The Cumberlege review into independent medicines and medical devices safety reminds us once again of the damaging impact of financial conflicts of interest on patients.
The review’s analysis of the regulatory framework which covered the use of pelvic mesh, sodium valproate and Primodos, found that clinicians with conflicted interests sat on expert working groups and advisory committees reviewing the efficacy and safety of these interventions and that the medical devices safety regulator (the MHRA) had strong links to the industry it was overseeing.
While the direct link between financial interests and patient harm can be hard to demonstrate they are often at the heart of many patient safety scandals.
For example, a 2019 study of the origins of the opioid crisis in the US suggested that doctors in receipt of payments from pharmaceutical companies prescribed more opioids than their unpaid colleagues, thus contributing to the widespread availability of the drug and the ensuing pandemic of addiction.
Closer to home, the recent James Inquiry into the breast surgeon Ian Paterson revealed how financial incentives were a factor in his decision to provide unnecessary and brutalising surgery to hundreds of women.
In the UK patients are very poorly protected against these risks. The framework governing financial incentives in healthcare is a patchwork of statutory guidance issued by the NHS and the health professional regulators, and laws issued by the Competition and Markets Authority, none of which are fit for purpose from a patient safety perspective.
Despite the fact that clinician ownership of facilities and equipment is associated with the provision of unnecessary treatment, in the UK it is permissible for doctors to own up to 5% of a facility to which they refer patients and to also own diagnostic and therapeutic equipment. Our research from 2019 showed that 637 consultants owned shares or equipment in private hospital facilities and 177 consultants owned equipment such as PET and CT scanners and lasers for ophthalmic treatment and often received a fee each time the equipment was used.
These financial interests are permitted in the UK on the basis that they are declared, however, doctors rarely make the necessary declarations. Our review of 265 doctors who were known to have shares in private hospitals found that just 19 had publicly declared them via their NHS Trust’s website.
And despite the fact that the NHS guidance prohibits doctors from receiving gifts and hospitality worth more than £75 our research identified that over £1.5 million of corporate hospitality was provided by the private hospital sector to clinicians over a 2 year period, including numerous lavish trips to sporting events worth over £1000 a head.
Nor are any of these laws and regulations enforced. Where significant breaches of the laws governing share ownership have been notified to the GMC no action has been taken on the basis that there is no direct impact on patient care.
But while evidence is mounting about the scale of the problem, there is no clear plan about what is to be done to rid medicine of this blight and to improve patient safety.
One recommendation put forward by the Cumberlege review is that the General Medical Council (GMC) should maintain a publicly available list of the financial interests held by practising doctors.
But, while greater transparency about the nature of the financial interests is important, on its own, such a move is unlikely to mitigate the risks to patient safety and may make matters worse.
In the first place, such a policy has the potential to normalise the conflicts between the interest of the patient and the financial interests of the doctor.
By virtue of declaring a financial interest on a statutory register, an impression is created that the interest is benign and above board. It also suggests that the doctor (or their employer) is able to manage the conflict and so avoid any detriment to the patient.
Moreover, it is doubtful whether it will be possible to distinguish payments that inappropriately influence clinical decision making from those which are made for contributing to scientific innovations.
Another issue with the proposed policy is that it puts the onus on the patient to ensure that their doctor is safe to practise. One of the drivers behind the recommendation appears to be that patients should be made aware of financial conflicts so that they can reach informed decisions about who is best to treat them.
However, “caveat emptor” or “buyer beware” should never be a principle which applies within healthcare. The information asymmetries which exist between the patient and the doctor are the reason why stringent forms of regulation are required in the first place.
Moreover, very few patients know how to access the relevant data to check up on their doctor or are motivated to do so; GMC research in 2015 found that only 11% of those searching the Medical Register were patients.
As a result, before any such register is introduced there needs to be a focused debate about which types of conflicts are sufficiently harmful to require prohibition and which can be safely managed through declarations.
Given the potential for systemic harm caused by clinicians with conflicted interests and the lack of willingness across parts of the profession to be open and transparent about them, the presumption should be in favour of prohibiting financial conflicts of interest rather than just managing them.
David Rowland, Centre for Health and the Public Interest.
Competing interests: None declared