Cystic Fibrosis Drugs: Orkambi

Teresa Pearce Excerpts

Monday 10th June 2019 Westminster Hall

[Paul Scully]

The hon. Lady is right. The fact that people have to resort to such things is ridiculous given that we have a comprehensive health system. It is about time Vertex recognised that there is plenty of time for it to make a reasonable profit on its drugs portfolio. It is not helping the situation. There are a number of people from the Cystic Fibrosis Trust in the Public Gallery, but unfortunately, as the hon. Member for Bury North (James Frith) said, many sufferers cannot be here because of the danger of cross-infection. They are hopefully watching the debate on television or on their computers.

[Teresa Pearce (Erith and Thamesmead) (Lab)]

The hon. Gentleman is being extremely generous in giving way. On the issue of shareholdings and profit, when I was doing research for this debate, I came across something in the Wall Street news that told me that Vertex gives a higher than average return on investment. Most companies that operate in this area give a return on investment to shareholders of 20%; last year, Vertex gave 45%.

[Paul Scully]

I am grateful to the hon. Lady for pointing that out.

Autism

Teresa Pearce Excerpts

Thursday 29th March 2018 Commons Chamber

[Dame Cheryl Gillan]

My right hon. Friend, who chairs the Education Committee with distinction, is absolutely right. That is why I am so pleased that this year, for the first time, the Government are putting a compulsory autism module into initial teacher training. That is significant, and I hope that my right hon. Friend’s Committee might look into that provision.

The inquiry of my hon. Friends the Members for Bexhill and Battle and for Lewes also found that four in 10 families were initially turned away when asking for the extra help that their child needs. To address these challenges, we have recommended that the Department for Education develops an autism strategy. That call has been enthusiastically taken up by the National Autistic Society and Ambitious about Autism, which launched the Held Back campaign to support the report’s recommendations.

More than 20,000 people, including 70 Members of this House and the House of Lords, have signed an open letter to the Secretary of State for Education calling for the report’s recommendations to be implemented. It is really important that Lord Agnew, the Under-Secretary of State for the school system, comes forward with the Department’s response, as it has confirmed that it will respond to the inquiry. It will be good to hear what it is doing to make improvements in this area.

I turn to the autism employment gap, which is a major problem.

[Teresa Pearce (Erith and Thamesmead) (Lab)]

I thank the right hon. Lady for the work that she does on the APPG, which is much needed and welcomed. I agreed with what she said about children in school, and I think that everybody here knows of such cases. My constituent, Lucy, has a bright seven-year-old son who is in year 4 but is working at year 1 level because he has not had his diagnosis. That an absolute disgrace for the child, who is missing out on his education, but Lucy also wrote to me to say, “I am exhausted”. She is fighting with all her energy, but says,

“I still have fight in me, but the whole family is exhausted”

because they feel that there is a barrier at every step.

 Orkambi and Cystic Fibrosis

Teresa Pearce Excerpts

Monday 19th March 2018 Westminster Hall

[Mr Iain Duncan Smith (Chingford and Woodford Green) (Con)]

I am grateful to you, Mr Evans, for your chairmanship today. As you suggested, I will be brief.

So much has been said already about this drug that I want to make only two points about it at the end of my speech. I congratulate my hon. Friend the Member for Sutton and Cheam (Paul Scully) and hon. Members from both sides of the House on having been responsible for the assistance and support that has been provided—both the roundtable that took place earlier, which I was not able to attend, and the e-petition—and on representing the sufferers and their families so well. I congratulate them, and I am pleased and grateful that they have managed to secure this debate.

I am really here because one of my constituents is standing outside hoping that there may be some resolution as a result of this for her daughter, who suffers from cystic fibrosis. I have known the family and the daughter for a little while. The contrast is interesting between two children of my constituents. On the one hand, Megan Bridge is a cystic fibrosis sufferer—her mother, Gill, as I said, is outside just now— and she has made the point to me that at the moment she is old enough to study law. Like any of our children of that age, she should have great prospects, hopes and aspirations, but hers are limited because the prognosis is that she probably does not have more than another two years if things carry on as they are.

