The MacNeil/Lehrer Report; Saacharin

ROBERT MacNEIL: Good evening. These are some of the hottest selling items in this country today. They all contain saccharin, and since the Federal Food and Drug Administration proposed banning saccharin as a cancer risk there`s been a stampede by irate dieters to stock up -- cancer scare or no cancer scare.

Tonight we look at the great saccharin anguish. The country seems to have exploded with frustration ever since the FDA proposed banning saccharin, a derivative of petroleum, two weeks ago. An army of opposition has counter- attacked. It is led by a coalition of industries which used more than five million pounds of saccharin last year in soft drinks, ice cream, cosmetics, diet foods and drugs, together with unusual bedfellows: the American Diabetes Association, Dental Association and Heart Association and a panel of medical scientists. They claim that the removal of saccharin, the only artificial sweetener on the market since the banning of cyclamates, is unnecessary and leaves some 50 million Americans -- including ten million diabetics -- without a necessary alternative to sugar. Tonight we look into this flaming row. Jim?

JIM LEHRER: Robin, the FDA`s proposed ban of saccharin came about because of what happened to 100 white rats in a Canadian laboratory and to 100 of their offspring. After being fed a scientific dosage of saccharin three in the first group and fourteen in the second came down with cancer of the bladder. The results of those tests said the FDA, left no choice. The law required that saccharin be removed from the market. The law in question is a 1958 amendment to the Food, Drug and Cosmetic Act. It`s called the Delaney amendment after its sponsor, Congressman James Delaney of New York. It requires the FDA to ban any food additive found to cause cancer in humans or animals. The Delaney amendment says that any risk of cancer is intolerable, period. That amendment thus was joined with the Food and Drug Administration as a villain in this piece, according to the anti-ban forces, but the major heat of the controversy has come to the FDA. John Walden, as FDA Deputy Commissioner for public affairs, has been the Agency`s main heat shield. Mr. Walden, is there any doubt at your agency about the validity of those Canadian tests and that saccharin in effect causes cancer?

JOHN WALDEN: There`s no doubt. The tests are definitive, they are excellent, they are in line with established tests that have been conducted in this manner and for this purpose for many food additives for many years. These tests conducted by the Canadians were tests that went to school on the mistakes of past tests, and are in line with the recommendations of the National Academy of Science in this country. They were definitive, the statistics were good; they left no doubt about the fact that they have now demonstrated in controlled animal tests that saccharin does cause bladder cancer in animals.

LEHRER: If there was no such thing, then, as the Delaney amendment, would the FDA still have proposed this ban?

WALDEN: In all probability. The Delaney clause being there was an automatic trigger and left the FDA no room for consideration of any possible benefit from the substance -- economic, nutritional or otherwise; we could only consider the risk under Delaney. Without Delaney we may have had more leeway for consideration, but we probably would have ended -- given the clarity of these findings -- in the same position.

LEHRER: All right. The Canadian findings -- there have been a lot of criticisms of them, obviously, and one of them is that no human being could consume as much saccharin, equivalently, as those rats were injected with or fed.

WALDEN: That`s the most misunderstood and misrepresented point in the entire debate thus far. It is absolutely true that science uses exaggerated dosages in a limited number of animals as the only practical way to measure potential harm for humans. Science universally uses this system; this was a classic use of such a system. The accusation that there were 800 bottles a day, and everybody would have to drink that and it`s ridiculous is an outlandish and unscientific and anti-intellectual approach to the issue.

LEHRER: It`s just not so, you mean -- those dosages that were given to those rats in Canada do translate into realistic terms in terms of human beings?

WALDEN: That`s correct. I`m saying that Canada used established means for testing for the potential of a substance -- saccharin -- to cause cancer in humans. They used a classic test and it came out positive.

LEHRER: Finally, Mr. Walden, this ban as you`ve proposed it is to go into effect this summer. Of course you`re getting much reaction, in Congress and also from the public. Is this negative reaction lessening your agency`s resolve to hang in there on this ban?

WALDEN: Not at all. We will propose a ban in the next couple of weeks, as soon as we can prepare it. We will allow, as required by law, sixty days for comment -- or as allowed by law -- and at the end of that time we will issue a final order. And our intention now, based on good science and an unequivocal law, is to ban it, unless the Congress tells us otherwise.

LEHRER: Thank you. Robin?

