Medical Cannabis 101

Cannabis has been in the lives of humans for thousands of years. Many historians point to instances where cannabis was used more than 3,000 years ago. I've seen it quoted several times that Queen Victoria was prescribed cannabis for her period cramps. So cannabis has been used — for religious, medicinal or recreational purposes — for a very long time.

Cannabis became illegal in the UK in 1928, when it was added as an addendum to the Dangerous Drugs Act of 1920 — and that's what made its use illegal. When the Misuse of Drugs Act was created in 1971, cannabis was made a Class B drug, and therefore an illegal drug as well.

There was a change in the legislation in 2018 where, under popular demand, cannabis was rescheduled from a Schedule 1 to a Schedule 2 drug. Schedule 1 are the illegal drugs that have no benefit for health; Schedule 2 are other drugs that may have a health benefit and are controlled drugs. Since then, patient advocates and patients around the UK thought that would mean easy access to medical cannabis — but that's not the case.

The reason there was so much demand to change the scheduling was the example of other countries. Israel has been providing medical cannabis to its patients since the mid-1990s, and everybody knows about the great change in Canada, where medical cannabis has been legal since the mid-2010s and recreational cannabis was made legal in 2019.

So that's the global landscape. Right now, medical cannabis is available as a Schedule 2 controlled drug. There are some licensed drugs, and there's also a market for unlicensed drugs. The licensed drugs are all licensed by GW Pharma, and the ones everybody knows are Sativex and Epidiolex. Sativex has an indication in spasticity in multiple sclerosis, and Epidiolex has an indication for epilepsy in Dravet syndrome and Lennox-Gastaut syndrome. That's mainly the landscape for licensed drugs.

Many people are looking for medical cannabis for other diseases, and are therefore relying on unlicensed drugs. If you look at what's available in the UK, the majority of unlicensed medical cannabis products are final products imported from Israel, Australia or North America, mainly.

In the UK there was a lot of popular attention to two particular cases — two children with refractory epilepsy whose families have been very vocal in the media about the fact that none of the anti-epileptic drugs were working on their children, and that they knew CBD was helping them greatly.

To give you a bit of understanding: Epidiolex is a CBD medication that GW has licensed for Lennox-Gastaut syndrome, as we said earlier. Children with those diseases can have up to a hundred epileptic seizures a day. When they're treated with CBD, they can go as low as ten seizures a month — a complete difference in their life.

Those two families, the Caldwells and the Dingleys, were very vocal to make sure people understood that medical cannabis can make an enormous difference in the lives of their children. They procured medication from outside the UK — the Dingley family moved to Holland to get treatment in The Hague for their child. At one point they decided to come back to the UK, and they brought that knowledge back with them.

So under the pressure of patient groups, the health secretary at the time decided to review the state's position on medical cannabis. And that's what led to the change in the legislation.

Of course. Most people know about illegal cannabis. It can come in different forms — flower, resin, or any other form you can buy on the street. And we have to be really clear that this should absolutely not be used. There's no control over quality, no control over manufacturing. The resin can contain a lot of things that are extremely harmful. I really want to emphasise: this is not medical cannabis, and it should not be used for self-medication. Absolutely not.

The second one you mentioned is CBD oil as a food supplement. There's a consumer CBD oil industry providing CBD oil through high-street shops as a food supplement. The level of quality is very different from medical cannabis. This is oil obtained through hemp, which by law has a level of THC that's less than 0.2%. That consumer CBD market is booming right now — there are more and more brands in the UK. The UK is the biggest consumer of CBD food supplements per capita in Europe, so we hear and see it everywhere.

But because the requirements around manufacturing are completely different, I wouldn't use this for self-medication in patients who have an actual medical need. It's true that a lot of people use it because it's much cheaper than medical cannabis in the private market. But if you have a condition like epilepsy, you want to make sure that every time you take a drop of that oil you get the exact same concentration of active ingredient — and that from one bottle to the next you have exactly the same active ingredient. That's not how the supply chain for consumer CBD oil is designed.

And finally — the area where I work — there's medical cannabis, which is very different from the two we've talked about. There's a great deal of attention paid to the supply chain. All the flowers are grown in a very controlled manner, with as little variability as possible between one flower and another, and a lot of control of the active components within the flower. There's a lot of control in the manufacturing and distribution processes too. That means you have as little variability between one product and another as possible.

And this is the most important point. If you have a very debilitating disease, you need to be able to rely on the product you're using, so that it actually improves your life — you don't want to be questioning whether this month's bottle will be effective or not. That's why the medical cannabis industry is designed in a very different way.

