Medicines and Medical Devices Safety Review — House of Lords, 2018-02-22
Topic: Health
Sarah Virginia Brinton (Liberal Democrats, Centre to centre-left): 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.