Medical cannabis panel is failing us, families tell Sajid Javid

This was the heading in today’s Times.

I wondered how broadly the access to medical cannabis would be under the new licensing system. Would it be broad enough so that people with chronic illnesses such as MS, Parkinson’s, Huntington’s disease and cancer could benefit? Not to cure their condition, but to ease symptoms and potentially extend life.

My fear was that the review would only recommend medical cannabis for cases of the rare form of epilepsy in children, such as Alfie Dingle and Billy Caldwell whose cases had extensive media coverage. Both had shown dramatic improvement by having access to the drugs they needed in other countries.

The outcome seems to be even worse than I had feared. Alfie had already been approved before the expert panel was set up, Billie’s licence was approved on the day the panel was announced by Sajid Javid. Only one other licence has been issued, because the panel requires very difficult conditions to be met.

Evidence must be provided of exceptional clinical circumstances. They are asked if the product has already been effective for the patient – since it is illegal here this would have had to be in another country. Not an option for many families. There should be evidence that no suitable medical product is available in the UK – but there are about 20 anti-epileptic drugs and it would take a long time to try them all without success. Medicinal cannabis would be cheaper and not harmful, but doctors and NHS trusts are fearful of accepting clinical responsibility for prescribing it and parents have been unable to obtain the medication without their support.

Rather than radical change in the availability of medical cannabis for many people it seems we have a system which blocks change for all but a trickle of exceptional cases. Why don’t we learn from the experience of other countries where it is legal?

As the world’s largest exporter of cannabis for medical and scientific use providing nearly half of the world total it seems hypocritical not to allow UK patients to benefit. At the very least we should be doing research into effectiveness for different conditions and optimal dosage. But pharmaceutical companies can only make money if they can manufacture a new formulation – there is no money in natural remedies. Universities don’t seem to be doing any meaningful research into medical cannabis. Why isn’t there a publicly funded body to investigate this and a range of other treatments which are not commercial money spinners but could help patients and save NHS money?

The Care Oncology Clinic is a private clinic researching a combination of repurposed drugs which seem to be helpful for cancer. Metformin, Atorvastatin, Doxycycline and Mebendazole. These are all licensed for other conditions but seem to be helpful in blocking the processes used by cancer cells. Searching PubMed, I found a drug, Memantine, which might be helpful in reducing the impact of neurocognitive decline after brain radiotherapy. But not enough research has been done on it, and there is no commercial incentive for it.

The NHS expensively sells us late stage cancer patients short. We need to fund research and gain acceptance for integrated oncology treatments in the meantime. Sadly, medical cannabis so far does not seem to be the door opener.

Broadening the range of treatments for patients with secondary cancer

Today the NHS is 70 years old. And Parliament is going to review the guidelines on medical cannabis.

Lots of debates to be had about how good the NHS is, where it fails and how to spend the additional funding of £20bn recently announced. While I am benefiting from excellent care and expensive treatments from the NHS I want to focus on what more can be done additionally to help late stage cancer patients like me to have symptom relief or life extending treatments in addition to those they can access through their oncologists. Because we know that the UK lags behind almost all advanced economies in the 5-year survival rates for cancer. For breast cancer the UK results rank 23rd in the world.

The NHS provides no guidance on these complementary and adjunct drugs and therapies. Worse, in many cases the doctors and oncologists actively put people off trying them. The argument is that there is no evidence that X or Y will work for cancer patients.

It is understandable that GPs and oncologists will err on the side of caution. They don’t want to give false hope. They have no knowledge of the treatments (or curiosity it seems!) They might fear litigation. They prefer to deal with drugs and treatments where they have knowledge and control. And they don’t like their authority being challenged.

So, the question is: what counts as acceptable evidence? Randomised Control Testing (RCT) of drugs, funded by the pharmaceutical companies is the gold standard that the medical profession will accept. But for many practical and financial reasons it isn’t possible to do this kind of testing on cannabis, curcumin, repurposed drugs such as aspirin and metformin, diet or mindfulness meditation, to name but a few.

