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COMMENTARY AND DISCUSSION Anita Johnson Samuel E. Stumpf Richard L. Veech Milton R. Wessel Alexander Leaf Virgil O. Wodicka ANITA JOHNSON I would like to make some general comments on themes that have run through the proceedings today. The comments are entitled "Consumer Principles for Food Additive Decisions." I am employed by Public Citizen Health Research Group, an organization affiliated with Ralph Nader that is supported by many individual, small donations. The first consumer principle for food additive decision is: Demand that the additive entails no health risks. If there are possible health risks, do not balance the risks with the benefits to allow marketing approval. Food additives, unlike drugs, are not required by law to demonstrate a consumer benefit. The only thing they are required by law to show is that they have "function." This is in contrast to the situation with drugs. For drugs, the balancing of benefits and risks is entirely legitimate. For one thing, the drug law requires controlled clinical and preclinical evidence that the drug is effective. There have been foul-ups for this requirement. For example, in the Bureau of Drugs, they occasionally slip up and ap- prove a new drug on the basis of chemical efficacy rather than thera- peutic efficacy, and there have been several tragedies from this type of slip-up, such as the MER/29 case and the case of the oral anti- diabetics drugs. However, in general, the Bureau of Drugs requires evidence of both the benefits and the safety, such that in the drug area there is approval for a very limited use, not a use uncontrolled throughout the population. Moreover, the benefits and risks of the drug for each patient are individually assessed after FDA assesses the benefits and risks. And last, the benefit accrues to the same person who gets the risk, which is not always true in the food additive area. 2l5
2l6 Dr. Melmon's comments earlier today were very much to the point. In the drug area, controlled evidence of efficacy is required. According to him, there is no such evidence for nonnutritive sweeteners. When- ever we get into balancing the benefits in the food additive area, peculiar specters appear. First, on the benefit side we see ludicrous estimates of costs to the consumer or of money saved for the consumer. For example, with diethylstilbestrol, we had the industry and the government claiming that removal of diethylstilbestrol from the market would cost the consumer anywhere from 2 cents to 38 cents extra per pound of beef. These estimates were never substantiated. In fact, Congressman Fountain's subcommittee later showed that there was serious basis to question whether DES really made meat any cheaper, since the committee found that beef-raising requires a great deal more feed when DES is used than when it is not. Similarly, a recent article in the Washington Post by Marian Burros pointed out that the cost of saccharin-sweetened soft drinks was keep- ing pace with the rising cost of sugar-sweetened soft drinks, so that in essence the saccharin drinks were giving the food industry the extra profit that it was losing from sugar drinks. In that case, the con- sumer was not benefiting financially from the use of saccharin, even though profits to the industry were much higher because of its use. Another ludicrous thing I see when the government starts getting in- to benefits on the food additives is the so-called psychic benefit. This has been used particularly in a recent American Enterprise Insti- tute book that purports to do a cost-benefit analysis on food additive use. The author, Campbell, believes that FDA must weigh the psychic benefit against the health cost. The typical question the "psychics" would ask in a pinch is: How happy does it make a consumer to see a red-cherry soda? We have heard today that the benefit of nonnutritive sweeteners is to be measured as improvement of the quality of life -- very nebulous. We also heard today that nonnutritive sweeteners stop internal con- flicts among obese patients, i.e., they can have their cake and eat it too. How do we prove that it stops internal conflicts? Who says? How do we design an experiment to show that nonnutritive sweeteners improve the quality of life? This quality of life stuff also runs throughout the medical profes- sion. It is an area in which drug regulators have to be careful, too. You often hear doctors say, "I want to make my patient happy; I want to make my patient feel that he is leading a normal life." That is not the function of the doctor. The function of a doctor is to do what he can for the therapy of an abnormal condition, not to make his patient happy. The aim of happiness by the doctor is what leads to an over- drugged society, which NIMH studies have documented, the kind of soma society where what the doctor is trying to do is not treat your dis- ease, but make everybody feel happy. The peril of the government's getting into the benefits game in food additives is indicated in the nitrite situation. Nitrites have been approved solely for the coloring of meat, and they have not been
