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the agency we need - defending the fda...an interview with philip hilts
photo of the cover of protecting america's health

In his book Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation, published in March 2003, the veteran reporter Philip Hilts does something rather unfashionable: he defends the U.S. Food and Drug Administration. Telling the story of the agency's political history, from its beginnings at the turn of the century to its fight for survival in the 1990s, Hilts reminds us of the crucial role the FDA has served over its lifetime, not only as guardian of public health but as guarantor of the pharmaceutical industry's credibility and as a spur to the innovation of safe and effective drugs. More than ever, Hilts shows, it's an agency we cannot do without -- an agency we depend on to do its job with integrity.

Hilts has written on science and health for both The Washington Post and, since 1989, The New York Times. His previous books include Smokescreen: The Truth Behind the Tobacco Industry Cover-Up, Memory's Ghost: The Nature of Memory, and Scientific Temperaments: Three Lives in Contemporary Science, which was a finalist for the National Book Award. He spoke with FRONTLINE's Wen Stephenson on Oct. 16, 2003, from Botswana, where he is working on a new book.

One of the things I find interesting about your book is that you end up having to defend the FDA and its crucial role as regulator and protector of the public health.

"Defending" the FDA is a peculiar business. Writing a history of it -- especially as some on the hard right still want to kill the agency altogether -- you end up writing about regulation and can't help but defend regulation in general. A writer recently asked why I didn't give the "conservative" version of the FDA's story. Actually, the current incarnation of the FDA is the conservative version of it. It could do much more to regulate. In fact, it could not easily do much less without ceasing to be a serious regulatory agency. Yes, ultimately, most of its decisions are based on science, and most are pretty good. But there remains a long list of things that some of us would want them to do if we lived in a more socially conscious body politic.

That is a problem I had to wrestle with throughout the five or six years I was working on the book -- that the FDA does make mistakes, and you wonder about how much they're a guardian of the public safety, and all that. But you discover that really what's happened to the FDA is they have this public health mission, but they're under constant pressure to be as friendly toward free-enterprise as they can. They're really pushed very hard all the time in that direction -- to give in to the companies, to shorten the process, to be efficient. All this constant pressure. So if you're going to regulate, this is the absolute most conservative way you can do it.

The physician and author Jerome Groopman, in a review of your book, notes that the FDA has "often served as a convenient whipping boy for frustrated constituencies across the political spectrum." The agency kind of gets it from all sides, doesn't it?

It's because they have the dirtiest business you could imagine. If you're the Centers for Disease Control, or you're the National Institutes of Health, you're out there doing science, and it's pure science, and you have nobody knocking at the door day to day, saying, "You're damaging me. You're costing me money." They have the really nice jobs. The really dirty job is when you take the policy, you take the science, and you have to try to put it into the real world. And so you say, "Okay, now let's look very carefully at this drug. Oh, actually, this is not safe enough. We've got to hold it back." And then immediately you've got an enemy on that side. Or if you say, "Well, this has got a problem, but the benefit is just a little bit greater than the risk, let's push that one out there" -- then you have enemies on the other side.

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And, of course, the companies are always pressing to have these things put out faster. And the people who are worried about the large number of drug side effects and the hazards of modern treatments are always pushing to be more careful. They say, "There are all these drugs out there already. Why do we have to have one more? Can't we be a little more careful?" So nobody is happy. There's no way of putting science into policy, into real life, without having a lot of unhappy people. So they have the dirty job.

You donžt want to dismiss the achievement of establishing for the entire world what it means to test a drug for safety and effectiveness. They invented the rules, test by test, over 20 or 30 years. Thatžs quite an achievement, putting science into policy that way. I donžt think therežs any achievement like it, actually, thatžs enshrined in law.

Then you take all of that and you drop it right down in the middle of Washington politics. You add this whole other layer to it -- partisan politics, party politics -- on top of the stuff about real safety and real efficacy and the real debate over whether this drug should go out now or later. So it's very difficult, very difficult.

You could almost say anything about the FDA and be right, in a way. I mean, you could say, "They make a lot of mistakes." Yeah, yeah, absolutely. And you could say, "But they're the last bastion. They're the ones guarding science and the public health." Yeah, that's true also. So that's why it's a peculiar business to try to write about it and defend them.

The reason I'm in the position of defending is largely because, at this moment in history, there has been a strong movement to eliminate them. And so what you do is you start arguing about why, historically, that doesn't seem like a good idea. If we were in another era, it might be the opposite. If they were putting out much more stringent regulations, you might be arguing, "Well, actually, we could be more efficient." But that's not the era we're living in.

