Generation RX

GUEST: Greg Critser
VTR: 10/17/05

I’m Richard Heffner, your host on The Open Mind. And my guest today, journalist Greg Critser, seems to be getting into the habit of writing about too many Americans’ bad habits … first with his Houghton Mifflin best seller Fat Land: How Americans Became The Fattest People In The World and now with Houghton Mifflin’s cleverly titled Generation Rx – How Prescription Drugs Are Altering American Lives, Minds, and Bodies.

Here Greg Critser’s indignation is directed unfortunately quite appropriately at the pharmaceutical industry, the “big pharma”, as he calls the incredibly profitable and powerful drug companies … at a weakened Food and Drug Administration very much in bed with those they should be regulating in the public interest … at direct-to-the-consumer drug marketing policies and practices that never should have been tolerated…and at doctors themselves who as the beneficiaries of drug company largesse too often permit seeming conflicts of interests to surface in their writing of some 3 billion – and climbing – prescriptions each year.

Now, whether or not we Generation Rx Americans are over-dosing on prescription drugs is, of course, a major question of our times … but one that isn’t going to be answered on a television talk program. What I can ask of my guest, however, is that he explain his book’s subtitle charging that “prescription drugs are altering American lives, minds and bodies”. What do you mean by that?

CRITSER: Well, I’m glad you asked the easiest question first. Well, let’s just start with lives, okay? The argument I make in the book is that Big Pharma by embracing culture, culture and the generation of culture through direct to consumer advertising has transformed itself from what was once a kind of a fuddy-duddy, unsexy industry into a very sexy industry that is, is … makes its money by telling us stories.

Now what do you mean by that? Pharma for many, many years only talked to doctors. Okay. It’s because doctors had the scientific background to understand the studies that were behind the new drugs that were coming out.

But beginning in the 1980s, there was an enormous amount of new competition from generic drugs and pressure from managed care to limit the amount of drugs that patients got. So Pharma basically fell back on itself and said, “We need to get better at talking directly to the end patient, the end user”. And in that case it was the patient.

So that’s what I mean when I say that they’re transforming our lives. Their transforming the way that we think about out bodies. And the greatest example of that is the story we’re told about Vioxx, which we now know is a half-billion dollar liability for Merck & Company.

Vioxx, remember, was approved for treatment of arthritis pain in people who had stomach ulcers. That was a relatively small group of people. But the company used, as how has been shown in, in the court case and a number of other cases, they used this ability to reach out directly through the advertising community and through the marketing community, directly to the patients to, to basically sell the over-prescription of that drug and that’s why, and that’s why you’ve had the enormous response we’ve had the withdrawal of this drug now.

HEFFNER: Of course, until the government, until “we the people” permitted them to have that access directly …

CRITSER: (Laughter)

HEFFNER: … to the consumer, that didn’t happen.

CRITSER: That’s right. You know, when they … when the direct to consumer advertising grew out of a lawsuit, basically, in the mid-seventies. And who do you think that lawsuit was originated by? Do you …

HEFFNER: Tell me.

CRITSER: It was originated … by Ralph Nader. Okay.

HEFFNER: Oh, that’s right.

CRITSER: Who was a great critic.

HEFFNER: In your book you make that point.

CRITSER: He is a great critic … now … of direct to consumer adverting. But back in the seventies … you have to remember that one of the big battles that was waged was over patient access to information. Okay.

So that’s why you first started seeing lawyers advertising in the last seventies. And also you saw optometrists and doctors, dentists, etc. Those were a series of cases that Nader originated. Basically in which he took to task State medical societies, state medical professions, for self-regulating. And he was say, “No, look, we’re entering a period in which the consumer can needs more and more information.”

So, in this case, what he argued was that pharmacies should be allowed to advertise the price of drugs on the outside of their, their stores.

And he did win the case; it went all the way to the Supreme Court. And what was really interesting about this is … who do you think the biggest dissenter on that case was? It was Judge Rehnquist, the Conservative. And what did he say, he said two things. First of all, State medical societies have the right to self-regulate, he said. More interestingly, he said, “What this is going to lead to is awful. This is going to lead to commercials that tell you to ask your doctor now.”

So he was, has this very prescient sense of what was going to happen. And the other thing he said is that there is an enormous public interest at stake when the consumption of, of prescription drugs is sort of the first response to every medical condition we have. He said, “And we’ve really got to watch out for that.”

HEFFNER: What about the doctors themselves?