2l7 approved for the control of botulism. There are not the extensive con- trolled studies on botulism, nor the consideration of alternative botulism controls such as adequate factory processes or refrigeration. Finally, there is the extraordinary suggestion by Dr. Crampton this morning that the benefits of saccharin could be demonstrated from pro- duction figures. The second reason that balancing is very inappropriate in the food additive area is that I worry about who does the balancing. Dr. Van Houweling, the current director of the Bureau of Animal Drugs, stated at the Food and Drug Law Institute several months ago that the benefits and the risks should be "balanced by businessmen through their trade associations." Certainly the NAS Food Protection Committee should not be in the business of balancing benefits and risks. This committee has a long history of indifference to chronic hazards (as opposed to acute hazards). This history is documented in detail in our book by Philip Boffey, The Brain Bank of America, a study of the National Academy of Sciences and its committees. We recently have heard FDA officials essentially saying that the way they balance the benefits and risks is to take the middle position between what industry thinks and what the consumer groups think. Lastly, the exact quantification of chronic risks is very difficult, and it is very hard to find a common language to balance benefits and risks. My own feeling is that if anyone balances benefits and risks in the food additives area, it should be the Congress, which should make specific exemptions for each single additive when it concludes that the benefits exceed known risks or known possible risks. Such balancing should never occur at FDA. I say this not because the Congress is always ideal, but because we run tremendous risks in getting unbiased groups for balancing if we do not use the Congress. The second consumer principle is: Evaluate the negative data as critically as the positive data. We have seen here today the vultures close in on the positive data on saccharin, the two reports determined to show a significant increase in bladder cancer from saccharin. Sud- denly the troops are called into action. Suddenly bladder stones be- come a major concern to invalidate these tests. Then we have the problem of impurities, and consensus has developed that OTS, which is not a proven carcinogen, must be responsible for the positive results. We have no proof of this at all. We have chronic animal studies of saccharin and OTS together, not of either alone. Yet everyone is desperate to absolve saccharin itself. Then the comments are made that these studies are invalid because the animals lost weight. Where is the equally critical attention given to the negative studies, the studies that are alleged to show that saccharin is safe, that saccharin does not cause cancer? Let me tell you briefly what I found in looking at the allegedly negative studies. Of eight chronic feeding studies, I could not get ahold of two of them - - the German and the Shubik studies -- from the NAS or the FDA (which raises the question of how they could have been studied). Four of the studies were essentially useless for any
2l8 information at all. Two had totally inadequate examination of animals. In one, only seven animals were examined; in another, there was no microscopic evaluation of the bladder. (Bladder tumors are not always visible to the naked eye.) Another study, the Bionetics study, had such a high rate of pituitary tumors in the controls that according to a National Cancer Institute analysis, you could not show that any chemi- cal was carcinogenic relative to those controls. In summary, four of the studies cited by the Food Protection Committee and other speakers here as being negative were essentially useless. Four others, by our preliminary analysis, were positive -- and I say preliminary because more work will be done. In the Bio-Research mouse study, the overall tumors were significantly increased. Primarily they were lung tumors. This corroborates the early Fitzhugh findings of in- creased lung tumors. In the Japanese study, while there were not bladder tumors and the Food Protection Committee was correct that it did not show increased bladder tumors, there was a dramatic excess of overall tumor incidence in animals fed saccharin. In the Canadian study, it is true there were no bladder tumors. However, there was a twofold increase in leukemias and lymphomas. In the area of cancer, multisite cancer is common. Initially vinyl chloride was found in animal studies to produce angiosarcoma only. Recent animal studies have shown that vinyl chloride can also induce brain tumors and lung tumors. Yesterday, at the New York Academy of Sciences meeting on occupational cancer, evidence was presented that vinyl chloride workers not only contract angiosarcoma, but also brain tumors and lung tumors from exposure to this chemical. Saccharin may well be responsible for cancer in sites other than the bladder. I disagree with the derogatory remarks that merely cormercial sac- charins were used in these positive studies. When we are exposed to saccharin, we are not exposed to pure saccharin; we are exposed to the commercial variety. Wessel says that unfortunately the results of the NAS report are not clear to the public. I say the report is entirely clear to the public. Saccharin has caused positive results in two well-designed, responsible experiments that were conducted by prestigious scientists. How can we go on ingesting this material until we have proof of safety? It has no business on the market until the cancer questions are answered. The third consumer principle: Do not refer important health deci- sions to committees. The committee mentality hits everyone. In a committee there are perhaps six to ten or fifteen people sitting around the table nodding comfortably. The old school attitude prevails -- "Joe looked at the data. It must be okay." Who goes home with that data and takes out a calculator to go through it? How many people have even looked at these negative studies? How many people have really looked at these positive studies? Who knows whether the lines of figures are the same as the committee summaries? This has been a terrible problem throughout the FDA advisory committees. When an advisory committee enters the picture, all of a sudden the hard, serious,