MacNEIL: Clearly, if the saccharin ban persists, it will have initially a devastating effect on the diet food industry. As just one example, the manufacturers of Sweet `n` Low say they will have to lay off 700 workers. Robert Kellen is president of the Atlanta-based Calorie Control Council, a lobbying organization supported by the diet industry. Mr. Kellen testified against the ban at this week`s Congressional hearings. Mr. Kellen, in 1970 two widely publicized studies suggested that saccharin caused bladder cancer in mice, and three years ago the FDA took saccharin off its list of generally safe substances. In the light of those facts, did this decision come as a complete surprise to your industry?

ROBERT KELLEN: Yes, indeed it did; and it did because the National Academy of Sciences had the responsibility of evaluating all of the tests that have been undertaken with regard to saccharin, and they have been numerous. It`s been said that it`s probably the most studied substance around. The National Academy of Science, in a report they gave to Food and Drug in 1975, said there was no basis for any indication of regulatory action. They said that saccharin, used as it is by humansat the levels allowed in the United States, was a perfectly safe substance.

MacNEIL: In the light of these earlier reports that I`ve referred to before that National Academy of Science report, had your industry run any tests of its own on saccharin?

KELLEN: Yes, we did. One of the more, I think, important ones was placed in England at St. Mary`s Medical College under a Dr. Taquin Williams. The purpose of that test was to determine whether or not saccharin was metabolized; and that`s a very important subject because...

MacNEIL: Retained by the body or absorbed into the body.

KELLEN: No, broken down by the body into other substances, because all known carcinogens are metabolized and broken down. Saccharin is not. In every animal that was tested, including humans, saccharin is not metabolized.

MacNEIL: Do you have any proof, as the industry interested in saccharin at the moment, that it does not cause cancer?

KELLEN: If we did, we would have done the impossible, and that is to prove a negative. No one can prove a negative.

MacNEIL: So you cannot prove that it doesn`t.

KELLEN: Cannot prove that it doesn`t, and no one has proved, in my ,judgment, that it does.

MacNEIL: Do you dispute the validity of the Canadian findings, or are you just saying the FDA should have amassed a lot more evidence before it took such a drastic step?

KELLEN: I don`t know that I want to dispute the Canadian evidence. Certainly I would agree that the tumors that the pathologists identified are there; but I take a different posture with regard to that Canadian study than Jack has just indicated, for these reasons: the Canadian test was not a test done under the normal protocols for carcinogenicity; it was indeed not even a test on saccharin -- it was a test on OTS, otholuine sulfonamid, an impurity in saccharin. The portion of that test at one level on saccharin was a control. All good carcinogenicity tests feed the substance at several levels, as was the OTS.

MacNEIL: I see. We`ll come back to that aspect of it in a moment. Thank you. Jim?

LEHRER: Yes. Robin, another witness at those Congressional hearings from the opposite point of view is Dr. Sidney Wolfe, head of Ralph Nader`s Health Research Group here in Washington. He`s for the saccharin ban but he has a bone to pick with the FDA nonetheless. Doctor, you told the House committee that the FDA had acted with "a high degree of irresponsibility" in this whole saccharin affair. What do you mean by that?

SIDNEY WOLFE: We were upset, I guess, that the FDA hadn`t done a better job of explaining to the American public just how extensive these studies had been on saccharin and that the basis for the ban went far beyond just the Canadian study that was mentioned when the FDA announced to this country it was going to ban saccharin. There was a whole series of studies; we`ve had a pathologist working with us for the last year reviewing all of these studies, and there are three studies showing that it causes bladder cancer. Interestingly, they`re all done in the offspring of mothers who were taking saccharin while they were pregnant, and this is the group...

LEHRER: You`re talking about rats now.

WOLFE: Right. And the rats whose mothers were taking it when they were pregnant had a higher amount of cancer than in previous studies. So we were concerned that the FDA hadn`t mentioned all of the other studies that had been done, and secondly, that it hadn`t explained -- although as Jack says, it`s difficult to explain -just why large doses are done. I would disagree strongly with Mr. Kellen and side with Jack in terms of the protocol; it was a very well-designed protocol. The, reason they were studying another chemical was that there was some suspicion that this chemical, which is present in small amounts in saccharin, might itself be the cancer causing substance, although it`s present in saccharin as it`s sold. So I think the study was done properly, as...

