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Hunt announces Medicines and Medical Devices Safety Review

Review to cover handling of concerns over Primodos, sodium valproate and vaginal mesh implants

Louise Prime

Thursday, 22 February 2018

The Government is to review three areas of potential medication error where serious concerns have been raised by patients and their families, Jeremy Hunt has announced, ahead of tomorrow’s release – at the world patient safety, science and technology summit in London – of a landmark report on the extent of medication errors in modern healthcare systems and the NHS’s plan to tackle them.

The health secretary told the Commons yesterday afternoon that the Medicines and Medical Devices Safety Review, to be led by Baroness Julia Cumberlege, will include the hormone-based pregnancy test Primodos, which is claimed to have led to miscarriages and birth defects during the 1960s and 1970s and was prescribed to more than 1.5 million women before it was withdrawn from use in 1978, partly because more modern pregnancy tests became available; sodium valproate, which has been definitively linked to autism and learning disabilities in children when taken during pregnancy, with claims of up to 20,000 children affected; and vaginal mesh implants, which he said, “have been linked to crippling, life-changing side effects”.

Jeremy Hunt said in his statement: “We must acknowledge that the response to these issues from those in positions of authority has not always been good enough. … patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse. So today, in addition to practical steps for each of the three cases, I am setting out plans to establish a fairer, quicker and more compassionate way to address issues when they arise, bringing different voices to the table from the start and giving individuals and their families a clear path to answers and resolution.”

He added that the chief medical officer had told him that clinical experts agree that, when used appropriately, many women benefit from the use of vaginal mesh, ‘hence a full ban is not the right answer in the light of the current evidence available’. But because of the suffering that many women have experienced, he said the government will be publishing a retrospective audit to investigate the links between patient-level data to explore outcomes, and investing £1.1m to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues.

Labour (Co-op) MP for Leicester Jonathan Ashworth generally welcomed the commitment to a review into the ‘ongoing public health scandal’ of vaginal mesh implants that have left women ‘in permanent pain, unable to walk, unable to work’, but called for the government to do much more to support those affected.

He then asked the health secretary to accept that an earlier expert working group report into Primodos was a ‘whitewash’ that had raised concerns on both sides of the House. Mr Hunt responded: “We are not proposing to revisit the science, but we are giving Baroness Cumberlege full freedom to look at what the expert working group did and to come to her own views.”

Jonathan Ashworth also pointed out that a survey last year found that almost a fifth of women taking sodium valproate still do not know its risks during pregnancy, and he welcomed the health secretary’s assurance that the government is to change NICE guidelines and labelling, and work towards greater awareness among patients. Mr Hunt said: “When it comes to valproate, we want to push for this to be a contra-indication for women of childbearing age who are not taking effective contraception.”

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