Oral Answers to Questions

Siobhain McDonagh Excerpts

Tuesday 7th February 2017 Commons Chamber

[Nicola Blackwood]

AMR is a global issue. We are world leaders in this, and we are working proactively with international partners to identify new and innovative approaches to the treatment of a range of challenging resistant infections, including malaria.

[Siobhain McDonagh (Mitcham and Morden) (Lab)]

11. What assessment he has made of how the accelerated access review will improve access to breast cancer drugs.

[The Parliamentary Under-Secretary of State for Health (Nicola Blackwood)]

We are absolutely determined that we will improve access to cost-effective, innovative medicines, including breast cancer drugs. That is exactly why we introduced the cancer drugs fund.

[Siobhain McDonagh]

The Minister will know that “cost-effective” is not an easy thing to define. Many women will not get access to the breast cancer drugs they need unless there is a review of how NICE assesses cost-effectiveness. Will she support an independent review of those processes, and will she say something about off-patent cancer drugs?

[Nicola Blackwood]

The hon. Lady and I have debated this in the House before. It is worth looking at our record. The cancer drugs fund has helped 95,000 people to access cancer drugs, to the tune of £1.2 billion, and NICE has approved three breast cancer drugs, while there are others that it has not yet approved. It is important that politicians do not intervene in this debate, as these are very difficult decisions that will always be challenging in the situation where the NHS has a finite budget.

Breast Cancer Drugs

Siobhain McDonagh Excerpts

Thursday 26th January 2017 Commons Chamber

[Siobhain McDonagh (Mitcham and Morden) (Lab)]

I beg to move,

That this House notes the provisional decision not to provide the breast cancer drug Kadcyla for use in the NHS on 29 December 2016; and calls on the National Institute for Health and Care Excellence (NICE) and pharmaceutical company Roche to come together and re-assess this decision to ensure Kadcyla is kept available for patients, and consider how access to both innovative new breast cancer drugs and off-patent drugs used for breast cancer, such as bisphosphonates, can be improved.

I thank the Backbench Business Committee for the swift manner in which it allocated time to have this important debate. I want to put the spotlight on an issue that affects the lives of millions of people—those who are living with breast cancer and their family and friends. I am sure that almost everyone here today will know someone who has had this disease. My own friends have suffered from breast cancer, and I am so pleased that many of them are in the Public Gallery to watch today’s debate. I have received a large amount of communication on this, including as late as last night in a message from a Vivienne Ashley, who cannot be here today but will be watching on TV.

The disease affects people irrespective of their class or job. Many hon. Members have suffered from breast cancer, such as my hon. Friend the Member for Bristol West (Thangam Debbonaire)—also my Whip—who has had a great recovery. An Opposition Member approached me only yesterday to explain that she was receiving treatment, and that although she wanted to be involved in the debate, she felt the issue was too close to her to do so at the moment.

I am sure all Members would agree that we need a health system in which the most effective cancer treatments are available to all patients. Today, I want to let people living with cancer, especially secondary breast cancer, know that we have not given up on them and that we all want an NHS that provides us all with access to the most effective treatments.

[Sir Desmond Swayne (New Forest West) (Con)]

If the deliberations used by the National Institute for Health and Care Excellence, particularly for metastatic breast cancer, take insufficient account of the needs of young families to spend more time with their mothers, is the remedy something that NICE itself can provide by altering the way it goes about those deliberations, or is it something that we in this House and the Government need to do?

[Siobhain McDonagh]

The answer to the right hon. Gentleman’s question is both. There are issues with how NICE assesses new drugs, particularly cutting-edge drugs such as Kadcyla. He will know, because of his involvement in the last Government, that they established the cancer drugs fund. It is not an either/or, but something we all need to come together to discuss, and that people with more scientific knowledge than me might wish to consider.

[Norman Lamb (North Norfolk) (LD)]

I congratulate the hon. Lady on securing this important debate. Does she share my concern at news that the Government appear to be ready to leave the European Medicines Agency following the Brexit vote? Many people fear that that will lead to a slowdown in access to new medicines. She talks about the importance of NHS patients getting access to medicines; this could make the situation worse and leave us disadvantaged compared with other countries in Europe.

[Siobhain McDonagh]

Breast cancer knows no boundaries, whether class, social or geographic. Anything that reduces access to better forms of treatment is detrimental.

The ability to lead an enriched and longer life as a result of medical advances should not be limited only to those who can afford private healthcare. Those advances should be accessible to us all. This debate will focus particularly on the provision of the breast cancer drug Kadcyla, which is under threat. Most Members will be aware of the lease of life that Kadcyla has brought to thousands of women in England with incurable secondary breast cancer. These women rely on Kadcyla to enrich their lives and to give them extra precious years to live. Indeed, in many ways it is a revolutionary drug. By targeting cancer cells directly, it helps to reduce the number of side effects, boosting women’s quality of life immeasurably. Members who have heard these women talk about their experiences will be humbled to learn of the distress and despair that they face as a result of NICE’s decision to provisionally reject the future use of Kadcyla on the NHS.

Today we are all supporting Breast Cancer Now’s “Keep Kadcyla” campaign to encourage NICE to reverse its decision and enable continued access to the drug, which both improves the quality of life and extends the lives of thousands of women in this country, on the NHS. Since NICE’s decision was announced at the end of December, thousands of people throughout the country have had their views heard. They have signed the petition and contacted their local MPs to ask that we do not give up on women, on the children who are dependent on mothers, and on the families who want that precious extra time with their loved ones. That is why we are all here today: to raise our collective voice in support of these women and defend the treatment that allows them to live their lives.

