By Ruth MacLeod and Kath Sansom of Sling the Mesh campaign. A blog written for HealthSense Summer 2024 newsletter.

The UK boasts an ambition of being a life sciences superpower, yet with great power comes great responsibility. Advocates like Sling The Mesh fear that the health sector has become a free-for-all with a focus on profits before patient safety. Which is why we’re urging the new Government to put transparency at the heart of its plans on healthcare.

We urgently need a UK Sunshine Act, making it a legal obligation for the pharmaceutical and device industry to log all monies they give to the health sector, with this payment information to be held on a central, public register.

This transparency would enable us to determine when potential bias can creep into prescribing, the scientific literature, health charities, parliamentary groups, surgeon societies and on a more subtle level, into clinical consensus via the use of key opinion leaders.(1)

Yet the General Medical Council have made it clear they do not wish to hold such a register. And as patient safety advocates, we believe it is unacceptable for it to be held by the Association of the British Pharmaceutical Industry, or any other industry body – as suggested in a recent Government consultation.(2)

Instead, the information should be held on Government-run open database which would give researchers, journalists, campaigners, and the public the ability to search up the scope and scale of industry monies, to gauge their impact.

This is the system used in the USA (3) and France,(4) for example.

Too few checks

Currently, industry money and influence seeps in with too few checks into the coffers of clinical key opinion leaders, medical societies, NHS Trusts, charities, and training budgets.

Of course, the existence of a financial payment from industry does not carry an automatic assumption of bias, or wrongdoing. 

But evidence shows industry payments to doctors can affect their choice of treatment for patients(5) – and that studies sponsored by drug or device companies are more likely to find results favour the company.(6)

It is against this background that the decades-overdue need for transparency is clear.

Industry payments are argued to be an inevitable part of medical innovation. But whatever arguments can be made for their benefits, there is no good argument against transparency round their existence. Transparency would at least enable the influence of industry on the use of particular medicines and devices to be fully assessed.

Voluntary, non-statutory systems for declaration of interests in medicine have long been in use – but all the evidence suggests they don’t work well.

Funding not declared

Scientific journals are supposed to require study authors to declare any relevant financial conflicts of interest – but Sunshine Act legislation in the USA has demonstrated that this system is failing.

The Act has made it possible to compare doctors’ legally-required declarations of money they receive from industry, with what those same doctors actually disclose when they publish a scientific paper in a journal. A recent analysis of American authors of studies on pelvic mesh found that 53 of the 56 reviewed had at least one author who received industry funding near the time of publication. For 47 of these 53 studies, this funding was not declared.(7)

And whilst NHS Trusts have guidance encouraging employees to disclose relevant conflicts of interest, evidence suggests recording and disclosure is poor.(8)

In a landscape of health scandals such as mesh implants, valproate, Primodos and the infected blood scandal,(9) it is clear these payments require heightened public scrutiny.

So, we were pleased when, after years of lobbying by Sling the Mesh and other advocates, the government ran a consultation on transparency of payments from industry to the healthcare sector in October.(2) This followed draft legislation in the Health and Care Act 2022 laying the foundations for a Sunshine Act, a duty on manufacturers to report details of the payments they make to healthcare professionals and organisations.(10)

The draft legislation had resulted from a recommendation in the 2020 First Do No Harm report of the Independent Medicines and Medical Devices Safety (IMMDS) Review(11) led by Baroness Cumberlege for a mandatory register of payments. The report showed us that industry and the healthcare system must adapt to listen to patient needs and prevent the failings of the past.(12)

Proposals confused and unworkable

Yet when the Government consultation came out, the proposals appeared confused and unworkable. And imagine our disappointment when we and other interested groups – including HealthSense – wrote to the Health Select Committee chair to query this,(13) urging them to enact transparency of payments legislation – only to have our letter ignored for four months. We only received a response following intervention by politicians in the First Do No Harm All Party Parliamentary Group.

And the response was disappointingly uninterested: 

“Unfortunately, an administrative error on our part prevented this reaching you sooner. This response has been amended to reflect the latest position.”

The then Government’s reply went on to reiterate a widely held view that the voluntary system currently in place in the UK is sufficient and merely needs jigging up a bit – a system patients know will never work. The main database currently in use, Disclosure UK,(14) is overseen by the Association of the British Pharmaceutical Industry, a conflict of interest. Healthcare professionals can opt out of having their payment data declared on this database, and many do.

And there is no database tracking payments to the healthcare sector from the device industry, nor any plans to develop one.

Industry should be responsible

We believe it should not be the responsibility of healthcare professionals to report but instead industry should do the heavy lifting by logging all the payments they make to the whole healthcare sector.

As mesh-injured patients, overseeing a support group of more than 10,600, we are at the daily coalface of how industry payments can lead to patient harm.

It is difficult to describe the carnage on the group page. Day after day, women describe unrelenting chronic pain, job loss, marriage breakdown, suicide ideation. We feel helpless in the face of it. Most strikingly, the majority of women who developed problems after mesh surgery report these were dismissed by their surgeons, that they were told they were an outlier. Often, women were told the problems were all in their heads.