2l9 scientific work that goes on in individual offices slacks off for som- nolent avoidance of controversy. Last, I feel strongly that FDA should regard one of its primary missions as being a cancer-prevention agency. Cancer is epidemic in our society. One-quarter of us will contract cancer, and two-thirds of this group will die from it. About 80 percent of cancers are caused or influenced by exposures in the environment, such as chemicals. As Dr. Shubik stated at the National Cancer Advisory Committee last week, the old idea that viruses cause cancer has pretty much gone down the tubes. Cancer is caused by chemicals. When we have a widespread chemical that almost all of us are exposed to, the first thing that should come to our mind is if l case of cancer, if l0 cases of cancer, l0,000 cases of cancer might be caused by this chemical with two posi- tive studies, we should not be taking it in. Cool Whip, Squiggles, Pink Panther, diet sodas, and the rest are possible for us only through the use of additives. I think that the question that we must ask - - and the context of carcinogens is a very good place to ask it -- is whether our technologi- cal abilities will dictate our human values, or whether our human values will determine the course of our technology. With what we know about saccharin today, if we continue to use it in the absence of further studies, it would be one example of a society abandoning its humanity for the chance to display its technological gimmicks. SAMUEL E. STUMPF As I have listened during the past two days, some issues seemed to crystallize. There has been some talk that we find ourselves function- ing in a democracy, and I think it is worth raising this issue, in a general way, in the form of questions. What is the justification for government intervention in the lives of the members of a society? At what point is it appropriate to limit the freedom of our citizenry? Or to be more specific in relation to the subject of this Forum: Should we be free to bring onto the market a new food, a new additive, a new drug? What are the appropriate limits to the freedom of any member of our society? Some comment was made by Dr. Crampton that there is a discernible line, and I know he was referring to a platonic reference here. Inci- dentally, it is interesting that he referred to a line that takes freedom all the way to tyranny. The Greeks had a concept of democracy that Plato particularly did not feel was a good mode of government, be- cause he thought there was something about freedom, something specifi- cally about freedom, that inevitably led to tyranny. He made it very clear in the Republic that it was a particular use of freedom that leads to tyranny, and he gave a rather interesting example that is pertinent to the concerns of this Forum, because he described what happens in the individual as an analogy to what happens in collective society.
220 He talked about unrestrained freedom and that in the concept of free- dom in Athens at that time, even the dogs did anything they wanted and would not even get out of your way when you were walking down the street. Everybody seemed to have the same rights. What he was really driving at was that we have certain inborn capacities, we have certain drives, certain appetites -- this is what he calls them -- and that if we permit each appetite to have the same rights, to express itself at any time and every time, a particular appetite may overcome the indi- vidual and the time will come when he can no longer restrain that appetite, and it tyrannizes his own life. In trying to sort this out in relation to sugar, let's make the question very sharp: At what point is it appropriate for government to come into the picture and to regulate human life? I think that probably the most coherent answer that we have ever had to this par- ticular question comes from a nineteenth-century philosopher, John Stuart Mill, in which he said, in essence, that it is never appropriate for the government to try to make an individual a better person. The only justification for the intrusion of government into our life is if a mode of action on the part of somebody will have a deleterious ef- fect upon someone else. Then it is no longer my private freedom that is involved, but the collective welfare. At that time it is appropriate to come in. With respect to sweeteners, then the question is: Has something happened that now justifies the bringing of government regulatory powers into the picture? This is, in a sense, the question that I had asked yesterday morning: What is the evidence of a fundamental social problem? I distinguished various ways of putting it, and I think we have had some examples very recently on how it possibly could be ex- pressed from the point of view of public opinion. It seems to me that it is not sufficient simply to have an emotional reaction to a possible danger. To suspect that there is a possible danger is not yet sufficient grounds to mobilize the regulatory power of a government, because at that rate, you see, we can suspect a great deal in the environment. This is not to say that we should not have any critical attitudes toward things; but I am fundamentally raising another question: What is there here that justifies, at the moment, a regulatory exclusion or control? It is very interesting the way the logic of the Forum has developed. There are those who would point to the sugars as having genuinely dangerous characteristics so far as the health of the population is concerned; but at the same time, great question has been raised with respect to the safety, let's say, of sweeteners. The possible con- clusion is that we should eat neither sugar nor the sweeteners, which is to say that you are going to have to eliminate or remove an entire category within our food supply. Here, then, is this question: Has this Forum at this point defined a clear and present danger, if you please, to the safety, to the health, to the welfare of the people? That leads me to the next point, which I think is provoked here and with which I have a real concern.
