Valproate and Foetal Anticonvulsant Syndrome

Debate between Norman Lamb and Kate Green

Thursday 19th October 2017 Commons Chamber

[Norman Lamb (North Norfolk) (LD)]

I beg to move,

That this House notes with concern that there has been a systematic failure to inform women of the dangers of taking the epilepsy drug sodium valproate during pregnancy, resulting in thousands of children being born with congenital malformations, disabilities and developmental disorders since the 1970s as a result of fetal exposure to the drug; welcomes the launch of the Valproate Toolkit by the Medicines and Healthcare Products Regulatory Agency in February 2016 to ensure that women are informed of the potential risks of the drug, but further notes with concern a recent survey which found that 68 per cent of women have still not received these safety warnings; calls on the Government to take immediate steps to ensure that the materials in the Valproate Toolkit are distributed to all prescribing clinicians, pharmacists, and women who are being prescribed the drug; calls on the Government to require all clinicians prescribing sodium valproate to women and girls of childbearing age to discuss annually with the patient, the risks during pregnancy before a prescription is renewed; and further calls on the Government to bring forward proposals for a care plan and financial assistance to the victims of sodium valproate in pregnancy and their families.

I congratulate you, Madam Deputy Speaker, on getting through this debate’s catchy title.

I start by thanking the Backbench Business Committee, on behalf of the all-party parliamentary group on valproate and other anti-epileptic drugs in pregnancy, for facilitating this debate. I also pay tribute to Janet Williams and Emma Murphy, who are present today. They have fought tirelessly on this cause over many years, and we owe them an enormous debt of gratitude.

It is fair to say that “scandal” is an overused word in political discourse, but it is appropriate in this case: a family who have suffered as a result of a mother taking valproate in pregnancy would regard it as an absolute scandal, and we need to treat it in that way. There are many similarities to the thalidomide scandal. A group of women, over many years, took a drug during pregnancy without knowing the risks, with awful consequences, and we owe them a duty—that is the important point.

[Kate Green (Stretford and Urmston) (Lab)]

I apologise to the right hon. Gentleman for not being able to stay for the whole debate.

I, too, pay tribute to Janet and Emma for the campaign they have run. This debate is a great tribute to their efforts. Does the right hon. Gentleman agree that the real scandal is that we have known about the problems with this drug since the 1960s, but, as he says, expectant women were not told? The Government and the pharmaceutical industry knew there were dangers.

[Norman Lamb]

I thank the hon. Lady for her intervention, and I completely agree with her. Interestingly, the original product licence in March 1974 stated this, way back then:

“In women of child bearing age, it should only be used in severe cases or those resistant to other treatments.”

They knew in the ’70s, yet the appalling scandal is that so many women since then have had their life turned completely upside down, with enormous consequences for their children, because they were not told.

--- Later in debate ---

[Norman Lamb]

I thank the hon. Lady for the intervention. I am aware of that figure and again it is shocking. It makes the point that this is a continuing scandal, not something from the dim and distant past.

Since the 1970s, more information has emerged bit by bit. In 2000, the information given to patients was changed to refer to the warning, but it took until then for anything to emerge. In 2005, Sanofi made an addition to this, and an interesting question is whether it downplayed the risk. That is one point that raises the question whether some sort of panel investigation needs to take place. In 2005, Sanofi said on its warnings to patients:

“Some babies born to mothers who took Epilim during pregnancy may develop less quickly than normal and may require additional educational support”.

That is putting it at its mildest, because the implications were far more serious. The question is, did it know then? These things need to be investigated further.

