The Government has announced a review into public health scandals caused by failings in the regulation of vaginal mesh implants, anti-epilepsy drug sodium valproate and hormone-based pregnancy test Primodos.
Announcing the review at Prime Minister’s Questions, Theresa May said in light of the harms caused to patients “we need to do better” and that responses to concerns needed to be faster.
Health and Social Care Secretary Jeremy Hunt said the failure to listen to patients whose children were born with birth defects, or who had been left in chronic pain, had “added insult to injury”.
The failings in these cases were overlooked by successive governments, and only came to light because of organised campaign efforts by patients.
In the case of vaginal mesh implants, women were left “crippled” by pain, MPs said, after plastic mesh implants, used to prevent prolapse after pregnancy, warped or deteriorated, cutting into their vagina walls.
While the epilepsy medication sodium valproate and pregnancy test Primodos, used in the 1960s and 1970s, have been linked to serious birth defects and learning difficulties.
Mr Hunt said: “Many have endured and continue to endure severe complications and a tremendous amount of pain, distress and ill health, alongside the feeling that their complaints have not reached a satisfactory resolution.”
“We must acknowledge that the response to these issues from those in positions of authority has not always been good enough.
“Sometimes the reaction has felt overly focused on defending the status quo rather than addressing the needs of patients, as a result patients and their families have felt too long like they have not been listened to, making the agony of a complex medical condition even worse.”
The Government has now asked former Conservative health minister Baroness Cumberlege to review the regulatory failings in these cases, and make recommendations on how the health service responds in future.
This will include a new system for monitoring the safety of medications used in pregnancy, and stricter training and reporting requirements for doctors and pharmacists where issues are raised.
Her recommendations could also include a statutory public inquiry where patients have been harmed in these cases, as called for by campaigners and Labour, but the Government has not made this mandatory.
MPs backing a public inquiry said it was not enough to address the scandal around the hormone-based pregnancy test Primodos as part of a wider review.
On several occasions they highlighted that the use of the test in the 1960s and 1970s had been clearly implicated in birth defects and evidence of its risks was “covered up” by NHS bodies and drug companies, and previous reports had been “whitewashed”.
Sir Mike Penning, Conservative MP for Hemel Hempstead, said “there will be huge disappointment” among Primodos victims about the lack of an independent public inquiry.
“The Department of Health is fully implicated in this because these drugs were given out by GPs in GP surgeries,” he added, warning this undermined Lady Cumberlege’s ability to make recommendations and have them carried out.
Mr Hunt said there was disagreement between scientists on the risks and response in the case of Primodos, and Lady Cumberlege would have an open remit to look at these issues.
He recognised that launching a statutory public inquiry would “have implications for compensation” payouts to patients in these cases, but said this decision should not be made based on the groups with the loudest voices.
The ongoing scandal around vaginal mesh implants, which recently had their recommendation for use by the NHS withdrawn by medicines watchdogs in light of insufficient evidence, has led to legal action by thousands of women worldwide.
While the Government had announced a review, today it made clear there will be £1.1m in funding to develop a database of mesh implants and complications they caused.
Chair of the all party parliamentary group on surgical mesh implants, Owen Smith, welcomed the review but said the use of implants should be stopped immediately.
“The news of a prospective registry is also hugely welcome, and is one of the key things we’ve been asking for,” he said.
“I’m pleased that the Government has listened and this registry, together with the recently announced retrospective audit currently being undertaken, will provide us with a better understanding of problems related to mesh.”
“It is a shame however that NICE is still unable or unwilling to bring forward its review into the safety and efficacy of mesh and that the Government will not suspend mesh until the reviews have been undertaken, as has happened in New Zealand.”
Lady Cumberlege said: “I look forward to undertaking this tremendously important review and in particular to working with patients to ensure that our health system learns from those it may have failed.
“It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes.”
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