First Do No Harm: an independent review of the safety of medicines and medical devices

Posted: 10/07/2020

First, do no harm: one of the most iconic, fundamental and prevailing maxims of the medical profession. We know only too well, particularly in the midst of the current healthcare crisis, that the majority of individuals enter the healthcare profession with the sole intention of helping those in need, saving lives and delivering the best possible care and treatment they can.

The First Do No Harm review, spearheaded by Baroness Julia Cumberlege and published on 8 July 2020, highlights the issues arising from innovation in medical care; in particular, where there has been a lack of comprehensive pre-market testing and post-marketing surveillance with long-term follow-up assessments of the safety of medications and medical devices. The report compiles findings of a two-year review of hundreds of patients and families from across the UK whose lives have been seriously affected by avoidable harm arising from medicines or medical devices.

The report makes clear that the issues do not result from a single or handful of rogue medical practitioners; it is a system-wide issue where risks and harm are not fully appreciated or communicated to patients as a result of the lack of vigilant and long-term monitoring.

Scope of the review

Whilst the report focussed on the three key areas below, it is clear that the issues are not unique to these medications or medical devices, but are also relevant to many new devices, techniques or treatments. The three medications and devices reviewed within the report are:

• the use of hormone pregnancy tests, such as Primodos (which was withdrawn from the market in 1978);
• the use of anti-epileptic drug sodium valproate in pregnancy; and
• the use of polypropylene pelvic mesh for stress urinary incontinence and organ prolapse.

Hormone pregnancy tests

Hormone pregnancy tests (HPTs) were used from 1950 to 1978, which was the year that all HPTs were withdrawn from the UK market; however, various medications containing the same hormones remained available on prescription. Primodos was one of the market leading HPTs. In the late 1950s, concerns were raised around HPTs causing abnormalities in developing foetuses, with various malformations subsequently linked to HPT use (such as limb defects, sensory deficits, intellectual disability, skeletal problems and many more).

Sodium valproate

Sodium valproate is commonly used in the UK to treat epilepsy, bipolar disorder, migraines and pain disorders. Since its introduction, evidence emerged throughout the 1980s, 1990s and 2000s that it can cause physical and neurodevelopment effects in children if taken by mothers during pregnancy; a condition known as foetal valproate spectrum disorder (FVSD). Neurodevelopmental deficits caused by the disorder include developmental delay, limitations to verbal IQ and the development of autism spectrum disorders.

Pelvic mesh

Pelvic mesh has been inserted during surgery to support pelvic organ prolapse, which occurs when one or more of the pelvic organs moves out of its normal position. The organ often pushes into the vagina or rectum, causing a bulge. Pelvic mesh has also been used to treat stress urinary incontinence, a term used to describe the involuntary leaking of urine when the bladder is under pressure (for example when coughing, sneezing or laughing). Stress urinary incontinence can be caused when pelvic tissues, muscles and ligaments that support the bladder are weakened. Both injuries can be associated with childbirth.

Whilst many women have successfully benefitted from pelvic mesh, others have suffered chronic pain, infection, reduced mobility, sexual difficulties, psychological harm and even suicidal thoughts as a result of erosion of the mesh implant.

Common themes

Culture and attitude

The report highlighted common themes of derision, a culture of dismissive attitudes and resistance to change despite increasing evidence of safety concerns. There was an unwillingness to acknowledge or accept when something had gone wrong through a fear of blame or litigation. Further issues included the motivation of manufacturers to seek returns for their shareholders, the burying of negative or inconclusive product research and failures to declare conflicts of interest where positive findings were reported.

Patient consent

The report highlights the importance of tailored consent that addresses the specific concerns of the individual patient alongside potential adverse outcomes, both short and long-term. Many patients undergoing pelvic mesh implantation gave consent for ‘tape insertion’ and were unaware that they were being implanted with polypropylene mesh. Other women who subsequently underwent removal surgery, on the understanding that it would be a full removal, discovered weeks, months or years later that this was not the case.

The use of patient information leaflets and decision aids has increased but is not standardised across the industry. Both patient information leaflets and decision aids do not always convey the reality in clear, plain terms to allow patients to make a fully informed decision about their treatment and treatment options.

The recommendations

Whilst many patients will have benefitted from effective treatment using sodium valproate or have had their prolapse or stress urinary incontinence successfully managed with pelvic mesh implants, their success does not diminish the avoidable harm suffered by others who were less fortunate and who underwent treatment without knowledge of the true risk of harm.

The review therefore sets out nine recommendations to the Government as follows:

• to immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh;
• the appointment of a Patient Safety Commissioner who would be an independent public leader with statutory responsibility, to champion the patient voice and encourage improvements to patient safety;
• the creation of an Independent Redress Agency for those who have suffered harm by medicine and medical devices. The Agency will be funded by levies from pharmaceutical companies. Placing medical products and devices on the UK market would be conditional upon pharmaceutical and manufacturers contributing to the redress scheme. The Agency would administer decisions using a non-adversarial process and offer financial and non-monetary resolutions;
• separate schemes should be set up for each of the three interventions (HPTs, valproate and pelvic mesh) to meet the costs of providing additional care and support to those who have suffered avoidable harm. Those who obtain compensation from litigation or out of court settlements will not be eligible for support;
• the creation of a network of specialist centres to provide comprehensive treatment, care and advice for those affected by mesh and those adversely affected by medications taken during pregnancy;
• reform of the Medicines and Healthcare products Regulatory Agency (MHRA) to engage more with patients and outcomes of adverse events. The MHRA should raise awareness of its public protection role and for patients to have an integral role in its work. It is acknowledged that post-Brexit, the MHRA will need to change, offering a springboard to launch such cultural and legislative reforms;
• the creation of a central patient-identifiable database collecting key details of all implantable medical devices with specific registers to research and audit long-term outcomes;
• the introduction of transparency requirements of payments made to clinicians, teaching hospitals and research institutions by pharmaceutical and medical devices industries. The General Medical Council (GMC) register should be expanded to include a list of financial and benefit in kind interests of all doctors. The register should also include details of every doctor’s particular clinical interests and their recognised accredited specialisms; and
• the immediate creation of a task force to implement the review recommendations, including the publication of a timeline for such implementation.

The recommendations are encouraging and seek to overhaul patient safety and accountability for avoidable harm. However, this is just the first step in the right direction and plenty of work remains to be done. The full report can be read here.

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