A Federal Case; 14

This is a federal case a weekly show that takes up an issue of government and takes a good look in Washington D.C. for the national educational radio network. This week a federal case is called the FDA story. That may sound like the beginning of a crime serial involving murder. Suspicion intrigue and some kind of law enforcement. If it does you're all wrong. All we're going to do is look at one more of those government agencies. And this one's called The Food and Drug Administration or the FDA. We're not going to take the usual look. I haven't interviewed all the top people in the commissioner's office. You are going to hear from a Nader's Raider called Jim Turner. Now I have a friend who says whenever you really want to know about what's going on in this specific branch of government talk to a rater. That's what I've done and you'll hear him say several things that haven't made the news much but that

are important. Turner talks about the FTA with respect. You won't be listening to any scandalous exposé. But he has been investigating the FTA for nearly two years now for an organization formed by Ralph Nader called the Center for Responsive law. Mr. Turner cares about democracy. He has high expectations for all our democratic institutions including this one. And he doesn't take excuses. Later on in the program you'll hear from Dr. Robert and a lot of the Bureau of science within the FDA. Right now here's Jim Turner explaining what he does. I am one of five people who are working on general government agencies looking at them seeing how they function and asking why they don't function in a better manner. And I look specifically at the Food Drug Administration. I'm an attorney member of the Ohio bar and for whom we're doing this for Ralph Nader with Ralph Nader.

And how long get on. And we look at the Food and Drug Abuse Well I think you know looking at the Food and Drug Administration in March of 1968 that's when I first contacted around and said that I was interested in doing some kind of public public interest law work and. He suggested that the food industry and specifically the food agency you know the regulatory agency the FDA and I began looking at it them. It's been almost a year and a half almost two years now. How did look when you first looked out of the house to change to get if you want if you can talk about the terms of it as a very large agency. Well first of all it's not that large an agency had to has a 70 million dollar budget. And is charged with the responsibility for regulating a number of industries one of them the food industry which is one hundred twenty five billion dollar industry. Nearly the largest industry in the country it also regulates the drug industry which is approximately a 10 billion dollar a year industry the cosmetic industry which is two billion dollars in a number of others hazardous substances one deals with pesticides for example. And so it has a very

large responsibility for a relatively small amount of resource and people are less than 5000 employees for the entire agency and they have 17 district offices and a very extensive operation in Washington. Now on my I've come to believe that in many ways the FDA is shot through with competency. There are people who are very good at the agency who are trying very hard to do some very important job and behalf of jobs on behalf of the public. Unfortunately it's my feeling that both in the way that the agency is organized in the philosophy of its leadership. Both. All these people are working very much against the arts and I'm afraid I have not been as effective as they could be. I've heard that that there's been an enormous cut for example in manpower last year that that part of the Bureau of science has been reduced by a hundred people and it's going to be reduced by more this year this fiscal year. That is one of the problems at the FDA that I've heard about is that he really isn't doing it because they don't have enough money they're

reducing their personalities Well this isn't exactly all that all that accurate. The first of all it's a mistake to do as the FDA does constantly. It is a mistake to rely only on the argument that there are not enough people and not enough money not enough resources. And if only we had those things we would have good food protection because many of the things that happen at the FDA that do not work toward public welfare and work in fact against the public interest have nothing to do with the number of people in the agency. For example when the commissioner is told something that is untrue by a subordinate or when something that a subordinate tells him is deleted from a memo in transit by an intermediate supervisor. These are not problems which. Are related to the. Fact that there is not enough money or people. Both of these things that I just described to you happened one in the cycle made case when a scientist recommended in January that cyclamates be immediately taken off the market and that

particular recommendation was deleted from a memo without informing the author and without informing the commissioner whose office the memo was directed dress to in the case of MSJ monosodium glutamate which is used massively in baby foods and up until very recently it's still up in current it would still and it will be taken out soon presumably. In that case a great deal of misinformation was passed along to the commissioner by subordinates. This kind of this kind of activity has nothing to do with the problem of manpower. Also there are a number of programs in the FDA which are self supporting or intended to be self-supporting. For example the whole question of the 10000 tasters. This is been bandied around for a long time now that why do we have 20 tasters and only 2. For packaging and labeling people the fact of the matter is that the Teac conceived of the tea tasters as being paid for by the tea industry. And what really is needed is an upgrading of the assessment industry in order to pay their salaries at the level that is now required.

