Will there ever be justice for the Primodos children? Including Nicola who died after first birthday

It is an enchanting image that will strike a chord with most parents: baby Nicola, surrounded by her adoring family, as she gazes curiously at the single candle on her first birthday cake.

The day was, however, a rare moment of joy in a tragically short life, marred by severe illness and invasive medical treatments.

It’s not immediately obvious, thanks to the pretty pink dress she is wearing, but at the time Nicola’s tummy was so swollen – distended by a build-up of fluid in her abdomen – that she was unable to stand. Just weeks after she was born, jaundiced and unable to hold down fluids, doctors discovered abnormalities in her digestive system which led to irreversible liver damage.

Nicola was given months to live, but she defied the odds. Her mother, Jo Moreno, recalls: ‘Every night I would put her to bed and worry that something might happen to her in the night. When she smiled, I sometimes thought maybe the doctor had made a mistake and that she was going to live. But then she would get really sick again, and she was in so much pain.

‘The year seemed to pass so quickly. We got a professional photographer to take the picture of her on her birthday because we knew it would be one of the last photos we ever got of her.’

Baby Nicola, surrounded by her adoring family, as she gazes curiously at the single candle on her first birthday cake. The day was, however, a rare moment of joy in a tragically short life, marred by severe illness and invasive medical treatments

SUFFERERS: Ann, left, now 52, was born with severe cerebral palsy while Kirsteen, right, also now 52, has struggled with profound deafness and asthma

Just weeks after the poignant snapshot was taken in 1971, Nicola lost her fight for life.

‘I was so distraught. I still am to this day,’ says Jo, 74, from Devon.

For years after, the reason her daughter had become so desperately and suddenly ill was unclear.

‘There were no liver problems or birth defects in our family,’ she says. ‘I supposed I blamed myself.’

Then, in the early 1980s, she read a newspaper report about other babies who’d been affected in similar ways. What linked the cases was an early home pregnancy test their mothers had taken called Primodos.

It dawned on Jo that she too had been given the groundbreaking test in the form of two white pills.

Today, she remains convinced that Nicola’s health problems and untimely death were a result of Primodos. And she is far from alone.

Since those early reports, more than a thousand women have come forward to say they suffered miscarriages, stillbirths and that their babies were born with deformities after taking the test.

The tablets, containing high doses of female sex hormones, triggered a period if the woman was not expecting. If there was no bleeding, then she was pregnant.

Primodos was discontinued in the UK in 1978 after medical authorities concluded there were credible safety concerns. Since then, research has repeatedly suggested that taking the test dramatically increased the risk of children being born with debilitating and life-shortening birth defects such as malformed limbs, brain damage and heart problems – most recently in a major review conducted by experts at the University of Oxford in 2018.

The families affected have sought recognition – and compensation – for what happened to them. Yet, distressingly, a legal case they brought in 1982 against Bayer, the German drug company behind Primodos, was unsuccessful. And last month their hopes were dashed once again after a High Court judge dismissed their latest claim.

Campaigners say they are planning to appeal the decision, which contradicted the conclusion of Conservative Peer Baroness Cumberlege in her Government review into Primodos, published in 2020.

A Primodos advert from 1961 – it was discontinued in the UK in 1978 after medical authorities concluded there were credible safety concerns

She said the families affected had been failed by the NHS – leading then Health Secretary Matt Hancock to issue a public apology. They deserved compensation from Bayer, Baroness Cumberlege added.

Campaigner Marie Lyon, 77, who believes her daughter was born with a malformed left arm because of Primodos, says she will continue to fight for the pharmaceutical firm to take responsibility.

‘We don’t accept the court’s judgment,’ she said. ‘We won’t stop until we have justice for our children. It’s not about the money, we want the company to admit they were responsible.’

Former Leader of the House of Commons, Jacob Rees-Mogg, has branded the ruling ‘extraordinary’. He added: ‘The High Court case was thrown out not on the scientific evidence but for legal reasons. The recommendations of the Cumberlege report should be completed, and that includes compensation for the affected families.’

Bayer denies that Primodos was responsible for causing any problems. In a statement, the company said: ‘Previous UK litigation in respect of Primodos, against Schering (which is now owned by Bayer), ended in 1982 when the claimants’ legal team, with the approval of the court, decided to discontinue the litigation on the grounds that there was no realistic possibility of showing that Primodos caused the congenital anomalies alleged.

‘Since the discontinuation of the legal action in 1982, Bayer maintains that no significant new scientific knowledge has been produced which would call into question the validity of the previous assessment of there being no link between the use of Primodos and the occurrence of such congenital anomalies.’

But families who believe they were affected by Primodos disagree.

Jo Moreno, who was just 21 when she took Primodos, said: ‘I was in disbelief when I heard the news [that the latest case had been dismissed]. For decades there has been evidence that Primodos causes birth defects. I don’t understand why the court can’t see this, too.’

So what is the story behind Primodos – and, crucially, what is the evidence against it?

The drug first went on sale in the UK in the late-1950s. It involved taking two pills on consecutive days, each containing norethisterone, an artificial version of the female sex hormone progesterone, and ethinylestradiol, an artificial version of oestrogen.

Progesterone and estradiol are both found in modern contraceptive pills. But the levels used in Primodos were about 40 times higher and remained in the body for a far longer period of time due to their synthetic nature.

