Safety of Medicines and Medical Devices

Baroness Cumberlege Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Cumberlege (Con)]

My Lords, my interests are in the Lords’ register. I thank my noble friend for securing this debate. There are few who are better informed on this subject or more knowledgeable and committed than he is, as we have heard today. As has been said, I chair the Independent Medicines and Medical Devices Safety Review. It is focused on how the healthcare system has responded to concerns about medicines and devices raised by patients.

When the review reports later this year, we will make recommendations to improve matters, but in terms of what has happened up to now, three medical interventions are in our scope. The first is Primodos. This drug was withdrawn from the market in 1978 but concerns had been raised years earlier. Babies were born damaged. Those that survived are disabled. The second is sodium valproate. The link between sodium valproate and birth defects has been known for many years, yet women and babies continue to be exposed to the risk. Experts suggest that around 20,000 people have been harmed. For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.

The third intervention is surgical mesh. Many thousands of women have had mesh inserted for incontinence or prolapse. The majority have not reported any problems, but a significant and growing minority have suffered terrible complications, including: excruciating chronic pain, which has been described as feeling like razors inside the body; damage to organs; autoimmune problems; the loss of mobility; the loss of a sex life; and depression and suicidal thoughts. The impact of mesh is not only on the woman herself but on her family. The physical and mental pain has led to the break-up of marriages and partnerships, and many cannot work. If they lose their job, they face losing their home. Children have become their mothers’ carers and some women even face the prospect of their children going into care.

So concerned were we by what we heard about mesh that as an interim measure we recommended a pause in its use until the stringent conditions that we set have been met. That pause has been in place since last summer. I have carried out a number of reviews into health-related matters, but I have to say that this is the most troubling and the most harrowing. The suffering of so many people and their families is heart-breaking. The pain, both physical and emotional, is almost impossible to imagine. My team and I made it our priority to do something that the system has failed to do for all these years: to listen and to learn from what we hear.

We have travelled the length and breadth of the UK. We have met many hundreds of people who have been directly affected, and their families. We have heard from many more by email or phone. I pay tribute to all those we have met. Their courage and dignity in the face of such suffering are truly remarkable. It has been a privilege to meet them. The campaign groups that support them do simply wonderful work. I have been deeply saddened, not just by the personal stories but by the constant reminder that this harm was avoidable. Their lives have been turned upside down, but they did not need to be.

We will continue to listen to those affected. We have also received a huge amount of written evidence, all of which is on our website. We are now in the midst of our oral hearings, taking evidence from regulators, medical colleges, manufacturers, the NHS and others. These evidence sessions are video recorded and available via the review’s website. We are looking not to blame but to ensure that we learn.

Our starting point has been some simple questions. Could and should things have been done differently? Could actions have been taken more quickly? What needs to happen now, and who needs to do it? We have more evidence to hear before we write our report, but there are some emerging themes: the lack of proper warnings about risks; the lack of informed consent; a system whose first inclination is to deny there is a problem or simply to ignore concerns; where concerns are eventually heard, the sluggishness of a proper response; the dismissiveness and arrogance of some—I stress only some—in the medical profession; the byzantine complexity of a regulatory system that few within it, let alone patients and the public, seem to fully understand; the fight for diagnosis and support when things have gone wrong; and the inadequate resources available, whether for follow-up surgery in the case of mesh, or medical, social and educational care in the case of sodium valproate and Primodos.

Most troubling to me is that these issues have come to our attention not because they have been raised by regulators, doctors or the NHS but because of people power. People affected have organised themselves into campaign groups and, with the help of Members of Parliament, push the issue up the agenda until finally someone takes notice. That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.

Of course, no medical procedure is without risk, and innovation is crucial in healthcare; we must not stifle it. But it is vital that an individual is able to make an informed decision, based on a clear and full explanation of the benefits and risks, about a medicine or procedure. It is vital that regulators act with independence and impartiality in approving a medicine or device, that safety comes before commercial interest, and that they listen carefully to patient-reported concerns and act swiftly on them. It is vital that surgeons carry out operations for which they are suitably trained, that they have the right level of experience, that they show compassion and that a comprehensive database exists. When things go wrong and avoidable harm is suffered, the test of a good healthcare system—indeed, of a good society—is our ability to listen, to say sorry, to learn and to provide the right care and redress.

