Independent Medicines and Medical Devices Safety Review

Yasmin Qureshi Excerpts

Thursday 8th July 2021 Commons Chamber

[Hannah Bardell (Livingston) (SNP)]

I am grateful for the opportunity to speak in such an important debate. I congratulate, again, the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) and it is a pleasure to follow the right hon. Member for South West Surrey (Jeremy Hunt). It is rare in these political times that this House is united on an issue, but it is united today, more than I have seen it for some time. I hope to speak directly for a moment to those out there who are watching who have been affected by hormone pregnancy drugs such as Primodos, like my constituents Kirsteen and Wilma Ord, or sodium valproate or vaginal mesh, or mesh that is used in men: this House is united and there are Members in this place who will not give up the fight to make sure that you get justice and redress.

I want to talk specifically about families affected by Primodos. I pay tribute to Baroness Cumberlege and I am very pleased that she is here today. She and her team did an incredible job on her review, “First Do No Harm”. I pay testament to the bravery, dedication and passion of the Primodos campaigners, led by Marie Lyon. She is the personification of persistence and I know that she will be watching, because it is unimaginable that families and victims of Primodos had been subjected not only to the harm of the drug, but years and years—decades—of waiting and campaigning. We have to recognise, as Members including the right hon. Member for Maidenhead (Mrs May) did, that it is so damaging that these things can take so long. They are corrosive and debilitating—I have seen that in my constituents.

Time and again, we see families treated this way, whether they are the victims of thalidomide, contaminated blood, the families of Hillsborough or now the victims of Primodos, sodium valproate and medical mesh. There have been years of inquiries and public money is being spent for those who have suffered and are still suffering, and very often, they do not get justice or have to wait for decades, or they and their family have died before they have the truth. It is a culture of kicking the can down the road and it is toxic.

One key thing, particularly in relation to Primodos, is the guilt that those women live with—that they somehow were responsible, and have been told by doctors that they were responsible, for the harm of their own child, which we all know is absolutely incorrect and not true. I hope that any family, any victim and any woman affected, particularly by Primodos or, indeed, sodium valproate or mesh, know that it is not your fault. You did not do anything wrong.

The Cumberlege review was a huge step forward in recognising the unnecessary and colossal harm inflicted on victims of the Primodos drug. The review was supposed to mean that victims had finally been heard and believed and I think that many, many felt that they had been. After it was published, the Conservative Government made a very welcome and long overdue formal apology to victims, and I pay tribute to the former Health Secretary, the right hon. Member for South West Surrey, and the former Prime Minister, the right hon. Member for Maidenhead, for their part in the work that they have done in that area.

However, we need to be reminded, and those now in power need to be reminded, that an apology means nothing if the action to rectify those issues and make sure they cannot happen again does not happen. Only two of Baroness Cumberlege’s nine recommendations have been implemented. Given that these families—the Primodos victims—have waited almost 60 years, including my constituent Wilma Ord and her daughter Kirsteen, they cannot be forced to wait any longer, surely. An apology and a patient safety commissioner is a big step forward. In Scotland, we have also brought forward a review and intend to bring forward those plans, and I am sure that we will continue to work with this Government and the Health Secretary to make sure that we do all we can in Scotland.

The injustice continues, however, because the families have not received the compensation or lifetime care that was rightly awarded to thalidomide victims earlier this year. Like thalidomide victims, Primodos survivors face constant uncertainty about the cost of their care as they get older. Many surviving victims are now in their forties and fifties, and they are facing physical challenges with their bodies. Many have relied on care from their parents who are now getting older and facing their own challenges. That is truly heartbreaking.

My constituent Wilma Ord has spoken very candidly to me about the burden she feels, and the fears she has for her daughter as she gets later into her life and may not be able to cope. She worries about what will happen when she has gone. She just wants to know that her daughter will have the support she needs. I do not think that that is very much to ask. Financial support for these families is the least they should be offered. That should just be the starting point in addressing the harm that was done to them. Thalidomide campaigners did not have to obtain proof of a causal link in their fight for justice and rightly so, so why is there a higher bar set for Primodos victims before the Government will provide equal treatment? I hope the Health Secretary can answer that question.

The UK Government repeatedly cites—we have not spoken about this yet, I do not think—the 2017 expert working group report. Its failings have been widely acknowledged. Having worked closely with the hon. Member for Bolton South East (Yasmin Qureshi), who has done a huge amount on this issue, and campaigner Marie Lyon who sat on that group, we know the expert working group was not only a whitewash but a disgraceful waste of public money. There are serious questions around the process and independence of that report, but we want to move forward.

[Yasmin Qureshi (Bolton South East) (Lab)]

The hon. Lady mentions the expert working group’s report, which was, as she rightly says, universally panned in this Chamber. The interesting thing is that the Cumberlege review took place after the expert working group. It had a look at the report and also came to the conclusion that it was not worth the paper it was written on.