The focus of much of what I have to say today will be on Kadcyla, but we also need to consider other specific breast cancer drugs, as well as the broader issue of how decisions about access to treatment are made. Unfortunately, we are yet to see any improvements in access to off-patent drugs, some of which can prevent the development of certain cancers, thereby saving countless lives, as well as saving the NHS a great deal of money. Just a few months ago, the front pages of national newspapers highlighted the poor access to vital bisphosphonate drugs, which can prevent women from developing secondary cancer, yet the Government have barely acknowledged the problem of access to such treatment. I look forward to hearing from the Minister about when we can expect tangible results regarding access to off-patent drugs, including bisphosphonates. To be clear, many of the women who today owe their lives to Kadcyla might never have developed secondary breast cancer had they had access to bisphosphonate drugs in the first place.

[Nick Thomas-Symonds (Torfaen) (Lab)]

I will discuss off-patent drugs in my own speech, but on bisphosphonates, which are in the category of repurposed drugs, is my hon. Friend as concerned as I am about the results of the UK-wide survey undertaken by the UK Breast Cancer Group in March last year, which showed that currently only 24% of breast cancer clinicians are offering bisphosphonates to patients? That is something that the Government could urgently address.

[Siobhain McDonagh]

I completely agree with my hon. Friend and hope to say a little more about that later in my speech.

This debate is about not just Kadcyla, but the lives of the thousands of women who rely on it to survive, so I want to share the words and experiences of two of my friends whose lives have been transformed by having access to Kadcyla. One of my friends is present today—I went to primary school with her, but I shall not tell the House just how many years ago that might have been. Her name is Samantha, and she said:

“When I got the breast cancer diagnosis, I glibly thought—oh it’s OK I’ll get cured, but sadly about 18 months ago I found out that this wasn’t the case and my cancer had spread to my liver. And that’s when I really knew that my cancer meant business!

And that is where Kadcyla comes in. You see for breast cancer, although I coped and kept going with surgery, chemo and radiotherapy, it was grim. I worked a bit, but regular chemotherapy is not a doddle. Exhaustion and hair loss is just the least of it.

Putting on a brave face and wearing a wig is just a surface issue, getting up vomiting and going to work to deal with the VAT is about the hardest thing I have ever done. It wasn’t simply because I don’t have enough sick pay at work to cover my mortgage, I actually like work—work allows me to make my contribution, and I think that’s pretty near the most important thing, making my life make a difference. And Kadcyla? Well that means that my life isn’t over, it really gives me hope.

There is a big hole where my 45 mm tumour used to be in my liver, and scar tissue and other bits, but I am cancer free without having to take another year off my life. My work is precious; I have kept the business going. Eight people are employed, because I could keep going, and Kadcyla made it possible for me.”

[Mary Creagh (Wakefield) (Lab)]

I congratulate my hon. Friend on securing this debate. She certainly makes a powerful speech on behalf of her friend. Does she agree that when NICE looks at the cost-value ratio, stories such as that of her friend, who kept eight people in work, should also be a factor? We should be looking at women’s economic life and economic role, in both the workplace and the home.

[Siobhain McDonagh]

I completely agree with my hon. Friend. I appreciate that the equations and calculations are difficult, and I do not underestimate NICE’s work, but it is about life and quality of life, and it is about so many more people than only those who have the cancer.

My friend Leslie said:

“In 2013 my world was turned upside down when I was diagnosed with inflammatory breast cancer, a rare and aggressive kind of cancer that develops in the lymph vessels.

After 15 months’ treatment comprising 8 chemotherapy treatments, a mastectomy, 15 radiotherapy treatments and a year of Herceptin, it appeared that the cancer had gone. However, 4 months later I noticed a rash around the scar tissue of the mastectomy and a biopsy showed that the cancer had recurred in my skin.

My oncologist told me that I was in a very tight corner. Because the cancer had returned so quickly I wasn’t eligible for the usual drug treatments, radiotherapy wasn’t an option because I had recently completed a course, and surgery wasn’t possible because of the location of the cancer. I was told the cancer was incurable and referred to the Royal Marsden. They confirmed that surgery was not feasible because the cancer had spread so quickly over a large area making skin grafts impossible. I was told Kadcyla was my best chance.

I have now been treated with Kadcyla for 22 months and I have been told of others that have been treated for 5 years. Signs of the cancer disappeared very quickly and so far I have remained cancer free. Kadcyla has enabled me to live a reasonably normal life and participate in and contribute to my local community. Kadcyla has been a life saver for me and without it my future was very uncertain. I feel profoundly fortunate to have received it and I am incredulous that such an effective drug will now be denied to other people in my situation.”

I also wish to mention Rosalie, who was featured in Friday’s Evening Standard. She is just 33 and is living with incurable breast cancer. She is a single parent to two children, aged three and six, and is terrified of a future without the option of Kadcyla and terrified of her kids’ growing up alone. These are Rosalie’s own words:

“I hate feeling like a victim. But I have to fight for my kids. They are more important than me feeling vulnerable about going public. I have to fight for life for them.”

Then there is Mani. Members may have seen her last week on the “Victoria Derbyshire” programme when she spoke so eloquently about how Kadcyla had given her hope. She said that it had improved her life both significantly and quickly, enabling her to live a much fuller and richer life, going on holiday and playing an active part in her young daughter’s life.

These are just a few of the many women whose lives have been made possible through access to Kadcyla. I am sure that many hon. Members will share the experiences of their constituents. The hon. Member for Croydon South (Chris Philp) will no doubt talk about the incredible Bonnie Fox, the face of the Keep Kadcyla campaign of Breast Cancer Now. Thanks to the hard work of Bonnie and of Breast Cancer Now, this campaign has seen more than 100,000 people sign the petition, calling for NICE and Roche to come together to reassess the decision and find a solution to keep Kadcyla available.

Bonnie is an incredible advocate for the Keep Kadcyla campaign, inspiring so many others as she leads the case for this treatment. Bonnie says that her inspiration comes from wanting to have as much time as possible with her two-year-old son, Barnaby. These are her own words:

“I already feel cheated being diagnosed with secondary breast cancer at 37 with a baby, so having a drug taken away that would potentially add years to my life and give me more quality time with my son is so cruel.”

