Safety of Medicines and Medical Devices

Lord O'Shaughnessy Excerpts

Thursday 28th February 2019 Lords Chamber

Moved by

[Lord O’Shaughnessy]

That this House takes note of the steps being taken to improve the safety of medicines and medical devices.

[Lord O'Shaughnessy (Con)]

My Lords, I am delighted to be able to lead this debate today. I thank all noble Lords who will speak in it and wish the noble Lord, Lord Carrington, the best of luck in delivering his maiden speech—an auspicious occasion that we are all looking forward to.

I also express my gratitude to all those who have provided briefing for today’s debate: In-FACT, Sling The Mesh, The Royal College of Surgeons, the Nuffield Council on Bioethics and others. We are deeply fortunate in this country to have well-informed patient groups, professional organisations, charities, trade bodies and others. Their knowledge provides an indispensable contribution to our national conversation. The same is true of our superb House of Lords Library, which has produced a typically comprehensive and incisive briefing, for which I am grateful.

The reason for this debate stems from my time as a Health Minister, when I had responsibility for medicine and medical device regulation, and for promoting innovation in the NHS. That experience introduced me to the amazing benefits that come from life-changing and life-saving new therapies, but also exposed me to the dreadful harm that can occur—however rarely—as a consequence of the innovations on which we all rely. There is an innate tension between innovation and safety, and that is the principal idea I wish to explore today: how to balance that risk and encourage innovation—especially for those most in need of hope and help—but also act faster, be more agile and more compassionate when things go wrong.

We all have reasons to be grateful for the medical innovations that have become available through the NHS over its 70-year history, many of which were pioneered in this country. From mass vaccination programmes to joint replacement surgery, from organ transplantation to the creation of monoclonal antibodies —the medical and life science research community in the UK has saved and improved the lives of hundreds millions of people around the world. It is a record of which we should be immensely proud, and which the Government are supporting through the Life Science Industrial Strategy.

Our regulatory system can also be seen as a strength. As a Minister, I spent time with many European colleagues, who were always complimentary about the quality of medical regulation in this country, led by the MHRA, CQC and other bodies. They were right to be so, but the experience of the last two years—and the fact that we are having this debate—shows me that we can and must do better.

As I mentioned in responding to her superb maiden speech, my noble friend gave me some excellent and wise advice in 2017, when I joined her as a colleague in the department. She told me to watch my postbag, because it could provide warning signals about problems in the system. How right she was. Among the many letters I had from MPs and noble Lords raising concerns about problems associated with medicines and medical devices, there was a steady stream on two particular areas, which I want to focus on today: mesh, a device often used in a variety of procedures to fix prolapses, incontinence, hernias and other related conditions; and sodium valproate, a highly effective medicine used largely to treat people with severe epilepsy.

It is one thing to read about the problems suffered by patients when medicines and devices cause harm, but it is another thing entirely to meet in person those affected. I have had that opportunity on many occasions, and some of the stories I have heard have been truly heart-wrenching. I will never forget meeting for the first time two remarkable women to discuss the issues associated with sodium valproate. They are here as my guests today: Janet Williams and Emma Murphy of In-FACT, supported by their friend and fellow campaigner Mikey Argy. I was horrified to hear that, despite the risk of the drug’s teratogenic effects—that babies exposed to it in utero ran an unacceptably high risk of developing a range of physical and mental impairments—being known since the 1970s, thousands of women, already vulnerable because of their epilepsy, were still being exposed every year.

I was deeply impressed by the quiet but iron determination of these two women, whose own children have been significantly affected by valproate, and their commitment to reducing risks of other women in this situation. Following that meeting, I worked closely over two years with In-FACT, the APPG and the MHRA—I pay tribute to Dr June Raine and Sarah Morgan for their work—and the heads of the relevant Royal Colleges and other learned societies, to try to do something about this issue. We made a number significant policy changes, including mandating pregnancy prevention programmes for women of child-bearing potential on valproate, and insisting that “do not take in pregnancy” images ought to be put on every prescribed pack.