Sometimes stories can trump data and capture the public imagination. This is what has happened recently with the media coverage of the cases of Billy Caldwell and Alfie Dingley where their epileptic seizures were shown to be massively reduced by cannabis oil. Is this evidence? Obviously, evidence in these cases, but how widely will our legislators open the goal posts for medical cannabis for other conditions, such as MS, Parkinson’s or Cancer?

Absence of evidence is not the same as evidence of absence of effectiveness.

Unfortunately for now there is not much between the narrow NICE review of evidence and cost effectiveness, and the plethora of anecdotal stories, documented case studies and the large number of self help information groups, such as closed groups on Facebook. How are patients to wade through and evaluate all this information, sifting through the suppliers of supplements and regimes promoted on YouTube, some of which are excellent, and some are questionable.

A number of organisations are actively trying to promote integrated oncology, through conferences, interviews, books etc. These include Yes to Life, College of Medicine, CANCERactive and the British Society for Integrative Oncology (BSIO). Excellent stuff, but while there is great consensus at their conferences they don’t seem to be having any meaningful traction in broadening the NHS view on what they might sanction for their patients, so that they might stand a chance of living a bit longer and managing their cancer as a chronic disease. Why not? I don’t know, but I suspect it is due to a combination of factors. Amongst the different organisations no one body takes the lead – nobody is driving the bus and the individual voices are less strong than a united front with an activist agenda. MPs are heavily reliant on doctors to advise on any changes, and the medical profession is heavily influenced by the pharmaceutical companies. While I don’t believe that all Big Pharma is wicked, it’s certainly true that it is not in their commercial interests to support investigation into off-licence drugs which seem to have good effect in tackling cancer. (Off-licence doesn’t mean they are illegal – simply that they have a licence for one condition such as diabetes, but did not go through RCTs for cancer, so while there may be epidemiological evidence of effectiveness this is not “evidence” the NHS will accept.)

Where are the voices of other parts of the medical world and patients themselves? Hospices, palliative care specialists and nurses all may have a broader view of what is helpful, based on what they see helps patients.

I don’t expect any of the complementary drugs and therapies that I use to cure me of cancer. But if I want to live longer than the NHS drugs normally achieve I need to look outside their protocol. I hope to live long enough to take advantage of the emerging approaches of individual treatments, based on DNA profiling of the patient’s tumours.

If medical cannabis becomes available on the NHS, then the basis of what counts as acceptable evidence will have been challenged. It is my hope that this will lead to other drugs and treatments being investigated – they won’t need a change in the law, but permission for oncologists to recommend trying them or at least not discouraging patients from trying them would be a big step forward.

It is my view that the kind of culture change necessary in the NHS would take a generation to achieve. I would like to see an authoritative body to be set up, equivalent in status to NICE, which can firstly propose ground rules for what can count as evidence and then go on to investigate the very many options available to cancer patients. Particularly late stage patients, who might then have a realistic chance of living longer.

Some no-brainer cases showing why medical cannabis should be legal in UK

Billy Caldwell had up to a hundred seizures a night until his mother took him to America where he was prescribed cannabis oil. His seizures stopped, and his autism improved. When she ran out of money they returned home to Northern Ireland and her GP prescribed medicinal cannabis for 13 months. Then the GP received a letter from the Home Office and a warning at a meeting with drug enforcement officials telling him not to repeat any more prescriptions.

Billy’s mother went to Canada to legally buy the cannabis oil, but when she attempted to bring the bottles back into the UK they were confiscated at Heathrow. She begged Nick Hurd, a Home Office minister, to give her back the medicine but was told to apply for a licence which would take many months and could cost £100,00.

She insists that the medicinal cannabis oil is anti-epilepsy medicine, not a dangerous drug that could be used recreationally. He had a fit last night after missing his dose – his first in more than 250 days.

Many families face the same predicament, including six-year-old Alfie Dingley whose case I forwarded to my MP. His seizures reduced from 3,000 a year to 20 when he received the oil in Holland. Theresa May met his parents and said she would help, but nothing has changed so far. It is still classed as a schedule 1 drug and illegal to buy in the UK.

