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.
Since Bad Pharma came out four months ago, we have seen some important positive developments. While the ABPI have attempted to claim – laughably – that the problem simply does not exist, the House of Commons Health Select Committee have already called on the GMC, NICE, and the pharmaceutical industry to address the problem of missing trials; the Public Accounts Committee may be looking at Tamiflu; the Science and Technology Committee have now announced an Inquiry into missing trials; there have been questions in parliament, including a PMQ, and there is more to come. The campaign at www.alltrials.net is already supported by such august bodies as the Medical Research Council, the Wellcome Trust, the National Rheumatoid Arthritis Society, and more.
It is very important that we maintain the pressure on this issue, as it may be our only opportunity to push for change. If you feel strongly about it, please sign the petition at www.alltrials.net, send it to your friends, ask your organisations to support it wherever possible, and do also consider contributing to justgiving.com/alltrials to support the lobbying work that we are doing, both behind the scenes and in public.
Withheld clinical trial results are the biggest untold scandal of the 21st century. It is modern medicine’s equivalent of bloodletting, and future generations will look back in amazement to think that we were ever so stupid as to tolerate it.
Lastly, before the press release, I would like to add one thing. There are two things at stake in this EU legislation: transparency, on which industry is lobbying hard; but also the administrative and “ethics committee” barriers to getting trials done in the EU, which are often disproportionate and destructive. I fully support industry and academics on the need to make the trials approval process more streamlined, and to get more trials done in the EU. I set out the case for this at length in Chapter 5 of Bad Pharma – “Bigger, Simpler Trials” – because the book is about problems in medicine far wider than simple industry pressure. We also set out similar arguments in this open access paper in the BMJ, in which we describe two low-cost trials in the UK using routinely collected health records.
But more importantly: a giant bravo to Glenis Willmott.
Monday 4 February 2013
Press notice for immediate use
Labour MEP leads drug trials transparency drive
“Too many results from clinical trials are misleading, biased or missing,” according to Glenis Willmott MEP, Labour’s health spokesperson in Europe and Leader of Labour MEPs. “It is time that all pharmaceutical companies and researchers made the full results of studies on new and existing drugs publicly available.”
Mrs Willmott is the European Parliament rapporteur, or lead legislator, for the revision of the European rules on clinical trials. Her report, calling for wide-ranging transparency measures, has been released today.
“I want to see comprehensive results from clinical trials published on a public database,” said Mrs Willmott. “A summary of the results is not enough. Summaries written by those that carried out the research can be biased, and make a medicine sound more successful than it really is. Independent researchers need access to the results of the trial in order to verify the sponsor’s claims.”
Mrs Willmott is proposing that a full clinical study report is published. This is the same document that companies must submit to regulators for approval of their medicine, and therefore contains a full account of how the clinical trial was conducted and what the results were.
“I also want to see financial penalties imposed on those that do not upload their results on time,” said Mrs Willmott. The law in the US requires all trial results to be uploaded within a year, but a 2012 audit found that 80% of trials had failed to comply. “If we are serious about openness in medicine then we have to levy fines on those not following the rules.”
Numerous academic studies have found that around half of all trials are never published, usually those with negative or disappointing results.
“For too long unflattering studies have gone undisclosed,” said Mrs Willmott. “It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective or even dangerous.
“When a patient makes the decision to take part in a clinical trial, they do so to help advance medicine, to improve treatment for themselves and for those in a similar situation. They do not do it to help a particular company promote a particular drug.”
Notes to editors:
- Glenis Willmott’s full report can be found here: www.europarl.europa.eu/
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- The report will be voted on in the European Parliament’s Committee on Environment and Public Health before Mrs Willmott begins negotiations with EU governments.
- The original proposal from the European Commission can be found here: ec.europa.eu/health/
- Research on problems with the US law can be found here: www.bmj.com/content/
- Research about unpublished results can be found here: www.hta.ac.uk/fullmono/
For more information contact Andy Flagg on 00 32 228 47459 / 00 32 49359 1499