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1 Promoting Patient Safety in the Supplement Industry Patient Power Health Issues March 5, 2010 Andrew Schorr; Peter Frishauf Andrew Shao, Ph.D. Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. Please have this discussion you re your own doctor, that s how you ll get care that s most appropriate for you. Introduction Hello and welcome to Patient Power Health Issues. I'm Andrew Schorr in Seattle. And this is Peter Frishauf in New York City. Well, Peter, everybody knows who checks out our website and you know so well, years ago I was diagnosed with leukemia, and when you're diagnosed with anything really but certainly a serious life-threatening condition, you want to know not just whether the medicines your AMA M.D. has proposed will be right but is there something from a naturopath or acupuncturist or anybody you might talk to or even in the health foods store, the pharmacy, dietary supplements, for instance, that can help you cure the cancer or at least live better, strengthen your immune system. So what we're going to talk about today is promoting patient safety in the supplement industry. Isn't it like a $23 billion industry, Peter? I think that's right. There's certainly no shortage of people offering helpful remedies. Is More Regulation Needed in the Supplement Industry? All right. Well, our guest today can help us. This gentleman who is with us, Dr. Andrew Shao, who's a Ph.D., is senior vice president in scientific regulatory affairs, senior vice president at the Council for Responsible Nutrition, or CRN, in Washington, D.C., which is the trade association, and probably one would say maybe the lobbying group for manufacturers, suppliers in this industry. Dr. Shao, thank you so much for joining us. There's been a lot in the press and in Congress now around Washington discussing does your industry need to be much more regulated because people don't know what they're getting, is it effective, and most importantly is it safe. What's your comment on that? 1

2 Well, first of all, thank you for having me. It's a pleasure for me to be here. One of the things that we do try to do as an organization representing the industry is to educate, and so the first thing I want to say to your listeners is the dietary supplement industry is regulated. It's regulated by the Food and Drug Administration, FDA, and the advertising is regulated by the Federal Trade Commission, the FTC. That's the first thing I would want to say. Now, it's a relatively young industry, and the regulations and the enforcement of them are evolving really as we speak. Regulations requiring certain standards for manufacturing, requiring reporting of adverse effects to the FDA, all of these have recently been developed and are now in the process of being implemented. Okay. Well, you said that you're regulated by the FDA, and for prescription drugs we know that the basic test is safety and efficacy. A drug has to be proven to be safe and effective, presumably, before the FDA will approve it. Is that the same for FDA regulations of the supplements that Council for Responsible Nutrition represents? So dietary supplements are regulated by the FDA, but they are regulated differently from prescription and over-the-counter drugs. They are regulated as a category of foods, and dietary supplements do go through a sort of premarket review. It's not the same kind or scope of premarket review that drugs go through, and that's actually the right approach because drugs, as you know, have very potent effects and potent side effects, hence warranting very careful premarket review and approval. Dr. Shao, let me just jump in on that, though. So last year there was a presidential commission. There have been, and I'm not saying it doesn't happen with pharmaceuticals, but there were deaths reported, concern that people were taking lesser-regulated drugs and they were harmful. And of course the bigger question even is are they truly effective or are there claims made that have no scientific basis. So the concern about all this is that your industry has maybe some very responsible companies, but some outliers who just say anything. The products are not made in a consistent way, and if you go to your AMA M.D. typically you say, what about taking this from the health food store, and they say, you know, I have no way of knowing whether it's effective. I haven't seen the studies, and I don't know if the brand you're getting is consistent in its dosage, so I don't know what to tell you. That's what a lot of people are faced with. What do you say to them? Well, thank you for bringing that up. First of all, dietary supplements as a category of foods, as I said, they're regulated differently from drugs. They're not allowed, companies are not allowed to market their products for therapeutic uses. And so how they're used by practitioners or used by consumers if they're used for therapeutic uses, that's their choice, but companies are not allowed to market their products for that purpose. 2