NICE published its guideline on cannabis-based medicinal products in November 2019 — almost exactly a year, day for day, after the change in the legislation. They looked at where there is sufficient data to recommend prescription of medical cannabis. Across the pathologies they examined, the ones where they found a clinical benefit were intractable nausea and vomiting — especially in the context of chemotherapy — spasticity, and the treatment of refractory epilepsy.

They also looked at chronic pain, and found several studies showing an improvement with medical cannabis, but NICE established that there's a lack of sufficient quality data to claim an indication in chronic pain. That doesn't mean it's not used in chronic pain — many prescribers use it for patients with an unmet clinical need. Because if you've tried every licensed medication available under UK law, then you can try an off-label medication or an unlicensed medication. That's where a lot of prescriptions happen currently.

You can access medical cannabis on the NHS, because the licensed medicines are available in most trusts' formularies. You'd be able to access Epidiolex or Sativex through pretty much every doctor in England — that's the benefit of having licensed medicine.

The problem arises when you don't have access to licensed medicine because you have a different indication from the one those drugs are licensed for. In many cases you'd get that medication off-label — you could benefit from Epidiolex or Sativex as an off-label medication. It becomes much more complicated when you have an unmet clinical need, where your prescriber thinks medical cannabis could be beneficial but there's no licensed medicine and off-label use isn't indicated. That's when you turn to the unlicensed medical cannabis market.

It doesn't mean the manufacturing criteria are different — the criteria for manufacturing are the same for a licensed and an unlicensed medicine. It's just that it didn't go through phase one, phase two, phase three to prove there's a licensed indication for that medicine. That's what unlicensed medical cannabis means.

If you have a patient with an unmet clinical need who needs an unlicensed cannabis-based medical product, the main way prescribers do it right now is through the private system. It's extremely complicated for any NHS trust to validate the indication of an unlicensed product. So patients turn to private prescribers, and the private prescribers use an FP10CD form — the normal form for prescribing controlled drugs privately.

In our case, we have patients and doctors who've contacted us. We send those doctors our information leaflets to explain the process if they want to prescribe an unlicensed cannabis-based medical product, making sure they have the proper prescription forms, showing them what a prescription would look like and where to send it. And we have a partner pharmacy that receives all those prescriptions and delivers the medications to patients within the next 72 hours.

Exactly.

Healthcare is one of the industries where the level of regulation is the highest. Pharmaceuticals in general, healthcare in general — the only industry I can think of that might have an even bigger level of regulation is building firearms. It's incredible, the amount of red tape you have to go through. And I mean red tape with the utmost respect, because it's absolutely necessary to make sure you're providing a high-quality product and protecting patients. But it still makes it a very difficult industry to enter.

That was one of the many obstacles we had to meet: the difficulty of navigating the regulatory landscape. Because it's not a single set of regulations. You have the Home Office, the MHRA, NHS England, the Department of Health — many, many regulatory agencies and governmental bodies involved, that sometimes have conflicting information. That makes this industry a very tough nut to crack.

You have both sides of the same coin. Some people are extremely excited, and some of them have expectations or preconceived notions of what medical cannabis, or cannabis in general, is. You'll see a lot of people who are advocates for the deregulation of aspects of cannabis that aren't medical cannabis. You'll have people who are purely interested because it's a brand-new chemical compound, and they're excited by the possibilities. You'll have people who are very afraid of it because of all the social taboo associated with it for so many years. And you'll have people who are afraid not because of the taboo, but because they recognise it's a controlled drug — one of the highest levels of regulation, within one of the industries that already has one of the highest levels of regulation. It creates so many barriers at so many levels. You see literally the entire spectrum of people. It's really interesting.

I love to quote a very interesting study by Harvard Business Review, which looks at the age at which an entrepreneur creating a company is most successful — I'll share the link so you can include it in the description. The result shows that the average age of a successful startup founder is 45.

Forty-five! If you think about the common knowledge around successful entrepreneurs, everybody quotes Bill Gates, Steve Jobs, Mark Zuckerberg — guys who were barely 25 or 30, who created incredible unicorns. There's very much a narrative that's actually not reflected in the data.

I've seen many medics try to think of the best moment to create their startup as being right after medical school. Some say, "I've just done my last year, I'm at the top of my game in terms of medical knowledge, I know a little bit of everything, I understand how the medical system works, I'm young, I'm full of energy — I need to create my startup right now." I'm not sure that's actually the best moment for you. I think you need to look at what you really want to do, and acquire an even deeper understanding of that particular field.

If you're thinking about a software company — an app or a platform — maybe go and do a bit of computer science. Or go and work as a junior doctor with an incredible emphasis on the tools NHS trusts are actually using. Because having a little bit of knowledge may not be enough to make a difference. That's why the average age of a successful founder is 45 — you need a deep knowledge of your industry before you can actually service that industry in the right way. And I don't think that's said enough.

