Will there soon be a new weight loss pill for people who struggle to lose weight on the path to better health? Qnexa is in the hands of an FDA panel once again because the drug's maker, Vivus Inc., provided new safety information about the drug.

The weight loss pill combines two currently approved drugs: phentermine and topiramate. Phentermine is the safer part of the wildly popular "phen-phen," which is still sometimes used for weight loss. However, topiramate is used for seizures and migraines, which does list troubling side effects.

The problem is, people want a pill to aid in weight loss to be a quick fix, and it seems clear that there is no magic weight loss pill out there. They seem to have way too many side effects, or they are not effective. The last time the FDA panel voted on this drug, it was 10 to six against approval. Perhaps things will change, but even then this isn't going to be a magic pill. Ultimately, there will be risks to be weighed against the health benefits.

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Originally posted here:
Weight Loss Pill Qnexa in FDA's Hands: Will it be Approved?

A group of weight-loss clinics in Southern California is under fire for an aggressive advertising campaign and the death of five patients.

The 1-800-GET-THIN marketing campaign and its affiliated surgical centers are being investigated by local, state and federal agencies, including Congress.

If you travel Los Angeles freeways you've undoubtedly seen the billboards advertising the weight loss Lap-Band device. The group also has a catching ad jingle, which is even available as a phone ringtone.

The ubiquitous ad campaign and the surgeons affiliated with it are under intense scrutiny. At least three wrongful death lawsuits have been filed, and the Los Angeles County Coroner is investigating one of the deaths. And according to a spokesman at the California Department of Insurance, the agency has initiated an investigation into allegations of insurance fraud.

 

Mona Misra is a bariatric surgeon at L.A.'s Cedars Sinai Hospital. She says she's glad regulators are looking into the practices, but she says many of her patients are getting the wrong message.

"For a lot of patients, the band might be the perfect operation for them and we don't want them to be afraid of it because they think that it is such a dangerous operation," Misra says.

The Lap-Band is a small, surgically-implanted silicone ring that, when inflated, restricts part of the stomach so only a small amount of food can get in.

Democratic Congressman Henry Waxman, whose district covers much of Los Angeles, says he wants more regulatory oversight of the Lap-Band.

"Here you have an outfit that is putting up billboards urging people to get this Lap-Band product, and they're not giving people all the information that they are entitled to have about the risk, cautions and possible side effects," Waxman says.

The Food and Drug Administration recently sent a warning letter to the 1-800-GET-THIN marketers ordering them to include more prominent safety warnings. The group's website now has disclaimers, but an FDA spokeswoman said the agency could not comment whether the marketers had fully complied with the warning. She would only say that firms are expected to correct violations, and failure to do so may result in enforcement action.

Those new disclaimers are too little and too late for Alexander Robertson, a lawyer who has brought five different lawsuits, including two wrongful death claims, against the 1-800-GET-THIN marketers and its affiliated surgeons.

"They really preyed on a very susceptible group of the population that obviously would like to look like those skinny beautiful people on the billboards and were told it this is a safe one hour procedure," Robertson says. "You come in and get it done and you are going to be thin right away."

A lawyer for the surgical centers and others affiliated with 1-800-GET-THIN declined to be interviewed. But he did send a written statement denying all allegations against his clients and touted "the success we have achieved in improving the quality of life of thousands of patients."

Meanwhile for years Allergan, the manufacturer of the Lap-Band, continued selling the device to surgeons affiliated with the 1-800-GET-THIN campaign. Earlier this month the company reversed that stance and announced that they would no longer sell to Top Surgeons, Inc, which is affiliated with the controversial ad campaign. A spokeswoman for the company would not elaborate why the decision to halt sales was made.

Scott Cunneen the head of Bariatric Surgery at Cedars Sinai, applauds the move. He and 29 other doctors recently sent a letter to members of congress denouncing the approach to anti-obesity treatment used by the 1-800-GET-THIN surgical centers. Cuneen says he fears Congress will crack down on the use of the Lap-Band instead of monitoring surgeons who he says, improperly use it.

