Hormone Pregnancy Tests

Peter Dowd Excerpts

Thursday 7th September 2023 Commons Chamber

[Yasmin Qureshi]

I thank the right hon. Gentleman for his intervention. It is important to stress that it was the state, the NHS, involved in this.

In July 2015, I stood in this House and urged the Government to disclose all the evidence they had and to set up an independent inquiry. The then Minister, the hon. Member for Mid Norfolk (George Freeman), heard those concerns and agreed to an independent review, which would be led by an expert working group.

However, first, the expert working group was not independent. In fact, many of the experts were found to have conflicts of interest with the industry. Secondly, the review of the evidence conveniently ignored several important studies and then later said, “Oh, well, there was insufficient evidence.” Thirdly, the terms of reference of the review had said that it would try to find a possible link. Yet the reports’ conclusion said it was unable to find a “causal link”. How exactly does the Government intend to find a causal link, short of testing the drug on pregnant women?

[Peter Dowd (Bootle) (Lab)]

On that point about evidence, so many medical records were destroyed. How is it possible to have an absolute evidential base for the reports, when the evidence seems to have been destroyed?

[Yasmin Qureshi]

That is absolutely right; I thank my hon. Friend for that point.

I am pleased to see the right hon. Member for Maidenhead (Mrs May) in the Chamber. I know that, as Prime Minister at the time, she read this report. I note that in a recent Sky News interview she said

“I felt that it wasn’t the slam dunk answer that people said it was.”

I am truly grateful to her for commissioning Baroness Cumberlege to carry out a review that was both independent and credible.

Knowing what we now know, that the expert working group report was a whitewash, riddled with factual inaccuracies and conflicts of interest; knowing that studies from Oxford University have proven that the evidence in this report was deliberately manipulated to reach its conclusion; knowing that the Prime Minister of the day knew something was not right and then commissioned another review—how can it be right that any Government can continue to use this report to hide their sins?

Only a few weeks ago, lawyers used the report in court to defend their preposterous claims, and Ministers have used it as a basis to refuse and deny families redress. It is outrageous. I ask the Minister today: will she take a stand and do the right thing? Will she be courageous and read beyond the lines of the ministerial briefing she has been given? Only then will she agree with me that the expert working group report is not worth the paper it is written on.

The report stands in the way of justice for families affected by Primodos. I urge the Minister to work with us to set up an independent review of the scientific evidence, because I can assure her that only a truly independent review will find that there is an association between Primodos and malformation.

The scientific evidence is vast. Over several decades, numerous studies and animal experiments have found that the use of such tests can cause potential birth defects. In 2018, a team of academics at Oxford University conducted a systematic review of all previous human studies. They pooled together the data and found a “clear association” with several forms of malformation. At Aberdeen University, Professor Neil Vargesson has been working on this issue for years. He published research on zebrafish, which are genetically like humans, and found that the drug caused deformities in embryos. More recently, he has been working with human tissues and has again found the same association. There is another groundbreaking study take place in Sweden, which will be published soon. Again, that will continue to show how much evidence there is regarding this particular medication.

I have no doubt that later in the debate the Minister will stand at the Dispatch Box and tell the House that there is nothing she can do for the Primodos families because there is no proven association, because she has been convinced by the civil servants, the Medicines and Healthcare products Regulatory Agency and others. Would she like me to send her some of these studies—or perhaps I can hand them to her today? Is she willing to confront the truth, or is she going to be like her predecessors, burying her head in the sand? As long as she takes that position, she is standing in the way of truth and justice.

--- Later in debate ---

[Jeff Smith (Manchester, Withington) (Lab)]

It is a pleasure to follow my near constituency neighbour, the right hon. Member for Tatton (Esther McVey), and I join her and others in paying tribute to my hon. Friend the Member for Bolton South East (Yasmin Qureshi) for her campaigns over the years, and of course to Marie Lyon for her many years of campaigning for justice for the families affected, including in my constituency.

When Baroness Cumberlege’s report “First Do No Harm” was published in 2020, it finally offered those families hope of justice. It was unequivocal in finding that those affected by Primodos had “suffered avoidable harm” and should be entitled to support and financial redress. That should have been a landmark moment. The then Health Secretary apologised, appearing to take responsibility and accept the report’s verdict, so it is really so disappointing that, as I stand here today, no Primodos-affected families have received any compensation payment to address what they have been through.

I want to emphasise the impact on individual lives by looking at two families in my constituency. Patricia McClellan had two children, giving birth to a daughter in 1969 and to her son, John, in 1971. She did not take any hormone pregnancy tests before giving birth to her daughter, who was born healthy, but she was prescribed Primodos when pregnant with John, who was born effectively missing an arm. When doctors came to assess him a couple of days after his birth, Patricia described being asked if she had taken any medication during her pregnancy, to which she replied that she had been given Primodos. She said:

“I will never forget the professor and the Doctors took themselves into my bathroom for a private conversation. I felt powerless as events happened around me.”

She had a succession of other disempowering, worrying and disappointing experiences with medical professionals while caring for John of the type that were highlighted in Baroness Cumberlege’s review.

