Food, Drugs, and the Public Interest, Part II

THE OPEN MIND
Host: Richard D. Heffner
Guest: Dr. David Kessler
Title: “Food, Drugs and the Public Interest, Part II”
VTR: 9/3/92

I’m Richard Heffner, your host on The Open Mind. And this is the second of two programs with one of the most interesting and important young men ever to serve in American government…indeed, to some people, one of the most controversial. In fact, introducing my guest last time, I asked “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.”

Well, 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.

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.

Now last time Dr. Kessler and I talked about some of those private agendas…and of the “spin control” that dominates public issues. Today there’s more to be said, of course. And so, Dr. Kessler, I, I want to go back to something you said about other countries. We are, in a sense, the shining light for the world. Tell us about that. What about Food and Drug Administration counterparts in other parts of the world?

Kessler: We really are the gold standard in this country. When you go buy a drug, when your, your doctor prescribes a drug in this country, you go pick it up at the pharmacy and you take it home…you can rest, be rest assured that it works, that it does what your doctor says it’s going to do, and it does what the manufacturer claims it does. That it, that it basically, that it’s effective. That standard is a very important standard…

Heffner: And you’re saying it doesn’t exist…

Kessler: Well, go abroad…I mean go abroad and pick a number of countries. You can find, you can go buy drugs that will treat Alzheimer’s disease…do any of them work? No. imagine our health care dollar, imagine, you know the, the enormous pressures that we’re under with regard to the percent of the GNP that’s going toward health care costs. Imagine if we were spending our money on medicines that didn’t work. It’s the one thing that really…I mean we’re admired…you know when a drug is approved in this country, now sometimes the, the drug manufacturers they, you know they grumble, they complain…it takes too long, our standards are too high, but boy, it’s, if a drug’s approved by the Food and Drug Administration in this country that drug has got to become an international blockbuster because the rest of the world is going to know that it does what it says it does.

Heffner: Of course, I don’t want to go back into the conversation we had last time, but let’s remember that there are also those who say, “My god, they won’t let us have the drug that I could pick up in England, or pick up in France, or pick up in Mexico, and that I know is an effective drug”.

Kessler: Choice. I want choice…I want to be able to take, you know, whatever I want to take. And we hear that. But we also hear that “Gee, I want choice, but if something goes wrong, it’s your fault, FDA. It’s my fault, as Commissioner”. So it’s choice up to a point, but I also want to make sure that I’m not going to be hurt. And that’s a system that we’ve developed. It’s a difficult balancing system, but it’s set out in our nation’s food and drug laws…it says before you, as a drug manufacturer, go sell your product, that you establish, that you come to us at the agency, and demonstrate that the product is safe and that it does what you say it does. That you have that burden, the burden is on the manufacturer to prove, affirmatively that the product is safe. You know that’s one of the problems we got…you know the issue is not only for drugs. But that’s the standard also for devices. And, and never did it hit home as much to me…the importance of that affirmative standard as it did in breast implants. Breast implants came on the market before there was a…the law for medical devices is only 15 years old…and, and these devices were put on the market before there was that affirmative standard that before you go put something on the market, that you show, affirmatively, that you do the testing, that something is safe and, and that it works. That testing was never done…it was never required. And those products were “grandfathered” in, and now we have to clean up the mess that’s associated with the, the fact that those were never done. And, and women who have had those devices, I mean they lose sleep…we still don’t know very, you know basic questions…what percent of these rupture…do they interfere with mammography, do they interfere with the detection of, of breast cancer…do they cause certain autoimmune diseases? Basic questions that, that the patients who have these devices, the women who have these implanted have a right to know, and we don’t know because we don’t…that affirmative standard was never in place…that before you go sell a product, that’s going to be implanted in people’s bodies, or that I’m going to prescribe to my patients, or that I’m going to give to my children or to my family, the manufacturer has to demonstrate affirmatively that it’s safe and effective. It, it, it, you know, people say that they don’t want to meet that standard, that it’s a costly standard. That it takes time in order to demonstrate, all that is true, but I still think we’ve ended up with the safest, most effective medical armamentarium In the world.

