Low Dose Naltrexone

Debate between Nia Griffith and Simon Burns

Thursday 8th December 2011 Commons Chamber

[Mr Burns]

I am grateful to the hon. Lady for raising that point on behalf of her constituents. The short answer is that it is simply because there have been no clinical trials to assess the drug in its low-dosage levels, and so the conditions of the NHS, under the ways in which we operate in the provision of drugs for patients, have not been fulfilled at this stage. If she will wait for a minute or two, I will get to the nub of the point made by the hon. Member for Llanelli about how we could move forward to seek to address that situation. I hope that the hon. Member for Mid Dorset and North Poole (Annette Brooke) will find the way forward helpful and positive.

The hon. Member for Llanelli will no doubt appreciate that it is in everyone’s interest to see a booming medical research industry in the UK, because that leads to real improvements in the lives of patients, their families and carers, and we are determined to support it. We demonstrated our commitment to health research by increasing spending in real terms up until 2015. In August, my right hon. Friends the Prime Minister and the Secretary of State for Health announced a record £800 million, five-year investment in a series of biomedical research centres and units, which will translate fundamental biomedical research into clinical research that benefits patients and the NHS.

The coalition Government are committed to the promotion and conduct of research as a core function of the health service. The Health and Social Care Bill, which is now passing through another place, will turn this into reality by placing appropriate powers and duties on my right hon. Friend the Secretary of State for Health, NHS organisations, Monitor, and local authorities. We will make sure that the systems and processes for commissioning by the NHS Commissioning Board and by clinical commissioning groups promote, support and fund clinical research. The Government will consult on amending the NHS constitution in order to support patients to have access to novel treatments and to be part of the development of wider patient benefits, so that there is a default assumption, with an ability to opt out; that data collected as part of NHS care can be used for approved research, with appropriate protection for patient confidentiality; and that patients are content to be approached about research studies for which they may be eligible to enable them to decide whether they want a discussion about consenting to be involved in a research study.

The clinical practice research datalink will be introduced by the MHRA in partnership with the National Institute for Health Research, building on the NIHR’s research capability programme. This £60 million investment will offer data services, including providing access to data for researchers, data matching and linkage services, and data validation, to support the clinical trial and observational study work of the life sciences research community.

The NIHR will launch an updated UK clinical trials gateway in spring 2012. That website will enable patients and the public to access information about clinical trials and will be a development of the test site launched in March 2011. To increase the number of patients who can benefit from being involved in trials via the gateway, the NIHR has also developed a free smartphone app, which is available for iPhone users and will shortly be available for Android users. It provides a practical and innovative way for patients to access information about clinical trials.

I will now turn to the question of clinical trials that the hon. Member for Llanelli raised and that the hon. Member for Mid Dorset and North Poole raised, by default, in her intervention. I think that this explanation may provide the hon. Member for Llanelli with the basis for making progress in her quest. Clinical trials are a fundamental part of the drug development process, as she accepts. Trials and health research more generally are funded by a range of groups in the UK, in particular by the NIHR, the Medical Research Council, medical research charities and industry. The NIHR welcomes high-quality funding applications for research into any aspect of human health, including the use of LDN. Such applications are subject to peer review and are judged in open competition, with awards being made on the basis of the scientific quality of the proposals. As she has suggested, a new clinical trial will be required to support a licence for the use of LDN.

The MHRA regulates clinical trials on medicines when they are carried out in the UK. That includes granting approval to conduct a clinical trial and ensuring, through inspection, that the highest possible standards are maintained. However, the MHRA does not initiate clinical trials. A clinical trial needs a sponsor. Sponsors have usually come from industry, the NHS or academia. The hon. Lady is seeking Government funding for a clinical trial to prove the efficacy and safety of LDN. I can tell her that funding is available and that university-based researchers can apply for it.

The efficacy and mechanism evaluation programme is funded by the Medical Research Council and managed by the NIHR. It funds evaluation of the clinical efficacy of treatments. If evidence from such evaluations is promising, larger-scale trials can follow. That is one of the purposes for which the NIHR funds the health technology assessment programme. That programme produces evidence on the effectiveness, cost and broader impact of treatments and other types of health care intervention. In the case of LDN, as with all other novel treatments, I cannot prejudge how successful that pathway of research might be, but I can tell the hon. Lady that a pathway does exist, as I have described.

In addition, the hon. Lady expressed concern about whether the systems in place make provision for patients to say what research they would like to happen. I can assure her that patients can make a suggestion for the efficacy and mechanism evaluation programme to consider. Topics prioritised for funding may be advertised, inviting researchers to submit proposals for clinical trials in those topical areas.

I am grateful to the hon. Lady for raising this subject and giving me the opportunity to explain the background to a matter of considerable interest to many people, not least some of her constituents and those of the hon. Member for Mid Dorset and North Poole. I hope the last part of my speech in particular, in which I have explained an existing avenue that they and others interested in LDN may wish to pursue, will be helpful to them.

[Nia Griffith]

May I take this opportunity to thank the Minister for his very full and helpful reply?

[Mr Burns]

And may I, in the spirit of Christmas, thank the hon. Lady very much for the way in which she presented her case? It was quite clear from listening to her speech that she rightly felt very strongly about the issue on behalf of not only her constituents but people up and down the country who need LDN and who, at the moment, are having to go through the procedures that she described.

Question put and agreed to.