CRITSER: MmmHmm.

HEFFNER: Must be a source of enormous pressure …

CRITSER: MmmHmm.

HEFFNER: … to have all of this advertising … use this product, ask your doctor …

CRITSER: MmmHmm.

HEFFNER: And I know that patients do ask their doctors and I gather that doctors are kind of reluctant to stand up against this push.

CRITSER: Sure. And, and what I think you’ve got to understand is what’s the background of the modern doctor. He and she are not in that godlike position they were when we were kids. Where you went to the doctor and you asked for …got “the word” … and this is what you did, right?

Now there’s a whole bunch of people behind the scenes at managed care, at HMOs, etc., etc., who are saying “Oh, by the way, doctor, we’d like you to see 30 people today.” Not 10 people, 30 people. “By the way, doctor, we … if you prescribe that drug, we want you to double check with us about that. Okay?”

So enormous pressure to economize and drugs in a sense, are one way that managed care makes money. Okay. People say, when I say that people ask, “What do you mean?”

A good example is Prozac. Prozac is the first indicated line of treatment by every major managed care company if you’re diagnosed with depression. In other words, the doctor says, you go to the doctor, he gives you this little test called the HamD test and he says, “Well, you’re depressed. Now let me look at your insurance. You should be taking Prozac.”

That’s a vast difference from 20, 25 years ago, when the first …the default was to send someone to therapy for more extended, monitored care. So in that way, managed care companies make an enormous amount of money because of their inclinations to use pharmaceuticals first.

HEFFNER: And doctors reaction to this directive, because it is essentially a directive.

CRITSER: They don’t like it, but there’s not a lot they can do about it. I mean on the one hand there’s, there … part of it is a blessing. That is to say, you advertise a drug directly to patients and you do get a patient that is a little more engaged. I mean that he’s not … he or she is not just saying “Cure me”. They’re saying, “Well what about this?”

So in that sense, if it makes the doctor uncomfortable; I don’t think that such a bad thing. I think that patients should be free to engage with the physician about their treatment. I think what they feel the pressure is, however, that, more and more people expect a prescription at the end of every treatment. It’s almost it’s like a narrative, it’s a … it’s like a narrative that goes on between the patient and the physician and they expect there to be a prescription.

And I think that combination of the advertising and the expectation that they’ll be some kind of prescription or “cure” at the end of it, is, is what is kind of driving enormous pharmaceutical drug use today.

HEFFNER: Do you have some feeling that we don’t have better living through chemistry?

CRITSER: Yeah, I do. You know, I get asked this a lot, and I get … asked a lot by the alternative medicine community because they’re against all drugs and they assume that I am, too. And I’m not. I think that, that the pharmaceutical companies have come up with some remarkable new drugs. I just don’t think they’re in the areas where they’ve been … that they’ve been marketing them. What you tend to see is a lot of the focus is on chronic disease. Okay? Everything from, from gastroesphagial reflux disease to erectile dysfunction to depression to attention deficit disorder … a wide range of seriousness. Some of them are quite serious, some are not.

The drugs for almost all of these conditions have not been break-through drugs. They’ve been incremental improvements. And if you look at their safety record and their efficacy record, they’re nothing to really brag about. Depression is a good example. Paxil is a good example, right? It’s a so-called “selective seratonin re-uptake inhibitor.”

Let me tell you something, it’s not selective. If you look at the data. And it doesn’t just affect seratonin. It affects a lot of other brain chemicals. The consequence is a lot of side effects and adverse effects that we’re only finding out now.

The FDA just ordered Paxil last year, along with other SSRIs to warn parents that if its used with children to watch out for suicidal thoughts and suicidal actions.

HEFFNER: But now where does this lead you in terms of your concerns about direct company … pharmaceutical company to consumer advertising?

CRITSER: Yeah. My, my thought and if I were going to be … I were in charge, pressing buttons and controlling the world, would be to say, “Tell the drug companies you know you really shouldn’t advertise a new product that you’ve only been tried out on maybe three thousand people to 50 million people until it’s been out in the market for a couple of years.”

HEFFNER: Isn’t that the business of the Drug Administration?

CRITSER: Actually, it’s not. No. What, what most people don’t know is that, you know, commercial speech is protected. Commercial speech has almost as much protection … that is to say Constitutional protection … as does so-called political speech. And in fact the … there is an entire industry in Washington, DC … legal consultants and largely Conservative activist groups … who spent a lot of time and money lobbying and filing court cases to make sure that commercial speech receives all the protection that political speech does. So there’s not a lot the FDA can do.

