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  1. ITV Report

PM orders review into pregnancy test drug Primodos, vaginal mesh and anti-epilepsy drug sodium valproate

  • Video report by ITV News Political Correspondent Paul Brand

Theresa May has ordered a review into how the NHS addresses patient concerns about the safety and side effects of treatments.

In particular, it will look into concerns raised about potentially harmful effects of the hormone pregnancy test drug Primodos, vaginal mesh and anti-epilepsy drug sodium valproate.

Mrs May told MPs at Prime Minister's Questions she wanted to see a "faster, more understanding response to patients when they raise concerns".

The review will be led by Baroness Julia Cumberlege and will also consider whether any further action is required, including whether a full investigation or an inquiry is necessary.

In a Commons statement, Health and Social Care Secretary Jeremy Hunt said responses to the issues raised "have not always been good enough".

What are the main issues that have raised safety concerns?

It has been claimed the hormone-based pregnancy test Primodos led to miscarriages and birth defects during the 1960s and 1970s.

Mr Hunt told the Commons it was prescribed to more than 1.5 million women before being withdrawn from use in 1978.

Anti-epilepsy drug sodium valproate, has been "definitively linked to autism and learning disabilities in children when taken during pregnancy," Mr Hunt said.

Vaginal mesh implants, often used to address complications after childbirth, have also been linked to "crippling and life-changing side-effects," he added.

Concerns also been raised about anti-epilepsy drug sodium valproate and vaginal mesh implants.

Mr Hunt said that the stress and frustration felt by campaign groups in relation to the issues raised had often "added insult to injury".

He also pledged to come up with a quicker and more balanced system.

"We must acknowledge that the response to these issues from those in positions of authority has not always been good enough," he said.

Mr Hunt said the review will also consider the processes followed by the NHS and regulatory bodies after patients report their concerns - including how they communicate with patients.

"Over the years, there have been significant concerns raised by individuals and campaign groups about the potentially harmful effects of three products used by the NHS - the response they have received from those in positions of authority has not always been good enough," Mr Hunt said.

"From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many."

Jeremy Hunt acknowledged the response to patient concerns had not 'always been good enough'.

Mr Hunt also announced plans to invest £1.1 million to develop a database for vaginal mesh which could help identify safety issues.

Shadow health secretary Jonathan Ashworth said Labour's 2017 manifesto called for an inquiry into medical devices and product licensing and regulation.

He said: "We do offer this review our support, though we note it falls short of the calls for a full public inquiry that campaigners have been (demanding)."

Mr Ashworth also said women and children affected deserved full compensation and support, and asked if the Government would establish a compensation fund.

"Isn't it time they were given a full apology, surely it's the very least they deserve?" he added.

What has been the reaction to the review?

A spokeswoman for the campaign group Sling the Mesh said: "We are delighted that at last a review is to be carried out but also deeply saddened that so many women's and families' lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally.

"These are three huge women's health disasters."

Marie Lyon, chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, said: "We are disappointed that the three campaigns are being reviewed together.

"We are not prepared to support this proposal without consultation and agreed terms of reference."

Clare Pelham, chief executive of the Epilepsy Society, said it was "delighted" a review was now taking place and new measures introduced.

"Over 28000 women with epilepsy take this drug every day and these measures (when implemented) should dramatically reduce the number of babies born with avoidable disabilities.

"Our hearts go out to all the mothers since 1974 who have taken sodium valproate during their pregnancy in ignorance of the risk to their unborn baby. It is a tragedy for any baby to be born with an avoidable disability."