LEHRER: You`re talking about the Canada study, and you disagree with Mr. Kellen`s interpretation, obviously, of that study.

WOLFE: Certainly. The study was looking at saccharin, among other things; it only looked at one dose, but saccharin had been looked at before at lower doses. If we`re worried about twenty or fifty million people taking a substance and getting cancer, we would be upset if even a few hundred of them got cancer. And in an animal experiment where there are just fifty animals in each group the reason for using a higher dose is to make sure that you don`t get a false negative experiment. In other words, if none of the animals out of fifty got cancer, we couldn`t say that saccharin doesn`t cause cancer; we could just say that in that small group saccharin doesn`t cause cancer.

LEHRER: To tell you the truth, I`m not sure I understand your criticism of the FDA. It sounds to me like you think they did a bad PR job -- is that it?

WOLFE: Part of it may have been that there wasn`t much time.

The Canadians announced their ban, and the FDA put together an announcement very quickly. We`re also concerned, possibly, that they may have been trying to at least open up the question of modifying the Delaney clause again. We believe the Delaney clause is a strong law; it has only been used eight times ever, and it keeps manufacturers on guard against putting cancer-causing chemicals in the food supply. Without the Delaney clause we believe that many other chemicals that cause cancer would be in the food supply and that the competitive system that we have that encourages manufacturers to come up with a better product wouldn`t exist. For example, I think the main problem now is that there are a lot of people that would like to have a diet drink, and they are faced with the choice of one that is under heavy suspicion of causing cancer, or none. Why isn`t there another alternative, namely, a sweetener that doesn`t cause cancer? The signals that came off four or five years ago, when the suspicion of the safety problems of saccharin first were raised, should have encouraged more companies to come up with an alternative and I think, very clearly, that after saccharin is banned there will be an alternative or perhaps even before then. A lot of people in this country think that saccharin has already been banned; the rest that don`t think that it`s been banned think that the ban has been proposed. As Jack pointed out, the ban hasn`t even been proposed yet, and at the earliest -- realistically -- saccharin may be banned in another five, six, seven months. And I think that the innovativeness of American industry is such that they will come up with a real choice for the American public, namely, a sweetener that doesn`t cause cancer.

LEHRER: Do you feel that the Delaney amendment, then, is a good thing that should remain on the books -- in fact, if anything, it should be made stronger?

WOLFE: At the least it should stay as it is. It`s not something that the FDA just uses carelessly; as I said, they`ve only used it eight times in the seventeen or eighteen years since it was passed, and as Jack pointed out, it was very possible and it still may be possible that the ban on saccharin doesn`t even involve the Delaney clause. Canada doesn`t have a Delaney clause, and based on the same evidence they have proposed to ban saccharin.

LEHRER: All right, thank you, Doctor. The push in Congress right now, of course, is for a weaker Delaney amendment, not a stronger one. One of those pushing is Congressman James Martin, Republican of North Carolina. He`s chairman of the Republican task force on health policy and is an organic chemist by profession. He has introduced legislation which would modernize the current law, the Delaney amendment, and delay the saccharin ban, period, until Congressional hearings could be held. Congressman, do you want Congress to make the decision on whether or not saccharin should be banned?

Rep. JAMES MARTIN: I want Congress to make that decision; I also want Congress to make a decision to bring more reasonableness into the additive section of the Food, Drug and Cosmetic Act so that the Food and Drug Administration and the Secretary of Health, Education and Welfare can make some reasoned judgments that they`re now prohibited, under this very absolute, zero-tolerance law, from being able to make.

LEHRER: There are two things that we`re really talking about. Let`s talk about saccharin specifically now. What would you want Congress to do right now about the proposed ban of saccharin by the FDA?

MARTIN: I think there ought to be a different procedure rather than just to pick saccharin and say, "Let`s set it aside." I think it`s a broader issue; I think it would be a mistake for Congress just to pick and deal with these questions as they come up one at a time. I`m perfectly willing to do that and if necessary to try to get legislative action to suspend or defer to allow more time in a decision on saccharin, but I think there is a major responsibility that we have, which has been recommended by numerous people over the last decade or so, including several former commissioners of the Food and Drug Administration, including a wide range of scientists and medical experts from all over the country, who believe there needs to be some room for judgment -- judgment of the various benefits and risks that are tied up into this question of each particular additive. Now, there are some of my colleagues who want a bill that would, for example, overrule the massive dose experiments and thus disregard that kind of experimentation. I don`t believe that; I think that would be a great mistake, because in many in stances that`s the only evidence that you have.