[Norman Lamb]

I am really grateful to the hon. Lady for giving way again. She will be aware that the Government’s accelerated access review last October recommended that NICE should review its whole health technology assessment processes and methods. Is she concerned that the review of Kadcyla and other drugs under the cancer drugs fund is happening before that review takes place? We might learn the lessons about how the review process needs to improve, but we will not benefit from them.

[Siobhain McDonagh]

I agree with the right hon. Gentleman. I am sure that he knows more about this process than I do. It clearly makes sense to consider these unique, unusual first-tier drugs in the light of that reconsideration.

I hope that we will hear the stories of the many women whose lives, having been affected by secondary breast cancer, have been enriched by Kadcyla. The drug Kadcyla matters so much to all these women for one simple reason: it works. It is effective. It has already been available on the NHS for more than two years and, compared with other treatments, its side effects are limited. Today, it is nothing short of a tragedy to know that countless women who thought that Kadcyla would be the next treatment they would receive for their breast cancer are having their lives shortened before their eyes.

I ask Members to imagine this: they are living with breast cancer; there is no cure, but there is something that could give them extra time with the people they love—the people who depend on them. It could be a year, five years or even longer. If they needed the drug today, the NHS would give it to them, but if they needed it in a few months’ time, they may have lost their chance.

[Dr Rupa Huq (Ealing Central and Acton) (Lab)]

My hon. Friend is making a very powerful speech. May I congratulate her on securing this debate, and say how proud I am to be a co-signatory? The phenomenon of there being drugs in the pipeline that would make a vital difference to patients, but which are being held up by conflict between NICE and pharmaceutical companies over pricing or value for money, applies not only to breast cancer but to other cancers, too. My constituent David Innes is one of 20,000 sufferers of chronic lymphocytic leukaemia. He was diagnosed in 2009, when he was 39. He was in Parliament earlier this week, making the same argument, and saying that both parties need to end the logjam and come up with a deal to ensure the availability of these drugs. They need to put patients first. Life is too short not to do so.

[Siobhain McDonagh]

I completely agree with my hon. Friend. I wish her constituent, David, all the best.

How can we withdraw a drug from the NHS that is working, especially when we are offering nothing in its place? It seems senseless to me, and it is truly devastating to those for whom it really matters. Of course, as my hon. Friend says, Kadcyla is just one drug that we need to look at. What will happen with other key breast cancer drugs now and in the future? I wish to consider just two more examples. Perjeta is currently available through the cancer drugs fund, but unlike Kadcyla it has not yet been re-appraised, although it will be soon. Perjeta is used for HER2 positive secondary breast cancer patients. In many ways it is even more effective than Kadcyla, as it enables women to live for an additional six months without their breast cancer progressing, and can extend life by an additional six months or more. However, because it is administered with two other drugs—Herceptin and Docetaxel—it would not be considered cost-effective under NICE standards even if the drug manufacturer gave it away for free.

The other drug is Palbociclib, which is used on women with hormone receptor positive and HER2 negative breast cancer. It is a new drug, which is being assessed for the first time by NICE. It is extremely effective and enables women to live for at least an additional 10 months without their breast cancer progressing. However, because women are living longer, robust overall survival data are not yet available. Perversely, that will count against it in the NICE appraisal. Overall survival data are given greater weight than progression-free survival in NICE appraisals, despite the fact that the outcome is the same—a longer, more enriched life.

We are seeing effective treatment after effective treatment being rejected or facing rejection by NICE. I want to know this: is it really right that we have a health service that plans to take away those lifelines? How is the decision to take away these life-extending drugs beneficial for people living with cancer, or for any of us who might one day need access to them? Who makes these decisions, and how can we be sure that they are the right ones?

We have a drug appraisal process, which is certainly valuable and necessary, but I question the factors that constitute that process. It is too easy to assume that the experts must automatically be right. The process is: numbers in, formula used, and then a yes or no answer. Let us not forget that we are talking about people’s lives. The lives of those affected and those for whom this decision is all too real are in the hands of a formula—the NICE appraisal process—and yet this life-changing formula has had little examination for many years. How many of us actually understand what factors are taken into account in these life-or-death decisions? The drug Palbociclib is proving so effective that, at present, it only has data on how long people are living without their breast cancer progressing.

[Julie Elliott (Sunderland Central) (Lab)]

Does my hon. Friend agree that the fact that that drug is routinely available in France, Germany, Austria and Canada shows that our appraisal system is not working in this country.

[Siobhain McDonagh]

I agree with my hon. Friend. It is amazing to think that, for this particular drug, it will take longer to get overall survival data because people are living longer without their cancer spreading. That obvious success is seen as a big disadvantage in the NICE appraisal system. The cost of Palbociclib will appear to be much higher in the NICE formula because overall survival data are given much more weight than progression-free survival. That seems illogical to me.

Consider also the criteria for determining end-of-life treatment. If a treatment is end-of-life, it is allowed double the quality-adjusted life year costings of other drugs. End-of-life is considered to be two years, but why not three? How have we ended up with such an arbitrary, fixed figure, especially when the figure in Scotland is three years? There is no cure for secondary breast cancer, but as people start to live longer it will place them at a disadvantage when accessing treatments, because it will be harder for those treatments to become approved, as they are no longer considered under the end-of-life criteria.

Therefore, how can the Minister be sure that the NICE process is still fit for purpose? Will she respond specifically on two suggestions: first, to review the weighting for progression-free survival when overall survival is not available because a treatment is so effective; and secondly, to change the criteria for end-of-life treatment to three years’ survival instead of two?

I want to return to the issue of off-patent treatments. In recent years there have been two private Members’ Bills on the topic, one of which was introduced by my hon. Friend the Member for Torfaen (Nick Thomas-Symonds). We heard many commitments from the then Minister for Life Sciences, but we have not yet seen any improvement in access, which is hugely disappointing. The Minister committed to establishing a working group to investigate what could be done to enable the routine use of such treatments. I believe that the working group is due to conclude its work next month and publish its report. Will the report introduce a clear pathway for off-patent treatments, and will the Minister write to me with the details of the pathway and state explicitly how it will work for bisphosphonate drugs for the prevention of secondary breast cancer?

