Hormone Pregnancy Tests

Nigel Evans Excerpts

Thursday 7th September 2023 Commons Chamber

[Allan Dorans]

I would welcome that type of inquiry and the opportunity to view the outcome.

Despite serious concerns being expressed by the eminent paediatrician, Dr Isabel Gal, in 1967 indicating the possible dangers of Primodos, no official warnings were issued about these drugs until eight years later. There is strong and compelling evidence of systematic regulatory failures, demonstrating that the committees tasked with safeguarding the health of pregnant women failed in their duty of care.

When I was elected in 2019, I had never heard of the drug Primodos, and I suspect that is the case for many Members. I had heard of thalidomide, as it received far greater coverage in the media at the time. However, since then I have learned much about the horrors caused by Primodos—the devastating effect it had on unborn babies and on the babies born with horrendous birth defects, and the continuing, unimaginable tragic consequences for the mothers and families whose lives have been so cruelly affected by the drug. It is an absolute disgrace and shameful that those families have not only been utterly abandoned and ignored by the drugs companies responsible, but also by successive Governments, who actively put up barriers to avoid accepting the consequences of the manufacture, approval, prescribing and giving out of Primodos.

The drugs companies involved in the production of Primodos, the medical authorities at the time who failed to protect people and successive Governments are all liable for the suffering caused to the victims of Primodos. They are all culpable and guilty of negligence, for failing to put right this horrendous wrong put upon innocent people. It cannot be right that the fight for justice in these circumstances has been left in the hands of a few determined individuals battling against a huge global pharmaceutical conglomerate with millions of pounds of resources and our own Government.

I highlight the case of my constituent, Nan. I have her permission to share her experience and the effect that Primodos had on her and her daughter, Michelle. In January 1975, Nan was a recently married, healthy young woman. Feeling sick and suspecting she may be pregnant, she went to her GP for a pregnancy test, expecting—as was normal at that time—a urine test. Instead, her doctor gave her two Primodos tablets. By 1975, Primodos had already been banned for use as a pregnancy test for five years in Norway and Sweden. Nan put her utmost trust in the knowledge, experience and expertise of her GP. It was subsequently confirmed that she was about seven or eight weeks pregnant. She had a very uneventful pregnancy during which she neither smoked nor drank alcohol.

On 28 August 1975, Nan’s daughter, Michelle, was born. It was immediately discovered that Michelle was born with a hole in her diaphragm, which had allowed her bowel and spleen and part of her liver and kidney to be forced in to her chest cavity, crushing her lung. She was not expected to live, but through the exceptional skills of our national health service she survived and is now 48 years of age. Throughout her life, she has endured numerous operations and surgeries and long periods of hospitalisation. She has suffered severe health issues, including breathing difficulties, a weakened immune system, numerous bowel obstructions and inflammatory bowel infections, and she has been unable to conceive children. The horrendous effects of the debilitating physical, psychological and medical conditions and the extremely challenging health conditions suffered by Michelle and her parents for the past 48 years just cannot be adequately described by me with words.

When Michelle was born in 1975, Nan was unaware that the drug that she had been given to test for pregnancy had been associated with birth defects for the previous eight years. It was not until some two and a half years later that she read an article in the press that reported on a number of cases linking birth defects to Primodos, including internal organ damage similar to that suffered by Michelle. Since that time, Nan, along with many other women, has been fighting the injustice, where no one has ever been held responsible for the damage caused to so many lives through prescribing Primodos, which had been approved by the Government.

In February 2018, the then Prime Minister, the right hon. Member for Maidenhead (Mrs May), announced that Baroness Cumberlege would oversee an independent medicines and medical devices safety review. This review was, among other things, instructed to consider the consequences of Primodos. One of the conclusions in the report by Baroness Cumberlege is that Primodos should have been withdrawn from the market in 1967, after the first report by Dr Gal. However, the Government refused to accept responsibility for the effects of Primodos without a proven causal association, but admitted later, in a Sky TV interview, that there was a possible association. There was a moral duty for Government representatives on the Committee on Safety of Medicines to protect patients, but they failed in their duty of care by suppressing the evidence of harm caused by the drug. Even today, the Government continue to deny that they suppressed evidence, while supporting the flawed conclusions of the 2017 expert working group.

The damage to individuals, lives and families caused by Primodos, successive Governments’ lack of action and the failure to prevent, is immeasurable. This could be a far greater tragedy than thalidomide. Apart from frustration at the pharmaceutical companies and the glacial pace of Government in righting this tragic, historical wrong, the most chilling words we hear, increasingly regularly, are: “We have recently lost another of our Primodos family.” The tragedy is that we all know that those people died without receiving the justice they deserved. Even if compensation were paid, it would never fully compensate the families who were so tragically affected, or take away the immense guilt experienced by mothers who feel that they were in some way to blame for the defects that their children suffered.

