Oral Hormone Pregnancy Tests

Luciana Berger Excerpts

Thursday 23rd October 2014 Commons Chamber

[Luciana Berger (Liverpool, Wavertree) (Lab/Co-op)]

I thank my hon. Friend the Member for Bolton South East (Yasmin Qureshi) and the other sponsors of the debate for ensuring that the House discusses an issue that has been ongoing and unresolved for 40 years. I greatly admire my hon. Friend for her tireless campaigning on behalf of the families, who have never received the answers they deserve. I thank other Members for their thoughtful contributions, which are testimony to how much the issue has moved those in all parts of the House. I also pay tribute to Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Testing, who has never given up what has been a real struggle to get to the bottom of what happened and why. I had the privilege of meeting Marie and hearing her own story.

Today I speak not just on behalf of my party’s Front Bench and as a member of the shadow health team, but in my role as a local constituency MP. I was visited in Liverpool by my constituents Pat and Terry Hughes, who told me their story, which I have their permission to share with the House. Pat had taken the oral hormone pregnancy test, primodos, in 1971, and her daughter Katherine was born by caesarean in October of that year. When Pat came round from the operation, she was told that something had gone horribly wrong. Katherine had been born with no gullet and no back passage. She had kidney problems and disfigured feet. Very tragically, Katherine survived for just two hours. Pat and Terry never had the opportunity to see their baby. I was incredibly moved to hear that story about Pat, Terry and Katherine’s experience, and about Pat and Terry’s immense bravery, but also about their determination to find out why Katherine was born the way she was.

As we have heard, Pat and Terry Hughes are not alone. Many hon. Members in all parts of the House have shared their constituents’ stories. It is worth reminding the House of how many stories we have heard. We heard from my hon. Friend the Member for Bolton South East about Nichola Williams. The hon. Member for Aberconwy (Guto Bebb) told us about his constituent Mrs Roberts and her son Garry. My hon. Friend the Member for Makerfield (Yvonne Fovargue) shared the story of Mr and Mrs Tilly and their son Stephen. My hon. Friend the Member for Coventry North West (Mr Robinson) talked about Christine Pettifer. The hon. Member for Enfield North (Nick de Bois) spoke on behalf of his constituents, Chris Gooch and her daughter Emma-Victoria. My hon. Friend the Member for City of Durham (Roberta Blackman-Woods) spoke on behalf of Mr and Mrs Chapman and their daughter Margaret. The hon. Member for Romsey and Southampton North (Caroline Nokes) talked about her constituent Vicky. My hon. Friend the Member for Hayes and Harlington (John McDonnell) spoke on behalf of his constituent Kulvinder Sidhu. My hon. Friend the Member for Airdrie and Shotts (Pamela Nash) spoke on behalf of her constituent Mrs Rose Stallard and her daughter Elizabeth.

Those are just some of the many hundreds of individuals and families who have endured for more than 40 years not just the disabling physical conditions but an overriding sense of injustice. We are here today to determine whether there is a case to answer, whether there are unanswered questions, and whether there is information out there that might help fill in the gaps. I think that the case is clear.

Let me summarise the points we have heard. We have heard about the drug itself. Like the hon. Member for Enfield North, I am not a medical professional, but we do not need to be doctors or scientists for alarm bells to ring when we hear that a drug that was approximately 40 times the dosage of a contraceptive pill prescribed today was then prescribed to be taken by pregnant women twice within the course of 12 hours.

We have heard about the many women who took the pill at the time and who went on to suffer instant miscarriages. Thousands more gave birth to babies with missing limbs, abnormalities in their internal organs, brain damage, and heart defects. Many of those children died before reaching adulthood. Of course, many mothers who have not taken this pill also gave birth to babies with disabling conditions such as these, but the scale of the proportion of women who had taken the drug and who experienced complications gives rise to some serious questions. There were between 500 and 700 UK members of the Association for Children Damaged by Oral Hormone Pregnancy Tests, although it is thought that the true number of alleged victims may be in the thousands. The Government have estimated the number to be 3,500. In Germany, where a primodos equivalent was distributed, another 500 families are fighting for their claims to be heard.

We have heard about the studies on the drug that were undertaken at the time. In 1968, the Royal College of General Practitioners sent a letter to Dr Inman of the Committee on Safety of Medicines stating that 10% of abortions recorded after primodos were unlikely to be due to chance. The committee received a letter from the Usher Institute of Public Health in Edinburgh, which had concerns about its study on rats and abortions. It stated:

“Primodos should be withdrawn from use.”

