Hormone Pregnancy Tests

Margaret Greenwood Excerpts

Thursday 7th September 2023 Commons Chamber

[Margaret Greenwood (Wirral West) (Lab)]

I congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on securing this debate, and thank her for her outstanding work in leading this campaign in Parliament. I also pay tribute to all the families of children who were born with birth defects after their pregnant mothers took Primodos for the courage that they have shown. In particular, I pay tribute to Marie Lyon—who, I am pleased to see, is here with us today—for her tireless work.

Those affected should not have to fight for justice. I join colleagues in the debate in calling on the Government to acknowledge the fact that the recommendations in the Independent Medicines and Medical Devices Safety review relating to Primodos-affected families have not been implemented, and to explain why; to implement those recommendations and to set up a redress fund for families affected by Primodos; and to withdraw the 2017 expert working group report on hormone pregnancy tests, which has been disputed by academics and is inconsistent with other more independent studies.

In their fight for justice, the families have suffered setback after setback. The latest came a few months ago when claims for damages against Bayer Pharma, Schering Health Care Ltd, Aventis Pharma Ltd and the Government were struck out in the High Court, partly owing to lack of funding for legal representation. That was a bitterly disappointing blow.

The Government have a moral duty to set up the redress fund for those affected. As far back as the late 1950s, concerns were raised that hormone pregnancy tests, the most commonly used of which was Primodos, could cause abnormalities in a developing baby. Further studies in the UK and elsewhere from the late 1960s to the early 1970s suggested a link between the use of hormone pregnancy tests and a wide range of serious birth defects.

It took until 1975 for the Committee on Safety of Medicines to recommend that hormone pregnancy tests should no longer be used. The committee said that there was “little justification” for them, as alternatives were available. It then sent an alert letter to all doctors in the UK, advising them of a possible association between hormone pregnancy tests and an increased incidence of congenital abnormalities. The letter recommended that doctors “should not normally prescribe” those products as pregnancy tests.

However, it has been reported that Primodos sometimes continued to be used as a pregnancy test within the NHS until it was withdrawn from the market by the manufacturer, Schering Chemicals Ltd, in 1978. By that stage, the damage had been done. Legal proceedings by the affected families began, but were discontinued in the early 1980s. It was not until early 2014, and the discovery of documents from the 1960s that reportedly showed that studies suggested that hormone pregnancy tests caused miscarriages and congenital abnormalities, that a new campaign called for an independent public inquiry into them.

Criticisms of the 2017 independent expert working group report on hormone pregnancy tests included the fact that it did not examine regulatory issues and that a number of documents had not been included in the review. Additionally, the methodology and findings in the report have been disputed by academics and are inconsistent with other academic reviews, as today’s motion highlights. One of those reviews was by a group of researchers at the University of Oxford, led by Professor Carl Heneghan. The researchers concluded:

“The evidence of an association”—

by which they mean between hormone pregnancy tests and birth defects— “has previously been deemed weak, and previous litigation and reviews have been inconclusive. However, we believe that this systematic review shows an association of oral HPTs with congenital malformations.”

Despite that, the Government say that they currently have no plans to reassess the findings of the expert working group review. I hope that, today, we hear a different response from the Minister.

In 2018, the independent medicines and medical devices safety review was announced by the Government, led by Baroness Cumberlege. Despite the Cumberlege review’s finding that Primodos caused avoidable harm, and the clear recommendation for redress for those affected, the Government have refused to even acknowledge it. That is a grave injustice and an insult to those who have suffered. Let us remind ourselves of some of the adverse impacts that affected individuals and families have attributed to hormone pregnancy test use: congenital heart defects, dysmorphic facial features such as cleft palate and lip, digestive system and bowel issues, intellectual disability, limb defects and, tragically, death.

[Sir Mike Penning]

Could I add to that those who were told to have an abortion, and those who had a miscarriage or a stillbirth? Their families have been damaged almost as much, and the guilt is still with them.

--- Later in debate ---

[Margaret Greenwood]

The right hon. Gentleman makes an excellent point and I agree. The Minister must recognise the clear moral case to support those affected. Back in 2017, the then Health Secretary apologised

“on behalf of the NHS and the whole healthcare system...to those who’ve suffered and their families, for their frustration, for the time it’s taken to get their voices heard.”

However, in the years since, the Government have failed to provide the recognition and redress that those affected by Primodos deserve. The Government must fully implement the recommendations in the independent medicines and medical devices safety review and set up a redress fund for those affected by Primodos as a matter of urgency. Those affected by Primodos have suffered enough, and they deserve justice.