Breast Cancer Now and others have been disappointed by the extremely patchy availability of this treatment for eligible women. As a result, it recently launched the “43p a day” campaign to highlight the low cost of the treatment and the fact that it would save over 1,000 lives every year in the UK if it was routinely available, not to mention millions of pounds for the NHS.

[Chris Philp (Croydon South) (Con)]

I congratulate the hon. Lady on securing the debate. I want to put on the record my support for the case she is making and draw the House’s attention to the case of my constituent Bonnie Fox—she is in the Gallery today—who is suffering in the way the hon. Lady has described, and whose life chances would be greatly improved if something more could be done to preserve the availability of Kadcyla. I once again express my support for the case the hon. Lady is so eloquently making.

[Siobhain McDonagh]

I thank the hon. Gentleman. He is very lucky to have a constituent as exceptional as Bonnie Fox, who has already been mentioned because of all her work.

As a result of Breast Cancer Now’s campaign, the Minister has said that clinical commissioning groups are responsible for commissioning the treatment for bisphosphonates. What contact has been made with CCGs on the use of this treatment in these circumstances? As I understand it, the treatment presents a challenge to existing commissioning arrangements because it does not fit squarely into either specialised services, which are commissioned by NHS England, or local commissioning by CCGs. Does the Minister agree that if we want genuine progress on the availability of this treatment, we cannot take the path of least resistance and just say, “It’s up to CCGs; CCGs are independent bodies and can make their own decisions.” That is the “do nothing” option.

Treatments do not always fit into the neat categories that we create. This is an old treatment that requires a new approach. It requires our commissioning strategists at NHS England to make a considered decision about how to commission the treatment routinely. Will the Minister agree to meet Ian Dodge, the national director for commissioning strategy, to discuss this specific case with him and will she keep Members here today updated on those discussions? Will she also agree that it is indeed worrying that a treatment that could prevent over 1,000 women getting secondary breast cancer every year is not routinely available?

Finally—I think that everybody will be delighted that I am about to finish—I hope that the Minister will consider meeting some of the women affected by the decision on Kadcyla and the women from Breast Cancer Now who are here today. I would like to thank those women in the Public Gallery for coming here to show their support for this debate en masse. I wish every single one of them well. Access to life-enhancing and life-saving drugs should be a right in the UK, not a decision based on a lottery of access to private healthcare. I sincerely hope that NICE will reverse its decision and give every woman with secondary breast cancer their future back.

--- Later in debate ---

[Siobhain McDonagh]

I thank all the Members who contributed to this debate and thank the Minister for her detailed response. Most importantly, I thank the women in the Public Gallery for coming here en masse to show their support for this debate. I wish every single one of them well, and I hope that they will join me for tea afterwards. Perhaps unconventionally, I also invite any hon. or right hon. Members here to join me and those women for tea to thank them for their campaigning efforts and to understand more about their case. I expressly invite Suzanne from the office of my hon. Friend the Member for Wythenshawe and Sale East (Mike Kane)—there is a cake in the Pugin Room with her name on it. Happy birthday, Suzanne.

Question put and agreed to.

Resolved,

That this House notes the provisional decision not to provide the breast cancer drug Kadcyla for use in the NHS on 29 December 2016; and calls on the National Institute for Health and Care Excellence (NICE) and pharmaceutical company Roche to come together and re-assess this decision to ensure Kadcyla is kept available for patients, and consider how access to both innovative new breast cancer drugs and off-patent drugs used for breast cancer, such as bisphosphonates, can be improved.

National Health Service Funding

Siobhain McDonagh Excerpts

Tuesday 22nd November 2016 Commons Chamber

[Siobhain McDonagh (Mitcham and Morden) (Lab)]

The “South West London Five Year Forward Plan”, published last week, states its intention to save a staggering £828 million by 2020—a contribution to the attempted national saving of £22 billion by 2020. However, that draft sustainability and transformation plan, published by the south-west London partnership, does not shed much light on how it will actually be managed other than by reducing A&E attendance by 40% in three years. That is a totally implausible aim that has not been achieved by any health system in the world—let alone one so strapped for cash.

That unsustainable ambition brings us to the long-standing proposal, which has so often been denied, to reduce the number of acute hospitals in south-west London from five to four or even—God help us—three. The five acute hospitals are St George’s, Croydon, Kingston, Epsom and St Helier, whose closure I have been fighting for 18 years. Of those five acute hospitals, St George’s will rightly be protected from closure. It is also clear that Croydon university hospital or Kingston hospital are unlikely to close, which leaves just St Helier and Epsom, both of which have been under threat before. No amount of vaguely-worded statements from the partnership will change the fact that the intention is to close St Helier. The STP clearly states that the partnership needs to

“Review our acute hospitals to ensure that we meet the changing demands of our populations, and to ensure that acute providers deliver high quality, efficient care… we will need four acute hospital sites in south west London”.

It continues by stating that the partnership will

“undertake further work, including analysis of revenue implications on 3, 4 and 5 site options”.

Not only will one acute site definitely close, but commissioners are considering the closure of two sites. We know from the STP’s former iteration in 2011, the Better Services Better Values programme, that the closure of St Helier was the main recommendation. Despite that, however, colleagues on the Government Benches, including the hon. Members for Wimbledon (Stephen Hammond) and for Twickenham (Dr Mathias), have been taken in by the STP, peddling the myth that no hospitals will close.

When is a closure a closure? If A&E and maternity services, and all the associated diagnostic and other services, are removed, that is precisely a closure. I want to make it clear to the House, the Government, the partnership and, most importantly, my constituents that we have come together as a community before to fight the closure of St Helier hospital and will do it again. We will do that not only for those who use St Helier, but for those who use every hospital in south-west London. The closure of St Helier would mean the undermining of all those other hospitals.

