SPEAKER_00 0:00

You're listening to Confidence to Thrive, the podcast for ambitious healthcare practitioners and entrepreneurs, brought to you by our Liberty Advisors. Welcome to Confidence to Thrive, the podcast helping growing practitioners and healthcare entrepreneurs navigate the challenges and risks of regulation while building brands that matter. Every episode, Christopher Cloak Brown tackles a different issue facing healthcare practitioners or entrepreneurs, or interviews a guest who is working on the leading edge of private healthcare, building something that matters in their sector or profession. My name is Jody Rainsford, and on today's episode, I'll be discussing with Christopher how to build and grow a practice in functional medicine and ensure it is properly protected and so you can grow without constantly looking back over your shoulder. Welcome, Christopher.

SPEAKER_02 0:45

Thanks, Jody.

SPEAKER_00 0:46

Thanks for having me. Okay, so let's go right into this then. So let's have a little bit of context here. What is functional medicine and what does the current landscape look like?

SPEAKER_02 0:57

So functional medicine has been around for quite a few decades really, but it's really gaining traction now. It is what Dr. Peter Attier has referred to as medicine 3.0, so a new generation of medicine, which, well, I'm sure we'll talk about Jody, brings all sorts of issues up for practitioners. But it's really an approach that looks to move away from the idea that if you're sick, you go to the doctor, they prescribe you with a pill, and the pill somehow magically makes you better. And it is a long-term approach to your general health and well-being. It is a view that most chronic disease, so if you have a heart attack in your 50s, the root causes of that are probably in your diet, exercise, and lifestyle in your teens and 20s, even. So there are sorts of long-term problems that accumulate, and that's down to imbalances in the biochemical processes in the body, which cause accumulations of all sorts of substances that are bad for you, and that leads to poor health.

SPEAKER_00 2:00

And so where does the issue come from? Is it that because uh functional medicine operates in that space, the regulatory frameworks haven't caught up, or is it because we have a framework that's very much built on the NHS and its provision, therefore it simply doesn't have the capacity to cover that? Where's the issue in terms of the grey areas around this?

SPEAKER_02 2:21

Yeah, I think Jody, it's it's all of the above. If you think that uh, and again, I'm trying to remember PTAS sort of transitions, but you had the early version of healthcare, which in many ways is more like current functional medicine, which was you plant plants and herbs and whatever you could do, and nobody really knew what happened, but people knew that if this was wrong with you, you you know, you suck the leaves of this tree and it helped. There was sort of the early medicine, and then you moved on from that into what would now be medicine 2.0 in modern-day medicine, which is all based on pharmaceuticals, foreign substances designed to treat diseases, surgeries, the surgical intervention, all that sort of stuff. So the idea that medicine is there to take you in the state that you are and fix you is medicine 2.0, and then medicine 3.0 is moved back to that idea that actually your body is very efficient and very effective and quite good at regulating and correcting itself, but the world can push it so far out of kilter that it goes wrong and you get quite sick. But I guess the two of the sort of big phrases in it are personal and prevention. Again, you can imagine the major pharmaceuticals, there's nothing personal about a packet of aspirin. There's thousands of production lines, and there's nothing preventative about a packet of aspirin. You have a headache, you take an aspirin. So those two aspects certainly are part of what makes this whole personalised preventative and functional medicine different.

SPEAKER_00 3:52

And so where is the challenge then for someone that is uh looking to start a functional medicine practice? Is the issue that it's unclear where it starts or where they need to start seeking regulation, or what are the where do what are the common kind of pitfalls that someone has when they are when they're looking to create a practice that delivers this?

