Primodos patients ‘betrayed’ after being left out of health scandals redress report

UK ministers are facing a backlash after families affected by the hormone pregnancy test Primodos were excluded from a review about redress for victims of health scandals.

A report by the Patient Safety Commissioner says there is a “clear case for redress” for thousands of women and children affected by the epilepsy treatment sodium valproate and vaginal mesh implants.

The commissioner, Dr Henrietta Hughes, wanted to include in her review patients who had suffered avoidable harm as a result of hormone pregnancy tests, including Primodos, but was told by the Department of Health and Social Care (DHSC) they would not be included.

Marie Lyon, the chair of the Association For Children Damaged by Hormone Pregnancy Tests, said families who took hormone pregnancy tests between 1958 and 1978 felt “betrayed”.

She said many were never told of the risks of Primodos and were instructed to take the drug – which is 40 times the strength of an oral contraceptive pill – by their GPs as a way of finding out whether or not they were pregnant.

Hormone pregnancy tests were withdrawn from the market in the late 1970s and manufacturers have faced claims that such tests led to a number of adverse outcomes including birth defects and miscarriages.

Lyon said families felt as though they had been “left out in the cold”, adding: “I feel betrayed by the Patient Safety Commissioner, by the IMMDS review [Independent Medicines and Medical Devices Safety Review] and by the secretary of state for health – all three have betrayed our families because basically they have just forgotten us. It’s a case of ‘it’s too difficult so we will just focus on valproate and mesh’.”

The Labour MP Yasmin Qureshi, a longtime campaigner on the issue, said: “It is deeply disappointing that the government has ensured families affected by Primodos are sidelined from this report.

“Many of those who would benefit from redress are on borrowed time, they do not have the luxury of waiting for the government to do the right thing. They urgently need financial support.”

The new Patient Safety Commissioner report states: “Our terms of reference did not include the issue of hormone pregnancy tests. This was a decision taken by DHSC and should not be interpreted as representing the views of the commissioner on the avoidable harm suffered in relation to hormone pregnancy tests or the action required to address this.

“The Patient Safety Commissioner wanted them included in the scope but, nevertheless, agreed to take on the work as defined by DHSC ministers.”

A group of 172 claimants attempted to bring legal action against Primodos’ makers and the government in an effort to get compensation, but their claims were thrown out by a high court last year.

The report highlights how thousands of women’s lives were “destroyed” due to pelvic mesh, and thousands of children “will never be able to live independent lives” after being exposed to sodium valproate.

Epilepsy treatment sodium valproate has been linked to physical malformations, autism and developmental delay in some children when it is taken by their mothers while pregnant.

Vaginal mesh implants have been used to treat urinary and gynaecological conditions, but have caused debilitating harm to some women.

The report says “there is a clear case for redress based on the systemic healthcare and regulatory failures” for women and children affected by the issues in England.

It says the government should create a two-stage financial redress scheme – an interim scheme and a main scheme.

An interim award of £25,000 was the “median amount patients said would be appropriate”, the commissioner said.

This would be followed by a main scheme with payouts based on the individual needs of each patient.

Hughes said: “My report could not be clearer – the case for redress has been made. It highlights in detail the daily problems that impact on those who have been harmed, who have seen their lives destroyed by pelvic mesh, and the children who will never be able to live independent lives.”

Kath Sansom, the founder of the Sling The Mesh campaign group, said: “While we are pleased that this report validates the suffering of thousands of women many who have lost jobs, pensions, homes, partners, and live in constant pain, there are also concerning elements to it.

“Most notably, the initial sum of £25,000 for mesh is disappointingly low. We hope second stage payments for women directly harmed will compensate for that. All women harmed by pelvic mesh trusted they were having a gold standard surgery, with little to no warning of risks from their surgeon, and as a result experienced irreversible, life altering complications.

“Many were then gaslit for years, and, just like the Post Office scandal, told they were the only one suffering, forcing them to suffer in silence.

“Finally, our hearts go out to the Primodos families who have been campaigning since the 1960s and 70s, who have no positive financial redress news at all in this report.”

, chief executive of the Epilepsy Society, added: “The recommendations within the Hughes report are frank, fair and long overdue.”

The Guardian