In looking at the political history of the FDA, was there a particular moment or period of time when the FDA became politicized in a way that it hadn't been before? Or has it always been this politicized? You note that Richard Nixon set a precedent of making the FDA commissioner a political appointee. I don't know if that's the moment or not. Is there a "before and after" moment?

It was politicized when it was being born [at the turn of the 20th century], because there were severe politics over whether you should have such regulation to begin with, whether you set up a federal agency that would actually police business. So it was politicized enormously until the laws were passed to put in place. Then it became a public service agency, and people did not attack it politically very much. Occasionally there were issues. But for the most part, it wasn't a highly politicized agency. And the people who ran it were public servants; they were not politically appointed people.

But then in the 1960s and '70s you had this situation in America where the left and right were fighting quite fiercely, I mean literally, in the streets. We had the civil rights and the Vietnam demonstrations, and the bitterness back and forth. And the FDA got caught up in that same struggle.

And when Richard Nixon won the presidency in 1968, he represented the conservatives and the anti-regulators, and he made the decision to start politicizing, not so much the FDA itself, but the federal government in general. The idea was that there were too many Democrats in Washington. The Democrats had owned Washington for a long time, and all the people in these jobs, all the way up and down the agencies, were mostly Democrats: the guys who take the merit tests, the technicians, the bureaucrats who -- by law, in fact -- are not politicized.

The trouble was that the conservatives coming in viewed the whole establishment as left, and decided that all these folks in the agencies, especially at the top of the agencies, needed to be changed. They wanted to replace them with their own people because they wanted to change the whole flavor of government.

Well, that was quite a radical idea. It jumps you all the way back to the 19th century and the debate over whether to have a civil service that is intentionally non-political and to have an agency that works in a non-partisan manner, based on policy and facts. Well, the idea under Nixon was to go in and radically change that.

And the FDA got caught in the grind as a result, and it became quite politicized. They managed to fire a number of people in the agency on pretense -- people who had done work in the agency for a long time, and perfectly good work, their records were good, but were Democrats. And they weren't supposed to be able to be fired, according to the civil service law, but the Nixon administration went in and found pretexts, and fired some of them and moved other people in. So you can imagine the effect on the agency. It was the first time they had seen this kind of raw politics coming into an agency that thought of itself as a science and public health agency. That was the moment of politicization. And it got worse after that.

And it was kind of surprising, in a way, because Nixon, as a president, wasn't that far right compared to some of the others. He wasn't as far right as Barry Goldwater or, later, Newt Gingrich. But the effect in some of his agency work was just as radical, and the FDA was one of those cases.

So the struggle within the agency was to keep it from going over the cliff, to try to make it an agency that was well managed, so that those kinds of bitter political fights did not run it off the edge. You had to keep bringing it back, to keep it on mission, which was essentially to judge each drug as it came in by the science and not by the politics -- "So, what company does this come from? And who's the owner of that company? And how is that related to the president?"

What was the politics really about? Was it on an abstract, ideological level: regulation versus no regulation? Or was it more about the growth of the pharmaceutical industry, and money, and real politics? What was going on at that point?

You had two things going on at the same time. The major event, the thing that was really happening from the early '60s to the early '90s, was that the Congress had passed a law in 1962 that said you must test each drug on a scientific basis for safety and effectiveness. So the agency started thinking, okay, what does that mean? So we have to have some animal studies, right? Then we have to have some toxicology on the bench. And then we have to have some studies in people. And they started figuring out how to do that. Well, it turns out that it's really hard to do, and it had not been done before. So it took them about 30 years, the FDA scientists and the industry scientists, to fight over how much is enough studying. Arguing on every case, vehemently, what's the best way to do it?

That's what was going on at the scientific level, between the companies and the FDA. Then on top of that is the politicization coming in, so that halfway through the conversation about a drug, you start talking about Democrats and Republicans. And it's totally confusing, totally confusing. You had this pull from the outside, people saying, "You guys shouldn't be arguing about this at all because we really don't need any of this regulation." And then you have the people on the left saying, "You guys shouldn't be arguing this way at all. You should just let the scientists in the agency decide. And don't let the industry come in here at all. They don't come in the door. You just let the scientists in the agency do the science and come out with their decision."

So it's the struggle between science and policy. How do you insert science in policy at the same time you're arguing about regulation versus non-regulation?

In your chapter on the deregulation wave of the 1980s, one of the main ideas is this struggle between science-based policy and values-based or ideology-based policy. And that becomes a recurring theme throughout the last part of the book: how FDA commissioners, Republicans and Democrats alike, ended up having to defend science -- sound scientific data and scientifically rigorous testing -- as the basis for regulatory decisions.