IVF: Welfare of Women

Siobhain McDonagh Excerpts

Wednesday 20th January 2016 Westminster Hall

[Siobhain McDonagh (Mitcham and Morden) (Lab)]

I beg to move,

That this House has considered the welfare of women undergoing IVF treatment.

I want to draw attention to the Human Fertilisation and Embryology Act 1990, which is also known as the HFE Act. It contains worrying failures that are endangering women’s lives and long-term health. As a result of the failures, it is time for Parliament to take action to protect the welfare of women undergoing IVF treatment. IVF is a huge industry, estimated to be worth some £500 million, with most treatment taking place in the private sector.

The Human Fertilisation and Embryology Authority code of practice, which follows from the 26-year-old HFE Act, rightly requires clinics to take into account the welfare of the child before providing IVF treatment, but the HFEA’s narrow interpretation means that women’s welfare is not considered. IVF treatment works by stimulating the ovaries of a woman to grow multiple follicles through the use of a drug identical to the natural stimulating hormone called follicle stimulating hormone or FSH. In turn, the growth of such follicles causes a rise in oestrogen in a woman’s bloodstream.

However, if levels become too high, there can be a profound and adverse effect on a woman’s health. Indeed, extensive research has shown that the high stimulation given to women during IVF can significantly compromise their health. The most common adverse effect following the use of such hormones during IVF is ovarian hyperstimulation syndrome or OHSS, which can be mild, moderate or severe. Mild OHSS can occur in up to 33% of IVF cycles, while 3% to 8% of IVF cycles are complicated by moderate to severe OHSS. Women with severe OHSS are hospitalised, some in intensive care, needing intravenous infusions and drugs to save their lives. In its most severe form, OHSS can be fatal and women have died in the UK as a result of the complication.

[Joan Ryan (Enfield North) (Lab)]

Given the serious health risks that can arise from women being treated with too much hormone medication during IVF, does my hon. Friend agree that the HFEA must collect and publish information on the type and amount of drugs given to women so that they can make a more informed choice about the treatment they may receive?

[Siobhain McDonagh]

I wholeheartedly agree with my right hon. Friend and hope to expand on that point in my speech.

[John Howell (Henley) (Con)]

I thought I would get an intervention in while the hon. Lady was in the mood for taking them. I appreciate that she is talking about women who are going through IVF, but has she considered the health effects on women who want IVF but are prevented from doing so due to their age?

[Siobhain McDonagh]

I have no comments in my speech that address the hon. Gentleman’s concerns about age and effectiveness. I mostly want to ask the Minister, and through her the Department of Health, to consider how figures are recorded, what the practice is and how we can improve on what is now a 26-year-old Act.

It goes without saying that OHSS has a huge emotional cost to women and a huge financial cost to the NHS, but it is preventable. It is widely known that there are modern OHSS-free protocols that can entirely prevent the syndrome from manifesting, but they are underused. In a 2011 article in The BMJ, authors Bewley and Braude reported on women’s deaths as a result of the complications around IVF treatment. The article states:

“The last Confidential Enquiry into Maternal Death recorded four deaths directly related to IVF via ovarian hyperstimulation syndrome and three deaths related to multiple pregnancy after IVF. Thus, more deaths were related to ovarian hyperstimulation syndrome than to abortion…despite many fewer procedures (for example, 48,829 IVF cycles v 198,500 abortions were performed in the UK in 2007). IVF associated maternal deaths may be underestimates, because record linkage is not allowed by the Human Fertilisation and Embryology Act”.

The article worryingly concludes that:

“infertility treatment now poses a higher risk for maternal death.”

Despite the potentially fatal risks to the health of women going through IVF, there is little accurate or complete information regarding the incidence of OHSS. Instead, the HFEA records it only via a flawed self-reporting system. In practice, that means that clinics must indicate when a patient has been admitted to hospital with severe OHSS when it is entirely induced by their IVF treatment, but that system of self-reporting is inadequate, for obvious reasons. The HFEA’s own data suggest that there is gross under-reporting of the condition.

We know that the number of eggs collected is a predictor of OHSS. The collection of more than fifteen eggs significantly increases the risk of OHSS, without improving the live birth rate. Bearing that in mind, over the first half of 2013, there were over 1,700 IVF cycles in which more than 20 eggs were collected—cycles that therefore posed an increased risk of OHSS. Yet, that same year, only 46 cases of severe OHSS were reported. Between 2010 and 2012, only 60 cases of severe OHSS and 150 cases of moderate OHSS were reported. During the same period, however, there were more than 3,000 IVF cycles in which more than 20 eggs were collected per cycle. Those examples demonstrate the worrying, and dangerous, trend of under-reporting. We also know that the stimulation dose given in IVF is negatively correlated to live birth. In other words, the higher the stimulation, the lower the rate of live births. Research has also shown that a high number of eggs collected increases rates of prematurity and low birth weight in babies. The risks are clear when considering how many cycles feature high stimulation and high numbers of eggs collected.

The HFEA database demonstrates that, between 2008 and 2013, more than 20 eggs were collected per egg collection procedure in more than 18,000 IVF cycles, more than 30 eggs were collected in 2,285 IVF cycles, and more than 40 eggs were collected in 313 IVF cycles. It cannot be stressed enough that those figures show a very worrying trend in IVF treatment in the UK, potentially placing women in real, and avoidable, danger. The evidence also demonstrates the pressing need for a change in legislation and for reliable data to be collected by an empowered regulator.

Furthermore, research from last year has observed an increased risk of ovarian cancer among women undergoing IVF in the UK compared with national averages. That was based on the HFEA database of more than a quarter of a million women who have received IVF treatment between 1991 and 2010. Similarly, a large Dutch study from 2011 of 20,000 women who had received IVF treatment concluded that ovarian stimulation for IVF may increase the risk of ovarian malignancies, especially borderline tumours. The link between ovarian cancer and IVF treatment, as well as the many health risks I have outlined, so obviously justifies the collection of reliable data by the HFEA.

