With 3/4 of adults, 4/5 of elderly individuals, and 1/3 of children taking dietary supplements, it is imperative that healthcare professionals understand what their patients are ingesting and why, and how this may affect other treatments, including for CVD. Guest Rhonda Cooper-DeHoff, PharmD, also addresses cannabinoids, and resources to help you and your patients navigate the sea of dietary supplements.
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Geralyn Warfield (host): Thank you so very much for joining us today, where we're going to be speaking with Dr. Rhonda Cooper-DeHoff about supplements in cardiovascular health. Dr. Cooper DeHoff. could you tell us a little bit about yourself before we get into the questions?
Rhonda Cooper-DeHoff (guest): Sure. And thank you for this opportunity to share some of this information on this podcast. I am an Associate Professor at the University of Florida in the College of Pharmacy, as well as the College of Medicine in Cardiovascular Medicine. And, I have been there for over 30 years now. So, a long time.
Geralyn Warfield (host): Well, we appreciate you sharing your expertise with us, and we're going to talk about supplements. And can you tell us a little bit [00:01:00] about what we know about who is using supplements today?
Rhonda Cooper-DeHoff (guest): Sure. So dietary supplements have been around for a very, very long time, and we now know that dietary supplements are used by three out of four adults.
And even more importantly, four out of five elderlies. What's new, or just emerging, is that one out of three children are actually being given a dietary supplement as they walk out the door to school, whether it's an energy supplement to help them make through the day or, or what have you. So that's, I think, a field that we're going to see getting more uptake in the years to come.
Geralyn Warfield (host): So, in terms of what happens in a clinical setting, would you suggest that a clinician be asking about supplements with each and every visit?
Rhonda Cooper-DeHoff (guest): Absolutely. And that's a theme that I think we need [00:02:00] to really ingrain in every touchpoint of the patient in the healthcare system. We know that over $39 billion is spent in the U.S. on dietary supplements every year. Globally, that number is $130 billion.
And we know that there's a lot of claims being made to our patients, whether it's on TV commercials, or on ads that come across your Amazon feed, or what have you, making these supplements sound very enticing, and interesting, and inexpensive. But the problem is that none of the claims are substantiated, and the products can actually be harmful depending on other medications the patient may take, be taking, or other diseases that the patient may have.
So, we need to be asking the patient about these products, in a very accepting way, so they're willing to [00:03:00] tell us. So, rather than asking. “You know, are you taking any dietary supplements?” we should expect that our patients are taking dietary supplements and maybe ask, “What supplements are you taking right now?”
And then that might allow them to be more willing to, you know, have a conversation about them.
Geralyn Warfield (host): That's a great piece of advice for us all to take back with us and to utilize in clinical practice. So, I think I know the answer to this, but could you tell me, and could you tell our audience, about who's really responsible for the oversight of these supplements?
Rhonda Cooper-DeHoff (guest): So, going back to the early nineties, there was a law approved called the Dietary Supplement Health and Education Act that was signed into regulation by President Clinton back in [00:04:00] ‘94. And what that Act did, the Dietary Supplement Health and Education Act, was place dietary supplements under the purview of the FDA, but on the food side of the organization and not the drug side. So, if you look at a bottle, you'll see that it says a serving size as opposed to a dose. And part of the Act put into place that no claims were allowed to be included on the label.
However, many, many manufacturers of these products disobey that rule, and they place claims on the labels and that's what our patients see and believe. There is some organizations in place, for example, the USP that does some oversight on these products, but, unfortunately, not very many [00:05:00] manufacturers of dietary supplements use these, use the USP because it costs money to do that.
But Nature Made® is one example of a company that does verify through the USP almost all of their supplements. So, when I'm talking to patients who tell me they are going to take these supplements, I encourage them to take USP-verified supplements. So that at least we know what's in the bottle and we know that there's no contaminants in the bottle that could potentially harm them.
Geralyn Warfield (host): So, I have seen on supplement bottles, a very small line of text somewhere on the bottle that has a star by it and says something to the effect of this information has not been verified by the Food and Drug Administration. But as I said before, it's in very small print and right. I suspect most of our patients aren't paying attention to that. And I realize that you have just finished talking about USP and verification of what the information is on the label.