It is important to state what the risks are. Among the general population there is a 2% to 3% risk of foetal abnormality. If valproate is taken during pregnancy, that risk rises to 11%, and possible defects include spina bifida; malformations of the face, including cleft palate; malformations of the skull, limbs and organs, including the heart; and respiratory issues. It is incredibly important not to disregard the fact that when people take valproate during pregnancy there is also a 30% to 40% risk of developmental problems, including life-changing issues such as poor speech and language skills, delayed walking and talking, behavioural problems, interaction and communication issues, low intellectual abilities, memory problems, noise sensitivity, sensory issues, attention deficit hyperactivity disorder and autism spectrum disorders. The consequences are incalculable. It is estimated that 20,000 babies have been affected since the 1970s. It is also important to remember the profound impact on the mothers themselves, who too often have been treated as if they are to blame for the problems their children face and who then face years of guilt. That is a really shameful aspect of all this.

I have some case studies. Becky Parish, a mother from my own county, Norfolk, says:

“Logan is 7 and was born with a 7 mm unilateral cleft lip and palate…which the geneticist confirmed was due to Fetal Valproate Syndrome…He also has grommets and struggled with glue ear and bronchitis as a baby”.

He has needed “constant speech therapy” and suffers ear infections.

Becky describes how Logan

“has all facial features of FVS”

and is short in height and low in weight for his age. He has

“severe aggressional and destructive behaviours, including violence against others and self-injurious behaviours”

and so it goes on. This is really significant. There is sometimes a danger when we talk in general or abstract terms, but when we hear the stories of the affected families, we realise just how awful it is.

Becky says “social”—social services—“blamed me for it”. Her assertion is that in her case social services thought that the problems related to a detachment disorder, with the implication being that the mother was in some way to blame. She says:

“Social blamed me for it and so did the school—and now I feel more guilt due to it being FVS. Because no matter how much someone says I didn’t know and it wasn’t my fault, the guilt never goes away. And sadly it never will.”

That is really shocking.

Becky decided not to continue with valproate when she became pregnant with her youngest child, who is now five. She says that it was not a difficult decision, because in her view her child’s health was “far more important” than her own seizures, but that must have been a terribly difficult judgment for her to make. Nevertheless, she stopped straight away and was not put on any alternative treatment, despite conflicting messages from health professionals. Her specialist nurse told her that—wait for it—she was being selfish, and made her upset at her 12-week scan. However, her neurologist said that coming off the drug was the best thing she ever did. So she got two completely conflicting messages.

Carolyn Allen in Southampton talks about how her son requires support for a number of the effects of the condition, including deafness in his left ear, noise sensitivity, and speech and language delay. She says:

“He has been referred to portage, speech therapy, occupational therapy, ophthalmic, hearing clinic, physiotherapy, community paediatricians and has already had one operation to release his tongue tie.”

Just imagine the massive impact of this condition on that family.

Paula Hartshorn, a mother from Leeds, says:

“The powers-that-be need to think about the devastating impact this has on families, and how these families have to just cope and instantly know how to deal with all these complex medical issue. We have been left to give up on our jobs, careers, social interactions, and everything that goes with a well-rounded life. There are no breaks for us.”

The stories are heartbreaking.

Kazzy Southam from Blackpool tells a story of not finding out about the condition until her daughter was nearly 20. Her voyage of discovery began when she met Janet and Emma in 2014. This was after her daughter had been diagnosed with learning disabilities, dyspraxia, and social anxiety disorder. She had to fight to get a geneticist to investigate and give advice. Eventually, it was confirmed that her daughter had foetal valproate syndrome. It was a shocking fight for her to get justice, and she should not have had to go through that. She says:

“To me, she is an angel and I wouldn’t change her for the world. She said to me not long ago: I wouldn’t want to be ‘normal’—I like my mad head. But it hurts me to say, she doesn’t and won’t know any different—all down to the pills I took for my seizures.”

I ask Members to imagine living with that throughout their life. The Minister really needs to reflect on this. It seems to me that the Government have an obligation to do good by these people and not just to say that they must resort to the local authority or the clinical commissioning group for whatever might be available in their locality. There is a moral duty here and we must accept it just as we did with thalidomide.