It is well past the time for the current Government to put right this historical wrong, end the scandal and give some security to those who have suffered so much, thus allowing the mothers, fathers and the children who have survived some dignity and compensation for the tragedy that was caused through no fault of their own. The very least the Government can do is accept responsibility for the tragic circumstances, immediately issue a full apology to everyone affected by Primodos and compensate the victims. I and my party urge the Government to accept and commit to implementing the full recommendations of the Independent Medicines and Medical Devices Safety review and to set up a redress fund for families affected by Primodos.

[Mr Deputy Speaker (Mr Nigel Evans)]

When we get to the winding-up speeches, it will be six minutes, eight minutes, eight minutes and then we will leave two minutes for the proposer of the motion.

--- Later in debate ---

[Sir Mike Penning (Hemel Hempstead) (Con)]

It has been an honour and a privilege to sit through this debate. As usual, I will be speaking with no notes, because a lot of what has been said today I would have said myself. I pay tribute to the chair of the all-party parliamentary group, the hon. Member for Bolton South East (Yasmin Qureshi). We have done much work together over the years.

I pay tribute to Marie Lyon and all the other campaigners, but there is something about this debate. Every time we have it there is unity, conformity, passion and love in the Chamber but, as my right hon. Friend the Member for North East Somerset (Sir Jacob Rees-Mogg) said, it disappears into Government and does not come back out. Governments of all descriptions have known about this for years and could have done something about it, but, for some unknown reason, they did not. When I was a Home Office Minister under my right hon. Friend the Member for Maidenhead (Mrs May) we did other inquiries together, but we had to battle to get them.

I do not understand why Governments, of all descriptions, do not come to the House to make statements, so we have to UQ them. It is plainly obvious that we will get a statement. We had three statements today, and quite rightly, but the Government would have been UQ-ed if they had not come to the House. Perhaps common sense is prevailing.

When it comes to really serious issues, like Primodos, for some unknown reason the Government, the Department and the Treasury pull down the shutters. It is not one Department, and I fear for the Minister when she stands at the Dispatch Box, because this is way outside the remit of just the Department of Health and Social Care.

We heard earlier that Government lawyers are threatening activists who are trying to get justice for their families, loved ones and others. Many of these campaigners have lost their loved ones, and some of them were victims themselves when they were told to have an abortion or when they had a miscarriage or stillbirth. A lot has changed in society but, in the 1960s and 1970s, it was a really difficult thing for a woman to go to her GP because she thought she was pregnant, especially if she might be a single mum. These couples and single mums were passionately waiting for this pregnancy to make their life fulfilled, and then, a short time later, they were told that perhaps the best thing to do was to abort the child because they would have terrible deformities, or they might go through childbirth. I am lucky enough to have just become a grandfather. I remember being there 33 years ago when my wife punched me on the nose halfway through childbirth. She did not intend to do it; she had no idea what was happening. She was just in a lot of pain and doing that made her feel better. These women were there and then all of a sudden they realised that the disfigurements and abnormalities were there to be seen—or, as we have heard in this debate, not seen until a little later.

We will be having a debate later, which I will be leading, about a situation where babies are born exactly like that and people are being told, “Oh, they’ve got bunions.” They do not have bunions; they have a genetic deformity. But because that deformity is so rare, no one understands it. On this issue, however, the Government, the NHS, the GPs and the drug company knew what they were doing. If the drug company had withdrawn Primodos after a year, when it first started to see this, most of us would have understood that these sorts of situations occur and it should, rightly, have compensated. However, that is not what happened. This went on year after year, with it knowing about this drug.

My point about the word “prescribed” is not just semantics; this drug was not prescribed. A prescription is a prescription. Opening a drawer and giving out a couple of tablets to the lady in front of you is not a prescription; it is a handout. This was done with no information given as to the dangers that we all see today. We have only to buy a packet of paracetamol to see written across the back of it what could happen. These ladies were not given that opportunity. They needed to know whether or not they were pregnant, for whatever situation they were personally in, and the GP then opened the drawer. This was in an NHS surgery, with a GP who was self-employed, as they mostly are, but paid for by the NHS. Those drugs were given not through a pharmacist, but directly from the drug company to the GP to hand out.

Let me conclude on an area that we have not really touched on, and it is something that Governments need to understand. I was a shadow health Minister for four years and I was passionate about this. The damage to our NHS of public understanding of this is so, so bad. The public need to trust the NHS. When they go to their GP, they need to be able to trust that if something needs to be done, it will be done for them and not for the system. Our NHS is being damaged by the way this cover-up continues. Government lawyers have accepted bits of Baroness Cumberlege’s report, but the fundamentals of it, which my right hon. Friend the Member for Maidenhead made sure happened, have been completely ignored. We can run around the head of a pin and say, “It is because there was legal action here and legal action there,” but we should say, “Let’s just do what is right. We have made a mistake, in the Department or in the drug company, and we are going to put it right and put it right today, for those families who are still there and for those families we have lost.” That is the decent thing that this House should do.

[Mr Deputy Speaker (Mr Nigel Evans)]

We come to the wind-ups. I call Hannah Bardell.