SMART: I know that you two have a keen interest in what goes on at the FDA and in Congress regarding freedom of choice in terms of nutritional supplements. What have you learned about the workings of government at this level that can help us assure that the flow of nutritional supplements is not impeded?
SANDY:We recently heard about a method of lobbying that involved the local people. It's something anyone can do. Rather than calling Congress in Washington, not that that wouldn't have an effect, you get better results by contacting your Congressperson's local offices, recalling that they all have to run again in two years.
DURK: Now, anybody who donates more than $1,000 is on the public record; you can get that information. You may find out that you know somebody who's a major contributor to your Congressperson.
SANDY:And then you could just talk to that person about how the government could save $100 billion a year in health care through the use of nutrient supplements.
DURK: "Don't you think it would be a good idea to say a word about this to your Congressperson?"
SMART: Now, you've written a new book telling what this legal battle is all about.
SANDY:Yes, it's called Freedom of Informed Choice: FDA vs. Nutrient Supplements. In it we discuss in detail our proposal for reforming the FDA so that the FDA is changed from an agency that restricts health information to one that provides health information. Right now the FDA is standing in the way of the use of methods to prevent disease through nutrient supplements because they don't allow companies that sell nutrient supplements to provide truthful health information on the labels and in advertising.
DURK: Conservatively, the FDA's prohibition of information is costing Americans at least 100,000 premature preventable deaths per year and at least $100 billion in unnecessary health expense!
SANDY:We think these are conservative numbers.
DURK: Just to give an example of what we're talking about here, a UCLA epidemiological study of some 11,000 Americans over 10 years found that men who were getting less than 800 mg. of vitamin C a day, primarily from supplements, lived on the average 6 years longer than men getting RDA levels. The women lived 1 year longer. That is just for vitamin C alone. When you start adding in beta carotene and vitamin E, you get a synergistic effect. It's going to be much more than that. So we're talking about a staggering amount of disability and death being caused by the FDA's prohibition of truthful statements of the virtues of nutrient supplements.
SANDY:We wrote our new book because we felt we had to get information like this out before the FDA destroys preventative medicine.
DURK: One of the major problems that we have in America is that we do not have a health care system: we have an illness care system. And the FDA is not going to allow the development of a healthcare system, because that would mean they'd have to give up their policy of considering statements of medical fact about the value of nutrient supplements as drug claims. Treating vitamin C as a drug, they require clinical testing costing upwards of $230 million just to get it approved for reducing cardiovascular risk. Nobody's going to do that because individual vitamins can't be patented.
SANDY:Prevention of illness through the use of nutrient supplements means the individual makes choices for himself based on the best available information. That's why we call our proposed system "freedom of informed choice." But the FDA does not like individuals making their own health choices, and more and more they're restricting the ability of individuals to make those choices. In our new book we describe:
SANDY:And now people are seeing that information appearing in the newspapers and magazines, even on television. The FDA is no longer able to completely prevent people from getting that kind of medical information.
DURK: In a way, the dam got blown up by our book Life Extension: A Practical Scientific Approach. From that point on millions of people became very well aware that, despite what the FDA would like them to believe, taking vitamin C could do things like prevent heart attacks or reduce your risk of cancer. FDA director David Kessler has actually said that he wants the FDA to be the sole authoritative source of information on health and nutrition. Well, shades of the Spanish Inquisition! Come on, folks. This is almost the 21st century. Is there going to be a monopoly on information? Whatever happened to the Constitution?
Since they no longer control the information successfully, what they're now trying to do is control the substances themselves. Gary Dykstra, the Deputy FDA Commissioner in charge of regulatory affairs, announced in an interview in The New York Times last year that it's the FDA's intention to take all vitamins off the market that are above the RDA potencies. If they have their way, you couldn't even get a 100 mg. tablet of vitamin C except with a prescription.
SANDY:Plus they would remove nearly all . . .
DURK: . . .all amino acids and all herbs.
SANDY:Well, this isn't just a bad news book. We talk about the good news, too, about how you can really prevent a great deal of disease through nutrient supplements. And we also describe how we think the FDA should be reformed. We propose that the FDA be reformed so that it provides information rather than restricting it, and that we have a system of freedom of informed choice. Now this is not something that is politically unlikely. It's very likely, because this year Congresspeople are becoming more aware than ever before of the potential for nutrient supplements to reduce the risk of disease and thereby reduce the tremendous costs of health care.
DURK: It's sometimes hard to think about so many people dying because of the FDA's policies.
