Primodos scandal: Government should consider ‘redress’ for victims, Theresa May says

The government should consider “redress” for the victims of pregnancy test drug Primodos, Theresa May has told Sky News.

In an exclusive interview, the former prime minister heavily criticised the health regulation system that also allowed people to suffer with another drug, sodium valproate, and the medical product, vaginal mesh.

Primodos – packed with hormones – was given to women in the 1960s and 1970s.

Many parents believe it damaged the foetus in the womb, leaving children with life-changing malformations.

There has been a 40-year campaign for recognition of its potential dangers.

Mrs May praised campaigners, who had been “beating their head against a brick wall of the state”, she said.

She also criticised former governments and healthcare professionals who she said had tried to “stop them in their tracks… saying that ‘you didn’t really suffer’ despite the fact that there was obvious evidence”.

In an interview for Sky News documentary Bitter Pill, she said: “I think it’s important that the government looks at the whole question of redress and about how that redress can be brought up for people. They’ve had an apology and that’s important, but obviously, lives have suffered as a result.”

It comes after an independent review, instigated by the former PM two years ago, found last month that government health regulators had failed patients.

Epilepsy drug sodium valproate can cause damage to unborn babies, while vaginal mesh surgery has left some women with debilitating and chronic pain.

In a Sky News documentary which investigates Primodos, Mrs May explained why in 2018 she ordered a second review into the drug.

She said: “I almost felt it was sort of women being patted on head and being told ‘there there dear’, don’t worry. You’re imagining it. You don’t know. We know better than you do.”

She cited her concerns after reading the conclusions of a previous scientific review overseen by the Medicines and Healthcare products Regulatory Agency in 2017, which claimed evidence did not support a causal association between Primodos and congenital malformations.

Mrs May said: “Certainly, when I looked at the report, I felt that it wasn’t the slam dunk answer that people said it was.”

She added: “At one point it says that they could not find a causal association between Primodos and congenital anomalies, but neither could they categorically say that there was no causal link.”

Mrs May asked her then health secretary Jeremy Hunt to call a new investigation, and on 8 July the Independent Medicines and Medical Devices Safety Review, led by Baroness Cumberlege, concluded there had been “avoidable harm” caused by Primodos and the other two products, sodium valproate and vaginal mesh.

The review team said both the state and the manufacturer had “an ethical responsibility” to fund a financial scheme for “those harmed” to help them with the cost of care.

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The government has apologised but is yet to respond fully to the review team’s recommendations.

The manufacturer of Primodos, Schering, which is now owned by Bayer, says it is not responsible for a financial settlement, claiming there is not strong enough evidence to suggest the drug was damaging.

Bayer denies responsibility, saying there isn’t evidence of a link between the drug and malformations.

But Theresa May told Sky News: “I think they need perhaps to look at the history of this; that at the time Primodos was still being prescribed, where there was a known potential risk, and ask themselves whether it was right for that to have carried on.”

Of the women who campaigned for recognition, Mrs May said: “It’s incredible that somebody like Marie Lyon and other campaigners have held fast to this campaign, despite all the many potential setbacks they’ve had in terms of the government and health care professionals trying to stop them in their tracks.

“It takes immense courage and actually, it takes a huge toll on people to carry on campaigning when every time you raise your voice, you seem to be knocking your head against a brick wall. So all power to their elbow.”

The former PM added: “I think this is a very sad example of a situation where people were badly affected, not just by the physical and mental aspect of what Primodos actually did, but by the fact that nobody then listened to them.”

Mrs May also praised the investigative work of Sky News for “picking this up”, while criticising the regulatory system which she feels tried to hold it back.

She said: “One of the other problems within the public sector is there’s often a natural inclination to protect the institution and not listen to people’s complaints in order to sort of clam up and protect the institution itself.

“When I became prime minister, the first speech I gave on the steps of Number 10 was about social justice and the need to deal with burning injustices. And I think the way that the campaigners on Primodos were treated was an injustice. They deserve to be treated fairly. They weren’t. They weren’t listened to.”

While some will always remember her premiership as a period of stalled Brexit negotiations and Tory party infighting, it is clear that Theresa May sees righting this apparent historic injustice as a key plank of her legacy, along with other investigations into controversies such as contaminated blood, the Hillsborough tragedy and the independent Inquiry into Child Sexual Abuse.

She told Sky News: “The important thing for a prime minister is actually to be able to look across the board and to pick up and identify those issues where something does need to be done.

“I hope that when people look at my time in office, my time in government as a whole actually, they’ll see that there were various issues where there were people who had suffered or were suffering, who had been raising their voices, whose voices had not been heard. And I was able to ensure that their voices were heard.”

Bayer told Sky News that it “sympathises with people who struggle day to day as a result of physical disabilities”.

It added: “The totality of the available scientific evidence, however, does not support the existence of a causal relationship between the use of Primodos and adverse outcomes in pregnancy.

“We understand that the Cumberlege Report acknowledges that this is also the conclusion of detailed reviews by the UK and EU regulatory authorities.

“Bayer does not, therefore, believe that any form of ex-gratia payment scheme is appropriate.”

:: Watch Bitter Pill: Primodos, on Sky Documentaries at 9pm on Monday

(c) Sky News 2020: Primodos scandal: Government should consider ‘redress’ for victims, Theresa May says