19.05.2021

Cumberlege inquiry: Royal College investigating failure to take part in landmark NHS probe

The RCPCH was one of three Royal Colleges that failed to respond to the inquiry’s call for evidence in 2018 along with the Royal College of Physicians and Royal College of Midwives.

Campaigners today criticised the colleges for their lack of involvement which they said made families feel they had been “left alone.”

The Royal College of Paediatrics and Child Health has launched an investigation into its failure to take part in a landmark inquiry that revealed how thousands of women and children suffered avoidable harm from medicines and surgical implants.

The college today apologised to victims and their families as well as to Baroness Julia Cumberlege and her team that led the inquiry.

The damming inquiry, published on Wednesday, revealed how tens of thousands of women and children suffered avoidable harm including birth defects and chronic pain over decades.

It said failures by the healthcare system to respond to concerns about the use of epilepsy drug sodium valproate, hormone pregnancy test Primodus and pelvic mesh surgical implant meant patients could still be at risk from harmful drugs and devices.

It has called for a national patient safety commissioner, a new redress agency to financially compensate patients harmed by drugs and medical devices and the creation of new databases to track patients and their implants.

The inquiry’s final report listed organisations that had not responded to its call for evidence. As well as the Royal colleges it included dozens of manufacturers of pelvic mesh and pharmaceutical firms.

Jo Cozens, from the Organisation for Anti-Convulsant Syndrome charity, which campaigns for many of the victims said: “We are disappointed at their lack of involvement as they are a key part in this process. It’s made families feel like they have been left alone.”

Asked why it did not give evidence to the inquiry, an RCPCH spokesperson accepted it should have done so adding: “We would like to apologise to patients, their families and to Baroness Cumberlege and her team. We’re investigating why we didn’t submit evidence to this important report at the time as it would have been entirely appropriate for us to respond.

“We look forward to working with fellow Royal medical colleges and other stakeholders to implement the recommendations in the report.”

Separately, the Royal College of Physicians said it would have given evidence to the inquiry had it known it would focus on wider medicines and medical devices regulation.

This is despite the RCP being sent the inquiry’s terms of reference in 2018 which included it may consider and make recommendations “more broadly, based on its assessment of any lessons to be learned, on what could be done in the future to identify and acknowledge problems with medicines and medical devices effectively and quickly.”

In a statement to The Independent professor Andrew Goddard, president of the RCP said: “When we were first asked to contribute to the Cumberlege inquiry, we were under the impression it had a narrow focus on areas outside of our specialty expertise, including pelvic mesh injury and birth defects. Of course, had we known that the review would focus on all device and medicine regulation we would have most certainly contributed at the time. Patient safety is at the heart of all we do.”

He said many of the recommendations made by the inquiry were supported by the college adding: “The harrowing stories in the report show that the NHS needs to be able to identify which patients have had which treatments and where and when they had them. We support the use of global standards to implement unique identifiers and registries and this was one of the very matters we discussed with Baroness Cumberlege [after the inquiry had completed taking evidence].”

The Royal College of Midwives told The Independent it did not give evidence to the inquiry because most women taken sodium valproate would be under the care of doctors rather than midwives and the role of midwives in their care was limited.

The RCM’s executive director for professional leadership, Birte Harlev-Lam said: “This review makes heartbreaking reading and we support its important recommendations. Far too often, women who have suffered have been ignored, not been listened to or worse. It is vital that women’s voices are heard, and lessons learned from their experiences.

“Midwives have a responsibility to advocate for women and act in their best interests. The cornerstone of that is listening to them and recognising that women are the experts in their own bodies.

“Because women who have been prescribed sodium valproate should be on a specialist pre-conception care pathway, any pregnancy needs to be planned due to the potential side-effects of sodium valproate. Pregnant women in this situation will be supported by a multidisciplinary team, rather than receive midwife-led care.

“Over recent years, the RCM has been working with the MHRA, NHS Resolution and others to develop guidance on sodium valproate which we actively share with our members so that they are able to provide the support for women who become pregnant while taking the drug. We will ensure that Baroness Cumberlege’s report informs this ongoing work”.

The Cumberlege Inquiry was created by former health secretary Jeremy Hunt in 2018. It was not a public inquiry and did not have powers to compel evidence or testimony from individuals.

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