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February 24, 2012, 1:03 AM EST

By Anna Edney

(Updates shares in first, second, ninth paragraphs.)

Feb. 23 (Bloomberg) -- Vivus Inc. gained the most in 12 years after the company’s pill Qnexa won the backing of a regulatory panel, moving the drug a step closer to gaining U.S. approval as the first new obesity treatment in 13 years.

Vivus jumped 78 percent to $18.73 at the close of New York trading, its biggest single-day increase since December 1999. Competitor Orexigen Therapeutics Inc. also rose after the Food and Drug Administration advisers voted 20-2 yesterday that Qnexa’s benefits outweigh its risks.

While the FDA isn’t required to follow the panel’s recommendation, it often does. Several panel members said Qnexa would be prescribed for millions “if not tens of millions” of people, wrote Christopher James, a New York-based analyst for MLV & Co., in a note to investors today.

Qnexa “has the highest efficacy in terms of weight loss,” compared with other obesity drugs, said Sanjay Kaul, a professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member, during yesterday’s meeting. “That shifts the balance in terms of requiring a post-approval study rather than a pre-approval study.”

Patients that took Qnexa in studies lost 10 percent of their body weight on average, Vivus said on its website.

Once approved, Qnexa carries the potential to become “the next Lipitor,” MLV’s James wrote. Lipitor, made by New York- based Pfizer Inc., is a cholesterol pill that had $10.7 billion in sales in 2010 before losing patent protection last year.

One of Three

Qnexa is one of three medications vying for the first U.S. approval of a prescription weight-loss treatment since Swiss drugmaker Roche Holding AG’s Xenical in 1999.

The FDA plans to have advisers discuss in March the possibility of requiring heart-risk studies for all weight-loss drugs. Panel members yesterday discussed whether Vivus should conduct such a study before or after approval. The FDA is due to decide on Qnexa, which it rejected in 2010, by April 17.

Orexigen, which is developing Contrave for obesity, rose 14 percent to $3.66 and Arena Pharmaceuticals Inc., testing lorcaserin for the same ailment, fell 1.7 percent to $1.78. NeuroSearch A/S and Novo Nordisk A/S, Danish companies developing obesity drugs, also gained.

Trading in Vivus stock was halted yesterday before the FDA panel vote. NeuroSearch, which is developing tesofensine for obesity, climbed 5.6 percent to 17 kroner and Novo Nordisk, which is studying its Victoza diabetes drug as a weight-loss treatment, climbed 1.5 percent to 796.50 kroner in Copenhagen.

Attractive Target

Vivus may be a more attractive target for a partnership and acquisition, wrote Steve Yoo, an analyst for Leerink Swann in New York, in a note to investors. Vivus has been looking to sell the rights to its erectile dysfunction drug Avanafil, and “it would not be too much of a stretch to convert those discussions into a more wide-ranging discussion,” he wrote.

Regulators raised concerns that Qnexa may contribute to a greater risk of heart ailments and birth defects. The medicine combines the appetite suppressant phentermine with topiramate, an antiseizure and migraine drug. The Mountain View, California- based company has proposed a post-approval trial to assess Qnexa in reducing major heart complications in obese, at-risk patients. The trial would involve 11,300 patients and take four and a-half years.

Analysts say the drug, if approved, may generate $448 million in sales in 2015.

Topiramate

Topiramate is the active ingredient in Johnson & Johnson’s Topamax. The anticonvulsant is also associated with confusion, difficulty with concentration and memory loss.

Vivus’s analysis of heart risks for Qnexa was “somewhat reassuring,” though the significance of an observed increase in heart rate was “uncertain,” FDA staff said Feb. 17 in a report.

More than one-third of U.S. adults are obese, and another third are overweight, according to the Centers for Disease Control and Prevention. The obesity rate among adults has more than doubled since 1980 to 72 million people.

Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the Atlanta-based CDC.

Orexigen, based in La Jolla, California, and San Diego- based Arena also are seeking approval for their obesity medicines, which the FDA refused to approve without more data on safety risks.

Claims Data

Vivus examined medical claims data and found five oral clefts in a group of 1,740 children whose mothers had taken topiramate alone in the first trimester of pregnancy, for a prevalence rate of 0.29 percent, the company said Dec. 21 in a statement. That compared with a rate of 0.16 percent in the group whose mothers had taken antiseizure drugs, including topiramate, before pregnancy.

Vivus plans to finish the results in the third quarter of this year, after the April 17 deadline for the FDA to decide whether to approve the drug. The risk of oral clefts hasn’t been fully answered by the interim data, FDA staff said.

The FDA asked Vivus in January to remove wording from Qnexa’s proposed prescribing label advising women with the potential to become pregnant against taking it. The FDA staff said in the Feb. 17 report severely restricting Qnexa isn’t practical because topiramate also treats other serious conditions.

Restrictions Considered

Panel members, meeting yesterday at FDA headquarters in Silver Spring, Maryland, suggested the agency should consider restricting topiramate used for seizures and migraines for women of childbearing age.

“I just can’t get my mind around why it would be different,” said Lamont Weide, chief of diabetes and endocrinology at the Truman Medical Centers Diabetes Center in Kansas City and a member of the panel.

Russell Katz, director of FDA’s neurology products division, said the agency hasn’t considered restricting the drug because there aren’t many options for migraine prevention.

Vivus has suggested restricting distribution of Qnexa to less than 10 large mail-order pharmacies with pharmacists trained in dispensing the drug, Barbara Troupin, senior director of global medical affairs at the company, said.

In addition to Roche’s Xenical, London-based GlaxoSmithKline Plc’s Alli, a half-dose version of Xenical’s active ingredient, won FDA clearance in 2007 as the first diet drug available without a prescription.

