Oral Answers to Questions
Debate between Ronnie Cowan and Maria Caulfield(2 years, 5 months ago)
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Ronnie Cowan (Inverclyde) (SNP)
As was pointed out by the hon. Member for Lichfield (Michael Fabricant), this Government promised medical cannabis on the NHS 1,183 days ago. Since then, a child with epilepsy will have experienced, at a modest estimate, 35,490 seizures. We have free NHS prescriptions, which proves that the medicine exists and is approved for use in the United Kingdom. How much longer must those children suffer?
Maria Caulfield
As I have said, I met the Scottish Minister on this. Scotland is facing exactly the same problem. Where medicinal cannabis is licensed, 9,631 prescriptions have been issued in primary care and 58,000 in secondary care, thanks to my right hon. Friend the Secretary of State who changed the law at the time.
Medical Cannabis: Alleviation of Health Conditions
Debate between Ronnie Cowan and Maria Caulfield(3 years ago)
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Maria Caulfield
I take my right hon. Friend’s point. I will come on to that, and to timelines for the research that is in progress. Many of the products that we are talking about have not been licensed by any licensing authority across the world, including the Food and Drug Administration, the European Medicines Agency and our domestic MHRA. This is not just a UK problem; it is not the UK Government who are holding this back.
As I said yesterday, I encourage manufacturers of these products to invest in clinical trials. Part of the Department’s work is providing funding for the National Institute for Health Research, which is actively opening its arms to charities, academics, researchers, manufacturers and third-sector organisations. Funding is available for clinical trials, if anyone wants to come forward with one, be it a randomised control trial, an observational study, a randomised control trial without a placebo arm, or a phase 1, 2 or 3 clinical study. The MHRA is willing to provide advice and support to any potential applicants who want to conduct a clinical trial or seek a licence for their medicines. There is funding and support; we need researchers to come forward with clinical trials.
Ronnie Cowan
A lot of research institutes are restricted in what they can do because they are trying to access a category 2 product. If it was category 4, life would be a lot simpler for them.
Maria Caulfield
The hon. Gentleman makes an excellent point, and going forward we perhaps need to unblock some of the blockages in that area. I take that point on board.
Clinical trials and the licensing process provide evidence and information that doctors rely on to support their treatment decisions. Many clinicians have fed back that they are reticent to prescribe these products until there is more evidence, because ultimately they are responsible for their patients when it comes to a treatment’s safety and effectiveness. Doctors are particularly unwilling, given the THC element of cannabis products; there is some emerging data and evidence of harm, particularly to children, including effects on the developing brain and heart. That is why the evidence base is so crucial, but I am happy—I say this especially to the hon. Member for Manchester, Withington, who sponsors the Medical Cannabis (Access) Bill—to consider what blockages could be unblocked to speed that process up.
Doctors are right to be cautious when prescribing any product if they are not confident in the evidence base. As I said yesterday, I am clear that prescription remains a clinical decision, as does prescription of any medication. It would be inappropriate for the Government to force clinicians to prescribe a medicine, but we will try to unblock some of the licensing blockages.
Let me highlight some of the studies that are starting to take off. This might have been mentioned, but from 1 April we have the establishment of clinical trials for NHS England and the NIHR. We have introduced a national patient registry, which will record patient outcomes, with a view to its being rolled out across the devolved Administrations. It is England-only at the moment. We are aiming to record the data of those who receive the medicines, and to consider side-effects, efficacy and a whole range of issues, in order to support clinicians working with patients, and to start to build an evidence base.
In addition, a randomised control trial is being set up. It has three arms, which will include one arm with CBD or THC, and one arm with a placebo. We expect it to open fairly soon. Those looking to access these drugs—children in particular—will be able to do so in a blinded way and can take part in the study. If the data come through relatively quickly, that will open up opportunities to submit evidence to the MHRA.
Ronnie Cowan
Who would offer a child who is on medication that stops them having 100 seizures a day a random test that potentially contains a placebo?
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.
Medical Cannabis under Prescription: Children with Epilepsy
Debate between Ronnie Cowan and Maria Caulfield(3 years ago)
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Maria Caulfield
There are concerns, particularly around the THC element, that there could be some effect on the developing brain and on heart conditions. Research is needed not just on the effect of the drugs, but on their safety.
I want to point out that the Government have made funds available for good-quality research. That does not have to be done by the manufacturers; it can be done by charities, clinicians or researchers. A range of people can come forward to carry out clinical research. The MHRA—
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.
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.”
Ronnie Cowan
We have to re-categorise cannabis from schedule 2 to schedule 4. That will open the gateway to medical research. Right now, it is hard for a lot of medical researchers to gain access to the product in the first place.