Is New Diet Pill a Magic Bullet?

The Food and Drug Administration approves the first non-prescription diet pill. It's half the dose of the drug Xenical that's already available through a doctor. Taken about an hour before meals, it prevents the body from absorbing some of the fat in food.

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NEAL CONAN, host:

Right now, the Food and Drug Administration yesterday approved the first non-prescription diet pill. It's called Alli. It's a half dose of the drug Xenical, which is currently available through a doctor by prescription. Taken about an hour before meals, the drug prevents you from absorbing some of the fat in the food that you eat. But there are side effects.

If you have questions about Alli, about what this new drug is, how it works, our number is 800-989-8255, that's 800-989-TALK. E-mail is talk@npr.org. In a few minutes, we'll talk with a doctor who's prescribed this to some of her patients. But first, NPR's Joanne Silberner joins us here in Studio 3A. It's nice to have you on the program, Joanne.

JOANNE SILBERNER: Nice to be here, Neal.

CONAN: And the manufacturer says it will be available this summer at the price of about $2 a day, so let's start with the big question. Is this the magic bullet?

SILBERNER: Well, that's an easy one - no. You can't just take this pill and eat whatever you want. Even the manufacturer says that. You must also be on a relatively low fat diet. And you must also exercise.

CONAN: And there are those side effects.

SILBERNER: Especially if you don't keep to a little fat diet, because what this pill does, it prevents you from absorbing some of the fat. That disturbs the GI System. There's a little bit of extra fat going through there. I think the nicest way to say this is it commonly causes fecal incontinence. So the better you stick to a low fat diet, the fewer side effects you'll have. And you know, you've got to exercise as well.

The side effects don't seem to be that serious. There have been some questions raised about long-term use in possible cancer, but I don't think that that's really been seen yet, clearly. Right now the issue is comfort.

CONAN: And you talked about the GI System, the gastro-intestinal system. You're guts, basically.

SILBERNER: Your guts.

CONAN: Okay. Now, if there are other products in drug stores that claimed to be for weight loss as well, what's the difference between them and this?

SILBERNER: The FDA approval. The FDA, by an act of Congress, cannot really get involved in dietary supplements. It doesn't, you know - unless they are really bad in killing people, the FDA basically has to sit back and let those products be sold. This product is being sold as a medicine, so the FDA got involved. It looked at the data and decided to approve it. So it is the first product to be approved by the FDA for over-the-counter sale.

CONAN: And there has been a history of some problems with weight-loss drugs. We all remember the combination known as phen-fen, which had to be taken off the market several years ago. How safe is this drug?

SILBERNER: Well, you know, that's a great question, because with any drug you take you have to consider the risks and the benefits. So far the risks don't seem to be great. You know, there are some people saying there might be a chance of cancer. Not really been seen yet.

The risk of obesity is high. Everybody knows that. The ways to lose weight? You have choices. There are other ways to lose weight. Should you risk this? You know, you know that you can be risking the gastro-intestinal side effects. Are you risking anything more? Not clear. It's always a balance.

CONAN: Let's get some help now with some of the specific medical questions about Alli. Joining us is Jana Clower(ph). She's a weight nutrition expert in New York City and joins us from her office in Manhattan by phone. Thanks very much for taking the time to be with us today.

Ms. JANA CLOWER (Weight Nutrition Expert): Thank you, Neal. I am delighted to offer my opinion on this new medicine.

CONAN: Well, you have some experience with Xenical, the prescription version of this drug. What kind of success does it have? What kind of patients is it appropriate for? And which kind not?

Ms. CLOWER: I do. I do have experience with it. We have a lot of people in New York City that I've tried it, I've tried it with. One thing that I do like about Xenical is that it works in the digestion system. It works in the lumen of the digestive track. It does not enter the systemic circulation.

As Joanne kind of touched on, the side effects with weight loss medicines are considerable. And because most of them are taken into the circulation, their effects are to raise the blood pressure and to raise the heart rate. Xenical does not do that. It works because it works - it doesn't go into the circulation. It works just in the digestive system, but that's why there are the side effects of fecal incontinence. You can have cramping. People don't seem to tolerate it well.

My patients have not liked the drug as a prescription medication, have not had great success with it. And I don't think that it's going to be a very popular medicine for people over the counter, either.

CONAN: And, well, that's, I guess, some questions for the manufacturer about why they think it's going to be popular. But as some of your patients experience this drug, you say they had difficulties tolerating it in terms of the side effects Joanne was talking about?