3 Now, you are correct absolutely in that there are outliers in this industry, and frankly that's what keeps me and my colleagues up at night all the time, and yourselves, too, I would imagine. It makes it very difficult for our members who represent the responsible players in this industry, and we take that very seriously, and some of the efforts that we've undertaken are to educate, to put into place self regulatory initiatives which I could expand on, and also to lobby the government for more resources for the regulators, the FDA and the FTC. Frankly, that's where we see the greatest problem here when it comes to these outlier companies is inadequate enforcement. The FDA has the authority to go after these companies that are making therapeutic claims that are unsubstantiated, that are not manufacturing their products to the right standards. They have the authority, they lack the resources. Dietary Supplements and FDA Approval Okay. Well, I have two questions then. Clearly, there are a lot of claims that are made. If you flip on my cable channel you see ads for natural male enhancement and fat-burning pills, so is that in the category of what you call claims that are not substantiated? And when you say FDA regulation, any FDA regulations of food is to assure food safety, but when you have nutritional supplements that are really suggesting that you can help with things like erectile dysfunction or obesity, those are very serious problems to people, and if they're taking substances that are either ineffective or sometimes harmful, that's something to worry about, isn't it? Yes, and we take that very seriously. I think that the products that you're referring to, and although you may see them on a lot of late night ads and perhaps on the internet, they really represent the minority of products in the industry, certainly the minority in terms of sales. Now, that doesn't mean that we don't take this any less seriously. We absolutely take it seriously. And depending on the claim that's made for dietary supplement it may or may not require FDA approval, but irrespective of that any claim that's made must be substantiated by credible evidence, and both the FDA and the FTC are closely monitoring the industry for that. In addition to that we've initiated with the Better Business Bureau, the national advertising division of the Better Business Bureau, a self-regulatory program to assist the FTC with the monitoring of the very ads that you're describing here. The NAD reviews advertising aimed at anyone 12 or older, 12 years of age or older of any type of consumer product. What we've done is committed to them from the past three years and another five years funding to allow the NAD to increase its monitoring of the dietary supplement industry's advertising. So you're saying that you'd love to see natural male enhancement and fat burning pills off the air, but I've been seeing those for many, many years and they seem to have an awful lot of mind share. You see banners in front of health food stores even advertising them, 3

4 and they seem to be, I know you're saying that it's a small percentage of your membership, but don't they have an awfully large share of voice? They're not really a small percentage of our membership. They're a small percentage of the industry, but in fact, well, we happen to have a naturopath, a licensed naturopath on staff here, a colleague of mine. He's actually up in New York attending an integrative medicine conference up there, but if you were to ask him he would say there are legitimate products that do address some of these issues, maybe not in the magic bullet type of way that consumers might want and some unscrupulous manufacturers might advertise, but they do have a legitimate place. With that said, we are trying to, for this small number of companies, they attract a lot of attention. That's the first thing that detractors of the industry will point to is those companies and those ads, nothing else. That's what gets the attention. It is the minority, but as I said we do take it seriously which is why we've invested a tremendous amount of resources in trying to find an independent way, independent of the industry, independent of our organization, to review advertising and ask these companies for substantiation for the claims they make, and if they can't substantiate it ask them to modify the ad, eliminated the ad, and if they refuse the process involves them being referring directly to the Federal Trade Commission. Dr. Shao, we're going to continue our discussion in a minute, and of course as we do this program this is all while, quite frankly, your industry is in the crosshairs of at least one prominent senator in the minority party but certainly a prominent senator, John McCain from Arizona, who wants more stringent regulation on your industry. So we'll talk more about that, about what you can do, and also acknowledging that your organization members have committed well over a hundred million dollars to public relations and public occasion, which I think is very appropriate, so that we can all understand this better and make informed choices. So let's come back in a second and we'll continue our discussion with Dr. Andrew Shao from the Council for Responsible Nutrition. We're back with Patient Power Health Issues. Andrew Schorr in Seattle with my dear friend Peter Frishauf in New York. We're visiting with Dr. Andrew Shao, who is with the Council for Responsible Nutrition, and he is the senior vice president of scientific and regulatory affairs there. Dr. Shao, as I said just before the break we are having this discussion now where some might say you are kind of in the crosshairs of some powerful people in your home city there, Washington, D.C., and I know your, the head of your organization has responded saying you welcome more responsible behavior, and you want to have your industry be well respected and you believe you provide a lot of value, but you're kind of balking at some of the legislation being proposed. How come? 4