If a decision is not taken about this drug soon and agreement is not reached, it is at Megan’s end of the spectrum that that becomes very difficult, because not only will further damage set in, as was said by the hon. Member for Sutton and Cheam earlier, but a decision might not be made within a year or two, in which case the prognosis for her and for her family is incredibly poor. She begs that we and the Minister—I will come back to this point shortly—make a clear decision with the drugs company as soon as possible.

At the other end of the spectrum is somebody called Amelia, who is only five years old. Her mother, Lucie, came to see me in my surgery to talk about her condition and about how the family copes with it. This poor girl, like so many others who have been mentioned, has to take 40 tablets a day, and has huge amounts of physiotherapy, including three nebulizer treatments, every single day. She is not yet on a feeding tube, but her mother has been told that if the current situation goes on for much longer then she will be.

My point is that these accounts are two ends of the spectrum. In a sense, they are not representative; although they are representative of sufferers, they are not representative of a vast number of people out in the country, because this is such a peculiar genetic condition that, as has been said time and again, not a huge number of people have it. That is where this place and Governments of whatever persuasion—this is not party political—sometimes have to recognise that the common good is not always about majorities and large numbers. It is more often the case that this place is set up to deal with those who are so small in number that they are unable to make the case for themselves. They are unable to drive the point home; they are unable to muster the vast number of votes that it might take a matter to the point where MPs listen very carefully.

What we have seen today is of enormous credit to the humanity of my colleagues on both sides of the House. These people are not likely to change the vote in my colleagues’ constituencies, but they care enough about the idea that these people’s lives matter that we might be able to do something for them.

[Teresa Pearce (Erith and Thamesmead) (Lab)]

I thank the right hon. Gentleman for giving way. I am listening carefully to what he is saying, and he is saying exactly what I was just about to point out, namely that this is why we are here. This is why we are sent to this place, to speak up for the people who cannot speak up for themselves. My constituent, John Bacon, who is in his twenties, sent me a very simple email that said, “Please help me. Please speak for me and advocate for me. And not just for me, but for all those with cystic fibrosis, and remove the price that has been placed on our lives. We are worth it.” They are—and if we do not speak for those who cannot speak loudly, we should not be here.

[Mr Duncan Smith]

I completely agree with the hon. Lady, and that is really the point that not just me but pretty much everyone who has spoken has been making.

I do not know what detailed conversations and discussions are going on about this drug. I sat in government, so I know how complex these things are sometimes. I say to my hon. Friend the Minister that “frustrating” was the word I often used when bodies are set up and fall back on their rules because they are not so exposed to public scrutiny.

The latest evidence—I understand that it comes from the company—shows that there is stronger data and that this drug is even more vital than it was before. It now slows lung decline by 42% and it might turn out that it is even more effective than that, which would give somebody like Megan, who I mentioned earlier, the possibility of longer. What is that delay about? The possibility of transplant, and even further down the road the genetic changes that may well be able to be introduced. So, buying time matters dramatically for this group, in the hope that things will improve for them.

When I was in Government, I know that we spent a lot of time on social impact bonds. One area we worked hard on—the Government have incredibly good data on it because we made a number of case studies—is the cost-benefit analysis, to allow us to say that local authorities and so on could set up social bonds to change the number of people going into prison, or to affect the number of people who fail at school. So it was possible to forecast how a cost-benefit analysis would work; it exists.

Right now, I am not certain that NHS England and for that matter NICE are employing that system. I urge my hon. Friend the Minister to go to the Cabinet Office and say, “We have done the work on a proper cost-benefit analysis of this drug, and once it is tied in with future developments of other drugs and balanced with health treatments in hospital, constant work with physiotherapy and all the rest of it, I am certain that this group will not only to be able to have this drug, but we will ask ourselves why that didn’t happen before when it so mattered and it benefits them. It also benefits us because instead of their being in hospital, others may be able to use that hospital treatment.” That is a good cost-benefit analysis and I urge my hon. Friend to look at it.