--With assistance from Makiko Kitamura in London, Elizabeth Lopatto in New York, Frances Schwartzkopff in Copenhagen and Ryan Flinn in San Francisco. Editor: Bruce Rule, Reg Gale.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net; Reg Gale at rgale5@bloomberg.net

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Vivus Doubles After Winning Panel Backing for Weight-Loss Pill

Federal Panel Endorses Weight-Loss Drug Qnexa

The controversial weight-loss drug Qnexa is one step closer to gaining approval as the first new prescription obesity medication in 13 years. A Food and Drug Administration advisory panel voted 20 to 2 Wednesday to recommend its approval, despite rejecting the drug two years ago in light of safety concerns. The panel of medical experts argued that the weight-loss benefits of Vivus Inc's Qnexa outweigh potential heart risks and birth defects associated with the drug, USA TODAY reports. In a clinical trial of 4,323 obese adults, Qnexa patients lost an average of 10 percent of their total body weight during the first year of use. However, the researchers also found that Qnexa slightly boosted heart rate, which can heighten the risk of heart attack and stroke. And they noticed an increased risk of birth defects in the babies of women who became pregnant while taking the drug. Panelists recommended that Vivus further study the drug's heart effects, and supported the company's plan to forbid pregnant women from using it. The FDA will issue a final ruling later this year, but typically follows the recommendations of its advisory committees. "Everyone around the room knows obesity and its substantial health risks," panel member Susan Yanovski, director of the obesity and eating disorders program at the National Institutes of Health, told Reuters. "I would say not treating obesity is not risk neutral. We have few treatments for obesity for those who don't respond to lifestyle treatments."

High-Protein Diets for Weight Loss: Are They Healthy?

"High-protein diet"—burgers, steaks, chops, and more burgers, steaks, and chops. Right? Wrong. Few diets, even those like Atkins that portray themselves as a carnivore's delight, dish out more than about a quarter of their daily calories from protein. The federal view classifies diets as high-protein if the protein content exceeds 35 percent.

But even a quarter is high. Most Americans get only about 15 percent of their calories from protein, says nutritionist Teresa Fung of Simmons College in Boston, a member of the U.S. News Best Diets expert panel. That's roughly one 3-ounce burger a day. So studies of "high-protein" diets generally take aim at those at the "higher end of the recommended range" of 10 to 35 percent, says Kathie Beals, another panelist and an associate professor in the division of nutrition at the University of Utah.

These higher-protein diets, as they should be called, are gaining popularity among those who want to both drop pounds and build muscle. The protein in these plans typically comes from meat, although soy, peanuts, whey, and other plant-based protein often appear on the menu. Proponents say such diets boost metabolism, promoting weight loss while making dieters feel full. [Read more: High-Protein Diets for Weight Loss: Are They Healthy?]

7 Stick-to-Your-Diet Tricks You've Never Heard of for 2012

Another year, another resolution. The goal may be the same, but the outcome doesn't have to be. You can succeed in 2012. No more falling off the weight-loss wagon a couple of months in, or sheepishly returning the skinny jeans you bought with such hope. These 7 easy and unconventional tricks can help you stay on track this time around:

Picture yourself. Find a photo of yourself you either love or hate, whichever hits you harder. Carry it around—and whip it out and stare at it whenever temptation strikes. Seeing yourself at your thinnest or heftiest—maybe even snapshots of both—might stiffen your resolve when you pass Dunkin' Donuts or watch The Office with potato-chip-addicts, says registered dietitian Keri Gans, author of The Small Change Diet. Need a stronger reminder? Magnet the visuals to your refrigerator, too, she says.

Bet on it. "Diet betting" is catching on among friends, relatives, and coworkers. The idea is to place real bets on who can lose the most weight over a specified period, tracked by weekly weigh-ins. A study published in 2008 in the Journal of the American Medical Association found that people given financial incentives—for this study it was a chance to earn about $200—were more successful at weight loss than those without money on the line. Can't find willing competition? Sites like stickK.com require dieters to hand over their credit card information and sign contracts pledging to meet certain goals. If they fall short, say by failing to lose the weight they vowed to, it'll cost them—their credit card will be charged anything from a couple of dollars to $200 per week, depending on the terms they agreed to, with the money donated to a designated person or charity. [Read more: 7 Stick-to-Your-Diet Tricks You've Never Heard of for 2012.]

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Health Buzz: FDA Advisors Back Weight-Loss Drug

Kerri Miller (host): The Food and Drug Administration has not okayed a diet pill in a long time. Side effects like heart problems and birth defects had kept many of the medications off the market but today the agency will turn to a panel of doctors who a reviewing the medical data on a drug called Qnexa, it's a medication that was rejected by the FDA in 2010. The doctors will make a recommendation later this spring to the FDA. Our question today as the obesity epidemic rose in America how are medical experts weighing the risks of diseases like diabetes and heart disease against the risks of weight loss medications when we know that many Americans gain back the weight that they have lost are medications key to permanent weight loss? Our guests are going to join us in a moment, but I want to hear from you. Have you ever used medications to help you lose weight and if a new drug was on the market how much would you work about side effects if it meant that you could lose a significant amount of weight. Tell me a bit about your experience with medication and weightless and if there was a new drug approved on the market how much would you worry about the side effects if it meant that you could lose a significant amount of weight? Our guest this hour is Dr. David Katz the founding director of Yale University's Prevention Research Center and he is with us from New Haven, Connecticut. Dr. Katz thanks so much for the time today.

Dr. David Katz (guest): My pleasure Kerri, thanks for having me.

Miller: Simone French joins us she is a Professor of Epidemiology at the University of Minnesota Public Health and she is an expert on the issue of childhood obesity and she is with me in the studio. Simone welcome good to have you here.

Simone French (guest): Good morning Kerri.

Miller: Dr. Katz let's talk about what the FDA is doing today in just a moment but I want to come back to this idea of balancing the consequences of obesity against the potential side effects of a medication and I wonder if you sense that the FDA has a renewed interest in that?

Katz: I do clearly Kerri and by the way it's a pleasure to be on the line with my friend Dr. French. Really the issue for the FDA always is to look at the drugs in context. Everything in medicine involves potential risk. But for instance if you are looking at treatment for a life threatening cancer the notion that some breakthrough chemotherapy would involve some potentially quite serious risk is acceptable because the risk of non-treatment is no high. So the issues are always what's the tradeoff between the risk and benefit, what else is available out there? In the obesity case and before we are done I will tell you I am not enthusiastic about drug treatment for obesity but we can start by acknowledging we haven't go much and in terms of pharmacological therapy we have got nothing that is safe, effective, and reliable and we have epidemic obesity as one of the gravest public health threats of our time. You know we have surgery, bariatric surgery, but that's pretty drastic in its own right and there's no question that the FDA's question to reconsider Qnexa which they had looked at and rejected before is in context. WE don't have much of anything; we have a very serious problem on our hands. Is it possible that even thought this drug isn't terrific that the tradeoff between risks and benefits still favors its approval that's how they are thinking?