22l Approximately ten years ago in a conference here, one of my col- leagues on the platform was Allister Frazier from Great Britain. The fundamental point of his presentation had to do with what I am going to call methodology. Throughout these two days I have been very concerned about the constant analogy between man and animal, or the animal orga- nism and the human organism. I have been recalling Allister Frazier's statement that there are some chemicals, some substances, which react identically in man, on the one hand, and in the animal, on the other; whereas, there are other things for which there is no real analogy in man and in animal. Although that was recognized up to a point, it was referred to only with respect to two things, namely, dosage and the method of induction or intake. Allister Frazier raised a quite dif- ferent kind of a problem with respect to the contrast between man and animal, and that has to do with metabolism; in other words, the thing just does not have the same consequence in man as it does in animals. I would have thought, as a layman, that the scientists themselves would have clarified this particular methodological problem somewhat more than this Forum has indicated. There is more discussion, more disagreement about the appropriateness of experiments than I would have expected the front line of experimental scientists to be hung up on. In other words, there are problems enough on the logic of the science that it is too bad that one will have to invoke this particular methodo- logical principle, which it seems to me is very important to clarify. We are hearing now that not only different animals, but different strains of the same animal make a big difference. We heard a very powerful point from Morley Kare indicating how significant it is how something is given. But I am talking about this possible gulf between man and animals. All this raises a very major question with respect to the first question: What is the justification for government coming into the picture? The justification is a genuine danger. How do you know the danger? I yet have not sensed any kind of information about a danger coming from an analysis of human evidence, that is to say, any epidemic- logical information about human consequences from the use of sweeteners. There have been some few instances of animal experimentation that are, at most, equivocal, especially since one can read the NAS report and come to a conclusion that there is no danger. I daresay that if I were to ask the members of this audience what their reaction is to the scientific response to the present knowledge of these matters, I think we would all come away feeling that on the whole the scientific evidence indicates that there is not that much danger, except in rare cases. We cannot expect, of course, a perfect logic here. The question of DES was brought up. We are all aware that there was a time when DBS was banned for the purposes of raising beef, while at that very time it was permitted to be ingested by females as a morning-after birth con- trol pill and approved, to my understanding, by the same Food and Drug Administration. Then somebody calculated that inasmuch as you can find one part per trillion of DES in beef liver, you would have to eat one
222 million pounds of liver to ingest as much DES as a woman would take in one pill. Now just how that was rationalized in the FDA is not exactly clear to me. At what point is it justified for the government to come in, to re- strict the freedom either of science, of commerce, or for that matter, of any individual? The scientific evidence regarding smoking is so definitive and so decisive by comparison to what is, to my knowledge, available with respect to saccharin or cyclamate that one wonders how, with such minimal inference, such a significant decision can be made with respect to these sweeteners, whereas with respect to cigarettes, we are all aware of the enormous deleterious and tragic consequences of a product that is at the moment not banned. RICHARD L. VEECH I don't really know what I am supposed to say. I am only rarely out of the lab, but I will make a try. The only point I would like to make is that in regard to the evalua- tion of the relationship of carbohydrate intake to atherosclerosis, animal studies suggest that sucrose is the most lipogenic substrate that can be given. It seems to me that this should serve as a warning to a society in which this is a major disease. I further think the tools are now readily available to evaluate the relationship between diet and atherosclerosis more thoroughly than they have been evaluated in the past. Having said that, however, I do not wish to imply that the govern- ment should ban sucrose. Perhaps I am not used to these kinds of sessions, but I tend to see basic sciences under attack by people who want instant answers, who perhaps don't understand how halting and fragile a flower science is, and in fact how approximate its answers must be. In regard to the question of sucrose, there is no doubt in my mind that the rates of fatty acid synthesis are much higher with sucrose than with glucose or with starch, and this can be documented. What we cannot say is what this increased rate of synthesis means in terms of the atherosclerotic process. But that is not to denigrate science. That is to say, rather, that you need more good science to study the effects of an increased rate of synthesis on the deposition of plaques in the vascular endothelium. We really do not know how to handle this, and we need to understand more the role of the degradation of lipid. We also need to understand what controls the rate of lipoprotein synthesis. These are the problems, and this is a call for more science, not a denunciation of its admitted deficiencies. The same things could be said for the question of cholesterol synthesis. We should admit that maybe these have very little to do with atherosclerosis, but at any rate this is obviously a major health problem and studies of this basic kind are warranted.