Deafness and Hearing Loss

Teresa Pearce Excerpts

Thursday 30th November 2017 Westminster Hall

[Teresa Pearce (Erith and Thamesmead) (Lab)]

It is a pleasure to see you in the Chair, Ms Buck. I too express gratitude to my hon. Friend the Member for Poplar and Limehouse (Jim Fitzpatrick), not just for obtaining the debate, but for the work he has done on deafness and hearing loss for many years; he is a great champion of the cause. I also want to mention the hon. Member for Rochester and Strood (Kelly Tolhurst), who shared her personal story. I was struck by what she said about her mother’s isolation, because my late mother-in-law was one of the most sociable people anyone could meet—show her a piano and she would play for two hours—but then she lost her hearing, and with that, she lost her social circle and became incredibly lonely. We hear a lot about elderly people being lonely, and I wonder how much hearing loss has to do with that.

The debate is very broad—as broad as the challenges that people living with deafness face; so I shall confine my remarks to two areas, the first of which is cochlear implants. A constituency case has been brought to me by several constituents, including the grandmother of Jacob, who needs a cochlear implant. He is profoundly deaf in the right ear and severely deaf in the left; he is four years old. He has been tested by St. Thomas’ Hospital cochlear implant team, who supported the case for an implant, but the NHS has turned him down. The family have been told he can have the implant only if they can raise £44,000. My constituents are not the most affluent in the country, but they are truly wonderful, and this will not be the first time they have crowd-funded help for someone. Last year they helped a young mother to get a second stem cell transplant. Their campaign, “Help Jacob Hear”, has run boot sales, raffles and fêtes and raised nearly all the money, which is great news—but it raises the question of what the NHS is for if it is not to help children such as Jacob. The spending of taxpayers’ money at this point would potentially be handsomely repaid over the lifetime of that young boy. It might be expensive, but what is the financial and social expense of not funding it?

The second area I wanted to focus on is Access to Work. Quite a number of my constituents are British Sign Language interpreters, and many of them have written to me. One, Joanna, works regularly with people who are helped by Access to Work to participate equally and fully at work. In 2015 the DWP, as has been mentioned, imposed a cap on Access to Work awards, and Joanna is worried that the cap will act as a glass ceiling on deaf colleagues’ and friends’ career aspirations. Those with hearing loss will not be able to apply for promotions or look to develop their career, because the Access to Work support will not be sufficient. That means that they will be able to book interpreters for perhaps only three days a week. What will happen on the other two days? Deaf professionals are left at a disadvantage, experiencing stress and frustration as it leads to their being removed from viable career paths. The consequences can be reduction of their working hours and in some cases complete removal from employment. There are self-employed deaf professionals in the arts who have not been able to develop projects, because of lack of access. Research done by the group DeafATW with people whose awards have been capped already or are due to be capped next year, shows a negative impact on careers and aspiration. Especially affected are deaf people who are in or who aspire to professional, managerial or leadership roles, or those who are self-employed and who run their own business.

Another of my constituents, Andrew, is deaf. He uses British Sign Language and works as a senior team administrator with Surrey County Council. Access to Work pays for the interpreters and note-taking that make it possible for him to communicate with colleagues, customers and others, and help him to participate more fully and equally at work, even though it does not stretch to providing assistance at longer meetings where it is impossible to focus on the interpreter and to take notes at the same time. That said, it is likely that the support that Andrew gets via Access to Work, which we all agree is a fantastic system, is much more than what would be seen as a reasonable adjustment for his employer to make. Access to Work has revolutionised the career opportunities for people like Andrew, and shattered the glass ceiling that previously often limited people to doing manual jobs. It has ensured progression for deaf people that is based on talent, which is as things should be. There are now deaf chief executives, deaf intermediaries working at the Ministry of Justice, deaf theatre directors, deaf social workers and a deaf senior team administrator at Surrey County Council. I am concerned that a new policy will undo that good work.

