Dr. Brent Bauer, MD, director of Mayo Clinic Complementary and Integrative Medicine Program, talks about nutritional supplements. Dr. Bauer covers various aspects of the supplement industry, including information you should learn about a supplement company before purchasing its products, as well as what FDA regulations apply to the supplement industry compared to the drug industry.
How to Choose the Right Supplement Company
Description: The video begins with the Mayo Clinic logo of three interlocking shields on a blue background. After a few seconds words appear, prompting the first topic of discussion in the video. They read: Mayo clinic Complementary and Integrative Medicine Program. After an appropriate amount of time to read the title, Dr. Brent Bauer, MD begins to talk in an interview setting, with a title card describing him as the Director of the Mayo Clinic Complementary and Integrative medicine Program.
Dr. Brent Bauer:
This is kind of fun right? I mean this is you have to do something with your life you might as well do something that means something. And what's been interesting about this journey with integrative medicine is you know it's fun to help people when they're hurting. It's very meaningful to help them when they're sick. It's a lot more fun and I think probably a lot more productive to help them stay well. If we can train somebody in meditation we can train somebody in yoga if we can give an older person Taiichi lessons so they can go home do Taiichi they're gonna fall less often that's what the studies tell us.
Description: As Dr. Bauer talks, we see b-roll of people meditating, doing yoga, and a class of people taking part in a Taiichi lesson.
Br. Brent Bauer:
I started Mayo Medical School in 1984. Graduated did a three-year residency did a year of fellowship and I actually joined the staff down at Mayo Clinic Arizona. And literally the first patient I saw down there walked in and had a jar of echinacea and wanted to know, “What's this stuff and can I use it?” Next patient told me about a harmonic convergence she had had up at the Red Rocks of Sedona. And so I realized this is something I wasn't trained for and recognized that we knew a lot of things our patients were doing were helpful and we didn't know enough about them, but we also know some of the things that are doing were dangerous or weren't helpful and they were wasting money or putting themselves at risk. So that led to the idea that we should have a program back then we called it Complementary Alternative Medicine and that was actually housed in the Department Medicine but with participation across the institution. And really we were charged to say if our patients are asking these questions, how do we give them good information? And we did studies we found out, guess what? A lot of our patients were stressed. They needed something help with stress. We brought in some massage; we brought in some mind-body training; we did studies, we found good outcomes we expanded. We had a lot of patients with chronic pain; acupuncture seemed to work; did studies, it worked we expanded. And so now we have, I think last year we 30-35 thousand unique patients at Mayo Clinic received acupuncture massage meditation training, things that weren't in existence here 15 years ago.
Description: As Dr. Bauer talks we see a shot of the Mayo Clinic building in Arizona, an image of the Red Rocks of Sedona, a graphic indicating that the Complementary Alternative Medicine program was founded in 1990, b-roll of colleagues discussing things, massage therapists working, hands gesturing at acupuncture models, and acupuncture needles being used, all appearing as he mentions them to emphasize his words. As the next section begins, text appears onscreen reading: Mayo Clinic on supplements
Dr. Brent Bauer:
The way to find a good supplement manufacturer is do your homework. And by that I mean you actually have to look and find some information about how that is a company produce its supplements. So when I go to the website, when I look at the company literature I really want to see how do they harvest, (if they're harvesting, if it's a botanical or an herb), how do they harvest it how do they know that they've got a good product? And then I want to know, how do they do product control? So as they're manufacturing and processing there should be a number of steps and I'd like to see all that in plain language. And then at the final step there's going to be a capsule or some other product and it's going to go into a bottle that's gonna be sold. And I want to see again how does that manufacturer show us that's what's in the bottle is the same as on the label? So that should be pretty clear. If we go in and do our homework and look at all those steps, if the company's got all those things lined up that's a really good start. Now the nice thing is there's some third parties out there who are taking the next step in saying I'll look at that supplement and I'll evaluate it and if it's good, I'll certify that. So there's a company called NSF you may see that label, USP is another company, United States pharmacopoeia so those are some extra helps beyond your own homework that can help you find the right manufacturers.
Description: We see footage of herb farms being harvested and processed by workers, using tiny scissors to trim off imperfections. As Dr. Bauer continues to talk, we see shots of supplements being dropped into bottles, and then a graphic showing the NSF website, logo and USP logo. As the next section begins, text appears onscreen reading: My physician seems reluctant.
Dr. Brent Bauer:
Right many physicians who especially train many years ago can still remember or at least remember stories of patients being harmed and so forth. So there's a history and I think there's a legitimate reason why many physicians are a little cautious. And remember it wasn't that long ago that a lot of things on our shelves really weren't good quality, so let's give them credit for that kind of trepidation or maybe a little pushback. Now having said that, with the market changing, with the quality moving up, with good manufacturers coming on board who are presenting good products to the public, I think we have to shift our attitudes. So I think the way I would address those concerns—I do this with my colleagues if they have a patient who's using supplements and they're very dismissive—I always want to go back and remind them that's an indication at least that the patient's trying to be healthy. So that's a good thing and we can work from that and I think if you can approach your physician with, “I want to be healthier I think part of that might be this supplement can you help me figure out the pros and cons?” As opposed to, “I found this on the internet must take it you must help me with that.” I think most of my colleagues will come around they may not have all the knowledge to give you all the answers but increasingly most medical centers have a physician, a pharmacist, somebody trained to answer those questions.
