Independent Medicines and Medical Devices Safety Review

Hannah Bardell Excerpts

Thursday 8th July 2021 Commons Chamber

[Emma Hardy]

Absolutely. One of the points that I will come to later is that people who have had rectopexy and hernia mesh implants have also been badly affected.

The recommendation that I want to focus on is the one that requires immediate action from the Secretary of State to set up an implementation taskforce to oversee the progress of the other eight recommendations, and to offer a timeline for the actions. Unfortunately, the Government declined the recommendation and instead offered the creation of a patient reference group to

“ensure that patients voices are heard”.

With respect, patients’ voices have been heard in the Cumberlege report. We already know that women are not listened to in the healthcare system. We need action to change that, rather than another review kicking the can down the road. I would be interested in hearing from the Minister how the Government intend to ensure that women’s voices are placed at the centre of their treatment when the patient reference group publishes its report.

[Hannah Bardell (Livingston) (SNP)]

Like others, I thank the hon. Lady for securing this vital debate. Does she agree with me that we need to encourage women to speak up and to support them to deal with their own health issues, but that comments made by some in Government recently that it is down to women individually to speak up can be unhelpful? We have to see this through the lens of the institutional challenges that women have faced for decades. Although we need to celebrate our clinicians, we really need to do more to educate them and give them resources and support to ensure women are not treated in the way the hon. Lady is describing.

[Emma Hardy]

I thank the hon. Lady for her intervention and I agree with her absolutely, which brings me on to the point about the redress agency, which is one of the recommendations in the report that has been rejected. Instead, the Government have said:

“The government and industry have previously established redress schemes without the need for an additional agency.”

That goes to the point that she made, because this puts the burden of redress in entirely the wrong place: on the victims, not on those responsible. Seeking redress requires enormous effort on the part of those who are already suffering, not just financially but emotionally, as was set out in Baroness Cumberlege’s report. It recommends that without waiting for the establishment of a redress agency:

“Separate schemes should be set up for each intervention…to meet the cost of providing additional care and support to those who have experienced avoidable harm”.

Sadly, no such moves have been made, so I would be interested if the Minister gave an indication of the progress on such schemes.

The report also recommends transparency on payments to clinicians, with a UK-style Physician Payments Sunshine Act 2010 to require the mandatory reporting of all payments made to doctors, teaching hospitals, research institutions and charities. The Government’s interim response said that they would “consider” this recommendation, in discussion with other parties, including the General Medical Council. I understand that there are suggestions that this could be done by expanding the voluntary system of reporting, but, as we have seen, voluntary systems simply do not work.

By way of a quick example, a high-profile academic recently admitted that he had failed to declare £100,000 from the manufacturer of one of the types of vaginal mesh implants that he was assessing. He has now published a correction, but this is almost seven years after he first did his report and it came only after a complaint was made about him. A section 60 order in the Health and Care Bill would allow for legislation to cover this, because transparency is vital to patient safety. There should be no opportunities for payments made by industry to introduce bias into prescribing or the scientific literature that is used to inform our National Institute for Health and Care Excellence guidelines. This report recommended creating a database to record which device was used when, in which person, and what the outcomes were in terms of safety and patient feedback.

The roll-out of the medical device information system has begun, but questions are arising as to what data is being collected. This is really important. To give an indication of that, let me raise the case of Kath, an extremely fit and healthy woman who used to be interested in skydiving. She had mesh implants and afterwards was in such pain that she was unable to move or get out of bad. This completely changed her life forever. However, her procedure was recorded as a success because she no longer had incontinence and that was the measure being looked at. We need to be looking at all patient outcomes when we are recording that data in those data sets.

That brings me on to my next point, which relates to the current moratorium on using mesh, as recommended in the report. Kath has said that there is no way she would ever have had this procedure had she had any indication of the risk of harm. I understand that there is pressure from some of the surgeons to reintroduce mesh, but I do not believe we can do that without fully informed consent, and we can have that only if patients are fully aware of all the risks. They can be fully aware of all the risks only if all the data is collected and recorded accurately. Until that is done, we cannot have informed consent and we should not consider lifting the moratorium on the use of mesh implants.

--- Later in debate ---

[Mrs May]

The hon. Gentleman is absolutely right and I shall come to the issue of redress in relation to these particular aspects of pelvic mesh, sodium valproate and Primodos and other HPTs. I was making the general point that I see constituency cases of individuals where a mistake has been made by the NHS. They want an apology and to know that change is going to take place, but they come up against a brick wall and sometimes find themselves battling and ending up in court to try to get some redress—with all the problems that that creates—because the institution has defended itself, rather than taking the patient’s voice seriously.