The very simple legislative change is that one of the things that you think is wrong or the kind of the basic way the agency is set up. But I want to talk a little bit about the philosophy of leadership or the philosophy of the leadership is a very interesting one and I'm afraid not a unique one in terms of regulatory agencies in Washington. The Food and Drug Administration's top leadership seems to believe that the most important reality for consumer protection in the country is the existence of the Food and Drug Administration. And then they argue that what we must do on a day in and day out basis is protect that agency because anything that in jeopardizes that agency will jeopardize consumer protection in the country. But the problem with this kind of analysis is that there are a number of issues in which the good of the agency and the good of the consumer do not coincide. For example if the agency is asked to risk a great deal of its effort and resources in fighting a very long and involved legal suit against a given drug for example. And says to itself well we can't really afford to do that because we might be risking too much of the

agency then in fact they have said we are going to protect the agency at the cost of protecting the consumer and the result is in their own in their own way. They are really not protecting the consumer and they are even doing a worse thing. They are not protecting the consumer in a way that suggests everybody in the country that they are in fact protecting the consumer. So people live on a day to day basis believing they have a kind of protection which they just don't have. And I think this is one of the these are the major failings in the philosophy of the leadership. I think also there has been a lack of vigor in the prosecution of of the requirements of the law and there has been a lack of awareness of the magnitude of the problems facing this society in terms of chemicals food additives drugs pesticides and so forth. I'd love to get his top priorities the whole question of IRAs is really kind of a central issue with the food. Station does and and why for example has it been now finally after to gain

quite a bit of fun I say. Banning a cyclamates when there hasn't been an awful lot of action taken on cigarettes when they when and when they've been proven to be cancer producing. Well the very technical and direct answer to the reason for the action and cyclamates and the lack of action on cigarettes is the fact that cigarettes do not come under the Food and Drug Administration's authority or under AGW as authority in a lawsuit. Many years ago on drugs where cigarettes were declared to be neither drugs nor foods and therefore outside the purview of the Food and Drug Law. And this was a very carefully done piece of legal work with a very important reason for having it done. It left cigarettes with no regulation. Now interestingly enough at the time of the pesticides hearings were held it was shown that because of this lack of regulation of cigarettes there was a high level of pesticide on tobacco much higher than would ordinarily be accepted in say lettuce and this is the kind of a problem that you get

into again of course I'm sure that you want a lot of other people assume that cigarettes were under the regulation of the recommendation but they are not. Now there is a broader question of priorities However that's raised by the cycleway case. What we are dealing with I think in the case of cyclamates is a symbolic kind of action cyclamates are relatively unimportant economically. They were apparently only about 6 percent of the total product of the major producer of cyclamates they did get involved with a major industry and did were a part of it. One point seven billion dollar industry the diet food industry. However that particular industry is based more on the gullibility of people than on the existence of cyclamates and will probably continue in spite of the lack of cyclamates most interesting by the way about cyclamates in relation to diet food is that time. Experiments on both people and animals have indicated no appreciable weight loss from the use of cyclamates And what's even

more interesting in view of the recent modification of the cyclamates ban it's now being allowed to be circulated in any food other than any beverage. As of last week most interesting about this particular change in the man is the fact that it was justified on the grounds that diabetics needed cyclamates in order to live. Now this is just incorrect. First of all cyclamates has no i have no dietary value to diabetics and diabetics have been controlled for years without the use of cycling. But secondly and more importantly is the fact that the population group most susceptible to the kinds of damages that cyclamates have been implicated as perhaps causing the population most susceptible will be diabetics of childbearing age or younger. So what we are doing is putting on a market a substance which obviously causes in animals at least genetic breakdowns chromosome breaks terabit treta genic or thalidomide effect the form it

is and cancer and we are saying to the population that is most likely to have these effects happen to them. Why don't you use it. And we're putting it right on the label. How did that come about. Well it's not clear that it's legal to do what has been done. It is not clear what authority or what grounds have been used to say that this is the way it will be done. But what is clear is that when the ban was taken was made and on October 18th it had a very serious hardship effect for one segment of the industry and that was the can diet food industry. This industry had put up one whole summer's worth of diet foods in cans and had them on the shelves and there was no possibility of their selling them by the deadline of February 1st. And a large group of canners came to Washington and said we are in deep trouble. We are going to have to sue the government for reparations. The figures were mentioned between 80 and 100 million dollars that the government was going to be asked to repay the canners for the loss. And as a

