(B)3-Bad Science, Bad Pharma…now Bad Guidelines
The latest front in the increasingly strained relationship between the pharma industry and the medical profession has just opened up. Bad Guidelines, an initiative led by doctors and medical students points the finger at this 2012 document “Guidance on collaboration between healthcare professionals and the pharmaceutical industry” by saying that “Most major medical organisations in Britain have signed a document that contains a number of statements that are demonstrably wrong. These statements concern important issues such as medical education and the availability of data from clinical trials.” And that “In signing this document, these organisations have made a mistake” and then goes onto appeal to the better sides of the organisations’ leaders by saying that “many are led by good and thoughtful people. We are confident that they will do the right thing.”
PLOS Medicine never signed up to this initiative. We understand and have consistently published on the inherent conflicts in the relationship between pharma and the medical profession and the risks to patients if the relationship is not robustly managed. Moreover, a 2010 systematic review found that exposure to information provided directly by pharmaceutical companies found no improvement in quality and at worst led to higher costs, or lower prescribing quality.
Prompted by Bad Guidelines and one of its leaders Tom Yates, organisations are now beginning to backtrack from this initiative, starting with the Lancet last week. What’s more surprising is that they ever signed up. This document at best glosses over some areas which have been challenged directly by published research, such as this statement “Information about industry-sponsored trials is publicly available.” A 2012 BMJ article showed, by contrast, that most trials subject to mandatory reporting under the US FDAAA act did not report results within a year of completion.
While there are legitimate reasons for collaborations between pharma and healthcare professionals, organizations that work for patients or the medical profession need to think for themselves what’s needed, be very wary of any pharmaceutical company led-initiative and insist on developing their own guidelines and transparent rules of engagement.
It’s also of note that organisations that signed up to guidance document have been rather less willing to sign up to the AllTrials initiative, which aims to get all trials registered and all results reported.
The medical profession, journals and all those who champion evidence-based medicine need to actively challenge the rosy picture of the relationship between pharmaceutical companies and the profession that the companies paint and to advocate instead for an equal relationship that puts full disclosure of evidence at its heart. Journals such as the BMJ and PLOS Medicine, organizations such as Pharmaware, PharmedOut, the National Physicians Alliance and public advocates for change such as Ben Goldacre are all playing a role here; other organizations need to decide where their loyalties lie.
You refer to the BMJ 2012 paper by Prayle et al. to underline your point that the statement as if “information about industry-sponsored trials is publicly available” is not correct. That paper however shows that although overall compliance to the results reporting is only 22%, industry actually complies “better” than non-commercial sponsors. The All Trials initiative is to be applauded but applies both to industry- and publicly funded studies, and perhaps even more to the latter.
Henk Jan Out, Radboud University Nijmegen Medical Centre, the Netherlands
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