Miller: So Professor French I thought we would break that down just a little bit more. Here's what the company that is making Qnexa said in the documents that they originally submitted. "The ability of Qnexa to produce durable weight loss can be expected to contribute significantly toward ameliorating some of the consequences of obesity and weight related comorbidities." I mean that's a lot of language there but they are essentially arguing what we are asking this morning right? That if there are side affects you still get enough of a benefit from losing the weight that that ought to be considered. What's your view of that?

French: Well I think that there's only one drug that's FDA approved for weight loss and that's Orilstat and I agree that having options out there for people are important. That would be something that we would want to see options out, but just to put a context on this we do have a broad range of available approaches for overweight and obesity ranging from behavioral approaches which are mostly education and behavioral change approaches up to pharmacotherapy and then as Dr. Katz mentioned bariatric surgery. So each of those approaches might be appropriate for different people with comorbidities and different levels of overweight and obesity and these drug trials and drugs might be appropriate in my option for morbidly obese people with very severe obesity problems and maybe even a subset of those people might be helped. Individuals might respond to some of these but again even the trails that have been examining these drugs in morbidly obese people still see only a small subset who have good results from those so I think that even from a public health point of view so drug treatment of obesity really isn't an approach you would consider from public health treatment and that's 70 percent of the U.S. population. But from a clinical point of view helping find approaches that might help people who are severely overweight and whom behavioral approaches have not worked well that might having additional drugs out there might help a small group of clinically obese people who have health conditions but I fear that because you know people translate these approaches down into the general population of these people like bariatric surgery now being considered for adolescents and that blows my mind. That's something that you would never even thought about before and I don't think it's appropriate so when the drug treatment issue comes up you just worry that that will be translated down to the people who have a BMI of 26 or 27 and that we wouldn't want to see. I think a behavioral approach would effective in those types of people.

Miller: I want to talk to you a little more about that. But Dr. Katz is that why you are concerned about the wide spread potential use of drugs and people that don't really need it as Professor French is talking about.

Katz: Well actually Kerri that's only one of my concerns and in some ways perhaps the lesser one because I don't think people with lesser degrees of obesity are going to rush out and use drugs particularly on their children where people are at. Although I quite agree we have seen expanded uses of bariatric in younger people and frankly it's because our population is desperate for something that will work for weight loss. My concerns are that if we turn to pharmacotherapy for obesity we are trading the cost of obesity for the costs of the drug. I don't think it solves the economic problem but I think it's just fundamentally decided and to sort of situate this we have epidemic obesity because we eat too much and do too little we are sort of fish out of water. We were designed for a world where calories were relatively scarce and hard to get and physical activities was unavoidable and we devised a modern world where physical activity is scares and hard to get and calories are unavoidable. I compare that to a fish out of water. Now if the fish gets and infection you can put antibiotics in fish food and treat it but if the fish is flopping around out of water imagine trying to design a drug to fix that. It's a profound distraction from the obvious problem and that's really my biggest concern here. The longer we think, and I quite agree by the way with Professor French that there is a limited role for pharmacotherapy for drugs in severe obesity in medicalized cases, but the notion that pharmacotherapy is going to ameliorate obesity as the drug companies suggest is dangerous. It is dangerous because it is like thinking that we can design drugs to help polar bears survive in warmer climates or fish survive out of water when the real answer is to restore a healthy environment and the longer we fiddle around with pharmacotherapy I think the longer we spend not looking at the problem which is all around us and creating environments where being active and eating well lie along a path of lesser resistance. And of course there is the fact that the drugs themselves are not terrific. Qnexa is a mix of two drugs, Phentermine and Topiramate. Topiramte is an anti-epilepsy drug and side effects include things like brain fog and confusion and nausea so this is not a free ride and phentermine is a stimulant I don't think it surprises anybody that stimulants can cause weight loss. Frankly cocaine can cause weight loss but that doesn't make it a good idea so we have just about no evidence that people can safely take this drug for the long term and we have abundant evidence that when you stop taking a weight loss drug you gain back the weight. So the real issue here is that this is not an effective solution.

Miller: We are talking in depth this hour about the FDA's reconsideration of a new diet drug, talking about the risks of that whether it's some of the side effects, how they balance out with the benefits, clear benefits of losing weight. I'd like to hear from you this hour. Have you taken medication to lose weight? How did it work for you? And what if there was a new drug on the market but you were concerned about side effects, how would you reconcile that? We are in depth on diet medication and lets turn to the phones to Steve in Minneapolis, Hi Steve I appreciate you waiting.

Steve (caller): Thank you. I am 58 years old, I'm a truck driver and I have a family history of diabetes after 50 and I was on former drugs for weight loss before and I just finished the process for bariatric surgery. If I had a choice again I would probably do the pill because I only have 65 pounds to lose and I had good success with the pills and I'm not really crazy about doing the surgery which has some risks also.

Miller: Steve may I just ask you one question. What about the side effect of the pills?

Steve: I didn't have any side effects and I think even with the bariatric surgery there are side effects to that as well also. More so for women than it is for men but there are side effects and there are actually people that die from the surgery so I think it's kind of gone on equal grounds in my mindset but I'd rather take the pill. I don't get much time to exercise driving fourteen hours a day in my type of situation I'd like to protect my job and do it with the pill instead of the surgery.

Miller: Yeah, I appreciate the call. Professor French it sounds like medication, bariatric surgery, there are going to be side effects and this brings us back to what you were saying earlier bout what you were saying about exercise and perhaps behavioral help with this yes?

French: Well we just did a study on bus driver so I empathize with the situation of being in a seat all day driving as part of your work. It is hard to get physical activity in that kind of work situation. I don't know if the caller had tried behavioral weight loss programs and for some people those work and for some people they struggle and try that for years and years and so then they want to try something that might work for them when behavioral approaches have not worked. So in the callers case maybe the drug therapy which seemed to work well, I'm not quite sure why he moved up to the bariatric surgery, and not going back to those drug therapies.

Miller: Can I ask you this? Have methods in the cognitive therapy for weight loss, have they evolved much or have they changed or is what we knew about this I don't know thirty years ago what we do today?

French: Well they have evolved and we are learning more and more how to tweak those more and more to make them work even better but a standard behavioral approach the treatments that have been evaluated by research studies have lengthen and the standard approach is six months of weekly meetings and the techniques have been shown to work and they produce about ten percent of initial body weight loss after about a year of treatment and the techniques that are learning don't cost money, you don't have to buy drugs and they help you develop skills that in your environment that you are living in you can help make better choices and enlist support and look at your environment and know what triggers you to eat and in what circumstances. All of those are skills that you can learn and apply in your daily life and they don't cost much.