So, what I'm hearing you [00:06:00] say is, you really can't trust most of the things that you see on the label because of the fact that it's coming from the food side—servings, those kinds of things—rather than the drug administration.
Rhonda Cooper-DeHoff (guest): That, that's exactly true. And the USP really only verifies the contents of the ingredients. They don't verify what's on the label.
The other thing that's important to keep in mind is that the compounds or the products that are on various markets, you know, whether it's through Amazon, or on the shelf at Walmart or CVS or Walgreens, could be tainted and nobody would pick up on that until there's a complaint about them; and the FDA comes in and then, you know, does a screening of the compound.
And there's many, many compounds that have been marketed for purposes of erectile dysfunction that have been found to actually be tainted with sildenafil, [00:07:00] or tadalafil, or other compounds that we know work for erectile dysfunction.
And that's why they become tainted. There's also tainted products for weight loss. So this, these are. reasons, common reasons, why our patients take supplements. They, you know, they don't want to do the work of dieting exercise, etc. They think, “I would just rather take a pill.” So, they take supplements that are earmarked for dietary, for weight loss, and then come to find out they have sibutramine in them, or other compounds that we know causes weight loss.
Sibutramine is a weight loss drug that used to be on the market, was pulled by the FDA because of increases in blood pressure, heart failure; that was very harmful to patients. That's not why we wanted that weight loss smart drug on the market, and so it was withdrawn.
But these dietary supplement [00:08:00] manufacturers are still able to find it and put it into these compounds that you can buy on Amazon any day of the week.
Geralyn Warfield (host): Wow. We're going to take a brief break and then we'll be back with Dr. Rhonda Cooper-DeHoff to talk a little bit more about supplements and CVD.
Geralyn Warfield (host): And we're back talking about supplements in cardiovascular health and learning a lot about what you see on the label is not necessarily what you get. So, Dr. Cooper-DeHoff, can you tell us a little bit more about, there's a huge market that you've described—billions of dollars that's being spent on supplements. So, is there any evidence to support their use?
Rhonda Cooper-DeHoff (guest): So, sadly, there is almost no evidence. To do an evidence-based study, you have to spend money and, you know, have a, have a really well-designed randomized clinical trial. That takes a fair number of patients to be included. You might randomize them to supplement X, Y, Z versus [00:09:00] placebo, and then follow them over time for not only efficacy, but also safety and tolerability.
And those kinds of studies are important. And every drug that gets on the market is required to have those studies. Even over-the-counter drugs are required to have benefit, and that the risk-benefit ratio is in, in the favor of the patient who would be taking them. However, for dietary supplements, that evidence is not required, and so it's really, hardly ever available.
There are some small studies, they may be so small that the results are inconclusive. They may have a positive, you know, spin, but they're so small that, you know, they would need to be replicated, validated, etc., in larger populations. There may be some studies done in, you know, [00:10:00] cell-based work or animals. And then the manufacturers will extrapolate that it worked in this muscle cell, so of course it's going to work the same way in humans.
And, of course, we know that that's not true, but our patients don't understand that. And so, it becomes very confusing when we tell a patient that we really don't know what this is doing in your body when they say, “But the commercial said it does this.”
And, and there really is, for no supplements, is there overwhelming evidence to support efficacy and no issues with safety. I mean, most drugs we know have side effects, so that's expected, but the, the side effect, to risk-to-benefit ratio has to be, such that it's you know, okay for a patient to take it.
Geralyn Warfield (host): You have given us a lot of food for thought, and I'm going to change gears just slightly to talk [00:11:00] about the newest kid on the block when it comes to supplements. And that is the cannabinoids that we are seeing in greater numbers, it seems like with each and every day. Can you talk a little bit more about cannabinoids and the issues associated with them specifically?
Rhonda Cooper-DeHoff (guest): Sure. So, in 2018 we had the Hemp Farming Act approved. And what that did was that took hemp from being a THC-based compound to not being a THC-based compound, removing the Schedule I designation from it. And, thus allowing hemp farming to become, you know, almost commonplace.
Now those fields of hemp are tested. And if [00:12:00] it's, the percent of THC in the hemp, is too high, the fields will be demolished, and the growers stand to lose a tremendous amount of money. So, there is some reason on the part of the growers to make sure that their fields meet the requirements of the Hemp Farming Act.