result of this in part at least in pri thing primarily the Food and Drug admit the Food and Drug Administration under the direction of the secretary of H.W. said that we will not take cyclamates off the market in canned foods until September 1st and then subsequent to that and unknown to me why they want to hand said we will not take them off the market at all they can go ahead and be circulated now this is perhaps. Going to be changed or is not perhaps seems more drastic in initial accounts than it actually is. Nonetheless it does appear now that cyclamates will be on the market in canned foods. You said that you said that the site from its case is really a good example of kind of a symbol of priorities. Well it's a symbol it's a symbol of a very important problem which has gone on for far too. It's gone unnoticed for far too long and that problem was interestingly enough identified in the Food and Drug Administration by a Nobel Prize winner Hermann Mueller in 1983. He called the Food Drug Administration and said I would like to make a presentation to

your scientists about what I consider to be the major health problem of the next decade and this is in 1963. And the problem he identified was the ability of chemicals to affect the genetic makeup of people. And he cited three kinds of effects that this can have. One was the treta genic or thalidomide effect and the other was the ability to changed. The hereditary make up of individuals and a third was the ability to cause cancer. All three of these items were traced to the fact that many chemicals can break chromosomes and can cause a mechanism to operate which will cause these three kinds of deformities. He identified this to the Food and Drug Administration and the Food and Drug Administration gradually began to build a cell biology research section which was going to carry out research in this area for the express purpose of trying to identify and isolate this particular. Scientific health problem.

Interestingly enough no major announcement was ever made about this. As a matter of fact Doctor view our speech was held confidential at FDA until 969. Why. Well I don't know. This is one of the things that I'm trying to get. So this is one of the things I'm trying to identify as the breakdown of science at FDA. I believe that there has been a major scientific breakdown in the agency and I call it a basic misuse of professionals. Ordinarily it appears that the FDA will arrive at a regulatory decision. It may be something like getting rid of DDT or it may be something like. Setting a certain food standard and then it will ask a scientist who could direct its research their research in a direction that will lead to that kind of a scientific outcome which will support the already arrived at regulatory decision. Now this kind of occurred before the horse scientific activity has been I think a very unfortunate contribution to

misconceptions about health in America. I think that the agency could have done a much more effective job in protecting health if it had taken the scientific suggestions that it had and followed them systematically without interruption to their logical conclusions. Those logical conclusions would have been very damaging and would have created and will create in the future a great deal of concern in this country. But nonetheless it seems to me to be much more honest and much more important and much more in the consumer health interest of the people to pursue even unpleasant scientific suggestions to their conclusion rather than to allow them to hang around and come back and haunt us in terms of something like the cyclamates decision. Very small and isolated decision as far as the general public is concerned but merely the point of the iceberg as far as scientists are concerned. Well I think it's time now in the FDA that the horse gets put before the cart. You think they are going to still be able to do an extremely good job they don't have more money people. No I don't believe that the Food and Drug Administration can be if expected to do an admirable job with in terms of the massiveness of the problem with the

resources that they now have. However Conversely I can assure you that a massive injection of resources into the agency as it now exists will perform even more incredible disservice to the American public than would forcing them to continue with the limited resources they have now and correcting their internal problems. Not until they clearly clean up their organization and replace the personnel that are ineffective now. Will they be. Will it be justified. Well any additional resource addition to their what they already have be justified. What are you trying to do to get this to bring this about. Well we spent we've approached this problem on several different fronts. First of all in the time that I have been examining the Food Drug Administration I have turned up another number of very serious problems in the agency. And each time that I have turned up a serious problem in the agency I have communicated it directly to the commissioner of the Food and Drug Administration and to people in the other offices of the. Department of AGW. I've talked to

Secretary Finch I have one occasion write him a letter about certain problems I have talked to people in the Consumer Protection Environmental Health Service outlining problems and I must say that in many cases we have been able to bring about at least a re-examination of some of the problems in FDA. OK well that's one way of approaching the problems. What is that one of the other one right now that the one way that I've outlined was to go to the agency people responsible and origin of the problems in addition to that we have consistently and will continue to consistently use the news media to make known to the American people what their government is doing. We are very much and happy with the concept of the interoffice memo. Much of the important work that's done by FDA is buried in our office memos. All kinds of very competent people have to make recommendations some of them different than others and are presented to the commissioner and the commissioner acts up until our activity at FDA. Those kinds of recommendations were kept secret and we do not believe they should be kept secret if we are