Change is happening, but despite everyone’s good intentions, the pace is glacial. According to In-FACT, around 30,000 women nationally are prescribed valproate, which is roughly the same as in 2015. While the number of in utero exposures is falling, during a recent valproate stakeholder network meeting, the MHRA stated that some 200 babies have been affected by valproate since April 2018, which was when the pregnancy prevention programme came in. Professor Thangaratinam, professor of maternal and perinatal health, stated in evidence to the Cumberlege review team that every year 350 to 400 women prescribed valproate get pregnant—this for a drug that has a perhaps 50% risk of harming the baby in some way.

I also very clearly remember, following an Oral Question from the noble Lord, Lord Hunt, who I am delighted is speaking after me today, meeting a large group of women whose lives had been ruined by mesh. Some were confined to wheelchairs and all had suffered or were suffering considerable pain as a result of what they had been told at the time was a minor and uncomplicated procedure: the insertion of synthetic mesh. I had several further meetings with affected women and parliamentary campaigners on this issue, and I take this opportunity to thank Kath Sansom and the Sling The Mesh campaign for highlighting the human costs of some of these mesh procedures and for working constructively to change the policy and the regulatory environment to reduce the risks to women.

Again, change has happened—the number of procedures involving mesh is falling and certain categories of use are now effectively banned—but the health system has been too reactive in dealing with a problem that has been apparent for at least 15 years. Faced with the anguish and determination of these women, it was obvious that the Government had to do more. I had also been dealing with the results of the Commission on Human Medicines inquiry into the historic Primodos case, where again a number of families, led by the redoubtable Marie Lyon and her husband, were convinced that their children had been adversely affected by this hormone-based contraceptive.

These cases—Primodos, mesh and valproate—were very different in many ways, but it was also clear, in dealing with these and other issues, that they had critical factors in common. First, our methodology for discovering and verifying adverse events needs to improve. While the UK has one of the best pharmacovigilance regimes in the world, it is still dependent on old-fashioned ideas, such as the voluntary yellow card scheme. Furthermore, the process for regulating devices is not always as rigorous as that for medicines.

Secondly, as must have been obvious from my speech so far, all three cases largely affected women. Of course, women are the greatest users of health services, a fact intimately linked to the fact that they give birth, so we would expect more adverse events to be experienced by them, but there is much more to it than that. In all these cases, I heard women reporting patronising and often patriarchal attitudes from a largely male medical workforce administering a pat on the head, sometimes literally, and telling them that the pain was all in their minds.

Thirdly, and related to the previous point, all these women had been campaigning for years to have their voices heard, their pain and suffering recognised, and it had often fallen on deaf ears. In this respect, the parallels with scandals like the one at Mid-Staffordshire could be seen: a system that too often turns its back when criticised, rather than offering a compassionate and understanding face that seeks to help those affected and prevent the problems occurring for others. It was this insight—that there were common themes that warranted further explanation—that led to my suggesting to the then Health Secretary, Jeremy Hunt, whose abiding principle was that patient safety should always come first, that we needed an independent review into our medicine and medical device safety regime. I was delighted when he and the Prime Minister supported the proposal, and even happier when my noble friend Lady Cumberlege was appointed to lead it. It is fantastic that she is able to speak in the debate today. The work she is doing is so important, and I believe that the way she has engaged patient groups around the country through her review has been truly exemplary. She has already made a big difference, because it was on her recommendation that a pause was instigated on certain mesh procedures in England.