Nevertheless, that is what has driven the market of compounds: CBD oil, CBD, you know, edibles that are made from that. And we know that on recent surveys, that anywhere from 14 to 20% of Americans, and this is during the pandemic, have said that they are taking CBD products. The reasons they admitted using those products is—whether [00:13:00] it's for pain, or anxiety, or inability to sleep, etc.—these are reasons why people who admit to taking these products have said that they're taking them.
The, the concern about them is that many of the edibles are not labeled very well. For example, you could buy a whole drink bottle that maybe has a hundred milligrams of THC, which is a lot, when the typical dose is five milligrams, the allow dose might be five or 10 milligrams.
And so, the serving might be, you know, a tablespoon or an ounce of what's in that bottle. But the problem is that, you know, like, like a bottle of tea, the patient would just sit down and drink the whole drink, like a can of Pepsi, as opposed to just drinking one ounce and putting the rest back in the refrigerator for another day.
The same is true for the candy [00:14:00] bars or the gummy squares that you can get that have this CBD. You know, there might be 10 milligrams of THC or, or CBD, in a square of chocolate, but you know, most people will sit down and eat the whole chocolate bar, which has a whole lot more. And, and really, you know, someone's on warfarin and they eat one of these candy bars, their INR is going to go through the roof.
So, so it is concerning and there's a lot of problems with education and, and labeling of these compounds that, that, you know, hopefully, we'll see improve over the days and weeks and years to come. But right now, I think there's still a lot of concern on the part of our patients.
And so, the best thing that we can do as providers is really understand what is our patient taking. If you have a patient that's been very stable on their warfarin dose, or on their DOAC, and all of a [00:15:00] sudden, they come to you bleeding, why their INR is, you know, sky high when it, for years, it had been very stable.
Then, you know, ask, “Have you started taking any new supplements? What new supplements have you started taking in the last, month or so?” And you know, that might help you get at the root of the concern that the patient's now presenting with.
Geralyn Warfield (host): Well, that is definitely a lot of different kinds of information, about a lot of different kinds of supplements.
So, my next question to you is if our audience is interested in learning more, where would they look for accurate information?
Rhonda Cooper-DeHoff (guest): Yeah, so there's actually some really, really nice resources that are now available. A couple that are available for the patient is JAMA. So the journal JAMA has a couple of patient pages. They call them patient pages because they [00:16:00] publish them in lay language, for a patient to be able to understand, pick up and read.
And you, they have one on dietary supplements, and they have one on medical marijuana. So, you can, you can go in on onto the JAMA website and find them, and download them, and make copies and keep them in your exam rooms and hand them out.
Also, the American College of Cardiology has a nice website called CardioSmart that is available for all patients to access, and providers to access. And they have a nice patient page for dietary supplements, things for the patient to think about, questions for the patient to ask, because they haven't, maybe, thought about it before. So, those are nice resources for the patient.
There are also nice resources for our listeners. [00:17:00] There's a couple of websites that the NIH has, that is easily accessible. One is at, Medlineplus.gov, and that has a, I call it “herbs at a glance” page, and they're alphabetical. And you can just click on, you know, the letter. So, if you're looking for say ‘Ginkgo biloba’, but you can click on the G's at first and then scroll down and find Ginkgo biloba, and pull up a whole page just on that. And then you can either, you know, have that available when you have that conversation with the patient, or you can even give it to the patient and let them read about the harmful effects.
And then, lastly, there are some new apps that are available through the Apple app store and the Google app store, Android, that is called “herblist app.” “Herblist” is all one word. And you can download this app on [00:18:00] your phone and it, is really just like the herb-at-a-glance one. And you can look at that, you know, and pull up the herb of interest or what have you, and have that information right there on your phone.
So, you know, these resources are really only very newly available, but I would encourage all of our listeners to pull those up and, and have them, you know, on your phone during a visit with your patients.
Geralyn Warfield (host): Well, Dr. Cooper-DeHoff, you have given us a lot to consider and a lot to apply in everyday practice. And I really appreciate you taking the time to visit with us today. I look forward to learning more, at some of these sites and on these apps. And this is Geralyn Warfield, your host, and we will see you soon.
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