Medicines and Medical Devices Safety Review

Baroness Brinton Excerpts

Thursday 22nd February 2018 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the Minister for repeating the Statement. I should also like to thank him personally for meeting representatives from the mesh campaign group two weeks ago, which is much appreciated.

Today’s announcement is an acknowledgement that there are major issues which go back decades in areas that concern safety and a lack of proper scrutiny and research. We have heard how mesh implants have left women in permanent pain, unable to walk and unable to work. Welcome as the Statement is, the Government need to do much more to support those affected. Mesh has been suspended in Scotland and banned in other countries. The most recent interventional procedure advice from NICE on prolapses states that it should be used only for research purposes and not as a front-line treatment, but I ask the Minister whether he thinks we need to go further and suspend the use of mesh until NICE has completed its review into the safety and efficacy of the product. If the Government are not prepared to go as far as suspension, will he at least write to all trusts and indeed private hospitals to remind them that the Health and Social Care Act 2015 requires them not to cause avoidable harm? The review in itself signals that mesh is now acknowledged to cause harm.

I refer the Minister to Owen Smith’s comments in the other place; he chairs the All-Party Group on Surgical Mesh Implants. He said that:

“Lessons must be learned from the awful complications many women have experienced since undergoing mesh surgery and proper processes must be put in place to stop this happening in the future … The mesh scandal shows what can go wrong when devices are aggressively marketed to doctors and then used in patients for whom they were unsuited or unnecessary”.


Will the review chaired by the noble Baroness, Lady Cumberlege, look into that particular aspect?

The Minister mentioned in the Statement the investment of £1.1 million, part of which will go to improving clinical practice. Clearly, one should always seek to improve clinical practice, but mesh campaigners would say that the real issue is not the clinical practice but the product itself, which is not fit for purpose.

The retrospective audit is very welcome indeed, but there is a real question about whether it will capture all the women affected. I have certainly received evidence to suggest that some women suffering greatly from mesh implants are not aware of the reasons and therefore do not approach the health service. Will the Minister also say whether the mesh audit concerns only hospital statistics and records or whether it will cover GPs and primary care as well? Also, will the review extend to when men and women are affected by hernia mesh?

The Secretary of State has said that the review will not go into the science of mesh. But most studies do not use quality-of-life questionnaires, so they do not pick up the devastation of pain, lost sex lives or constant urinary infections. Studies concentrate on whether the mesh has cured the problem of prolapse or incontinence. Many studies are short-term or compare mesh to mesh. Trials should compare mesh to the old-fashioned natural tissue repair to get a proper evaluation of whether the use of these products should be continued in the future. Many trials have low numbers and any woman who has had a mesh implant can feel like a ticking time bomb, as the product can shrink or twist years down the line. No amount of surgeon training can counteract that.

Will the review extend to those with mesh bowel prolapses? Will it also look at what help the NHS needs to give to people currently affected as mesh sufferers? Obviously each country in the UK is taking a slightly different approach but, in his role as the Minister responsible, will he work with Scotland, Wales and Northern Ireland to pull together research and co-ordinated action, which would make great sense?

I hope that the noble Baroness, Lady Cumberlege, will be asked to look at whether device regulation needs to be tightened up. As the Minister knows, it is much less stringent than medicines regulation and there has been an ongoing debate about that. I hope that that will be included within her review.

On Primodos, the Minister indicated that the department would drive forward and accept the recommendations of the expert working group. But in the other place when the report was published in October, it was met with concern from all sides of the House. I hope that he will take that into account.

I am grateful that the Secretary of State has included sodium valproate in this work. The Minister will know that last year a charity found that almost one-fifth of women taking the drug still did not know the risks that this medicine could pose during pregnancy. I therefore welcome government efforts to raise awareness of the dangers of valproate. I also hope that the House can be offered an assurance that the review will gain access to medicine regulation files held in national archives, access to any valuable evidence cited in unsuccessful legal actions and access to documents and information held by pharmaceutical companies, and that all such material will be made public.