Unless they start to make claims that are … that aren’t supported by the label, the FDA has some statutory imprimatur in the area of label claims.

HEFFNER: What was the point at which this business began? The direct to consumer advertising?

CRITSER: It’s, it’s really ….

HEFFNER: Just Ralph Nader’s …

CRITSER: No. No. I mean what’s interesting is that, that there was enormous resistance by the pharmaceutical companies.
The pharmaceutical companies in 1983 … there was a, there was a Senate or a House hearing and they were all … all of the CEOs were asked to write a letter to the, to I think it was Billy Townsend at the time, or it was Charlie Rangel … I can’t remember who it was. But, but anyway, their point was, “What do you think of “DT” … direct to consumer advertising?

And the CEOs of every one of these companies wrote back, “That is an awful idea because it will not only fuel over prescription, interfere with the patients relationship with the doctor and it will distract our R&D, research and development, efforts into marketing rather than into R&D. They all said that … 20 years ago.

HEFFNER: What happened?

CRITSER: And that was because … you have to remember the nature of the pharmaceutical CEO has changed dramatically in the last 25 years. It used to be somebody that had some scientific or medical background.

Today they’re all marketing people. But these were kind of the … the last of the old guard and they were saying, “Oh, wait a minute, that just doesn’t feel right, you know. They’re going to talk bad about us at the country club if we do that.”

And so, so what happened the cudgel was really picked up by Madison Avenue and by the broadcast networks. And because they were dying for pharmaceutical advertising. They were seeing these two page things in Newsweek for, for whatever the drug was and saying, “Why don’t we have that?”.

And the reason was that the FDA had requirements to have a very long, three to five minutes, sometimes label readout over the air. And of course, no one was going to buy five minutes of air time for, for a prescription drug ad. And so it was the, it was the broadcast networks who funded very Conservative legal organization and, and advocacy groups in Washington, DC to sue the FDA and force the FDA to rescind the so-called “brief summary” requirement.

And the year that happened, 1996, all of the champagne corks were popping on Madison Avenue and at the broadcast networks, because they knew it was going to be a billion dollar incoming of money.

HEFFNER: Now you feel that changed our lives.

CRITSER: I absolutely do. And I think that it did this a lot of different ways. But I think the main way that it affects our lives is that it sets our default in terms of medical conditions and treating medical conditions at the level of pills. And using pills and lotions rather than in seeing medical care and sometimes long-term medical care that requires a lot of oversight, lifestyle modification, things that aren’t as easy to do.

HEFFNER: That you must get … that attitude you must get from your book on how damn fat we are.

CRITSER: You know … laughter … there were a lot of people who didn’t like that. It was funny … I got a lot of letters from fat people. And they were all pretty supportive. And then there kind of the fat-advocacy organizations, that, that claim that any time you make a statement about how unhealthy fat is, you’re discriminating against fat people … which, of course, is, I think, nonsense.

But yeah I did get a lot of guff for that. But, you know, my feeling is, is that what I’m trying to do with my book is … yes, I definitely point a lot of fingers but there’s, there’s a commonality between the two.

They’re both talking about the expansion of appetite in an affluent society. And what happens. And I, I believe that if you understand where these different influences originated, how they started. How their original intents were kind of twisted, that you can start to understand why, why it’s so easy for you to (a) over eat or (b) take that pill. And start to ask yourself, “how can I counter program?” Because that’s really what, what the individual has to do. Yes. I think there are substantial political and government initiatives that can be done. But ultimately I’m always looking at … if you can understand this well enough … “what can I do a little bit differently myself?”

HEFFNER: And where are the doctors?

CRITSER: There are … you know, I don’t think it’s a very sexy life being a doctor … (laughter) … I think it’s a very tough life. And I think they’re all, I think they’re all stressed out for one thing. They’re tired of being told what to do by managed care. But they don’t see any alternatives. They really don’t. And so in terms of using drugs, in terms of using prescription drugs, the, the discussion about whether or not to prescribe, to be, to be more sober … prudent, etc., etc. that’s not even part of their discussion. They’re trying to get paid. And I don’t mean paid by prescription drugs, I just mean to make a decent living. I think it’s very difficult for a physician right now.

HEFFNER: Do you feel we’re being sucked into wanting, demanding more and more of these “do it quick” responses to anything we call an illness?

