No such thing as a free lunch – why recording conflicts of interests must be mandatory - Medical devices (existing) - Patient Safety Learning

PUBLISHED 9 April, 2021
ORIGIN UK
TYPE Blogs
CONTENT TYPE New
SUGGESTED AUDIENCE Everyone

TAGGED

Summary

Kath Sansom, is a journalist and campaigner who, following a pelvic mesh implant, was left in intense pain and subsequently founded the Sling the Mesh campaign. In this powerful opinion piece, Kath highlights the lack of transparency and reporting around financial conflicts of interest in UK healthcare, and why this poses a serious threat to patient safety.

Drawing on legislation that was introduced in the US and recommendations from the Cumberlege Review, Kath calls for urgent action to be taken to prevent patients from suffering harm in the future.

Content

Corruption, greed and deceit, sound like the basis of a gripping crime novel or a binge-worthy Netflix series, but for patient campaigners it’s what we find on an alarming basis when it comes to the lucrative world of healthcare. We’re in an age of miracles where modern medicine can achieve remarkable things, but this can lead to patient safety taking a backseat when shareholders have dollar signs in their sights.

We hear how tragedies such as the mesh scandal, Primodos, Valproate, metal hips and PIP breast implants must never happen again. But until we have tougher regulations, alongside strict rules forcing both doctors and industry to declare money and gifts which have exchanged hands in return for lectures, research, training and more, then tragedies will keep happening.

Mandatory reporting of conflicts of interest was one of nine key recommendations by the Baroness Cumberlege First Do No Harm review. Clinicians and industry should be forced to declare. Some argue that taking a gift will not lead to bias, but studies prove otherwise.[1] [2] As patient campaigners we will always argue there is no such thing as a free lunch.

As a matter of urgency, the UK needs a Sunshine style payment act, as was put in place in America in 2013. There are similar versions of this in Denmark and France. The act provides a public database to search who pays our doctors. It is so easy, a 10-year old could use it. Simply pop in a doctor’s name and hey presto! You can see money they’ve taken for sandwiches, training, research, papers and much more. We know of one medic who took more than £2 million from 2013 to 2019, leading to a huge question mark over his slick, pro-mesh website, which assures women that mesh implants are safe with minimal risks.[3]

A Sunshine style act would make it a legal requirement for healthcare giants to declare all monies and gifts given to doctors, teaching hospitals and research institutions.

Taking money from industry can lead to a ‘marking their own exam papers’, buddy culture, where certain healthcare treatments are pushed over others – not because they are better or safer even, but because of, for example, a great session on the golf course with free wine afterwards with the wives.

In the UK our reporting system is currently voluntary, to a database called Disclosure UK, set up in 2016.[4] But it is clear this is not working. Firstly, because of EU privacy law, declaration is voluntary. Health professionals can exclude certain payments or opt out entirely. And there is no option for a nil return so if a doctor isn’t listed this could mean either no payments were received, or the doctor declined to be identified.[5]

Additionally, the NHS is not great at logging employee interests, according to a BMJ study, which found that no NHS Trusts in England met all the transparency criteria. The BMJ contacted 236 Trusts, of which 217 responded: 51 did not provide a Gifts and Hospitality Register and only 31 of the registers contained enough information to assess employees’ conflicts of interest. Despite obligations to report, the current system is not functioning adequately.[6]

Scottish GP, Margaret Mc Cartney, is among a medic-led campaign for a Sunshine style payment act in the UK.

She said:

“Doctors may receive money and benefits from a wide range of sources.

“They may be paid by the pharmaceutical industry to give lectures to other doctors. They may run companies that sell health services to the NHS. They may receive hospitality, such as food and drink, or accept free travel and hotel accommodation from industry in order to attend conferences.

“They may accept free training about which treatments work best, that has been funded by drug companies. They may be paid by industry to conduct research. They may be paid by PR companies working on behalf of drug companies, or providers of health services, such as companies making supplements, health products, or foods.”

As patients we deserve to know who is funding our doctors, including if a husband or wife has financial interests.

It's not necessarily a bad thing if doctors are paid for their time and expertise. For example, working for NICE, or giving expert views to court. However, it's important such information is provided as a legal requirement and is freely available on a public database, so patients can draw their own conclusions.

Sling the Mesh (STM) recommendations

Consider the introduction of an American style Physicians Sunshine Payment Act to ensure mandatory reporting of all payments from industry to clinicians.
STM believes an American style Physician Payments Sunshine Act is essential in the UK to ensure mandatory reporting of all payments from industry to medical professionals. In this we are joined by the British Medical Journal and by prominent medical professionals such as Dr Ben Goldacre of the University of Oxford. Such an act would have the aim of increasing transparency around the financial relationships between healthcare professionals and drug and device companies.
The existence of a financial payment from a drug or device company to a doctor or author of a medical study does not, of course, carry with it an automatic assumption of bias, or wrongdoing. However, it has been proven that industry payments to doctors can affect their treatment of patients.[7] [8] In addition, it has also been shown that studies sponsored by drugs or device companies are more likely to find results that favour the company.[9] [10]
It is argued that industry sponsorship of clinical trials, and the payments industry makes to medical professionals, are an inevitable part of the development and use of drugs and devices. Whatever arguments are made for the necessity of personal payments to medical professionals by drugs and device companies, it would seem sensible that all such payments are publicly declared. This would enable the broader influence of industry on the use of particular drugs and devices to be assessed. Whilst rules and recommendations for the declaration of industry payments already exist in the UK, at present they are haphazard and fragmented
Since 2016, the Association of the British Pharmaceutical Industry (ABPI) has maintained a database of payments to healthcare professionals from drug companies. This database is known as Disclosure UK.[11] However, disclosure of payments to this database is not mandatory for healthcare professionals, and the database does not cover payments made to healthcare professionals from medical device companies. For these reasons the Disclosure UK database is not sufficient for the purpose described above. In addition, in 2016, a rule was introduced that required NHS hospitals to keep a list of gifts and payments to NHS staff, but it is unclear whether this is being adhered to. A recent analysis by Dr Ben Goldacre and others of clinicians’ conflict of interest disclosures to NHS hospital employers in England showed that “recording of employees’ conflicts of interest by NHS trusts is poor”.[12]
STM believe the most practical solution is the enactment of an American style Physician Payments Sunshine Act. In the United States reporting of all payments made to medical doctors by both drug and device companies is now mandatory. It is the responsibility of the companies to declare such payments to the US Government’s Centers for Medicare & Medicaid Services (CMS). A publicly accessible database of such payments is maintained by the CMS[13] Such a system should also work well within the UK.