Without the influence of payments from mesh manufacturers(15) on surgeon key opinion leaders, the professional societies, conferences and training days, and on the scientific literature cited in defence of mesh,(16) we don’t believe this institutional denial that led to the mesh scandal would have happened.

Studies stating mesh was safe and effective were cited to justify its continued use, and the dismissal of those harmed. Yet later analysis of NHS hospital episode statistics(17) showed the mesh removal rate alone was far higher than the official 1-3% complication rate cited in the academic literature for the main type of mesh surgery.(18)

Investigated by Cumberlege

Similar stories played out with the opioid crisis,(19) as well as the use of sodium valproate and Primodos, the other interventions investigated by the Cumberlege review.(11)

Statutory transparency wouldn’t remove the risk of tragedies like the mesh scandal recurring. But it would allow for proper analysis of the role of industry in the healthcare sector in 2024.

In the early days of our campaign, it was difficult to get the media to understand the problem with some of the scientific research – had we been privy to an open database publicly listing payments to the health sector, our voices would have been taken seriously with greater speed.

We believe a Sunshine style Act for the UK would shine a light into the dark corners of hidden payments and become an essential tool to support transparency. It would become first step on a long journey of helping the public, media, politicians and health charities understand the flaws that are weaved into the scientific literature and healthcare promotion.

How can you help?

Write to your newly elected MP asking them to email the Health Select Committee, urging them to put transparency at the heart of healthcare and enact section 92 of the Health and Care Act 2022,(9) introducing secondary legislation placing a duty on manufacturers to report details of the payments they provide to the health sector to a central, government-held registry. You will find them here: Find your MP – MPs and Lords – UK Parliament.(20)

Ruth MacLeod and Kath Sansom

Sling the Mesh

What is the campaign about?

References

1. Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? BMJ 2008;336:1402
2. Dept of Health and Social Care, HM Government. The disclosure of industry payments to the healthcare sector. Online at: https://www.gov.uk/government/consultations/the-disclosure-of-industry-payments-to-the-healthcare-sector
3. Centers for Medicare & Medicaid Services. Open Payments. Online at: https://www.cms.gov/priorities/key-initiatives/open-payments
4. Grundy Q et al. Decoding disclosure: Comparing conflict of interest policy among the United States, France, and Australia. Health Policy 2018;122(5):509-518.
5. Ornstein C et al. Now There’s Proof: Docs Who Get Company Cash Tend to Prescribe More Brand-Name Meds. ProPublica, 17 March 2016. Online: https://www.propublica.org/article/doctors-who-take-company-cash-tend-to-prescribe-more-brand-name-drugs
6. Lundh A et al. Industry sponsorship and research outcome: systematic review with meta-analysis. Intensive Care Medicine 2018;44:1603-1612
7. Coderre-Ball A, Phillips SP. Extent, transparency and impact of industry funding for pelvic mesh research: a review of the literature. Research Integrity and Peer Review 2024;9:4
8. Feldman HR et al. A cross-sectional study of all clinicians’ conflict of interest disclosures to NHS hospital employers in England 2015-2016. BMJ Open 2018;8:e019952
9. McArdle H. Denial, complacency: What blood inquiry reveals about NHS. The Herald, 22 May 2024. Online: https://www.heraldscotland.com/news/24337776.denial-complacency-blood-inquiry-reveals-nhs/#comments-anchor
10. UK Government. Health and Care Act 2022. Section 92. Online at: https://www.legislation.gov.uk/ukpga/2022/31/section/92
11. Independent Medicines and Medical Devices Safety Review. First do no harm. 8 July 2020. Online: https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
12. Haskell H. Cumberlege review exposes stubborn and dangerous flaws in healthcare. BMJ 2020;370:m3099
13. Letter to Rt Hon Steve Barclay MP, Secretary of State for Health and Social Care & Steve Brine MP, Chair of the House of Commons Health and Social Care Committee. 16 October 2023. Online: https://committees.parliament.uk/publications/42087/documents/209337/default/
14. Association of the British Pharmaceutical Industry. Disclosure UK. Online: https://www.abpi.org.uk/reputation/disclosure-uk/
15. Gornall J. Vaginal mesh implants: putting the relations between UK doctors and industry in plain sight. BMJ 2018;363:k4164
16. Gornall J. The trial that launched millions of mesh implant procedures: did money compromise the outcome? BMJ 2018;363:k4155
17. Devlin H. ‘Scandal’ of vaginal mesh removal rates revealed by NHS records. The Guardian, 15 Aug 2017
18. Letter from Sir Bruce Keogh, NHS Medical Director for England, to NHS medical directors, 21 November 2012. Online: https://assets.publishing.service.gov.uk/media/5a7bfb82ed915d414762209a/Vaginal-tapes-and-meshes-letter-to-NHS-final1.pdf
19. Spithoff S et al. Drivers of the opioid crisis: An appraisal of financial conflicts of interest in clinical practice guideline panels at the peak of opioid prescribing. PLoS One. 2020 Jan 24;15(1):e0227045
20. UK Parliament. Find your MP. Online: https://members.parliament.uk/FindYourMP