First do no harm: Independent Medicines and Medical Devices Safety review makes key recommendations for reducing the risk of avoidable harm

The doctrine “First do no harm”, is attributed to the ancient Greek physician and “Father of Medicine”, Hippocrates, and is a fundamental principles of medicine throughout the world.

It is also the title of a damning report from the Independent Medicines and Medical Devices Safety Review, published in July of this year. The review, which was chaired by Baroness Julia Cumberlege, examines how the healthcare system in England responds to reports of harmful side effects from medicines and medical devices. The two-year review heard from patients, mainly women, whose lives have been severely affected by avoidable harm arising from medicines or medical devices.

The scope of the review into medicines and medical devices

The panel were asked to investigate what had happened in the case of two medications and one medical device and to make recommendations for the future. The review looked at:

• hormone pregnancy tests, such as Primodos, which was withdrawn from the market in the late 1970s and are thought to be associated with miscarriage and birth defects;
• sodium valproate, which is commonly used in the UK so treat epilepsy, bipolar disorder and pain disorders. Sodium valproate is known to cause physical and neurodevelopmental effects in children, if taken by mothers during pregnancy; and
• pelvic mesh implants- used in the surgical repair of organ prolapse and to manage stress urinary incontinence. Their use has been linked to crippling life changing, complications, such as chronic pain, reduced mobility, infection and loss of sexual function.

What the review found

Whilst the review focussed on these three separate areas, the report highlights common themes found in each situation:

• They are all taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage is during pregnancy;
• Patients affected by each tell similar and compelling stories of their battles to be listened to when things go wrong;
• Patients turning to each other for help and mutual support;
• Patients campaigning for years, if not decades, to achieve acknowledgement, resorting to the media and politicians to take up their cause because the healthcare system did not.

The review looks at not just what happened in the three individual cases, but how the healthcare system reacted as a whole and how that response can be made more robust, speedy and appropriate.

The review identified common themes in each case, such as a failure to acknowledge when things go wrong for fear of blame or litigation; an institutional and professional resistance to changing practices even in the face of mounting safety concerns; a failure to ensure that patients properly understand the risks of treatment and the alternative options available to them; a culture of dismissive attitudes and the widespread and unacceptable labelling of symptoms as “ normal” and being attributed to “ women’s problems” .

Ultimately, the review concluded that the system is not safe enough for those taking medications in pregnancy or being treated using new devices or techniques.

In her covering letter to the Secretary of Sate, Baroness Cumberlege states:

“We have found that the healthcare system- in which I include, the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers and policymakers- is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has often moved glacially.”

The review makes nine major recommendations to support those harmed in those cases and to reduce the risk of avoidable harm from medicines and medical devices in the future, which are:

• that the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh;
• that a Patient Safety Commissioner is appointed to champion the value of listening to patients and promoting user’s perspectives in seeking improvements to patient safety;
• a new independent redress agency for those harmed by medicines and medical devices should be created;
• independent redress schemes should be set up or patients affected by hormone pregnancy tests, sodium valproate and pelvic mesh, to meet the cost of providing additional care and support to those who have suffered from avoidable harm and are eligible to claim;
• networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken in pregnancy;
• the Medicines and Healthcare products Regulatory Agency (MHRA) which is a government agency responsible for ensuring the safety of medicines and medical devices, needs a substantial overhaul to ensure that it engages more with patients;
• a central database should be created by collecting key details including the patient, the implanted device and the surgeon responsible. This can then be used to audit outcomes both in terms of the device safety and patient reported outcomes;
• transparency of payments made to clinicians needs to improve. The register of the General Medical Counsel (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms;
• finally, the Government should immediately set up a task force to implement the review’s recommendations. Its first task should set out a timeline for their implementations.

The words of Baroness Cumberlege, and the findings of the review, will come as no surprise to patient safety campaigners, some of whom have been campaigning for decades for an independent investigation into the life-changing side effects of these medicines and medical devices.

As a lawyer who represents claimants in cases involving medical negligence, I often hear from patients who feel that healthcare professionals have brushed their concerns aside. In my experience, this is an issue that arise time and time again when women seek help or advice for injuries following childbirth or relating to the menopause. Often patients live with debilitating injuries, which are dismissed by healthcare professionals as “normal” or “just one of those things”, something that should be seen as completely unacceptable and yet appears to be part of the culture in some areas.

I welcome the recommendations set out by Baroness Cumberlege. They are sensible, long overdue and, if implemented properly, will go a long way to improving patient safety as a whole. However, this will be just one step in the right direction and it is clear that there is still a great deal of work to be done to address systemic failings and move away from a culture of dismissive attitudes, resistance to change and unwillingness to acknowledge and listen to patients concerns.