"We hope that Congress regulates the practices and the facilities in such a way that the safety is maintained and doesn't condemn the whole category of therapy," says Cunneen, who insists that surgery, when performed properly and marketed truthfully, is the best and most effective way to combat obesity.

Link:
The Big Squeeze: Calif. Weight Loss Clinics Under Investigation

Weight loss is not as simple as eating less and exercising more, and for those who struggle to shed the pounds, a new equation may offer some help.

Scientists are now using mathematics to better understand the physiology of weight loss, and more accurately predict just how much weight someone will lose on a specific diet and exercise regime, researchers said here today at the American Association for the Advancement of Science's annual meeting.

In the past, physicians assumed that eating 500 fewer calories per day would lead to about a pound of weight loss per week, said Kevin Hall, a researcher at the National Institutes of Health in Bethesda, Md.

But it turns out, this rule of thumb is wrong, Hall said, because it doesn't take into account that metabolism slows down during dieting. Thus, predictions that used this rule were overly optimistic, Hall said.  

Hall and colleagues have developed a model that takes into account an individual's age, height, weight and physical activity level to better predict how much weight they might lose on a diet and exercise plan. Currently, the model is intended only for use by physicians and researchers scientists, Hall said.

Hall's research has also come up with a more realistic rule of thumb for weight loss. The new rule says you need to cut 10 calories per day from your diet for every pound you want to lose over a three-year period. So cutting 100 calories per day will lead to a 10-pound weight loss over three years, Hall said. Half of this weight loss would occur over the first year. To lose more weight after the three-year period, you'd have to cut more calories, Hall said.

The model may help policy makers understand the impact of public health measures on the obesity epidemic. For instance, one estimate of the effect of a 20 percent tax on sugar-sweetened beverages predicted that such a tax would lead to a 50 percent reduction in the number of overweight people in the United States in a five-year period. Hall 's new equation predicts about a 5 percent reduction in the percentage of overweight people in five years, Hall said.

 

The rest is here:
Weight loss not so simple as previously thought?

VANCOUVER — Weight loss is not as simple as eating less and exercising more, and for those who struggle to shed the pounds, a new equation may offer some help.

Scientists are now using mathematics to better understand the physiology of weight loss, and more accurately predict just how much weight someone will lose on a specific diet and exercise regime, researchers said here today at the American Association for the Advancement of Science's annual meeting.

In the past, physicians assumed that eating 500 fewer calories per day would lead to about a pound of weight loss per week, said Kevin Hall, a researcher at the National Institutes of Health in Bethesda, Md.

But it turns out, this rule of thumb is wrong, Hall said, because it doesn't take into account that metabolism slows down during dieting. Thus, predictions that used this rule were overly optimistic, Hall said.  

Hall and colleagues have developed a model that takes into account an individual's age, height, weight and physical activity level to better predict how much weight they might lose on a diet and exercise plan. Currently, the model is intended only for use by physicians and researchers scientists, Hall said.

Hall's research has also come up with a more realistic rule of thumb for weight loss. The new rule says you need to cut 10 calories per day from your diet for every pound you want to lose over a three-year period. So cutting 100 calories per day will lead to a 10-pound weight loss over three years, Hall said. Half of this weight loss would occur over the first year. To lose more weight after the three-year period, you'd have to cut more calories, Hall said.

The model may help policy makers understand the impact of public health measures on the obesity epidemic. For instance, one estimate of the effect of a 20 percent tax on sugar-sweetened beverages predicted that such a tax would lead to a 50 percent reduction in the number of overweight people in the United States in a five-year period. Hall 's new equation predicts about a 5 percent reduction in the percentage of overweight people in five years, Hall said.

Pass it on: New math models may be able to more accurately predict how much weight people will lose if they follow a specific diet and exercise regimen. 

