Food, Drugs, and the Public Interest, Part I

GUEST: Dr. David Kessler
VTR: 09/03/1992

I’m Richard Heffner, your host on The Open Mind. And my guest today has been one of the most interesting and most important young men ever to serve in American government…indeed, to some people, one of the most controversial. Well, how could it be otherwise? For doctor/lawyer/administrator David Kessler, Commissioner of the United States Food and Drug Administration, works right at the confluence of many, many dollars and, hopefully, great good sense, as he directs the Agency that affects each one of us right where it helps or hurts so much: our health…our drugs, our medical services, our foods.

Now, as my guest himself has pointed out, whether its daily concern is about Halcyon for sleeplessness, or breast implants, or new medications for AIDS, because of the seriousness of its on-going decisions that can spell life or death for many Americans, the FDA will always be criticized for its self-proclaimed balancing act in permitting a drug or a device to go into the market to some seemingly too quickly, not making sure there is enough safety data…or, to others for seemingly dragging its heels and not making a potentially life-preserving product available soon enough.

Well, Dr. Kessler’s task is always reasonably, responsibly and directly to balance costs of all kinds against real effectiveness…for individuals, as well as for society at large. But sweet reason and a finely honed sense of public responsibility may not be enough in Washington today, where everybody, as US News and World Report noted recently, everybody has an agenda, a private interest “spin” on all the controversial issues before the FDA that may have little to do with the public interest, which alone concerns its intrepid commissioner.

Remember of course, that Dr. Kessler is a lawyer, too, so he knows all about the adversarial system and “spin control”, and is quoted as saying” the US legal system is based on the concept that the truth emerges best from an adversarial process”. Yet he doesn’t swallow that whole anymore than many of us lay person do, says, in fact: “The adversarial process…never seemed to me the right way to get at the truth”, then agrees with an interviewer that “this only proves that, by temperament, he’s a scientist, not a lawyer”.

Which is why it would be interesting to know Dr. Kessler’s own feelings about the conflicts of interest that so often surface now in the context of the FDA’s product approval process: “It’s nearly impossible”, he says “to find someone that doesn’t have a conflict…at the FDA we have to learn how to manage conflict”.

“Well there used to be an honor system”, says the Commissioner, “but it’s out the window…the world is changing. Everything that comes to this agency – everything – has potential for bias”. So, given this insight, and given the prevalence of “spin control” everywhere – everywhere today – I want to ask Dr. Kessler what his sense is of the proper relationship between public and private – between government, which he represents, and the private interests that come before him, as well as the private persons he is sworn to serve. Dr. Kessler, what is the proper relationship?

Kessler: You know the agency…the Food and Drug Administration is 75 years old, and all agency action begins with a statute…and in our case, it’s the Food and Drug Laws…it was enacted first in 1906, it was amended substantially in 1938, it’s been amended oh, literally hundreds of times since then, but that basic set of laws, some say it’s as complex as the Internal Revenue Code, hundreds of pages, some of the most arcane “legalese” sets out the mission for the agency. It really comes down to two things…to protect the public health, and to make sure there’s fair dealing in the marketplace when it comes to the products within our jurisdiction which are very, very vast…all foods, all drugs, over the counter drugs, prescription drugs, generic drugs, animal drugs…all medical devices. You know, I…I watched “60 Minutes” not too long ago to find out that, you know, radar guns, the police radar guns, because emit certain electro-magnetic radiation, they’re under our jurisdiction. I woke up one morning, “Washington Post” halogen lamps…they’re under our jurisdiction because they emit certain frequencies. So our responsibilities are over a trillion dollars worth of products…25 cents of every consumer dollar comes within the jurisdiction of the FDA. And it’s that basic mission to protect the public health and to make sure there’s fair dealing in the marketplace…that’s what it comes down to.

Heffner: What do you mean by “fair dealing”?

Kessler: Well, there, there are, you know, some basic principles set out in that statute. The prohibition against false, or misleading claims…false or misleading statements…it goes to the basic concept tin our parlance of “mis-branded”. If you put a claim on a product, if you say something is something it’s not, then it’s mis-branded and we can take action.

Heffner: But, you know, it depends, doesn’t It upon the question of how far and how deeply one goes into this question of fairness? You’re you’re making it sound as though, right on the surface, one can tell whether something is fair dealing or not. You don’t really feel that way, do you?

