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Government must apologise to those affected by Primodos, valproate, and mesh, says review

BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m2726 (Published 07 July 2020) Cite this as: BMJ 2020;370:m2726

Linked Editorial

Cumberlege review exposes stubborn and dangerous flaws in healthcare

Linked News

Scotland to create patient champion role

  1. Elisabeth Mahase
  1. The BMJ

The UK government must immediately issue an apology “on behalf of the healthcare system” to people affected by three medical interventions—Primodos, sodium valproate, and pelvic mesh—and ensure they are listened to, supported, and compensated, a long awaited safety review has concluded.1

“The system, and those that oversee it, need to acknowledge what has gone so badly wrong,” said the report of the review, chaired by the life peer Julia Cumberlege. It came after years—decades in the case of sodium valproate and Primodos—of campaigning by patients and affected families.

The independent review was commissioned in 2018 by then health secretary for England, Jeremy Hunt, to assess use of the three medical interventions across the NHS.2 The report has found that in all three instances patients’ concerns were often dismissed and that as a result they had to fight to be heard. There were many occasions where regulatory bodies could have acted sooner and where poor communication with doctors and between doctors prevented patients knowing about the risks of the interventions.

Concerns were also raised regarding conflicts of interest, “both potential and real, in the provision of care or treatment, particularly where doctors have financial and other links with the pharmaceutical and medical device companies.”

Primodos was a hormone pregnancy test taken by more than 1.5 million women between the 1950s and its withdrawal in 1978. It is claimed to have led to miscarriages and birth defects. Sodium valproate has been definitively linked to autism and learning disabilities in children when taken during pregnancy to treat epilepsy. Pelvic mesh has been used to treat stress urinary incontinence and pelvic organ prolapse in women, many of whom have suffered badly from complications.

Cumberlege said, “I have conducted many reviews and inquiries over the years, but I have never encountered anything like this: the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.”

The review team has instructed the government to appoint a patient safety commissioner to listen to patients, hold the system to account, and demand action. Separate schemes for the three medical interventions should also be established to meet the cost of providing additional care and support to people who have experienced avoidable harm and are eligible to claim. Additionally, networks of two types of specialist centres (for mesh and medications taken during pregnancy) should be established and located regionally to provide comprehensive treatment, care, and advice.

The review also said that the Medicines and Healthcare Products Regulatory Agency needs “substantial revision, particularly in relation to adverse event reporting and medical device regulation.” The MHRA should keep a register of all devices approved for the UK market, and manufacturers should be required to apply to it before marketing their devices. Devices should be approved after they have been assessed for their risks, the evidence base, and postmarketing surveillance plans and have met the appropriate criteria.

A central database should be created to collect key information, including the patient, the implanted device, and the surgeon. This should be linked to registers focusing on device safety and patient reported outcomes.

The vice chair of the review, the retired paediatric nephrologist Cyril Chantler, told The BMJ, “I don’t want people to think this review is anti-doctor. It is pro-patients. The vast majority of doctors are people who work terribly hard and do the best to serve their patients, not least over the last three months.”

Chantler, former chair of Great Ormond Street Hospital, said the review was about learning from the past, acknowledging and apologising where mistakes have been made, and working to stop them happening again.

Implementing recommendations

Other recommendations included that the General Medical Council should have a list of financial and non-financial interests of all doctors, as well as doctors’ clinical interests and specialties. A redress agency for people harmed by medicines and medical devices in future should also be established. The government must immediately set up a task force to implement all these recommendations, the report said.

It concluded, “If accepted, in principle, [the recommendations] now need to be implemented with a sense of urgency and real determination to stop future harm and provide care and support for those affected. Acceptance of our findings is the basis for action, not a substitute for it . . . On behalf of those affected we cannot stand by and let our recommendations gather dust”

Kath Sansom, founder of Sling the Mesh, a campaign with around 8200 people in its support group, told The BMJ, “There are no celebrations in knowing so many women had to tell embarrassing, personal, and distressing stories to the review and in the media to have our voices heard.”

She said the review showed how “broken the health system is in this country in terms of patient safety and highlights the catastrophic failings in scientific evidence, the lack of databases to record problems, an appalling lack of regulatory oversight, and the seeming lack of interest in doing anything to fix this for more than 20 years.”

However, Sansom added that she was “delighted” that women will be given an official apology and that a patient safety commissioner has been recommended to oversee problems in the future.

The review team only has the power to make recommendations, which the relevant bodies can choose to act on but do not have to. Chantler said, “This [change] will only happen if people want it to happen. It is the government, for sure, but it is also the patient groups, it’s The BMJ, the Lancet, it is something for all of us. It will happen if we want it to happen.”

References

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