Guest guest Posted July 10, 2000 Report Share Posted July 10, 2000 > > > DR DAVID KESSLER, YALE UNIVERSITY > > SCHOOL OF MEDICINE There are thousands of > > products being marketed that make claims for which > > there is no strong scientific basis. > > TED KOPPEL They’re marketed like drugs, but > > they’re sold like food. > > SARAH INGHAM (ph) I thought that they only sold > > things that were good for you. I didn’t know that things > > were sold that would kill you. > > TED KOPPEL Tonight, the dangers of dietary > > supplements. Should the government step in? > > ANNOUNCER From ABCNEWS, this is Nightline. > > Reporting from Washington, Ted Koppel. > > TED KOPPEL It’s easy to understand our fascination > > with folk medicine. There is something profoundly > > reassuring about herbal remedies and cures that our > > colonial forefathers and mothers used in this country > > before the FDA or even the AMA was a glimmer in > > anybody’s eye. There is also something comforting > > about the so-called ‘natural medicines’ that our > > grandmothers employed back in the ‘old country,’ > > whether that old country was Sierra Leone, Ireland, > > Poland or China. Then again, there appears to be > > something artificial and manufactured about drugs, while > > herbal remedies sound so, well, natural. > > Natural or not—and some dietary supplements imported > > from Asia were found to contain, among other things, > > lead, arsenic, and mercury—it’s a huge growth industry. > > This year alone, some $15 billion in sales. And anyway, > > we reassure ourselves, if there were anything wrong with > > that ephedra or St. Johns Wort, if there had been any > > problems from taking melatonin or ginseng or ginkgo > > biloba, the government would step in. Right? No, the > > Food and Drug Administration has nothing to do with > > clearing most of these products for sale. > > In the case of manufactured drugs, a pharmaceutical > > company has to get FDA approval before it can put a > > new drug on the market. In the case of dietary > > supplements, the FDA would have to prove that > > something was wrong with the product to get it off the > > market. And the people who put out the dietary > > supplements, what obligation do they have to report > > instances in which one of their products caused illness or > > death? Zero. None. We’ll talk about how and why that > > came to pass a little later. First, though, this report from > > Nightline correspondent John Donvan. > > JOHN DONVAN, ABCNEWS (VO) Sometimes the > > heart of the matter lies in the small print. And here’s > > what the small print says these days on some of the stuff > > that’s been bottled for your health. “Fuel for Thought” > > by Nature’s Plus. “Healthy Brain Function and General > > Well-Being” the bottle reads, but there’s an asterisk. > > “This statement has not been evaluated by the Food and > > Drug Administration.” Or “Nutritional Support for > > Joints” by the Vitamin Shoppe. There’s that asterisk > > again and that same disclaimer about the FDA. And > > that’s how it is as Americans, over the past several > > years, have rushed the doors of what used to be called > > health food stores. This represents the traffic, of course, > > speeded up several times during a one-hour period at > > GNC here in Washington this afternoon. The bottles > > may come with asterisks, but the business is booming. > > 2ND BASEBALL ANNOUNCER He launches one > > to deep center field. > > JOHN DONVAN (VO) The king of home runs, Mark > > McGwire, gave some of the credit for his amazing ’98 > > season to a dietary supplement and its sales soared. > > When we asked some prep school lacrosse players > > who’d been down to the local supplement store, two > > acknowledged taking an amino acid called creatine. > > WILL WILKINS, HIGH SCHOOL STUDENT It > > helps me gain weight and I did notice it helped me to > > build up more muscle. > > JOHN DONVAN (VO) Then there’s weight loss and > > an ingredient called mahuang from the plant of the same > > name, known chemically as ephedrine. People like Heidi > > Vanderwaal (ph) have taken it to lose weight. > > HEIDI VANDERWAAL I lost seven pounds in two > > weeks and then 35 pounds in three-and-a-half months > > and found it to be the most freeing tool that I’ve ever > > come across. > > JOHN DONVAN (VO) All told, last year, Americans > > spent $15 billion buying vitamins, minerals, herbs, and > > amino acids to feel stronger, to think more clearly, to > > digest their food better and so on and so on. From > > Butcher’s Broom to Gotu Kola, to Hawthorne Berries, > > which are supposed to fight insomnia and smooth > > digestion. > > (OC) Now, without a doubt, some of these herbs, long > > overlooked by western