I've seen many aspiring entrepreneurs say, "I'm a junior doctor, I don't want to see patients in the future, so there's no point acquiring deeper knowledge in cardiology — that's a waste of my time." Well, not really. Being a junior doctor in cardiology isn't going to help if what you want to build isn't related to cardiology. But if what you're really motivated about is imaging — MRI of the heart, ultrasound of the heart — being a full-fledged cardiologist will make a world of difference. For funding, for talking to investors, for approaching the NHS and any regulatory agency, having actually worked within that industry gives you an incredible edge. So if you're a junior doctor and what you want to work on is the application of AI in healthcare, of course there's no reason to become a GP and do full junior years — but go and do a PhD in AI. That's what will make you so much more competitive.

I think it is, and I'm living that challenge every day. I have two kids under the age of four, which means my nights are not that awesome. I worked full-time as a consultant during the first 18 months of our company, which — as an obs and gynae — meant multiple night shifts a month. I was doing all my theatre lists, my consultation lists, working 40 hours a week for the NHS and then 40 hours a week for my company, and having quite a demanding personal life. I recognise it. I haven't seen my friends much, because at the end of the day, when I had a little bit of time, I spent it with my family.

So I agree — it's a very different set of challenges. But as you get older, you save a lot of time. I had a much better understanding of the regulatory network and landscape, and a much broader network to help me — that saved a lot of time too. I had industry knowledge that wouldn't be available to a last-year medical student, and an understanding of the patient relationship that a junior doctor definitely doesn't have.

Even for funding, it helped me a lot. When you talk to investors and say, "This is what I've been doing, I'm now an NHS consultant, I've worked in this industry, I know it like the back of my hand, and I've also worked in health tech all these years — more than 15 years of experience in the medical field and more than 10 in health tech," that creates opportunities you wouldn't have as a junior doctor.

Exactly. A lot of people say, "I've got this great idea and now is the time." A lot of people put too much emphasis on the idea. Great ideas in the health tech field come all the time — as long as you have a little bit of understanding of the field, you'll have great ideas. The problem is execution. And execution relies on a deep, deep understanding of the industry.

That's a very broad question. First of all, you need the right team. That's a personal belief — doing a startup on your own is extremely difficult. You need a sounding board, and having a great co-founder is really important. I'm very lucky: Eric is a great co-founder. But your co-founder isn't your only sounding board — you need friends, mentors and colleagues you can talk to. I always call my old colleagues from the different trusts I've worked with and have small conversations. "What do you think of this? What do you think of that?" Even though they don't know much about medical cannabis, that's really important. That would be the first step.

The second step is being extremely well-organised, because when you're working on a startup it's very easy to go in multiple directions. You need to be focused, you need timelines, you need to be organised. That's one of the most important things if you actually want to deliver.

And finally, you need to have a balanced life. For me, the only reason I've been able to do all of this is a very balanced life. I'm blessed with a wonderful wife and kids, and that's given me an escape boat. Sometimes you're just sinking, because you have so many problems in your company and you feel like you've hit a wall — but then you take a day off, spend some time with your family, and it helps you. Being all consumed inside your company will literally kill you. There have been so many stressful moments in this company that if I didn't have my family, I would have been lost. Definitely.

You told me you'd ask me this, and it's interesting, because I've thought about it. There are many, many books I could quote, but they're always the same ones. The Lean Startup by Eric Ries is the one everyone reads. There's The Innovator's Dilemma by Clayton Christensen — again, anywhere you go, entrepreneurs will talk to you about that. If you want something a little easier to read, there's The 4-Hour Workweek by Tim Ferriss. I read that in my 20s and thought, "Oh my God, this guy has understood everything" — and then you realise there's a great lack of depth inside the book.

But the one book that maybe not everyone has read, or that you don't hear about all the time, is by Richard Thaler, a behavioural economist and the recipient of the Nobel Prize in Economics in 2017. He's an incredible mind, and he wrote Nudge: Improving Decisions About Health, Wealth and Happiness. It's not too difficult to read, and it's all about the revolution behavioural economics has made around the world. If you look at the applications of behavioural economics across the different aspects of life, you realise it can help you run your life better — it can help you negotiate better in your professional life. To me it's a well of information for how to run your life on many different levels.

The one point clinicians need to focus on is that you should think about medical cannabis in the same way as any other medication. Follow all the right guidelines and everything you've trained on before. It is not a magical drug. It's not something that's going to solve every problem. There are so many grandiose headlines in the media about curing cancer, helping against COVID-19, so many things — but you need to keep a very scientific eye on all of that. It has side effects, it has clear indications, and it needs to be of the best quality. That's what matters most.

Thank you.