I became aware of this scandal when I was a Minister and met the campaigners in September 2013. I was horrified by what I heard, having known nothing about the condition until then. I asked the Medicines and Healthcare Products Regulatory Agency, which attended the meeting, for an urgent review of what was being done to stop more and more mothers giving birth without knowing of the risks. In October that year, the MHRA asked the European Medicines Agency to undertake a full review. That review reached the conclusion—it was very little different from what the product licence said back in 1974—that the product should be used only if all other drugs are ineffective or are not tolerated. It also advocated a strengthened warning to ensure that all mothers were aware of the issue.

In January 2015, the MHRA issued new information with stronger warnings, education materials, patient information leaflets and so on. Eventually, in February 2016, the toolkit was issued: I have it here. It may not look like a toolkit, but it is. It is of value, because it gives information to clinicians and patients about the risks involved. Again, the scandal is that the information has not been communicated to very many of the affected women.

In September this year, a survey carried out by the UK’s three leading epilepsy charities—Epilepsy Society, Epilepsy Action and Young Epilepsy—found that the warnings were not getting through. Some 68% of women of childbearing age had not had any of the materials released as part of the valproate toolkit. That is not acceptable.

[Kate Green]

I thank the right hon. Gentleman for accepting a further intervention. He is making a very powerful case. The hon. Member for Central Ayrshire (Dr Whitford) mentioned the paternalistic approach that the medical profession has perhaps taken in the past. Is he as shocked as I was to learn that that paternalistic approach was still in evidence some two years ago when I met the pharmaceutical company Sanofi to discuss getting information out to mothers? The company told me that it would be inappropriate to make the information available, as it was unsupported by detailed advice from doctors. Of course it is important that women should be able to discuss the matter with their clinician, but they are able to understand and interpret intelligence, too.

[Norman Lamb]

I thank the hon. Lady for her intervention and pay tribute to her for her work on the all-party group for valproate and other anti-epileptic drugs in pregnancy, and for her campaigning. Yes, the response she got from Sanofi two years ago was unacceptable. It had the effect of hiding from women the full extent of the risk. Women should be presented with the evidence so that they can have a full discussion with the clinician about what steps to take. The September 2017 survey also found that 18% of women did not know of the harm—it was not that they had not received the toolkit, but that they still did not know. The system is failing those women.

Healthier Together Programme (Greater Manchester)

Debate between Norman Lamb and Kate Green

Tuesday 22nd July 2014 Westminster Hall

[Julie Hilling]

rose—

[Kate Green]

rose—

[Norman Lamb]

I give way first to the hon. Member for Bolton West.

--- Later in debate ---

[Norman Lamb]

I have made the case very clearly that the whole purpose of the pioneer programme is to use the pioneers—although we are not simply focused on them—to identify the barriers to integration and to remove them. That is the whole point. There are concerns about all sorts of things that could block integrated care, such as information sharing across different providers and competition.

I should stress, incidentally, that in the section 75 regulations is a specific recognition that integrated care is an ambition that should be achieved, so commissioning can be for the whole integrated care pathway. There should be no problem in securing our ambition. Where barriers are found, they need to be addressed and removed.

I am conscious that the hon. Member for Stretford and Urmston asked to intervene—

[Kate Green]

indicated dissent.

[Norman Lamb]

The hon. Lady has moved on, so let me make some progress.

It is important to recognise that we are discussing proposals that originated with local clinicians. Dr Chris Brookes, who is not a politician or a bureaucrat, who too often get condemned, but an accident and emergency consultant and a medical director of Healthier Together, says—

[Norman Lamb]

May I make this point? I am sure that the hon. Lady will be interested to hear it. Dr Brookes said:

“Currently, there are too many variations in the quality of treatment, whether its emergency surgery or getting to see a GP when you need to. Not one of our hospitals in Greater Manchester meet all the national quality and safety standards.”

I am sure that all hon. Members present are concerned about that. He goes on to say something which, if we think about it, is shocking:

“At present your chance of being operated on by a consultant surgeon in an emergency at the weekend is much less than midweek. Your chance of recovering well from surgery carried out by a consultant is greatly improved.

