9 March 2013 – BMA withdraw from ESHLSG and from Guidance Document
The Bad Guidelines campaign welcomes the British Medical Association’s decision to withdraw support from the Ethical Standards in Health and Life Sciences Group (ESHLSG) and associated guidance, including the ‘Guidance on collaboration between healthcare professionals and the pharmaceutical industry,’ the document that triggered this whole initiative.
We call on the other members of the group to do the same.
This news comes just as we prepare to submit comments to the ESHLSG on what we believe is wrong with the guidelines as part of their review on the guidance document.
More news to come soon! You can find the BMAs official statement here.
16 February 2013 - Bad Guidelines briefing document – progress and what must happen next
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 The current version of the guidelines are misleading and should be withdrawn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.
To download the full press release, please click here.
5 February 2013 – we write to signatories
We have asked the organisations that have endorsed these guidelines to respond to our arguments. We will let you know when we receive any responses.
1 February 2013 – Campaign launches with a bang!
Day one of the campaign saw our first big win with leading medical journal the Lancet withdrawing their support for the guidelines, following an email from us…
In a comment article published on 1 February 2013, editor Richard Horton wrote
‘I am grateful to Tom Yates, from University College London, for alerting me to a campaign that deserves our support. His target is a document, whose creation was led by the Association of the British Pharmaceutical Industry (ABPI), entitled “Guidance on collaboration between healthcare professionals and the pharmaceutical industry”. It is signed by some great and good institutions: the Royal Colleges of Physicians, Psychiatrists, and General Practitioners, the British Pharmacological Society, Department of Health, the Scottish and Welsh Governments, and even the British Medical Association. And The Lancet. Let me quote Tom Yates in his own words, with additions for clarification. “The guidelines are problematic as they contain claims that are demonstrably false. For example, points 4 [Industry plays a valid and important role in the provision of medical education] and 6 [Medical representatives can be a useful resource for healthcare professionals] in ‘10 things you should know’ are at odds with Geoff Spurling’s recent [PLoS Medicine, 2010] systematic review on the impact that information from pharmaceutical companies has upon prescribing [“With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality…”]. Point 3 [Information about industry-sponsored trials is publicly available] implies that hidden trials data is a historical problem, where, as you will know, it is now the focus of a major campaign and at least one [UK] parliamentary enquiry…Do you think there is any possibility that The Lancet might be able to publicly distance themselves from the Guidelines?” The statements made in the “guidance” certainly do not match the latest evidence about the behaviour of pharmaceutical companies today. Indeed, this evidence undermines the principles we originally signed up to, principles that attempted to forge a new and more constructive partnership between medicine and the pharmaceutical industry. It’s time for us to withdraw our name from the “guidance” as it currently stands.’
1 down, 17 to go! In the next weeks we will be asking the other signatories to these guidelines to reconsider their support in light of the evidence. Can you help? We’d love to hear from you.