Freed: This is Steve Freed with Diabetes In Control and we’re here at AACE 2018 in Boston. We have a special guest with us, Laura Shane-McWhorter, and she is not an endocrinologist, she is a PharmD, but she specializes in something that we’re all interested in and that is nutritional products, especially for the treatment of cardiovascular disease in diabetes. This is going to be the subject of our conversation. Laura, you presented here today and the presentation was, “Nutritional, Herbal New Perspectives: What’s Up with all these Supplements?” Can we start off by you briefly giving a summary on that and the important points that you want medical professionals to walk away with so they can better explain to their patients. I would imagine that every doctor on this planet gets questions all the time that he or she cannot answer.
Shane-McWhorter: Well, I think that we all get a lot of questions and I think it’s important to know that the presentation today was a symposium that looked at a lot of issues related to weight management and weight loss. So, my presentation was specifically on different types of dietary supplements for weight loss. I think the biggest message is that there are so many of these different products and it’s really important for clinicians to establish a good rapport with their patients. Communication is key in first asking, “Are you taking any of these products? If so, what are they? Tell me what you hope to gain from taking these products and are you experiencing any types of side effects.” It’s also important to think about what these products may be doing in terms of other medications that they may be taking for their diabetes or cardiovascular disease and to try and keep it all in perspective while still maintaining that respect for a patient.
Freed: So, in deciding to take a nutritional supplement, I go to the store and there are 32 different brands. Now I can go on the Internet and buy it from somebody’s basement who put it together in capsules. How do you know, because it is not really regulated, the quality of the product that you are getting? So, if someone says, “Can I take Gymnema Sylvestre?” You don’t want to say just, “Yes.” You want to say, “It depends on where you get it.” So, how do you know where to get products that you as a medical professional can say to your patient, “You need to go here if you want to use it.”
Shane-McWhorter: I think the best way to answer that is to think about different types of agencies that will evaluate the content of the product and evaluate the quality of the content in the ingredients. I think that there are certain regulatory agencies that United States Pharmacopeia (USP) can verify the supplements and tell, for instance, whether or not that product actually contains what it says on the label. But in evaluating the product, the USP also verifies whether or not that product is free of microbes, for instance, and also, whether or not it dissolves appropriately. It doesn’t verify that it is safe nor effective but at least we know that, that product really is something that would be what it says on the label.
Freed: What are some examples of where you can go because I remember hearing about a company that would basically review your product and do a survey on your product and then they charged you money. Therefore, if you want to be OK’d, you got to pay us a fee and we will give you a label that you put on your bottle that says we approved it. So, if you want to validate something, where do you go?
Shane-McWhorter: Well, I think the main thing is that most of the time, from my understanding, is that there probably is going to be some sort of a fee to evaluate the product and I think that it is something that different agencies may do that. For instance, you may have something from consumer labs and I think there is going to be some sort of a charge to be able to do that. I don’t think that it is any different than what you see in the pharmaceutical industries where you are going to have somebody looking at quality assurance and looking at that sort of thing that is all part of that manufacturing process. I think that for a consumer, however, if they go with something like the USP then there is probably already some sort of a stamp or a label or emblem on a supplement that states that, that product is safer to take. That doesn’t mean that there aren’t other products out there that are safe but it just means that some things already have that built-in to the process.
Freed: So, your presentation was on weight loss. What are some of the better products that you would recommend for weight loss because if you go into a pharmacy, you have all these products that are for weight loss and they all have nutritionals within those products that are over-the-counter – which ones do you recommend?
Shane-McWhorter: Well, I think that I have to defer to my clinician colleagues and always go for things like healthy diet and physical activity – that is something that I think is key because you cannot take these products instead of healthy diet and physical activity. I also this it’s important to remember that these are supplements which means that they will help somewhat – you’re not going to get to a target weight. Just like a supplement is for diabetes, it’s not going to get you to a target A1C or blood glucose. I think they are intended to help and to supplement the diet, not take the place of all of these other things that I think are proven. If you think about studies like the Diabetes Prevention Program, it was lifestyle that was more effective than any other medication that was used in that study. And I think the same thing is true of supplements – they are a help but they are not the overall means by which weight should be achieved in an ideal way.
Freed: I don’t think there is a pharmacist on planet Earth that hasn’t been asked the question, “What should I take for my diabetes?” [Pharmacists] get questions like, “Is cinnamon good? Is Gymnema Sylvestre good?” I can think of, and I wrote down 15 of them, that are supposed to help regulate blood sugars. My comment is always, “They may help a tiny, little bit but don’t expect miracles.” Like you said, nutrition and physical activity are the building blocks for you to improve your health and if you expect cinnamon to do something – yet, you get these questions all the time. So how do you get people to back off on those and do what is really important?
Shane-McWhorter: I think that is probably the key question of the century. I think you would probably get a Nobel Prize if you’ve figured out the answer to that. When you think about all those other things, then the modalities that we were taught like motivational interviewing and trying to establish rapport with a patient and really figure out what it is that they want to do and achieve and why, and look at what are the pros and cons of them doing some of the appropriate things – as I have mentioned, lifestyle and, if necessary, taking medications that have been shown to decrease blood glucose and A1C and better yet, achieve certain outcomes, for instance, cardiovascular outcomes that may be beneficial. I can tell you that there are not really any supplements that have been studied to that extent where we can say there is long-term diabetes control or long-term weight control or safety in terms of cardiovascular disease.