She said:

“I have felt as though I have been kept in the dark for over 40 years. I just want answers and justice for my son and hopefully some closure to the trauma, guilt and stress that has affected almost my entire life.”

Sadly, Patricia died in 2019, never having received the closure and justice that she needed.

John has lived his whole life with the impact of his disability, and struggles with red tape and constantly having to go through the processes to get recognition of his disability from the Department for Work and Pensions. He and his daughter Leah, Patricia’s granddaughter, continue to fight for justice alongside other Primodos-affected families. Leah said to me:

“Being the daughter of a Primodos victim has also had its effects on me. I’ve lost trust in our health officials, I’ve witnessed the lies that have been told time and time again. Seeing my father deteriorate mentally and physically because of this is worrying for me.”

In Leah’s words, too many people affected by Primodos

“have sadly died since all this began. It truly feels like the Government is just waiting for them to pass on so this can be brushed under the carpet.”

[Peter Dowd]

The mother of one of my constituents was given Primodos in August 1972, two years after the standing joint committee for propriety in medicine said that it should have been withdrawn. Warnings were there for years. Why did that happen? Does my hon. Friend agree that my constituent, and his mother and father, who are up in the Gallery today, require justice to be done, and to be seen to be done by way of redress?

[Jeff Smith]

I could not agree more, and families across the country have been affected in such a way.

The Pierce family are another family in my constituency whose whole lives have been shaped by Primodos. Edward and Janet Pierce’s daughter, Louise, is now 54 years old. She was born with several different disabilities, which the families are convinced were caused by her mother having been prescribed Primodos. Louise has a severe mental disability, profound hearing loss, and difficulty walking. She has always required full-time care, which has been provided by her parents for most of her life. She lived at home with Edward and Janet until she was 50. Edward said:

“We didn’t realise the physical and mental effect this was having on our lives, it just creeps up on you.”

In 2018, Janet had a serious stress-related breakdown, leaving her with short-term memory loss and lack of awareness, and Edward now acts as her full-time carer. Louise went into full-time residential accommodation at the time of Janet’s illness. Edward said:

“I’m sure you can imagine the devastating effect this is still having on all our lives.”

It is so disappointing that the Government rejected the report’s recommendation for a new independent redress agency, and instead again highlighted the existing legal routes for redress. The Government apologised to people affected by the Primodos scandal, but are offering them no support. Those families lack the funding to be able properly to challenge the Government in court and get redress from existing legal routes, and they are being offered nothing else by the Government.

One of the specific recommendations in the Cumberlege review was the establishment of an ex gratia scheme for the victims of hormone pregnancy tests, and discretionary payments to provide redress for the stress, anxiety, psychological harm and toll of fighting for recognition experienced by those affected. That is what these families deserve.

Haven’t these families suffered enough? The mothers who were given Primodos are in their 70s and 80s now, and some have sadly died. Their children are mostly in their 50s. Time is running out to give them the redress they deserve. The Cumberlege report stated that

“while there is disagreement between experts about whether Primodos caused birth defects, the fact remains that thousands of women and unborn children were exposed to a risk that was acknowledged at the time.”

Primodos was deemed dangerous enough to pregnant women to be pulled off the shelves, and Baroness Cumberlege found that those families had suffered avoidable harm. In such circumstances, and having commissioned the report, surely it is the Government’s moral duty to implement that report’s recommendations in full or, failing that, to explain how those families will get the financial redress they deserve.

In July 2021, the then co-chairs of the all-party parliament group first do no harm responded to the Government’s response, welcoming their acceptance of four of the review’s nine recommendations, and a further one in principle. It also said:

“But we are deeply disappointed the Government has rejected calls for an independent redress agency or any redress for families whose lives have been devastated by medicines or medical devices. For those families justice has not been done today.”

One of those co-chairs, the right hon. Member for South West Surrey (Jeremy Hunt), is now Chancellor of the Exchequer. He has the purse strings and he could make those ex gratia payments happen.

We have heard today from the former Prime Minister, the right hon. Member for Maidenhead (Mrs May). She knows this issue so well and her remarks were powerful. I completely agree with the right hon. Member for Kingston and Surbiton (Ed Davey) that the drug companies must be held responsible. Ultimately, they should be the ones who pay, but in the meantime it is time for the Government to stop hiding and avoiding their responsibilities. It is time to act, and time to give these families the justice they deserve.

--- Later in debate ---

[Allan Dorans]

I thank the right hon. Member for his intervention; he is absolutely correct. The surviving victims are now mainly in their 40s and 50s. Many face a host of new medical problems and their bodies continue to suffer. Many have died prematurely.

[Peter Dowd]

The Public Authorities (Accountability) Bill—the Hillsborough law—would require public authorities to admit responsibility following adverse and mass casualty incidents. Some 97 people died as a result of Hillsborough, and a scandalous cover-up went on for decades. Would the hon. Gentleman agree with me, my constituents in the Gallery and other constituents in the Gallery, that it is time to end the cover-up and to establish how many people have died prematurely as a result of Primodos?

[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.