SPEAKER_02 4:17

Yeah, very much Jody. We uh internally within LSD, we we call functional medicine the the Bitcoin of the medical world, and it has a similar problem. Where does Bitcoin fit into the financial world? Um, and and what regulation do you need to worry about and adhere to? It's exactly the same in functional medicine. So, CQC, do you need CQC approval? Possibly. Do you need to be a doctor? Well, if you are diagnosing disease, you need to be a doctor. But because functional medicine is very much based on diet, exercise, nutrition, and those sorts of factors, quite often nutritionists and biochemists are probably better qualified than the doctor to determine what's going on. So we have seen situations where you have practices that have these sort of broad mix of backgrounds and skills, and you've had non-doctors giving what is you've had patients claiming that a non-doctor has diagnosed them, which would be against the GMC rules and regulations for everybody. It's a particular problem for the GMC registered owner, because the GMC will take a very dim view of having allowed that to happen in the practice, if indeed it had, which we I think that one sorted out and we don't believe that there was a problem in the end. But those are just some of the problems you face every day. You really are in a grey area where you don't quite know what regulation you need to adhere to, and even once you've determined that, you don't really quite know how you can adhere to it. And we're always there to help and advise our practitioners.

SPEAKER_00 5:48

Is it's part of the issue that you have doctor-led practices who are offering additional functional medicine services, and then they are understanding how to interact with that, make sure that the diagnosis is not happening because they're not falling out. But do you have situations where there are non-doctor-led uh practices opening up and wanting to offer services and what happens in in those situations?

SPEAKER_02 6:14

This world is a bag of problems, Jody. You have all of those problems. So if you go through all the scenarios, you can be a standard GP offering standard GP services, but like the functional approach, and that would be called integrative medicine, where you try and integrate the standard and functional approach, but you can then run into the problems of the functional approach being non-standard, bringing in other skills and other practitioners. You can be a doctor who's decided I like the functional approach, they do amazing training. So anybody who says a functional medicine practitioner is just a standard GP is badly wrong. The amount of training and knowledge they have is mind-blowing. I've been to conferences and you know, I'm an engineer by background, not a scientist, but the level of science that to me is a postgraduate biochemistry level, it's very advanced. So, you know, you have people who have all that understanding and the GPs, but that's their world. It's a different world. They've got to worry about how their regulation and their patient obligations and so on fit into that. And finally, there is to be a functional medicine practitioner, especially as they try and avoid prescribing. You need to be a registered GP to prescribe. But the whole purpose is that you use diet exercise lifestyle supplements and a variety of other things and don't prescribe, you don't resort to man-made chemicals to fix the problems. So non-GPs can set up practices, and in some ways, the tragedy is it's easier for them because they can't get struck off the GMC register because they're not on it in the first place.

SPEAKER_00 7:44

So, where is the challenge in terms of needing to say register it with the CQC? Is it clear by their own standards as to when you need to register when it falls under their purview, as it were, or is it a lot greyer than that?

SPEAKER_02 8:05

Yeah, it's probably not clear, Jodie, and there are various loopholes that people have used to not register. For us, it comes down to I think you need to think about regulation as fitting that traditional world. In a traditional world, the diagnosis and treatment of disease is a medical doctor-led activity that requires you to be registered by the GMC and then to have the CQC accreditation on the premises and all those things. All that regulation applies to a world in which you diagnose and treat disease. So there's a whole sort of spectrum on that functional medicine where some people just at one level people will just refer to themselves as health coaches, and you just get people who tell us what we all know and need somebody to remind us of, and hopefully enforce that we should exercise more and drink less and sleep more and have a better diet and all those good things. And there are people who do that, and that's great. But when you start to get into these poor people who have really chronic diseases, and those can lead to massively overweight, chronic pain conditions, chronic fatigue, all those kind of chronic modern life conditions, are actually generally down to some really quite severe imbalances in the body's biochemistry. But of course, once you're delving into that level of detail, and it does get right down to I've been to conferences where it's down to not just you need yakls and you to improve your gut microbe, it's people who are actually looking at the microbes in your gut and not just the microbes in your gut, but they actually do DNA analysis on those microbes and the different strains of those microbes. Some of these things come down to not having sufficient numbers of a particular strain of a particular microbe. And there are now people who provide supplements to supplement that, and then you know there's a whole sort of structure around that as to sort of what diet you need to feed them and then nurture them and so on. So it is, as I say, when you get into it, it is amazingly complex, but it is not necessary traditional medicine, you know, despite the complexity, at the end of the day, these gut microbes are, at least in the world of regulation, they're viewed the same as a top of Yakult that you can buy in your local supermarket.