Noble Lords would be forgiven for thinking that these points are a statement of the obvious. A year ago, before I started this review, I would have thought so too. Having heard and seen what happens to people when the system fails, I now know they are not. There is much to be done before we can be assured that the system listens to concerns and responds as we would wish. I am determined that my review plays its part in making that happen, but this is a challenge for all of us in this place and in the healthcare system. Noble Lords taking part in this debate and others in this House possess expertise and experience that will be invaluable in ensuring we have a system fit for the future. I hope my review can draw on that as we continue our work.

Maternal Safety Strategy

Baroness Cumberlege Excerpts

Tuesday 28th November 2017 Lords Chamber

[Lord O’Shaughnessy]

I thank the noble Lord for his support for today’s announcements. Obviously, independent investigations are just that. They will be operated by HSIB, which will be able to delve into the causes of the tragedy, however it might have happened, and provide an opinion on that. On the interaction with the coroner’s report, obviously we have focused mainly today on these new independent investigations and we are looking at extending coronial law to take in stillbirths that were previously not included. That is one of the issues that needs to be worked out in the coming months through interaction with the Ministry of Justice.

[Baroness Cumberlege (Con)]

My Lords, I start by declaring my interests. I am a fellow of the Royal College of Obstetricians and Gynaecologists, the Royal College of Midwives and the Royal College of Nursing, and president of the National Childbirth Trust. Those positions are unremunerated but I am remunerated by NHS England for implementing the report of the review of maternity services.

There is absolutely no doubt that the Secretary of State has concentrated the minds of all of those working in and for the NHS on safety. It is the golden thread that has run throughout his time in office, especially now when he is concentrating on maternity services. We have never seen safer services, but we are being urged to go further with some new initiatives that have been declared today.

I welcome the Statement, particularly the part on investigations. Those of us tasked with implementing the report Better Births—the review of maternity services for England—have been concerned by the way many investigations have been conducted, causing further misery and trauma to the families concerned. We have full confidence that the Healthcare Safety Investigation Branch will ensure independence, and above all, will involve the families. After all, the families were there; they knew what took place. They have a legitimate role in investigations, but often their views and experiences are ignored. Even worse, the learning that has been gathered has not been passed down to the teams within the trust, nor indeed has it spread to other organisations in the wider world. It is absolutely essential that that happens so that we see fewer stillbirths, early neonatal deaths and brain-injured children.

It was those anxieties that made us in the maternity review consider a new scheme, for which we coined the title “rapid resolution and redress”. I pay tribute to Professor Sir Cyril Chantler, who was my vice-chairman. He has worked tirelessly with colleagues across the world and in this country to frame the scheme, so we are delighted that Ministers see the merit of this proposal. However, I should like to question my noble friend about the timing. I understand that more policy work is to be done, but is it possible to bring forward the second part of the implementation of rapid resolution and redress so that the families in question do not have to wait until 2019?

I am interested in the coroner’s investigations. I understand the desire to ensure that no stone is left unturned, but I want to express my concerns at this moment because it is another inquisitorial initiative, when RRR is designed to avoid using the courts in order to spare parents from trials and tribulations. Therefore, I ask my noble friend to consider whether there could be a pause so as to wait for the evaluation of RRR; otherwise, we will have a range of initiatives which not only might cause confusion but will be in conflict with one another. I thank my noble friends for introducing continuity of care—something that is very close to my heart.

[Lord O’Shaughnessy]

I am delighted to be able to respond to my noble friend, who, probably more than anyone else, has really led the charge in this area. I pay tribute to her for her work on better births, as I do to Sir Cyril Chantler, her deputy. She is right that patient safety is the golden thread that runs through all the work that the Secretary of State has led, and she is right to highlight that we have safer services. The changes that we are making, together with bringing forward the “halve it” ambition, will save 4,000 babies’ lives, which is a great prize.

With regard to my noble friend’s questions, the endorsement of the HSIB is very welcome. Some months ago I organised a briefing for noble Lords with Keith Conradi, who runs it, and I shall be very happy to organise another one. It is a very interesting organisation with an interesting methodology that has proved incredibly effective in the airline industry, where Mr Conradi comes from.

On RRR, I appreciate my noble friend’s concerns about the timing and I will certainly look into whether it is possible to bring forward its implementation. As she knows, there are some issues around governance and how it will operate that mean that we need to tread carefully, but I shall certainly take that into consideration because we want to get the scheme up and running as soon as possible.