medicine, do some people some > > good. And recent scientific research, especially in > > Europe, backs that up. So why then that asterisk? Well, > > it’s the FDA’s way of saying that it’s not entirely sure > > what’s inside the bottle. The testing that’s demanded of > > conventional pharmaceuticals—the clinical trials, the > > hundreds of millions of dollars in research—it’s not > > required by law for the pills and potions marketed as > > dietary supplements. The result, wrote former FDA > > Commissioner David Kessler recently, is a public that > > does not “understand how potentially dangerous these > > products can be,” that, for example, at least one > > supplement may be linked to cancer. It is time, he says, > > to “change the law.” > > DAVID KESSLER I don’t know how we’ve gotten to > > the point where we walk into a supermarket, or we walk > > into a drugstore and we see literally hundreds of > > products on the shelves. We see claims that have very > > little scientific basis. We see products that are being sold > > that have real risk. I mean, we’re turning back the > > standards that we have developed in this country where > > if you walked into those stores, you could trust what was > > on the label. > > JOHN DONVAN (VO) With the passage of a 1994 > > law, the FDA got a lot of power to regulate the labeling > > of dietary supplements so manufacturers cannot make > > outlandish medical claims. > > (OC) But when it comes to what’s inside the bottle, the > > FDA has about the same regulatory power over that as > > it has over the quality of seafood. Seriously. Brand new > > supplements—and they are relatively few—yes, the > > FDA can block those pretty easily. But the thousands of > > traditional supplements—those products are presumed > > safe and sent to market, just like seafood, until > > somebody gets sick or until the FDA can prove that > > there is a problem. > > DAVID KESSLER By putting the burden on the FDA > > to prove that, in fact, a substance is unsafe, to prove that > > a claim is false or misleading, I mean, it’s like letting > the > > horses out of the barn and asking FDA to go chase all of > > them. > > JOHN DONVAN (VO) But the supplement industry > > says it’s not necessary to regulate its products with the > > stringent rules applied to pharmaceuticals. > > JOHN CORDARO, COUNCIL FOR > > RESPONSIBLE NUTRITION A prescription drug is > > designed to treat, cure unmitigated disease. A dietary > > supplement is—is used by consumers to fill a gap in their > > nutritional dietary eating patterns. A dietary supplement > > is used to help to reduce the risk of—of certain diseases. > > JOHN DONVAN (VO) But then there’s mahuang, or > > ephedra, an ingredient in the supplement that Heidi > > Vanderwaal used to lose 35 pounds. We want to > > mention at this point that an ephedra trade group lobbied > > us repeatedly to include Vanderwaal in this program > > once the group learned that we were planning to speak > > with this woman, Sarah Ingham, 24 years old, who > > suffered a stroke in April and walks with a limp. She > > was engaged to be married and wanted to lose weight > > and started taking a product with ephedra in it. > > SARAH INGHAM I got it at a General Nutrition > > Center, and I thought that they only sold things that were > > good for you. I didn’t know that things were sold that > > would kill you. > > JOHN DONVAN (VO) Michael Hofstedter (ph) is > > Ingham’s doctor. > > MICHAEL HOFSTEDTER You see advertisements > > on TV and the radio. It’s just endless, hawking these > > products. This is a multibillion dollar, very profitable > > industry for these supplements. And people don’t realize > > they’re actually drugs. > > JOHN DONVAN (VO) Is it proven that ephedra > > caused Ingham’s stroke? No. But Dr. Raymond > > Woosley, a leading pharmacologist, sees plenty of red > > flags for ephedra nationally. > > RAYMOND WOOSLEY In the last year, I and seven > > other people independently looked at 140 of the over > > 800 cases that have been sent to the FDA and everyone > > agreed that the strokes, the heart attacks, the deaths that > > were in those cases were most likely the result of this > > drug. > > JOHN DONVAN (VO) Clearly, the supplement > > industry is on the defensive about the ephedra scare, in > > light of the fact that so many people use it without > > apparent harm. And again, if you go to the fine print, > > responsible ephedra makers always spell out that it’s not > > for everybody. > > WES SIEGNER, EPHEDRA EDUCATION > > COUNCIL We believe that if you use it appropriately > > and according to the standard national warning label, > > that the product is safe for the general public. > > JOHN DONVAN While a lot of this