It was a peculiar position for the commissioners because many of them were Republicans. And many of them came in with a conservative market-oriented bias -- like the current commissioner, in fact.

But what happens to them when they get in the agency is like what happens to Supreme Court justices. They get into the job, and whatever their ideology is, it turns out that what happens is somebody walks in, in the morning, with a problem, and they say, "Here, look at the details of this problem. What do you think we should do?" And it turns out the decisions have to be based on the facts in front of them. And then by noon there's two other problems that have to be decided that way. And then five months into it they realize, "Hey, wait a minute. I haven't made an ideological decision in a month, or five months, or a year, or five years. And half of the decisions I made may actually be counted as lefty. And I didn't even know it because I was focusing on the job in front of me." That happens to people. What they have to do is try to keep the agency on track, making rational decisions at the same time they're getting pulled from the outside.

After the incursion of politics into the arguments starting in the 1970s, the national politics changed radically again, took an even farther turn right in the 1990s with Newt Gingrich and the Republican Congress. They had the ability, in theory, to go ahead and fix these things they had been talking about for many years, and they had the people in power who were the most outspoken, hardline anti-regulatory forces. So it looked like they would not only have the ability to tell the FDA to loosen up, they could just get rid of the FDA -- which is what they actually suggested.

So you were back in 1896, where the argument was over "Are we going to regulate or not?" In fact, almost exactly the same words were used in many of the arguments made in 1995 and 1895. It was pretty extraordinary to have come all the way back around and have this total amnesia.

Thinking about the current state of the FDA, what is the legacy of that political battle from 1995 to '97, when there was the effort to dismantle, or drastically weaken, the FDA? Do you have to understand that battle in order to understand where the FDA is today?

Yeah. One of the things that's happened is that, because we had this total amnesia in politics, we have to go back and start over. So now, when you start talking about the FDA, the first thing you have to do is identify where you are on the political spectrum, and say, "Now, I understand the market. We really believe in the free market. And even in medicine we believe in the free market." You have to make these statements first, because it's necessary to go all the way back and justify the basis for the reason you have a regulatory agency.

It used to be, in the 1930s and then again in the '60s, you didn't have to justify it. Everybody knew why you were doing it -- you were doing it because you wanted safe and effective drugs. But you can't start there anymore. You have to go back two steps and say, "I understand we have a free market system. But when we're dealing with drugs there are some things we can't afford to do." We can't afford to put out unsafe drugs, and then take our time and see if they're really bad while the company makes its money. That's okay for other things; it's okay for brooms -- you have a bad product, it won't work in the market. You can't do that with drugs. A bad product in the market means dead people. So you can't let the free market operate in the same way in health.

Now, we thought we knew that. But it turns out that because of that bitter time in the '90s, we now have to start each discussion all the way back at that point, justifying the reason we're doing this at all. You hope that the arguments are now clear again. But I don't know if that's the case. It depends on the next election -- which is not a good thing to say, by the way, about the FDA and public health.

In the story of the congressional battle in 1996 over "FDA reform" -- at the height of this struggle over the fate of the FDA -- you describe the industry as being in an awkward position. They weren't exactly gung-ho in support of what the Republican Congress were trying to do. Can you explain that? Where did the industry find itself in all of this?

The industry, of course, had grown up with the FDA during this 30-year fight about what is good science and what's a good drug. And they had actually put a lot of scientists on their staff, and they had a lot of people actually learning medicine and the basis of the body and the biology, and so on. They came an enormous distance in caring about the details of the body and how drugs work. And they were now depending on the high-end science, on knowing the exact details of how these things work, to discover new drugs, to find new products.

So here they are in the '90s, far along this line, doing high-end science, being very careful about the studies -- these are the best companies I'm talking about -- and all of a sudden somebody comes along and says, "Don't you remember? You didn't want to have regulations a few years ago." And the companies said, "Well, now, wait a minute. If we pull off the regulation and all of a sudden we're not testing publicly, and these products are not being certified as safe, where are we?" And in private they were quite plain about it. They thought they had got themselves into a very bad bind because they had been supporting the Republican Party and the conservatives more than they had the Democrats. And then this legislation came along which would have really desperately hurt them.

You mean it would hurt their credibility?

Yeah. The credibility of the drugs comes from the existence of the FDA, the existence of deep scientific testing, the real stamp of approval, saying, "This is actually quite safe. And this does actually work." That's something that they earned over the previous 40 years, which they were now about to lose if the FDA goes away or gets weakened. And they knew that perfectly well, because now they have a lot of scientists and doctors on their staff.

