‘How can we still be waiting for justice?’
Marie was one of 1.5 million women in Britain who took Primodos, a German drug prescribed by GPs in the Sixties and Seventies, in the early stages of pregnancy. She believes the tablets stunted Sarah’s development in the womb.
But Sarah, now 47, was in many ways lucky. A huge number of alleged victims were left appallingly damaged. According to research carried out at the time, some women given the drug suffered instant miscarriages, thousands more gave birth to babies with missing limbs, abnormalities in their internal organs, brain damage and heart defects. Many of these children died before reaching adulthood; of those still alive, some are deaf, dumb and blind.
It is now known that one dose of Primodos contained super-strength hormones that, later, would be used in the morning-after pill. They were essentially a powerful oral contraceptive, made up of 10mg of norethisterone and 0.2mg of ethinylestradiol. If a woman was pregnant, these large doses of progesterone would, it was thought, be absorbed into the body. If she wasn’t, they would trigger menstruation. But the concentration was extremely high – one dose of Primodos is 40 times the strength of a current oral contraceptive.
Marie had no idea what had caused the malformation of Sarah’s arm until a phone call eight years later. “It would seem the association set up by some of the victims had accessed records from the health authorities to find children who had been born with disabilities. That was where they found my details,” Marie says. “The woman on the phone asked me if I had taken any tablets during my pregnancy. When I told her about the two pregnancy test tablets I had taken, she said: ‘Have you any idea what’s in them?’
“I couldn’t take it in. I was thinking: ‘She’s just told me I’ve taken two tablets that are 40 times the strength of an oral contraceptive.’ I just felt pure anger.”
I have been following this story for many years, striving to find the truth behind a terrible injustice that, much like the Thalidomide scandal, seems to have been covered up at every turn.
My investigation began six years ago when a man called Karl Murphy emailed me about a discovery. He’d found four suitcases in his mum’s attic in Liverpool full of documents about pills she had taken as a pregnancy test. Karl, now 44, was born with shrivelled hands and feet. His mum, Pam, had been in a campaign group that tried to prove Primodos had harmed their babies.
Karl’s files showed that in June 1975, a warning had been placed on Primodos packets by the UK regulators. It stated that the drug should not be taken during pregnancy because of the risk that it may cause malformations. At this stage, it had been on the market for 15 years. Two years later, regulators wrote to doctors stating: “The association is confirmed.”
This compounded evidence discovered 10 years earlier, in 1967, by a paediatrician called Isabel Gal, who had observed a worrying pattern in babies born with spinal defects. Her research found a high proportion of those with spina bifida came from mothers who had taken hormonal pregnancy tests.
I met up with Dr Gal in 2011. She told me she had fought a 10-year battle to get the drug removed from the market, but had been stonewalled by every institution, from the Department of Health to the Committee on Safety of Medicines. I then spoke to Norman Dean, a statistician who had conducted a study in 1968 that showed the incidence of birth malformations in the UK rose in tandem with sales of the drug. He told me he had recommended to the German manufacturer, Schering, that it conduct further studies. He does not know if they were ever carried out.
Given the evidence, you might presume mothers who used this drug would have a strong chance of claiming for compensation against Schering. But that hasn’t been the case.
In 1982, an attempt to bring the case to court by the alleged victims fell through and legal aid was withdrawn from the 700 families who were battling to be heard. It was deemed they would be unlikely to prove a causal link between the drug and the malformations in their children.
Marie, who is chair of the Association for Children Damaged by Hormone Pregnancy Tests, recalls: “We were told if we wanted to proceed with the case we would have to remortgage our homes. It was as stark as that.”
After the Government opened its 2014 inquiry into the drug, a breakthrough came last year. Hundreds of files about Primodos that had been stored unseen in the Berlin national archives for decades showed that in January 1975, a Dr William Inman, principal 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”.
Dr Inman wrote to Schering, but in order that it could “take measures to avoid medico-legal problems”; he doesn’t tell it to recall the drug, and it doesn’t. A later document explains that he destroyed the materials on which his findings were based, “to prevent individual claims being based on his material”.
When we put this to the current drugs regulator, it told us the decision was taken to inform the manufacturer of preliminary findings, so the company could decide whether to remove it – a lame reaction to such widespread anger by the very body that was put in place to protect the public in the wake of the Thalidomide scandal.
Schering is now owned by pharmaceutical giant Bayer, which insists Primodos was on the market in the UK “in compliance with prevailing laws”. It says the view at the time and, after a full review, today is that “evidence for a causal association between the use of hormonal pregnancy tests and an increased incidence of congenital malformations was extremely weak”. It “rejects any suggestion” that anything has been concealed by Schering, other than privileged documents.
Next month, the body of experts assembled by the Government will reassess the evidence and, for the first time, the newly unearthed documents.
Marie, who has never given up hope of being given answers, says: “It’s unthinkable that more than 40 years after our children were born, neither the sufferers nor their mothers have had justice.”