BETTY ANN BOWSER: For nearly three years now, Steve Kelly has made a monthly pilgrimage from his home in southern New Jersey to the Obesity Research Center at St. Luke's Hospital in Manhattan. First stop: The scales of dietician Carla Wolper.
STEVE KELLY: Now, remember, take 20 pounds off for clothes (laughing).
BETTY ANN BOWSER: Wolper gives Kelly a five-pound allowance, and he tips the scales at just under three hundred pounds.
STEVE KELLY: Two hundred ninety-nine.
CARLA WOLPER: Good, excellent.
BETTY ANN BOWSER: Kelly is still one hundred pounds overweight but that's a far cry from where he began, at 450 pounds.
BETTY ANN BOWSER: Oh, you look so different.
STEVE KELLY: This is November of '94. You know, it was very, very hurtful. It was a big handicap, being 450 pounds. I would walk out of my office and walk down the street, and people actually laughed at how, you know, how hard it was for me to get down the street, my jiggle in my stomach.
BETTY ANN BOWSER: You mean, people would stare at you?
STEVE KELLY: Sure. Would actually point and laugh, "Look at the fat man."
BETTY ANN BOWSER: After trying just about everything to lose weight, Kelly heard about a drug called Fen-Phen --actually a combination of two appetite suppressants: Fenfluramine and Phentermine. The two have been around for decades as individually FDA-approved weight loss medications. But in the early 90's a study showed they were more effective when taken together. Suddenly a new diet craze was underway--a craze for a drug combination that even today is not sanctioned by the FDA. Dr. Michael Friedman is the agency's acting commissioner.
DR. MICHAEL FRIEDMAN, Acting Commissioner, FDA: In the United States, once a product is approved for one indication, then a properly licensed physician may use it in any way that he or she thinks is medically appropriate. That's medical standard of care, if you will.
BETTY ANN BOWSER: Do you think most people have any idea that Fen-Phen is not an approved FDA protocol?
DR. MICHAEL FRIEDMAN: I don't know the answer to that. The individual products have been reviewed by the FDA. This combination has not been reviewed by the FDA.
AD SPOKESMAN: (Nutrisystem Ad) Everyone's looking for a magic pill to help control their weight.
WOMAN IN AD: Give it to me. I'll buy it.
BETTY ANN BOWSER: All over the country ads hailed Fen-Phen as a magic bullet. Even commercial diet centers that once thrived on selling packaged low-calorie foods have jumped on the bandwagon. Steve Kelly is something of a walking Fen-Phen ad himself.
STEVE KELLY: The Fen-Phen helped to change my lifestyle so that I wasn't eating fast food all the time. It's a really effective appetite suppressant.
BETTY ANN BOWSER: And now that you're off of it are you hungrier?
STEVE KELLY: Yes, I am hungrier. But I've had two years to learn, and that's the most important thing about Fen-Phen; it gives you the chance to learn how to eat again, a new way of eating.
BETTY ANN BOWSER: But for some people Fen-Phen has a dark side. Joanne Dignan had keen taking it for a month when she developed an incurable, potentially fatal disease known as primary pulmonary hypertension, or PPH. The blood pressure in her lungs skyrocketed, five or six times beyond normal.
JOANNE DIGNAN: I don't know how to explain it but it was just like something was sitting there. And I couldn't breathe right, you know, I couldn't get any air. I'd have to sit down and relax. I thought "God, I don't like those pills at all. I don't like what they did."
BETTY ANN BOWSER: Eventually, Dignan's over-stressed heart began to fail. If left untreated, she'd have about one year to live. On the day we met her at the University of Maryland Medical Center in Baltimore, she was having a special catheter implanted in her chest to continuously deliver a medication that might prolong her life. Dr. Lewis Rubin is chief of pulmonary medicine and critical care.
DR. LEWIS RUBIN, Pulmonologist: She is, unfortunately, because of her weight, not a candidate for transplantation. And certainly her weight is taxing her heart even more. She's taken all these medications, she's still terribly heavy, but now she's lost the gamble.