So now they're in a position where, if they speak out publicly on that, they're getting themselves in deep trouble with the party in power. I talked to four or five regulatory people and scientists in the big companies, and they really were crossing their fingers hoping that this would go away -- that Gingrich would go away and this threat to the FDA would go away -- because it was really a big threat to their credibility.

So this was very awkward for them. And there were various times when they secretly tried to help out the other side, secretly tried to support the FDA. And there were a few stories in the news where you would find them actually saying that the people who were suggesting tearing down the FDA really didn't know what they were talking about, didn't know the facts. These were the big pharmaceutical company people, who knew the most about it, saying, "No, we don't actually want to go there."

One of the main things behind this push for "FDA reform" in the 1980s and '90s was the idea of "drug lag," and the need to speed up the review and approval process for new drugs, which led to the Prescription Drug User Fee Act (PDUFA). You and others see that law as a mixed bag. On the one hand, it's been praised as a real, workable compromise between the industry and the FDA to try to make the review process more efficient. And it did allow the FDA to hire a lot more reviewers, so in some ways it strengthened the FDA. On the other hand, you point out some ways in which the user fees paid by the industry can undermine or weaken the agency, make the agency a little more susceptible to industry influence. How does that work?

If you start from the basic idea that you want the FDA to be a public agency which is taking care of the safety and effectiveness of drugs -- and a public agency funded by taxpayers, so there's no intrusion of private money in it -- that's the ideal.

But what happened was the public money was not coming through. Congress was not giving the FDA enough money. So they tried to solve the problem at hand, which was that they had too few resources to do this job properly, so that they ended up either doing it too slow or letting out drugs that were unsafe, and various kinds of problems. So the User Fee Act felt like a wonderful compromise at the time, that we could actually cut through this Gordian knot if the companies give the money, because they really want these reviews done fast and effectively. You'd get the problem solved. You'd build up the FDA. You'd build up the review process. You'd get a really good body of reviewers.

But the problem is that the method you've used takes you away from your ideal, and has the industry in a position where they're now saying, year by year, "Well, the reason the FDA is doing this well is because of us. We're paying for it." And that's a very strong argument when you go to Congress, to say, "Now we need some more favors because we're paying, and every year, we're paying more for this."

And I think it puts the industry in a position of strength that the original idea did not have them in. The original idea is for the public to take care of this independently. These scientists are supposed to be independent. And now you've put them in a funny position, when the reviewers are getting paid, at least in a substantial part, by the industry. That's a very awkward thing.

And the trouble is you perpetuate that, because as they put more money in, the industry is in a stronger position. The User Fee Act expires periodically, and so every time you renew it, the pharmaceutical companies show up and say, "Okay. This is our money, remember. We're paying for this." And they're in a strong position to argue for change. And it puts the other side arguing for scientific purity and carefulness in a weaker position. So that's the trouble, I think, because you've now made a fix that tends to pull the agency off center.

Well, it was certainly convenient for Congress to shift the funding over to the industry.

It was convenient. And imagine yourself in that position. You can see the review process is totally overburdened, and you know you can fix it, for right now at least. I'm not sure anybody would refuse to do that, even knowing you're going to have a future problem. So the temptation was too great.

The question is, what are the consequences of the fix going to be? And will you ever get Congress to responsibly evaluate how much money is really needed for the FDA to do its job? Because there's many more things that are not being done. For example, the monitoring of drugs after they go on the market. Where is that money going to come from? Are you going to ask Congress to fund that? Well, they won't do it. Historically, they have not been willing to come up with the cash to do those kind of jobs. So then they'll lean on the industry. The industry will come up with some of the cash. And then, again, the industry helps make the decisions because they're coming up with the cash.

So it comes full circle. The Congress is getting used to the industry putting in the money. Now it feels, "Oh, well, we don't have to do that. It's not our job anymore." So you're outsourcing or "outfunding" the FDA to industry. That was not the idea originally.

This question of whether the FDA is too cozy with industry -- is that anything new? When did that begin to really show up as a concern?

It was a concern beginning essentially in the late 1950s. In the 1950s, the pharmaceutical industry was in its first boom years. They had the first really wonderful drugs that were very powerful, like penicillin, and the steroids, and these kind of things -- the first time we had really powerful drugs. And the industry was doing brilliantly, and everybody appreciated that.

So the industry was simply running the show in the '50s. But after a little while, the miracle wears off, and you say, "Now, wait a minute. We're having some trouble. Aren't there some of these that aren't actually working right?" And some of these drugs are actually causing blood disease, and so on. And when those first cases started coming in, there began to be some rethinking of whether the industry was really the brilliant miracle industry, and whether the FDA shouldn't actually be a little more careful about letting drugs on the market.