Kessler: Well, sometimes it’s easy. I…my first experience at the agency, started on…started with certain food products. I remember I was at a Congressional Hearing and certain…a certain Congressman handed me certain food labels…and they were tomato sauce…and they were the big word “fresh” was on the label…it said, “fresh tomato sauce”. And it was canned, it was preserved, certainly my grandmother would not have thought that that was fresh tomato sauce by any stretch of the imagination. And the Congressman said, “what are you going to do about it, Commissioner?” And I said, “Well, it looks like that’s false or misleading to me”, it’s not hard to reach that. That’s some of the easy ones. There are certainly ones that are more complicated. And many of the things that we deal with are much more complicated than that. But, you know, the snake oil salesman which really started the Agency’s mission back at the turn of the century, that stuff really isn’t as hard as it’s made out to be.

Heffner: But doesn’t that make your mission one that’s going to grow and grow and grow as you get more deeply into what’s fair and what’s not fair? I mean “fresh”, rather than canned…well, suppose its “fresh canned tomatoes”…

Kessler: Then say it’s fresh, canned tomatoes. I have no problems with that. There…there is a sense, I think where the Agency has a responsibility to set out what is acceptable. I mean we’re dealing with industries, the food industry…now 99 percent of the food industry wants to comply, wants to comply with the rules. So, our job is to set out what’s acceptable, and then I think…what does the industry want…the one thing the industry wants is…you know, the fair, the level playing field, “okay, we’ll abide by the rules, but just make sure our competitor has to abide by the rules”. You know we saw when I, when I came to this job…you walked down the supermarket aisles…and you looked at all these claims on products…and food is just one area that, that we regulate. But you walk down those supermarket aisles, you got to the point of not knowing what to believe…no cholesterol, all these products that were, you know, were labeled as being good for you, you know, 92 percent fat free, tings that had hearts on it. And we had gotten to the point where what was happening in the industry, at least what I think was, it wasn’t an industry that intentionally wanted to mislead, although some part of advertising…obviously there’s puffery allowed. I don’t expect a jolly green giant to exist. That’s okay. But when it comes to issues of the public health, there I think we have more of a responsibility to make sure that the claims are accurate. And what we were seeing was, you know, a manufacturer would see the other guy put a claim that would stretch the truth somewhat, and that manufacturer would see, you know, his or her market share eroded. And say, “Gee, that’s not fair, he’s doing it, and so maybe I have to do it”. And what you had was, you know, one company sort of leap frogging the next until you got to the point where it was hard…words on the food labels for example, really didn’t have any meaning. So, it’s our job at the agency sort of to, to set out what’s acceptable. But once we do that, I think the industry does come into compliance.

Heffner: You’re talking about a level playing field…

Kessler: That’s certainly what the industry wants.

Heffner: That has to do with competition.

Kessler: That has to do with competition.

Heffner: What about the other player? The consumer?

Kessler: Oh, I think the consumer, I mean, is the key player. I think the consumer especially…I mean put yourself in the position of someone who’s had a heart attack, who wants to be able to affect their health through their diet. This is important stuff…this is not just level playing field, this isn’t just someone eroding my market share, this is, you know, I really want to affect the quality of my health. And I need, at least accurate information in order to be able to make certain choices.

Heffner: Then truth is advertising…more than truth in advertising is your concern…truth and the well-being of the consumer.

Kessler: Oh, I mean that, you know, fair dealing in the marketplace is only one part of the FDA’s mission. The more important role, at least, I mean I’m a physician, and what’s important to me, you know, is to, to promote and to protect the public health…that’s what the agency…

Heffner: It seems to me, though, and I don’t mean to be argumentative about this…it seems to me that an agency as small as your own, with as limited resources as you have at your disposal, has here taken on, or been assigned long since in terms of what you say…long since been assigned a role that is absolutely staggering in a society that believes, well, it may believe in fair play, but it also believes in competitiveness and it also believes in the bottom line, and almost everything is subservient to, or secondary to that bottom line. How does an agency as small as yours going to accomplish what the giants of advertising and the giants of promotion and giants of spin control have managed to do in our society in the last two generations?