debate focuses on > > whether the law is good enough, another argument holds > > that the real problem is funding, that even with, let us > > say, it’s limited “seafood power” to regulate > > supplements, the FDA still could still enforce a pretty > > decent standard of safety in the supplements market. But > > that will take staff and money, and that is another story. > > I’m John Donvan for Nightline in Washington. > > TED KOPPEL In a moment, a leading critic of the > > dietary supplement industry and one of its leading > > lobbyists. > > ANNOUNCER Nightline, brought to you by... > > (Commercial Break) > > KOPPEL: And joining us now from New York, Dr. > > Victor Herbert. He is chief of the nutrition center and > > research at Mount Sinai School of Medicine. And > > joining us here in Washington, Michael McGuffin is > > president of the American Herbal Products Association, > > one of the leading trade groups representing the dietary > > supplement industry. Dr. Herbert, let me begin by finding > > out from you what you really think. Do you think that > > most of these products are essentially benign, mostly > > damaging or like little sugar pills which are neither benign > > nor damaging? > > DR VICTOR HERBERT, MOUNT SINAI > > SCHOOL OF MEDICINE I think some are mildly > > helpful. Many of them are seriously harmful. And most of > > them are just a waste of your money. > > TED KOPPEL Talk about, just for a moment, about > > the ones that you think are seriously harmful. When you > > say “seriously,” what do you mean? > > VICTOR HERBERT Death, maiming, things like > > ephedra, which was mentioned earlier in the program. > > Mahuang is ephedra. It’s basically adrenaline and it’s > > like taking pills of adrenaline. > > TED KOPPEL Do you have evidence that, indeed, > > people have died as a direct consequence of taking > > ephedra? > > VICTOR HERBERT Oh, yes. And the FDA has > > evidence on a number of cases. > > TED KOPPEL So why haven’t they stopped it? > > VICTOR HERBERT The FDA is forbidden to > > protect the public against any product the seller labels a > > supplement. Senator Hatch, who is the supplement > > industry’s man in Congress, got through Congress the > > Hatch Act in ’94 called Dietary Supplement Health > > Education Act and The New York Times properly > > characterized it in an editorial as the ‘Snake Oil > > Supplement Act.’ > > TED KOPPEL All right. Let’s get—let’s get Mr. > > McGuffin in here because I think he’s probably got a lot > > to say in—in—in his own behalf and really more to the > > point... > > MICHAEL MCGUFFIN, AMERICAN HERBAL > > PRODUCTS ASSOCIATION Sure. > > TED KOPPEL ...in his industry’s point. > > MICHAEL MCGUFFIN Ted, these products are > > actually quite well regulated. We need to understand a > > little... > > VICTOR HERBERT That’s contrary to fact. > > TED KOPPEL All right. Hold on, Dr. Herbert. > > Let’s—let’s let... > > MICHAEL MCGUFFIN We need to understand... > > TED KOPPEL ...Mr. McGuffin talk for a moment. > > MICHAEL MCGUFFIN We do need to understand > > a little of how this regulation came to be. The US > > Congress unanimously approved the Dietary Supplement > > Health and Education Act partly in response to FDA’s > > efforts to take herbs and vitamins away from Americans > > and limit their access... > > VICTOR HERBERT That’s untrue. > > TED KOPPEL Dr. Herbert, try—try and control > > yourself just for a couple of minutes. > > VICTOR HERBERT OK. He’s saying so many things > > that are untrue. > > TED KOPPEL I—I will give you a chance to talk in > > just a moment. > > VICTOR HERBERT Thank you. > > MICHAEL MCGUFFIN The agency attempted to > > limit access to truthful information about these products. > > The resulting regulations, the resulting legislation and the > > regulations that came from them, if I can quote the > > current commissioner, Dr. Jane Haney—what she has > > told a congressional committee is that the regulations, as > > they exist today, provide sufficient legal authority to > > protect the public health. > > TED KOPPEL Let me—let me just have you address > > directly something Dr. Herbert said about ephedrine. > > MICHAEL MCGUFFIN Yeah. > > TED KOPPEL Do you accept the notion some people > > have died as a direct consequence of taking ephedrine? > > MICHAEL MCGUFFIN No, I don’t. I do, however, > > recognize that ephedra is an herb that needs to be > > treated with respect, and that’s why the dietary > > supplement industry established meaningful > > self-regulations that limit the dosage that requires > specific > > labeling cautions on all ephedra products. We have > > shared those ideas with FDA and requested that they > > adopt a similar regulatory control. > > TED KOPPEL When you say effective