Breast Cancer Drugs

Nick Thomas-Symonds Excerpts

Thursday 26th January 2017 Commons Chamber

[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.”

--- Later in debate ---

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

I begin by thanking the Backbench Business Committee for selecting this very important topic for debate this afternoon. I pay tribute to my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) for the passionate but very thoughtful way in which she introduced the debate. I endorse everything that she said. On the drug Kadcyla, she said, quite pithily, that, first, it works and, secondly, it has far fewer side effects than many other cancer drugs. I was also very proud to have backed the “43p a day” campaign that she mentioned.

I declare an interest as the chair of the all-party group on off-patent drugs and should also say that one of my first actions as a Member of this House in 2015 was to become a breast cancer ambassador. I was very proud to do that, as the person who inspired me to come into politics, my grandmother, died of the disease some years ago.

I was lucky enough in my early months in this House to be drawn in the ballot for a private Member’s Bill. I introduced the Off-patent Drugs Bill, and although it was talked out in quite controversial circumstances on 6 November 2015, I was none the less pleased after that to work on a cross-party basis to achieve legislative progress. I pay tribute to the hon. Members for Central Ayrshire (Dr Whitford), for Bury St Edmunds (Jo Churchill) and for Daventry (Chris Heaton-Harris), and to the former Minister for Life Sciences, the hon. Member for Mid Norfolk (George Freeman), for the work that was done in those months to make legislative changes which were incorporated in the Access to Medical Treatments (Innovation) Bill, which received Royal Assent in March last year.

I want to come to the pledges that were made on 29 January 2016 and how things have moved forward since. I say to the Minister that in setting out a number of questions about this matter, I do not necessarily expect them all to be answered in detail in her closing remarks. If there are aspects that she feels she cannot answer in detail, I would be grateful if she wrote to me about them after the debate.

On 29 January 2016, I and others in the House tabled a package of amendments to the Access to Medical Treatments (Innovation) Bill. Some were substantial and went into the Bill. Others were probing amendments designed to extract the promises that I have talked about. The then Minister for Life Sciences said:

“Broadly, the intention of the package of amendments is to introduce off-label repurposed medicines in the Bill, and to put it four square at the heart of the agenda.”

That is precisely what we sought to do that day. He added:

“I wholeheartedly supported the intention of his Bill and its predecessor, but not the mechanism. We now have a mechanism that will work”—

we had spoken that day about the mechanism.

One of the amendments requested an action plan, but the Minister decided he did not want that on the face of the Bill. However, he said:

“let me set out my commitment and that of the Government to pursuing this agenda with time and rigour.” —[Official Report, 29 January 2016; Vol. 605, c. 543.]

[Dr Huq]

I remember very well my hon. Friend’s Bill and the shameful way it was talked out by the professional filibusterers on the Government Benches. However, does he not agree that any action plan needs to look at these things in the round? It should look at the poor post-diagnosis support and information that patients get across other types of cancer, not just breast cancer. It should also look at the limited availability of the effective drugs we have talked about, which do not have side effects, and at the fact that drugs have been de-listed from the Cancer Drugs Fund.

[Nick Thomas-Symonds]

I certainly agree that the pathway has to be comprehensive, and I will come back to it in a moment.

In addition that day, the then Minister for Life Sciences said he would

“explore mechanisms for ensuring NICE can look at evidence and develop evidence-based guidance on off-label medicines, so that doctors are aware of which drugs are being used in an off-label indication…NICE is now looking at ways to collect evidence on repurposed medicines.”

He spoke about the “British National Formulary”, and I am pleased about the progress that has been made on it, which I will come back to in a moment.

We proposed—this would have applied to NHS England—that there should be a new system of national commissioning for repurposed drugs. Again, our amendment was not accepted, but this pledge was given:

“The NHS is hungry to look at all options for promoting off-label and repurposed drug use.” —[Official Report, 29 January 2016; Vol. 605, c. 544-45.]

I hope that that pledge can be repeated by the Minister at the Dispatch Box today. There was also a commitment to consult all relevant stakeholders. Again, I would hope that that is fairly uncontroversial and can be repeated.