Primodos was a revelation: prior to its release, convenient at-home pregnancy tests did not exist. If women wanted to definitively find out if they were in the early stages of pregnancy, the only available and reliable tool was a hospital test carried out in a lab that – bizarrely – involved injecting women’s urine into a female toad to see whether it ovulated. However, it was only reliable two weeks after a missed period, took several days to get a result and was expensive.

As a result, Primodos was marketed using a picture of a toad with the tagline: ‘The toad is slow to let you know. Quicker, cheaper, equally reliable… two tablets of Primodos.’ While available, it was prescribed by GPs to about 1.5 million women in the UK. In 1967, a study showed a significant association between hormone pregnancy tests and birth defects. In light of this, and subsequent research that came to similar conclusions, drug regulators issued a warning in 1975. But is was not until 1978 that the Government halted sales. The reason for such a delay has never been fully detailed.

In his 1997 autobiography, Dr Bill Inman, senior medical officer at the Department of Health and Social Security at the time, wrote he was worried ‘a thalidomide-type scare in the media could easily cause panic among women using oral contraceptives [which contain the same hormones].’

He was, of course, referring to the anti-pregnancy sickness drug thalidomide, which led to severe deformities and death in more than 10,000 children.

Had health authorities acted quickly in response to the 1967 study, campaigners say it may have saved the suffering of many women.

Janice Mills, 74, took Primodos in July 1970. When her daughter Ann was born, she was diagnosed with severe cerebral palsy. She is now 52, has never been able to talk or walk and requires full-time care.

Janice says: ‘I asked my GP if these pills were going to hurt my baby because I was worried about the thalidomide scandal. He said Primodos was completely safe.

‘I will always regret the decision to take it.’

Karl Murphy, who died last year aged 50, was born with deformed limbs after his mother took Primodos. He said he was ‘100 per cent convinced’ his abnormalities were caused by the pregnancy test.

STRICKEN YOUTH: Karl Murphy, was ‘convinced’ that Primodos caused his deformed limbs

Another mother, Wilma Ord, 75, from Livingstone, also believes her daughter was born with cerebral palsy due to Primodos. Kirsteen, now 52, was also born profoundly deaf and she is severely asthmatic.

‘I have no doubt that Primodos damaged my daughter,’ says Wilma. ‘We were treated like guinea pigs with a drug no one understood at the time.’

One of the main obstacles for the families seeking justice is that all of the research into Primodos, naturally, dates back four or more decades.

‘The vast majority of scientific studies carried out in the 1970s and 1980s don’t meet the standards we expect nowadays,’ says Prof Neil Vargesson, a developmental biologist at the University of Aberdeen who helped discover the dangerous effects of thalidomide.

‘It’s very hard to look at just one study from this period and make a conclusion. What’s more, the amount of data we have on it is small in comparison to, say, sodium valproate, an anti-seizure drug which we regularly used for 30 years before we realised it caused birth defects.’

In 2017, UK drug regulator The Medicines and Healthcare Products Regulatory Agency (MHRA) formed an expert working group to look at the impact of Primodos. It concluded there was no evidence it caused birth defects – but the report was labelled a ‘whitewash’ at the time by MP Yasmin Qureshi, who accused the group of not looking at the evidence presented to them.

One senior scientist who submitted evidence, but asked to remain anonymous, said it was no surprise that the group found no link. ‘The MHRA were the ones who approved Primodos in the first place,’ they said. ‘It was like they marked their own homework.’

We put this allegation to the MHRA. It maintained the report was based on the available scientific evidence and no members of the group had conflicts of interest.

Then, in 2018, University of Oxford researchers published new research which suggested a clear causal link between Primodos and birth defects. The report, which looked at 26 hormone pregnancy test studies involving over 76,000 women, concluded that taking drugs like Primodos increased the risk of birth defects by 40 per cent.

However, this study has proven contentious. In 2019, MHRA experts rejected it because they argued the quality of the studies examined was poor and the methods used to analyse them were ‘not in line with best practice’. And last month, the High Court chose not to consider the study as new evidence. Bayer’s lawyers argued that researchers involved in the study had been influenced by the opinions of campaigners.

The researchers have strongly denied this claim.

‘When we set out to examine the link between Primodos and birth defects, we always planned to publish our research regardless of whether we found one or not,’ says Professor Carl Heneghan, a clinical epidemiologist at the University of Oxford. ‘Our analysis followed all the necessary steps expected of a high-quality scientific study. We looked at old evidence in a new light and drew a clear conclusion. I challenge any health expert to look at this evidence and disagree.’

Conservative MP Sir Mike Penning, who is vice chairman of the All-Party Parliamentary Group on hormone pregnancy tests, labelled the High Court ruling a ‘disgrace’.

Some families have gone as far as to say they believe Bayer is dragging out the court battle in an attempt to cover up the scandal.

‘I believe Bayer are prolonging this case,’ says Marie Lyon, who is chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests. ‘They are waiting for us to die – we are in our 70s and 80s now and perhaps Bayer thinks that we won’t be around much longer to fight this battle.’

Yasmin Qureshi MP, who is backing the Primodos families’ appeal, said: ‘We are determined to ensure this is not brushed away. Primodos families will be given justice.’