It was never “just women’s problems”. After decades of having their suffering dismissed, many patients will have been relieved about the publication of the Independent Medicines and Medical Devices Safety Review yesterday. Led by Julia Cumberlege, the review has spent two years investigating three medical interventions: pelvic mesh, used in prolapse surgery, which resulted in chronic, life-changing pain for many women; Primodos, a hormonal pregnancy test, used up until 1978; and sodium valproate, an epilepsy treatment. The latter two have both been linked with birth defects.
Stories of harm in the report, predominantly from women and children, are harrowing. After using mesh, many women reported severe pain and loss of normal pelvic function. They also spoke of the difficulty in having their symptoms properly investigated or believed. Mothers now in their 70s who took Primodos decades ago expressed their guilt and worry about who would be there to care for their children; many were born with lifelong special needs as a result of the hormonal therapy.
What went so badly wrong? Take pelvic mesh. This substance is placed into the pelvis during surgery to strengthen the tissues and prevent prolapse. It’s a permanent measure – so you’d think that the mesh would need to be adequately tested, and shown to be safe and effective. Did this happen? Not sufficiently. Lax regulation meant companies could state their products had “equivalence” to older products without undergoing stringent new trials (even though some of the products they were supposedly “equivalent” to were later withdrawn out of safety concerns). Although some regulations have now been tightened, many doctors fear this hasn’t gone far enough – and I agree.
Part of the problem is conflicts of interest. The usual operation for pelvic prolapse is invasive and takes a long time to recover from. Hospitals want to reduce waiting lists – so a company offering a faster, better operation may find a captive audience. An investigation by the British Medical Journal in 2018 found mesh implant manufacturers “aggressively hustled” their products into widespread use. Ulf Ulmsten, the Swedish obstetrician and gynaecologist who pioneered mesh after a first trial showed impressive results, received funding from Johnson & Johnson to conduct a larger trial of the device in 1997. Unbeknown to his patients, Ulmsten had also signed an agreement with a Johnson & Johnson medical devices company that would make him a fortune should the larger trial agree with the first. Unsurprisingly, the second trial showed the product worked. It was a case of marking your own homework.
Cumberlege’s report includes several recommendations to prevent similar problems in the future, such as proper surveillance to reliably track side effects, and accurate patient information leaflets detailing the risks of procedures. It also recommends that doctors make statutory declarations of their interests. This is something members of parliament have long been doing. Every MP must make a declaration of potential conflicts, which are publicly accessible on parliament’s website. This allows us to choose where we place our trust. If an MP may financially benefit from supporting a particular policy, we want to know.
So why should this be any different for doctors? If a doctor recommends one treatment over another, we should be confident they don’t have a financial interest at stake. Campaigners who have been harmed by mesh have found that some doctors who recommended the device also received payments from manufacturers – as speakers, for travel, or as consultants. To be fair, the large majority of healthcare professionals don’t receive industry funding. But a small number of doctors can have a disproportionately large effect. If a doctor acts as a consultant to a company that manufactures joint replacement devices, and also works on a guideline committee, for example, then a bias towards a particular treatment doesn’t just affect a few patients, but all the patients whom the guidelines apply to.
How would a declaration scheme work in practice? There are currently several hybrid, incomplete and fuzzy systems, none easy to use. The Association of the British Pharmaceutical Industry publishes a list of healthcare professionals paid by industry. It’s voluntary, and millions are unaccounted for (in 2019, pharmaceutical companies paid a total of £157m to healthcare professionals and organisations for “payments and benefits in kind”). And it only covers pharmaceutical products – not technology or devices, or supplement companies.
Hospitals in England are meant to publish registers of interest of staff – but a 2016 study shows that only a minority give the details they should. A publicly accessible digital register, updated at least annually and compelled by the regulator, would create transparency and get rid of the huge amount of work that campaigners have had to do to untangle where conflicts lie. We also should talk about “declaring interests” rather than “conflicts” – we need light, not heat.
Declarations alone can’t sort the problems of conflicted medicine. But a public register would allow us to know whose advice isn’t independent. We will still need to be alert to the unintended consequences of a register, and research will be needed.
Many “sunshine acts”, which allow patients and colleagues to see who is being funded for what, are already operating across Europe – in Portugal, France, Denmark – as well as in the US and Australia. And we should not stop at doctors: pharmacists and nurses are also subject to some of the same problems.
The UK is lagging behind. Kath Sansom, a journalist who founded the Sling the Mesh campaign, recently told me: “I had no idea that I couldn’t trust my doctor or surgeon to give the best advice. It is essential that medics declare industry funding.” I agree. After the publication of this inquiry, there can be no more excuses.
• Margaret McCartney is an author and broadcaster who was one of the founders of whopaysthisdoctor.org
