David and Beth from the National Committee recently attended the Evidence Live in Oxford. Evidence Live is a huge conference all about Evidence Based Medicine and included speakers like Ben Goldacre and Peter Gøtzsche amongst others.
Whilst at the conference, David and Beth both did an interview with doc2doc and BMJ editor Matthew Billingsley talking about EBM at medical school amonst other topics like Bad Guidelines.
Have a listen to the podcast in the video->
We wrote a response to an article entitled "Drug company gifts to medical students: the hidden curriculum". You can read it here.
Furthermore, in response to the Bad Guidelines campaign, of which we are part of, the BMA has withdrawn from the Ethical Standards in Health and Life Sciences Group. You can read the full press release here.
We urge the remaining members of the ESHLSG to state why they believe our assertions to be inaccurate or withdraw from supporting the statement and the group.
Much has happened since we launched the campaign and since the Lancet withdrew their support for the Ethical Standards in Health and Life Sciences Group’s guidelines on interactions between healthcare professionals and
the pharmaceutical industry. These are our responses to key developments.
1. We welcome growing recognition that these guidelines are deeply flawed
Following the Lancet withdrawing their support for the guidelines on 1 February, a number of other signatories have made it clear that they are reviewing their endorsement of these guidelines. The Medical Schools Council stated in a letter to us that the‘potential risks of interaction with
industry should also be made clearer in the guidance’.
2. The current version of the guidelines are misleading and should be withdrawn
A number of signatories to the guidelines have stated a desire to revise the guidelines. This is a reasonable medium term goal. On 13 February, a note on the ESHLSG website stated their intention to review these guidelines at their next meeting. The ESHLSG note states that ‘there has been some criticism and misunderstanding’ of the guidelines but does not elaborate. We continue to assert that the guidelines as currently drafted
contain misleading statements on important issues. The ESHLSG should either state why they believe our assertions are inaccurate or promptly remove the document from their website.
3. Scrutiny of decision-making processes within leading organisations in healthcare is needed
It is concerning that major organisations signed a set of guidelines containing statements at odds with published systematic reviews and other high quality syntheses of the available evidence. Before commencing work on a replacement set of guidelines, we suggest the ESHLSG and those organisations that endorsed these guidelines review their decision making processes. Healthcare professionals need to know what went wrong this time and to understand the changes that have been enacted to prevent similar mistakes in the future.
4. Members of the ESHLSG should sign up to the All Trials Campaign
The demands of the All Trials Campaign are very moderate – simply that ‘All trials past and present should be registered, and the full methods and the results reported.’ Until this occurs, patients will come to harm as a result of decisions not based on the totality of the evidence. Members of the ESHLSG are notable for their absence among the group of organisations that have endorsed the campaign. It is time that they joined GlaxoSmithKline, the Wellcome Trust, the Medical Research Council, the Cochrane Collaboration, more than eighty patient groups, professional organisations such as The Faculty of Intensive Care Medicine and tens of other organizations in showing real leadership and standing up for patients.
For more information about Bad Guidelines go to: www.badguidelines.org
The Bad Guidelines campaign gets a mention today in the BMJ "Lancet withdraws its support of document on collaboration between doctors and drug industry" and Wired "Campaign scrutinises relationship between doctors and pharmaceutical industry".
"It's important to be clear that these aren't controversial issues, nor are they "anti-industry". We're talking about the fabric of evidence based medicine: how evidence is brought together, and then disseminated to doctors and patients, to make informed decisions. Industry education and drug reps are biased ways to disseminate evidence to practitioners. Withheld trial results are an ongoing problem, and this distorts the evidence that doctors and patients use. This is the mainstream bread and butter of how medicine works, and we need to have realistic open discussions about the problems, not headline statements that say everything is fine."
Dr Ben Goldacre
The Association for the British Pharmaceutical today published a response to last weeks Lancet editorial on their website here.
The ABPI has responded by saying that the document is not an ABPI document, nor was it led by the ABPI, but it was "agreed and signed by a range of healthcare organisations". The statement outlines some of the measures the ABPI has taken to drive change within the pharmaceutical industry, including deciding to cease the provision of promotional aids and forcing pharmaceutical companies to disclose any payments they make to medical professionals to endorse their products by 2016. The ABPI says that it has a code of practice that requires companies to disclose details of the results of all clinical trials within one year of the drug being authorised for market. Companies also have to publically register clinical trials within 21 days of them starting. "We believe that greater transparency of clinical trial data is in the best interest of patients, medicine and science. Our differences lie in how this should be achieved." The ABPI is part of an EMA working group looking into the "mechanics of exactly how to do this".
Speaking in an article posted on wired.co.uk earlier today, Author and epidemiologist Dr Ben Goldacre, who supports the Bad Guidelines campaign, is not satisfied with this response. Read his full reply on Wired.
Yesterday saw the launch of badguidelines.org, a campaign led by doctors and medical students. This campaign is in response to a document Guidance on Collaboration between Healthcare Professionals and the Pharmaceutical Industry.
Most major healthcare organisations in Britain have signed this misleading set of guidelines. This document contains a series of factually incorrect statements on important issues that have a significant impact on patient care, including medical education, and the availability of withheld data from clinical trials. The groups who have signed this misleading document include: the British Medical Association, several Royal Colleges and the Department of Health.
It claims that ‘Information about industry-sponsored trials is publicly available’. This is untrue. The best current estimate is that data from half of all the clinical trials that have been completed have never been published. There is an active campaign on this problem at alltrials.net, with support from groups including the BMJ and the Medical Research Council, with a Commons Select Committee inquiry into the issue recently announced.
The document also claims that drugs company sales representatives ‘can be a useful resource for healthcare professionals’. This, again, is a misleading statement. The best available evidence from 58 studies summarised in a recent academic review shows that overall, doctors who see drug company sales representatives are worse prescribers, prescribing more and with higher prescribing costs. No research has ever shown that “drug reps” improve prescribing.
In an article published on the Lancet website yesterday morning, Richard Horton withdrew the Lancet’s support for the document, stating ‘The statements made in the “guidance” certainly do not match the latest evidence about the behaviour of pharmaceutical companies today’. Read the article here.
We call on the organisations that have endorsed these guidelines to heed the evidence and reconsider their position.
If you're a member or know any members of the BMA, RCPsych, RCP, RCPEdinburgh, RCGP, RCN or Royal Pharmaceutical Society, contact us firstname.lastname@example.org or at our website.
1. The Bad Guidelines Campaign is a joint initiative by Pharmaware, Healthy Skepticism UK, Conflict Free Conferences, Dr Ben Goldacre and Medact. More details can be found at www.badguidelines.org.