Up to now I have focused on areas where patients have been put at unnecessary risk and provided with inadequate information, and where the system has been too slow to respond. It is certainly my belief that, for medical products with wide usage, where patients expect to live long and broadly healthy lives, we need to do better, but the tension between innovation and safety can manifest itself very differently for people whose outlook is poor. In these cases, the boundary between risk and reward can fall in a very different place. Last January, we in this House were privileged to bear witness to one of the most extraordinary speeches in living memory from our friend, the much loved and much missed Baroness Jowell. I had the honour of responding for the Government to the debate she initiated on improving cancer outcomes. The noble and courageous lady raised many important ideas that day. One of the most significant was that when you do not have long to live, you have little to lose by trying experimental therapies that, in ordinary circumstances, no clinician would dream of giving a patient.

This insight was, of course, also behind my noble friend Lord Saatchi’s Medical Innovation Bill, considered some years ago and inspired by the tragic experience of his own late wife. In these situations, when sadly and frankly the prospects are grim, it is right that the balance between risk and benefit is flexible. In our efforts to improve the safety of medicines and medical devices in general, we must not prevent those willing to take great risks to extend their lives from doing so—quite the opposite. The regulatory regime we need to create must be able to draw a much more sophisticated distinction between the balance of safety and innovation, so that it is dependent on the needs of each individual patient.

There are some really encouraging developments in this area. Next week I will visit Professor Colin Watts and his team at the University of Birmingham. Together with the Brain Tumour Charity they have created BRAIN-MATRIX, a clinical trials platform for people with brain tumours that is the first of its kind. It not only allows patients with a very poor prognosis to access experimental therapies, but also uses adaptive techniques and other methodological innovations to make sure that outcome data is gleaned from every intervention and used to improve each patient’s course of treatment, as well as that of those who will follow them.

I strongly encourage my noble friend the Minister to look at what is happening in Birmingham, and other similar approaches such as Precision Panc, because they have the potential to offer a new way to make sure that patients with these dreadful diseases can quickly access experimental therapies in an ethically acceptable way that generates better treatments for all.

I will conclude by making a few suggestions for how things might change. The current system can be bewildering for patients who do not know where to turn when things go wrong. I think that we need a new national office of patient safety—a compassionate, patient-facing agency that is the first port of call when harm is suffered, that can provide the analytical rigour needed to look at cases on their merits, and that can provide a single focal point for action among the many professional and product regulators that operate in the system.

I am sure that my noble friend the Minister will rightly want to see the results of the Cumberlege review before fully setting out the Government’s own plans, but I am keen to know her thoughts on this proposal. Can she also use the opportunity of this debate to reassure the House—and the many interested patient groups—that the department is fully behind the review and will look at its recommendations later this year with an open and constructive mind?

But we do not have to wait for my noble friend’s review to conclude before we act. It is imperative that the Government support the MHRA and other agencies to use technology and other innovations to improve post-licensing surveillance of medicines and medical devices. This should include using the upcoming EU medical device regulation, the NHS’s own “scan for safety” system and the application of machine learning to the NHS’s unique data resource. It must also include new registries for high-risk devices, such as the one the Government have already committed to for mesh. Can my noble friend the Minister inform the House how the department intends to move forward on this agenda?

For families affected by valproate, does my noble friend agree with me that the ambition should be to limit in utero exposure to as near zero as possible, and to make sure that every eligible woman should be on a pregnancy prevention plan and able to make an informed choice about whether to have a baby?

For women affected by mesh, as well as further strengthening the regulatory regime, will my noble friend ensure that there is a properly funded and staffed national network of expert removal centres and surgical teams who can try to repair some of the damage that has been done?

As medicine evolves and becomes more personalised, and as patients become better informed and more active in managing their own care, the balance between innovation and safety needs to evolve as well. I hope I have set out some of the questions we need to answer as we make these changes, and eagerly anticipate the contributions of noble Lords, including my noble friend the Minister, as we collectively seek to achieve the highest standards of patient safety, care and innovation in our NHS. I beg to move.

--- Later in debate ---

[Lord O'Shaughnessy]

My Lords, it has been a privilege to be part of what has been a superb, incisive and moving debate. I pay tribute to noble Lords for their varied but always excellent contributions. As my noble friend Lady Cumberlege said, the quality of the debate is, in a way, testament to the courage of those who have been affected by medicines and devices when they go wrong—often, as the noble Lord, Lord Hunt, said, in the face of an unresponsive system. It is to them that we must truly pay tribute.

