Mittwoch, 14. November 2018

What we must learn from mesh

Fiona Godlee, The BMJ
What can we learn from the shameful story of vaginal mesh? That thousands of women have been irreversibly harmed; that implants were approved on the flimsiest of evidence; that surgeons weren’t adequately trained and patients weren’t properly informed; that the dash for mesh, fuelled by its manufacturers, stopped the development of alternatives; that surgeons failed to set up mesh registries that would have identified complications sooner; and that the National Institute for Health and Clinical Excellence and the UK regulators let them off the hook (doi:10.1136/bmj.k4137, doi:10.1136/bmj.k4164). As our editorial says (doi:10.1136/bmj.k4231), unless mandatory national registries are now established another mesh tragedy is inevitable.
The mesh story tells us something else: the extent to which surgeons, researchers, and professional bodies are entangled with the device manufacturers. This is nothing new. Indeed discussion of it will be as tediously familiar to most readers of The BMJ as it is to us editors. But we make no apology for raising it again. Why? Because of the evidence that researchers’ conclusions and clinicians’ decisions are influenced in favour of their sponsors’ products. If this were not the case, why would manufacturers spend the money? GlaxoSmithKline has just confirmed the usefulness of paid opinion leaders by reinstating payments to clinicians who speak and write about its products (doi:10.1136/bmj.k4157).
So I have two questions. First, should clinicians and researchers take money from industry? My answer is no. We don’t allow judges or journalists to take money from the people they are judging or reporting on. Doctors should be equally independent in their advice to patients. This is why, uniquely among the major medical journals, The BMJ ensures that the authors of clinical education articles and editorials are free from relevant financial interests (doi:10.1136/bmj.g7197). As for industry sponsored research, we welcome the call by Paula Rochon and colleagues for journals to ensure that academic authors retain full control of the process (doi:10.1136/bmj.k4224).
Second, given that doctors and researchers do take money from the industry, should the details be readily available to patients and the public? My answer is yes. Jonathan Gornall found this wasn’t the case with mesh (doi:10.1136/bmj.k4164), despite NHS guidance on declaration of financial interests. NHS trusts are catching up with their responsibilities, but slowly. The Association of the British Pharmaceutical Industry’s database is voluntary and therefore ultimately ineffectual. The device industry’s equivalent body, the Association of British HealthTech Industries, has refused to take even this baby step. The GMC has been asked to establish a register of doctors’ interests (doi:10.1136/bmj.h396) but shows no signs of doing so.
In the US the Sunshine Act hasn’t solved the problem (doi:10.1136/bmj.k4151) but it has put doctors on notice (http://bit.ly/2C94j6G). Other countries should follow this lead.
Follow BMJ Editor Fiona Godlee on Twitter @fgodlee and the BMJ @bmj_latest

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