SPEAKER_00 10:20

So presumably, the like you were mentioning there, the it's the Bitcoin, and because it's the Bitcoin, it's the exciting side of medicine that is quite pioneering, it's leading edge, uh, offering things that uh maybe other people haven't offered, and it offers the opportunity for health entrepreneurs and practitioners who are forward looking to be able to uh create these uh this new world of being able to offer these things as well. Um and because it's private, uh presumably there are costs involved, high costs because they're not offered on the NHS, and uh as a result of that, because of anywhere where there are patients pending a lot of money and results are expected, then you are going to have claims and you are going to have all those issues as well. So if you are a business who is in that space, what should you be doing to protect yourself? What should be your immediate uh focus to make sure that you're not looking back over your shoulder, you're not going to be suffering all of those things that do tend to uh overfall pioneers in any space.

SPEAKER_02 11:23

Yeah, it's uh so the biggest issue we see our client base is the claim, and this, as you imagine, in GMC regulation land is about as fatal as it gets. A claim that you are offering treatment purely for your own financial gain. It's basically, yeah, I came to you, I spent all this money, and absolutely nothing's happened. You know, you haven't given me any pills, you've just told me to do this, nothing's happened, and I've spent thousands. So you need to be very clear up front with your patients what you're doing, why you're doing it, what the costs are, what the expectations are, what the time frames are, the fact that it is uncertain, that it is not subject to, as you can imagine, this stuff doesn't have large-scale clinical trials to back it up, especially personalized medicine. How do you do large-scale clinical trials on personalized medicine? There are people, and we're very impressed by Nordic Laboratories. In fact, I should probably try and get one of the founders of that onto onto the podcast. So they've been around 30 years and they don't produce anything themselves. They just go out and they find what they think are all the best functional tests and the best supplements and so on, and then they package them up really nicely. They do really nice documentation that explains it, and they're logistic experts. They deliver to our 138 countries in the world, primarily you know, Nordic Labs, I guess, where they are in Scandinavia, Denmark mainly. But they are extremely good at all this kind of stuff, and then they encourage all their practitioners to document their results. So there is now a body of evidence growing, and actually the stuff is really quite scientifically supported on many different levels, and actually that's a big change, is in classic medicine world, this whole idea that you develop a medication or a drug, and then you do all these clinical trials, and eventually you get to these randomized trials and so on, and you that produces a positive result, and that's the pinnacle of everything. As we discussed, that's not going to happen here. So you have some clinical evidence, you have the scientific view as to what you're trying to achieve and why it might make sense, you have more overall views and processes and so on, and you have a variety of different elements. And in terms of getting comfortable in ensuring this stuff, we have to draw on what we look for is a variety of evidence from different sources that all points to the same result, as opposed to this one big towering pyramid of randomized controlled trials. That is interesting, and that is a big difference in it. But yeah, the risk is that people don't understand what you're doing and is expensive, and clearly that upsets them. And the way of managing that risk is to be very clear as to what you're doing and why you're doing it.

SPEAKER_00 14:05

And in terms of how businesses protect themselves with regards uh insurance, what is the sort of landscape like around that with a pioneering situation that's changing all the time? How often is it that they find themselves not covered correctly or not even being aware that they need cover or they need protection against claims against them for any of these things?