I thank the noble Lord, Lord Carrington, for his excellent speech. He will have found that he got a warmer welcome than his forebear, which I am sure he appreciates. I am struck by something he said: that patient safety is paramount but must be balanced with innovation; not to give someone a potentially effective treatment is also an issue of safety, because they could be harmed. This is what we have been grappling with today.

I am deeply grateful to my noble friend the Minister for her comprehensive answers, not only to my questions but to all those posed by noble Lords. She is quite right to applaud the UK’s record in innovation. How reassuring it was to hear from her about the importance of patient voices being heard, the commitment to an evolving regulatory system and the deep support for my noble friend Lady Cumberlege’s review. I am particularly pleased that she has been able to discuss the service specification for the network of experts on mesh, the commitment on valproate exposure in pregnancy and the comments on Scan4Safety and other matters. I thank her for all that.

I found the speech of my noble friend Lady Cumberlege particularly moving. She has spent time with hundreds of families who have been affected by these issues, and I know this affects her. She has shown great courage and perseverance. I hope she has been reassured by the broad support that her review received in the debate today; we look forward to it with great anticipation.

Noble Lords have covered all topics today. The noble Baronesses, Lady Walmsley and Lady Jolly, and the noble Lord, Lord Brennan, talked about valproate; the noble Lord, Lord Hunt, the noble Baronesses, Lady Walmsley, Lady Jolly and Lady Bryan, talked about mesh; the noble Lord, Lord Alton, talked about Primodos; and my noble friend Lady Cumberlege talked about all three. Of course, we have covered other topics too. There has been support for and discussion of many policy ideas. I hope my noble friend the Minister will go away with lots of suggestions about things that we could do next.

The mesh network was mentioned by the noble Lord, Lord Hunt, and the noble Baroness, Lady Walmsley; the National Patient Safety Office was supported by the noble Lord, Lord Alton; and device registries were mentioned by the noble Baronesses, Lady Masham and Lady Finlay, and the noble Lord, Lord Bethell. As the noble Baroness, Lady Thornton, said, we also need to think about what this means for self-care, as consumers become increasingly involved in their own healthcare. The importance of data was mentioned, to make sure that treatment is more targeted but also for better reporting and mandatory reporting—as mentioned by the noble Lord, Lord Brennan, the noble Baronesses, Lady Bryan, Lady Finlay and Lady Thornton, and the noble Earl, Lord Dundee.

The critical point was made that regulation must not inhibit innovation—the right to therapy, which the noble Baroness, Lady Finlay, spoke about—which relates to our attitude to risk and our need for a sophisticated system. After all, as the noble Lord, Lord Brennan, pointed out, as our medical knowledge expands, complications will only grow. We will need a different, better and more sophisticated system for dealing with those complications. As the noble Lord, Lord Bethell, and the noble Earl, Lord Dundee, pointed out, that includes having adaptive pathways so that we can take difficult, experimental treatments and make sure that they are properly targeted. We need to do that in common with our partners in the EU and around the world. That is particularly true for rare diseases, an area where the numbers of people are not big enough to do anything significant in one country but where we can really change treatment if we act together. I warmly endorse the intention that we should have a deep and lasting relationship with the EMA after Brexit, because that is for the good and the safety of patients in our country and across the European Union.

I finish by reflecting on three things that my noble friend Lady Cumberlege said, which are the lessons for today: we need to be better at listening, better at learning and better at caring. We owe patients in this country better on all those fronts, and I am sure that as a result of today’s debate we will do so. I thank all noble Lords for their contributions, as well as all those families and people who have been affected and have kept at us on these topics to make sure that change happens—critically, often not for their own benefit but for the benefit of those who are not yet affected. I thank them all and I commend the Motion to the House.

Motion agreed.