going to have a dialogue of between government and people in this country. So we are constantly going to go and will and have and will continue to go to the news media whenever they are interested in what we have to say. And then thirdly we are preparing six very detailed reports on the six agencies that we investigated this summer and these reports will be made available in mass regulation copies for less than a dollar apiece at your local bookstore so that the average person can sit down and read for himself what it is that these inner office memo said and what it is that the review committees we have cause to be instituted have done and we will end meticulously and all of our activities try to be very fair to the people in government and most important reality that we discovered in the FDA is that there are many good people who are trying to do a very very diligent job and who are systematically as far as the FDA is concerned excluded from influencing decisions in the agency by methods which. What to me are indefensible in any organization that wishes to run effectively and to to work in to

achieve any of its goals. I think they're particularly offensive in an agency whose primary goal is to protect the public interest is the matter that there is people. Well it's very difficult to to separate a totalitarian act from a dictator. They seem to go hand in hand. And what we have operating in the agency is a series of acts to do not give the kind of respect to scientific and regulatory independence that one would expect in a democratic society. Out of that. Well it's a it's a very difficult one of the reasons that it has come about is this confusion of the identity of the agency as being most important in protecting the consumer with the fact that the consumer must be protected. Whether or not it risks the agency's future existence and when the agency is too weak to carry out that protection it must make that graphically clear to Congress so that it can get further authority. Secondly it has come about by the fact that there has not been any real

scrutiny of what the agency has done by anybody it has operated for approximately 60 years in a relative twilight zone of unconcerned by the general public and even by most of the members of Congress. This is allowed many people to evolve into positions of relative comfort where they have done things on a day in and day out basis that have never been questioned. And finally I think it stems from the fact that the agency has never really faced up to the fact that it is no longer dealing in a relatively unsophisticated simple food industry and I'm talking about food now but the same is true of drugs. The industry has become very complex for the first time this year for example over 50 percent of all food is processed food. This is a such a shocking and important revelation because the agency is not really organized to deal with anything but the traditional problems of rodents in bread factories and so forth. Now these kinds of problems while they are important and doing in many

ways help the consumer are not going to answer questions like the assault of the chemical environment on individuals there are now for example three over a roughly 3000 food additives in 1058 there were a little over 700. Jim Turner touched on a number of problems within the FDA which people in the agency itself already know about. One of the scientists who worked on an interoffice memo within the FDA that later got leaked to the press and became known as the Kinslow report. Is Robert and a lobby. Said he considers those memos that never get public attention. Unfortunately he also said that the FDA is shot through with competency. So I asked Dr. Angela d about that. Somebody told me that the FDA as a whole is filled with good guys and bad guys. I'm a good guy I think you know. So Dr. Angela he is a good guy but he's also careful. Listen well why do you think the FDA gets a bad press.

Well I tell you I'm not going to answer you I never asked. I'm going to talk to you about what I didn't oh ok ok and how we provide services to the public. That kind of question you have to go ask somebody else. OK. Do you think yourself the best possible way. I mean thank you. As a division you mean. Well I think that this division has as any federal arm I suppose we could use more facilities more people more budget. He got the job before us at the moment beyond our present capabilities. In terms of cap and cheese I think that the competencies that we have on board are pretty good and adequate to do the job. I have a problem at the moment is not enough people to

cope with the magnitude of the problems that are before. Now the reason Dr. Angela is being so careful is because he doesn't really agree with Jim Turner the problems within this government agency should necessarily be brought before the public. But what he just said took courage even so. He said the job before us is beyond our present capabilities and we need more money and personnel. Now technically he's not even supposed to admit that. The commissioner of the FDA Herbert Lay was recently fired and Secretary Robert Finch of Health Education and Welfare has said that the FDA must be reorganized and Dr. Angelo Adi worked on some recommendations himself in that Kinslow report. But he won't say much about it to me because the policy in the FDA is to have it scientists say nothing that conflicts with what has already been known. You see back when the cyclamates case was developing the scientists there Dr. Jacqueline

barrette told reporters that cyclamates may cause deformities in children. And when the commissioner was asked about them he said that cyclamates were generally regarded as safe. Now that disparity made the agency look bad. What's important is not making the FDA look bad or good do you. What is interesting is that there is this difference of opinion between Turner and jalopy over what the public should and should not know and who should do the talking. Well now you know a little bit more. You know what this public minded rater Jim Turner thinks needs fixing. And you know about the disagreement over whether you should ever know that any fixing is going on it'll And that's one FTA story anyway. This is been a federal case. Your correspondent.

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