In September DeafATW ran a survey among deaf people about Access to Work. Among those who will be subject to the Access to Work cap from 2018, nearly half said they would not apply for promotion in future, because they were worried that in a new job they would not have enough communication support as a result of the cap. For the same reason, a fifth said that they had already had opportunities to apply for promotion, but had not done so. Nearly half said that they would stay with their current employer as long as possible, because they were worried about what a new employer might think about the effect of the cap on their ability to do their job. When talking about growth we hear a lot about the “productivity puzzle”. It is not much of a puzzle really if we are limiting where people’s talent can take them with such a cut.

In about a third of cases, the employer was either taking or thinking about taking action to check whether the individual could still do their job properly. Deaf people fear that having a capped award means that they will not be able to do their job properly, and employers are concerned about it too. As a consequence, deaf people, whether they are already subject to a cap, are expecting to be subject to one in 2018, or are without a cap in their current work, have said that they are already avoiding applying to work in professional, managerial and senior roles.

In 2015, the Government were clear that a key challenge in administering Access to Work was managing a demand-led programme within a defined budget. They said

“We must achieve a balance between meeting customer need and achieving value for money for the taxpayer. It has been a long-standing aspiration of the programme to support more disabled people into work, so we must address the challenge of supporting this growth whilst keeping Access to Work affordable”.

I would say that it is money well spent. I could not find more recent figures, but the Sayce report in 2011 said that for every pound spent £1.48 came back to the Treasury. That is clearly a case of spending to save.

The Minister may be aware that in July 2015 the Government responded to the Work and Pensions Committee report entitled “Improving Access to Work for disabled people”. The report was scathing about the statistics, stating:

“This lack of transparency is unacceptable. We recommend that DWP change its approach to Access to Work statistics and that, as a minimum, it regularly publish the following information: an indicative annual budget; annual expenditure outturns, broken down by support element and impairment type (including autism spectrum disorders); the number of service users by size of employer; and employers’ mandatory and voluntary financial contributions, broken down by size of employer.”

In their response, the Government admitted that there was work to do to meet those requirements. Will the Minister now, or perhaps by writing to me, update us on progress with the Access to Work statistics? The previous Minister said that there were a lot of statistics available, so I should be pleased to know what progress has been made in supplying the information. Will the Minister also provide figures to show the trend in the number of deaf people supported by Access to Work prior to the introduction of the cap, and afterwards?

The Select Committee also highlighted a particularly strong case for the DWP to improve the accessibility of its disability-related services, recommending that it introduce a video relay system to enable deaf BSL users to contact the Department more easily. Has there been any progress on that? By way of a reminder, I noticed when I arrived that there is a signer for the debate, and I recalled that when the Work and Pensions Committee undertook a review of Access to Work in 2015, we had a sitting when deaf people came to give evidence, and there were deaf people in the Public Gallery, and no one had thought to book a signer. Luckily, one of my constituents had come to watch. He was a qualified signer, and he took over and helped us. In this place, sometimes we do things very well and sometimes we overlook things. If a Work and Pensions Committee looking into accessibility for deaf people did not think to have a signer, it goes to show that we must do better on this. Today’s debate is a step forward.

Valproate and Foetal Anticonvulsant Syndrome

Teresa Pearce Excerpts

Thursday 19th October 2017 Commons Chamber

[Fiona Bruce (Congleton) (Con)]

I pay tribute to the right hon. Member for North Norfolk (Norman Lamb) for so eloquently articulating the concerns that many of us share about the taking of sodium valproate by expectant mothers.

