How is it that our system is still allowing repeated harm to be done to patients, by the clinicians, health providers and manufacturers, despite all the previous failures, the Cumberlege Inquiry suggests some answers.

“Tens of thousands” of patients, mostly women, have suffered avoidable harm, from three NHS interventions: surgical mesh implants, pregnancy tests and an anti-epileptic drug.  The independent medical devices and medicines safety review, chaired by Baroness Cumberledge, which interviewed over 700 people has now delivered a damning and insightful report about the impact.

The Inquiry heard how, over decades, patients had battled to be heard by the medical establishment, manufacturers and the NHS. Rebuffed and discouraged by the authorities they were forced into long, hard-bitten campaigns just to receive basic acknowledgment and actions.

It is a story of outrageous failures; of many missed opportunities to stop using interventions that have proven harmful to some, before they went on to harm many more.

The Cumberlege report nails this systemic failure, but it’s not the first time. Previous inquiries have also exposed the failure to act early: after the unnecessary deaths at Mid staffs, after the eleven infant deaths at Morecambe and it is true too of the response to the rogue breast surgeon Ian Paterson; who went on to wound and mistreat many more women, despite concerns having been raised with the NHS and private hospitals that he worked in.

The inquiry

The Cumberlege inquiry, ordered by Jeremy Hunt in 2018, set out to examine how the NHS in England responded to patient concerns about three interventions, but what they learned led them to conclude that similar problems could well affect other treatments too.

Echoing the popular view amongst patient groups that today’s NHS lacks accountability, the Cumberlege report calls for a patient safety commissioner, a new voice, with statutory powers, to hold the system to account and who would themselves be accountable to Parliament. But why stop there?

In recent times big reorganisations of the NHS have created bodies that are corporate in structure with accountable public voices kept on the periphery of NHS planning, rather than at the heart of it.

And yet If you read them, you will find that the language of inclusivity and accountability spread liberally throughout NHS public documents. The government trumpets its plan for new “publicly accountable integrated care”, but it is evident from Cumberlege that this language is at best a  rosey-glossing of the reality.

Cumberlege highlights a fragmented, under resourced system with conflicting financial interests, which puts up walls against patients’ views and is therefore much more likely to fail to protect its patients from harm.

The report explicitly states that it believes that most NHS care is effective and acknowledges that innovations have saved many lives, however points to dangerous fissures in the system, such as the regulation of medical devices which, “without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous”


The three interventions looked at by the Cumberlege Inquiry:

Sodium valproate, an effective medication for epilepsy. But still today this medication causes harm to unborn children when their mother, unaware of the risks, takes it when she is pregnant.

Pelvic mesh, used to treat pelvic organ prolapse and urinary incontinence. Many women have suffered terrible complications following their mesh surgery.

Primodos, a hormone pregnancy test taken by women between the 1950s and the late 1970s, associated with damage to children, and those children now adults, are still needing care and support


Why didn’t doctors listen?

Repeatedly, first-hand testimony to the inquiry suggested that patients were met with professional resistance and unwillingness to take their experiences seriously.

“almost universally women – spoke in disbelief, sadness and anger about the manner in which they were treated by the clinicians they had reached out to for help. The words ‘defensive’, ‘dismissive’ and ‘arrogant’, cropped up with alarming frequency.”

Lack of knowledge was evident. Patients talked of having to “educate” their GPs to access the services they needed.

Conflicts of interests played a part too. In some cases, women were told they needed to go private in order to receive any treatment. Campaigners reported that clinicians have been paid or offered incentives by manufacturers, which they believe swayed their advice. The inquiry concluded that a public register of all financial interests should be kept, making these relationships transparent.

Why didn’t manufacturers act?

Commercial interests and the need to rush to market to deliver returns to shareholders have prevented proper checks, according to evidence given to the inquiry.

The inquiry team also reported hearing much about research that “is funded by manufacturers that never sees the light of day because it is negative or inconclusive for the product in question, or is less than transparent in its declaration of conflicts of interest when positive findings are reported.”

Currently, the regulatory body the Medicines and Healthcare products Regulatory Authority (MHRA), is not involved in the pre-market phase of the development of a medical device. Generally, medical devices are not subject to the same level scrutiny as medicines and the inquiry is critical of the lack of regulation, but also of the way patient experiences are not being used.

By not talking to patients, the links with various adverse effects are harder to make, which helps to obscure the harm. The inquiry pointed out that all too often the NHS does not compile treatment registers until after tragedy strikes – eg with PIP breast implants.  This needs to change, by more often collecting data from patients directly, to help answer the question, is this medical device or treatment actually safe.

Some progress has already been made here as the government has introduced one of the new databases requested by the inquiry team.

Around the world though those suffering from the complications of having the polypropylene mesh inserted in them have faced resistance from the authorities and companies, and have often resorted to legal processes to seek redress, proving that governments need to step in.

In the UK Valproate-affected families failed in their group litigation attempt, but in France the inquiry reported that a government-backed scheme will pay compensation to those who have suffered one or more complications.

Why weren’t the complaints heard?

The inquiry concluded that there are many routes to complain, but most are limited in the scope of what they can do. Patients found it difficult to know where to start and to chart a course through these organisations, each time retelling upsetting details, only to be referred on to another service and the inquiry said some patients were “broken” by the process.

The report cites the General Medical Council as an example; it can only take complaints about a doctor’s fitness to practise, but the fact that two thirds of the complaints they receive are about other matters, including non-clinical and parking disputes, shows the scale of the confusion.

There was widespread dissatisfaction with the way complaints were handled including by the GMC, Care Quality Commission and the various NHS trusts.

The inquiry proposed that: “All organisations who take complaints from the public should designate a non-executive member of the board to oversee the complaint – handling processes and outcomes and ensure that appropriate action is taken. “

Where were the checks and balances?

Ultimately the inquiry believes there is a lack of accountability at the top and the public needs an influential figure to help “champion the value of listening to patients” and fight for the improvements in policy that are needed.

Patient groups point to murkier questions about the independence of the organisations tasked with regulation and advice, citing the MHRA whose funding comes from the pharmaceutical industry (for medicines) and 95% from the Department of health and social care (on devices).

Since the Mid-staffs inquiry seven years ago, which reported comprehensively and made 290 recommendations, the NHS had made efforts to move away from a culture of blame, so that the system can openly learn from mistakes, but the Cumberlege inquiry reports that health professionals are resistant to speaking out. Fear of litigation and blame are still strong barriers to making healthcare safer.

Subsequently legal duties around patient safety have also been introduced. Since 2015 both NHS and private healthcare providers both have a legal duty of candour to inform patients about incidents of harm, provide support, information and an apology. However, the inquiry reports that the system isn’t being properly adhered to or regulated. No end of patients told the inquiry, “I was never told” about the dangers.

The inquiry concluded: “the healthcare system in its entirety does not work for some patients.” and admitted that for hardworking NHS staff this will be hard to hear.

But responsibility for these failings must be shouldered by government, manufacturers, health bodies as well as the NHS. They must all be subject to change if the harm is to stop and lasting protection for patients found.


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Co-editor of the Lowdown

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