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Genetic Medicine

Volume 564: debated on Thursday 13 June 2013

Motion made, and Question proposed, That this House do now adjourn.—(Karen Bradley.)

Thank you, Mr Deputy Speaker, for your patience—and that of the House—in waiting for me to raise this important subject at this time of the week. I also thank the Minister for her presence. I pay tribute to her long interest in this subject, her work at the Department of Health on cancer, screening and public health—she is a tolerant and fair-minded advocate of public health in the Members’ Tea Room—and her interest in the difficulties of the early onset of dementia. I was struck the other day by her moment at the Dispatch Box, when she was greeted with extraordinary affection in the House, which was a sign of the great respect and affection in which she is held and the respect for the work she does.

My interest in this debate comes from a family interest in cancer—an interest that I know is shared by many in the House and across the country. Few families have been untouched by the disease, which is increasingly understood to be a genetic disease. I lost my father and my mother-in-law to cancer, and, as the parent of two children, take a close interest in something that I might have inadvertently passed on to them. I also have an interest because I come to this House after a 15-year career in biomedical research and speak in my role as Government adviser on life sciences, taking a deep interest in how current breakthroughs are changing the assumptions on which we base public policy.

For the purposes of giving some background and declaring an interest, I want to explain what I did in those 15 years. I spent four years running a predictive toxicology business, which looked at drug compounds and analysed their likely toxicology and efficacy in different patient groups. I also spent six years in translational medicine, working with academic health science centres up and down England and Scotland, helping to set up the Scottish translational medicine research institute and working at University college London on the cardiovascular institute and at King’s Health Partners on dementia. I was delighted two years ago to be given the chance to support the Government as life sciences adviser. I stress that I have no ongoing commercial interest in the sector. For the purpose of clarity, I draw the House’s attention to my entry in the Register of Members’ Financial Interests. It details historical investments, including a very small shareholding in GlaxoSmithKline, which has been passed down through our family since my grandfather met the founder and decided that the then baby milk business might have a good future.

Indeed. The register also shows a very small shareholding in a women’s cancer diagnostics joint venture business that I helped to set up with Cancer Research UK and UCL Partners.

This is a topical debate. We have seen in the newspapers recently the news of Angelina Jolie’s decision to have a double mastectomy, having received a diagnosis of a high chance of developing breast cancer based on the most well-known and acknowledged genetic test, the BRCA mutation. The widespread coverage in the press of her decision has been helpful in raising public awareness, as have the powerful and moving descriptions of the thinking behind her decision and of her husband’s support for her.

Only yesterday in The Times we saw the news of the NHS cancer registration service launching a project to bring together all the available data on the 350,000 types of cancer across the 50-million-patient database in Britain. Over the past month, we have also seen the launch of Cancer Research UK’s contribution to the global alliance on sharing genomic and clinical data. Topically, there is also an ongoing battle in the American Supreme Court involving Myriad Genetics and the ownership of the BRCA gene.

I believe that the revolutions in translational medicine, in experimental medicine and in the personalisation of medicine are a huge force for good. They raise a number of important issues, some of which we might touch on in the debate. By way of illustration, I want to share with the House a couple of stories illustrating how I came to see that force for good in practice.

The first involves a project at King’s Health Partners in south London, led by Professor Simon Lovestone, who is a pioneer in clinical research into psychiatric disorders, particularly dementia. The project is funded by the National Institute for Health Research, and I congratulate the previous Government on putting in place that infrastructure, which we have developed and continued. Professor Lovestone and his team have developed a case register information system, which is a portal for data for the whole of the South London and Maudsley NHS mental health trust, involving 250,000 patients. It brings together all the information, anonymised and in large datasets, on medical records and clinical histories and on the often complex drug histories involved in treating mental health, along with MRI brain scans, to create a powerful database for the purpose of shedding light on the mechanisms of action and the clinical drivers of early-onset and late-onset examples of the disease.

The portal is now being used by researchers on campus for purely academic work, alongside researchers from industry who, quite fairly, pay substantial amounts of money to King’s Health Partners in order to use the facility. They often find themselves working alongside leading-edge researchers. As a result, King’s Health Partners has signed up to a number of collaborations with industry to work on some very expensive drug programmes. That is an example of how data can accelerate academic research and bring academic and industry researchers together in pursuit of a common cause.

The other company that I want to mention is the joint venture set up by UCL Partners called Abcodia. It is based around a database of 250,000 women who are at risk of gynaecological cancer. It was funded by Cancer Research UK and the Medical Research Council over 20 years, but at the end of the academic study, the database was sitting gathering dust. It is now being used as a powerful database to provide all sorts of screening and diagnostic molecular biomarker services, and is helping to identify the biomarkers that predict and are implicated in the onset of gynaecological cancer. It is also a powerful database for all the diseases of ageing in women, many of which are the same in men. It is a powerful tool for understanding the molecular biomarkers and the drivers for the early onset of a whole range of late-life diseases.