Freed: Why isn’t the government sponsoring studies for nutritional products when the drug companies do it all the time? They take tree bark and they do studies with it. Obviously being able to patent something has a big role to play but when it comes to things like cinnamon and Gymnema Sylvestre, the products are out there, it’s just that there is nobody who stands behind them as far as government officials (FDA and so forth).
Shane-McWhorter: Exactly and I think that there are a lot of entities that are really pushing to appropriately regulate the supplements. The Obesity Society is one of those trying to do that. That is really to be able to ensure patients’ safety and health. I think also that many, many patients see the allure of all of these products and because they are natural, they feel that they are going to be safer, better, or somehow, more desirable to take than what they perceive as other chemical entities when in fact, supplements are drugs – supplements do contain active pharmacologic ingredients that have theorized mechanisms of action as well as side effects and potential interactions with either other supplements or drugs or disease states.
Freed: Are there any weight loss nutritional products that could be dangerous that we should stay away from?
Shane-McWhorter: I think there are a few that could be dangerous. For instance, HCG as an OTC being sold as supplement over the counter without the supervision of a physician. I think that, that could be very dangerous. There are case reports, for instance, when patients have had some sort of a thromboembolic event, possibly because of some sort of a hypercoagulable state that existed that could be dangerous. I think that there are certain ingredients in some of the supplements that, again, have been banned but we don’t know whether or not they’re in the supplement itself. Also, for instance, stimulants like DMAA. Some supplements have also been found to be contaminated with substances, for instance, with drugs that have been banned such as Sibutramine. Also, some of them have other ingredients, for instance, diuretics or laxatives to actually help people lose weight. Sometimes the products may have something like a beta blocker to offset the cardiovascular side effects that a supplement may produce. So, I think that there can be a lot of substances that in and of themselves are not dangerous such as the beta blockers but, again, the intent to try and hide or mask adverse effects I think would be something that is not appropriate.
Freed: So, let me ask you, there’s been recently, within the last month or so, a couple of studies coming out basically saying fish oil is a lot of bunk. And yet, there must be a thousand different brands and there are doctors recommending them all the time. What do we really know about the fish oils?
Shane-McWhorter: Well and again, I think that fish oil is somewhat of a difficult compound. Once again, I think I would go with ones that either are prescription products that are being prescribed by a physician so that appropriate monitoring is taking place or supplements that have that USP verification label may be something else that is appropriate. I think as far as the efficacy of fish oil, some of the studies that were done that really showed its [fish oil] tremendous benefit were in the days before things like statins or ACE inhibitors were used. So, now it seems that the benefit of fish oil is not as great as was once thought. But I think it still has a tremendous merit and it’s something that may help, especially to lower triglycerides.
Freed: I’ve got to ask you a question. With your background in nutritional supplements and being a CDE, there probably is at least 50 nutritional products that in some way can help someone with their blood sugars. You are aware of all of these. Have you thought about putting together your own product?
Shane-McWhorter: (Laughs) No I have not thought of that. I am certainly a pharmacist by training but I don’t think that is something that I would be able to do.
Freed: Couldn’t talk you into it, huh?
Shane-McWhorter: No couldn’t talk me into it. If you could bottle up lifestyle, then I think that would be the key.
Freed: You know, if you go on the Internet and you put the word “diabetes” in, you’ll get 62 million hits in about a tenth of a second but can’t trust them. My last question is: If a physician is asked by his or her patient, “Is this good for this disease,” where is the best place that you can refer to for a medical professional if he or she wants to answer the patients’ question intelligently? Where can [medical professionals] go?
Shane-McWhorter: Well, my go-to is actually the Natural Medicines website. That particular website has evidence-based information. It’s a result of the merger between the Natural Medicines Comprehensive Database and the Natural Standard. This database is updated daily, Monday through Friday and references are provided. I think it really spells out exactly what is known about a product. It’s theoretical, mechanism of action, when it may or may not be useful, and certainly, talks about the side effects, what to monitor, drug interactions, maybe even things like lab interactions or interactions with other supplements. I think it is something that is such a vast body of knowledge that the best way to keep up with this is this particular reference that is online. Once upon a time, it was available as a hard copy but I think the information is just coming in so quickly that the best way to maintain this database, is through the online. And, one of the things that is nice about it is that you can download consumer handouts for a patient that is written more in lay language but it also has all of the scientific information that a clinician would want to see.
There are other very good references. The National Center for Complementary and Integrative Health (it used to be NCCAM but now is Integrative Health) is funding a lot of studies on supplements and I think that they are a great source of information. The Office of Dietary Supplements under NIH is another very good source of information.
Freed: Yes because no one is expected to know it all.
Freed: You need a good resource but you have to have a resource that you can rely on that is reputable, otherwise, it all falls apart.
Shane-McWhorter: Well, I think that’s absolutely critical to have a good resource and there’s a customary way to approach information that is solicited drug information. You probably remember this, Steve, but whenever you were asked a question, you wanted to be able to verify the answer in at least three different references and then sometimes if there was conflicting information, you had to figure out a way to be able to resolve any of those conflicts.
Freed: Well, I want to thank you for your time. It was very interesting. I hope our listeners learned something from it. Enjoy the rest of your time here in Boston.
Shane-McWhorter: Ok, thank you very much.