Description: While the majority of this section is Dr. Bauer talking in interview, there is a b-roll shot of a doctor having a conversation with a patient. After the section is over, more words appear on a white background setting up the next topic: Are there prescription medications that cause interactions with supplements?
Dr. Brent Bauer:
So there's a broader question there and I think the broader question is are there risks for herbs and drugs to interact and the answer of course is yes. And we've seen some very serious reactions to St. John's Wort, a very popular herb helps for depression but it actually interferes with a lot of different drugs. So we've actually had a couple case reports of patients developing heart transplant rejection because the St. John's Wort Herb affected the drugs that affect transplant rejection. So there's clearly risks and that means we have to be very smart about mixing herbs and the drugs.
Description: As Dr. Bauer talks, we see a shot from a news report. The blue news ticker at the bottom displays a warning about heart transplant patients and St. John Wort. A new topic is prompted through text: Does the FDA play a role?
Dr. Brent Bauer:
There's a perception that dietary supplements aren't well regulated; that the FDA doesn't have much oversight. And I think especially in the realm of adverse effects things that might be associated with dietary supplements that could cause harm there's actually a lot of rules and regulations. In fact they're very much similar to what we expect with drugs. So if a drug causes an adverse effect it can be labeled either serious or minor. The serious ones have to be reported right away, the minor ones are collected and we learn a lot that way about what's the safety of our drugs. Well exactly the same rules apply to a dietary supplement. So if a dietary supplement causes a significant reaction, a severe reaction, that has to be reported I think within 15 days to the FDA. So there's a very quick response time to find out, “Hey something on the market has caused a problem.” If it's a more minor problem, well the companies have much more leeway in reporting those but they have to collect the data, track it over time, and keep a record. And so that's a good way to actually for the supplements to stay safe because we can find out if something's changing, something new has entered the market, something's not being manufactured appropriately or maybe something snuck in there as an adulterant by mistake. So a lot of ways that FDA treats dietary supplements are very similar to how the FDA treats drugs.
Description: Another question is raised via onscreen text: Who monitors adverse events?
Dr. Brent Bauer:
So the companies are actually required to collect that information if there's an adverse event it's supposed to come to the company. So I would say most companies have an in-house service, they collect the data themselves, they report it and that's good. But I think you can distinguish really good companies—best in class—by those who also have an independent group, an independent company also collect that data. Now these independent companies will sometimes have toxicologists, physicians, other experts so they can really look at that data and find out if anything's changing or if unexpected adverse events are occurring. The labels can tell us a lot about what's in there. That's probably the most important. We also want to make sure that there aren't things in there we don't want. So some of the fillers or magnesium stearate is in a lot of these supplements we like to keep people away from those because there's probably no health benefit and maybe some health risks. So looking for what's in there, does it have what you're looking for, for example if you heard about a good study on… Mayo Clinic did a study on ginseng for cancer related fatigue. But you'd want to find the same ginseng produced the same way and manufactured the same way so look for what's in there. And also maybe you look for what's been added that you don't need.
Description: As Dr. Bauer talks about labels, we see the back of a supplement label illustrating the kinds of information that can be found there. Another question appears onscreen: Can just any company make supplements?
Dr. Brent Bauer:
For quite a long time the market has been fairly loose in the United States and there was a lot of manufacturers putting things on the shelves that weren't good quality that's very clear and that made a lot of physicians skeptical about dietary supplements cuz there's lots of cases where a government agency would pull 10 or 20 different brands off the shelf and show that for example the ginseng product had no ginseng in it. So we have that history. What's changed quite a bit since 2010 is something called current Good Manufacturing Practices. Let's say and mandate that anybody that sells or manufactures supplements United States now is supposed to follow something called Good Manufacturing Practices and that's meant to bring that quality back up to work.
Description: As Dr. Bauer talks about Current Good Manufacturing Practices we see a definition onscreen saying: Guidance for industry: current good manufacturing practice in manufacturing, packaging, labelling, or holding operations for dietary supplements; small entity compliance guide. A final question appears onscreen: what does CGMP (short for current good manufacturing practices) require?
Dr. Brent Bauer:
And this was rolled out over span of several years but fully implemented in 2010. And what that requires for dietary supplement manufacturers is basically to have pretty much good control of the quality process from harvest to processing to on the shelf and even into the quality and how long it might last in the shelves and so forth. So that's all fairly recent and really the full implementation was in 2010. Now that's pretty close to what we expect of our drug manufacturers. Our drug manufacturing requires even further testing for shelf-life and expiration dates and so forth but if you look at how we are now supposed to handle our herbs and dietary supplements it's very similar in terms of those quality control measures that are now mandated.
Description: We see shots of every stage of a botanical supplement – being harvested in the field, bottled in a factory, and then on display in the health section of a supermarket. A final graphic suggests that you can learn more at www.MayoClinic.org, followed by an ending screen with a Mayo Clinic logo, with a copyright notice at the bottom reading 2016 Mayo Foundation for Medical Education and Research. All rights reserved.