SPEAKER_02 14:31

I think it's what I mean. We literally speak to the insurers that support product a few times a week, and there's always something new and there's always something different, and it's making sure that we're all understand it and make sure we're happy with it and so on and so forth. It's one of those awful things uh where it is just you just have to be very clear about again, so it's all about clarity and clarity with your insurer and exact clarity as to what you're doing. Insurance laws changed, so a lot of people remember the bad old days of insurance law when the idea was that so you had to explain every risk to an insurer. So you know, if you had a garage and you park your car on the road, you had to tell your insurer that you park your car on the road, otherwise they could say you didn't declare that to me and you know invalidate your uh the claim for somebody stealing your car. Um and that really did happen back in the bad old days of insurance in the sort of mid mid-10s, so about 1950, sorry, about 2015, or so the law has sort of caught up with the fact that generally on your car insurance, your insurance is thousands of claims a day, so they know they know a lot more about the risk than you do. So your obligation now is to give your insurer a fair assessment of the risk. And the test is had the insurer known that piece of information, would they have still accepted the risk? And if they would have still accepted the risk, their only recourse is to say, oh, you know, had we known that, we would have charged a bit more premium for it so they can keep a bit of premium back from the claim that they pay. So it's improved a lot. But when you start to look at this stuff, so to me, in this whole sort of space that we're talking about, peptides are going to be the classic example. So peptides are uh very short chain amino acids for our audience who know these things, and they are biologically extraordinarily powerful. In fact, the the weight loss drugs, GLP1 drugs, are peptides. Now, again, for analogies, and uh I I started my career in IT, which I wasn't very good at, but I still have friends and contacts who are from IT, who are good at IT and also do uh uh also do pharmacy actually, so so help us a lot with this. And they describe peptides as the machine code of medicine. They are the most fundamental building blocks, so they affect the body in the most basic fundamental way. Uh so they are incredibly powerful, uh, and and you see how powerful the weight loss drugs are. The problem is the weight loss drugs do one thing, or you're using the weight loss drugs to affect certain biochemical pathways in certain ways, and they're brilliant at that. They also do dozens of other things affecting dozens of other pathways in ways that you don't know, which go on to affect other pathways in ways that you don't know. So the problem with peptides is you just simply don't know what the side effects are uh of them, and those side effects can be quite powerful. But because peptides are naturally occurring substances in the body, they're not licensed medications, they're food supplements. So I can go to my insurer and say, all I'm doing is recommending food supplements, and my insurer will go fine, but my insurer, in my insurer's mind, I'm going, you know, go and get a tub of vitamin C pills from Holland and Baron. When I present a claim with I've given them, you know, BPC157 is one of the sort of most popular peptides. It increases blood flow and reduces well, with your running, you might have heard of it. It increases blood flow and reduces injury and inflammation, and you recover from injury much faster. But it also stimulates all the pathways that various cancer drugs try to suppress. So there could be a well unknown link because it's never been tried, and there aren't trials or any evidence between this and cancer, or at least enhancing cancer. So when I turn up to my insurer and say, I've got this claim from giving food supplements, my insurer's probably going to go, had I known that, I wouldn't have insured you.

SPEAKER_00 18:30

And so does that mean that you then have a burden to declare as much as possible with your insurer uh specifically about what you are doing and doing it in such a way that does guarantee that you're protected?

SPEAKER_02 18:46

Yeah, I think it's also if you think it's a fair presentation of the risk, so it's really ensuring that you understand the risk and that you make sure that your insurer is aware of that risk so they can make a decision on that. Uh so interestingly, we are just starting. So we have got sign-off to cover BPC 157 as a peptide, and we've done that because we've understood the risks. And my friend I mentioned, he's a pharmacist, wrote us an enormously detailed report on the whole thing. So we know an awful lot about it, and we could work out how we got comfortable with managing or at least getting informed consent, and we've talked about informed consent before for the additional risks of BPC 157, and that's how we we can get to a position where we can offer insurance on it. So the devil's in the details, you have to understand that as a leading-edge medical practitioner, you're probably one of a quite a few, a very few people who really truly understand the risks, and you have to make sure your insurer understands the risks, and you have to be very comfortable the insurer has understood and accepted those risks. And I think our warning would be uh that most insurers will probably just glaze over and not accept it. You know, where we're putting ourselves is uh out as somebody who can understand that risk, and we run a team to understand that risk, and we work with insurers who are willing to also put the work in and listen to that and understand and accept that risk. So that you know, when it comes down to that fair presentation test, you have done a fair presentation and they've accepted they've accepted what you're doing.

SPEAKER_00 20:23

And so for people operating in that space, they don't have the threat of being struck off. So what is the main threat a commercial threat from suffering from uh issues with claims, not being shored correctly, essentially threatens the business itself, or are there any other kind of existential threats by not doing this the right way?