Dr. KLAUER: Yes. Not only that, but I think people are uncomfortable. They feel kind of insecure. You know, if you don't know that you might be having - a lot of times, fat is hidden in foods, and you don't know that you have consumed fat in a particular food, well, that can cause a reaction with the medication. You can have a bad effect.

So - and I think that's a consideration, too, that people just are a little uncomfortable with it because you certainly wouldn't want to have an accident somewhere - that, and another thing I would point out is because it's decreasing the absorption, about 30 percent of the fat that you take in, you're also not getting - it would be difficult to absorb the fat that we really do need, like the fat-soluble vitamins.

There would be a danger in not absorbing the vitamins. You need Vitamin D, Vitamin E and Vitamin A, Vitamin K for your body. So general health - so that's a consideration. Also for osteoporosis. Women need calcium, and they need Vitamin D to absorb that calcium. That wouldn't be absorbed with this medication. So I just think those are cautionary things that we have to be aware of.

SILBERNER: Now, I don't want to defend the drug here, but...

Dr. KLAUER: No.

SILBERNER: ...the new version, Alli, is going to be at half the dose. So the data that the FDA give out shows a slightly lower rate of side-effects. They are still real, they are still there, but it's a few percentage points lower than the prescription part.

But I think one of the areas that's worth thinking about is teenagers. The FDA was very clear yesterday that this drug is not approved for use - they are not saying this is good for kids under 18 because of the concern of how they'll take it. Because they're concerned that kids think that they're fat when they're not, and because of the issue of the vitamins.

They are recommending vitamin supplementation with this, and I think they're just worried with all of those things together, kids under 18 just wouldn't be able to handle this themselves.

Dr. KLAUER: Yeah. I think you bring up a beautiful point. You know, what about people who - this medication is prescribed for people who are overweight or obese. It's not for someone who wants to lose five pounds or who's trying to fit into a sexy dress for their anniversary. This is a serious medicine, and I think it will be taken inappropriately.

I think teenagers are, you know, a group that we have to protect, and also because, again, about the bone - the risk for bone loss and not achieving peak bone mass because you can't absorb the fat-soluble vitamins.

So those are just, they're cautionary tales. And I guess I wonder, too. We have such a big issue with weight in this country, I think our emphasis should be on diet, educating ourselves so that we know what to eat, what is a healthy diet. People need to know that, and they need to exercise. Exercise is so beneficial for overall health and for weight.

CONAN: Let's get some listeners into the conversation. 800-989-8255, if you'd like to join us, 800-989-TALK - e-mail talk@npr.org. We're speaking with Dr. Jana Klauer, a weight nutrition expert, and with NPR's health policy correspondent, Joanne Silberner. And let's turn to Eldon(ph). Eldon's calling us from Tucson, Arizona.

ELDON (Caller): Hi, Neal.

CONAN: Hi.

ELDON: Hey, thanks for having me on. I had - I took Xenical for about eight months about two years ago, and all the things that your guests have pointed out were the reason I stopped doing it. But I've got to say that probably one of the benefits is that the belly fat, you know, the Dunlap Disease, went away, but one of the main concerns was the loose moments I would have. And basically, there was no way around it.

I remember one time, my health provider said - she's a nurse practitioner - said you ate a piece of pizza? Because anything that has fat, it just comes out, and it comes out in unexpected moments.

CONAN: Ah-ha.

ELDON: But after doing some more research and realizing that probably diet and exercise was just as good, as all your guests pointed out, you know, it only cuts down a certain amount of fat, and it only - and you lose some of that nutritional value. I felt like just going to diet and exercise was better.

CONAN: But the eight months, were you able to keep that spare tire off?

ELDON: Yes. Yes, I was. Yes, it did help with that. I mean, like I said, the benefits are there. I think it's just one of those things that you've got to take everything else into consideration while you're doing that.

Dr. KLAUER: Well, that's beautiful, what your guest says. And actually, there are studies that show an equivalent weight loss with just a walking program, and the type of weight that is lost is belly fat, and that's without a dramatic change in the diet.

You know, aerobic exercise is key. So why wouldn't one do that? Do an aerobic exercise program, a walking program, lose belly fat, and you don't have to worry about annoying accidents.

CONAN: Well, why one wouldn't do that, there's millions of Americans who don't do it.

SILBERNER: It's a billion-dollar industry right now with the dietary supplements. And people are looking for something, and the question is: Is this it? And I think we heard from Eldon that, you know, it's got its pluses and minuses.

CONAN: Eldon, thanks very much for the call, and continued good luck with your program.

ELDON: Thank you, Neal.