This story was provided by MyHealthNewsDaily, a sister site to LiveScience. Follow MyHealthNewsDaily staff writer Rachael Rettner on Twitter @RachaelRettner.  Find us on Facebook.

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New Weight-Loss Equation: Researchers Determine Key Calorie Cutoff

TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration plans to take a second look at the weight loss pill Qnexa on Wednesday, after initially rejecting it because of concerns about heart problems and possible birth defects.

While effective at reducing weight, the drug, manufactured by Vivus Inc., was denied approval in 2010 because of its potential side effects. An FDA advisory panel will now review two years of data; when advisers last voted on Qnexa, only one year's worth of follow-up data was available.

The drug combines the appetite suppressant phentermine and the anti-seizure/migraine drug topiramate. Phentermine was once widely prescribed as the "phen" part of the fen-phen weight loss drug. This combo was withdrawn from the market after its use was linked to high blood pressure in the lungs and heart valve disease. The problems were related to the "fen" or fenfluramine part of the combination, not the phentermine.

No new weight-loss drug has been approved in the United States in the past 13 years, according to published reports. As it stands, Xenical is the only FDA-approved drug specifically for long-term use -- up to a year -- for weight loss. Xenical is sold over-the-counter as Alli. However, other drugs may be used off label to promote weight loss.

Last April, a study funded by Vivus found that obese patients taking Qnexa lost an average 22 pounds over a year, while also lowering their blood pressure and cholesterol levels.

Dr. Louis Aronne, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, is cautiously optimistic that Vivus did a good job responding to FDA safety concerns, and that the FDA will give the drug its nod of approval, with some caveats. Aronne was not involved in the trials but has been an adviser to Vivus and other companies developing weight loss medications.

"I am not as pessimistic as most people," he said.

Vivus has reported that Qnexa may increase the risk of cleft lip in babies of women who use the drug while pregnant. Aronne said the birth defect concern could be addressed through education on who should and should not use the new drug.

"We have learned our lessons with weight loss drugs," he said. "They need to be used in the right people under the right circumstances." The heart risks need to be weighed against reductions in heart disease risk factors that come with weight loss, he said.

Qnexa is not any riskier than bariatric surgery, according to Aronne. "The problem is that it can be distributed more widely," he said. He hopes for a compromise that allows the new compound to be prescribed, but not misused. "Once new medications are approved, local medical boards will need to enforce rules and make sure these medications are prescribed appropriately to the right candidates," he said. "We don't want to open up pill mills."

One thing is clear, he said: More options to treat obesity are needed. "For hypertension, there are 120 medications in nine categories," Aronne said. "We need new options and we need to get physicians thinking about obesity and obesity treatments."

Dr. Scott Kahan, an obesity expert at Johns Hopkins University in Baltimore and director of the National Center for Weight and Wellness in Washington, D.C., agreed. He is optimistic about the FDA's upcoming decision on Qnexa. "The weight loss effects are striking and approaching the amount of weight loss over two years that we get with bariatric surgery," he said. "This is really impressive."

More information

Learn more about weight loss medications at the U.S. National Institutes of Health.

Excerpt from:
FDA Weighs Fate of Qnexa for Weight Loss, Again

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Safe Quick Weight Loss Using the e84 Health Challenge Program - Video

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How To Lose Weight In 10 days Only ! - Video

09-10-2010 23:41 http://www.weightwatchersfood.org . . . FREE INFO - If you want to Lose Fat -- STOP the CONFUSION Right Now ! Isabel De Los Rios. is one of the most knowledgeable nutrition experts I've come across over the years and I was extremely impressed with her information and her program, "The Diet Solution". bit.ly If you really want "The TRUTH" when it comes to losing fat...no fads, no pills, no starvation...this information is definitely for you. Here are some of the great topics that Isabel demystifies regarding your diet: *How to determine the exact types of foods that are most appropriate for your specific body and metabolism type. After all, we are all different, so 1 specific diet is NEVER right for everyone. *The dangers of eating certain types of soy products... which types are ok in moderation, and which types shouldn't be eaten at all, unless you WANT more belly fat! *What you need to know about dairy before ever buying another dairy product again *Why "whole grains" are not always as healthy as the label claims, but there is an "other type" of grain that is a contender for the superfood lists *Is organic food worth the price? *The honest truth about carbohydrates and how much you really need *The major misconceptions about dietary fat that you need to know about *Ideal protein-carb-fat ratios based on your specific metabolism and body type *Everything you need to know about salt, sweeteners, alcohol, and more In my opinion, this info is a MUST-SEE for everyone that cares ...

