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Ep. 16 - Is there an effort to remove dietary supplements from the market place?

Why would you perform a study that you knew would fail? That’s what a large group of researchers from the Cleveland Clinic recently did. Why would they do that? Dr. Chet will give you some things to ponder in this episode of the podcast

Welcome to Straight Talk on Health, I'm your host Dr. Chet Zelasko. Together with WGVU in Grand Rapids, Michigan I examine the latest and greatest in the world of health. Whether it's research that makes headlines, another miracle diet, a new supplement, or an exercise trend. I look at the science behind them and then let you know whether it's real or not. You can check out the other things that I do at my website, drchet.com, and sign up for my free e-mail.

Let's begin with a quote from a physician during an interview: “Dietary supplements do not promote heart health. They do not improve levels of bad cholesterol.” And another from Doctor Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and a coauthor of a recent study: “Patients often don't know that dietary supplements aren’t tested in clinical trials.” And he calls the supplements, “21st century Snake Oil.” Now, what was the source of that? Well, it was an interview with NPR. No, that's not a bad thing, don't get me wrong. But I think that the research needs to be explained because oftentimes a lot of the material that's gained is gained from the press release from the Cleveland Clinic. And so the quotes that they had in there were even much worse than that. So, is this an attack on the dietary supplement industry? I'm going to leave that up to you, but going to give you a set of circumstances and you make the decision after that.

So let's unwrapped the study that got my attention here and then let's check out the implications afterwards. The study was presented at the American Heart Association Scientific Sessions in 2022, October 2022 and simultaneously published in the Journal of the American College of Cardiology. The title: ‘Comparative Effects of Low Dose Rosuvastatin, Placebo and Dietary Supplements on Lipids and Inflammatory Biomarkers.’ They called it the “SPORT Study” SPORT stands for Supplements Placebo or Rosuvastatin study and it was a single center prospective randomized single blind clinical trial. Where was it done? Cleveland Clinic, of course. Here's something to pay attention to; 190 subjects began the study with approximately ending up with 25 in each group.

So how did they do the study? They took 5 milligrams of the statin, which is the lowest dose possible They compared it to 6 dietary supplements and the amounts were something that were reasonable, I’m not going to go into all the numbers here, they used garlic omega-3 fatty acids, phytosterols, those are extracts that have a steroid shape, but they're not steroids, which are only found in human beings. But we call them plant sterols, red yeast rice, which is where statins originated, turmeric, cinnamon.

How long was the study? 28 days. Why 28 days? That doesn't seem like a very long time. Because it isn’t. But, when you dig back into the literature, when they came up with what would be considered effective 4 to 6 weeks was chosen decades ago as the criteria for testing any other type of pharmaceutical. And in this case, a dietary supplement in comparison with how much does it lower, specifically, LDL cholesterol.

So what did they find? First, what did they test? Well, the participants had a fasting lipid panel. That means triglycerides, total cholesterol, LDL cholesterol by measurement, not by measurement, but they did it by subtraction. There's a formula called the Freed-Wall Equation that they used. And they also tested high sensitivity C-reactive protein. All the testing was done at the Cleveland Clinic Laboratory. The study regiment adherence rate was determined by how many pill counts from returned bottles.

Now, the only problem with that, and I'm not saying that impacted the results, it could have because it was only a 28-day study. And if people instead of feeling guilty but turning pills in tossed them well, that could have had an impact. I’m that saying that it did, it could have. So the they did the lipid testing on day zero before they started taking supplements. And again on day 28, the last day. And then they compared the statin results with each of the dietary supplements as well as a placebo. The statin lowered the LDL cholesterol by 37.9%. And that's about 50 points from about 132 to 82 milligrams per deciliter. Now, neither the placebo nor the supplements showed any significant differences in LDL cholesterol.

The researchers concluded that none of the supplements contribute to cholesterol health and therefore those claims should be removed from supplement labels. [Sighs] - That's about as heavy a sigh I'm going to give you. The researchers undertook a study that they knew, they knew would not be successful and then leaped up and down when they got the results they expected to get. There's no doubt they knew it wouldn't work! It's like a professional basketball team playing some high school team and then boasting that they won. But the question is, why? Why do this to begin with? Well, as I suggested with the title of this podcast, is there an attempt to remove dietary supplements from the marketplace? And if so, why?