[Hannah Bardell]

I thank the hon. Lady for her intervention. She makes an excellent point. We know there were serious questions around the process and the independence of the report. I remember going with her across the road to the conference centre where it was being launched, and being denied entry. Two democratically elected Members of Parliament working for our constituents were refused entry to the launch of a report funded by public money. It was an absolute scandal.

The evidence uncovered by Sky News reporter Jason Farrell suggested that significant sections of the original draft were changed before publication, including the omission of a graph showing that the majority of historical studies found an association between the drug and malformations. In short, evidence was deliberately omitted and censored, and Government money was spent on that. You know the worst of it? Families and victims were strung along for months and months and months only to be let down. That can never happen again.

If the Government seek to rebuild trust after such devastating scandals as Primodos, they must give the public and most of all the victims a fair and open process. That cannot be achieved, however, if it relies on a report and findings that are not fit for purpose. Everybody in the House knows that and the public know that. How many times are we going to see public money spent on placating people, while report after review gathers dust on a shelf rather than action being taken? Processes have to be open and robust. When they are and when reports such as Baroness Cumberlege’s report are produced, they have to be put into action. It is vital that that now happens and that we find a way forward for Primodos victims, and for the victims of sodium valproate and mesh.

All the failings in the system that led to this awful situation are in the past and cannot be undone, but we have to be sure that the public have confidence not just in their medical practitioners, who have done a phenomenal job through covid, but in the processes and in our ability as parliamentarians to do our job. Now, in 2021, why are the Government continuing to perpetuate that wrong? They are compounding the pain and suffering that the families have endured at the hands of the state’s failure to regulate private pharmaceutical companies properly. It feels very much like profit over people. We do not want to hear, and I know that my constituents do not want to hear, “We’re in litigation; we’re engaged in a legal process.” That is all very well, but the Government have a duty to implement the recommendations of the report that they commissioned.

All I would say to the Minister and the Health Secretary is that they have the opportunity to right a wrong. Let us not continue down the road of defensiveness and turning our back on those victims who have waited decades—literally lifetimes—to get answers and justice. Ministers should do the right thing and give them the justice and the recompense that they deserve.

--- Later in debate ---

[Yasmin Qureshi (Bolton South East) (Lab)]

I congratulate my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) on obtaining this debate. I am chair of the all-party group on hormone pregnancy tests, which contains 135 MPs. This is just one of the countless times I have stood on the Floor of this House on behalf of thousands of victims affected by the hormone pregnancy test drug Primodos to plead with this Government’s Ministers to do the right thing. I have used most of my Prime Minister’s questions and Health orals on this issue. Some 1.5 expectant women in the UK were prescribed Primodos, a hormone-based pregnancy test used in the 1960s and 1970s that caused them to have babies with malformations and disabilities, to have miscarriages and to have stillbirths. For decades, these families have been dismissed and have been told repeatedly that despite all the evidence of a cover-up, it is all in their heads and there is no link. So imagine my relief, and theirs, when one year ago today the Cumberlege review was published. It was the most comprehensive assessment of all the evidence on the hormone pregnancy tests and it said very clearly that Primodos caused avoidable harm. The report exposed widespread systemic failings, where warnings were ignored. For hundreds of Primodos families across the country who had campaigned for the truth and closure, the conclusion of this report was a significant moment of recognition. The review also said that had Primodos been removed from the market in 1967, when concern was first raised, many of these families would not have endured the decades of suffering. It was also very clear that compensation should be made available for these people.

Today, we are in this House to ensure that this report does not gather dust, which the cynic in me would say is the Government’s intention. I pay tribute to Baroness Cumberlege, who is sitting in the Gallery today, for conducting this review and to her colleagues. The review was thorough and sensitive over the course of two and a half years. Baroness Cumberlege has been so affected by this report that she has set up an all-party group on first do no harm. In her review, she found that the root cause was a failure of the healthcare system by some in the medical profession who have ignored the concerns of women and their families. From these findings comes clear guidance and recommendations on how to support these people and ensure that these things do not occur again. The Minister will be aware that in Scotland some of these measures have been implemented so I would like to ask: why the delay in this Department? The Government refuse to acknowledge the Primodos families and instead keep telling us, “We refuse to comment due to an ongoing legal action.” That is a smokescreen, an excuse, a deliberate refusal to accept that Primodos families deserve justice. Baroness Cumberlege remarked in the other place that

“rumours are…rife of a ritual burial”—[Official Report, House of Lords, 2 September 2020; Vol. 805, c. 385.]

of the report. Frankly, from the answers to the parliamentary questions that I have asked, it is easy to see why that conclusion is reached. Today is the Minister’s opportunity to give an assurance to the families that the report will be implemented in full.