223 I feel compelled to make one further comment. I think the motives of the public in watching what industries are pushing on them or what they are giving you in your baby food and all of this is very reason- able; but sometimes the answers are not so clear. At that point the public may opt for legal fiat in control of its diets, out of disen- chantment with the waffling of the scientist, or it may opt for more and better science to answer these questions. In the particular field where I work, which is ethanol, we know that this is a very toxic substance. There is good data now from the World Health Organization that many of you are going to go out and have two martinis. We know that this is going to double your cirrhosis rate if you continue it. But the government tried 50 years ago to have pro- hibition, and all that happened was that illegal booze was made, the Mafia came in, and you got all sorts of nonsense. We know, for instance, that alcohol causes increased rates of car- cinoma of the liver, carcinoma of the esophagus, carcinoma of the bowel. There is no question about it. What a society does to itself, a self- indulgent society, a society that is based on excesses -- and this is what we have -- is often extremely upsetting to a sensitive and well- intentioned observer. In medicine we deal with a society that overeats and gets premature atherosclerosis, diabetes, obesity, and hypertension. It drinks too much and makes cirrhosis the seventh cause of death, since 90 percent of these deaths result from too much alcohol. We now see that gonorrhea is more prevalent than influenza. So in almost any aspect, this society is a self-indulgent one, given to excesses that are destructive to its own health and well-being. We eat too much sucrose on the face of it, but this form of over- indulgence is not unique. In my opinion, neither government nor science can really ban overindulgence. Science can only inform. Why do people do what hurts them? I don't know, nor does anyone else; but more regulations are unlikely to help. In science you can pick your problem. In medicine the problem walks through the door, and you are forced to deal with it. I think the FDA is forced to deal with many things that walk through the door also, and it has my sympathy. MILTON R. WESSEL The hour is late and the time is short. For these reasons I will not present at this time the paper I have prepared. (See Appendix B.) But this is a terribly important subject, and I think it is important for all of you to understand it. There was laughter when Miss Johnson said something. Don't laugh. She has the ear of the public far more than any of you; she has the ear of Congress far more than any of you. I hesitate to say this, but I will say it bluntly: You are talking to yourselves, and you cannot do that. The issues are not the same as they were when this great institution was founded. The law and society and consumerism and environmental ism and the whole gamut of how we live
224 and what we do is no longer what it once was. If you continue to speak to yourselves, without being aware that others will take what you say, as Miss Johnson just did so effectively with your report, then you will find that the voice of science will continue to be heard inadequately in the halls of Congress and in the community. This is part of the process. This gathering is not a meeting of scientists. It is a public Forum. It is the fourth public Forum, and that distinguishes it from everything else that you do. You are speaking to the public; you are speaking to the public because it is important that you do so. The public needs what you have to say. But you have got to speak in a way that the public can understand, because in a democratic, free society the public is going to make the decision about what it is the public is to have, and what it is the public is not to have. The law has changed. This hearing is part of a legal process all the way on up through final appeal. Those who don't believe it can go and watch the next litigation, at which the report of this Academy will be quoted against Dr. Coon on cross-examination, before lay judges on appeal, in administrative agencies, in the press, on both sides, wher- ever you go. You must recognize that. You must recognize that your communication has to include in it a satisfactory explanation to laymen, albeit in- formed laymen, of what they need to be able to understand. You must put it in their language. You must include all the components. You must speak to them at their level. What cannot be understood by lay- men must be identified to them. The law used to be much more simplistic: Who shot the gun? Who signed the contract? Who did what to whom? But this is no longer a case between two individuals or between the government and one indi- vidual. Now there are at least three parties, and by far the most important party in any one of these new scientific, public-interest litigations is the public. It is not you and some consumer advocate. It is you and the public and the consumer advocate in a court, trying to reach a decision in which the party really at greatest concern and at interest is the public. Incidentally, this is not limited to the kinds of issues before us here. It includes the anti-trust case, because that involves the issue of what conduct is reasonable? What conduct will society accept, and what will it reject? It includes the civil rights case: What discriminations are reasonable? What discriminations are to be criti- cized and condemned? In every one of these new kinds of matters, the public is the key and third party. It no longer is a matter of taking one side of an equation alone and hoping that some informed scientific peer will make a decision on the basis of a scientific report. Our society depends upon different views being brought together in these kinds of matters, with the public ultimately deciding between them. Miss Johnson and others have learned how to communicate to the public. Unless you do the same thing, the public will never have the benefit of your necessary contributions to the equation.