5 Well, first of all, the act that really defined our industry today, and that's the Dietary Supplement Health and Education Act, which was passed back in 1994, as you know, now, that law itself has not even been fully implemented by the FDA. So we're asking questions of why are we generating new legislation when the existing laws on the books haven't even been fully implemented. That's the first thing. The second thing as far as Senator McCain's bill is concerned, now we have not come out with an officially public statement although our CEO has made some comments to the trade press, except that there's a number of provisions in that bill that we're already on record as supporting through food safety legislation that's been proposed on Capitol Hill. It seems redundant to include it in other legislation when it's being covered by food safety legislation. For example, registering facilities, manufacturing facilities with the FDA, giving the FDA mandatory product recall authority, we're already on record as supporting that through food safety legislation. There are other provisions in there that simply don't make sense and even FDA has open opposed them, such as requiring manufacturers to report to the agency all adverse events that they receive from their consumers, as opposed to just the serious ones, which is what the requirement is today from a law that was passed in late FDA has said they can't handle all of that information, manufacturers reporting all adverse events. I had headache, I took your multivitamin, I tripped on the curb. They can't handle all that data. It actually makes their job much more difficult because they have to look for signals. That's how they use post market surveillance and adverse reporting is to detect signal problems with products and classes of products, and if there's too much background noise, as would be the case if all adverse events were submitted to the agency, then they wouldn't be able to detect these signals. And they've even said that themselves. They simply, they don't have the resources to accept all of that. Legislation for FDA-Regulated Products So help me understand this a little bit better because you said the initial legislation was passed in 1994 and has not been fully implemented. What are those aspects of that legislation that if they were implemented would make Senator McCain's legislation unnecessary? Well, one of them is the establishment of good manufacturing practices for dietary supplements. Now, all FDA-regulated products, drugs, foods, devices, all have what's called good manufacturing practice regulations behind them, a set of standards and requirements that manufacturers must abide by when they manufacture their product. And Dushay in '94 called for those specific to dietary supplements, and it took FDA 14 years to publish them. They finally were published in 2007, and they are in the process of being implemented. As of June of this year, 2010, all manufacturers in the industry have to be in compliance with that. 5

6 So is what you're saying, now, in the absence of this, there, good manufacturing practices are not regulated, so what confidence can a consumer have that supplements are manufactured correctly and are as potent as, that there's some kind of brand equivalence like there is in prescription drugs? These are in the process of being implemented, so they're being phased in over a three-year period. FDA has started so conduct inspections now of large- and medium-size companies. It's the small ones that have June of this year to comply. But it's being phased in. And the regulation is actually very close to drug GMP regulation. So these are very strict standards, and much of the industry has already been complying with something very similar to what FDA is ultimately requiring here. So there's no reason for consumers to have any less confidence than they had before. They should continue to have confidence. But how do I know who is a big manufacturer, who is a manufacturer who your organization may be looking after? How do I know? Excellent question. So now we're getting into consumer advice. Consumers should use brands, products as they would with any other consumer product, brands that they know and trust, and certainly have a dialogue with their healthcare professional. Any time you're going to choose a supplement, you're going to change your diet, you're going to change your lifestyle, have a dialogue. Those are the first two things. The next thing is look at the products that you're considering, know that these products are not intended to have therapeutic uses although it's possible that in some cases they do, but that's not what they're intended for. Also look at what the product a claiming. A claim that sounds too good to be true probably is. And you brought it up earlier, one of you brought it up earlier about lifestyle types of products, weight loss products, male enhancement products, these are products that are not only issues for supplements but also for the drug industry as well. I mean, if I wanted to I could get Viagra on the black market easily, and so this is an issue with lifestyle types of products, that category where consumers want the quick fix. Well, a lot of these are serious issues. Yeah, absolutely. Obesity is a huge problem, erectile dysfunction is a real issue. 6

7 Right. I think just to call it a lifestyle issue is a little bit dismissive. Well, I'm thinking about in terms of product category, and, you know, energy products, sexual dysfunction. Okay. And weight loss. And companies, unscrupulous companies feed off that consumer desire to have that magic fix and try to market their product that way. They do. I've got a question for you. So I don't know exactly how Washington works but I know they're something like, you know, 3,000 or more lobbyists. Your organization obviously lobbies in Congress, and the pharmaceutical industry, which is highly regulated, does too. Now, I know you have members like Pfizer Healthcare and others, divisions of otherwise ethical pharmaceutical companies, but do you think that your enemy or on the other side of the table here, talking in Senator McCain's ear and others is the pharmaceutical industry and that they take umbrage at what your industry is able to do? No, I don't believe that. I think that there are some people out there that subscribe to this fallacy that there's a big pharma conspiracy against the dietary supplement industry or the natural products industry, and I don't believe that. Not at all. The true potential with using dietary supplements is in health maintenance and wellness and reducing risk of chronic disease. That's really where the true potential is. There are some therapeutic uses, but from a broad perspective that's where the true use is. And even consumer surveys show the main reason consumers use our products is for wellness and health maintenance, not to treat problems. Disclosing Supplement Use to Your Doctor However, as a cancer survivor, believe me, there are cancer patients who say Aunt Suzie or Uncle Charlie or maybe a practitioner, maybe not an AMA practitioner but others, say, well, you know, it's not widely known and there wasn't a hundred million or five hundred million dollars to do a study on this but I can tell you anecdotally that this supplement will boost your immune system and fight back against the cancer. And that's what I worry about. 7