As if the risks were not enough, several clinics are using a cocktail of drugs off-label in a manner for which they were not intended. It is most common in the use of drugs and intravenous infusions during IVF treatment and pregnancy that affect a woman’s immune system. However, they are often used without any supporting scientific evidence, posing significant risks to women. Both the Royal College of Obstetricians and Gynaecologists and the US Food and Drug Administration have issued warnings about the use of drugs off-label. The HFEA, while stating on its website that there is no evidence to support such practice, has admitted that it has no powers to stop it from happening despite being aware of the considerable potential harm posed to women. That clearly needs to change.

Despite the potential threat to women’s safety, the HFEA states that it does not have the statutory authority to take action in the so-called areas of clinical judgment and drug administration. Indeed, in relation to the HFEA’s limited response on the incidence of OHSS, the Minister stated the following:

“They have no express powers concerning the administration of drugs, which is a matter of clinical judgment. Although the HFEA does not collect data about the overall incidence of OHSS, clinics are asked to report when a cycle has been abandoned because of risk of OHSS. Severe OHSS is treated as an incident and depending on the nature of incident and the patient outcome, the HFEA will either expect an incident report or conduct an incident review itself”.

Given the severity of the risk to women that I have outlined, however, that response is clearly inadequate.

Considering the evidence, the absence of comprehensive data collection seems to be the result of a bizarre regulatory remit. That limited remit seems to see the safety of women as secondary. The McCracken review into the HFEA, the recommendations of which were entirely accepted by the Government, argued that the balance of HFEA activities was unacceptable. Recommendation 10 stated:

“The HFEA should conduct a review of the balance of its regulatory focus to ensure that it reflects the relative risks of the different activities that it oversees. Its approach should reflect the relative maturity of the sector it regulates…the need to ensure appropriate oversight of technical developments in the field of ART”—

assisted reproductive technology—

“the need to ensure that appropriate standards of practice are implemented consistently throughout the sector, and the continuing need for a high degree of public assurance regarding the sensitive activities that it oversees. This should not lead to any overall increase in regulatory activity or cost, but a rebalancing of activity.”

Further, as part of the preface to the recommendation, McCracken stated:

“Similarly where there are well known side effects of ART techniques, such as…OHSS…the HFEA should make sure that appropriate standards in managing them are being adopted across the sector...It is worth noting here that the work that the HFEA led in reducing multiple births, the ‘One at a Time’ project, is universally praised and may provide a model for addressing some of these other topics.”

To reiterate, the report states that reviewing the HFEA remit should not lead to an increase in regulatory activity or cost, but simply a rebalancing of its activity. However, the HFEA has not taken any specific action on OHSS or on the other interventions so desperately needed. That is why we need Parliament to act.

What can be done? I have a number of recommendations that I hope the Minister will be able to implement to address the risk to women’s health. First, an explicit commitment to the protection of the welfare of women urgently needs to be added to the Human Fertilisation and Embryology Act 1990 in order to give powers to the HFEA to regulate and monitor drug administration to safeguard the short and long-term health and welfare of women undergoing IVF.

Secondly, the HFEA must immediately start collecting information about all drugs, dosages—whether daily or cumulative—and off-label drugs administered to women during IVF treatment and pregnancy. The HFEA already collects extensive data about embryos, including the use of consumables or culture medium. In other words, what is administered to eggs, sperm and embryos is regarded as of primary importance, but what is administered to women is deemed to be of limited importance. We urgently need to redress that imbalance. Adequate information is desperately needed to gauge the adverse effects of the drugs on gametes and embryos, and to assess their threat to women’s health. Those data are already collected in the USA, Australia and across Europe. It is about time the UK followed suit.

Thirdly, the HFEA should introduce a campaign and licence condition expressly focused on reducing the incidence of OHSS, which can be fatal. That could be modelled on the HFEA’s successful multiple births minimisation strategy.

Finally, the HFE Act should be amended to link the HFEA registry with the hospital, cancer and death registries. That would allow accurate recording and publication of the links between IVF treatment and incidence of severe OHSS, cancer and mortality among women. The HFE Act has typically used patient confidentiality as a reason to have a hands-off approach to collecting important information. Links between IVF treatment and such incidences, however, have already been established in other developed nations by using such data. I am sure the Minister will agree that the more we understand such links, the more we can do to prevent unnecessary harm to women.

We urgently need a regulatory body that has the powers to monitor drug administration during IVF treatment, and to take action where needed to protect the welfare of women. We need to have adequate information to assess the safety of fertility treatments. Indeed, it seems absurd to have a regulator that is dedicated to licensing and monitoring clinics that carry out IVF, but that is unable to take action because it lacks statutory authority.

According to the McCracken report, such changes can be cost-neutral, and the HFEA has already achieved success in other areas. By including the welfare-of-women protection in the HFE Act, alongside the “welfare of any child”, we can finally act on the issue. By doing so, Government can oversee the collection of information about drugs administered to women during IVF treatment and pregnancy. What I am calling for is not unusual elsewhere in the world, and such systems of data collection are prevalent in so many developed countries. Changing the Act will also enable the HFEA to implement fully the recommendations of the McCracken report, in particular that

“appropriate standards in managing…are…adopted across the sector.”

That should include the use of modern OHSS-free protocols that prevent the incidence of potentially fatal OHSS.

Patients undergoing IVF treatment are often vulnerable, forced into paying for treatment themselves, and they desperately need someone to protect them. As more and more people use IVF treatment, the issue is no longer one for only a minority. It is time to give the safety of women the recognition that it desperately deserves in the Act. Let us not sit back and allow another woman to suffer or die unnecessarily during IVF treatment.