Miller: Here is somebody on twitter reinforcing what you are saying, "no pills, no shortcuts, weightwatchers is the only thing that ever worked for me." I mean that's behavioral therapy right?

French: Yep, food, exercise, and having group support to learn and manage this obesigenic environment that we all live in. I completely agree with Dr. Katz that the big thing staring us in the face is our environment and our lifestyle in the way that our world is set up and that's why 70 percent of U.S. adults are overweight or obese. That's the big then but then when you step back from that well we can work on changing policy and the environment at the individual level on these behavioral approaches but for people where that is just not working or if they are genetically more susceptible we found actually the increase in prevalence of obesity has been higher in the upper end of the distribution so some people who may have a genetic susceptibility to our toxic environment are having super-duper effects on their obesity in the high end so this environmental effect is causing everybody to get overweight but among the susceptible its even magnified for people like that I can see how surgical and medical approaches might be entertained but for the vast majority and if those options get the news and they are detracting from the policy and support for environmental change then I think that's a draw back. But I don't think that relieves us from the responsibility for looking at our environment and trying to look there for solutions.

Miller: Dr. Katz what do you want to say about that?

Katz: Well I also empathize as again we have noted that the modern environment where physical activity is scarce and hard to get and nowhere more so when you are doing a job that requires you to sit all day. So for one thing we need to engineer solutions to that and Steve I commend to you when you get a chance when you're not driving take a look at abeforfitness.com these are free fitness videos you could put on a handheld device you could do them at truck stops. Actually what we are working on physical activity you can do isometrics while driving with an exercise using the steering wheel. One of the things we in public health need to do is talk about the behavioral approaches and facilitate them. I agree with Professor French that the behavioral approaches have evolved, many of us have been working on that and weight watchers is effective, it is a very good program, but even that can be enhanced. It can do a better job of reaching families; it can be tailored better for men. We have been focusing in our work on something called impediment profiling where identify for you the specific values in Steve's case it would be stuck in a truck all day to being physically active or specific values as eating well and help trouble shoot those. In terms of Steve's advocacy for using a drug he is basically saying I was staring at the options of surgery or medication and I'd like to have the medication option. I think we agree with him, I think that's why we can't just boycott the position of what the FDA is doing today. There are going to be severe cases of obesity or cases of obesity where behavioral solutions don't stick, don't work, the person can't do them, they have tried and failed, whatever the issues may be where the consequences of not treating the obesity effectively are greater than the risks of the drug or the surgery and then frankly what you are comparing is, and I think Steve nailed this, the risk of surgery versus the risk of the drug and absolutely there are important solutions for both. We do need to be very careful however, and I'll reemphasis that this particular drug Qnexa contains Phentermine which is an amphetamine like drug, it is a stimulant and that's not safe to take for the long term. One of the things it can do is drive up your blood pressure which is one of the very metabolic complications of obesity we are trying to prevent. And I think it is also important to note that the history of drug treatments for obesity serves up one precautionary tale after another. From my perspective a far more promising drug than Qnexa was Rimonabant. I think that was the most promising weight loss drug to come along.

Miller: And what happened to that?

Katz: Well it was never approved in the U.S. because of fears of psychiatric side effects because when you start tweaking pathways in the brain you get unintended consequences. It was approved in Europe and they also ultimately withdrew it there as well because of an increase in the rate of suicide. So again we are talking about playing around with fundamental pathways in human metabolism and there is real danger sometimes not originally seen there. We have not been very successful to date with drugs for weight management.

Miller: Let me grab a call here from John listening in from New York. Hi John I appreciate you waiting.

John (caller): Hi, Thank you I love the program. I am very curious as I am thirty now and when I was eighteen I experiment with the Xenadrine during its phase of being allowed over the counter and I had you know increased heart rate obviously that went along with it and I got off of it basically because I was having dizzy spells and I fainted in basketball practice and knew it probably wasn't the best for me. It did help and I lost thirty pounds you know I had tons of energy and numbers of friends my age that took it an had success you know we were younger and didn't have problems. Then the whole craze came out about what Xenadrine was doing and it got lopped off and we were obviously weren't taking it but it kinda caused a stir much like this weight loss drug and my question is if you watch the nightly news on any of the major networks every other commercial is something for erectile dysfunction or COPD and the list of side effects, and crazy side effects are longer than the commercial shows in the content of the commercial so I am wondering why is it a weight loss drug would cause such a stir if very common things such as heart medication and lung medications, you know I've had problems with Prilosec and Omeprazole with side effects that have caused panic attacks and depression and these seem to be all of the craze and have been for decades I mean what's the answer to that?

Miller: Dr. Katz what's the answer to that?

Katz: Well a couple of things, it's always an issue of the trade off so there is the inconvenience in the case of something like erectile disjunction is the effect on quality of life of the condition versus the side effects of the drug. One thing to note about those commercials, every possible side effect must be listed pretty much and that doesn't mean they are likely or common. In the case of a drug like Phentermine an elevation in blood pressure is very likely. In the case of Topiramate in Qnexa the likelihood of nausea or brain fog is pretty high. So some of those side effects on the TV commercials could happened but hardly ever do. We are talking about side effects that can be potential very serious and happen often. But I think frankly the bigger issue is efficacy. We are really not just talking about side effects, we are talking about the tradeoff between the effectiveness of the drug ad the side effects of the drug. All of the side effects on the TV commercials for heartburn or erectile dysfunction they work. Again the evidence at the population level the drugs are effective for causing weightless and keeping th weight off just isn't very good and so if the effectiveness is not great and there are side effects that are potentially dangerous when you look at the risk benefit trade off it becomes very questionable. And then again my critical point for this discussion is that obesity really is different from the other things we use drugs to treat. You know fish can get sick and you can treat it with a drug but if a fish out of water needs to be put back into water you wouldn't treat that with a drug. The obesity epidemic really is about the environment all around us. We can fix it there but the more we think about using drugs to do what we should be doing with programs and policy the longer we delay and I think that's really the gravest danger here of all.