I am speaking today because I believe there is a case for Ministers to answer on the grounds of compassion and justice as to how and why pregnant women were allowed to take sodium valproate for so many years without being better advised and informed, and without their unborn children being better protected from the risks. That is particularly the case since professionals became increasingly aware of those risks over the years—as early as 1973. As we have heard, the risks are huge. At the end of the day, the people who should have been able to weigh them up and choose whether to take valproate while pregnant were the mothers. I appreciate that in 1973 we were, as has been said by a practitioner in medicine, in a more paternalistic era, but that was not the case as the years went by, and certainly not in 2016, when the valproate toolkit—the patient guide that I have here in my hand—was published.

Mothers were not given the relevant information and, sadly, far too many still are not. It is absolutely critical that they are given it, because the toolkit is stark, stating:

“If you take valproate when you are pregnant it can harm your unborn child…Taking valproate…can cause birth defects and problems with development and learning…In women who take valproate while pregnant, around 10 babies in every 100 will have a birth defect”,

such as

“spina bifida…facial and skull malformations…malformations of the limbs, heart, kidney”

and other organs. It goes on to say that

“about 30-40 children in every 100 may have developmental problems”

such as

“learning to walk and talk…lower intelligence…poor speech and language skills”

and “memory problems.” It states that

“it is…important that you…know about these risks”.

But for years women did not know about the risks when medical professionals did. They might not have known, and probably did not know, all those details. However, I have with me a copy of a letter from the Committee on Safety of Medicines—the precursor to the MHRA—from 1973. It refers to a number of studies and says:

“it is now clear from other studies…that the use of anticonvulsants during pregnancy…is liable to produce other abnormalities as well as hare-lip and cleft palate. The risk appears to be low and not sufficient to justify stopping the use of anticonvulsants when they are necessary for the control of epilepsy.”

There we have it—the Committee on Safety of Medicines was aware of this in 1973. The documentation relating to the licensing application in 1974, which the right hon. Gentleman mentioned, says that the product is licensed

“for use in general, focal or other epilepsy. In women of child bearing age, it should only be used in severe cases or those resistant to other treatment”.

So we now know that the dangers were being raised as long ago as 1973 and 1974.

In response to these concerns, the CSM instructed that an alert must

“not go on the package inserts”

so that patients would be protected from “fruitless anxiety”. Because patients did not see anything, they were denied the information and therefore the choice to abstain from this drug. Yet very much more anxiety was caused for many of them when the reality was that thousands of babies were born with life-changing disabilities and deformities that could have resulted from taking this drug during pregnancy.

[Teresa Pearce (Erith and Thamesmead) (Lab)]

Does the hon. Lady find it even more shocking that it was decided to keep this information from women in 1973-74, in the wake of the thalidomide scandal, when it should have been uppermost in people’s minds that pregnant women needed warning about the drugs they took? That should have made it more likely that women were informed about the risks.

[Fiona Bruce]

The hon. Lady makes a very good point.

Further warnings were issued. In 2000, a patient information leaflet from the producer, Sanofi, said:

“It is known that women who have epilepsy have a slightly higher risk of having a child with an abnormality than other women. Women who have to take Epilim in the first 3 months of pregnancy to control their epilepsy have about a 1-2% chance of having a baby with Spina Bifida.”

In 2005, Sanofi added:

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

and that some

“babies born to mothers who took Epilim…during pregnancy may develop less quickly than normal or have autistic disorders.”

Warnings were emerging over the years, but nothing was done to ensure that patients were told. Why did patients have to wait almost 30 years to be warned of the risks?

Janet Williams and Emma Murphy, whom the right hon. Member for North Norfolk (Norman Lamb) mentioned and whom I have had the privilege of meeting, are tenacious and brave women who have campaigned for years and set up a support group for affected families. I pay tribute to them, and I want to tell the House a little bit about their family situations. Janet has two sons aged 26 and 28: Lee and Philip. Janet took Epilim, but nothing else, during both pregnancies. She told me:

“I wasn’t offered anything else—and no one told me of the risks.”

Lee, at 26, has curvature of the spine, Asperger’s, learning difficulties and memory problems, and he cannot hold down a job. Philip, at 28, has even more problems. He has problems with hearing, vision, speech, language and walking, as well as floppy joints. He is still fully dependent on Janet.

