Biome Bites Ep011 - Supplements performing like drugs

In this Biome Bite, Dr James McIlroy discusses the differences between food supplements and drugs, including their regulations and pricing. He suggests that some food supplements may be better than drugs for certain uses and indications, despite the higher standards and stringency for drugs.

What are the differences between a food supplement and a drug?

There are some key differences in the regulations. And those regulations govern how they're manufactured, how they're tested, the levels of quality assurance, and also the level of evidence. that has to be generated for them to be able to be put on the market.

So drugs are regulated by competent authorities. In the UK, it's the Medicines and Healthcare Products Regulatory Agency. Food supplements are regulated by food standards agencies. In the US, interestingly, they're both governed and regulated by the same group, the FDA, Food and Drug Administration, but they're separate divisions within that very large organization that create the standards that the companies and the organizations that are manufacturing, distributing, and marketing have to adhere to.

Now, classically, there are significant price differences between drugs and food supplements, and that's driven by the level of evidence that the companies have to generate to put the products on the market. And there's much higher stringency and standards in drugs rather than foods. Drugs often fail in clinical development as well because the standards are so high.

Therefore, the drugs that are on the market are priced by the companies to be able to recoup losses from a company-wide perspective, associated with failed drugs, and also to make a significant return, typically within a patent life. of an approved drug. Back to the topic. Food supplements could be better than a drug for certain indications, and certain uses.

Timestamps:

00:00:00 Intro

00:01:46 Key differences between supplement and drug

00:03:14 Lysine

00:09:54 Quercetin

00:15:19 Melatonin

TRANSCRIPT:

Biome Bites #11

 

Hi everyone, it's your host Dr. James McElroy here today for another Biome Bites. This is a solo episode so you have me and only me for the entirety of this episode. Today we're going to be speaking about three food supplements that could be better than drugs. Or rather, in a parallel universe, may in fact be regulated and distributed, marketed, and prescribed as drugs.

So what are the differences between a food supplement and a drug? There are some key differences in relation to the regulations. And those regulations govern how they're manufactured, how they're tested, the levels of quality assurance, and also the level of evidence. that has to be generated for them to be able to be put on the market.

So drugs are regulated by competent authorities. In the UK, it's the Medicines and Healthcare Products Regulatory Agency. Food supplements are regulated by food standards agencies. In the US, interestingly, they're both governed and regulated by the same group, the FDA, Food and Drug Administration, but they're separate divisions within that very large organization that create the standards that the companies and the organizations that are manufacturing, distributing, and marketing have to adhere to.

Now, classically, there are significant price differences between drugs and food supplements, and that's driven by the level of evidence that the companies have to generate to put the products on the market. And there's much higher stringency and standards in drugs rather than foods. Drugs often fail in clinical development as well because the standards are so high.

Therefore, the drugs that are on the market are priced by the companies to be able to recoup losses from a company-wide perspective, associated with failed drugs, and also to make a significant return, typically within a patent life. of an approved drug. Back to the topic. Food supplements could be better than a drug for certain indications, and certain uses.

I'm going to start with something called Lysine, also known as L Lysine. Lysine is an essential amino acid. Now, there are nine essential amino acids that we're aware of for the human body. That means that they cannot be synthesized by the human body and have to be consumed, have to be generated by your diet, so you have to consume them, you have to find them through some sort of intake, whether it's through food or a supplement.

High protein foods are rich sources of all the essential amino acids, red meat, poultry, fish, pork, nut, legumes, and soy products from a plant perspective, also contain a wide variety of amino acids. Typically they don't. contain the complete sets of amino acids in the case of plants. And interestingly, from a protein bioavailability perspective, animal proteins are typically more bioavailable than plant proteins.

What are we talking about now in the context of lysine? We're not talking about muscle hypertrophy. We're talking about cold sores, which are generated by the herpes simplex virus. And there are two that we typically discuss, HSV1, and HSV2. Typically there are cold sores on the face, but of course, there are also cold sores that can happen elsewhere in the body, most typically the genitals, HSV 1.

Impacts the face, and HSV2s typically impact the genitals, although I think there can be some vice versa in there. Now, classically, when treating a cold sore, the medical community would prescribe an antiviral medication that can be topical. Ciclovir, commonly known as Zovarax, now is an over-the-counter medication.

We can get into the differences between over-the-counter medications and prescription medications a different times and on a different podcast. But it would be typically an antiviral medication, topically, or systemic. Lysine has antiviral properties, which have been most classically demonstrated in what we call in vitro experiments.

So these are experiments. In a test tube, essentially, where there's no living organism or living thing like a mouse or a rat or some other different species. Now, Interestingly, there is quite a good bit of evidence for lysine as a supplement for the prevention and treatment of cold sores in particular.