It would be a very critical mistake, in my opinion, to throw out a good screening device which serves as an early-warning system for us, because then you`d have no economical way to find out that kind of information. What I want us to do is to also be able to take into account not only that massive dose data but also other kinds of evidence that we have -- experiments on other kinds of animals; experiments on baboons, for example, monkeys; experiments that relate to mutagenic effects on bacteria.

LEHRER: And to weigh it against the benefits also?

MARTIN: To weigh that against the other evidence. Which evidence is most valid? Which is most pertinent? The best of the evidence, in the opinion of most of the witnesses that have come and testified, both before the Health subcommittee in the House and also Senator Kennedy`s Office of Technology Assessment over on the Senate side, is epidemiological evidence -- human statistics taken from public health data is the best evidence we`ve got, because it`s pertinent to humans at the intake level that we use.

LEHRER: Congressman, under your proposal, who would make that godlike decision to weigh all of the pros and cons -- not the FDA, obviously, right? Who would? Congress?

MARTIN: You can choose various levels of government to make that decision, in my opinion, and maybe some difference on this -- we may not have an agreement, but in my opinion the best place to put it is the department in which the Food and Drug Administration resides. That would be the Secretary of Health, Education and Welfare.

LEHRER: In other words the FDA would kick that decision up to the Secretary of HEW or something like that, right?

MARTIN: If an animal experiment with massive overdoses finds evidence that there is some production of tumors, then upon a petition -- not automatically, but only if someone has an interest enough to petition and set forth the grounds for their petition -there would then be a panel of experts, scientists who could judge the carcinogenic effects, nutritionists who could judge the necessities of the material, representatives of consumers, representatives of the food industry, involved so that you`d have a range and an interplay. They would give a recommendation with minority views, I suppose, to the Secretary and then he would make a decision, a finding.

LEHRER: What`s wrong with the FDA making the decision as it now exists?

MARTIN: I personally don`t have any great reservation about that; in fact, it was at the suggestion of people at the Food and Drug Administration that I drafted the bill in such a way that the Secretary of Health, Education and Welfare would have that responsibility. In fact, I had quite a bit of input and very good help from the FDA officials.

LEHRER: Congressman, if you feel this way, why is it, then that you have proposed a bill that would require Congressional hearings, say, in the saccharin thing which would delay the ban until Congress has had hearings?

MARTIN: You may be referring to the first bill that I introduced the day that we became aware of the turmoil that was building up in the country over the fact that this was the last of the artificial sweeteners left on the shelf. Immediately we thought, "What can we do?" and the bill that we drafted then was in effect a sense of Congress resolution that we were against the ban on saccharin until we could have hearings. But that, we later found out, would not override the Delaney clause; it wouldn`t have any effect other than talk. And so we tried to draft a more careful bill. That`s why I went to talk with people at the Food and Drug Administration, talked with consumer groups, talked with people who are published in the field of food additives. And the idea or the principle, that they came up with -- and this is the key to my bill, because you do want to be very cautious in this matter -- is that you would make an exception to the Delaney clause, and also to Section 409 of the bill, which may have to be amended as well, if a finding is made by the Secretary of HEW that the public benefits of the additive clearly exceed the public risks. Notice the beauty of that: you don`t take into account business benefits, you don`t take into account economic impact statements, you don`t try to weigh those things of interest to producers against the interests of consumers. Instead, you weigh consumers` interests pro and con.

LEHRER: Well, let`s pursue that. Robin?

MacNEIL: Yes. Dr. Wolfe, what do you think of Congressman Martin`s plan to "modernize" the Delaney clause, or amendment?

WOLFE: Many of the ingredients that Congressman Martin describes are ingredients that the FDA already uses, for example, when it`s making judgments about a drug. There are many drugs that are dangerous, and yet when in fact you weigh the benefits versus those risks it turns out that it`s worthwhile and the drugs are allowed to be marketed. In fact, there are a number of drugs, particularly those that are used to treat cancer, which themselves are known to cause cancer in animals and in humans; and yet the judgment is made that benefits outweigh the risks. There have been a number of efforts in the past to try and get the Food and Drug Administration to have the authority to be able to weigh the benefits, the real benefits, of food additives. And interestingly, the group that has fought hardest against this has been the food industry because needless to say, a very great majority of food additives don`t have any benefits at all -- the additives such as the food dyes, which really, if anything, confuse and deceive people into thinking that foods which don`t have strawberries do have strawberries. So that overall, when we`re talking about food additives as opposed to drugs, we`re talking about a group of chemicals that have far lower benefits. and for better or for worse the food industry doesn`t want a hard judgment really being made about the benefits of these food additives, and I can understand that.

