Governments of all colours have blocked justice for victims of the Primodos scandal — today’s review must be a turning point
Yasmin Qureshi MP with families affected by the drug Primodos
Five decades on from the first warnings about a hormone-based pregnancy drug that inflicted suffering and misery on women and their children, the Cumberlege review shows that an apology is long overdue
It is a scandal that should never have happened and is one of the greatest medical frauds of the 20th century. 1.5 million expectant women were prescribed ‘Primodos’ a hormone-based pregnancy test drug used in the 1960s and 1970s. Its ingredients were similar to oral contraceptives but 40 times the strength.
Eight years ago, a valiant campaigner Marie Lyon shared files with me that revealed in 1967 a paediatrician at Queen Mary's Hospital in London, Dr Isabel Gal, had found a link between the use of hormone pregnancy test drug ‘Primodos’ and bodily malformations in new-born babies.
Dr Gal wasn’t the only one. The Royal College of General Practitioners also produced a report showing the drug was causing higher rates of miscarriages and infant deaths. The author of the report concluded "the drug should be withdrawn".
Similarly, a letter to the Medical Research Council stated: "It looks like this could be another thalidomide story."
The warnings could not have been clearer. Germany, USA, Australia, Ireland, Sweden, Finland and the Netherlands issued warnings and took decisive action to withdraw the drug as early as 1970. Our government failed to take those steps until 1978, despite the Committee on Safety of Medicines being the first medical authority to know of its dangers.
Files from the Berlin National Archives show that in January 1975, Dr William Inman, principle medical officer for the UK Government, had found that women who took a hormone pregnancy test “had a five-to-one risk of giving birth to a child with malformations”.
Instead of withdrawing the drug, Dr Inman called drug manufacturer Schering to warn them to “take measures to avoid medico-legal problems”. Other documents show that Dr Inman destroyed the materials on which his findings were based, “to prevent individual claims being based on his material”.
We should take a moment to reflect on how serious this inaction was. Thousands more lives were changed. Some babies were born prematurely and died. Others lived with permanent – and entirely avoidable - disability. Their continued suffering reminds us that this is not a historical issue but an ongoing tragedy.
Striving to find the truth behind what appeared to be a terrible injustice, and which like Thalidomide and Contaminated blood – seems to have been covered up at every turn, I raised this with ministers and received the standard line – “there is "insufficient evidence to prove causation". The Health Minister at the time eventually agreed to meet and I was the evidence would be reviewed by the Medicines and Healthcare Products Regulatory Agency (MHRA). Shockingly, the final report completely disregarded the evidence and told us again "insufficient data to conclusively prove a link". In other words, sorry – we’re not interested.
In 2017, the government responded to my calls for an inquiry by setting up an ‘Expert Working Group’ to review evidence. We had thought that was a small victory. What we hadn’t anticipated was that this was yet another time-delaying trap. The review was supposed to be independent but was overseen by the MHRA who were later forced to apologise for the callous way they took evidence from families. Unsurprisingly, when the report was published, it was a whitewash.
Governments of all colours have obstructed justice for Primodos victims. When I pleaded with then Prime Minister, Theresa May, on the floor of the house in 2018 with new evidence from Oxford University showing the link between Primodos and deformities, she chose to listen where her predecessors had ignored. Days later an independent review led by Baroness Cumberlege was announced.
Five decades on from taking a pill that changed their lives, the Cumberlege review published today is a significant moment in the long struggle for recognition. It’s the most comprehensive assessment of its cause and affects to date and calls for a long overdue apology to Primodos victims.
Nothing can fully compensate those women and their children for a lifetime of suffering, but this report contains detailed recommendations on how to improve the lives of those affected by Primodos. More than that, it offers a roadmap for how they can finally achieve the justice they have been denied for over 50 years.
Those affected are owed so much more than an apology, but the Government must start by saying sorry for half a century of inaction and coverups and then ensure that the recommendations in the review are fully implemented to help these families live the rest of their lives in dignity.
Yasmin Qureshi MP is chair of the All-Party Parliamentary Group on Hormone Pregnancy Tests