Surprisingly, Britain is the world’s largest exporter of cannabis for medical and scientific use. 44.9% of the world total. It is grown by one company, GW Pharmaceuticals, with a licence from the Home Office. The political angle is that the husband of Victoria Atkins, the Home Office minister, is responsible for this farm. Furthermore Philip May, husband of Theresa, is a relationship manager at Capital Group which part owns GW Pharmaceuticals.

GW makes Sativex, an oral spray for multiple sclerosis, which is the only legal use of medical cannabis in the UK. It sells for £125 for 10 ml. Anyone using any other form of medical cannabis theoretically faces a 14-year jail sentence.

The Home Office says that cannabis “in its raw form, it currently has no recognised medicinal or legitimate uses beyond potential research”. And yet thirteen European countries, thirty American states, Canada and Australia have found ways to legalise medical marijuana. Why can’t we? Is it because of the vested financial interests, or because of the lack of what the medical community here consider to be sufficient evidence of effectiveness? How can you gather evidence for something that is illegal? There is ample evidence of effectiveness from case studies around the world, but no UK based randomised controlled testing.

What counts as evidence? Tricky question which I hope to address in future blogs.

A surprisingly good meeting with my MP

I met my new (to me) MP, Jeremy Quin this afternoon.

I had emailed him off the back of a change.org petition about Alfie Dingley, a six-year-old boy who has around 30 seizures per day but had 27 days free from seizures when his parents took him to the Netherlands and he could access medical cannabis. They want to have a special licence to enable Alfie to get this here, but our rules say he can’t.

I sent the change.org suggested letter and prefaced it with some information about my interest in this as a person with terminal cancer. He replied with the expected outline of the status quo. Cannabis is not recognised in the UK s having any medicinal benefits, products must be thoroughly tested by the Medicines and Healthcare Products Regulatory Agency before they could be made available for medicinal use, so the Government would not issue licences for the personal consumption of cannabis.

I wasn’t expecting a positive response to what I wanted to tell him. This problem is wider than just cannabis – there is no recognised authority to say that any off licence, complementary or alternative treatment approaches, diet or supplements may be beneficial for cancer treatment.

It was news to Jeremy that there was lots of evidence that cannabis oil with THC kills cancer cells. And that off licence drugs such as those prescribed by the Care Oncology Clinic, or even aspirin, can make conditions tougher for cancer and so prolong life and perhaps enhance the effectiveness of chemo or ameliorate the side effects.

He told me that MPs are very dependent on what NHS medics tell them, as MPs themselves lack specialist knowledge. They are told that (except for Sativa, the one licensed drug) there is no evidence that cannabis is effective medically.

So what is evidence? The NHS currency is randomised controlled tests (RCT). Exceedingly expensive and normally funded by the big pharma company in their quest to find innovative profitable drugs. There is no commercial advantage for any organisation to do the research into drugs which are out of patent, and how could you provide RCT evidence for diet or cannabis?

He already knew that our performance for cancer survival is poor compared to other advanced countries, but he was genuinely surprised that epidemiological evidence exists for non-NHS treatments. He was very interested in whether my medical team supported my complementary treatments (they do, but most NHS oncologists are very constrained in what they can say outside of the usual protocol, and instead of being neutral they are often actively dismissive or hostile). He was interested as to how medical cannabis could be legalised without risking legitimising other forms of cannabis and increasing the risk of side-effects. Medical cannabis is, of course, a long way from street skunk and it would be easy to put in place adequate checks and balances.

He has undertaken to contact two MPs who have an interest and good knowledge in this area and agreed to do so with an open-mind. He feels that if the NHS is wrong in their approach things need to change. My view is that it would take far too long to bring about any change from within the NHS. What we need is a parallel body for integrated oncology, providing authoritative information about drugs and other treatments, and developing a framework for good evidence that isn’t RCT.

Let’s see what happens.

Shortcomings of the NHS for Cancer Care

I’m a big fan of the NHS, and very grateful for the treatment I am receiving for my grade 4 secondary metastatic breast cancer. Since being diagnosed I’ve made it my business to learn as much as I can about cancer treatments, both mainstream and complementary, in the UK and elsewhere in the world.  What I’ve learned has opened my eyes. We like to think of the NHS as a National Treasure. Best healthcare system in the world. 