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I LOST 30 pounds FAT forEVER . . .The MOST Effective way To Lose Weight QUICKLY

The Irish Times - Tuesday, February 21, 2012

DICK AHLSTROM, Science Editor in Vancouver

THE OLD models of how much weight you can lose by reducing calories are seriously off the mark. It is a lot more difficult to lose weight than these models suggest, according to the authors of a mathematical approach to weight loss and obesity.

Dr Kevin Hall and Dr Carson Chow from the US National Institute of Diabetes and Digestive and Kidney Diseases improved on the old linear model that suggested a 250 kilocalorie (usually just referred to as calorie) cut in food intake would deliver a 25lb loss over a year.

This ignored the reality of human metabolism, however, they told a session at the American Association for the Advancement of Science’s annual meeting in Vancouver.

Weight loss when dieting comes quickly when you start but soon diminishes over time until finally hitting a plateau, as habitual dieters can attest. For this reason assumptions about energy intake and expenditure based on each pound of fat representing 3,500 calories was not useful for calculating energy balance, they said.

Dr Hall pointed to a US study that indicated 67 per cent of people there were overweight or obese. It suggested that if the government introduced a heavy tax on sugar-sweetened beverages this would quickly drop to 50 per cent on the basis of the older models. The researchers ran a “dynamic simulation model” on the data and found that in fact the tax would only reduce obesity to 62 per cent because of the plateau effect.

The two decided to build a new, more accurate model of energy balance and weight loss. It took into account metabolic factors including the weight to lean ratio, sex, physical activity and other factors. They also built a simpler online version so people could log on and set up a weight loss programme. ( bwsimulator.niddk.nih.gov)

This was very different from the older calculators that suggested reducing calorie intake by 500 a day would deliver a 1lb loss per week. Their calculator allows you to set goals – how much weight you want to lose over what period of time – and then does the calculations for changes to calorie intake and exercise.

A person should reduce food intake by 10 calories a day for each pound of weight change required. At that rate about half the weight change would be reached in about a year and about 95 per cent of the loss reached in about three years, the researchers calculate.

They also used their model to look at the US adult obesity epidemic. They showed that reaching the average population-based weight gain only required seven extra calories a day.

The calculations were much more sophisticated, however, and also took into account the energy demands required by an individual to carry around the extra average weight. The average person needed to burn up an extra 215 calories a day to haul around the weight. Changing the energy balance will deliver weight loss, Dr Chow said. Eating one fewer biscuit a day could deliver a 15lb weight loss over a year.

“The surprise is such a little change can deliver such a large result,” he said.

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Researchers give less weight to established slimming tricks

If you’ve ever followed a weight-loss diet, you might be familiar with the 3,500-calorie rule.

It’s pretty simple: Since there are 3,500 calories in a pound of body fat, eating 500 fewer calories each day – or burning them off exercising – will lead to a slow and steady weight loss of a pound a week. (The math: 500 x 7 days = 3,500)

More related to this story

According to U.S. researches, this ubiquitous weight-loss rule is overly simple and overly optimistic. And it can lead to unrealistic expectations about how quickly you can achieve a weight-loss goal.

The rule contends that cutting 200 calories a day from your diet would lead to a loss of 20 pounds over the course of a year and the weight loss should keep on going. But in reality that doesn’t happen. Weight loss slows and eventually comes to halt despite the drop in calorie intake.