SANDY:But people are willing to think about the huge amount of money that would be saved if people were preventing diseases like cancer and cardiovascular disease and other age-related diseases. And the fact is that the government of the United States of America is bankrupt. They know it, and they're scared. They desperately need to save money, and the saving of $100 billion a year in healthcare costs would be a tremendous help to their problem of not being able to stop spending money. Anyway, what we've described is a way people can take care of a lot of their own medical problems by preventing the diseases before they occur in the first place. Let's face it, even if we get "free" medical care at the expense of the tax-payers, it's going to be much better from the individual's point of view not to get the disease in the first place.
DURK: Yeah, who would prefer a free cardiac bypass to not needing a bypass?
SANDY:Exactly. And it looks as though there's a very good chance that this idea is going to be a popular one in Congress, because it doesn't require the government to spend any money at all.
DURK: However, you know, the people in Congress don't know anything about how the free market works. The whole idea of freedom is alien to them in a very real sense. At least for most of them. There are a few exceptions. Senator Orrin Hatch had the courage to call his bill the Health Freedom Act of 1992. It is instructive to note that the new name for the latest version of the bill does not include the word "freedom." Apparently freedom is politically incorrect.
SANDY:The new name is the Dietary Standards and Consumer Education Act. Apparently the word "freedom" is too radical for a Congressional bill in the United States in 1993.
DURK: And the thing is there's going to be a whole lot of bills put out because it's going to be politically popular. Polls have shown that over 80% of the people think that . . .
SANDY: . . . truthful health claims for health products should be permitted.
DURK: And so as a result Congress is going to do something. Whether it does the right thing or not depends a great deal on the pressure people put on Congress to do the right thing, because most Congress-people don't know the difference between right and wrong when it comes to nutritional health.
SANDY:That's what we describe in the book more fully. We explain how to influence the Congress, how you really can have an effect.
DURK: Remember, right now the FDA is above the law. Congress specifically ordered the FDA to consider a health claim for folic acid to prevent neural tube birth defects such as spina bifida. The FDA simply ignored the law. The FDA ignores laws all the time. They ignore the Constitution. They are literally an agency out of control.
SANDY:We wrote a book that we think very well explains how this system can be reformed, how this can be done in a very politically acceptable manner, and what . . .
DURK: . . . the legislation that would make a difference should look like.
SANDY:And how the system would work for you, the nutrient supplement consumer.
DURK: Also there are specific details written by a Washington insider on how to go about influencing your Congresspeople. So, you know, this is really a how-to do-it book. Just like Life Extension. This is a how-to-save-life-extension book, because if the FDA has their way, there will be no life extension by the end of 1993.
SANDY:And one other thing. We wanted to get this information out so strongly that we are giving up all royalties. We're not getting any payment for writing this book. We did it simply because we desperately want to see the FDA reformed before they remove all nutrient supplements from the market and destroy the developing life extension technologies that are available to us now.
DURK: We have purchased about $10,000 worth of amino acids and two 23-cubic foot deep freezes to keep them, a 20-year supply of these amino acids . . .
SANDY: . . . just in case they actually go through with this threat to remove amino acid supplements from the market.
DURK: That is how serious we consider the problem. This is going to be an inexpensive book. It's going to sell for just $6.95. And really, if you value life extension, you'd better get this book. If we have our way, it's going to be a whole new world because it'll be possible to make justifiable health claims.
SANDY:You know, there are so many things that we can't say about our formulations in the interviews that we give in this newsletter. It's terribly frustrating and it also deprives people of important information.
DURK: For example, the effect of arginine plus choline and cofactors on helping you to build up your muscles with exercise is the least important thing about that formulation. It's trivial compared to what it can really do.
SANDY:But the First Amendment is not protecting us from the FDA. That's one of the things we address in the book, that the First Amendment is being ignored by the FDA.
DURK: We have given quite a few health lectures in Mexico in the past year or two, and we really enjoy doing them, because in Mexico, if you've got the scientific papers to back up what you say, you can say it. If it's true and you've got the proof, you can say it. And we have got a lot of doctors down there using our formulations to treat some very, very serious and generally considered incurable disease conditions, but we can't tell you about that up here. All we can do is let you die. And it's not our idea to do that. It's the FDA's.
SMART: Do you know if the new branch of the National Institutes of Health that's looking into alternative treatments is going to be looking into any of the vitamin supplements?
