely high profile organisations have signed up already, including: Read the rest of this entry »
This morning at 11:30, Dr Sarah Wollaston MP will ask questions in parliament about the ongoing scandal of missing trial data. This is widely recognised as a problem by academics and doctors, but governments, regulators, and journalists have neglected the problem, while industry simply denies it. Watch the questions live here or watch it later here.
As an example, we spent £500m stockpiling Tamiflu in the UK, but the company Roche are still withholding vitally important information about the trials on whether it works from Cochrane, the international academic collaboration who make gold standard reviews of evidence for doctors, patients, and governments.
Apparently this morning the Department of Health issued a statement to the Today Programme stating that all data from all trials on all drugs is already available by law. This is not true: but there may have been a communication problem, I am hoping to obtain a copy of this statement, and if you have one, please send it to firstname.lastname@example.org
Here are two articles from the Times today, on this issue. The first is a comment piece (by me). The second is a news piece about the growing number of doctors and academics speaking out on this issue, including editors of major journals, founders and directors of Cochrane, senior medics and academics, etc. Read the rest of this entry »