Heffner: Well, Judith Viorst, as she writes about you in “Redbook” of April, 1992 she keeps saying “I think I am in love” every time she comments about something else that you do, and have done…she writes, “The bad news is that the FDA by many accounts has been too ineffective and too venal in recent years to do all it should to safeguard the nation’s health. But the good news is that the FDA has started to become a vital, effective, consumer friendly agency now that it’s being run by a determined MD, age 40, who may turn out to be the Number One hero of the Bush Administration. His name is David Kessler. I think I’m in love”, she goes ahead and she proclaims that a number…in a number of points. When you talked about…with her about the, the approval of DDI, the only drug besides AZT currently available to treat AIDS, before all the safety tests were complete. Is that correct “before all the safety tests were complete?”.

Kessler: Certainly before all the tests on whether it worked or not. We knew DDI had an effect on certain immune cells that it increased the number of immune cells in the body of patients with AIDS. And that seems, it makes sense that that would be beneficial to AIDS patients. But you know, just because you increase certain cells…was, was that, that, that bounce in the number of cells…was it real? Was it really beneficial? Was it going to increase the length of time, the length of the life for patients with AIDS? Was it going to decrease the kinds of infections they had? We…there are a lot of unknown questions. But we didn’t wait, we can’t wait for every “I” to be dotted, or every “t” to be crossed when we’re dealing with people who are dying with a disease like AIDS.

Heffner: If it hadn’t been for the political pressure that has accompanied…the phenomenon of political pressure that has accompanied this epidemic, this scourge, what…would you have moved as you have?

Kessler: It, it’s not political pressure. I mean, you know, FDA is not a bunch…come down, meet the, the physicians, the people, I mean who are working at the agency…and we’re not a bunch of green eye shades who are…

Heffner: No, no, no.

Kessler: …who are sitting there wanting to keep important drugs off the market. All of us, I mean we’ve taken care of AIDS patients…it’s, it’s, it’s not the issue of political…meaning with the small “p”, kind of pressure. It’s simply it’s the right thing to do. I mean if we are sitting there, I mean we are no longer, you know, just waiting for the data to come in. we’re reaching out for that data. Even before manufacturers submit applications…I mean we are working day and night…we, you know we took, oh, there must have been a good 40 people that we took and put on that application for DDI. You know, we approved it on the basis of that increase in those immune cells, but we didn’t know…but we approved it conditionally, and we said there need to be further testing. And, in fact, that testing was done, and the results came back…and you know what, we were right. I mean, in fact, it decreased….the people actually benefitted clinically…that it was helpful, it decreased the number of infections that, that they had. And, and but even if we were wrong, even if the results down the road would not have demonstrated that it worked, I think it’s okay. I mean we took a risk, but the thing that we need to be up-front about, that we had to be very clear to certainly those who would take the medicine, who would prescribe the medicine, we have to tell them what we know at that point of time…you know the, the brochure that, that accompanied the drug…I mean was the most extensive brochure…I mean it was something like 40 pages…we told them what we knew and what we didn’t know, we told them where the risks were with regard to the medicine. But when it comes to, you know, life threatening diseases, I think we can act with less data.

Heffner: Dr. Kessler, what does it take to put 40 people on the job relating to a drug?

Kessler: Can’t do it with every drug.

Heffner: What does it take?

Kessler: It’s, it’s an enormous, enormous number of resources that are required.

Heffner: given the limited and they are limited, resources that you have at your disposal, and we’ve talked about…I raised the question, you didn’t raise it, I raised it because I know enough to know that you are hamstrung, handicapped by the fact that there aren’t enough dollars available to the agency. Given that, what does it take to assign 40 people…what do we have to do..do we have to have the press, do we have to have politicians, do we have to have Elizabeth Taylor…what’s required to put 40 people in the FDA on a task?

