ELIZABETH FARNSWORTH: Margaret Warner has more on the latest developments in this story.
MARGARET WARNER: Today, the Food & Drug Administration said it would require the manufacturers of Fen-Phen and Redux to provide tougher warning labels about the potential risk of these drugs. Also today, the New England Journal of Medicine published the results of the Mayo Clinic study we just saw on the link between Fen-Phen and heart valve disease. And this afternoon, Wyeth-Ayers, the company that makes both Fenfluramine and Redux said it will work both the FDA and medical research centers like Mayo to study the issue further. With us now is the acting FDA Commissioner, Dr. Michael Friedman, whom we just saw in the taped piece. Welcome live, Dr. Friedman.
DR. MICHAEL FRIEDMAN, Acting Commissioner, FDA: Thank you.
MARGARET WARNER: Why is the FDA taking this step now?
DR. MICHAEL FRIEDMAN: In July, when we first issued the health advisory, we asked physicians to please send us more information about patients who may have suffered these toxicities. We've received since that time more than 50 additional cases and believe that more cases will be reported to us. Based upon a preliminary review of that information and the previous information that you've just mentioned, we felt it was very important to reiterate and to clarify the warnings so that physicians would know best how to use these medications and so patients would understand what options they have.
MARGARET WARNER: All right. And it's the study that you were following up on, and you got the 58 new cases--involved dangers of heart valve disease, which is one of the things we saw.
DR. MICHAEL FRIEDMAN: That's correct.
MARGARET WARNER: Are the new tougher warnings also going to talk about the pulmonary disease that we saw?
DR. MICHAEL FRIEDMAN: They certainly will remind physicians that the pulmonary disease is a real possibility, so we envision that both of these warnings will be included in a way that will be understandable for physicians to help counseling patients, but in addition to that to provide the patients with readable, understandable information sheets that outline these and other sorts of toxicities.
MARGARET WARNER: All right. How many Americans do you think are taking one of these drugs?
DR. MICHAEL FRIEDMAN: We don't have precise figures. We know that some 18 million prescriptions were written in 1996.
MARGARET WARNER: For--
DR. MICHAEL FRIEDMAN: For these drugs.
MARGARET WARNER: The Fen-Phen and the Redux?
DR. MICHAEL FRIEDMAN: And the Phentermine. So all three of these medications have been widely prescribed in the United States. We don't have good information about the number of patients who are currently taking the medicines, but we're gathering some of that information.
MARGARET WARNER: Now, given everything we just saw, these three different potential dangers, why not just ban these drugs outright, or as the New England Journal editorialized today, at least impose a moratorium on them?
DR. MICHAEL FRIEDMAN: It's very important to note that when these drugs are used in accordance with the labeled instructions, the number of side effects from pulmonary hypertension or from the valve abnormality are extremely rare. When these medications are used outside of those labeled indications at a higher dosage, for a longer period of time, or in combination with one another, then these side effects are seen more frequently. We're looking very intently at this. We're gathering information to determine which populations might be particularly sensitive to these side effects, which populations might be helped most by these medications. But we've had very few, if any, valve abnormalities in patients who have used the products in an appropriately-labeled fashion. Even in the label indication it says to use these medications only for a short period of time, some few weeks, and in conjunction with dietary restrictions.
MARGARET WARNER: But we saw--the graph showed that even some patients who'd used it a very short time had increased risk of this pulmonary hypertension.
DR. MICHAEL FRIEDMAN: That's correct. There is an increased risk from pulmonary hypertension. We recommend that patients and physicians think very carefully about these serious and sometimes irreversible side effects and decide whether the medical value of losing weight is part of an overall program may be of such benefit to that patient that the patient and the physician choose this course of action in an informed, thoughtful way.
MARGARET WARNER: So do you think the use of diet drugs in this country has gotten out of hand?
DR. MICHAEL FRIEDMAN: Well, to the extent that there are patients who don't meet the standards that have been described for Dux Fenfluramine, Redux, we know that some patients have been treated who don't--who are not excessively obese, who do not have heart disease, or diabetes or hypertension, and we think it's inappropriate for those patients to be receiving that medication.
MARGARET WARNER: But given society's obsession with thinness, do you--what makes you think that patients who go to their doctors and say for cosmetic reasons they want to lose ten pounds, fifteen pounds, are going to be essentially frightened away by these warnings?
DR. MICHAEL FRIEDMAN: I think we depend upon the informed view of patients and physicians to make these sort of choices. I think that there may be better ways we can predict which patients may be at higher risk. We want to certainly look at that. But in the meantime we know that these treatments have relatively limited value in the label indications; in the label package insert for these medications, it said that these have limited value and only in conjunction with caloric restriction. In that way we think it can be valuable.
MARGARET WARNER: So you do think there's a tradeoff here?
DR. MICHAEL FRIEDMAN: There's absolutely a tradeoff, and each individual patient and physician needs to best decide.
MARGARET WARNER: All right. Well, thank you, Dr. Friedman, very much.
DR. MICHAEL FRIEDMAN: Thank you.