PHIL PONCE: Two of the nation's leading diet drugs--Redux and one half of the Phen Fen combination, Fenfluramine--have been pulled off the market. This comes amid growing evidence linking the drugs to potentially fatal heart and lung disorders. Fenfluramine had been around for decades as a Food & Drug Administration approved weight loss medication. But in the early 90's a study showed it was most effective when taken together with another drug called Phentermine. A combination of those two appetite suppressants, Phen Fen started a new diet craze for a drug combination that was not yet sanctioned by the FDA.
AD SPOKESPERSON: Everyone's looking for a magic pill to help control their weight.
WOMAN IN AD: Give it to me; I'll buy it.
PHIL PONCE: All over the country Phen Fen was hailed as the magic bullet. In 1996, the chemically related drug, Redux, came on the market. That year, according to the FDA, 18 million prescriptions were written for the drugs. Even commercial diet centers that once thrived on selling packaged foods jumped on the bandwagon. But some people started having problems. Joanne Dignan had been taking Phen Fen for a month when she developed the potentially fatal and incurable disease known as primary pulmonary hypertension. The blood pressure in her lungs skyrocketed five to six times beyond normal.
JOANNE DIGNAN: I couldn't breathe right--you know--I couldn't get any air. I'd have to sit down and relax. And I thought God, I don't like those pills at all. I don't like what they did.
PHIL PONCE: Then researchers came across something else.
DR. HEIDI CONNOLLY, Cardiologist: Today my colleagues and I from the Mayo Clinic report a new clinical observation of a possible relationship between heart valve disease and Phen Fen.
PHIL PONCE: Last July, a report released by the Mayo Clinic found a highly unusual heart value defect in women who had taken the Phen Fen combination for an average of 12 months. In a healthy heart the valves fit tightly when closed, preventing blood from flowing backwards. But in hearts of the patients studied, a waxy substance prevented the valves from closing completely. Blood leaked back, forcing the hearts to pump too hard. Although this condition is extremely rare, within months these researchers had identified 24 previously healthy women with the disease. Then last month, after receiving additional reports of the dangerous valve disorder, the FDA said it would require the manufacturers of Phen Fen and Redux to provide tougher warning labels about the potential health risks. But recently, the agency asked the makers to take Fenfluramine, half of the Phen Fen combination, and Redux off the market altogether. This came after a new FDA review of 291 patients at five medical centers showed that 92 people had developed problems in their aortic or mitral heart valves. And today, the companies that make the drugs announced they would follow the FDA's recommendation to stop selling them.
PHIL PONCE: With us now is Dr. Arthur Frank, medical director of the George Washington University Obesity Management Program. Dr. Frank, do you think this was a necessary step to take?
DR. ARTHUR FRANK, George Washington University: Oh, yes, indeed. Yes, indeed. This is a potentially serious problem, and I think it has to be dealt with promptly and effectively. And I think that is exactly what the FDA and the pharmaceutical companies have done.
PHIL PONCE: So you're comfortable with the conclusion that this was a dangerous situation, these valve problems and this pulmonary hypertension?
DR. ARTHUR FRANK: Well, it's not so much a dangerous situation in that there's an immediate, life-threatening problem, but there is something that you have to be careful about, you have to be cautious about, you have to be attentive to, and it is reasonable to stop taking the medication.
PHIL PONCE: How did people know that there was a causal link between the drugs and some of the things that some people were experiencing?
DR. ARTHUR FRANK: This is an interesting observation on the part of some very thoughtful and very astute clinicians in North Dakota and at Mayo Clinic when they recognize that at least some of the patients who had developed serious problems were also taking the Fenfluramine, the medication Fenfluramine, and they started looking for an association with other patients who were taking Fenfluramine and with some assiduous effort, they identified a number of people who were taking Fenfluramine, and who did have these heart valve problems. The association was quite real and quite consistent.
PHIL PONCE: So even though some people would say that the study was not widespread in the sense that it was extensive and exhaustive, even so, there were enough links to raise these red flags?
DR. ARTHUR FRANK: Oh, absolutely, absolutely, even though it is not a carefully controlled clinical trial, there's no question of the association. It occurs--it appears to occur much more frequently than you would see randomly in a random population, or even in an obese, overweight population. It seems that these valve problems are occurring more often than they ought to be occurring.
PHIL PONCE: Dr. Frank, this combination of Fen Phen has been around since the early '90s. Why did it take so long for these problems to crop up? Is that just sort of a natural evolution in medicine?
DR. ARTHUR FRANK: Well, yes, it is a natural evolution of medicine. It's a natural evolution of scientific knowledge and thinking, but, in part, a lot of the patients who have the heart valve problems don't have any particular symptoms. They are not troubled by the symptoms of the heart valve abnormalities. And so what we're doing now is looking for it. The problem with this is that the method we have of looking for it involves what is called the echocardiogram. And this is not the kind of thing that you would have done in clinical trials.
PHIL PONCE: Very briefly, an echocardiogram is what?