self-regulation, > > the fact of the matter is the law does not require you, > > even if there were a death or more than one death as a > > direct consequence of taking one of these products, the > > law does not require you to inform the FDA, does it? > > MICHAEL MCGUFFIN The law does require us to > > fully inform consumers of all material information. > > TED KOPPEL Would you—would you try and answer > > my question directly? > > MICHAEL MCGUFFIN Yeah. > > TED KOPPEL The law does not require you to inform > > the FDA, does it? > > MICHAEL MCGUFFIN The—the law, I believe, you > > are accurate, does not require—but it would be just > > in—in—unbelievable if a manufacturer had any evidence > > that its product had—if, in fact, produced serious > > adverse effects, to think that they would not inform the > > agency. > > TED KOPPEL Well, I mean, we—we already have a > > disagreement, in fact, between you and Dr. Herbert. > > And I want to go back to Dr. Herbert for a moment > > now. You said with some certainty just a few moments > > ago that, indeed, more than one person had died from > > the use of ephedra. And I asked you at that time, do you > > know that to be the case? Do you have evidence to > > support that? > > VICTOR HERBERT Yes. > > TED KOPPEL You said yes. What evidence? > > VICTOR HERBERT There are a number of dead > > people who have cases have been reported to the state > > of Texas and to the FDA. And you can get them from > > the records of the Texas Health Department... > > TED KOPPEL Well, I mean, there—there... > > VICTOR HERBERT ...and from the records of the > > FDA. > > TED KOPPEL There are dead people in every state at > > all times. That doesn’t... > > VICTOR HERBERT I’m talking about from ephedra. > > TED KOPPEL And—and what, there is a coroner’s > > report saying they died from ephedra? > > VICTOR HERBERT No. The coroner’s report says > > they died from heart damage. > > MICHAEL MCGUFFIN No causal relationship has > > ever been shown... > > VICTOR HERBERT That is a lie. > > MICHAEL MCGUFFIN ...in any instance. > > VICTOR HERBERT That is a lie. > > MICHAEL MCGUFFIN It simply has not. > > VICTOR HERBERT That is a lie. > > TED KOPPEL Well, I mean... > > VICTOR HERBERT There are two cases right now > > that I know of, of people who are suing the sellers of > > their ephedra caffeine products for severe heart damage > > brought about by taking those products. > > TED KOPPEL Al right. We’re going to have to take a > > break. Let me just point out that simply because they are > > suing, they haven’t won their suit yet, have they? > > VICTOR HERBERT There... > > TED KOPPEL They haven’t won it yet. They haven’t... > > VICTOR HERBERT I know of two suits that have > > been won. I’m talking now about two suits which are > > currently in court. > > TED KOPPEL OK. Let’s take a short break and we’ll > > be back with our guests in a moment. > > (Commercial Break) > > TED KOPPEL And we’re back once again with Dr. > > Victor Herbert and Michael McGuffin. > > Mr. McGuffin, what distinguishes a dietary supplement > > from any other kind of drug? > > MICHAEL MCGUFFIN Well, a dietary supplement > > is simply classified different in the regulatory model. But > > the—the issues that were raised in some of the early > > commentary about the need to regulate these in—as > > drugs is simply not the right approach to the regulation of > > supplements. > > TED KOPPEL Could we at least begin with your trying > > to answer my question? What distinguishes a dietary > > supplement from any other drug that may be on the > > market and that is subject to FDA approval? > > MICHAEL MCGUFFIN Well, OK. A dietary > > supplement is defined as a vitamin, mineral, amino acid, > > or herb that’s used to supplement the diet. And a drug is > > defined as a substance that’s used to treat, cure, > > mitigate, prevent disease. > > TED KOPPEL And Dr. Herbert, how—how does one > > distinguish whether one of these products is a dietary > > supplement or purports to be able to do something on its > > own? > > VICTOR HERBERT It’s—it’s all semantics, Ted. > > They’re all drugs. But the—the Hatch Act, the ‘Snake > > Oil Supplement Act,’ says that if the product is found in > > nature, in any dose, in any quantity, anywhere in the > > world, you can sell it as a supplement. > > MICHAEL MCGUFFIN That’s not true. > > VICTOR HERBERT That—you are lying. Not only > > can you sell it as a supplement... > > MICHAEL MCGUFFIN That’s simply not true. > > TED KOPPEL Dr. Herbert, I—I admire your > > enthusiasm. But maybe we can keep the charges of lying > > down just a little bit. > > VICTOR HERBERT All right. All right. > > TED KOPPEL What would be a sensible way, Dr. > > Herbert, of finding some