In 1968, the drug company’s lead UK scientist wrote to the parent company in Berlin:

“it is extremely disturbing that the results of statistics, human studies and other studies all point clearly to the possibility that Primodos may interfere with a pregnancy.”

Those are just some of the studies and warnings that were received throughout the 1960s and early ’70s, and we have heard from many hon. Members on both sides of the House about further representations and studies that were done at the time.

That takes us to the crux of the debate: the significant delays in communicating those warnings. By the early 1970s, primodos was no longer authorised as a pregnancy test. In fact, it contraindicated for use in pregnancy, meaning it was declared that it should not be taken during pregnancy. Despite that fact, primodos continued to be used as a pregnancy test until 1975, when the Committee on Safety of Medicines finally wrote to doctors to warn them that the drug “may cause congenital abnormalities”. A warning was placed on the packet, saying it was

“not to be used during pregnancy...may cause congenital abnormalities”,

but it was not until two years later, in 1977, that the committee wrote to GPs stating that the “association has been confirmed”. In 1977, there were 7,038 prescriptions of primodos to pregnant women. A 1975 paper for the World Health Organisation questioned why research on such a critical issue, published in the late 1960s, was not followed up for many years.

It is worth reiterating that the authorities in Sweden, Finland, Germany, the USA, Australia, Ireland and Holland issued warnings and took action on hormone pregnancy tests as early as 1970, five years before any warning was issued in the UK, despite the fact that the Committee on Safety of Medicine was the first medical authority to know of the hazard.

Let me be clear: the point today is not why this drug was ever allowed to be prescribed in the first place, although there are some very serious questions hanging over that. No one is questioning the GPs who prescribed the drug. Why would they question the safety of the medicines and drugs approved by the Committee on Safety of Medicines? The problem is why, after so many warnings, and after it lost its licence to be given to pregnant women, there were so many delays in communicating that information to GPs. It was that delay that meant that so many women continued to take the drug long after it was known to be unsafe. Had the drug been withdrawn when the warnings become clear in 1970, my constituent Pat Hughes would not have taken it in 1971.

Why are we here? Why has this case not been resolved before now? We have heard from many Members that an opportunity the group had to mount legal action—which was supported by Lord Ashley, the then Labour MP for Stoke-on-Trent South—against the pharmaceutical company Schering had to be abandoned before it got going, when the Legal Aid Board said it could not continue to provide public funding because it felt the weight of the argument was in favour of Schering.

That case, however, was more than 30 years ago. Just because the evidence we have knowledge of is insufficient does not mean there is not a case for investigating the issue further and trying to find out more. That is why we are here: to call for the full disclosure of all the documents held by the Government relating to this drug.

There are real challenges in obtaining scientific proof of a causal link, but the facts that we do have are incredibly compelling. The drug has been withdrawn, so it cannot be tested on women, and those women who were affected have gone back to their doctors for their records, only to find that they are no longer there, as my hon. Friend the Member for Makerfield has said. I will not speculate on why the records are not there any more—I will leave it to Members to draw their own conclusions—but I understand that the BBC has made a documentary to expose that particular issue.

The situation leaves us with a real problem, and not just for those families affected: this is a matter of principle about the integrity of how we do things in this country. Marie, the chair of the Association for Children Damaged by Hormone Pregnancy Testing, explained to me that whenever she visits a doctor now, she questions everything that is prescribed to her. She has lost trust. These families want to prevent this from ever happening again.

The primodos case also raises wider questions about the safety of medicines. It is not acceptable to have such a shadow of doubt hanging over the impact of a drug that was licensed, prescribed and taken by women without due and proper process. If there are documents relating to this drug, it cannot be right that they are not made publicly available.

I want to finish by coming back to Marie Lyon, my constituents Pat and Terry Hughes, and all the other families who are still looking for answers. Feelings of guilt and injustice have followed them throughout their lives. They had 40 years of grieving for the children they lost, or of caring for those who survived. As my hon. Friend the Member for Airdrie and Shotts said, these families are getting older. The parents are now heading into their 70s, and they are worrying about who will take care of their children when they are no longer here.

The families still do not have any answers. This cannot be right. They need answers not just for themselves, but to ensure that this can never happen again. The petition signed by hundreds of people, which has been handed in to No. 10 Downing street, shows that that goal is supported by people across the country. Today’s debate has demonstrated that Members from both sides of the House are clear about what needs to be done to achieve it. It is a very reasonable request. It is important that the documents are released and that they are reviewed by an independent panel. I wholeheartedly urge the Minister to commit to making that happen. I look forward to his response.