DR. ARTHUR FRANK: It's a way of looking at the heart with sound waves. It's like a radar view of the heart, a sonogram of the heart, sound waves which measure and tell you about the movement of the cardiac valve. But doing an echocardiogram is not something that's done routinely. It would not be something that would have done routinely in the kinds of clinical trials that were studied in preparation for the approval of the medication. And it's only retrospectively that we go back, look at these kinds of things, do echocardiograms routinely, and now identify the problem, which is occurring much more often than it should have been occurring.
PHIL PONCE: Does the medical community have any solid idea of the numbers of people who are taking these drugs, how widespread the usage was?
DR. ARTHUR FRANK: No. We really don't have a good idea because we know how many prescriptions have been written, and there are a lot of prescriptions written, but we don't know how many individual patients that they're written for, and we don't know and understand how many patients are taking these medications in a continuous, consistent way, and how many patients are using them intermittently and occasionally. So we really don't have a good sense of the magnitude of the problem.
PHIL PONCE: Just because there were 18 million prescriptions written in 1996 doesn't mean that 18 million people used these drugs last year?
DR. ARTHUR FRANK: Right. Because, you know, a lot of those prescriptions are repeat prescriptions for people who are taking it continuously.
PHIL PONCE: Well, what about the people who use those drugs, what's their prognosis now? If 30 percent of the people in some of the samples had problems, does this mean 30 percent of all the people who use these drugs might be in trouble now?
DR. ARTHUR FRANK: It's possible. There "might be" is the important qualifier. We are hoping that we have identified this problem early enough so that there is a possibility and a real possibility that we might get some spontaneous--some resolution of the problem, that the problem might resolve spontaneously when the medication is discontinued. That's something we don't know. And perhaps many of these people will recover spontaneously just for the discontinuation of the medication. Some of these people will have serious and significant heart valve problems, which will go on and become progressive and need much more intensive and complex medical management.
PHIL PONCE: So if you're someone who's been taking these drugs for a period of time, even if it's been a few months or up to a year or two, then what do you need to do, anything--should be pretty worried about it?
DR. ARTHUR FRANK: Well, I think you need to be cautious about it. I think first you need to stop taking the medication and, second, I think you need to be in touch with your physician, the person who's prescribing the medication and to have this evaluated. What you need is some kind of medical evaluation, a physical examination, probably an echocardiogram, and then dealing with it, depending on what kinds of findings are uncovered in this kind of evaluation.
PHIL PONCE: You wouldn't necessarily know, would you, according to reports, if you had heart valve damage, or if you had this pulmonary hypertension, that's not necessarily something that you would necessarily feel, for example?
DR. ARTHUR FRANK: Well, one of the things we're hoping is that because we are now looking at it more carefully we're going to be identifying people before they have symptoms at an earlier stage when we hope that we can get a resolution of the problems simply with the discontinuation of the medication. That's a hope, but we really have no way of assessing that because we don't have any experience with it yet.
PHIL PONCE: Dr. Frank, were these drugs over prescribed? I mean, do too many people consider themselves as being "obese" or "overweight?"
DR. ARTHUR FRANK: Well, that's been one of the complications of it. Yes, there are some standards by which they ought properly to be prescribed, but there's been an enormous amount of commercial exploitation on the part of irresponsible people who have used this in a casual way in prescribing these medications for people who really don't have serious or significant medical problems associated with their obesity.
PHIL PONCE: Who really should be getting medication for obesity?
DR. ARTHUR FRANK: Well, the general rule of thumb is that if you're more than about 20 percent overweight, then it is reasonable to use these medications. And you recognize that the complications of obesity start becoming significant when you're more than about 20 percent overweight unless you have other kinds of medical problems like hypertension or diabetes, in which case you could justify it sooner. And I think that what we're saying here, what we're recognizing here is that a lot of people with very small amounts of excess weight are using this as a quick fix and using this as a magic medicine and as a way of solving the problem. It won't do that. It won't solve the problem. It won't make you stop eating. It won't cure the disease. It will help people who are struggling with the disease, but it's got to be a lot of effort on the part of the individual to deal with the complicated disease of obesity.
PHIL PONCE: Well, do you agree that this might call into question the effectiveness of using appetite suppressants over a long period of time?
DR. ARTHUR FRANK: Oh, I think that's one of the biggest problems--one of the problems that's going to emerge from this, is that we're going to throw the baby out with the bath water. We recognize that obesity medications can be helpful; that there are potentially many medications and many things that are in the process of development now which might very well be helpful but that people are going to be so terrified and so upset and so fearful of this that they will abandon all medications and say, no, that's not what I want to do. And I think it will cast a pall over the whole issue of using medications appropriately, reasonably, and thoughtfully for the management of this disease. It's a very difficult disease to manage. It's a very exasperating and very frustrating disease for patients who struggle mightily with the problem. And to the extent that we can give them anything that can be helpful that is to be--that is what we hope for. And now along comes this, which makes us discouraged once again, but we still have the opportunity to use medications with other medications and with future things that are being developed.
PHIL PONCE: And with that, Dr. Frank, I thank you.
DR. ARTHUR FRANK: Thank you.