Then, of course, the concern became very focused and very public with Thalidomide, which is one of those drugs that was put out on the market in what now would look like an extremely careless way, but which was routine at the time. Because they asked the company, "So, did you do the studies?" "Oh yeah, we studied it." "Is there any problem with it?" "No, no." "Is there any problem with pregnant women in particular?" "Oh no. We have many women who are pregnant who are on our drug. We don't see any problems." They relied on the company. They didn't look for the data. And it turned out that they were wrong and that, around the world, about 10,000 infants were born with these horrible deformities, and another 10,000 that are never mentioned died in the womb for the same reason, because of this one drug. And that made it quite clear that you had to be more serious about looking at the data. [Editor's Note: In an email message sent after this interview was posted, Hilts clarified: "Although the drug did go on the market in many countries, including Germany, England, and Canada, it was prevented from making it to market in the U.S. There were serious problems in the U.S., including cases of deformed babies in the U.S. That was because the drug, while not let on the market, was permitted to be used by doctors 'experimentally' -- more than 10,000 doctors got samples to try out on their patients. That was not the FDA's fault, however, it was just a loophole in the law. It was corrected with the passage of the 1962 law." (11.15.03)]

From that point on, [people realized that] the FDA can't be in the pocket of industry. You really need them to be separate, and to not just ask the industry what they think and go with it. You have to have them actually be scientists, and look at this data, and review the data, and even have the power to say to the companies, "Give me more information. This is not enough." Or, "We believe this is wrong. Would you go back and retest?" And those kinds of questions were not permitted in the '50s. But after the 1962 law it became the responsibility of the FDA to face off against the companies in crucial situations.

And the argument since then has been, depending on which side you're on, are they too close still? Because the companies still have large resources to go talk to the FDA and to try to convince them of their view of the data. Whereas on the other side, the public side, it's just the FDA guys sitting there in the office. And they have very few people who are reviewing the data with them. Sidney Wolfe and Public Citizen's Health Research Group try to do some, but you're talking about a volunteer organization. They have very few -- what, three or four -- people paid on the staff. The rest are volunteers. So there's no opposite number really.

The opposite number to the industry has to be the FDA itself. They have to be the ones looking out for the details and the data, and actually saying to the company, "No. We're drawing the line here." So it's always going to be a question of, Are they doing their job properly? Or are they just being friendly with the guys who are coming into the office?

I get the sense that, in a way, you're also defending the FDA against some of its critics on the left. You seem to be saying that the FDA actually has done its job more often than not, and that it isn't quite as much in the pocket of the industry as some people say.

Yes. The rules are quite tilted in the favor of industry. And so the critics of the FDA are correct in that it heavily favors industry. The companies have much more access and much more ability to go into the FDA and say, "We really want you to see this study the way we see it." And the consumers don't have much ability to go in and do that.

But then you also want to say that the FDA has a serious standard that they're operating by. They're actually looking at data. They're seriously trying to test the safety of a drug. So you don't want to dismiss what they've done over the years -- the achievement, from 1938 to today, of actually establishing for the entire world what it means to test a drug for safety and effectiveness. They invented that from nothing -- from the point in the 1950s where they didn't even know, really, what a clinical trial would be if you were going to do it right. Nobody else in the world made that work except the FDA, working with industry on real trials. They invented the rules, test by test, over 20 or 30 years.

That's quite an intellectual achievement, putting science into policy that way. I don't think there's any achievement like it, actually, that's enshrined in law. So that's pretty remarkable.

Is it possible that the critics from the left, the consumer-advocacy type critics, are in some ways holding the agency to an impossible standard? This is awfully uncertain business, isn't it? Determining whether a drug is actually safe enough to go out on the market?

Yeah. They are holding them to a tough standard. But then again, you wonder what would happen if they didn't exist. If the critics on the left weren't there, what would you have? Well, maybe you'd have the 1950s, in which it was the FDA and the industry and nobody else. And the industry would have even more power. And it would be too easy for the FDA to slip back if there weren't somebody calling them up week by week, like Sidney Wolfe does, and saying, "Now, now. We looked at that thing, and we don't see that data like that. And we think that the pressure is getting to you guys."

So, I guess I like the idea of a balance. And I like the idea of them reviewing the data, and giving the FDA a hard time when they see the data being different. It would be hard to imagine the FDA without that critic, without that barnacle on the back, that gadfly. You've got to have that.

 

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posted november 13, 2003

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