This past weekend, at the American Association for the Advancement of Science’s annual meeting in Vancouver, an international team of researchers unveiled a new formula to better predict how people will lose weight on a diet.

The 3,500-calorie assumption doesn’t account for how metabolism changes during weight loss.

Your metabolism is the rate at which your body burns calories, and it’s largely determined by how much muscle you have, since muscle burns more calories at rest than body fat. Ultimately, it’s your metabolism that dictates how easily you will lose or gain weight.

As the body slims down, metabolism slows, causing it to burn fewer calories at rest. A smaller body also burns fewer calories during exercise. The net result: a sluggish rate of weight loss that can frustrate dieters and cause them to abandon their plan.

Now health-care professionals and researchers have a tool to more accurately predict a dieter’s expected weight loss over time, based on changes to metabolism. Having a more realistic sense of what to expect can help people stay motivated over the long term.

The new formula and accompanying web-based model were developed by researchers from the U.S. National Institutes of Health, the World Health Organization, Columbia University and Harvard School of Public Health,

The online tool – called the Body Weight Simulator – requires people to input their age, gender, body weight, height, activity level and weight goal (bwsimulator.niddk.nih.gov).

It then simulates what diet and exercise changes are required to reach the goal weight and what changes are necessary to maintain it over time.

Using this model, the researchers found that people’s bodies adapt slowly to dietary changes.

For example, the average overweight person needs to cut 100 calories from their current intake per day to lose 10 pounds over three years.

Half of the weight will be lost in one year and then you’ll reach a plateau, slowly losing the remainder by three years.

In contrast, for the same calorie reduction, the 3,500-calorie formula predicts you’ll lose 10 pounds in one year – and 30 pounds by three years.

The Body Weight Simulator isn’t aimed at consumers. It’s intended to be used as a tool for doctors, dietitians and researchers to re-evaluate client goals and identify necessary diet and exercise changes to achieve a weight loss goal at a realistic pace.

The online tool also highlights a salient point: Even though weight loss slows down over time, you will continue to lose weight if you stick to your plan. That’s a positive message for anyone trying to lose weight.

It also emphasizes the need to abandon our quick-fix mentality. Permanent weight loss takes time and requires persistence, consistency and patience. Not easy, I know.

There are other reasons weight loss slows down that have nothing to do with metabolism. They’re related to human nature and they’re within your control.

If you’re experiencing a slowdown, the following strategies can help you pick up the pace.

Don’t let lapses accumulate.

You’re bound to fall off plan occasionally. Losing weight is not an all-or-nothing endeavour.

If you slip, don’t tell yourself “I’ll start again on Monday.” Instead, get back on track, the sooner the better. One small lapse won’t make a difference to the scale.

Rein in portion sizes.

It happens gradually. Instead of one cup of rice, you’re serving yourself 1.5 cups and an extra 100 calories. The chicken breast that not long ago was a precise four ounces, now weighs in at six ounces.

A few extra calories here and there add up and can make the difference between losing and holding steady. If this sounds familiar, measure and weigh your foods again.

Be mindful of extras.

An extra dessert, a few tastes while making dinner, a bite or two off your kid’s plate. Those extra calories can – and will – stall weight loss.

Twenty pounds ago you could get away with eating something extra here and there and still lose weight each week. But not any more. Keep in mind that smaller bodies burn fewer calories, so you have less leeway than before.

Resume keeping a food diary to see if extra calories are sneaking into your diet.

Be consistent on the weekend.

Larger meals, alcoholic beverages, and a few extra snacks on the weekend can cause the needle on the scale to jump Monday morning. You play catch-up during the week to lose those few pounds. Then the following weekend, you put a couple more back on. The end result: no progress.

If weekends are your trouble spot, keep a food diary Friday through Sunday.

Leslie Beck, a Toronto-based dietitian at the Medcan Clinic, is on CTV’s Canada AM every Wednesday. Her website is lesliebeck.com.

Read more:
The new weight-loss math