Kessler: Oh, I think that…I think you’re right. I don’t think it’s an argumentative question at all. On certain days, certain nights, you know, in the, you know, the dark times…3 a.m., I think a number of us wonder what whether the job is actually “do-able”. Sometimes you wonder whether it’s an impossible job. I mean I can’t be on every corner…I can’t be in every food manufacturing plant, I can’t inspect every imported good that comes into our hundreds of import docks in this country. I mean, we just, you don’t have the resources to do that. I mean, I was part of a hospital here in New York, the running of a hospital who had a budget larger than the budget of the FDA. And it was up in the Bronx, and we only had to take care of portions of the Bronx, let alone all 50 united states. So it is, I mean it’s a herculean task. I mean it’s a daunting set of tasks. Now there are those who would just throw up their hands and say, “it can’t be done”. But I think what separates us, at least what we try is, we have amongst the, I mean we are the gold-standard in the world when it comes to the safety of consumer goods that are regulated by the FDA. The standards that we set in drugs, the medical armamentarium the physicians have available, that is the envy of the world. Because when there’s a product that gets approved in this country, the world knows that it’s been looked at, that it’s you know, that it works. Again, you’re right, the resources are limited, but that’s the realities of life. I mean that’s the realities of Washington. I mean there are no more dollars to go around. And you’re right with the degree of what’s at stake. I mean, if you look, if you go down to that town on the Potomac, within the Beltway, the pressures on the agency, the pounding, I mean there are literally thousands of people who get paid, whose livelihood is made by trying to influence what our agency does. Because a lot of what we do has enormous…mistakes are enormous for these giants. Our job is to try and resist that pressure and do what’s right. To stand up for the average, you know, person. I mean FDA is without a doubt, without reservation the most important consumer protection agency in the world.

Heffner: You know, if one wanted to be cynical, and certainly I’m hardly a cynic, I say jokingly, but if one wanted to be cynical, one would say, “look, in an age of deregulation, in an age when a great emphasis has been placed, certainly for the last dozen years upon ‘I’m alright, Jack, and the devil take the hindmost’, upon assuming that we will make greater progress in this country if we let people, business go its own merry way”. I would say the best, most cynical approach to your job would be to say, “let’s get this incredibly enthusiastic, dynamic young guy, bring him down to Washington, what he says makes people feel that the job he’s talking about is do-able and people will feel that they’re really protected by the man who is Commissioner of the Food and Drug Administration. But let’s not give him the resources to make what he says and what he wants to do and what he does with every fiber of his being, sufficient”. Now, respond that that bit of cynicism. Because you are that person…listening to you, I feel safer as a consumer, I feel safe. Now it’s one thing to feel safer, knowing that Kessler is there and I feel safe knowing that Kessler is there.

Kessler: You know, safety’s a relative…it’s a relative concept. Are you safer today than we were 20 years ago, 50 years ago?

Heffner: That’s the first question.

Kessler: Well, you know, look at the medicines you take. Look at the medicines we all take. They’re much more complicated, the technology, the devices that we use, I mean, I just, I mean they’re mind-boggling…the PET scanners, and CAT scanners, the things that are implanted in, in people’s bodies. I mean there, there’s an enormous amount that technology, I mean it is, it’s a wonderful thing what’s going on in, in medicine today. But everything we do, and what the public has to understand is that there really are risks, there are risks to, the medicines that we approve, there’s nothing that’s, that’s 100 percent safe. And you know, it’s, it’s interesting we approve a drug and it has, it has some good benefits. But if there is a, there’s a side effect, I mean and people aren’t told about it, I mean I’m going to be on the national news, and there’ll be the Congressional Hearings, “how dare the FDA do that…let that out”. And I think, I think there’s a shift in the public’s mindset.

Heffner: What do you mean?

Kessler: Well, I think that when it comes to, I think AIDS has taught us, I think in the AIDS community, I mean deserves a lot, because I think they’ve shifted our thinking a little, shifted the public’s thinking. I think when it comes to life threatening, serious diseases, diseases that really threaten…I mean our existence, people are willing to accept risks. And it’s okay if, if medicines…you know, we act on less of a data base, and there are some unknowns, and there’s some real risks. And people are willing to accept if they’re dealing with serious or life threatening conditions. But take a minor ache, take a headache, take a, you know, a minor stomach pain, the American public doesn’t want to take risks. I think we’re a, you know, we sort of have two standards evolving. One for life threatening, products that could combat life threatening illnesses, there we’re willing to take risks. When it comes to, you know, just routine kinds of medicines we still demand a very high degree of safety.

Heffner: Appropriately, in your estimation?

Kessler: Yes.