These databases are incredibly powerful, and across the NHS and across our university academic health science centres, they are being run under very high standards of ethical and regulatory regimes and with very strong patient consent. One lesson is that where clinician scientists work with patients to do basic and clinical research, patients and the research charities that work with them are hugely supportive of this revolution in genetics and computing.

More than 10 years ago we sequenced the human genome. It was a massive global collective effort, which took several decades and several hundred million pounds to achieve. It now costs about $1,000 to sequence the entire genome of one of us, and it takes no less than 24 hours—and those numbers are falling fast.

My hon. Friend is to be congratulated on the widely respected work he is doing as a Government life sciences adviser; he really is doing a fantastic job. I congratulate him, too, on securing this debate. I think he is aware of the campaign of my constituent, Les Halpin, to accelerate the use of drugs in the NHS in carefully controlled circumstances on a trial basis for people with terminal illnesses. With the sort of conditions my hon. Friend has been talking about, if we could change the protocol in the medical profession and harness our innovative bio-sciences sector, we could become a world leader in the development of new drugs.

My hon. Friend makes an excellent point, and I pay tribute to his advocacy, on behalf of his constituent Les Halpin, of the access to medicines campaign. We have plans to continue to help support it. My hon. Friend’s point is important, and the point that Les Halpin has made is that people like himself with a terminal disease actively want the opportunity to take part in trials and research so that their disease and suffering will not be in vain. My hon. Friend speaks powerfully on behalf of his constituent and on behalf of those with other diseases who share that view.

The truth is that this revolution of translational personal lives medicine is all about the end of the one-size-fits-all blockbuster model of drug discovery and development. The more we know about disease, the more we discover the genetic predispositions of disease and how different patients respond in different ways both to drugs and to the onset of disease. We discover that what was yesterday one cancer is today three or four and tomorrow will be 30 or 40. This is breaking down the size of markets and requiring a whole new model of research around patients. It puts patients right at the heart of the research process. That is challenging for hospitals and for companies, but ultimately, I believe—we are seeing the evidence—it is good for patients, leading to quicker innovation and quicker access to drugs. It is also good for our life sciences sector. It is a win-win, which is why the Government were right to describe the report on the subject as “health, wealth and innovation”. The three do indeed go together.

I would like to take this opportunity to congratulate the Minister and the Department on the work they are doing in pursuit of the life sciences strategy, particularly on the £100 million cancer genomics project. That provides an extraordinary opportunity for Britain to sequence the genomes of 100,000 patients and combine that information with the clinical data—one of the world’s most precious resources in our NHS—creating a global hub that would put Britain right at the forefront of unlocking this field of cancer genomics.

I pay tribute, too, to the work of the research charities, which do extraordinary work driving funding and research, but also in advocating some of the changes that need to be made. In the time available, I will not be able fully to go through all the information I have received, but the Minister and I may be able to pick up some of the points afterwards.

I do want to say that Cancer Research UK has done a huge amount of work in this field, setting out a very clear analysis of what it wants to see happening—support for NHS provision of genetic tests for inherited cancer risk, improving existing molecular diagnostic services for cancer and strong support for the 100,000-patient cancer genome project.

The Prostate Cancer UK charity—you will remember, Mr Deputy Speaker, the moustache that I sported in the autumn in support of the Movember campaign—has highlighted the fact that nearly 35,000 men are diagnosed with prostate cancer every year and that 215,000 of us are living with the disease. By 2030, it will be the most common cancer in the UK. One in eight men will get prostate cancer at some point in their lives. The genetics of prostate cancer is well behind that relating to other diseases and needs to be accelerated as it is not as well understood. However, recent developments in understanding the genetics of prostate cancer have been crucial to driving up survival rates and showing the potential for future improvements in treatment.

Breast Cancer UK is investing substantial sums in the study of genetics, and the Breast Cancer Campaign has already provided £10 million. It has highlighted the role of Angelina Jolie’s recent decision in drawing public attention to the importance of genetics in providing earlier diagnosis and better treatment.

The Alzheimer’s Society has raised some interesting points. In many respects, Alzheimer’s is the toughest of the blockbuster diseases for us to crack, and it is becoming increasingly apparent that it is one of those diseases that we will not crack through the magic discovery of some drug. What is needed to beat this disease is a completely new model: a massive collective effort by patients and researchers using data and online tools such as PsychologyOnline. The Alzheimer’s Society has said that genetic testing may cause difficulties in some cases. A genetic defect cannot be repaired, effective treatment to slow the disease is not yet available, and the society fears that some premature genetic testing may trigger inappropriate responses.