Miller: We are in depth here this hour if you have just tuned into the Daily Circuit on diet medications. The FDA is actually turning to a panel of doctors who are reviewing a drug that had earlier been rejected, re-reviewing this drug Qnexa for consideration of a diet medication. Sue Stein writes on Facebook "I have tried pills for weight control in 1966 and they didn't work and the side effects were awful. I've tried weight loss candy, weight loss drinks, and hypnosis and 500 calories a day, nurse supervised diets, weightwatchers twice, calorie counting. All have failed. Professor French I'd like to talk to you about I think this is something you have raised about excessive eating and some of these medication that target appetite control but I think you would say that much of the excessive eating, we have talked about the environment but some of this is emotional eating in response to what, depression or emotional problems?

French: Well people eat for a variety of reasons as well all know I mean personally I don't eat because I'm hungry all of the time or stop because I'm full, I'm influenced by my setting, my habit, when the mealtime happens to be if its lunch or breakfast, if there is food in the room. We get influenced in our eating and food choices by a variety of social cues and contextual cues and emotional cues so the drugs that are targeting hunger mechanisms and safety mechanisms grated those mechanisms do contribute to food intake and regulation but there are so many others and part of the reason that the environment influences we have been talking about had such a big impact on eating and weight is because those influences are real and they are strong and constant and so not that many of us just eat in response to hunger and stop when we are full so we are not that in tune with things and also there is a significant group of people who are more responsive to emotional eating. So people vary in how responsive they are to different influences on their eating maybe some more people are more responsive to biological feelings of hunger and there is another group that eats less when they are upset. I mean there are a variety of people out there and some have argue that introducing, going back to the drugs, that operate on different mechanisms because we have this big individual variability in reasons for eating and in our biological make up that having more choices out there would be a good thing. I mean so that's one argument, but it's true that the other point that has been raised that I just wanted to make is the cost benefit ratio of some of these drugs. I agree that this needs to be looked at and we don't have great data that some of these drugs really do produce lasting weight loss that is better than behavioral approaches. A good behavioral approach produces ten percent of weight loss after treatment and the most recent trial that I was looking at of Qnexa in the literature showed the high dose there was a high medium and a control placebo group, the high dose lost ten percent after a year so go figure. If you could get people to adhere to the behavioral program maybe that's another issue maybe these morbidly obese people can't adhere as well as an overweight person who doesn't have such a severe problem.

Miller: Dr. Katz you wanted to add?

Katz: Yeah if I may jump in, one other thing you introduced Simone as a childhood obesity expert and that's a focus we share, I'm actually the Editor in Chief of the journal Childhood Obesity and a lot of my effort is directed there as well because the earlier you intervene the greater the opportunity to improve quality of life for the whole life span and just stop for a minute to think about whether or not everybody in a family who is prone to obesity and maybe already experiences it at different stages is going to take the drug. Is there a his and her version and dad, mom and the kids? One of the things that a pharmacotheraputic approach ignores is that the basic functional unit of our society is not isolated individual it is the family and parents and kids are going to get the health together or probably not at all and so if an adult with children goes on a drug to lose weight it's not a skill they can leave with their children it's sort of leaving the kids behind. Its six p.m. and you take Qnexa what do you feed your kids kind of thing. So I think we can agree there is a limited role for pharmacotherapy as an alternative to surgery to fix a severe problem in an individual. But as we look at the social level we clearly need behavioral strategies and then we need to supports for those behavioral strategies in the environment the things that we can do and the places people spend your time schools, workplaces, and churches, shopping malls, and supermarkets and so forth to make eating well and being active easier for everybody for adults and children alike.

Miller: Let me grab a call here from Pamela in McKinley, Hi thank you for waiting.

Pamela (caller): Thank you, I am a victim of Fen Phen since 1996 and had two open heart surgeries with an artificial value for my fourth defibrillator and if I don't get a heart or a pump I will be dying and it's because Fen Phen was made by Wyeth who lied about the results and the FDA just slid it through and did not do the testing it needed so I am dying because Wyeth Laboratories and the FDA's urgency to get this medication out on the market and I really urge everybody to think at least twice before they try any diet medication, diet exercise, or medical help, or even the bariatric surgery are much preferable.

Miller: Pamela thank you so much for your call. Fen Phen Professor French, this is what the FDA is concerned about right as they look at these decisions about whether they will approve these drugs?

French: I think that their reluctance to jump into improving new weight loss drugs is no doubt colored by the Fen Phen disaster and I really am so sorry to hear about what happened to the caller. Fen Phen did heart valve damage to hundreds of people and it was an FDA approved drug and it was only after the fact that they realized this and then had to backtrack but in the meantime the damage was done and the trial that I mentioned with Qnexa combination was sponsored by a drug company. Many of the trials that are done are sponsored by the drug companies so no doubt they are more likely to show positive results but even those aren't long term results that they can rely on so I think that being conservative in light of what has happened terrible tragedies that can't be reversed being conservative is wise.

Miller: Professor French I appreciate you coming in today to talk about this and Dr. Katz thank you so much.

Here is the original post:
Do diet pills help people lose weight?

[REUTERS] Experimental obesity drug Qnexa won the backing of U.S. health advisors on Wednesday, raising hopes for approval of the first prescription weight-loss pill in 13 years.

Vivus Inc's Qnexa was one of three promising obesity drugs rejected by the U.S. Food and Drug Administration in the past two years over safety concerns.

It is the first to come back up for review after more extensive clinical trials, as public health officials urge the FDA to consider a medical treatment for a condition that affects about one-third of Americans.

A panel of outside experts to the FDA voted 20-2 to recommend approval of Qnexa, saying they were convinced that the benefits it offers in treating obesity outweighed the potential heart risks and birth defects associated with the drug.

Vivus shares nearly doubled in value to $21.01 in afterhours trade following the panel vote.

Panelists did say Vivus should conduct a study on possible heart problems and supported the company's plan to limit its use to women who are not pregnant.

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During discussions, panelists seemed divided on whether the heart-focused safety study should happen before or after the drug is approved. They took no formal vote on that issue. A pre-approval study could delay the time before Qnexa is available to patients.

Shares of fellow obesity drugmakers Orexigen Therapeutics and Arena Pharmaceuticals got a 17 percent boost in extended trading.

"The vote reflects the clinical community's concern about the challenge of obesity," said JMP Securities analyst Charles Duncan.

"I continue to believe Orexigen's Contrave and Vivus' Qnexa remain approvable drugs and are going to move forward," Duncan said. "I am less positive on Arena's Lorcaserin."

The FDA usually follows panel recommendations, although it is not required to. It will make a final decision by April 17.

"Everyone around the room knows obesity and its substantial health risks," said Dr. Susan Yanovski, an advisory panel member and director of the obesity and eating disorders program at the National Institutes of Health.