Kessler: We need to rethink the funding of the agency. It’s that simple. We can’t do it all. Every time I take 40 people, I’m taking them off of, you know, doing other things. In this case I had no problems doing it because there was nothing that was more important than getting that kind of drug out to the people with AIDS who were, who were dying. But I think we really do need to think about the basic…how the agency is funded. Now what’ we’re talking…what we’re thinking about now, and I think it has certain merit. Look, if there were enough money in the Federal budget, it would be easy, but let’s face it, with the deficit, with the budget constraints, with the…I mean Congress has finally recognized…I mean it used to be pretty easy to appropriate money. That’s no longer the case…with the Congressional caps on spending that hit in fiscal year ’93, there are enormous constraints. You know, we’re getting our share, but by no means is it going to be enough. So the question is “what can we do”? and one of the scenarios that we’ve come up with is the, is a sense that those who would submit an application, those who would potentially profit from an action on an application, that they pay a user-fee, somewhat like…oh, when I applied to college I send in…what 40 dollars with my application. Didn’t guarantee that I would get accepted, but it would help the process.

Heffner: But you’re not talking about 40 bucks, I would assume.

Kessler: No, we’re not talking about that, but we’re…when, when one looks at a drug, and if I’m a pharmaceutical company, and for every month that goes by that an application…if I’m dealing with a drug that has potentially 200 million dollars a year in, in earnings and has a margin of about 80%, you’re talking about 10 million dollars of lost potential revenue each month that we can’t get to that application. So if you’re the drug…if you’re a pharmaceutical firm and you’re going to lose that money because I don’t have the resources, doesn’t it make sense for you to pay, well, not ten million dollars, but at least something so that we can hire some more people to review that application. That’s the kind of thinking that we’re, we’re going through right now.

Heffner: Now, I just got the signal we have ten minutes left, and doggone it, I’ve got to ask you a couple questions that I, I want to know what you, you think about them before we have to say “Good night and good luck”. Number one, how would the experience that you are having now, have had an Administrator of the Food and Drug Administration change you as a practitioner of medicine.

Kessler: Oh, I think that it’s a greater understanding of what the agency does. It is…

Kessler: What about what a doctor does?

Kessler: Well there, there certainly the, the issue of a doctor sits there, just like we sit there and we have a lot of pressures on us, and all these special interest groups…I mean there are a lot of pressures on doctors…a lot of people making pitches to doctors to describe this or use that…and there’s a lot of promotional aspects to the kinds of products we regulate. And I think to some extent I would…you know the issue of whether it’s truth in advertising…we talked about last week on, on food labels…I think it also goes to, to the issue of medicines and devices. It is, one has to make sure in the end that whatever I do, that there’s a scientific basis for…and whatever claims are made, that there’s a scientific basis and that I’m willing to look for problems down the road. The problem…we talked a little about breast implants, the problem, I mean with breast implants, is that there were people who were using breast implants, implanting breast implants, wanting to do good, thinking they were doing good, but were unwilling to look for problems. Unwilling to, to say, “okay, how do I study what the effects of what I’m doing”. I mean when we’re dealing with drugs, when we’re dealing with things that are implanted…I mean in our patients, mean not…we’re not just talking about implanted for a day or a week…we talking about ten years, 20 years, what’s the effect of what I’m doing. I would think long and hard, everything I do that really has an effect on someone’s being on, on their body. I mean, is what am I doing…what’s the long term consequences. That’s I think what I’ve, what I’ve learned and would bring to practice.

Heffner: Would you wish that you were not put upon quite so much by the detail men of the pharmaceutical companies? That you had a source that the FDA, for instance, were providing you with the information you needed, rather than you’re having to pick and to choose and to make judgments about the claims that are made by the detail men.

Kessler: I think that…look everything has its up-sides and has it’s downsides for many physicians. There’s a…you know, the information they get is…sometimes they only get information through detail men…they’re not associated with the university, they’re they’re far away from a major teaching hospital, they don’t have time to read the academic medical journals, the detail men serve important functions in those cases. But they also, it comes with certain risks because there’s, there’s somebody who wants to sell you something. There’s someone who wants to, you to use something, and most of the time those detail men are very honest, you know, and stick to making sure that there’s a scientific basis, but unfortunately sometimes there’s always those who go beyond the line. And our job at the agency is to make use that there’s incentives for people not to cross the line.

Heffner: Would it not be best to increase the assigned task of the agency so that it became an impartial educator, rather than leaving that task to the detail men. As you say, of detail men and women…as you say, they perform an important function many times.

Kessler: There are a lot of things that I would love to do.

Heffner: Go ahead, tell us.