I think there is some evidence as well for genital herpes, but the majority of the evidence exists for oral herpes, which is essentially synonymous with the term cold sore. So what does the evidence show? The evidence shows, fascinatingly, across a range of studies, for the most part, that lysine supplementation can prevent or reduce the severity, and by severity, we're talking about how many are there across a particular defined part of the body, in this case, the face, the severity beyond just how many there are, so how deep are they, how sore are they, there are other mechanisms.

and predetermined parameters that clinicians and people working in this field use. And how long are the outbreaks? So what people have found is that daily supplementation with lysine in people who are prone to cold sores can, as I said, prevent and reduce the severity. Increased use of lysine during a cold sore outbreak can accelerate the time frame in which you have cold sores, so reduce the time frame that you have cold sores and indeed make the outbreaks less severe.

That's fascinating, right? Now in terms of dose typically one to three grams a day for the treatment. That's one thousand to three thousand milligrams per day for as long as you've got a cold sore. If you can feel a sort of what we call prodromal type syndrome coming on where you've got a bit of a tingle.

Some people know if they're about to get one things feel a bit strange in their face or elsewhere in their body. And that would be a good opportunity to load up and from a preventative point of view, it would typically be 500 milligrams. That's 0. 5 of a gram taken every day. Wide variety of sources available.

It's quite a cheap supplement. So you can get a tub of 30. Excuse me, I was just taking a drink. You can get a tub of 30 for between 5 and 15 pounds depending on the source. Now, you can take a lot more lysine than that. I had a look for the LD50, which is a pharmaceutical, clinical phrase used to describe what the lethal dose is of a medicine, and the LD50 was at an insanely high level.

That means you can probably take more than three grams a day. You could maybe load up to five or 10, see how that works for you. I've certainly done that. You can also get lysine as a topical formulation. Typically in the US, it's hard to find in the UK, so if you wanted a double whammy approach, you could take lysine systemically and you could also apply it topically around your lips.

It doesn't seem to interfere or cause pain. In the formulation that I've seen, it's more of an ointment rather than a gel. Or a powder. It just makes your lips a little bit shiny. Now, what about the evidence? The evidence is quite strong in some respects, but it's also mixed. The studies are not ideal insofar as they're not very large for the most part, and typically they're conducted in compliance with standards that you'd associate with a food supplement rather than a drug.

As I said at the start of this podcast, the Stringency, the level of regulation and rigour in the clinical studies is less for a food supplement than it is for a drug. So you might be wondering why has the pharmaceutical industry not jumped all over this. And I have to say anecdotally, i. e. based on personal experience, but also other people's personal experiences outside the confines of a robust clinical study.

The evidence for lysine is pretty awesome. Some people swear by this, absolutely swear by it. I am prone to cold sores around my lips when I'm stressed. It runs in the family. Interestingly, my dad never gets them, and has never had one, but my mum is prone to them. So there are obviously some genetic predeterminants there around how bad your outbreaks are.

But I, I've been taking lysine every day for years now. I was put onto the evidence by a former colleague called Dr Michael Butler. So shout out to you, Mike. If you're listening, I'm still listening to your advice. And here we are on Inside Matters talking about it in front of other people. So if you're prone to cold sores, I would recommend you give lysine a try.

In a later episode, we're going to be talking about how to select a good quality supplement so if you want to wait before buying until that episode it'll be coming out within the next week or two. So that's supplement number one, Lysine. Supplement number two is Quercetin. Quercetin spelled q u e r c e t i n and we'll have some post-show notes as well.

It's a type of flavonoid Flavonoids form part of a broader category called polyphenols and if you've been listening to this podcast You will have heard of the three P's prebiotics probiotics polyphenols again and again and if you want to take care of your microbiome the broad principles are, eat real food and focus on prebiotics, probiotics, polyphenols There's a plant pigment that's found in many fruits and vegetables this is quercetin I'm talking about now.

It has antioxidant, and anti-inflammatory properties, some people even say it has anti-carcinogenic properties, i.e. anti cancer. What kind of fruits and sources in the diet is it found in? Onions, apples, vegetables, grapes, tea, and Red wine. But we've talked about red wine in the past in the podcast as well. And if you want to get quercetin in high doses, I would recommend you look at a supplement.

So the one key benefit, I believe, from quercetin in the context of this supplement versus drug discussion is that it has antihistamine properties. So the histamine pathways are heavily implicated in allergy and allergic reactions. And these can range from what we call atopy, so a very mild type reaction, where you maybe get some inflammation in your skin, to anaphylaxis, where you have a total.

almost catastrophic systemic, so total body reaction to an allergen. Now Quercetin has antihistamine-type properties. There's a variety of evidence available to suggest that it can reduce the severity of allergy and atopy including hay fever. So for some reason, it stabilizes histamines from certain cells.

I'm not 100% sure what the pathways are that can reduce allergy symptoms. Typical doses range between 250 milligrams, and 600 milligrams per day, taken in divided doses throughout the day so you're not just getting a big dump of quercetin at some point in time. Now more studies are required for a definitive conclusion.

And we go back to the lysine discussion. Why are the pharmaceutical industry not all over this? They exist as food supplements already. It's hard to get a strong intellectual property position based on the studies that already exist, based on the fact that it's already ubiquitous as a food supplement.

And typically the pharmaceutical industry is only interested if it can have a defined intellectual property patent position. Ideally, sometimes they're okay with know-how, but basically, they're trying to stop people from copying and eating into market share. Reversing out now, from quercetin specifically, into flavonoids, bioflavonoids more generally, forming part of the bigger polyphenol complex.

The human body doesn't efficiently absorb all the flavonoids because of the complex structure that these compounds take. and the microbiota. through a series of bacterial enzymatic reactions, i.e. enzymes contained within the metabolism of bacteria can break down the bioflavonoids into smaller, more bioavailable compounds.

Now, this is one of these, we feed the microbes, they feed us, type discussions. And the things they feed us are classically beneficial. So The flavonoids themselves through the actions of the microbiota have several anti-inflammatory, potentially anti-carcinogenic properties. They may strengthen gut barrier function as well and we've talked about epithelial integrity a lot on this podcast.

Gut barrier integrity aka leaky gut. If you want more listen to the episode with Dr. Laura Craven on that. So there's some evidence to suggest that the flavonoids found in foods including quercetin, which is one of the best-studied flavonoids, can impact cardiovascular disease risk factors, certain cancers, and obesity-related complications, and part of that must be through their interaction with microbiota.

One final point. I believe that flavonoids are synergistic with fibre. Fibre, we talk on this podcast a lot. All prebiotics are fibres, but not all fibres are prebiotics, right? Prebiotic is a type of fibre that promotes the growth of beneficial bacteria within the gut and there is absolute synergy between fibres and flavonoids.

The good news is that the flavonoids that come from plants can have high fibre. There's a synergy there. So if you're eating colourful plants, You classically have a lot of flavonoids and you have a fibre content there as well in the form of cellulose, but also other prebiotic substances like, for example, pectin and inulin.

So that's quercetin. If you're struggling with allergies, you're allergic to a cat, you're allergic to a dog, or you have hay fever. Maybe give quercetin a try. Also personally, based on anecdotes, based on what I've seen, and based on the people I've spoken to, quercetin can also have an impact on systemic inflammation.

So if you've got achy joints, quercetin has been reported to be beneficial in some people, much like turmeric potentially has some benefits as well. Cercumin potentially has some benefits too. Now, number three on this list, and we're getting to the end of the podcast now, melatonin. Melatonin is a hormone produced by the pineal gland in the brain.

The pineal gland sits close to the pituitary gland if you're more familiar with that. And it helps regulate the body's sleep-wake cycle. Just as a brief aside, I like to go a little bit off-piece sometimes. The pineal gland is also thought to be the source of something called dimethyltryptamine, also known as DMT, which has very strong psychedelic properties.

Some people believe large amounts of DMT are released by the body in Death, which is why people who have near-death experiences report similar experiences to people who've taken DMT recreationally. Okay, back now to the drug versus food debate. Melatonin is not found in foods. It's quite hard to find hormones in foods.

Classically to do with the stability of the compounds metabolized by whatever it is where you're getting the source from. So if it's a slice of meat, then it would not find its way into the meat that you're eating. Now melatonin potentially because it's part of what we call circadian rhythm, i. e. your sleep-wake cycle could have beneficial effects in helping you get to sleep.

There's some evidence to suggest that for people who have jet lag, so people who work in shift patterns, melatonin can be a good way to reestablish a normal circadian rhythm. Now, the evidence is a little bit mixed. Some evidence suggests that it can improve sleep quality. And reducing the time taken to fall asleep.

Others say that it doesn't improve sleep quality, as measured through your sleep cycles, but may indeed reduce the time that it takes to get to sleep. This is another one of these anecdotal ones, where you have to try yourself, I think, to really understand how it affects you. Anecdotally, some people who take melatonin can feel groggy in the morning, they can feel slow, they can have brain fog, they can also feel a little bit nauseous, whereas other people, it gives them an amazingly deep sleep.

And our recent episode with Andy Scott, the bodybuilder, revealed that he's very big on melatonin. He takes a big dose. Classically, the recommended doses are 0. 5 to 5 milligrams. Andy was taking 10 milligrams. That's a lot, but he's also a very big guy. So if you're having trouble falling asleep. If you're doing a lot of international travelling, you should consider melatonin.

I would prefer melatonin to some of the other drugs that are available for sleep. Zopiclone is a classic one, but Zopiclone has an impact on REM sleep and other sedatives like GABA, and Agonist. So for example, the Azepam. are not things you want to be taking regularly at all because they have a high risk of developing dependency and a sort of rebound withdrawal effect can occur quite easily with limited use.

Interestingly with melatonin, there doesn't seem to be what they call this rebound insomnia, i. e. you stop taking it, you can't get sleep, that doesn't seem to exist based on what I've seen. And there are some people, classically people who describe themselves as naturopaths swear by melatonin for infections too.

I've not done much research on this. I'd encourage you to look at it yourself, but it might be an additional benefit. Melatonin as an antioxidant across the blood-brain barrier may be effective in delaying, preventing, and being involved with the development of some neurodegenerative diseases, most notably Alzheimer's.

So we're coming to the end now of this podcast. I just wanted to emphasize that none of what I've said today constitutes a practice of medicine. It does not equal the giving of medical advice. You should consult with your healthcare professional before embarking on a supplement routine.