"I would say not treating obesity is not risk neutral. We have few treatments for obesity for those who don't respond to lifestyle treatments."

LOSING 10 PCT OF BODY WEIGHT

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population obese and more than half overweight.

The FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them, and has not approved a new obesity drug since 1999.

The agency has experienced previous high-profile safety scares involving diet drugs. In 1997, the infamous diet drug "fen-phen" was pulled from the market after reports of fatal heart-valve problems in some users. Another diet pill, Meridia, was pulled from the U.S. market in 2010 after being linked to heart problems.

The only prescription obesity drug currently approved for long-term use is Roche Holding AG's Xenical, which got the FDA's nod in 1999. GlaxoSmithKline markets a lower-dose, over-the-counter version called Alli. But both have their side effect issues, including liver problems and uncontrolled bowel movements, and provide only modest weight loss.

Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said.

FDA staff reviewers said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

However, Vivus said the drug also reduced blood pressure, and a link between heart rates and heart health was not conclusive. Panelists called for the company to study whether a higher heart rate was tied to heart health.

"They need to step up to the plate and do the cardiovascular outcomes trial, and do it fast," said panel member Dr. Sanjay Kaul, professor in the division of cardiology at Cedars Sinai Medical Center in Los Angeles. "I also encourage the FDA to hold their feet to the fire."

FDA staff also noted that exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects. A Vivus study showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy

The FDA has said the rate of potential birth defects is about two to five times higher with topiramate than with a placebo.

Vivus officials said obesity, and its common symptom diabetes, come with their own risks to pregnancy, such as stillbirth, premature birth and other complications.

Arena and Orexigen have been pitching their own fat-fighters to the FDA after rejections.

In February, Orexigen agreed with the FDA on the design of a 10,000-patient heart-safety trial required for the approval of its Contrave drug. The FDA rejected the drug pending the outcome of the trial, despite a 13-7 positive vote from a panel of FDA advisers.

The FDA is also set to review Arena's lorcaserin by June 27, after rejecting it in October 2010 because of a potential cancer risk.

See the original post:
Qnexa FDA Approval of First Weight-Loss Pill in 13 Years

A panel of medical experts voted overwhelmingly Wednesday to endorse the controversial weight-loss drug Qnexa, clearing the way for the Food and Drug Administration to approve a new prescription obesity medication for the first time since 1999.

The FDA will issue a final ruling later this year, but the agency typically follows the recommendations of its advisory committees.

The 20-2 vote in favor of Qnexa was a surprising reversal from 2010, when the same advisory committee decided that the drug's risks of heart problems and birth defects outweighed its weight-loss benefits.

In a clinical trial involving 4,323 people, Qnexa — a combination of the anticonvulsant drug topiramate and the appetite suppressant phentermine — led to an average loss of about 10% of total body weight in the first year of use. Many users also saw improvements in blood pressure.

But the trials also found that that the drug caused a slight increase in heart rate, which can boost the odds of a heart attack or stroke. In addition, researchers detected an increased risk of birth defects — typically cleft lip — in women who became pregnant while taking the drug.

Vivus Inc., the drug's manufacturer, addressed those concerns by proposing a tightly controlled system for prescribing Qnexa. To prevent birth defects, patients who take the drug will have to undergo monthly pregnancy testing and healthcare providers will get special training on the medication's risks and benefits. Vivus will also restrict distribution of the drug to registered pharmacies, among other measures.

"We will know who the prescribers are. We will know who has been trained," Dr. Barbara Troupin, Vivus' senior director of global medical affairs, told the advisory committee. "We are confident the Qnexa [risk management program] balances the safeguards while allowing access for appropriate patients."

According to the clinical trial data and previous studies, the risk of having a baby with a cleft lip is two to five times greater in women who took topiramate.

"The simple reality is, if you're pregnant or planning on getting pregnant, it's not the right drug for you," said Joe Nadglowski, chief executive of the Obesity Action Coalition, a patient advocacy group based in Tampa, Fla., that supports approval of Qnexa.

Vivus, based in Mountain View, Calif., proposed a similar program to monitor heart risks in patients. Several panel members strongly encouraged the company to conduct a post-marketing study to help identify the potential cardiovascular risks.

At the panel's daylong meeting Wednesday in Silver Spring, Md., several members of the Endocrinologic and Metabolic Drugs Advisory Committee said they worried about Qnexa's side effects but believed the benefits outweighed the risks.

More than 35% of American adults are obese, including about 5% who are morbidly obese, and an additional 33% are overweight, according to the Centers for Disease Control and Prevention in Atlanta. Those extra pounds are more than just a cosmetic issue; they also increase one's risk of diabetes, heart disease, stroke, osteoarthritis, certain types of cancers and possibly dementia.

"The most encouraging thing is that just about every member really heard the message about the need to treat obesity," said Ted Kyle, the advocacy committee chairman of the Obesity Society. "Obesity is not a trivial disease."

Only one prescription diet drug is available in the United States. That drug, orlistat, blocks absorption of fat and is sold under the trade name Xenical. Qnexa appears to work by suppressing appetite and increasing feelings of fullness.

It's not clear why the medication raises heart rate, but such an increase is typically viewed as a marker of cardiovascular risk, said Dr. Michael S. Lauer, director of the division of cardiovascular sciences at the National Heart, Lung and Blood Institute and a member of the advisory panel.

Lauer cast one of the two votes against approval, saying that the FDA should first ask Vivus to complete a study that provided detailed cardiovascular risk data. Otherwise, he said, FDA approval "would be a decision based on hopes, surrogates and suppositions."

"We have seen many cases in medicine where we thought we understood the pathology of disease … and we turned out to be wrong," Lauer said. "With an epidemic as serious as obesity, we need to do this right."

If approved by the FDA, Qnexa would be targeted for people with a body mass index of 30 or above, or a BMI of 27 or above for people who also have weight-related health problems, such as diabetes or sleep apnea. A BMI of 25 to 29 indicates a person is overweight, and 30 or greater is considered obese.

The vote sent Vivus shares soaring to more than $21 in after-hours trading, double the official closing price of $10.55.

shari.roan@latimes.com

Read the original here:
FDA advisors endorse weight-loss drug Qnexa

February 23, 2012, 8:09 AM EST

By Anna Edney

Feb. 23 (Bloomberg) -- Vivus Inc. more than doubled in early trading after the company’s weight-loss pill Qnexa won the backing of a U.S. advisory panel, moving a step closer to gaining approval as the first new obesity drug in 13 years.