CRITSER: I think so. I think that, that if you look at the record … you know, these kind of dry statistical reports that the National Institute of Health puts out … from about 1955 to around 1980, 82, the average per capita household expenditure on prescription drugs was actually starting to drop. It was going down. The, the culture was starting to slowly evolve away from prescription drugs as the first alternative. We’ve since then seen it shoot up dramatically.

HEFFNER: Well, that’s in terms of dollars spent.

CRITSER: Yes.

HEFFNER: What about in terms of pills swallowed.

CRITSER: Yeah, clearly, there’s … we’re, we’re somewhere between … we were at around six prescriptions a year per capita, we are about 13 now. Obviously, some people don’t take any pills, but many, many people take several. I believe the number, the percentage of people over 65 taking more than three drugs has more than doubled.

HEFFNER: All right. Now, you’re a journalist and you’re very much concerned about this, as you were very much concerned about how fat we’ve gotten …

CRITSER: Right.

HEFFNER: … as a people. The medical profession, itself, has it at all mobilized in terms of the impact of these various …

CRITSER: These forces?

HEFFNER: … evil things. Evil forces.

CRITSER: These forces? Not, really, no. I mean … you know, as I said, when you get at the clinical … if you want to talk to academics, they’ve got all kinds of ideas, right. And if you want to talk to public policy people in medicine, they’ve got a lot of ideas. I think you and I were talking before this about Bob Goodman and “no free lunch”. That’s an activist organization of mainly one very dedicated physician pointing out to the rest of his profession that they shouldn’t be taking anything free from the drug companies. It’s fundamentally a conflict of interest. And its driving over-prescription.

That’s a wonderful organization, a great message. He’s having a very tough time even going to regular medical association meetings. He’s have a tough time getting a little information booth because there’s such an enormous pressure … economic pressure, by drug companies not to let that discussion into the box.

HEFFNER: Do you think he’s right?

CRITSER: Yeah, I do. I think that, that … I think he’s an idealist (a) …

HEFFNER: Good. We need them.

CRITSER: … and I think he’s right. The question is, “is it practical”? You talk to a medical student today who’s got those … he or she’s got a young family, they’ve got enormous bills, they got enormous bills coming out of undergrad … right … and then they’ve got these enormous bills that they’re taking loans on now. It’s very hard to tell that guy, “You know what, you should pay for your own stethoscope. You should pay for your own … You should pay for your own continuing medical education while you’re paying off these bills and listening to these managed care guy telling you how to run your, your medical business.” Very hard to tell him something like that. Nevertheless, I think that guys like Goodman are right. At the clinical level … I think in particularly the physician has got to make a concerted effort to be as distinct of an entity from the drug company as possible.

Now, one person will say … “Does that mean you shouldn’t take … they shouldn’t take free samples?” I think that’s a legitimate discussion because we know one thing that free samples does. On the one hand, we know that it can get to a few poor people, who can’t afford it. Right? We also know that it will fuel over-prescription. That you’re more … that a physician who is handing out free samples generally tends to write more prescriptions than one who doesn’t.

HEFFNER: I gather, too, the statistics indicate that the physicians who go on the junkets that the drug companies offer tend to write the … their prescriptions for the drugs those particular drug companies produce.

CRITSER: That’s right. There’s no doubt it works. Okay. I mean junkets work just like advertising works. That what works, that’s why they do it. You’re seeing a little less of that at least at the most crude level, you know you used to see a lot of it. Now, now they’re very circumspect about it because there’s been a couple of lawsuits … Pfizer, for example, I think lost about a half a billion dollar lawsuit over the drug Neurontin which is an anti-epileptic and which the company it had acquired had illegally … really illegally marketed.

HEFFNER: Okay. Now there are many people who say there are pluses to this whole business. There are pluses in terms of educating doctors to what’s available. There are pluses, not just in terms of giving them pens and pencils and pads of paper and buying them pizzas, etc. The payoff though is … supposedly comes in the incredible amount of good drugs that are produced …

CRITSER: Right.

HEFFNER: … for us. Now where are you?

CRITSER: That’s right. And where are they? Between 1990 and 2002 … 1,050 new drugs were approved. Fifty percent were considered having clinical significance … clinically significant improvement. The rest of them … in the FDA’s own words, and the industry’s own words, when you really look at their words, is that half of those new drugs were not clinically significant in the improvements.

HEFFNER: What about the other half?