But it’s not just about hospitals. It’s about access to a GP, and better community-based services—more services provided locally or at home and joining up the care provided by local authorities.”

That is a clinician making the case for integration.

Before I turn to the Healthier Together changes, it is probably best to make a few points about service changes in the NHS generally and Government policy towards them. The Government are clear that the design of health services, including front-line services and A and E, is a matter for the local NHS and, critically, the health and wellbeing boards, which have democratic accountability. Our reforms put doctors in charge of the care that people receive and how it is delivered to best serve their populations.

The NHS has a responsibility to ensure that people have access to the best and safest health care possible, which means that it must plan ahead and look at how best to secure safe and sustainable NHS health care provision—not only to meet today’s needs, but to plan ahead for next 10 or 20 years.

[Kate Green]

In Trafford, my understanding is that neither the local authority nor the CCG supports the proposals before us. Will the Minister explain the role of the health and wellbeing boards in the final decision on the plans?

[Norman Lamb]

I understand that the health and wellbeing boards are keeping a watching brief throughout. They will have a decisive voice at the end of the consultation process in declaring whether they support the outcome. They bring together the local authority and the NHS, so they are pretty central to the whole process—and rightly so. The local NHS is constantly seeking to modernise delivery of care and facilities to improve patient outcomes, to develop services closer to home and, most importantly, to save lives.

The hon. Member for Stalybridge and Hyde focused on specialisation, and expressed scepticism about the case for it. Let me give him a case. It is from during the Labour Government and should be applauded—the lessons from it should be learned here. Stroke care in London, centralised into eight hyper-acute stroke units, now provides 24/7 acute stroke care to patients, regardless of where they live across the city.

Transport links are not that great across much of London—[Interruption.] Hon. Members should listen to Members from London complaining about transport links. Stroke mortality is now 20% lower in London than in the rest of the UK and survivors with lower levels of long-term disability are experiencing better quality of life. Hundreds of lives have been saved as a result of the specialisation undertaken predominantly under the previous Government.

Health and Social Care

Debate between Norman Lamb and Kate Green

Monday 13th May 2013 Commons Chamber

[Kate Green (Stretford and Urmston) (Lab)]

It is a pleasure to follow the hon. Member for Worcester (Mr Walker). I, too, want to talk about social care. First, however, let me reinforce the comments made by my right hon. and hon. Friends about the announcement on compensation for sufferers of mesothelioma. That devastating illness affects a number of families in my constituency, as well as many workers in Trafford Park over many decades. Work was begun by Labour on a system of compensation for asbestos-related illness where employers and insurers cannot be traced, and we now at last have a proposal from the Government although it is disappointingly limited in its reach.

The proposed scheme will apply only to diagnoses made after 2012, and it completely misses half the victims of asbestos-related cancers because it is limited to mesothelioma sufferers and a cap is imposed on the level of payments. The deal favours insurance companies; it is not good enough for victims or for the public purse because many sufferers will continue to rely on payments from the Department for Work and Pensions as they will not be eligible for the compensation scheme. Although the proposals in the Queen’s Speech for a system of compensation are welcome, I hope we will be able to improve the legislation as the Mesothelioma Bill passes through the House.

On social care, everyone agrees that people would prefer to be cared for in their own home for as long as possible, but community-based provision must be in place for that to happen. As many right hon. and hon. Members have said, a lack of community provision is placing excessive strain on the NHS with regard to A and E and bed blocking, and my local authority in Trafford has received repeated reports that a lack of access to rehabilitation, physiotherapy, speech and language therapies—for example, after a stroke—and to support and care packages means that it is often impossible to discharge someone, even when they are medically fit to go home. That backdrop is of particular concern at a time when a significant reconfiguration of our national health service is being proposed in Trafford. There must be real concern about a squeeze on NHS services when community provision is not in place.