Vivus gained $12.20 to $22.75 at 7:44 a.m. The shares of NeuroSearch A/S and Novo Nordisk A/S, Danish companies developing obesity treatments, also gained after advisers to the Food and Drug Administration voted 20-2 yesterday that Qnexa’s benefits outweigh its risks. The FDA isn’t required to follow the panel’s recommendation.

Qnexa is one of three medications vying for the first U.S. approval of a prescription weight-loss treatment since Swiss drugmaker Roche Holding AG’s Xenical in 1999. The FDA plans to have advisers discuss in March the possibility of requiring heart-risk studies for all weight-loss drugs. Panel members discussed whether Vivus should conduct such a study before or after approval.

“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” said Sanjay Kaul, a cardiology professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member.

The FDA is due to decide on the drug, which it rejected in 2010, by April 17.

Trading in Vivus stock was halted yesterday before the FDA panel vote. NeuroSearch, which is developing tesofensine for obesity, climbed 8.7 percent to 17.50 kroner and Novo Nordisk, which is studying its Victoza diabetes drug as a weight-loss treatment, climbed 2.6 percent to 805 kroner at 1:43 p.m. in Copenhagen.

Heart Risk Concerns

Regulators raised concerns that Qnexa may contribute to a greater risk of heart ailments and birth defects. The medicine combines the appetite suppressant phentermine with topiramate, an antiseizure and migraine drug. The Mountain View, California- based company has proposed a post-approval trial to assess Qnexa in reducing major heart complications in obese, at-risk patients. The trial would involve 11,300 patients and take four and a-half years.

Analysts say the drug, if approved, may generate $448 million in sales in 2015.

Topiramate is the active ingredient in Johnson & Johnson’s Topamax. The anticonvulsant is also associated with confusion, difficulty with concentration and memory loss.

Vivus’s analysis of heart risks for Qnexa was “somewhat reassuring,” though the significance of an observed increase in heart rate was “uncertain,” FDA staff said Feb. 17 in a report.

Obesity Risks

More than one-third of U.S. adults are obese, and another third are overweight, according to the Centers for Disease Control and Prevention. The obesity rate among adults has more than doubled since 1980 to 72 million people.

Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the Atlanta-based CDC.

Orexigen Therapeutics Inc., based in La Jolla, California, and San Diego-based Arena Pharmaceuticals Inc. also are seeking approval for their obesity medicines, which the FDA refused to approve without more data on safety risks.

Vivus examined medical claims data and found five oral clefts in a group of 1,740 children whose mothers had taken topiramate alone in the first trimester of pregnancy, for a prevalence rate of 0.29 percent, the company said Dec. 21 in a statement. That compared with a rate of 0.16 percent in the group whose mothers had taken antiseizure drugs, including topiramate, before pregnancy.

Study Results

Vivus plans to finish the results in the third quarter of this year, after the April 17 deadline for the FDA to decide whether to approve the drug. The risk of oral clefts hasn’t been fully answered by the interim data, FDA staff said.

The FDA asked Vivus in January to remove wording from Qnexa’s proposed prescribing label advising women with the potential to become pregnant against taking it. The FDA staff said in the Feb. 17 report severely restricting Qnexa isn’t practical because topiramate also treats other serious conditions.

Panel members, meeting yesterday at FDA headquarters in Silver Spring, Maryland, suggested the agency should consider restricting topiramate used for seizures and migraines for women of childbearing age.

“I just can’t get my mind around why it would be different,” said Lamont Weide, chief of diabetes and endocrinology at the Truman Medical Centers Diabetes Center in Kansas City and a member of the panel.

Restricting Distribution

Russell Katz, director of FDA’s neurology products division, said the agency hasn’t considered restricting the drug because there aren’t many options for migraine prevention.

Vivus has suggested restricting distribution of Qnexa to less than 10 large mail-order pharmacies with pharmacists trained in dispensing the drug, Barbara Troupin, senior director of global medical affairs at the company, said.

In addition to Roche’s Xenical, London-based GlaxoSmithKline Plc’s Alli, a half-dose version of Xenical’s active ingredient, won FDA clearance in 2007 as the first diet drug available without a prescription.

--With assistance from Makiko Kitamura in London and Frances Schwartzkopff in Copenhagen. Editor: Phil Serafino, Bruce Rule

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

Read the original:
Vivus Weight-Loss Pill Qnexa Wins Backing of FDA Panel

The number of weight loss operations has risen 12% while hospital admissions for obesity have also jumped.

In 2010/11, there were 8,087 weight loss stomach operations in England's hospitals, up from 7,214 in 2009/10, according to data from the NHS Information Centre.

The report highlights around a 30-fold increase in the number of people going under the knife in the last decade, from just 261 weight loss operations in 2000/01.

Recent figures include operations to adjust an existing gastric band rather than fit a new one. Of the 8,087 procedures in 2010/11, 1,444 were for maintenance of an existing band. Bariatric weight loss surgery includes stomach stapling, gastric bypasses and a procedure called sleeve gastrectomy.

The report also found a dramatic rise in the number of hospital admissions for patients whose main diagnosis was obesity.

Over the last decade, these admissions have risen from 1,054 in 2000/01 to 11,574 in 2010/11. Admissions among women are almost three times higher than for men - 8,654 in 2010/11 compared with 2,919 for men.

The North East has the highest rate of admissions with a primary diagnosis of obesity (40 per 100,000 of the population), followed by the East Midlands (36 per 100,000) and London (35 per 100,000). The South West, south central and North West have the lowest rates, with 14 admissions for every 100,000 people.

Weight loss surgery was most common in the East Midlands (32 procedures for every 100,000 people) and least common in the North West (six per 100,000). The figure in the east of England and south central regions was nine procedures for every 100,000 population.

Chief executive of the NHS Information Centre Tim Straughan said: "The report charts the growing impact of obesity on both people's health and NHS resources. It also examines changes in physical activity and diet. Those working in this field may want to examine closely the findings of the report, including the significant regional variations that appear to exist in both the admissions for obesity and those for weight loss stomach surgery."

A Department of Health spokesman said: "We want people to live healthier lives so they do not need to resort to surgery. We are working with charities, local government and industry to make it easier for people to make better choices. This year a third of meals and takeaways served from popular high street chains will contain calorie information and over a million families are involved in our Change4Life campaign - helping people to eat well and move more."