CRITSER: I think …

HEFFNER: Does it make it all worthwhile? You don’t think so.

CRITSER: I don’t think so. And this is why. I think … and people say, “Well what do you want then?” This is a classic case of “What do you want, Greg?” And what I say is we need fewer, better drugs. In other words we need better drugs and we need fewer drugs. And what do I mean by that? We need to have, not just incremental improvements in chronic disease drugs, we need big breakthroughs and that does take time.

We also need breakthroughs in acute care, infectious care and in conditions like cancer, rheumatoid arthritis, Parkinson’s, Alzheimer’s …

HEFFNER: But is what the drug companies are doing now …

CRITSER: MmmHmm.

HEFFNER: Does it stand in the way of the kinds of things you think they ought to be doing.

CRITSER: Yeah. I mean, I’ll just … you know … those, those CEOs back in 1983 who testified said it all. If we do direct to consumer advertising, we’re going to be diverting a whole bunch of money into marketing and advertising that we could put in R&D. And you remember, a lot … if you read the Senate and the House Hearings about the deregulation of pharmaceutical drugs, etc., etc. a lot of it was predicated on the notion that there would be these big breakthroughs in the area of cancer, in the area of rheumatoid arthritis, Alzheimer’s and we haven’t seen those. We’ve seen a few, but in generally speaking, we haven’t seen those breakthroughs.

HEFFNER: You mean it isn’t a matter of big profits, therefore big breakthroughs.

CRITSER: No. It’s not. It, it has to do with leadership.

HEFFNER: Leadership?

CRITSER: Leadership from the CEOs. And I believe. If you look, for example, at Merck …you know, Merck is really, unfortunately taking quite a pasting these days because of what happened with Vioxx. If you look at Merck in the eighties when it was run by a guy named P. Roy Vagelos who was a physician. It was a completely different company. It was a company that was very much driven by science and research. Marketing was, of course, important, but, but by having the head guy be a medical man, who understood the imperatives of research and development, you had a much more finely honed company that was more focused on the breakthrough drugs.

And, indeed, if you look today … the other day … they’re debating this … above the fold in the New York Times … Zocor versus Lipitor, right. Zocor is based … is a Merck product and its going to go off patent and its going to be 28 cents a pill. That is a breakthrough that came … fifty years ago at Merck. It was finally put together in the eighties by Vagelos and launched in the mid-eighties. They’re still fighting over chemical breakthroughs a half a century ago.

What these companies need to be doing is focusing much more on human genome, on drugs that are more focused on the individuality of the pill taker. We know that about … there’s 60 percent variance in the way different people clear drugs in their bodies. So instead of launching these kind of blockbuster drugs, they need to be … they need to become companies that launch a lot of independent art films …

HEFFNER: You’re not going to get what you want, are you?

CRITSER: I don’t think so. Not in the short term.

HEFFNER: Did you get what you wanted in terms of the other book … we just have a minute or so left …

CRITSER: Well, there was enormous response to obesity as a health issue … and that’s what I wanted … sure.

HEFFNER: Do you think there will be response …

CRITSER: Yes.

HEFFNER: … to the questions you raise here?

CRITSER: Yes, because voters … I mean disproportionately people over 65 vote. They’re engaged with the pharmaceutical issue. They are tired of having five or six pills up on that … in that counter and not knowing what half of them are for …

HEFFNER: Seven.

CRITSER: Seven … and not knowing what happened … what they’re for … and having side affects that no one knows anything about. I think they are and will … will and are … rise up and demand change.

HEFFNER: I’ll tell you one thing as we end the program and I thank you for joining me today. Your book in many ways scared the hell out of me in terms of the potential for damage …

CRITSER: MmmHmm.

HEFFNER: … or unnecessary problems, except they’re necessary to the bottom line of the drug companies which makes both of us kind of doubting as to whether …

CRITSER: (Laughter)

HEFFNER: … there will be change.

CRITSER: Yes.

HEFFNER: Thank you for joining me. Thank you for writing “Generation Rx”.

CRITSER: Thank you.

HEFFNER: And thanks, too, to you in the audience. I hope you join us again next time, and if you would like a transcript of today’s program, please send $4.00 in check or money order to The Open Mind, P. O. Box 7977, FDR Station, New York, New York 10150.

Meanwhile, as an old friend used to say, “Good night and good luck.”

N.B. Every effort has been made to ensure the accuracy of this transcript. It may not, however, be a verbatim copy of the program.