I am pleased that the Secretary of State has recognised the need for a single named professional to have oversight of an individual’s health and social care needs, but the fragmentation and contracting of NHS services does not help. Competition works against the integration of primary, secondary, tertiary and social care and, as many colleagues have said, cuts to local authority budgets are having a massive effect. Trafford is cutting nearly £3 million this year from social care budgets, which means cuts to day services, for example, or increased costs for meals. Curiously, the local authority intends to achieve a large part of those savings through the introduction of personalised budgets, which we understood were not intended as a savings measure.

Families want to help and keep loved ones at home, but they are under great pressure and rely particularly on day services and respite care. They tell me that assembling a personal package is complex. One constituent —a highly resourceful and articulate businessman—told me of his struggle to use a personalised budget to assemble a care package for his partner. He called seven potential providers, but most could not cope with assembling the package she needed to meet her complex needs. If my constituent could not put together that package, how—as he rightly asked me—will the more marginalised and excluded manage? He pointed to the importance of decent brokerage services, yet at the same time we are seeing cuts to advocacy services. There is already evidence that personalised budgets do not work so well for elderly people or those without family and friends to help.

It is not clear what the long-term effects of spreading personal budgets will be, but they could lead to further fragmentation of services or exacerbate inequalities. For example, there is evidence of a lack of cultural awareness among brokers and providers, and the complexity of putting together a personal care package may leave the most excluded even further behind. I invite Ministers to tell the House what steps they will take to monitor the impact of personal budgets on inequality and outcomes for the elderly and most vulnerable.

[Norman Lamb]

rose—

[Kate Green]

I am pleased the Minister is seeking to intervene.

[Norman Lamb]

Does the hon. Lady accept that there has sometimes also been a lack of cultural awareness in the traditional way of delivering services when people make assumptions about someone’s care needs and the right way to deliver them? Putting the individual in charge and letting them determine their priorities gives us a better chance of getting it right and meeting the cultural choices that are so important to people.

[Kate Green]

I accept what the Minister is saying but evidence suggests that for certain more disadvantaged and vulnerable individuals, articulating those needs is very difficult and so culturally appropriate advocacy, representation and brokerage services will be of huge significance. Evidence from research carried out so far suggests that the effects of personal budgets are patchy. I am sure the Minister will wish to raise standards across the board, and I look forward to the further work that we—collectively and with local authority colleagues—can do to ensure that that is the case.

Work force issues relating to social care are also a concern. As others have pointed out, many of those working in social care earn the national minimum wage and contract pressures mean that they have little time to do more than rush in and out of appointments and provide the basic physical care that clients need. There is little time to stop for a chat or a cup of tea, or for some of the social interaction that is so valued by those in receipt of social care. Many providers have told me they are anxious and that they are being screwed down on pricing as a result of local authority spending pressures, which could lead to their contracts becoming unviable. Poor levels of pay— as my hon. Friend the Member for Bridgend (Mrs Moon) said, staff are often not paid as they move from one appointment to the next—mean that they will not be motivated to provide the best care in those circumstances, and some will be forced to give up their jobs.

Finally, I welcome the development of extra care for those in need of residential care, and some good projects are under development in Trafford. I hope the proposed development in Old Trafford will receive approval. As colleagues have pointed out, the Dilnot recommendations, as taken forward in a more limited form by the Government, will leave many families in my constituency with substantial costs but without liquid savings with which to meet them, meaning they are still likely to be forced to consider the sale of the family home.

Overall, the Queen’s Speech needed a much bolder approach to prepare us for an ageing society, including policies for maximising saving in working age—difficult when the Government are putting family budgets under such pressure—and a bolder approach that looks at combining health and social care budgets, investment in primary and community health provision to keep people out of hospital longer, integration over competition, personalisation accompanied by a service investment programme, and serious attention to work force development. I regret the many missed opportunities in those areas in the Queen’s Speech.