Diet Drug Orlistat (Xenical / alli) Better Choice Than Acomplia: British Experts

Claims that diet drug rimonabant (Acomplia / Zimulti) offers benefits beyond those associated with weight loss may not be justified, according to a new report by independent British medical experts.

The diet drug has been sold as Acomplia in the U.K. since June 2006 for treatment of obese and some overweight adults, and developer Sanofi Aventis has claimed some of the improvement in cardiometabolic risk factors observed in clinical trials cannot solely be attributed to weight loss.

Cardiometabolic risk factors -- including low HDL (good) cholesterol, high LDL (bad) cholesterol, elevated fat levels in the blood, high blood pressure and insulin resistance -- in combination increase a person's chance of developing heart disease and/or type 2 diabetes.

Acomplia "has a beneficial effect on blood glucose and lipid levels -- a more beneficial effect than would be expected from weight loss alone," Sanofi claims on its website.

But experts writing in the Drug and Therapeutics Bulletin (DTB), published by the British Medical Journal (BMJ) on May 30th, said there was no proof in the clinical trials that Acomplia had any beneficial effects outside those expected by weight loss.

"It might be related to increased activity based on the lifestyle advice given to participants at the start of the trials," according to their report. "Furthermore, it is not known whether rimonabant's effects on individual risk factors translate into a reduced long-term likelihood of cardiovascular events."

The experts said the trials also showed rimonabant to have no effect on LDL cholesterol and little or no effect on high blood pressure.

While the drug is available in the U.K., the country's National Institute for Health and Clinical Excellence (Nice) is still weighing whether and under what conditions the drug should be paid for by the National Health Service.

"Rimonabant has not been directly compared with other, less expensive, drug treatments for obesity. Also, as with these other treatments, it is not known whether rimonabant reduces the likelihood of obesity-related diseases, such as cardiovascular problems," the researchers concluded.

They said Xenical (orlistat) "is the drug for obesity for which there is the most evidence for efficacy and safety to date, and we have previously concluded that it is a reasonable option for obese patients where diet and exercise and/or behavioural measures alone have failed.

"On current evidence, we do not believe that rimonabant represents a significant advance for patients with obesity," they said.

Over The Counter - Alli Diet Pill

You won't lose weight in your sleep or shed pounds while eating anything you want - that's the sobering message from the maker of a weight loss pill poised to hit shelves next month.

While the cautionary marketing approach may not trigger stampedes to the counter, analysts say the drug's fate hinges on the pharmaceutical giant's ability to convince people that diet pills aren't a magic bullet. "People's hopes are ridiculously high when it comes to diet pills. That leads to disappointment and bad word of mouth," said Steven Brozak, an analyst with WBB Securities.

That's just what happened to the prescription version of the drug, Xenical by Roche Holding, which contains twice the dosage. People were let down when it failed to deliver dramatic results and the drug never really caught on, Brozak said.

GlaxoSmithKline has apparently learned the lesson and is counting on alli to become a star money maker. The company is spending $150 million on marketing alli this year, making it one of the drug maker's biggest campaigns to date. "We've done everything to go out of our way to be honest," said Steve Burton, vice president of the weight control division at GlaxoSmithKline Consumer Healthcare. "We're taking a very different approach than the fad diets people are constantly exposed to."

In clinical trials, the FDA says that people using alli lost an additional 2 to 3 pounds for every 5 pounds lost through diet and exercise. The FDA approved alli to be sold over the counter in February. When taken with meals, the drug blocks the absorption of about one-quarter of any fat consumed. That fat - about 150 to 200 calories worth - is passed out of the body, potentially resulting in loose stools.

About half of patients in trials experienced gastrointestinal side effects, including leakages and oily discharges. GlaxoSmithKline is frank about those unpleasant effects, which it says can be controlled if the drug is used properly. The campaign stresses the importance of keeping meals under 15 grams of fat to avoid effects.

Educational materials even recommend people start the program when they have a few days off work, or to bring an extra pair of pants to the office. Experts say a failure to adequately prepare consumers about the effects contributed to Xenical's limited success.

The alli event comes a day after the company's shares dropped almost 8 percent when a report this week found the company's widely prescribed diabetes pill raised the risk of heart attacks and possibly death. Some experts called it another Vioxx-like example of the U.S. government failing to protect people from an unsafe drug.

Glaxo shares rose 1.4 percent to $53.90 on Tuesday. The company estimates 5 million to 6 million Americans a year will buy the drug, translating to at least $1.5 billion a year in retail sales.

The drug will come in "starter kits" containing a food journal, a healthy eating guide and a fat and calorie reference guide. A 60-capsule kit will cost about $50 while a 90-capsule pack will cost about $60. Recommended usage is one to three pills daily.