BETTY ANN BOWSER: Dr. Rubin is part of a team that has linked PPH to appetite suppressants--not just Fen-Phen, but also a new drug, called Redux, approved last year by the FDA. Redux is almost identical to Fenfluramine, one of the two Fen-Phen drugs. In the general population, one or two people per million will develop PPH. But Rubin's research team found that people who took Fen-Phen or Redux for three months had a nine-fold increased risk for PPH. Six-month users had a 23-fold increased risk. To Dr. Rubin these findings suggest an alarming trend.
DR. LEWIS RUBIN: Does the risk go up from three months to six months and then continue to go up with a year's use? If that's the case, then we're in for a lot more cases.
JOANNE DIGNAN: What am I going to do now? It's too late for me. You know, I'm useless to my family. (crying) I can't play with my daughter anymore. It's like I'm worthless and useless. And I feel like I'm running out of air, and I can't--it took everything from me.
BETTY ANN BOWSER: And do you blame the drug for all of this?
JO ANNE DIGNAN: I blame the drug for it. And I think that they should ban the drug. I really think they should ban all of them, all the diet pills.
BETTY ANN BOWSER: Dignan is one of millions of Americans who've taken Fen-Phen. But Redux is rapidly catching up in popularity. Dr. Richard Wurtman is an MIT professor who helped develop Redux and still holds the patent on it. Although he does not defend Fen-Phen, he says the benefits of Redux outweigh any risk factors.
DR. RICHARD WURTMAN, Redux Developer: There are eight to ten million Americans who have adult onset diabetes and who are obese, who are going to lose their limbs or their eyes or their hearts or their lives if we don't weight off them now. At this point it's clear there is no epidemic of PPH out there that can be associated with the drug. So I'm frankly upset about the fact that the scare-mongering about non-existent side effects of Redux has kept a lot of people who really need this drug from taking it.
BETTY ANN BOWSER: The Redux package insert does say this drug should be given to people who are at least 30 percent overweight. And both Redux and Fenfluramine are labeled for the risk of PPH. But as critics point out, some doctors and diet clinics market appetite suppressants not just to the medically obese, but to anyone who'd like to lose a few pounds. Dr. Rubin says one out of four patients he treats for diet-drug related PPH are minimally, if at all, overweight.
DR. LEWIS RUBIN: There's no magic bullet. But there is Russian roulette. And Russian roulette is taking pills that have a substantial and to some extent not fully quantified risk when the benefits are cosmetic.
BETTY ANN BOWSER: And now there's a new concern about Fen-Phen, beyond the risk for PPH.
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 Fen-Phen.
BETTY ANN BOWSER: In July, Dr. Heidi Connolly reported finding a highly unusual heart valve defect in women who've been taking Fenfluramine and Phentermine for an average of 12 months. In a healthy heart the valves fit tightly when closed, preventing blood from flowing backwards. But in the hearts of the patients studied, a waxy substance prevented the valves from closing completely. Blood leaked back, forcing the hearts to pump too hard. This condition is extremely rare. But within months, these researchers had identified 24 previously healthy women with the disease.
DR. HEIDI CONNOLLY: None of the patients have died. However, many have developed serious cardiovascular diseases requiring either medication or surgery. To date, five of these patients have required open heart surgery to repair or replace damaged, leaking heart valves.
BETTY ANN BOWSER: On the day of the Mayo Clinic press conference, the FDA issued a "Dear Doctor" letter warning of Fen-Phen's possible risk for heart valve disease and asking health care professionals to report any similar cases associated with the use of Redux. The letter reminds doctors that the FDA has never approved the Fen-Phen combination.
DR. MICHAEL FRIEDMAN: If someone uses a particular treatment in a way other than the labeled indication, they should recognize that they're moving into an area of less precise information.
BETTY ANN BOWSER: This is a drug that's got a lot of problems. Should it just be an attitude on the part of the American consumer --buyer beware?
DR. MICHAEL FRIEDMAN: I think I would state is differently. This is an area for informed choice. If an individual has a serious medical condition or is seriously overweight and must lose weight, and these products help with the overall health picture of that individual, then it may be the right choice.