kind of a compromise here? In > > other words, if the FDA, for example, were given more > > money so that it could hire more people so that it could > > do more investigating, wouldn’t that be a step in the right > > direction? > > VICTOR HERBERT The sensible thing would be for > > the FDA to be given the funding to do what the German > > commission does. The German equivalent of the FDA > > has a phytochemical division—that is, a division for > > studying herbs. And they require anybody who sells an > > herb in Germany to meet specific standards for quantity > > of certain specific active ingredients... > > TED KOPPEL All right. > > VICTOR HERBERT ...per dose. > > TED KOPPEL Let me interrupt you only because > > we’re down to our last few seconds and I’d like to give > > Mr. McGuffin a last—the last word. What would be > > wrong with that sort of a model? > > MICHAEL MCGUFFIN Well, I’m—I’m—we’ve > > adopted elements of that model. We’ve certainly > > adopted some of the findings of the commission he—that > > Dr. Herbert’s referring to. But I don’t believe that > > the—the regulations in our country already work well to > > protect consumer health and to protect consumer access > > and that’s what they were designed to do. > > TED KOPPEL Dr. Herbert, we—we’ve got about 20 > > seconds left, and you—you’ve got the last word now. > > Go ahead. We had a little more than I thought. > > VICTOR HERBERT The bottom line—St. John’s > > Wort causes people with AIDS to die of their AIDS > > because it knocks out the efficacy of the protease > > inhibitors that help them. > > TED KOPPEL I thought everybody died of AIDS, > > eventually. > > VICTOR HERBERT No. Not anymore. > > TED KOPPEL No one has been cured of AIDS, to the > > best of my knowledge. > > VICTOR HERBERT It depends on your definition of > > cure. > > TED KOPPEL OK. > > VICTOR HERBERT There are a lot people who > > never get the clinical disease or whose clinical disease is > > in remission probably forever. But the point is that St. > > John’s Wort prevents the protease inhibitors from > > inhibiting the growth of the AIDS virus. It prevents oral > > contraceptives from working. So women taking oral > > contraceptives and take St. John’s Wort become > > pregnant because it doesn’t work. It prevents other > > drugs like digitalis from working properly. > > MICHAEL MCGUFFIN Doc—doc—what Dr. > > Herbert is referring to... > > VICTOR HERBERT It—and not only that, but > > ginkgo—ginkgo is an anti-coagulant. There was just > > recently a report... > > TED KOPPEL Gentlemen, I can’t—I can’t—I can’t > > stretch—I can’t stretch the time any longer than it is. But > > Mr. McGuffin, I have to give you a chance to... > > MICHAEL MCGUFFIN Yeah. > > TED KOPPEL ...to come back with a very quick > > comment. > > MICHAEL MCGUFFIN But what Dr. Herbert, I > > think, is pointing out is that there is specific information > > about specific herbs that does need to be made available > > to consumers. I agree with that. Our trade association > > has worked very diligently to... > > VICTOR HERBERT It’s not on your labels. > > MICHAEL MCGUFFIN ...differentiate that. > > TED KOPPEL Hold it. Dr. Herbert, hold it. Please. > > MICHAEL MCGUFFIN The—but this wholesale > > approach to that we should throw away all of the > > regulations and start over doesn’t make any sense. We > > need to look at the specific information about specific > > substances because the—the rules for chamomile are > > going to be different than the caution that you might put > > on, as Dr. Herbert has pointed out, St. Johns Wort > > products. > > TED KOPPEL And unsatisfactory as that may be to > > Dr. Herbert, that’s going to have to be the last word. I > > thank you both very much for joining us. Good of you to > > come in. > > If you have questions for Michael McGuffin, you can > > chat with him online at abcnews.com tomorrow at 5:00 > > PM Eastern time. > > And I’ll be back in a moment. > > (Commercial Break) > > TED KOPPEL Tomorrow on “Good Morning > > America,” a member of the rescue team which has been > > trying to save the penguins caught in an oil spill off South > > Africa. > > That’s our report for tonight. I’m Ted Koppel in > > Washington. For all of us here at ABCNEWS, good > > night. >> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 10, 2000 Report Share Posted July 10, 2000 OK, I believe there's a public perception and political problem. So what should we do? Sorry to ask this just as I'm leaving for 3 weeks but I wanted put at least one cent in. TTY on return. JOE - cha Monday, July 10, 2000 3:01 PM Nightline on Supplements Quote Link to comment Share on other sites More sharing options...
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