CONAN: Appreciate it.

Dr. KLAUER: Good luck.

CONAN: We're talking about the new over-the-counter diet drug, Alli, and you're listening to TALK OF THE NATION from NPR News.

And let's turn to Tawny(ph). Tawny's with us from Louisville, Kentucky.

TAWNY (Caller): Hi. I just wanted to comment also with the caller before. I noticed when I took the Xenical about three years ago, that the first pill I took, it seemed that, you know, I was trying to adhere to a low-fat diet. And it seemed like at that point, when I took the pill, it was, like, cleaning out every piece of fat I ever had in my entire life.

And I was thinking, okay, I'm done. So then I went to work, which was at an assembly line, where I could not get off of the line when I needed to, and an unfortunate experience happened. And after that, I just did not - I was afraid of it, basically. I did take it for a cure-all, to try to see if I could lose 40 pounds or whatever. But I just felt that it was too unpredictable for me, and I was - it really kind of scared me in that sense. I did not know, you know, what to expect.

CONAN: And were you able, Tawny, then to transition to another kind of program that's worked for you?

TAWNY: Yes. I actually just recently got diabetes, so since then, I've been trying to exercise and diet. And basically, that's really the only that's going to help, ultimately.

CONAN: Mm-hmm.

Dr. KLAUER: You're right. That's wonderful that you're doing that, Tawny, and that truly is the answer, as Joanne as I both have said today. And I'll say another thing. This is not an inexpensive medicine, either. So I think for people who are working and people who have limited finances, it's not even cost-effective.

CONAN: Tawny, good luck with your program.

TAWNY: Thank you very much.

CONAN: Appreciate the call. And Dr. Klauer, I have to say that it sounds as if you're dubious about this decision to make this available as an over-the-counter drug.

Dr. KLAUER: Well, I think that I am, and the reason why is because as a prescription drug - a drug that we carefully counsel our patients in - they're not great results. People have to be evaluated, and I just think, I think the cost - and I think also, it's very discouraging for people to try things and have them fail, and try and fail. And I just - I worry about the safety of also offering this, you know, nationwide without a prescription.

CONAN: And it says it's not for kids under 18, but that's not going to prevent kids from under 18 getting it if it's available over the counter.

Dr. KLAUER: Exactly, exactly.

SILBERNER: Yeah, the FDA had the option - they have been lately, you know, trying to figure out what they can do with things like this. Can you put it behind the counter? And they were asked about that at the press conference yesterday. And they said no, there're plenty of other drugs that they recommend only for adults that are available right in on the shelf, so that's what they decided to do with this one.

CONAN: Mm-hmm. Let's see if we can get one last caller in. This is Toni. Toni's with us from Grand Rapids in Michigan.

TONI (Caller): Yes. I just called in to chime in about the Xenical. I love the stuff. I used it, and I lost more than 100 pounds. Then I had two daughters that were overweight. Each one of them lost more than 100 pounds. One lost about 150 pounds using it, and the benefit - and I don't know if I should say this - but the benefit was that it also helped with some problems that we had with, like, hemorrhoids and things, actually. Because I don't know whether that was a side-effect that anyone talked about, but boy, we had great success with Xenical.

My daughter just got through having surgery to do a tummy tuck and so forth, because she lost so much weight that she had to get a tummy tuck. But that was a great side-effect.

CONAN: So - and were you able, then, to once you've lost the weight, to keep it off?

TONI: Yes, absolutely. My daughters - my one daughter went from a size 24 to a Size eight. The other one went from a size 22 to a size 12, and the same with me. So I just loved it. The only problem that I had was switching from one health care plan to another that didn't cover Xenical as a prescription. Blue Cross covered it, and another company that I switched to didn't, and that became a problem because it was so expensive. But it was great. It worked great for us.

CONAN: Well, Toni, congratulations, and thanks very much for the call. We appreciate it.

TONI: Thank you.

CONAN: So different opinions on the efficacy of Xenical. It's going to be available over the counter this summer in the form of a drug called Alli, and we've been talking about that with NPR's health policy correspondent Joanne Silberner. Joanne, thanks very much.

SILBERNER: Thank you.

CONAN: And with Dr. Jana Klauer, a weight nutrition expert, who joined us from her office in Manhattan in New York. Thank you, Dr. Klauer.

Dr. KLAUER: Well, you're welcome. And good luck to everyone.

CONAN: This is TALK OF THE NATION from NPR News. Tomorrow, Ira Flatow will be here with Science Friday. I'm Neal Conan in Washington. We'll see you Monday.

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