I ask the Minister to invite the noble Baroness, Lady Cumberlege, to meet victims to see whether consensus can be agreed on the terms of reference, to maintain trust and confidence in it. That would be a very valuable first step to gaining the confidence of campaigners who have worked so hard and have been gratefully acknowledged by the Secretary of State in his Statement.

[Baroness Brinton (LD)]

From the Liberal Democrat Benches, I am very grateful and thank the Minister for the Statement. I am particularly pleased about its tone, which moves on the Government’s debate with campaigners, families and clinicians about these very serious issues. It makes a break with the past.

I am particularly concerned that there should be regular assessments and updates for people with problems from Primodos and sodium valproate, because we know from our experience with thalidomide that everybody thought that everything had been sorted from the initial diagnosis of the children, but as they entered adulthood and more mature years further medical issues appeared. It will be important to recognise that we need to make sure these young people—and adults as they are now—get that protection.

The yellow card system was not available in its current format for these two drugs. One of the things that concerns me most about the Statement is the assumption that the only people involved with the yellow card are clinicians. Speaking as a patient who has been on a drug that has very serious yellow card incidents, I have been trained to recognise that if I get a side-effect I do not just go back to my hospital; I report it to the pharma company. The pharma companies are notable by their absence in this Statement. Will there be specific links back for clinicians and patients on some of the side-effects of drugs? That is easy to say for those who are formally expert patients. I absolutely accept the point made by the noble Lord, Lord Hunt, that some patients are inexpert for all the right reasons.

There needs to be a real focus on all the other health professionals that these patients come into contact with. Reporting a yellow card incident to a GP when it is very difficult to see your own GP these days means that it could quite often be missed. In the case of sodium valproate this certainly needs to include midwives and people involved in the obs and gynae departments as well. What training is to be provided for these non-specialist healthcare people to make sure that they understand, when a patient talks about a problem, that this may need to trigger a yellow card response? To that end, I welcome the proposal for an electronic yellow card. That will be extremely helpful. Printing out a yellow card, filling it in and sending it in is an absolute deterrent to it happening.

On Primodos and sodium valproate, will the longer-term effects also be covered by the Cumberlege review? It is important to have a reference back there. I am also concerned about the vaginal mesh issues, specifically those reported in the Statement. It would be useful to know what percentage of those who have had vaginal mesh implants have faced problems. It is fine to say that many have benefited. I completely accept that, but one needs to understand what the ratio is between those facing problems and those for whom it has benefited them, to understand whether a ban should be in place. What is the date for publishing the retrospective audit? It is fine to say that it will be done. I have no idea how far along the line the process is. Then there is the timescale for creating that computer database for vaginal mesh to improve clinical practice. When will it be not just commissioned, but completed and used in analysis? Will interim reports go to the noble Baroness, Lady Cumberlege, by the people doing this review if evidence emerges that she will need to take account of?

I am concerned about the idea of the creation of a patients’ champion. We already have panels and expert groups. Yet another person that patients may or may not know about, and may or may not be able to turn to, seems problematic. I urge the noble Baroness, Lady Cumberlege, to look at what is available now rather than creating yet another body.

Finally, I echo the concerns expressed by the noble Lord, Lord Hunt, about whether we should move to a public inquiry at this stage. I wonder whether the evidence that the noble Baroness, Lady Cumberlege, will undoubtedly turn up means that she may come back to Ministers and say, “Actually, this is the point at which this needs to go public”. Campaigners have highlighted for years that there are problems.

[Lord O'Shaughnessy]

I thank both noble Lords for their extensive, well-informed and probing questions; I will try to deal with all of them. I want first to take the opportunity to pay tribute to those involved in each of the three campaigns. They are almost exclusively women. A factor that needs consideration is not only that users of healthcare services are disproportionately women but that women seem to be disproportionately on the end of things when things go wrong—that issue needs investigating in itself. I have had the chance to meet not only the mesh campaigners but campaigners on sodium valproate and Primodos. They have gone to extraordinary lengths to raise these issues; they are remarkable women.