Kessler: I mean there are a lot of things, I mean that, that would be important for the agency to do. But within the confines, within what the kind of resources…our job is to…is, is, is a simple one…it’s to look at the safety and effectiveness of medicines. And to decide whether they should go on the market and decide what should be said. You know the…that test alone, within the drug and device arena, ensuring the safety of food, it’s an enormous set of tasks. I just, you know, there are a lot of other things…drug, you know, education of physicians, that would be nice to do. But I think that under the current constraints I have to be realistic, I have to stick to the mission at hand.

Heffner: Oh, oh…I understand, but in these last minutes that I have you at the table, I perfectly well understand what you say, what the mission of the agency is. Now, I’m not talking to you as an Administrator, I’m not talking to you as a lawyer, I’m talking to you as a physician who may practice again, and I’m asking you what you want from…

Kessler: I, I…

Heffner: …a governmental agency.

Kessler: I want the FDA to do its job. I want the FDA to resist all the pressures on it, and to make sure that the medicines that I’m going to prescribe, the devices I’m going to prescribe, that they are safe, that they have been adequately tested, and that the claims that the manufacturers make about them, you know, are well known and have been documented. That’s what I want. Because I don’t have time to check the safety and efficacy of all the medicines…I just don’t have time when I’m in practice. I want the FDA to do its job.

Heffner: Wouldn’t you feel, and you know the leading question…I’m not trying to back you into a corner, but I would imagine, if I were in the position of a physician, I would want to turn to, if I didn’t have the local university affiliation, or medical school affiliation, hospital affiliation, I would want to be able to run to this governmental source, this reflection of the best interests of us all to be educated.

Kessler: I think that there are a lot of ways to educate. We have a job to do with regard to education, but it’s not FDA alone. You know, we have information that we send out to physicians all the time, we have our drug bulletin. But the responsibility for it lies not, and I don’t believe, solely with a federal agency. We have to do our part. But the medical community has to be able to have the mechanisms in place to make sure that they’re well educated. Look, if I’m a doctor, things that I do, I need not only to be educated about the latest drug or device, what about all the procedures, all the surgery that goes beyond simply the jurisdiction of the FDA. So the medical community as a whole has to be able to have mechanisms to make sure that they stay state-of-the-art. We have a role, but we’re only one of a series of players in role.

Heffner: Well, then let me move from your agency to your profession. Is it doing what it should be doing along those lines?

Kessler: I think there’s no question that we’re all suffering from a…you know, the explosion in technology. And it’s, you know it’s…to be honest with you, it’s not easy always to keep up. And to, to be at the cutting edge. And it is, you really have to be enormously committed. I mean we’re, we’re talking about working real y36 hour days…I mean we’re talking, just to keep up with the kind of explosion in medical technologies. Are we doing as good a job as we could do…does every physician know everything about everything they prescribe? Absolutely not.

Heffner: No, I wouldn’t ask that…but in a minute and a half…what do you see as the future of your profession…what do you want to see in terms of the knowledge explosion?

Kessler: I think that the…in the end it’s to remember why we went in…why we became doctors…what, what this is all about. Which goes to the heart of the agency’s mission. When we, when you use a drug, when you implant a device, you an enormous ability for good, but you also have an enormous ability to cause harm, and it’s understanding and knowing everything possible about that drug or, or that device and understanding that we’re affecting human beings.

Heffner: But if my primary motive is “Do no harm”, I need to reach out to those who can point out to me how I may be doing harm, willy-nilly, unknowingly. So I reach out to you.

Kessler: And it’s not simply “Do no harm”. It’s to do good, too. You can’t just sit there and be afraid of about doing harm, you have to be able, there are certain risks that we all take, if we’re going to be able to cure diseases. It’s, it’s not, I mean in certain instances that there may be certain harms associated with certain of the therapies, and we have to be up front about it, and people have to understand that there are downsides, there are no magic therapies, there’s no magic therapies for the kinds of diseases we’re talking about. Take AIDS, the, the heart, you know we’re a long way from a cute. There, there is going to be certain downsides to the things we use, but we have to be up front about the risks.

Heffner: Dr. Kessler, you’re going to have to come back so that we can talk about the profession, not just the agency. Thank you so much for joining me today on The Open Mind.

Kessler: Thank you.

Heffner: And thanks too, to you in the 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.