Let's take a look at 3 different events that remarkably share some of the same language. They are independent, but they share some of the same terminology. And in the end, let me give you a little hint: I think it's all about the money. So I recently recorded a Straight Talk on Health radio show before we change to a podcast on videos jointly produced by the American Medical Association and the Food and Drug Administration. And it was a little curious because they were so short. The idea was talk to your patients about dietary supplements. Now, my feeling was that it was going to be instructional in nature, that they were going to somehow talk to their patients about dietary supplements, which are safe, which are not. No. There were two things that they wanted to get across. There were 2 videos, one, was background material on DSHEA, and I'll explain what that is in the moment and the other was giving adverse events to the right part of the Food and Drug Administration.

So what was the overwhelming theme of the first 5-minute video? Supplements are not Food and Drug Administration approved. And that's where you heard me say DSHEA earlier, DSHEA stands for the Dietary Supplement and Health Education Act. And essentially what it does is supplements are considered food, anything by mouth is something that would be considered a dietary supplement and what people don't understand, this also includes the amino acids that bodybuilders take, the protein powders that elderly people take. All of those things fall into the category. Don't think just in terms of pills, it includes everything. So they are not approved by the Food and Drug Administration. That's the deal that the business cut with the Food and Drug Administration. But the cost of that was, you can never make claims about your supplements that they cure, treat, prevent any kind of diseases. So you have to use something, like was criticized in the study I just reviewed. You're looking at benefits to cholesterol health.

Well, that's true that some of those do contribute to cholesterol health. You can’t say that it lowers it. But what does cholesterol health mean? Well, it ends up in the way that you interpret it. In some cases if it drops the entire amount by 5%, that can be significant. But you can't say that it lowered cholesterol by 5%. Supplements are not FDA approved, people. Hopefully, you know that again.

The second thing is you have to report any adverse events caused by supplements. That’s something that's relatively new. But the idea is you blame everything on the supplement and nothing on medication. That's my takeaway. You watch the video, they're still out there. But what was mentioned is that 20 years ago it was a 6-billion-dollar business. Now, in 2022, it's estimated to be a 59.1-billion-dollar business. And in every iteration of this, they underestimated the amount.

Let's move ahead a couple months. The United States Physicians Task Force on Dietary Supplements came up with not recommending a multivitamin nor any supplement because it will not improve mortality. You know, I've been talking about supplements for 20, 30 years. And, you know, in that amount of time, no one's ever coming up to me and asked me what will prevent cancer, what will extend my life? What will help me live longer? Nobody's ever said that. You know what they say? I don’t feel I have as much energy as I used to have. In fact, in the background research the task force used to come to their conclusion, that's exactly what people said. But they ignored that. In my opinion they did not ask the right questions in order to get the answers. And they didn't use the most up-to-date research either, especially the research on beta carotene and cigarette smoking has come a long way. But you know what they did talk about? They talked about the size of the industry. Now they got it wrong, they estimated to be 40 billion, but that's neither here nor there. It's going to be 59 billion.

One more thing. In the study that I reviewed for this, the one that was done by the Cleveland Clinic, they talked a lot, in the explanation about it, they talked a lot about the amount of money spent on dietary supplements and how the study that they just did, a 28-day study, proved that dietary supplements are not beneficial for lowering cholesterol. No one ever said they were. So those are events that have happened in 2022 so far. Is there an attempt to try and restrict your use of dietary supplements? I don't know. But the fact that the same language is used under three different circumstances, and the focus of all was ultimately: it's all about the money. I’ll keep my eyes open, you keep your ears open. Unfortunately, that's all the time we have for this show, until next time this is Dr. Chet Zelasko saying health is a choice, people, choose wisely today and every day.

Narr: Straight Talk on Health with Dr. Chet Zelasko was recorded in the studios of WGVU Public Radio in Grand Rapids, Michigan. The views and opinions expressed on Straight Talk on Health are not necessarily those of WGVU, its underwriters, or Grand Valley State University. Episodes are found at wgvunews.org and wherever you get your podcasts.

Dr. Chet Zelasko is a scientist, speaker, and author. Dr. Chet has a Ph.D. and MA in Exercise Physiology and Health Education from Michigan State University and a BS in Physical Education from Canisius College. He’s certified by the American College of Sports Medicine as a Health and Fitness Specialist, belongs to the American Society of Nutrition, and has conducted research and been published in peer-reviewed journals. You can find him online at drchet.com.
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