On the position relating to mesh, I have asked the MHRA and NICE as the two regulatory bodies to get in touch with their counterparts in Australia and New Zealand. There is some quite long, technical advice which I will not attempt to repeat, except to say that perhaps the simplified public view of what has happened in each of those countries is not entirely accurate. I shall certainly write to all noble Lords taking part in this debate and place a copy of that evidence in the Library. It is quite important. It is detailed, but it is well worth looking at.

I emphasise that collaboration is going on not only internationally but within the four corners of the United Kingdom. The CMOs of those four countries have met. I am meeting the Scottish Cabinet Secretary for Health—I think, next week—to talk about this specific issue and other things as well, so we are cognizant of the need for a joined-up UK approach.

On the scope of the review, it is very open. In the noble Baroness, Lady Cumberlege, we have an ideal chair: someone who has campaigned on safety issues, who is deeply knowledgeable, well respected and fiercely independent—as we know. She has the opportunity to look not just at issues around marketing, as the noble Lord, Lord Hunt, mentioned, but around the private sector. She will be able to look, too, at whether there should be public inquiries or other types of inquiry and to make recommendations. She will be able to look at pharma companies and gather evidence from wherever it is required. I want to emphasise that the review is very broad in scope. As the noble Baroness, Lady Brinton, said, we are trying to mark a break from the past. We know that we have not dealt with these things well. We are beginning to address that in the clinical and medical space in terms of medical practice; we now need to move on to medicines and devices, which is what we hope to do with this process.

On issues around the mesh, the audit and the registry, the audit is obviously retrospective. It will not be a perfect exercise, because the data is not always perfectly gathered, but it will be quite extensive in scope. It will be able to pick up not just complications associated by women, or indeed men, with having mesh but whether they have turned up in pain at another setting. We are confident that it will paint a much broader picture than we have had. The intention is to publish that in the spring. Obviously, if any interim reports relating to it come out, they will be shared with the noble Baroness, Lady Cumberlege, but clearly there needs to be robustness to them.

On the registry, this is an important moment. We have found the money to do this; it will be funded for the set-up and then for the first three years, which is the normal way in which registries are done. I do not yet have a timeline for how it will be delivered, but clearly we want to get it up and running as quickly as possible. It needs to be commissioned, but it is in everyone’s interest to do that.

Primodos presents a challenging issue, because it is not available on the market and has not been for 40 years, so it is not possible to carry out studies on what is happening to women now. However, new evidence has come to light which will also need to be considered and which was not available for the expert working group. Again, my noble friend Lady Cumberlege will be able to consider that as she looks at what needs to happen in each of those three cases.

One thing that we have to do—this moves on to the expert working group’s recommendations from the Primodos review, which is obviously very germane for women taking sodium valproate—is make sure that there is proper training for health professionals, not just in the yellow card scheme but for obstetricians in terms of their pharmacological advice and expertise. Indeed, that is one of the recommendations I will be taking forward, as was set out in the Statement. The valproate issue is very difficult, because it is an extremely effective anti-epilepsy drug but it can have very bad consequences for pregnant women and their children. I have met one of the campaigners; four or five of her children are affected and it is having a devastating impact on her life. We need to get to a position where no women of childbearing potential are using it. That needs to be done in the context of recognising that it does work for epilepsy.

Finally, I absolutely agree with the noble Lord, Lord Hunt, about meeting the groups to define the terms of reference. Again, we have learned from past experience that that has not always been done well and it is best done independently of government, with that degree of objectivity. I think that that is what this review will bring. As I say, the overall hope is that not only do we deal with the issues under each of these three headings, historical and current, but that we put in place a system that means that patients do not have to go through this tortuous process to get their concerns heard in future.