Oral Answers to Questions

Debate between Maria Caulfield and Christine Jardine

Wednesday 7th June 2023 Commons Chamber

[Maria Caulfield]

My hon. Friend is right on this and I encourage everyone to go to the gov.uk website, because the consultation closes at the end of the month. I mentioned that dementia is the leading cause of death in women, but many women are also caring for loved ones who are battling the disease, not just for days or weeks, but for months and years. As I said, this is about improving not just outcomes on dementia, but access and the support we provide to those who care for those with dementia. Listening to experts and experience is a key priority.

[Christine Jardine (Edinburgh West) (LD)]

We all welcome the major conditions strategy, but will the Minister reassure us about something? Women experience so many conditions differently from men, particularly in relation to heart attacks, and there is a lack of awareness about these things. Will the strategy examine how awareness of these differences and of symptoms to look for can be improved?

[Maria Caulfield]

The hon. Lady makes an excellent point, and one of our eight priorities in the first year is improving access to information. Later this summer, the NHS website will be launching a women’s information portal, which will be specifically about women’s health needs. So it will provide information on some of the key conditions that women suffer from, and it will be a go-to and reliable source for women on their health needs. She does well to raise this point.

Medical Cannabis: Alleviation of Health Conditions

Debate between Maria Caulfield and Christine Jardine

Thursday 4th November 2021 Commons Chamber

[Maria Caulfield]

I take the hon. Gentleman’s point, but many children are not accessing this medication, and this is a route to that. As I explained in yesterday’s debate, clinical randomised control trials with a placebo arm have extremely strict rules, and if one arm of the study is showing incredible progress and doing better than the other arms, the study must be stopped, patients unblinded, and everyone switched to the arm that is doing the best. In some circumstances, that has enabled people to access drugs under clinical research in a much quicker way. It does have some advantages.

[Christine Jardine]

That is all very well, but it brings us back to the fact that there are children who are already benefiting from the drugs. Even the NHS has asked whether it would not be beneficial to have an alternative trial, such as an observational one, and to use that evidence, rather than having a clinical trial with all these pitfalls.

[Maria Caulfield]

I take the hon. Lady’s point, but the MHRA, which is the regulator, and other regulators around the world have a tier of research that they will accept. The randomised controlled trial method is the gold standard, and the more randomised controlled data someone has, the more likely they are to get a trial approved quickly. Of course observational studies will be used. That is why, if researchers have a large group, want to do observational studies—we heard about the Sapphire clinic from the hon. Member for Inverclyde—and come forward with observational data, I encourage them to speak to the MHRA to see whether that is the sort of research that would be acceptable. It is important that they have those discussions with the regulating body, because it may well accept some of that evidence.

Until manufacturers, researchers, academics and those using these drugs in practice come forward with whatever research they feel would be acceptable and have those discussions, we will go round in a circle. I am keen that if observational studies are acceptable, we support them to happen. Whatever it takes, in research terms, to get a licence through, the Government are there, providing funding, advice and support. However, ultimately, they are not the body that can make that decision; but I think there is a willingness around the House to try to find a resolution.

It will take time to generate further evidence and see the results of clinical trials. The Health Secretary and I are committed to doing everything in our power to accelerate this work. There have been some helpful suggestions this afternoon that we may need to go away and look at.

I thank everyone again. Although this is the second debate on this subject in two days, I know that it will not be the last; the private Member’s Bill will come forward next month. I want to put on the record my commitment to this issue. It is extremely difficult. In yesterday’s debate, we heard constituents’ stories relayed by their MPs, including the hon. Member for Middlesbrough (Andy McDonald). They really are very moving testaments, and we want to find a way forward. We have changed the law, but that has clearly not been enough. We need to find a resolution, so that we can get these medications licensed if the clinical evidence is there, and we need to work with the regulator.

Medical Cannabis under Prescription: Children with Epilepsy

Debate between Maria Caulfield and Christine Jardine

Wednesday 3rd November 2021 Westminster Hall

[Maria Caulfield]

I will not; I have only a couple of minutes left.

The MHRA is well equipped to provide advice to any applicants wishing to conduct clinical trials.

[Christine Jardine]

Will the Minister give way?

[Maria Caulfield]

I have literally got two minutes left.

Currently, 13 trials are ongoing across the United Kingdom. In the previous 12 months, six of the other trials of cannabis-based products were completed, so some research is coming through the pipeline to help with that evidence base. I want to touch on one—the randomised clinical control trial mentioned by my hon. Friend the Member for South Leicestershire.

It is true that one study has three arms, one of which is a placebo. Having worked in clinical research myself, I reassure my hon. Friend that there are strict ethical guidelines for any clinical research. If someone is allocated to the placebo arm but it is clear when monitoring the research that one arm is doing significantly better than another, the trial has to be unblinded. Anyone on a placebo arm is automatically put on the arm that is doing best. I worked on clinical research for breast cancer, when we were trying to get Herceptin licensed, and for some patients that was the quickest way to get the drug. If there is clear evidence that one arm is working far better than others, patients can be moved on to that arm. It is a way of fast-tracking the drug for licensing.

I reassure Members that I absolutely understand the issue. The Government have changed the law to allow use of medical cannabis, but unless we give clinicians the confidence that the drugs, first, work—a feeling that they do seems to be the consensus in the Chamber—and, secondly, have a safety profile, they will not prescribe them. We can debate it forever in the House, but the clinicians have to be convinced. The way to do that is to get the product licensed, and the way to do that is to get good-quality research that the MHRA can look at to feel confident in licensing that drug.

The Government’s view is that there is funding for such research. My commitment to Members present today is that I will work with other colleagues to see whether we can speed up applications for research, encouraging them to come forward. For many Members, that is not the answer that they wanted to hear; they want me to stand up and say, “The drugs will be available tomorrow and we have people to prescribe them.”