225 ALEXANDER LEAF When I was invited to participate in this Forum, I wrote back and asked why would anybody want a professor of medicine to participate in a discussion related largely to sweeteners, and I was told, "Well, after all, we need a nonexpert on the panel." I am trying to fulfill that role. After listening for two days, one can justifiably ask why have we held this Forum and what have we accomplished? I would like to respond to that question with two points. First, has it clarified our understanding regarding the risk of saccharin and other nonnutritive sweeteners? Before I comment on that, I would like to put one point of perspective as a consumer myself into this. I think I have to consider that we are dealing, in terms of these nonnutritive sweeteners, with agents that are really not essen- tial to life. They may be necessary for pleasure, if you will, but they are not essential for life, and I have seen many cultures where people have lived to a vigorous old age and never were exposed to any of the compounds we have heard talked about today. Therefore, it seems to me that we have a right to expect that the regulatory agencies will be a little bit more critical in granting permission to allow these agents to be distributed to the public than if we were dealing with items that were really essential to life. As Dr. Veech said, we are dealing with compounds that have come out of the excesses, perhaps, and luxury of our culture, and they are not necessarily going to help anybody live a better life, and certainly they are not essential for the life of any individual in our society. We cannot be influenced by considerations of commercialism or profit here; only the health of the public can serve as a basis for our judgment. I would like to refer momentarily to the Academy report on saccharin. I was rather dismayed when I read this report to see the recommenda- tions on page 63 that have been referred to repeatedly. I say this with regard to the point that Dr. Stumpf mentioned, namely, the valid- ity of interpreting animal experiments of the kind that have been done in trying to judge the safety of these agents for the human, and the dose level that the human would be consuming is microscopic rela- tive to the doses that were used in these tests. So that I am rather disturbed that the panel that developed this report insisted that many more animal studies had to be done in order to assure it is otherwise safe in the human diet to have saccharin. I would submit that their point (E), which is a request that some epi- demiologic studies relating to the incidence of cancer with the long- term consumption of saccharin be made, is essential. We heard today the report that Sir Richard Doll and Armstrong have a paper in press on a very extensive epidemiological study. As a physician who is con- tinuously having to make judgment, often with inadequate facts, I would much rather lean on an epidemiological study by well-trusted and well- known colleagues than upon further animal experiments, which I don't
226 think, no matter how many we do, are going to assure me of the safety or of the danger of saccharin to the human as we are likely to use it. I think, furthermore, that we as scientists and members of the pub- lic have to begin to ask whether an experiment is really worth doing. We could go ahead and support the recommendations here to do more ex- periments, but since a judgment has to be made as to whether these experiments will answer the questions that we are faced with; and if so or if not so, what is the cost of doing these? And I would submit that there are many more pertinent questions relative to the health of the American public than the further detailed tests requested at the great expense that will be required to determine whether or not saccha- rin is toxic at these dose levels, even in rodents. I think it has been more interesting to watch the dynamics of our interaction as audience and panel and speakers than perhaps the infor- mation that is being conveyed at this meeting, because I am very con- cerned about the role of science in public policy today. Science does have a contribution to make, but that contribution can only be made if the public is informed and realizes the limitations within which the scientist has to act. We cannot do experiments on saccharin to answer the question of the difference of how man might react to large doses versus how the animals respond; it is proper that we cannot do such human experiments, but it does mean that we have to use great judgment in interpreting the animal experiments. I think that the audience probably feels that this performance by the scientists in the community who have been looking at this is just another example of how the scientist obfuscates, drags his feet, and hesitates to make a decision. But we are asked to find the facts on a certain question. The facts often are very, very difficult to come by, and we have heard repeatedly through the Forum about people who were insisting on a very simplistic yes or no answer. As a scientist I get as frustrated as many members of the audience do when they can- not get a clear-cut answer upon which to judge future behavior, or to legislate future behavior. But I think that if the public is not sensitive to what the