Let me come now to where we have got to. When I intervened on my hon. Friend the Member for Mitcham and Morden, I quoted the worrying statistic about bisphosphonates, which really do provide a case in point. They are used to treat osteoporosis, but they are very effective in their secondary form—the repurposed form—where someone has primary breast cancer, and they certainly help to prevent that from spreading to the bone. The statistic that only 24% of clinicians are prescribing bisphosphonates is very worrying, and it does need to be addressed, because there should be no barrier in the system to their being far more widely prescribed than they are.

Let me come to the working group. I understand that it will conclude at the end of next month. I am very grateful for the fact that I will be meeting officials from the Pharmacy and Medicines Directorate in the next few weeks to discuss this issue. However, if there is to be a pathway, I would appreciate it if the Minister was prepared to share it with me in draft form before that meeting, so that comments could be made on it, particularly going back to the pledges made last year.

The “British National Formulary” has begun work. Indeed, I looked up bisphosphonates specifically on BNF Online before I came to the debate. What makes the 24% statistic even more worrying is that BNF Online says:

“The use of bisphosphonates in patients with metastatic breast cancer may reduce pain and prevent skeletal complications of bone metastases.”

That is there already—it is in the prescriber’s bible, if you like—so the Minister really should focus on why it is not filtering through the system in the way that it should.

In addition, there is a pilot licensing scheme that brings together medical research charities and generics manufacturers to license off-patent drugs for their new purposes. If the Minister could comment on whether she is looking for that to become a fully fledged scheme, that would be helpful.

The scheme is an interesting development, because my Bill, in its original form, would actually have put a duty on the Secretary of State for Health to seek licences for drugs in their new indications, and that was the bone of contention between me and the then Minister, who thought that it was too onerous for the Secretary of State to have that duty.

Looking back at that debate, I think the other interesting thing is that a point was made about the EU’s licensing scheme. It was said that any changes could run a coach and horses through that scheme, but given that we will not be members of the European Union by the end of this Parliament, I would be interested to hear how the Minister thinks the end of the Brexit process will affect this issue. If the European licensing scheme was seen by the Minister at the time as posing something of a problem, perhaps she can tell us if she will consider whether the pilot licensing scheme can now become fully fledged and how she sees things developing here in the UK without the European scheme.

I appreciate that I have put a lot of points to the Minister. As I said, I am perfectly happy for her to write to me about them. However, we should not forget the difference that this off-patent drugs agenda can make to people’s lives. Those who face this disease show incredible bravery. For example, we have my hon. Friend the Member for Bristol West (Thangam Debbonaire) in the Chamber with us, and Bonnie Fox, a constituent of the hon. Member for Croydon South (Chris Philp), is in the Public Gallery. We in this House, as legislators, owe a duty to all who suffer from this terrible disease to take all possible steps to make what are extraordinarily cheap drugs as readily available throughout our country as possible.

--- Later in debate ---

[Mike Kane (Wythenshawe and Sale East) (Lab)]

I congratulate my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh) on securing this debate. She made an extraordinarily powerful and emotive speech. I join her in wishing everybody who is here today in the Public Gallery and everybody who is watching this debate at home all the very best for the future. It is also a pleasure to follow the hon. Member for Milton Keynes South (Iain Stewart), who made a very powerful speech citing the personal testimony of his constituent, whose case he argued eloquently. My hon. Friend the Member for Torfaen (Nick Thomas-Symonds) spoke eloquently about his grandmother being his inspiration for going into politics, and her dying of the disease. We come into politics for many different reasons, the profession of public pain being one. Nye Bevan did not create the NHS in 1948; he created it much earlier when his father died of pneumoconiosis in his arms before the time of the NHS. I hope that I can pronounce the drugs that I am going to mention just as well as the hon. Member for Portsmouth South (Mrs Drummond) did.