MacNEIL: Did I understand you, though, on the simple point of the Delaney clause, that you first said that you supported the Delaney clause -- at least that you would be against an attempt to ...

WOLFE: Modify it. I certainly would be, because it`s served us well. It`s only been used eight times. I think interestingly, the best example of how flexible and how much discretion there is in the Delaney clause is saccharin, because during this entire period of time when questions have been raised about saccharin -- as Jack says, for five or ten years -- the Delaney clause has been in effect and yet it was not invoked because it was the judgment of the FDA and the panels that the FDA referred saccharin to that the evidence wasn`t hard enough. We would say that the evidence was, but the fact was that saccharin is really the best example of how much judgment, how much room for conferring with other scientists and so forth there is in the Delaney clause.

MacNEIL: Okay. Let`s get the point of view of the food industry. Could the food industry live with that kind of change in the law, or does the food industry prefer the Delaney clause eliminated altogether?

KELLEN: We have no position on that at all, Robin. I favor what Congressman Martin is saying in that I don`t think commercial interests should be involved in these considerations. I think it should be entirely on health...

MacNEIL: That`s very altruistic of you.

KELLEN: I think it`s a very important point to be made by the Congressman and by Dr. Wolfe, by Food and Drug. We`re all people, we all consume the same products, we have the same concern. No one is interested in introducing any cancer in any food, and we don`t either. I think the Congressman`s point that is most important to consider is bringing up the other data that we know about, and that is the very long human use of saccharin. We have a very different situation here than we do in most food additives in that you`ve had eighty years of known human use, and a use that can be tracked by certain population groups that use much more than others. And the epidemiologists tell us there`s no relationship between any instance of bladder cancer and the use of saccharin.-

MacNEIL: Of course, the criticism made by some scientists of that epidemiological data is that it isn`t discriminating enough; with all the various chemicals that we put into our systems it`s hard to tell that only saccharin might have had an effect. I mean, if somebody gets cancer, you don`t know whether it might have come from one of many things in the environment or something else.

KELLEN: I think it`s a fair criticism, but on the other side of the fence we are looking at this subject with one question being raised with regard to one organ site -- that`s the bladder in males-- and the fact is that the instance of bladder cancer is not increasing.

WHOLE: I`d have to disagree strongly with that. First of all, there is rarely a correlation between that part of the animal which gets cancer and the human. There are a number of known human cancer-causing chemicals which cause cancer in one part of an animal, which cause cancer in another part of a human.

Secondly, the epidemiologists themselves, the ones that have done some of these studies looking, for instance, at diabetics who use some saccharin and other people who use less saccharin, are aware of the limitations of their studies. One of the studies that is most often referred to, a British study, says, "It may be that too few diabetics have consumed saccharin for long enough to produce an effect on bladder cancer mortality in the group as a whole." And they conclude the study by also saying, "Our data cannot exclude the possibility of a weak carcinogenic effect of saccharin on the human bladder."

MacNEIL: Okay, Dr. Wolfe. I`d like to get the opinion of Mr. Walden of the FDA. How would that sit with your agency to have to handle and recommend to the HEW Secretary such risk-benefit equations?

WALDEN: We`re used to doing it in the drug area. We now have that responsibility. We are under the present law restricted from making benefit judgments, but risk judgments only in the food area.

It would be an awesome responsibility. And certainly at the present time it`s very comforting, I suppose, to have the black-and-white limits of Delaney.As you know, Mr. MacNeil, the Secretary of HEW has now formed a group to look at the Department`s position on this and to make recommendations to the Congress about whether in our judgment there should be a change in Delaney in some way or whether it should remain as it is.

MacNEIL: Thank you. We`ll have to leave it there. Thank you all in Washington very much. Good night, Jim, and thank you. We`ll be back tomorrow evening. I`m Robert MacNeil. Good night.