Read more here:
Weight loss operations up by 12%

The View

Star Jones returned to The View Wednesday, almost six years after she left the show under unpleasant circumstances.

"It was ugly, everything around was ugly," Jones, 49, observed. "It was a bad, emotional time. Nasty things were being said in the media. It was just not a good emotional time." Jones, who was on the show to promote women's heart health, seemed surprised by Walters' line of questioning about her controversial exit. "I had eight fantastic years here. One was 'eh,'" she said. "I came back to congratulate you on all you accomplished. I hope you congratulate me on what I accomplished."

Check out photos from The View

In 2006, View creator and co-host Barbara Walters revealed to Jones that her contract would not be renewed for a 10th season, and said Jones could say that it was her decision. Jones then announced on the show that she would be leaving, but told People magazine that she felt like she was "fired." The following day, Walters informed viewers that Jones would no longer be a part of the show effective immediately, and her name was quickly removed from the show's credits and from its official website.

"I take real responsibility for my own behavior at all times, but I won't take responsibility if have not made a decision I can live with. I made the decision to go out on my own terms," Jones said. "I wanted to be able to control it so when I walk back in here, if I were ever invited, I would feel good about coming in."

Watch more videos from The View

Walters and Joy Behar also asked Jones about her 2003 gastric bypass surgery. At the time, Jones refused to confirm she had undergone the procedure, despite her subsequent 160 pound weight loss. "We tried to protect you. We were told, 'Don't say it was gastric [bypass]. Say it was pilates and portion control,' " Behar said. "You are now a skinny b---. Congratulations."

Added Walters: "We did lie for you!"

Watch the full semi-awkward exchange below:

What do you think of Jones' reason for leaving? Do you miss seeing her on The View?

See the rest here:
VIDEO: Star Jones Returns to The View, Faces Questions About Controversial Exit, Weight Loss

The most important weight-loss message - you have to use more calories than you eat - hasn't changed in decades.

But dieting experts say science has some new, surprising things to say about the other half of the standard recommendation - exercise - and about which diet to use.

Researchers are also refining the behavioral tricks that can change the way people eat, not only to lose weight but also to keep it off. Modern technology is giving dieters new options, such as Internet- and cell-phone-based programs or scales that can transmit your weight from your home to your doctor or dietitian.

Thomas Wadden, director of the Center for Weight and Eating Disorders at the University of Pennsylvania, said the last decade has seen "pretty aggressive diet wars" among the proponents of low-fat, low-carb, or low-glycemic-index approaches.

After years of comparisons, Wadden and other experts said the verdict is clear: What you choose doesn't matter. Pick a diet you can stick to, including liquid diets or prepared meals. If you follow the rules, the results are all about the same. Wadden said he does recommend that, whatever the diet, patients reduce saturated fats and trans-fats for better health. You can pick a more aggressive approach while you're losing, eventually transitioning to a diet rich in vegetables, fruits, and lean protein for maintenance.

Gary Foster, director of Temple University's Center for Obesity Research, thinks diet gurus have scared people off with too much information. "We tell people so much stuff, it's paralyzing," he said.

He agreed that the specific diet doesn't matter. "Calories drive weight loss," he said.

To lose a pound a week, a dieter needs to eat 500 fewer calories a day. That's simple enough, but your maintenance needs come down as people get smaller. That explains why weight loss gets harder as you go. Think of your body as a house. It takes more energy to heat a big house than a small one. A woman who weighs 300 pounds maintains her weight on about 3,000 calories. (Because they have more muscle, men use a few more.) A woman who weighs 140 needs only 2,050 calories to stay there. Caloric needs drop further as we age and lose muscle mass.

Cheryl Marco, a registered dietitian who runs Thomas Jefferson University's weight management program, starts patients on a prepackaged diet that includes shakes and bars. Dieters have few options.

"Fewer choices work better," Marco said. "What works is the narrowing of stimuli." So her most successful long-term dieters eat meals that don't vary much from day to day.

Some people may just have to stay away from foods that trigger overeating.

"I am not of the belief . . . that we have the ability to learn to eat high-risk foods in moderation," Marco said. Your high-risk food may be ice cream. Someone else's may be fettuccine Alfredo.

John McAroy, 38, dropped 70 pounds (from 300 on a 6-foot-2 frame) between Thanksgiving and early February using Marco's method. He hasn't cheated much and hasn't missed having more choices. "You'd be surprised," he said. "I'm rarely hungry."

So what about exercise? Isn't it the answer?

No, the experts said.

Exercise is "the single best predictor of who keeps weight off and who doesn't," Foster said. "It has very little effect on weight loss."

Exercise can help people lose weight, but so slowly that most people lose interest, he said. It's easier for most people to cut 500 calories out of their diet a day than to burn an extra 500 calories. You have to walk five miles to do that.

What exercise does do is help people maintain muscle mass, which revs up metabolism a little and improves overall health. Still, adding five pounds of muscle takes a lot of work, and a pound of muscle burns only about 15 calories a day.

In one of the cruel twists of our evolutionary history - the one that shaped our bodies to withstand famine, not a world full of junk food - people who have lost a lot of weight burn fewer calories during exercise than people who have never dieted. "It's as if your body's gone green on you," Wadden said. To keep weight off, dieters need to exercise 225 to 300 minutes a week: about 32 to 43 minutes a day.

Foster's group is looking at whether getting a good night's sleep affects weight loss. People who weigh more tend to sleep less, but it's not yet known whether sleeping more helps people lose weight.

On the behavioral front, researchers say that "accountability" is a crucial factor in making diets work. People do best when they keep track of what they eat and how much they exercise. They need to weigh themselves frequently, ideally every day. It also helps a lot to report what they're doing to someone else. The gold standard is a face-to-face meeting, but results also improve with telephone and Internet reporting.

"It's really important to be accountable to somebody else," Foster said.

It's also important to act quickly when the numbers on the scale start moving up. Experts recommend having an action plan when weight rises by two to four pounds - perhaps returning to more intensive monitoring of food intake - and when dieters fall off the wagon.

"One of the major differences between the average-weight person and the overweight person is the ability to recover from overeating," Marco said.

Wadden says technology is offering new alternatives to people who need to lose weight. While not yet in wide use for weight control, scales that transmit weights to doctors or diet programs can build in accountability. Internet- and phone-based programs make it easier to calculate calories and energy usage.

Continued here:
New science can help guide diets and exercise