In one of the letters that the Minister wrote to me, she said that there is no causal link between Primodos and deformities. She hides behind the expert working group report to justify her refusal to give the families of Primodos the dignity and justice they deserve. However, is she aware that the expert working group, which was done by the MHRA, a Department of Health and Social Care agency made up of civil servants, who decided who would be on the group, was so discredited by academics, campaigners and Members of this House? We had an urgent question in the House on its report, and I ask the Minister to look at that debate, because every aspect of the expert working group was discredited. It is surprising that the Government are using that group as a reason not to compensate these people.

I ask the Minister to remember that the Cumberlege review was set up after the expert working group. Baroness Cumberlege’s group looked at the expert working group’s report with a fine-toothed comb. Despite that, with all the other evidence it heard, it came to the conclusion that the harm was avoidable and that there was a link. In a Sky interview, the former Prime Minister, the right hon. Member for Maidenhead (Mrs May), said of the expert working group report:

“At one point it says that they could not find a causal association between Primodos and congenital anomalies, but neither could they categorically say that there was no causal link.”

It was also found at the time that the report’s initial recommendations had been changed to its final recommendations. Even in that report, there were discrepancies.

Why does the Minister continue to rely on the findings of that discredited expert working group report, and why does she continue to remind us that there is no causal link when she knows well that there was no causal link for the thalidomide victims and they have rightly been compensated? She also knows that it will be impossible to test these drugs on pregnant women, so there could only ever be a possible link.

The Minister will know the inspirational campaigner for Primodos families, Marie Lyon, with whom I have had the pleasure of working for the last 10 years. Marie Lyon will refuse to let this scandal be swept under the carpet, just as I and my parliamentary colleagues will. We are often reminded of the bravery and dignity of the people who have suffered and the families who look after them, including children and older people. They deserve respect and admiration—and they deserve justice. It is outrageous for the Government to suggest that justice for Primodos families could be delayed or denied. If they were given compensation, then we would not have to consider any legal recourse.

I ask the Minister again: please do not listen to the civil servants. Do not listen to the MHRA expert working group recommendations, which have been roundly condemned. Instead, please look at the report of the Cumberlege review, which was carried out by a Conservative former Health Minister and the experts who sat with her. They went through everything, and they have made it very clear what needs to be done.

I ask the Minister please to compensate the victims of Primodos and, of course, all the victims of mesh and sodium valproate, and I urge her please to stop listening to the bureaucrats—the civil servants—in the NHS and give justice to the victims of Primodos, mesh and sodium valproate.

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[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

I thank the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) and my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) for securing this debate on the implementation of the recommendations of the independent medicines and medical devices safety review.

Hon. Members have spoken passionately across a range of issues mentioned in the review, but before going into the detail of the recommendations I want to make a number of main points. First, the hon. Member for Bolton South East (Yasmin Qureshi) raised that issue of Primodos with huge passion again today, but I am afraid I have to rebut her criticism. I am not allowed as a member of the Government to discuss an issue that is sub judice and that is a live litigation in the courts at the moment; I am simply not allowed to do that. I have made this point a number of times and cannot make it much clearer: as a Government Minister, I am not allowed to discuss something that is in the process of live litigation.

[Yasmin Qureshi]

Will the Minister give way?

[Ms Dorries]

I will not, as I am about to move on to the other matters raised. I would also say that as a Government we make our decisions on the basis of scientific recommendations, and the scientific evidence provided to us at this moment in time does not support there being a causal link between Primodos and adverse outcomes in pregnancy. I am afraid that is all I am allowed to say. So on Primodos I say to those who have raised the matter that I hear everything they say and I hear the issues, but because it is sub judice I am not allowed to comment.

[Yasmin Qureshi]

Will the Minister give way?

[Ms Dorries]

I will give way, but I am afraid I will not be allowed to comment.

[Yasmin Qureshi]

I thank the hon. Lady for giving way. I heard both the points she made, but would the victims be compensated if the legal proceedings were withdrawn, or is this issue about the expert working group still going to be an obstacle?

[Ms Dorries]

I apologise, but I cannot answer the question.

Moving on, I want to address sodium valproate, in general terms now and later in more detail. I have heard the speeches today and some pertinent points were raised, and I would like to make an overall point on valproate again before going into the recommendations: valproate is a drug that saves the lives of women who can receive no other treatment for their epilepsy. Some women suffer life-threatening epileptic fits of such severity that only sodium valproate can save them; their lives would be lost if they did not take sodium valproate. Therefore it is not possible to ban the use of sodium valproate, because those women’s lives would be compromised.

A number of changes have taken place, too. A letter was sent out to women taking sodium valproate to make sure they were aware, and other measures have been put in place, which I will discuss in a moment, including ensuring that prescriptions for sodium valproate go into one box rather than being partial prescriptions, and the boxes have very clear and significant warnings on them. I could go into further detail, but the inquiry covers—