In the HFEA, we have a body dedicated to regulating IVF. Let us give it the tools to fulfil its duty. Twenty-six years since its creation, it is time to maintain what is good about the HFE Act and to reform what is inadequate. I hope the Minister will recognise the opportunity for the Government to pioneer a new chapter in the young history of IVF treatment.

Sight Tests in Special Schools

Siobhain McDonagh Excerpts

Tuesday 3rd November 2015 Westminster Hall

[Siobhain McDonagh (Mitcham and Morden) (Lab)]

I beg to move,

That this House has considered the provision of sight tests in special schools.

Every child has the right to a free NHS sight test. It is vital that all children have their sight assessed regularly and early on, as undetected problems can lead to deterioration or even permanent loss of vision. For a child with learning disabilities, it is an even more pressing issue. A relatively small number of students attend special schools, but they are the most in need when it comes to eye care. Those children also have a right to free eye tests, but often experience serious obstacles to getting the eye care they need. In fact, children with learning disabilities are 28 times more likely to have serious sight problems, and about half the children in special schools need glasses, but about 40% of children with learning disabilities have no history of sight tests. Many have to go to hospitals for specialist eye examinations, meaning more medical appointments and more time out of school. Those appointments are also more expensive than routine eye checks and, for those not under the care of a hospital, attending a high street optician can bring a whole new set of challenges.

In the very worst cases, children with learning difficulties who cannot access the eye care they need can eventually suffer from ultimately preventable sight loss. They are unable to make the most of their vision and are losing out, when a good pair of glasses could radically improve the quality of their lives. Therefore, I call on the Government, the NHS and the Department of Health to deliver eye examinations and dispense glasses to children in their special schools.

I draw the attention of hon. Members to the excellent work of the charity SeeAbility, which has worked extensively on this matter. The charity exists to support people with sight loss and multiple disabilities. Established in 1799 as the Royal School for the Blind, it now provides a range of services including residential care and supported living, and speech, language and rehabilitation services. Since 2005, it has run projects to address the health inequalities faced by adults and children with learning disabilities. Indeed, its “Children in Focus” campaign has attracted thousands of petition signatories and support from well-respected, professional bodies including the College of Optometrists, the Faculty of Public Health, and the National Association for Special Educational Needs. SeeAbility’s work is vital for so many reasons—most significantly because those children, who are most likely to suffer from the most serious sight problems, face the greatest challenge in accessing eye care.

Although the recommended guidelines for all children to be vision-screened at the school entry age of four to five need to be followed, the issue is significantly more pressing for children with special needs. When a child has a severe or profound disability, or multiple disabilities, they might not realise that they have a sight problem. They might not be able to tell a carer or a parent about it, or their sight problems might be overshadowed by other, more obvious needs. All of that means that parents, teachers, GPs and others might not realise that there is a problem.

SeeAbility has piloted an excellent project to offer sight tests for children in six special schools in London. It has used its own charitable funds and specially trained optometrists and orthoptists to visit those schools, including Perseid school in my constituency of Mitcham and Morden, to test sight and dispense glasses. Children, parents and teachers are all seeing the benefit of that work. Perseid school is a community special educational needs school that is rated as “outstanding” by Ofsted. It offers an exceptional, supportive atmosphere for children aged three to 19 who have severe and complex learning difficulties, including learners with an additional diagnosis of autism, or physical or sensory disabilities.

SeeAbility went to Perseid school with its proposal in May 2013, after consulting the eye clinic at Epsom and St Helier NHS Trust. One of the aims was to pilot the provision of eye examinations in the school for those who the clinic felt it was not necessary to see in hospital. It was after I visited the project at Perseid lower school in September 2015 that I felt compelled to table this debate. The visit was eye-opening in so many ways. I discovered just how much eye health and vision information a skilled optometrist can get from a child who may not be able to respond verbally, or to read. It was a real education to see the techniques that Marek, the SeeAbility optometrist I met, used to judge whether a child needs a pair of glasses or whether their vision is in more serious need of treatment. He was absolutely fantastic with the children.

I also met a super little girl, named Ellie, and her mum, Alyson. In so many ways Ellie is just like any other nine-year-old girl. She is active and sociable, loves music and chocolate, and her favourite colour is pink. Ellie was one of the first appointments of the day. She cannot speak and relies on her eyes to communicate by using eye gaze technology. Because of her condition, she has been attending hospital eye clinic appointments to ensure her sight is regularly checked. Her vision is her primary means of communication, but it is vulnerable to deterioration, making check-ups absolutely crucial.

Ellie gets very stressed having to go to the hospital for her sight checks. Taking time out of the school routine, and having the pressure to arrange it alongside her many other medical appointments is a logistical nightmare. She also uses a wheelchair and is now tube-fed, which add to the practical barriers she faces to access the eye care she needs. I heard from Ellie’s mum, Alyson, who said that SeeAbility’s work at the school has removed all that stress, and she has the comfort of knowing that Ellie is getting good eye care in school. Ellie can get her eyes tested, and glasses dispensed and fitted at school by SeeAbility, in a much more familiar, comfortable and convenient environment.

After I met Ellie, a little boy who is autistic came in for his eye test. He is nine years old and suffered sight loss in one eye in early childhood. Despite very little co-operation from the boy—who spent most of the time walking around the room—Marek, the specialist optometrist, was able to assess that his one good eye was focusing well and that he did not need glasses.

It is clear that it would be very difficult indeed for a standard community optometrist to assess the sight of children with special needs, such as the children I saw. Community optometrists rarely see a child with profound disabilities and may not command the necessary experience and skills, or have access to the specialist equipment that is so important. Furthermore, a child may become distressed in an unfamiliar dark room with lots of lights and menacing-looking equipment. In stark contrast, SeeAbility’s regular visits to Perseid school provide the children with the safe environment they need to have their eye sight assessed. The team can introduce themselves and become familiar with children in the weeks preceding an appointment and during regular visits. Furthermore, a child can have parts of their sight test on different days, if necessary, in the event that they need more time to become familiar with the process. It is even possible, if a child is very anxious, to complete tests in the classroom or in a sensory room, where they often feel more comfortable.

