Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests

Summary

This is the second in our new series of Patient Safety Spotlight interviews, where we talk to different people about their role and what motivates them to make health and social care safer.

Marie talks about her campaign for justice for families affected by hormone pregnancy tests, why she is passionate about reforming medicines regulation and the important role patient campaigners play in improving patient safety.

About the Author

Marie Lyon is chair of the Association for Children Damaged by Hormone Pregnancy Tests, patient representative to the Scottish Government Patient Reference Groups and member of the UK Government Patient Engagement Panels.

Questions & Answers

Hi Marie! Tell us who you are and what you do?

I am Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT). People’s eyes usually cross at this point because they don’t know what that means! I have been fighting since the early 1980s for people to understand what oral hormone pregnancy tests are and what this campaign is about.

Hormone pregnancy tests (HPTs) caused untold damage to thousands of babies in the 1950s, 60s and 70s, many of whom didn’t survive. Some were stillborn or miscarried and some were born with dreadful disabilities such as severe heart malformations, missing limbs, and malformed fingers and toes. Some had brain damage, including some whose heads were not properly formed.

How did you first become interested in patient safety and what caused you to start campaigning?

I went to my GP in 1970 because I thought I might be pregnant. He said, “I just need to give you two tablets – take one today and one tomorrow – if you haven’t bled within 48 hours, you're pregnant.” I took the tablets, that I now know were Primodos, without questioning. Nine months later when my daughter Sarah was born, her arm was missing from beneath the elbow. At the time, I didn’t even consider it could be anything I had taken.

Then, when Sarah was nearly eight years old, I received a phone call from a woman asking about Sarah’s disability. She asked me what happened when I went to my GP. I told her I had taken two tablets – and she told me what was in them. These oral pregnancy tests contain 40 times the strength of an oral contraceptive, taken in two days at the very start of pregnancy. 

I was even more shocked to find out that the first warning about Primodos had come in 1958. It took the wind out of my sails. I felt a mixture of guilt, anger and determination. That was when I started campaigning, because I knew that many more families would be in similar situations.

How does your campaigning work practically and how has it developed over time?

Campaigning was difficult when we started in the 1980s – we didn’t have media coverage like today. Instead we took any opportunity we could to speak about the issue, going into clubs and organisations to raise awareness and ask women to come forward. The biggest problem with any campaign is raising awareness; if you can’t reach the people affected, it won’t work.

Unlike with thalidomide, there wasn’t a clear, identifiable pattern in the disabilities caused by HPTs. Because of this, we didn’t get the press coverage that the thalidomide scandal got. I believe the evidence was being suppressed because the Government wanted to protect the oral contraceptive pill. Had women been aware that the tablets had the same components, some would have stopped taking them.

As a group of parents, we launched a legal action in 1981 against the manufacturer, because we had never been warned about the dangers. We were dealing with a huge drug company and the UK Government, so the balance of power was not in our favour. Unfortunately our legal action was unsuccessful so we were advised to disband – our solicitors were worried that the manufacturer would pursue action against the parents for compensation. 

Then in 2009, further evidence was found at Kew archives and from then on we’ve not stopped in our search for evidence. We have lobbied MPs, got the press involved  and travelled anywhere we might find evidence that this damage could have been avoided. A large law firm asked if they could represent us and this encouraged more people to come forward. We now have around 650 litigants. 

These days we have a website and are trying to use social media, which definitely helps get our story out there. We have had media coverage and have the support of an MP, Yasmin Qureshi, who has worked with me for 10 years to try and expose the reality of HPTs.

Whenever a new member joins ACDHPT, I ask if I can write to their MP and request an audience. Once we tell their personal story and describe the evidence, MPs are often keen to support us. We now have an APPG of 131 cross-party MPs and keep lobbying them to challenge both the drug company and the Government. 

I sit on a number of patient panels, including the patient safety representative board for the MHRA in Scotland. It’s time consuming, but so important to be there to watch, listen and share the information we've gathered. 

Which part of your role as a campaigner do you find the most fulfilling?

The most fulfilling thing is letting women know they didn’t do anything wrong. I had 89 families that I supported when I started – we now have more than 400.

I speak to each one of them and they often feel great relief when they realise that there was nothing they could have done to avoid the disability or death their children suffered. It’s upsetting, but the reward is hearing them say that we need to speak up, because the reason it happened was avoidable. The support from our families is invaluable and motivates me to continue.

I also work with the German campaign group on HPTs, who had no possibility of redress because of the structure of their political system. We managed to pull together a meeting with 50 representatives from the three major German political parties. It was extraordinary, and these German MPs have worked together to successfully lobby the Government to initiate a full investigation.

What challenges does patient safety face at the moment?

As I see it, the basic barrier to patient safety is the UK Government and its regulators. Policy makers need to understand that if we don’t have transparency and accountability, patients will not be safe. Accidents happen and mistakes are made – but they need to be admitted straight away and not covered up. Then you can do something about it and prevent the harm.

I believe the regulator is continuing to protect and deny when it comes to HPTs, rather than addressing the harm that has been caused. If we can’t get the regulator to be honest and open and look at the evidence, where can we go? This is the barrier we are all knocking against.

What do you think the next few years hold for patient safety?

There is a hunger for change in some areas, but we need to get past the barriers. We need legislation that gives us the right to find evidence about what the authorities knew and the actions they took. I'd also like to see more scrutiny and genuine accountability – acknowledging what went wrong, where the error was and what action has been taken.

For patients to be fully accountable for their health, they need to know all the relevant information about risks and benefits. One thing we need to do is work towards better informed consent for every treatment, so that patients understand the risks associated with the treatment they are offered.

Are there things you do outside of your role that have made you think differently about patient safety?

Outside of my role as a campaigner for HPTs I have been closely involved with patient groups who strive to improve patient safety, including Patient Safety Learning, who are relentless in their efforts to improve patient safety for everyone. I am a representative for the Scottish Government Patient Reference Groups and member of the UK Government Patient Engagement Panels.

Tell us one thing about yourself that might surprise us!

I think I’m quite an open book! You won’t be surprised to hear that I’m like a terrier and never let go of things that matter to me.

Related reading

Independent Report of the Patient Reference Group – response to the report of the Independent Medicines and Medical Devices Safety Review (21 July 2021)
Letter to MHRA on Irbesartan - 9 August 2021
Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies