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Do Supplements Contribute to Brain Health

Steven DeKosky, MD, discusses whether supplements contribute to brain health. He will describe the difference between rules that apply to FDA approved drugs and supplements advertised to provide health benefits or support good health, that is not FDA approved.

He will recognize the reasons why such differences in regulations exist and the difficulties of treating brain disorders while providing healthy nutrition to the brain.
Do Supplements Contribute to Brain Health
Featuring:
Steven DeKosky, MD
A distinguished lecturer on multiple dimensions of Alzheimer’s disease, Dr. DeKosky is a frequent commentator on brain aging for the press and has advocated for programs and support for people with dementia nationally and
internationally. 

Learn more about Steven DeKosky, MD
Transcription:

The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education, ACCME to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of .25 AMA PRA category 1 credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity.

Melanie Cole (Host):  Welcome. This is UF Health MedEd Cast With UF Health Shands Hospital. I’m Melanie Cole. And today, we’re discussing whether supplements contribute to brain health. We’re going to describe the difference between the rules that apply to FDA approved drugs and supplements that are advertised to provide health benefits or support good health that are not FDA approved. We’re going to recognize the reasons why such differences in regulation exist and the difficulties of treating brain disorders while providing health nutrition to the brain. Joining me, is Dr. Steven DeKosky. He’s the Deputy Director of McKnight Brain Institute, the Aerts-Cosper Professor of Alzheimer’s Research, Associate Director 1Florida Alzheimer’s Disease Center and a Professor of Neurology and Neuroscience at the University of Florida. Dr. DeKosky, thank you so much for joining us today. Tell us a little bit about what has been the thought previously about supplements and brain health.

Steven DeKosky, MD (Guest):  From the mid to three quarters of the way through the 20th century, no one thought very much about brain health per se at least as far as health maintenance was concerned. There was increasing attention to the fact that there were ways that we could prevent disease especially heart disease which was a major focus and stroke which was also a major focus, also somewhat related to cardiovascular disease. But it wasn’t until the rise in awareness of Alzheimer ’s disease and stroke dementia in the later parts of the 20th century that people really began to look at what could be done to either prevent or stave off the effects of the neurodegenerative diseases. With that, came I would call an economic opportunity for companies who made supplements that had a logic you could apply to their use in people based on what we knew about the pathobiology and thus an industry emerged that was able to take advantage of the fact that people have become increasingly concerned about their global health yes, but certainly about their brain health.

Alzheimer’s Disease has become one of the most feared disorders of late life and that has fueled the use of brain supplements across the country and in fact, in other countries as well. So, a lot of this has to do with the two different ways that we regulate things that people can take that are either dietary supplements or medications and in fact, the explosion of dietary supplements has been due to what many physicians think is a hole in the regulatory aspects of what people can sell and what kind of claims they can make. There are about 85,000 different dietary supplements sold in the United States in 2018. It was worth about 40 billion dollars in retail sales and 121 billion dollars worldwide.

So, what the study that we did tried to do was survey representative sample of adults who were 18 and over and how they used the supplements and above 50 and older was a major focus because this is the time that people really become concerned about their health moving into late life. So, it’s a burgeoning industry. We published a paper in collaboration with the Global Consortium for Brain Health and the American Association of Retired Persons and this survey was showing that over 25% of Americans 50 and older regularly take supplements specifically for their brain health. This clearly is something that has the population concerned. It has represented a commercial opportunity. And it is a very different world from the world of FDA approved medications for specific indications.

Host:  Well it certainly is and it’s a fascinating topic doctor, so tell us a little bit about the difference, before we talk a little bit more about your survey; tell us a little more about the difference between the rules that apply to those FDA approved drugs and supplements that are advertised that you just spoke of to provide these benefits for the brain. In general doctor, if the FDA considers new drugs to be unsafe until they’re proven safe, through clinical trials, such like that; does that mean that dietary supplements are considered safe until proven unsafe? Is that what we’re looking at right now?

Dr. DeKosky:  I think that is a view of many lay people. However, it does not mean that they’re safe until proven unsafe. They haven’t been tested. If you look on the label of all of the supplements, most of which are sold under a medical foods concern or medical foods label that is not under FDA supervision; all of these will contain a statement that say the FDA has not reviewed or proved any of the statements made by these people. When you look at the statements that are made, it is really remarkable that all kinds of things usually ending up with a comment that this particular nostrum preserves your brain health and then you look down at the bottom and it says these have not be shown to prevent or treat any disorder. And that’s somewhat where the holes are. If you see the ads on television or if you read the ads in print or see them on the internet; they still have this separation between what’s out there that you can simply buy over the counter and what is only sold by prescription.

Now the use of supplements has a long history all over the world that when people talk about snake oil salesmen; snake oil was sold for some particular cure back at least in the 1800s and supplements have been unregulated for a long time. The advent of the government assuming oversight for safety of some medications began as usual, with early disasters where something particularly toxic was given to members of the public and eventually regulations were made in the early 1900s all the way through to the last decade or so which called for the qualifications that you just mentioned. The medications have to be safe and they have to have efficacy. They have to work in some statistically significant way to either treat or defeat a particular disease for which they are intended.

That requires as most physicians know, a rigorous set of studies that are approved first by the FDA to say if you design your study the way you have done it, the way you have presented it to us and you are using the statistical plan that you’ve showed us; then you could submit that for approval and a mark of the caution is that you usually have to have at least two studies that show a statistically significant effect and you have to show through the use of a drug monitoring safety committee that there are not excessive harms that occur in the treatment. And usually, many drugs of course don’t make it into those so called pivotal trials, phase three trials because toxicity puts an early end to their potential use.

But if you can show that the drug does not have a serious safety profile that is problems with excessive amounts of side effects and you show that the drug was statistically significant, they you are on your way to an FDA approval for a medication that can be prescribed by physicians and some other healthcare professionals. That is not what is done with the food supplements which due to what I would consider a hole in our regulations, anybody can sell and make almost any claims as long as they don’t get too close to that third rail of claiming something excessive. In fact, within the last six months, the FDA issued letters of reprimand to 17 different companies that made supplements with the argument that they exceeded their ability to make claims about their products claiming that they treated diseases or that they provided preventive techniques that had not been proven and that they had to cease and desist and they’d be fined or worse if they did not do that.

You could fine some of those in my view, overestimations of the ability of these medications to work in almost every one of these supplement ads. In Americas, there are two things; number one, we’d like to be able to do everything we want to do and then have a pill that will fix it and we also don’t like to be constrained by someone saying oh, no that’s not safe for you. So, that’s what’s led to this multibillion dollar industry and with incredibly beautiful advertisements and seductive language about how healthy this will make you. My joke is that you could take the narrative of these ads and substitute whatever organ is of your interest and you can say this will maintain prostate health, maintain brain health, maintain heart health and none of those things actually are proven and in fact, at the bottom of the labels of all of these things and sometimes at the bottom of the ads on television, there is that quote that the FDA has not approved any of these things for treatment of disease, prevention et cetera, et cetera.

So, it’s an odd situation. It’s a loophole as far as I’m concerned for public safety but as long as, as you said, they have not proven excessively toxic and when they do they are taken off the market as several things have been over the last twenty years; people continue to sell these medications and people continue to take them and I did have a statistic on the number of people I think over 50% of the people over 50, believe that they’d seen advantage of taking these medications. Now of course, if they are taking a drug that is or a supplement that is supposed to prevent disease and they haven’t gotten a disease, they may feel that well it’s working. So, part of the other compelling aspect of this and where it gets tricky is many of these supplements are real chemicals or real enzymes that have an effect in a domain in which we know pathology occurs in human disease.

I’ll give you an example. We know that oxidative stress occurs in a number of diseases absolutely in Alzheimer’s Disease and to some extent Parkinson’s Disease, absolutely in cerebrovascular disease. So, if you have oxidative stress, if you give something that enhances oxidative metabolism, relieves oxidative stress; that is an antioxidant; well doesn’t that make sense? Let’s take that like we take anti-cholesterol pills. The problem is, that when we have done these kinds of studies as the FDA requires them; in a double blind placebo controlled trial; we have not found that any of these exogenous pills still sold as supplements do actually have a significant effect and I’m sure that if companies could prove that, they’d like nothing more than to go to the FDA and get it approved for prescriptions.

And we’ve seen that with a number of medications. I led a very large trial in the ought’s of the 21st century on ginkgo biloba to see if it could prevent disease in late life in people with either normal cognition or mild cognitive impairment. It was a six year study. People were heroically volunteering to do this, 3000 people. We didn’t find any effect of it slowing down the entry into mild cognitive impairment or into dementia. None at all. Proved it was safe. Didn’t have a lot of harmful side effects. But it didn’t work.

Now, if that study had proven positive, I’m quite certain that the companies who did the extraction from the ginkgo tree to make the extract that is used would certainly have applied for a prescription ability in the United States and other countries. As it is, the sales which I think approached 250 million dollars a year, I think that’s right, in the early 2000s dropped to 100 million or so by the end of the first decade of the 21st century.

So, there is this temptation if you can prove that it works, you can go to the FDA to get approval which certainly would help you sell these, but when you see advertisements, this is part of that crossover of logic that says this has been tested by laboratories and very careful language about exactly what those laboratories proved; usually that it’s safe, the inference is that it also is helpful for disease or prevention of disease. So, the issue lies to a major extent with regulation and of course, with all of us wanting to remain healthy and as I said, with this new emphasis on maintaining brain health which as the Boomers move into late life; as everything else this generation has done, they’ve transformed things, has swelled the numbers of people who are looking for supplements or ways to stay healthy. And there are some, but they are not just taking a pill unfortunately.

Host:  Well Doctor, I read about the antioxidants as well and I find that fascinating that pills versus foods. So, while you’re talking about this, and before we wrap up, what is the consensus Dr. DeKosky, what about the difficulties of treating brain disorders while providing healthy nutrition to the brain, if they’re allowed to discuss structure and function, but not reversing or slowing disease process; what’s a neurologist to do?

Dr. DeKosky:  The conclusion of the ARP GCBH Group was save your money. That none of these brain supplements work. None of them have been proven to work. And if somebody says I have proof that they work, I would be happy to see it. But, the better thing to do would be to take the moneys you would have spend on the supplements and invest them in healthy diet. One of the fascinating things about a number of these studies especially carefully done dietary studies indicates that if we give people pills for supplements, we do not see the kind of prevention effects or at least a lower group of people getting disease who take supplements. They don’t seem to have that happen. But if they eat foods that have those antioxidants and other nutrients in them; those are the people in whom we do see a decreased prevalence of dementia or of other late life diseases.

To me, that says that unlike our usual idea that if some is good more is better, giving the pure drug doesn’t happen to help. We’re pretty complex. Our brains, heaven knows are complex. And I think the reason that we can see it in good diets is because first of all, everything is complex, and it isn’t just a big dollop of vitamin C for example that you get in an orange or just a big dollop of an antioxidant in broccoli; there are a lot of complex things that happen during the course of nutrition. A lot of them probably have been evolutionarily specified.

But what we know is, when we look back at studies that compare pills to people who have gotten the same supplements via diet; the diet participants are the ones who show less disease. And that’s the major reason we’ve said save your money, if you want to help your brain, you do the things that do help maintain your brain. Exercise, proper diet with the right kinds of foods in it, no excessive sugars, keep an active brain, continue to be actively engaged with social groups, playing games works. There are all sorts of things that are associated with, in retrospect, less cognitive decline in late life.

One of the other things that everybody has to keep in mind is that just as aging is a slow process, the development of many of these neurodegenerative diseases is a slow process. Which means that you can’t come in, simply take a pill and bang there you are, you’ve helped it. The best thing that the Boomers could do is as soon as they can, start to develop these good habits or continue them. Turns out that we think most of the plate being set for the development of the neurodegenerative begins at midlife. Over and over again, we see for example, that high cholesterol in midlife, is associated with an increased rate of neurodegenerative disease. High cholesterol in late life is not. It probably has to do with diet in midlife, hypertension in midlife, cholesterol in midlife and a variety of other things including stressors and other things that to some extent we can control and others we can’t. Certainly exercise turns out to be an incredibly good medicine, one that we didn’t really even suspect until the NIH made a focus on studies of exercise and global and brain health in the – around 2010.

The same things that we hear about the microbiome, also were focused on the microbiome attempts or efforts of the NIH to try and investigate this and yield grants to do it and we do find that the microbiome changes in people who eat a healthy diet and most of those things, when you look at them in experimental animals at least, do facilitate positive brain health, positive brain changes when people stay on them. So, healthier population would certainly benefit from doing this for as long a period of time in their lives as they can and that is sort of at the opposite pole of saying yeah, when I’m 55, I’ll start taking a pill and everything will be fine.

Host:  Dr. DeKosky, what an amazing segment and so interesting. Thank you so much. Before we wrap up, do you have any brief final thoughts that you’d like to leave other providers with about the study with the Council, the Global Council on Brain Health that found that dietary supplements do not improve brain health or prevent cognitive decline?

Dr. DeKosky:  Well the first thing to say is that that study did survey the literature across multiple fields, epidemiology, psychology, medicine, nutrition, and so forth and could not find evidence for this. the second thing is, that I don’t argue with my patients when they take supplements. I insist that they tell me what they are taking because often people don’t think the things, they get from the health food store are medicines in the classic sense and so they often leave them out. But if someone believes that they are taking something which is helpful, I have three rules. The first is, it cannot interfere with any of the medicines that they are taking. The second is that it needs to have some logic for the reason they want it. And the third is it cannot cost them so much money that it is a hardship for them. Because given the fact that it is unproven, there is no reason in my view to have a financial hardship associated with taking something that the best of medical science says doesn’t work. Keep in mind that there are no placebo studies done with these in general. So, when someone comes in and say I am taking supplement X and boy it’s really helping me; almost surely, that is some degree of placebo effect but I would not want to fight that in my patient if it’s cheap and if it doesn’t interfere with the other medications they are taking.

And some of these supplements do have some biological effects that could interfere with medicines they are taking. So, always ask if you have a patient who has or is worried about a disease and make sure that you’re educated about the potential side effects and the interactions of those medications with whatever meds they are taking. And finally, that I always ask them well, what does it cost you. I don’t think that’s an intrusive question. What does it cost you per month to take these pills from the health food store? And sometimes I just sort of nod, okay, I do not believe this is helpful but if you do, you don’t have to stop and sometimes, my mouth drops open at how expensive things are that people are taking. And this is because as I said, we have a bit of a hole in our approval process for things that can be advertised as quasi medical.

Host:  Wow, thank you so much Dr. DeKosky. Absolutely fascinating. Thank you so much for joining us today. And that concludes today’s episode of UF Health MedEd Cast with UF Health Shands Hospital. To learn more about this and other healthcare topics at UF Health Shands Hospital please visit www.ufhealth.org/medmatters to get connected with one of our providers. Please remember to subscribe, rate and review this podcast and all the other UF Health Shands Hospital podcasts. I’m Melanie Cole.