Testing vision in the schools is not only more familiar and reassuring to the children. It also reveals so much to the teaching staff and parents about how the children see, which can really maximise the potential of children with special educational needs. The project is now well embedded in Perseid school and the visits fit in well with the school’s day. The school’s fabulous headteacher, Tina Harvey, said:

“It has been fantastic to work with SeeAbility and we fully support this initiative. Our pupils can’t necessarily tell us what they can or can’t see in the classroom and now we have that information. And parents aren’t having to worry about how to get their child to yet another medical appointment outside of school.”

As the Minister’s portfolio includes eye care, I sincerely hope that he accepts SeeAbility’s recent invitation to visit one of the special schools that it is working in and to discuss the detail of its proposals, as I have done. I assure him that such a visit would be a greatly inspiring experience.

The work at Perseid school strengthens the case for national reform of eye care for children with learning disabilities. Having provided 600 eye tests, SeeAbility’s pilot, with the help of Cardiff University’s school of optometry and vision sciences, provides the most comprehensive study of eyesight in children at special schools in England. The sight of vulnerable children is being failed again and again. The early vision screening programme should be available to all young children when they first start school, but present provision is subject to a postcode lottery.

Furthermore, suggesting the use of hospital examinations as an alternative for children with learning difficulties is not good enough. Hospital appointments mean more medical appointments, more potentially distressing locations and more expense for the NHS. For instance, the average reference cost of a paediatric ophthalmic appointment is £115, and SeeAbility has found that 75% of children who have been discharged from a hospital eye clinic have had no follow-up sight tests in the community, leaving those children lost to the system. The compromise is unacceptable. If children go without sight tests, the tragedy is that they can suffer unnecessary sight loss and live their lives with poor vision just for want of a decent pair of glasses.

Hon. Members may be surprised that the appropriate checks are not already happening in schools. A few health bodies fund local NHS services similar to the one provided by SeeAbility, but the vast majority do not, which means that appropriate care for such children is limited. I am sure the Minister will agree that it is not acceptable for those children, who are so much more likely to have serious sight problems, to be reaching their teenage years having never had a sight test or the opportunity to see clearly. We need a more preventive and beneficial method, and we need to commission a new national programme of eye examinations and direct dispensing of glasses for children and young people in special schools.

The Minister may highlight that it is for NHS England to decide its priorities on eye care commissioning. To their credit, NHS England officials have been engaged in SeeAbility’s work. However, the Department of Health plays a crucial role in shaping legislation and establishing a payment regime for sight tests. The Department does the latter under the general ophthalmic services—GOS—contract, but the associated contract fee rates for sight testing are compounding the inequalities in eye care that I have described, which does not sit well with the fact that addressing the health inequalities of people with learning disabilities is a shared priority for both the Government and NHS England. Indeed, it sits well within the Health Secretary’s legal remit.

In August 2015, SeeAbility was awarded a GOS contract to run NHS sight tests in the special schools in which it works, but the contract provides only a £21.31 payment per sight test. That is the amount paid for a routine test in a high street optician, but SeeAbility estimates the actual cost of its tests to be some £85, which means that the charity is having to fundraise to keep this important project going. The GOS contract provides only a quarter of the actual cost of delivering eye examinations for children with learning disabilities.

As I have described, the sight tests provided by SeeAbility and others are specially adapted to the needs of children with learning disabilities and require specialist expertise and equipment. Furthermore, skilled orthoptists who can assess unusual and uncommon abnormalities of eye movement, and specialist dispensing opticians who are experienced in fitting glasses for children with special facial characteristics, are often needed. Can we truly accept such an inadequate fee that represents only a quarter of the overall cost of providing such adapted tests? The overall costs include the cost of what is often a longer, specially adapted test and any repeat visits to a child in a special school.

The current status quo ill-advisedly applies a one-size-fits-all approach to a complex issue. The needs of children with learning disabilities are varied and often unique, and such children need eye care provision that reflects that. We all know there are funding pressures on our health and social care systems, but the eyesight of children with learning difficulties is not a sacrifice that should be made.

In a few instances, there is already some recognition that those adjusted and specialist sight tests need proper funding. That extra, local support sometimes comes from local commissioners paying optometrists an additional £60 towards supporting someone with a learning disability to get a sight test. Although that is a good step forward, it occurs in only a handful of areas. Furthermore, the Department of Health has set enhanced fee rates for disabled adults to receive a sight test at home if they cannot leave the house unaccompanied. Clearly, some officials already recognise that specially adapted tests cost more. I sincerely hope that the Minister will acknowledge that his Department has set an NHS payment of £21.31 that does not cover the cost of those tests.

I hope the Minister will agree to open a consultation, as is happening in Wales, on how to cover the shortfall between GOS contract payments and the cost of providing such a specialist service. The provision of a reliable long-term alternative is essential. The relatively small number of children in special schools should mean that a fully funded NHS programme to address their needs is wholly realistic. Indeed, the quality of vision, and quality of life, of those 100,000 children should not be left to a postcode lottery in our 209 clinical commissioning groups.

Children with learning disabilities need a one-stop shop for the input of optometrists, orthoptists and dispensing opticians, as needed, with glasses provided on site, breakages repaired quickly and good links to hospital eye clinics if necessary. In turn, a fully comprehensive and tailored system would help to reduce NHS costs from unnecessary hospital visits. The programme should also be wholeheartedly supported by the Department for Education, which purports to help children with special needs to achieve their full potential. Let us be clear that the target will not be met if children are not provided with the best possible eye care.

SeeAbility and I eagerly await the Minister’s indication of support for a nationally funded programme of sight tests in special schools and a commitment to meet us to discuss those plans further. I urge all hon. Members to consider signing early-day motion 629, which supports the provision of such sight tests. The eyesight of children with special needs has been let down for too long. We look forward to this vital issue being treated with the seriousness it truly deserves.