limita- tions of science are and does not realize that we can only look at facts or try to garner out what the facts in the situation are, then our culture is in great risk of sweeping aside the values that science can provide, because I think no other group in our culture is seeking in an objective manner the actual facts basic to the problems that confront our society. Don't be too hasty in expecting these results to be forthcoming. Be a little bit tolerant. We have just heard from Mr. Wessel how scientists have to communicate better with the public; I accept that and think it was very well stated. But I think also that the public has to be informed of what the limita- tions are on the kinds of answers they can get from the scientists, and be a little tolerant also. I would agree with Dr. Veech that what we need more than a lot of talk is a lot more research to get at actual information. I hope judgments as to what research is initiated will be done with the kind
227 of cost-benefit approach suggested by one of the economists here. We need to have all kinds of inputs now in settling these major issues today, and I hope everyone will go away feeling a little bit tolerant about the other person's role and position in this Forum. VIRGIL O. WODICKA I asked to be last in this group not because I lay claim to any special wisdom, but because after all, the announced purpose of this gathering was to set a background for the determination of public policy: pri- marily for the Food and Drug Administration; secondarily, probably for the Federal Trade Commission; and probably with some overtones for the Congress. I was hoping that I might serve as a transition between the comments of the panel and those from the audience in terms of perhaps being an agent provocateur and supplying some sharpening of the issues. Starting with the fact that we are talking about sweeteners in gen- eral, about the only thing they have in common is sweetness. We have heard a number of presentations centering on this fact, which has stim- ulated the reaction with me -- and I see that Morley Kare got it too -- that one segment of the body of opinion bearing on this sweetener issue undoubtedly is taking the position that sweetness is a pleasurable sensation; therefore, it is hedonistic; hedonism is wicked; therefore, we should take action against anything that is sweet. Some mention has been made about the Volstead Act and the Eighteenth Amendment, and I think that is enough of a commentary on that particular background and the indicated action. From there on out, I would tend to dichotomize between carbohydrate sweeteners and noncarbohydrate sweeteners. Summing up what I heard, setting aside for a moment the issue of cariogenesis, the best thing I can come up with is that the scientific climate of the twenties put the black hat on proteins. In the sixties, saturated fats were out. In the seventies, we are looking at carbohydrate sweeteners. The scientific literature reviews of the carbohydrate gums that are a part of the GRAS review would suggest that aside from cariogenesis, the evidence against the complex carbohydrates, particularly the in- digestible ones, which you might also call fiber or roughage, is about as alarming as that against sucrose or any of the other sugars. The symptoms are different, it is true, but there are some unpleasant things in there, too. Maybe that will be the villain of the eighties. Now, if that kind of suspicion is really the basis for our action against carbohydrates, or rather against sugars, it is a little hard to see what public policy should result from this. One suggestion has been, "Pass the buck to the public by telling them how much sugar is in there, and letting them take it from there." Even that breaks down into two, because two courses of action have been suggested. One of them would state the percentage of added sugar, which would have to be on the basis of the black hat theory, as I see it; the other one would
228 state the total sugar, which would more directly address the problem of cariogenesis. The only argument that I can see supporting the added-sugar thesis is the point on nutrient dilution that was addressed in passing in the discussion. I would suggest here, by the way, that there is less dis- crepancy between Dr. Sebrell and Dr. Stare than appeared on the surface, because Dr. Stare was pointing out that the normal diet can contain something of the order of 20-percent empty calories without serious harm. Dr. Sebrell was talking about a restricted calorie level, in which obviously every calorigenic food has to pull more weight in terms of trace nutrients, so obviously these two diets do differ in terms of the importance of nutrient dilution. I might point out that technologically the labeling of added sugar would present some difficulties because many foods, such as canned fruit, are formulated not to a fixed recipe, but to a fixed product. In other words, it is the total sugar in the can from both the syrup and the fruit that is the target, and there is not a fixed percentage of sugar added. So this would present some complications if that ap- proach were taken. The other alternative is that you could add an extra line to the nutrition label that states X grams of carbohydrate per serving. You could