Genetic Alliance UK has set out a detailed response to the debate, and has issued some important calls. In particular, it has called for the explicit inclusion of genetic testing in NHS England service specifications for all services that may utilise genetic testing. It has also called for investment in research that will help to elucidate the findings of whole genome sequencing and exome sequencing for clinical use, so that the benefits of the technology will be available to patients as soon as possible; for recognition of the importance of clinical genetic services as a resource for single-gene conditions; and for the linking of the commissioning of companion diagnostics with the stratified medicines for which they indicate patient response.

I have referred elsewhere to an Arab spring of health care. I believe that the current revolution—the stratification, targeting and, ultimately, personalisation of therapy, which cancer therapy is leading but in which other therapeutic areas are rapidly making progress—is all about patient empowerment. That applies both to someone like Les Halpin, who was mentioned by my hon. Friend the Member for The Cotswolds (Geoffrey Clifton-Brown)—someone who has a terminal disease, and wants to play his part in ensuring that others do not suffer in the same way—and to much younger patients with an easier diagnosis who want a chance to play their part in research. The aim is to give patients better access to information about their disease, and to earlier treatment. All the research findings show that patients on research programmes respond better, have better outcomes, and appreciate and enjoy—if that is the right word—the process.

There is also an Arab spring of disease charity involvement. Our disease charities are raising ever larger sums, and playing an ever bigger role. Movember, which was started five years ago by two Kiwis who raised $500, has now raised $23 million, and is the world’s biggest prostate cancer charity. It is using the internet and driving social media, establishing research committees, and setting standards for prostate cancer research all over the United Kingdom. The power of computing in genetics is transforming the way in which we conduct medical research.

Lord Saatchi’s Medical Innovation Bill, which is currently in another place but is coming our way, raises a number of the issues to which I have referred. It makes a powerful case for adapting regulations so that clinicians are no longer bound to stick to protocols that they do not believe will be effective. We need to make it easier for clinicians to innovate and to adopt new medicines and new treatments when they think there is a reasonable chance of a better outcome, without in any way undermining their duty to put patients’ interests first.

A number of other campaigns are coming our way. One of my reasons for initiating the debate was to give the Minister a chance to respond to some fairly specific policy questions. They cannot all be answered this evening, but let me present a few of them. Who owns the rights to genetic data, the rights to DNA—that issue has been highlighted by the Supreme Court’s ruling against Myriad Genetics—and the rights to clinical data? Some interesting work done in the other place suggests that, ultimately, we need to establish the idea that the data are ours. Your medical records are yours, Mr Deputy Speaker, and mine are mine. If we put patients at the heart of this, we will build a framework for consent and for enlightenment, which will be all to the good.

Who has the right to be tested, and when tested, what rights do they have to counselling? I want to reiterate that this has nothing to do with the insurance scare stories we sometimes read about in the press. I call again for the insurance moratorium to be extended. This is not about in any way wanting to undermine the ability of those who have had testing to receive health insurance. The point of this revolution is that it is about empowerment. It is about empowering patients actively to seek, and take, more responsibility for their health care earlier in their life, not penalising those who do that. There are also some important questions to be asked about how we open up the NHS to allow greater access to the types of medical breakthroughs that will fundamentally change the way we treat illness and disease in our society.

I am delighted to give the Minister some time to set out the Government’s support both for this important and emerging field and, as the Prime Minister said in his speech in December 2011 launching the life sciences strategy, for the inspiring vision that every patient in the NHS will be a research patient.

I congratulate my hon. Friend the Member for Mid Norfolk (George Freeman) on securing this debate and pay a warm tribute to him for the great work he does as the Government’s life sciences adviser. I also thank him for his kind words about me. I pay tribute, too, to my hon. Friend the Member for The Cotswolds (Geoffrey Clifton-Brown), who yet again, quite properly, advances the campaign of his constituent, Mr Les Halpin. There is much merit in that campaign, and my hon. Friend has brought it to the Floor of the House before, and so he should. We wish Les Halpin all the very best, and I pay tribute to the great work he has done and the valid points he makes in his campaign. I should also congratulate all the charities my hon. Friend the Member for Mid Norfolk mentioned that are concerned with prostate and breast cancer and Alzheimer’s disease; I pay tribute to them for all the work they do on those diseases, and all the campaigning work they do in advancing this topic.