SPEAKER_02 20:45

Yeah, uh I'm gonna Roger's here with me. I'm gonna throw this one at Roger because I'm I keep speculating that actually it's on our weekly get-togethers with a wide-ranging conversation, but this one hasn't come up yet. So, Roger, yeah, yeah, here's your input. So if I'm if I'm a nutritionist and and I recommend a whole bunch of peptides to someone and so on, then oh well effectively yeah, I diagnose. So if I'm a nutritionist and I diagnose a disease, then you can't complain to the GMC because I'm not GMC registered. But strictly speaking, I've broken the law. So actually your biggest threat is literally somebody who's going to nick you for impersonating a doctor or something, I guess.

SPEAKER_01 21:36

Yeah, and you'll have your own institute, whether it be a college or a health professionals council. So the fact that you're not a doctor.

SPEAKER_02 21:44

Yeah.

SPEAKER_01 21:44

I mean, as we generally say the healthcare sector is the most regulated broad profession, maybe second to the civil aviation. Who knows? But yeah, if it's not a GMC, it'll be someone else, Health Professions Council. I mean, quite a lot of these people are are nurses. Of the Royal College or nutritionists or nutritionists, yeah. And as you as you rightly say, it's only a doctor that can make a diagnosis and prescribe is the other thing. I mean, not with peptides because they're a food supplement. But yeah, if I see an evolutionary risk, which we do talk about, it's the bleeding between those categories that is the biggest risk for those that are not a doctor.

SPEAKER_02 22:24

Yeah. So in short, Jody, yeah, I think the conclusion is so strictly speaking, technically, you have broken the law. Now, whether the law is going to do anything about that is uh is a big question, but you are almost invariably going to be regulated somewhere. So it's probably the GMC can't do anything about it but your own regulator, and uh GMC won't be averse to phoning up any other regulator and saying, you know, what's your man doing?

unknown 22:51

Yeah.

SPEAKER_00 22:52

Okay, so so the risks will be from from your regulator, but also from a regulatory perspective based on your whichever regulatory body that you're operating through. So to round this off, then what is it that someone should do? So that they have they just want to make sure that they are covered, make sure that they are in the right place to continue pushing that growth, continue thriving, offering these forward-thinking services. But what do they what would they need to do right now just to make sure that they are properly covered, properly protected, so they can carry on doing so?

SPEAKER_02 23:30

Yeah, I mean it is, and uh and actually we like our clients who do this because it shows they're they're taking their insurance and their indemnity seriously. If you've got any concerns at all, you should be phoning your insurer, your broker, or whoever arranges your insurance for you and asking them a list of fairly awkward questions about do you realize that I do this? I mean, again, Chancellor. Just make sure your insurer really knows what you do and where you think the risks are.

SPEAKER_00 23:56

So it's about having a conversation with them and being open and honest and just not having that assumption that they uh fully understand it because you are working so far ahead of where the regulatory frameworks and and the law is working.

SPEAKER_02 24:10

Yeah, to take the example of food supplements, you know, if if I say food supplements to you, Joe, you you probably, you know, what do you think of? Whereas somebody's actually sticking in a very technical sense, that is some enormously powerful biological agents.

SPEAKER_00 24:24

Yeah, well, that's brilliant. We've gone into quite a lot of detail there about functional medicine and the risks. And everything that I think we've talked about in previous podcasts as well applies to this about making sure that documenting what you're doing, communicating effectively and everything feeds into this, all of these things. And of course, if anyone's ever unsure about it, they can always give you a call and you're happy to speak to them.

SPEAKER_02 24:45

Absolutely, Jody. As we say, we're not a sales outfit. If somebody just wants to have some advice, we're always happy to chat.

SPEAKER_00 24:52

Thank you very much, CRISPR. I'll see you on the next episode. Thanks, Jody. Thank you for listening to Confidence to Thrive. Before you go, please rate, review, and subscribe to Confidence to Thrive on your preferred podcast platform and help us spread our message to others who are making a difference in private healthcare. This podcast was brought to you by Ouritity, insurance advisors who support your business ambitions. Our litity advises practitioners, owners and entrepreneurs of healthcare practices on mitigating risks so your business can thrive. Learn more about how OurLitity can support you by finding the link in the show notes or visiting our literity.co.uk.