put another line that states Y grams of sugar, and sugar would then be defined by some appropriate analytical method, meaning total sugar. Beyond this, what could be done in terms of cariogenesis is not clear. Offhand, I do not see any authority in the Food, Drug and Cosmetic Act that gives the Food and Drug Administration a handle on this. Cariogenesis is not a function of any systemic action. It is local action within the mouth that gives rise to the problem and is not necessarily related to the specific sugar involved, but rather to the form of the sugar, the residence time against the teeth, the frequency, and various other manifestations not related to the chemistry of the diet. So this gets into a complex problem that perhaps should be more fully explored. Now, when we get over to the side of the noncarbohydrate sweeteners, except for the wickedness of hedonism, they do not share much with the carbohydrate sweeteners, and we are really looking at the ramifications of the Food Additives Amendment. Mr. Harvey made the interesting point that there have been only a small handful of direct food additives authorized since the passage of the Food Additives Amendment in l958, and the likelihood of adding to that list diminishes year by year as we add new impediments to approval. The law requires that any new food additive be demonstrated by the petitioner to be safe for its intended use. As we add more requirements to this proof of safety, we obviously reduce the incentive to develop any such new materials. It would be interesting, for instance, if somebody were to demonstrate that nickel salts are deficient in the diet and should be added, because they would obviously be food additives that are not generally recognized as safe, and would have to go through a multimillion dollar safety testing pro- gram before they could be added as an essential nutrient.
229 So in terms of the noncarbohydrate sweeteners, the only issue worth talking about is that of safety. As Miss Johnson pointed out, the law does not require that a benefit be shown, only a function; and it re- quires that the additive not be used at a level higher than necessary to accomplish that function. So you can take it from there. DISCUSSION EDWARD HAENNI: I should qualify myself as having retired two years ago as the Director of the Division of Chemistry and Physics in the Bureau of Food in the Food and Drug Administration. It seems to me, after these two days, that Mr. Wessel has indicated the most impor- tant matter that has come before this Forum. There is one aspect of this that I would like to comment on and that I think is related to part of our communication problem with the public. The public is exposed by and large -- through television and even through education in the schools - - to exact physical sciences. It is conditioned to expect that you can fire off a missile today, knowing that two years from now a second one will pass Jupiter. It has come to expect that when you shoot off a rocket half way around the world it will land within a quarter of a mile of where it was intended. Sometimes you can determine an element within parts per trillion perhaps. But this conditioning in terms of physical sciences means that the public must learn to realize that exacti- tude is possible only when you have control of the variables. Usu- ally you can control them, and if you do wrong, you can repeat your experiment ordinarily'without too great expense. But in the toxicological field and the general biological field not only are there endless variables, many of which you don't know, but it is very costly to do these experiments. You therefore try to get as much as you can out of an experiment. You cannot test each variable at once. I think we have got to get the message to the general public that you cannot expect out of the toxicological field and from the biological sciences, first on cost basis, and secondly within the realm of possibility, the kind of exactness that can enable you to run the experiment and say yes or no. ROBERT CHOATE: To help close this meeting, I congratulate you on run- ning an excellent show. I would like to answer Dr. Stumpf for a second. He brings up the bugaboo of federal regulation. If Dr. Stumpf would stop and think of the futile exercises that many of us have been through trying to beg sponsors and advertisers, broadcasters, and the nutritionists and food technicians who work with the food industry to help them reform how they sell food to children in this country through private self-regulation, only to end up with practically nothing after eight years of endeavor, then
250 he would know why so many of us now start to think about turning to government. On a final note, I hope that you will remember the remark of Mr. Ronk, who portrayed this auditorium as being covered with palm fronds. I did not quite get that connection, but I do hope that if you will all look at the ceiling, you will realize that the number of cavities in this room is the number of cavities that are found in typical l5-year-olds in this country. PFAFFMANN: I think it is the moment to return the meeting to Dr. Handler, who has been sitting here during a good part of this last and, from my own point of view, most stimulating and important discussion and exchange.