DURK: We don't know that, but it would be extremely unlikely that they could overlook it, considering the amount of material on the benefits of vitamins that's come out of NIH laboratories. In fact, recently there was a paper, a major review paper published in Science by Dr. Earl R. Stadtman, Chief of the Laboratory of Biochemistry for the National Heart, Lung, and Blood Institute of the NIH. He started the thing out by saying that Dr. Denham Harmon's free radical theory of aging is widely accepted and free radicals are intimately involved in cardiovascular disease, many types of cancer, and a great many other age-related diseases.
SMART: There were a couple of recent papers that you might like to comment upon. One regarding the effects of aspartame and protein on the endurance of phenylalanine in the body.
SANDY:And it simply verifies . . .
DURK: . . .confirms the basis of our design for formulations like BLAST and RISE & SHINE.
SANDY:The papers show that the phenylalanine that comes from aspartame is more available to the brain than the same amount of phenylalanine that's gotten through food.
DURK: And, of course, the reason for this is that the phenylalanine in the aspartame breaks down into aspartic acid and phenylalanine. Aspartic acid does not compete with the phenylalanine to get across the blood-brain barrier into the brain. But the phenylalanine in a hamburger and a milk-shake, even though there's plenty of it in there, has to compete with a lot of other amino acids for paths across the blood-brain barrier. As a result, relatively little phenylalanine gets in. I recently saw a paper in Nutrition Reviews on a comparison of the ability of carrots versus beta carotene supplements to raise serum levels of beta carotene. And it turns out that a single capsule of beta carotene supplement is roughly equivalent to eating 2 pounds of carrots. You might just check with the local supermarket and see what 2 pounds of carrots cost and then figure out what one capsule of beta carotene costs you. I think it might be very illuminating to do that with DUAL C-600 also. Find out what 12 to 20 oranges cost. There's about 145 mg. of vitamin C in a good sized orange.
SANDY:A large orange in the supermarket costs nearly 50 cents. So we're talking about several dollars a day in order to get the same amount of vitamin C from oranges as you'd get in the Dual C.
DURK: Also, you don't have 100% bioavailability of the vitamin C in oranges. A substantial amount of that vitamin C remains bound to the fiber and just goes out in the toilet when you sit down on it.
SANDY:Some scientists have made statements about how people can get the nutrients from foods much more cheaply than from supplements. Well, all I can say is, these people are not going to the supermarket.
SMART: It seems carrots compare very favorably with broccoli. I think one study that you cited showed that there was no increase in serum.
DURK: They fed human volunteers one pound a day of broccoli . . .
SANDY: . . . paid volunteers . . .
DURK: And I imagine they had to pay them a fair amount, too, for eating a pound of broccoli a day. And you know, there are things in broccoli other than beta carotene that are good for you which you're not going to get from a beta carotene supplement. But as far as beta carotene and broccoli is concerned, there was no measurable increase in serum beta carotene levels.
SANDY:So, what we say is you should eat plenty of fruits and vegetables, because there are a lot of things in there that are good for you, not just beta carotene. But if you want to have a lot of beta carotene available to you, you're better off taking the beta carotene by supplement.
SMART: On another topic, there was a recent paper in Neuroendocrinology about the impact of arginine on responsiveness to growth hormone releasing hormone (GHRH) administration in normal adults.
DURK: Yes. I thought that was really fascinating. The arginine increased the sensitivity of the pituitary to the effects of GHRH.
SANDY:Normally, after the release of growth hormone (GH) stimulated by GHRH, the pituitary becomes resistant to further releases of GH.
DURK: And this process occurs more and more as you get older, which is one of the reasons you release less and less GH as you get older. And arginine can counteract that very effectively.
SMART: Anything new on the nitric oxide front? NO was named the molecule of the year in Science Magazine.
DURK: Very well deserved. . .
SANDY:They found NO to be connected to so many basic processes, like long-term potentiation which is the basis of learning and memory, like motor control, like the dilation of blood vessels, like erections…
DURK: Like the bactericidal effects of macrophages. They use nitric oxide to wipe out the bad guys that they're killing and eating.
SANDY:Exactly. We're talking about something really major and really pervasive.
DURK: And just remember, the only way your body can get NO is from arginine. That's the only precursor to it that's known. There are certain drugs that are capable of providing NO when they break down, like nitroglycerin. But I thinks it's much wiser to use an arginine supplement than a nitroglycerin supplement unless you have really severe angina.
SMART: That's real interesting. NO was molecule of the year for 1992 in Science Magazine and in you were writing about it in 1990.
DURK: Well you know that means that mainstream science is really improving. They're only 3 years behind us instead of 10 years.
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