8 And then, you know, the other thing I would just bring up, and we have done programs with some of the leading leaders in the field related to supplements and cancer, and they have concerns when patients, cancer patients do not disclose the supplements they're taking to their medical oncologist and that these drugs actually regulated or not are not working, they may be working against each other. A legitimate concern, and that's why everywhere we go, and we do a lot of continuing education, let's say, for pharmacists, nurse practitioners, constantly reiterating to have that dialogue. And from the survey work that we've done, we've found that practitioners do try to ask and have that conversation with their patients about dietary supplement use. You're absolutely correct. It's absolutely critical, and I couldn't agree with you more on that. I think what needs to be recognized, I'm not saying that supplements aren't used for therapeutic uses, but that's not where their main promise is. I think the best approach is an integrative approach, that it takes into account diet and lifestyle in addition to conventional allopathic medicine and complementary and alternative medicines. I'm looking at a publication here, a JAMA from a couple of years ago that concluded that, I don't know, 70 some-odd drugs that were preapproved by FDA have been removed from the market between 1975 and That's astounding compared to really one supplement, which was Ephedra, that was removed from the marketplace. So I think it's important to have that perspective in context here. When we're talking about safety, these drugs don't prove safety actually. They're reviewed and approved, but they don't prove safety. They're associated with a whole myriad of side effects. Yeah, I guess it's fair to say there's a lot of science on both sides. There's absolutely no question that niacin will raise HDL. There's also no question that too much niacin can really cause severe liver damage and hepatitis, and not everybody can take it. Absolutely. And it's certainly true that some prescription drugs have problems. Some work and some don't. Some only work for given populations. The issue really is I think in nutritional supplements, first it's the quality of the information and being able to trust it, and the FDA does regulate very strictly what prescription drugs can say about their products and what they don't. And I understand it's controversial in terms of the information that's out there, but it's fair to say also that it's a pretty, a very heavily regulated industry, and supplements really aren't in terms of the claims that they can make. And the other is the issue that you raised before is that as a consumer I have no way of knowing who is a small brand and who is a big brand. If I have something which is 8

9 rebranded by my pharmaceutical chain, whether it's Walgreen's or Rite Aid or whatever, I would like to have some confidence that those are all well tested, efficacious supplements to the extent that we know about them. But people are taking these for very serious conditions. Vitamin D for bone health and things like that, there's a lot of good evidence that suggests that these are helpful, but of course we also want to have confidence that what we're taking might actually do us some good and isn't going to do us harm. Wow. Well, we could go on for a long time. You know, I was looking at a quote that our producer, Tamara Perkins, gave to us, and it's from Mary Ellen Camire, who is a food sciences chief at the University of Maine, and she studies natural remedies, maybe you know her, Dr. Shao. Anyway, she says in this field with millions of people seeking out what's right for them, she said you almost have to be a detective. So hopefully whether your industry can do it itself or whether old legislation can be finally kicked in to do what it was intended to do or whether we need new legislation, and we'll see how that turns out, we as consumers are hoping that we can have full information on what the formulation is, whether we can rely on it, and a clear understanding of whether it can be effective and for what. That's fair, isn't it? Yes, that's fair. And I think the responsible industry, and these are the mainstream products that you see in the mass market, the major brands that you know, that's what they strive for because it would be to their detriment to harm or hurt their consumer or not deliver for their consumer. Well, I want to thank you for being with us, Dr. Andrew Shao, who is senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, the industry trade group in the supplements industry. We'll see how this turns out. We want to thank our listeners for joining us. For Patient Power Health Issues, I'm Andrew Schorr in Seattle. And this is Peter Frishauf in New York, hoping for better times for the supplement industry. For all of us, thanks Peter. Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. Please have this discussion you re your own doctor, that s how you ll get care that s most appropriate for you. 9

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