Emma had her children a generation later. She has five children, aged eight to 14: Chloe, Lauren, Luke, Erin and Kian. They have all been diagnosed with a number of symptoms. All have varied problems, including autism, incontinence, deafness, cerebral palsy and curvature of the spine, and all are slow to develop. Emma took the same dose of Epilim during each pregnancy. She told me that she questioned that, but was told that it was the best drug to control her seizures and that her baby would be fine. She took no other drugs during her pregnancies. No one warned her of the risks.

The tragedy is that those two women represent more than 1,000 others in their support group, the Fetal Anti Convulsant Syndrome Association. Together, they founded the Independent Fetal Anti Convulsant Trust, a registered charity, to campaign for better awareness of the risks of taking valproate, to prevent further such difficulties occurring, and to challenge the Government. There is, as I say, a case to answer, and I do not believe that we would be here today were it not for these two women.

--- Later in debate ---

[Mims Davies]

Absolutely. Speaking about this issue in this Chamber will empower our women constituents, before and during pregnancy, so they can be informed and make the right choices. That is the outcome we should all be hoping for.

Similar issues were raised yesterday during a debate in Westminster Hall on mesh implants. New mothers in particular had taken the advice they were given without hesitation. A woman’s first pregnancy can be an unsettling time with all the changes their body goes through. I would imagine that for people suffering from epilepsy or bipolar disorder that time is even more nerve wracking. It is absolutely right that we are measured when we talk about these issues.

It is important that our specialists ensure that women are given the correct and proper guidance. Patients need knowledge and they need it more than anyone. They live with the consequences if things go wrong and they will always look back on their decisions. If they have not been given the right information, how can they truly know they have made the right decision for themselves and their family? Siblings are often impacted as well.

The Government and MPs have a really important role to play in raising awareness of medical issues during pregnancy, including those concerning sodium valproate. I recognise the efforts that have been made, with labelling on packages. I am sure the Minister will agree, however, that more needs to be done. This drug, introduced in 1974, has been crucial, but support for families affected is also crucial. I welcome the fact that young people who have been affected are to be included in the new framework for health and social care for children and young people. It has been a real battle, but clinical commissioning groups and local authorities are getting to grips with it. It is really important that they receive support on a local level. I welcome the Minister’s forthcoming meeting with the all-party group, and I know that Ministers are taking this matter seriously, but I ask the Department for assurances on similar health issues affecting women, such as those relating to Primodos and mesh implants. We have moved to an incredible place on blood contamination—some of my constituents were affected by that—and constituents have written asking me to raise this issue too. We want more action, and there is a common denominator.

[Teresa Pearce]

Two years ago, I asked the Minister to extend the Primodos inquiry to include valproate, but my request was declined because, I was told, the two issues were very different, yet they seem to be quite similar. Does the hon. Lady think that that was a missed opportunity?

[Mims Davies]

As a woman in Parliament, I think that any opportunity not taken to raise women’s issues is a missed opportunity, and I know the Minister is listening intently.

The hon. Member for Newport West (Paul Flynn) raised a point about the seemingly cosy relationship the MHRA has with the drugs companies, when it suits it, and sometimes the laissez-faire attitude it adopts, when it suits it. It is incomprehensible that greater independence cannot be injected into this area. We need openness and reform. I would like the Minister to take a look at the position in France and consider setting aside some funding for compensation for medical accidents.

Few in the Chamber can imagine the hardship, guilt and heartbreak of the impact of taking a simple prescription drug during pregnancy and finding out later that it might have had an effect on one’s child. I am lucky to have two healthy beautiful daughters. We are all at the mercy of decisions we take during our pregnancy and the professional guidance we receive. We are fortunate to have the opportunity to raise awareness among people in this situation, but there are those not lucky enough to be sufficiently informed. This is an important debate, therefore, and I urge the Department to work with the MHRA to give patients full confidence in it on all pregnancy matters.