Our NHS does amazing work day by day and it has done amazing work during the pandemic, but, sadly, when mistakes are made, it does not always respond in the right way. The report of the independent review made this very clear:

“There is an institutional and professional resistance to changing practice even in the face of mounting safety concerns. There can be a culture of dismissive and arrogant attitudes that only serve to intimidate and confuse. For women there is an added dimension—the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.”

It went on:

“Mistakes are perpetuated through a culture of denial, a resistance to no-blame learning, and an absence of overall effective accountability.”

It was apt that the report was called “First Do No Harm”; as the noble Baroness Cumberlege said:

“It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system. Too often, we believe it has not.”

Like the hon. Member for Kingston upon Hull West and Hessle, I am concerned that the Government have not responded to and accepted the recommendations of the review in full. The recommendations were not made lightly; they were made after listening to considerable evidence and hearing the voice of people who had suffered for years as a result of the use of these medicines or medical devices. The report identified where changes needed to be made. Of course responses take time and of course the Department has been dealing with the pandemic, but I hope that the Government are going to respond properly on all the issues raised.

The Government have agreed to set up an independent patient safety commissioner—partly, I have to say, because of the action in the House of Lords in relation to amendments to a Bill—and they are now consulting on the position, but we do not know when the commissioner is going to be in post. The commissioner is important, because it is the commissioner who will enable the user’s experience—the patient’s voice—to be heard. By hearing that voice, it will be possible to detect and stop the use of medicines and medical devices that lead to avoidable harms.

[Hannah Bardell]

The right hon. Lady has made the point about institutional cultures, defensiveness and the culture of litigation that it feels like we have now got into, particularly in respect of some aspects of the health service. Does she agree that the patient safety commissioner must have teeth and must be able to help us—I think there would be agreement across this House and in the other place on this—to try to move away from that culture so that we can learn from mistakes?

[Mrs May]

I absolutely agree about the importance of the patient safety commissioner; they have to be able to do the job that is intended and set out for them to do. I know that there will be those who will be concerned that their sponsoring Department is the Department of Health and Social Care. It is natural because this is a health issue, but I hope that the Department will make every effort to ensure that it cannot be accused of trying to water down the role of the independent safety commissioner, because, as we are saying, it is important for the user’s experience to be heard. This is not about trying to get at the Department of Health or the NHS or anything. It is about people who are suffering real-life experiences and impacts as a result of the use of medicines and medical devices; it is about identifying those situations and ensuring that action is taken to stop them happening so that others can be protected.

The issue of redress was mentioned by the hon. Member for Kingston upon Hull West and Hessle and the hon. Member for—I apologise, because the hon. Gentleman is in the House so frequently, but I have forgotten his constituency—[Interruption.]. Strangford, thank you. The issue was also mentioned by the hon. Member for Strangford (Jim Shannon). The Government have said that an agency is not needed, yet time and again the only redress for patients is through recourse to the courts. That is expensive and stressful. It is also expensive for the national health service; in 2018-19, the NHS paid £2.4 billion in clinical negligence claims. But redress is about far more than compensation. It is about relating to the real impact that the use of these medicines and medical devices has had on people, such as the need for special education for children who have been affected because their mothers have taken sodium valproate when pregnant. There are many other examples. I urge the Government to look again at that issue.

I also want to raise the issue of the patient’s voice, because this has all been about an unwillingness in the past to listen to the patient’s voice. Setting up the patient reference group was fine, but I understand that it is due to publish findings shortly, and nobody knows whether the patient’s voice is going to be taken into account or how it can be in the future. I urge the Government to ensure that patients are part of the implementation; it is their experience that we are talking about, so it is so important that they are included.

My final point relates to sodium valproate and it partly comes from constituency experience. This medicine has a one in two risk of causing harm to a baby if a woman is taking it while she is, or becomes, pregnant. What lies behind this issue is information and education, but it took a year for the Government to write to women to raise awareness of the risk. I hope that the Government do not think that that is job done, because this is an ongoing issue that has to be addressed. It is not just about providing information to women; it is also about ensuring that their clinicians are well informed when they are prescribing and dealing with their cases.

Women suffered considerably from the use of pelvic mesh, from hormone-based pregnancy tests, predominantly Primodos, and from sodium valproate, but they and their children are still suffering today. At the heart of this situation lay a health system that, in the words of the report, is

“not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that.”

The system did not listen. It saw real pain and debilitation as women’s problems. The service which at its heart has our safety and protection ignored concerns over safety for too many years. The independent report recommends steps for the system to change. I urge the Government to embrace the recommendations in full. That way, we will be on the way to ensuring that we have a system that genuinely first does no harm.

--- Later in debate ---

[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.