Mother Marie Lyon, who was prescribed Primodos and later gave birth to a daughter whose limbs were not all fully formed, describes for Sky News her painful fight for the truth…
Take these two tablets. Four words which would lead to a lifetime of guilt and regret.
Guilt, because I didn’t question, I just accepted the tablets because they were given to me by my doctor.
Regret, that my beautiful daughter has had to work harder to achieve all the everyday tasks we take for granted. Determined not to be labelled as disabled, Sarah drives a geared car, obtained her bronze swimming medal and competed in horse riding events.
The two tablets were called Primodos, a hormone pregnancy test manufactured by the drug company Schering, now Bayer. This was my first pregnancy, so I assumed I would give a urine sample and within a few weeks it would confirm I was pregnant. I was surprised but delighted that this new test would confirm my pregnancy within days.
When Sarah was born in October 1970, she was taken away immediately after delivery. I assumed this was normal and wasn’t particularly concerned. When the nurse brought her back into the room she told me that Sarah’s arm had not formed from below the elbow.
Instead there was a perfect tiny palm and five tiny fingers. These were amputated when Sarah was 13 months old. We were told there was no explanation for the arm not forming and that these things sometimes happened.
We got on with our lives and Sarah continued in her determination to participate in every activity, although the doctors at the limb centre were not too pleased at the frequency of new limbs needed, usually through Sarah doing handstands.
In 1975 we had a son and luckily we had moved house and had a new doctor. Luckily, because I would have taken the tablets again, as I had no knowledge of what they contained.
In 1978 I received a phone call which changed my life forever. It was from a member of the new Association for Children Damaged by Hormone Pregnancy Tests.
Initially, I couldn’t make sense of what she was telling me, but when the information finally sank in, I was horrified. The two tablets my doctor gave me were 40 times the strength of an oral contraceptive.
I immediately joined the association and assisted in fundraising to retain a solicitor to find out the truth.
How could tablets used to prevent children be used as a pregnancy test?
We obtained legal aid and were informed we had a good chance of proving our case in court, but we were no match for the might and money of Schering and we had to withdraw before the case came to court. The association was disbanded.
In 2009 I was contacted again to say that the association was being re-formed and I agreed to join and support the new chair. In 2012 the chair resigned without notice or explanation, which left us in the position of either closing down the association or finding someone who would take on the responsibility. It was never an option for me to agree to close down the association, so I agreed to take on the role of chair.
This meant starting from the beginning to ensure I had a good understanding of any evidence we had against Schering, which in turn meant many trips to look through the files in Kew (National) Archives.
When reading the files, I noticed the huge amount of documentation referring to the deaths and disabilities caused by the original contraceptive pills and documentation proving that this information had been covered up by the government health authorities.
It became clear that the various health committees were aware that to admit there was a problem with HPTs would highlight the previous problems with oral contraceptives, which had the same components.
At last it started to make sense. It was also in Kew Archives that I found the document stating “doctors can destroy medical records, however wrong this may be, if they are concerned about legal action from drug prescriptions”. Many of our members’ medical records are missing.
I was contacted by Andre Sommer, a campaigner in Germany, and agreed to share any information we found in Kew Archives, to help their campaign. I asked Andre if there was a similar archive in Germany we could access. We flew to Berlin and accessed the LandesArchiv, where we discovered 31 files full of documentation and studies, proving that both Schering and our own government health authorities had been aware of the dangers of HPTs.
We expected it from Schering, but it was a bitter blow to find out we had been sacrificed by our own authorities.
It was evident that we needed parliamentary support to progress our campaign and were backed by Yasmin Qureshi MP. My husband and I travelled to Westminster, sometimes twice a week, to lobby MPs to join the all-party parliamentary group chaired by Ms Qureshi. This support has been invaluable. We now have more than 80 MPs.
After four and a half years, two Westminster debates, travelling to Germany and Cologne, and many trips to Kew Archives, we finally have a government expert working group reviewing the evidence.
This story has yet to achieve a conclusion.
:: The current drugs regulator the MHRA told Sky News: “At the request of the minister the Commission on Human Medicines has formed a highly qualified expert working group to look at all the available evidence on hormone pregnancy tests from a wide range of sources and the group has now met on five occasions.
“The expert working group has heard directly from several families who are members of the Association for Children Damaged by HPTs who wanted the opportunity to share their experiences. The chair of this association has attended all these meetings as an observer.”
:: The Royal College of GPs said: “The link between the use of Primodos and birth defects or miscarriage continues to be inconclusive, as found by the medicines and healthcare products regulatory agency as recently as 2014. Individual clinicians might have their own opinions about this link, but there is no robust clinical evidence to support this.
“In the early 1980s, the college was contacted by lawyers for those trying to sue the manufacturers of Primodos, who requested access to data collected by GPs from patients as part of a large-scale survey. The college was concerned to protect the confidentiality of both the patients and doctors involved in the study and, on legal advice, concluded it should not hand over the data without due legal process being followed. As the data was not provided, we assume that the plaintiffs’ lawyers did not think it was necessary to take the legal steps necessary to access it.
“Nowhere in the RCGP’s archive is it suggested that the college, or any physicians working on behalf of the college, had been negligent in the handling of data regarding Primodos.”
:: Bayer told Sky News that the abandonment of the legal challenge in 1982 and the absence of any further evidence demonstrates there is no case to answer. They said Primodos was on the market in the UK “in compliance with prevailing laws”.
The say the view at the time and today after a full review is that “evidence for a causal association between the use of hormonal pregnancy tests and an increased incidence of congenital malformations was extremely weak”.
They “reject any suggestion” that anything has been concealed by Schering – other than privileged documents.
:: Sky News’ hour-long documentary Primodos: The Secret Drug Scandal will be presented by senior political correspondent Jason Farrell, who has been investigating it for six years. It can be seen on Tuesday 21 March at 8pm on Sky Atlantic and on Wednesday 22 March at 9pm on Sky News.