Heffner: You see, it’s so interesting to me, over the years I’ve been following very closely the attacks made on the, on the agency…before your arrival, certainly. That it delayed and delayed and delayed…looking for perfection, looking for the word that I used “safety” in an absolute sense, and therefore, entrepreneurs in the medical field, particularly in the drug companies, furious that they weren’t able to make their…put their efforts before the public sooner. Has the AIDS emphasis upon trying something sooner without the greater certainty, with lesser certainty, is that used as a food in the door to try to get you to trade…change your standards also relating to safety in less pressing areas?

Kessler: Let’s, let’s go back and let’s understand what the agency job is when we’re dealing with drugs because most people don’t understand. I even go to Congressional Hearings and I find that the Congressmen or Senators don’t really understand even what the agency’s job is when it comes to, to new drugs and regulating new drugs. You know we don’t undertake the research on drugs…we don’t’ undertake the discovery of new drugs. We don’t undertake the testing of new drugs. You know I got a phone call, I mean over the weekend, we’re holding up, somebody wanted access to a, a new drug and you know, a person was terribly ill and this was going to be the answer in that person’s eye and how dare we hold up that, that drug. The truth of the matter is, there was no application before the agency. There are, you know, the way we do drug development in this country is that we have a private system of drug development…the pharmaceutical firms, the giants, I mean, in this country, and the, the some are our sister government agencies, such as the National institutes of Health do participate…but we really are the reviewers, and an application needs to come before us. And what’s our job? An application comes in, and I’ve yet to see an application…an application says, “Okay, the product we want to sell is safe and effective. And here’s the data that shows that it’s safe and effective. And we want to make certain claims, this drug cures this disease, or improves your health if you have this condition”. and that’s what the application says. Then the question is, you know, is that true? I mean our job really, we’re the arbiter, you know, it may sound corny, we’re the arbiter of truth, really. That’s what we are. I’ve yet to see an application come in with a little note and say, “here are the gaps, here are the holes in this application, here are the reasons why what we’re saying really may not be the case”. You have the proponent, you have the sponsor making the case. And our job is to substantiate, make sure that the evidence substantiates the claims that are made. Now, now, what has AIDS done? No question the pendulum has swung. We are willing to take certain risks. In my opinion, you know, when we’re dealing with a life threatening disease, the riskiest thing that we can do, in my opinion, is to be unwilling to take risks. But if we’re going to do that in the case of life threatening diseases, we have to be up front about it. We approved an important drug not too long ago…DDC now, when we approved it, and we approved it for people dying of AIDS, we said up front, and I said, you know, we may be wrong, but what we did in that case is we approved it conditionally. We approved it with the condition that certain other studies would be done. And that if those studies don’t…when they, when they get done in the next year, some could say, “hey, we should have waited the year…don’t approve it yet, don’t let it out yet”….you know, some would argue that that’s, that’s the best thing to do. We let it out, we approved it on the condition that further studies would be done, and if those studies come back and don’t show the anticipated clinical benefit, if they don’t demonstrate, you know, that the drug actually works, then our job is to pull the drug back. I, I think in the end our commitment…they key is the follow-up when we’re dealing with these drugs for life-threatening diseases. We have to, some, some question are resolved whether we’re willing or able to put the genie back into the bottle, if you let something out. But we have to. But the whole system of speeding up the process, I think what the American people want is for us to be, to speed it up when we’re really dealing with diseases like AIDS and cancer and Alzheimer’s and cystic fibrosis. But, but I think it’s…that model only applies for life threatening or serious diseases for which there are not, I mean, really alternative drugs.

Heffner: The life threatening situation that I’m in right now is that I’m getting the signal that indicates that we have to cut, but you’ve already said you’d stay for a second program, so I’ll say goodbye to you know, Dr. Kessler, ask you to stay where you are, so our audience can hear more from you next week. Thank you for joining me today.

Kessler: Thank you.

Heffner: And thanks too, to you in audience. I hope that you’ll join us again next time. And if you’d like to share your thoughts about our program today, please write The Open Mind, PO Box 7977, FDR Station, New York, NY 10150. For transcripts send $2.00 in check or money order. Meanwhile, as an old friend used to say, “Good night and good luck.”.

Continuing production of this series has generously been made possible by grants from: The Rosalind P. Walter Foundation; the M. Weiner Foundation of New Jersey; the Thomas and Theresa Mullarkey Foundation; the New York Times Company Foundation; and from the corporate community, Mutual of America.

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