EBM Live was, as ever, brilliant (BTW next year it’s in Toronto, July 8-6). One thing that I was aware of previously but it hadn’t really registered was the scandal around vaginal mesh. For an overview of the issues see this video
I spoke with Kath Sansom (of Sling The Mesh) on a number of occasions, including an excellent session at Oxford’s Natural History Museum (alongside speakers representing Primodos and Sodium Valproate).
Lots has been written about these issues, a small sample being:
- Transvaginal Mesh Timeline
- What a Mesh
- Vaginal mesh implants: putting the relations between UK doctors and industry in plain sight
- Tape or Mesh: Take-home messages
- Harms in Healthcare: Primodos, Vaginal Mesh and Sodium Valproate
I’m raising this as it highlights a number of issues that are relevant to what Trip does:
- It was very useful for me to understand the way lives are affected by these things. It can be ‘easy’ to treat these as abstract issues. They’re not.
- There seems to be huge issues relating to the regulation of devices from a safety and efficacy issue. In the video I was struck by how self-satisfied John Wilkinson (from the UK regulators the MHRA) appeared to be. I’d prefer a regulator that was a lot more dynamic on these issues. His response was, in essence, to say everything’s fine with how we regulate devices.
- Outcomes – the outcomes used in the mesh studies seem laughable and certainly not patient focused. A main outcome being the number of Tena pads used over a period of time. Sure, that’s a measure to test one aspect of efficacy of the intervention but, given the severe adverse events that can occur, seems wholly inadequate.
- Declaration of interests. In the UK there is no requirement for doctors to declare payments from industry. The USA has the Sunshine Act which “…requires manufacturers of drugs, medical devices, biological and medical supplies covered by the three federal health care programs Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP) to collect and track all financial relationships with physicians and teaching hospitals and to report these data to the Centers for Medicare and Medicaid Services (CMS). The goal of the law is to increase the transparency of financial relationships between health care providers and pharmaceutical manufacturers and to uncover potential conflicts of interest.“. In the UK we have no such arrangement. Doctors like Margaret McCartney have been trying for years to improve the situation (see here and here as a couple of examples). Until that becomes compulsory we have no way of knowing if the doctors advocating an intervention (mesh or anything else) aren’t receiving ‘support’ from the device (or drug) manufactures. A key element of EBM is one of transparency so that shared decisions (between patients and health professionals) can be made. If the health professional is receiving ‘support’ from a manufacturer they’re getting this support to help guide decisions in the manufacturers favour which might not be the same as the patient! It really is quite simple.
- Kath was saying, as a non-health professional, it took a long time to start to get her head around scientific language. The medical literature should not be the preserve of health professionals. I’d like to think Trip could help here and I’m working on an idea to allow more support for ‘non experts’ to understand the medical literature.
I can’t help feeling Trip should use it’s reach to campaign more on things like this….