We have heard lots of statistics today. Stats, in themselves, are shocking, and it is also important to remind ourselves that behind every statistic there is a human story. The lives of women, all too often young women and mothers, are being cut cruelly short. We have heard many important interventions about access to breast cancer drugs for treatment of secondary breast cancer. At the heart of the motion is also the issue of how we can improve access to innovative new breast cancer drugs and off-patent drugs used for breast cancer. The use of such drugs relates not only to the treatment of breast cancer but to its prevention. I am immensely proud of the fact that my constituency is home to the Nightingale centre— Europe’s first breast cancer prevention centre—and the charity Prevent Breast Cancer. I am a Mancunian MP, so my constituency also benefits from close proximity to the Christie hospital, the largest single-site cancer centre in Europe, treating more than 44,000 patients a year.

The Nightingale centre opened at University Hospital of South Manchester—Wythenshawe hospital—in July 2007. It offers state-of-the-art diagnostic and treatment services to women and men with breast cancer and co-ordinates the NHS breast screening programme for the entire Greater Manchester area. It also provides training facilities aimed at addressing the shortage of breast cancer specialists, and it houses many of the Prevent Breast Cancer researchers who are looking at ways to predict and prevent breast cancer.

In the Prevent Breast Cancer research unit, several drugs that are now out of patent are being repurposed for preventing cancer from coming back. Women with a family history or other factors that make them high risk are known to benefit from these drugs, which prevent the disease. But women in that position find it difficult to obtain these inexpensive, tried-and-tested drugs because they are currently not listed in the “British National Formulary” as specifically licensed for the new purpose of prevention, despite successful clinical trials. There are currently three drugs in that situation: Tamoxifen, Raloxifene and Anastrozole.

[Nick Thomas-Symonds]

Will my hon. Friend give way?

[Mike Kane]

I would be happy to give way, having got the names of those drugs right.

[Nick Thomas-Symonds]

I understand that a new policy is being put together by those in charge of the “British National Formulary”, which will set out how they will get more off-label drugs into the formulary. Does my hon. Friend agree that the sooner that policy is available for us to see the better?

[Mike Kane]

I congratulate my hon. Friend on doing so much work in this area since he came to Parliament. We can only hope that what he says is true; perhaps the Minister can give us more information on that point in her summing up.

The Prevent Breast Cancer research unit has more out-of-patent drugs under investigation for breast cancer prevention which may be even better for the future. As well as doing everything we can to extend the life of women with secondary breast cancer, we must do all we can to prevent breast cancer from occurring in the first place. As we all know, the adage is that prevention is better than cure. For those with secondary cancer, for whom cure is currently out of reach, many people will be striving to achieve that for the next generation.

At the moment, the system is standing in the way. A solution to make those drugs more widely available that would cost very little money indeed would be to ask NICE to list such drugs as approved for the new indication of prevention in the “British National Formulary”—following the evaluation of relevant clinical trials, of course—so that doctors can have confidence in prescribing them. The requirement to obtain a new Medicines and Healthcare Products Regulatory Agency licence for the new indication is expensive and impractical for repurposed medications, because they usually lack a sponsoring pharmaceutical company to champion the new use of the generic drug. I am sure the Minister would agree that such a small change would be transformative in the prevention of breast cancer. I hope that she will ask NICE to consider that change to the way in which drugs are listed in the “British National Formulary” to allow drugs that have been evaluated for a new purpose, such as prevention, to be listed as approved for that purpose.

When we lose someone prematurely to cancer, grief obviously follows. It has been my experience that when we lose someone to breast cancer, the grief is particularly poignant. Tonight, my thoughts and prayers will be with all my constituents who have either succumbed to the disease or are battling it, and with their families who carry the consequences. I lost my cousin Maura Kane to the disease, and my two friends Tom and Claire both lost their mothers to it. I stand in solidarity with my constituent and friend Sheila Higgins, who is battling this disease. She has been like a mother to me for the last two decades. Finally, my parliamentary assistant Suzanne Richards came back to work after Christmas with a clean bill of health. She was diagnosed with a virulent strain last year, but she had world-class treatment at the Wythenshawe and Christie hospitals. Today is her birthday, but it is a birthday that many of us feared she would never see—happy birthday, Suzanne.