Every advanced economy in the world except for the USA has a universal healthcare system. That’s more than 30 countries. They differ in the drugs, treatments and therapies they fund, but all have something in common. Their cancer survival results are strikingly superior to the NHS.

This winter especially we’ve all read about the long waits in A&E, cancelled operations, and staff shortages. And now the government has plans to increase funding, perhaps with a designated NHS tax. Good! Because we’ve been underfunding our health service for many years. We currently spend 9.1% of GDP on healthcare, while the EU average is 10.1%. We’re far behind the Netherlands, (12.9% of GDP), France 11.75% and Germany 11.3%. 

Our poor spending record shows up in our survival rates for cancer.  You might expect us to be world leaders, given all the excellent research we do. But we are at the bottom, not the top, of league tables for cancer survival. 

According to a UK 2020 report, The UK Health System – An International Comparison of Health Outcomes, in breast cancer the UK ranks 23rd in the world for five-year survival. Sweden is the best country, and if UK performed to Swedish standards it would save 4,242 lives a year.

Why do other countries do so much better than us, when the same treatments and drugs are available to all? Partly it is down to what is authorised for access under the healthcare system in each country. In the UK NICE controls the purse strings, and sometimes effective drugs are not permitted on the NHS which would be available to patients in other countries. Additionally, I have come to believe that the medical establishment in the UK is too narrow in its view of what is appropriate treatment. Unless there is a sufficiently robust evidence base, NHS doctors will not endorse treatments, drugs or therapies outside of their approved protocol. So, what is sufficient evidence? Randomised controlled tests are the currency acceptable to the NHS establishment. Fair enough, but there are many, many approaches where this level of evidence is not possible. And rather than remaining neutral about them, most NHS doctors will at best caution their cancer patients and at worst actively discourage their patients from trying them.

If the NHS protocols produced outstanding results this might be acceptable. But the standard approaches of surgery, chemotherapy and radiation followed by extremely sophisticated and expensive big pharma developed drugs are quite simply not good enough. At least for late stage cancer. They may be lifesaving and the best option in the short term despite the often-horrendous side effects, but the extraordinarily expensive drugs are not expected to provide a lasting solution. They last on average a few months until the cancer finds a way to outfox them. Now a few extra months when you are told that you are not expected to live for much longer is very welcome, but wouldn’t it be better to also use other approaches which might make things more difficult for the cancer and thus prolong life, even if not actually providing a cure?

In future, advances such as immunotherapy and individualised treatments may provide much better outcomes. But for now, there are many things which terminal cancer patients can usefully do which might buy them additional, precious quality time. These range from adjunct drugs which are licensed for other conditions but have beneficial actions in cancer to supplements, diet changes, medicinal cannabis, homeopathic remedies and alternative treatments such as acupuncture, reflexology or Reiki. Most of these will not make the cancer disappear, but they may enhance the effectiveness of the mainstream treatments, alleviate the nasty side effects, make conditions more difficult for cancer to thrive, strengthen the immune system to better deal with new cancer development and generally help the patient to feel better both physically and mentally, which has a beneficial systemic effect in the body. 

These complementary and alternative treatments are not easily testable in randomised controlled tests. Off patent drugs have no profit motivation for further research by big pharma companies. Terminal cancer patients don’t have time to try one treatment alone and wait to see if it works before trying another. How would you provide reliable evidence for diet, apart from case studies? And for cannabis, which is still illegal in the UK?

So, the medical establishment doesn’t provide guidance on any of them and it is up to the patients to do their own research. 

There must be a better way. We need a way to evaluate these integrated oncology options so that the medical establishment can either endorse them or at least stop being negative about them. 

I would like to explore opinion from people in different parts of the system to see what they think works now, what doesn’t work and potential ways forward to get better outcomes. I’ll write these up as blogs over time on this website. If I am successful in confounding medical expectations about how long I can expect to live, especially now that I have brain metastases, I may even be able to collate all the results into a second book. Watch this space!