It is a good time to hold this debate, but I fear I will not have enough time to address the subject in as much detail as I would wish. Numerous questions have been asked, and the usual rules apply: if I do not answer any of them, I will, of course, write a letter—or, rather, my officials will write a letter—to my right hon. Friend. I just called my hon. Friend the Member for Mid Norfolk my right hon. Friend, and why not?

Yes, it is very kind of me.

It is a good time to hold this debate, as the development of genomic technologies, based on the individual’s genetic data, is a rapidly developing field that will bring benefits for NHS patients and the economy. The UK is a recognised world leader in scientific research in genetics, and the services that are available to NHS patients are among the best, if not the best, in the world. The NHS, in its unique position as a single, national health care provider, is ideally placed to harness this new technology and reap the benefits.

The data that are obtained from sequencing part of, or the whole, genome are limited in their usefulness unless they are linked to more information on the individual and the results of their treatment. That is why controlled access to patient records will be vital in our efforts to improve diagnostic capability, understand better the epidemiology—I hope I do not struggle in pronouncing that word—of disease and develop better health care tools and treatments.

On generating more data, the issue of ensuring we protect data obtained from an individual’s DNA has been discussed in many different forums, including the 2009 Lords inquiry into genomic medicine in health care and the consequent work by the Human Genomics Strategy Group, which was led by the Department of Health.

In December last year, the Prime Minister announced that we would be the first country in the world to put in place a programme to sequence 100,000 whole genomes. That is part of a programme that will receive an extra £100 million in funding over the next three to five years. The result will be the building of safe platforms of data that will open access.

Now that it is becoming a reality, access to genetic data will continue to be a subject of keen interest to many. It is only right that it is debated on the Floor of this House because it is so important. As with other data, DNA sequence data will be governed by strict legal controls. It will not be shared with other parties in a form that identifies the individual unless there is a legal and appropriate basis for so doing, and where such a legal basis exists, the patient has the right to be informed about how their DNA sequence data are used. The sequencing information will be strictly controlled within existing NHS arrangements and managed in a way that protects patient confidentiality.

As I said, the raw read-out data are of little value to clinicians, researchers or indeed the industry if they cannot be linked to phenotype and clinical data, so we need to ensure that information-rich data sets are developed that have been value-added through linking genetic and genomic data to disease development, treatment and results. Data need to be made available in an environment that fully meets consent and data protection requirements. To ensure that we harness that potential as part of the growth agenda, which my hon. Friend mentioned, we must develop an industry ecosystem that helps to promote innovation within a healthy, competitive economic atmosphere, which respects data protection and consent boundaries and allows open data sharing for academic research.

While the protection of personal data is important, we should not forget that sharing data has immense benefits. Those patients with cancer or rare diseases who will have their whole genome tested as part of the Prime Minister’s initiative may well argue that they want more of their data to be shared, to help research into their condition and to help fellow sufferers. The recent review carried out by Dame Fiona Caldicott recognised that people’s concerns about what happens to their information, who has access to it and for what purposes, is hugely important; but people also raise concerns about why their data are not shared more frequently when common sense tells us all that it really should be. On the other hand, there was high level of anxiety among some clinicians about when it is safe to share information and what safeguards are required, including concerns about breaching data protection laws or threats to their professional status.

Clearly, a cultural change is required to rebalance sharing and protecting information in patients’ and service users’ interests. We believe that the Caldicott recommendations strike a good balance between the rights of the individual and the need to develop new treatments and services for the greater good. There is no contradiction between demanding rigorous safeguarding of personal information and enthusiasm about sharing information. We want to develop systems that provide open data from what we call safe platforms. There should be no surprises to patients or service users about who has access to their information, and they should be fully informed about their rights in relation to their data. That includes explaining to individuals how their information will be used, including de-identified information, and that it may be used for public health prevention and research, as well as providing assurance that any misuse will be tackled vigorously.

If we are to get better, less fragmented care and to harness the potential of genetic and genomic data for the benefit of all, any lack of trust between individuals, be they individual patients or organisations, in relation to their practice of information governance has to be overcome. The Department of Health research indicates clear public support for using health and care information in research to better inform and develop new treatments. We want to ensure that individuals retain consent to any use of their personal information. That is why we have asked the chief medical officer, Professor Dame Sally Davies, to retain oversight of the programme to sequence 100,000 whole genomes, to ensure that the patient and public interest is protected.

I pay tribute again to my hon. Friend the Member for Mid Norfolk. We could have a huge debate on this subject, and I apologise again that we do not have the time to take it further today, but as I said, I shall ensure that he has a response to all his questions. He has kindly provided me with many of them already, and my officials have compiled a long, long set of answers—far too long for this short speech. He will be in full possession of our responses, and I am sure that he will share them throughout the industry. I thank him again for all his hard work.

Question put and agreed to.

House adjourned.