BETTY ANN BOWSER: In other words, the FDA recommends balancing the risks of obesity against those of appetite suppressants. But, according to Dr. Mark Molliver; both Fen-Phen and Redux may pose an additional risk not found in any FDA warnings. Molliver is a neuroscientist at Johns Hopkins University who's studied the effect of appetite suppressants on rat brains At recommended doses, both Redux and Fenfluramine cause a natural mood and appetite controller, called serotonin, to be released from certain nerve cells--this messy tangle of white from a rat's cerebral cortex. The problem is, at higher than recommended doses, the brain is flooded with serotonin, and the nerve cells being to die.
DR. MARK MOLLIVER, Neuroscientist: And this is after Redux. This is the abnormal, showing that there's a big loss of serotonin nerve fibers.
BETTY ANN BOWSER: Is there any question in your mind that these drugs are
DR. MARK MOLLIVER: There's no question that they are dangerous. The danger is dose related. Generally we like to have a big margin of safety, so that perhaps you can give 100 times the recommended dose before you have a toxic effect. In fact with Fenfluramine or with Redux, we see the clear cut toxic effect at doses two, three, or four times the recommended dose.
BETTY ANN BOWSER: Dr. Molliver tried, unsuccessfully, to get the FDA to put a warning about neurotoxicity on the Redux package insert. Dr. Wurtman, who opposed that effort, says Dr. Molliver's findings are irrelevant to people.
DR. WURTMAN: All this shows is that, yes, it is possible to deplete--to remove all the serotonin if you give Redux at absolutely crazy doses. But fortunately we have an immense backlog of studies on humans, okay? Where are the people with signs that their brains aren't functioning properly: There aren't any. I would say the clinical evidence is this is one of the safest drugs to come along in a long time.
BETTY ANN BOWSER: One of the safest, or a dangerous game of Russian roulette? Whichever side you come down on in that argument, there's another aspect to this debate: how well do these drugs really work? As dietitian Carla Wolper points out--
CARLA WOLPER, Dietician: For some people the effect of the drug wears off very quickly. And other people can last a little bit longer. But in the very beginning it can be very intense, and then it fades.
BETTY ANN BOWSER: We asked a group of dieters about that phenomenon--all of them now enrolled in a weight loss program at New York's St. Luke's Roosevelt Medical Center, where appetite suppressants are strongly discouraged.
TONY SEIDERMAN: I lost a lot of weight very quickly and gained it back as soon as I went off the drug.
ESTELLE GLASGOW: I didn't lose very much weight, and as soon as I stopped I put it back on.
DONNA HERMAN: I would start taking it, and it would be great, and then after a while, the effectiveness would go away.
BETTY ANN BOWSER: Only Tina Jessee, who's lost 70 pounds since January, has never taken appetite suppressants.
BETTY ANN BOWSER: Tina, what works for you?
TINA JESSEE: Diet and exercise.
BETTY ANN BOWSER: It's pretty basic stuff.
TINA JESSEE: Yes.
BETTY ANN BOWSER: That's what Steve Kelly's relying on now--along with a palm top computer programmed with calorie counts for 4,000 different foods. He uses it to record everything he eats as he struggles to keep off the weight he lost on Fen-Phen.
BETTY ANN BOWSER: What have you had today so far, for example?
STEVE KELLY: Well, today is not a good example (laughing). Today we had to leave at 8:00 to get here.
BETTY ANN BOWSER: I see.
STEVE KELLY: And I stopped at McDonald's and had an Egg McMuffin and a hash brown.
BETTY ANN BOWSER: You're cheating?
STEVE KELLY: No, not really. You know, you can eat anything you want, just as long as you eat within a certain calorie limit.
BETTY ANN BOWSER: You still love to eat?
STEVE KELLY: Sure..
BETTY ANN BOWSER: And do you think that will ever change?
STEVE KELLY: No. It won't change.
BETTY ANN BOWSER: But over the past three years he's developed strategies to deal with his love of food that he hopes will see him through losing the next 100 pounds. Unfortunately, the odds are against him. Studies show that, with or without drugs, the overwhelming majority of people who lose weight on a diet gain it back within five years.