Labeling indicates alli is appropriate for anybody who is overweight, or has a body mass index of 25 or higher. A body mass index over 30 is considered obese. Two-thirds of the U.S. population is estimated to be overweight or obese.

Just how many people find alli's benefits worth the cost of the drug is the "million dollar question," said Kelly Brownell, a food policy researcher at Yale University.

Diet drugs don't deliver the big results most people expect, and are only effective when used along with diet and exercise, Brownell said. The alli exhibit in New York City - featuring plates with sensible portion sizes and an interactive Web site - encapsulates the drug maker's marketing emphasis on that need for diet and exercise.

To prepare for alli's launch in mid-June, the company ran television spots directing viewers to a Web site where they could learn more about the drug. A retail book was also made available. The idea, Burton said, was to give "people some pause" and time to learn about the drug.

The message that alli isn't an easy fix marks a step in the right direction for pharmaceutical companies, said Michael Santoro, a professor of business ethics at Rutgers University. "One of the things we've seen so often in advertisements is that a drug can be an alternative to a healthy lifestyle," Santoro said. Still, he questioned whether a diet drug had any role in a campaign about healthy lifestyles.

Glaxo Vice President with new about to launch Alli Diet Pill

Steven Burton, vice president weight control division of GlaxoSmithKline Consumer Healthcare, displays a starter pack of alli, the first over-the-counter diet pill approved by the Food and Drug Administration, in New York, Tuesday, May 22, 2007. In clinical trials, the FDA says that people using alli lost an additional 2 to 3 pounds for every 5 pounds lost through diet and exercise. (AP Photo/Richard Drew)

Alli Debuts are all Set

Today, GlaxoSmithKline Consumer Healthcare introduces a new approach to weight loss that will debut through a public multi-media exhibit in New York City -- the alli(TM) Experience. The alli Experience represents part of GSK Consumer Healthcare's comprehensive educational program to prepare adults interested in losing weight with alli -- the only over-the-counter weight loss product approved by the U.S. Food and Drug Administration (FDA) -- before it goes on sale in pharmacies and mass retailers beginning on or about June 15. The alli Experience will be open daily beginning Tuesday, May 22 through Sunday, June 10, 2007, and is open Monday through Fridays from 11 a.m. until 6 p.m., Saturdays from 10 a.m. until 6 p.m. and Sundays from 11 a.m. to 5 p.m. The exhibit is located in New York City at 20 Union Square East

More than two-thirds of the U.S. population is overweight or obese, resulting in increased risk for serious diseases such as heart disease, diabetes, cancer and stroke. These serious health complications require the American public to take an honest look at the realities of weight loss. "We are here today to unveil the alli Experience and demonstrate our commitment to changing the way people think about weight loss," says Steven L. Burton, vice president, Weight Control, GlaxoSmithKline Consumer Healthcare. "People are fed up being bombarded with hyped products and fad diets that over promise and under deliver. Unlike all the hype, alli is about straight talk and an honest voice, being real about the fact that losing weight is hard work." Burton adds, "We are here to help and to partner with people who want to lose weight with a realistic approach. But we are not the total answer. The answer is individual commitment in partnership with alli, and all the support and education the alli program offers."

The alli Experience is designed to help overweight people revisit and engage the principles of modest, gradual weight loss. The exhibit, divided into five zones, begins with a sensory tour that leads to an interactive journey and multi-media education about weight loss realities. Each zone encourages visitors to embrace a more realistic approach to diet and exercise for improved health. Visitors receive meal planning ideas, delicious low-fat recipes and shopping lists with nutritious foods to help support a healthier lifestyle. The alli Experience will also help overweight people who want to lose weight determine if they are ready to commit to the alli program.

The alli Experience is open to anyone who is 18 years or older, as alli is for overweight adults. The exhibit will be closed Memorial Day. An online virtual tour of the exhibit will be available online beginning May 24 at myalli.com ( http://www.myalli.com/ ). For more information about alli and the alli program, go to http://www.myalli.com/ . About alli(TM)

alli, the only FDA-approved weight-loss product available to consumers without a prescription, combines a clinically-proven product with a comprehensive individualized action plan. The alli program encourages modest, gradual weight loss, known by experts as the best way to lose weight. alli is expected to be available in pharmacies and mass retailers nationwide beginning on or about June 15.

About GlaxoSmithKline Consumer Healthcare
GSK Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette(R), NicoDerm(R) CQ and Commit(R) as well as many medicine cabinet staples, including Abreva(R), Aquafresh(R), Sensodyne,(R) Tums(R) and Breathe Right(R).

About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com/ . GlaxoSmithKline Consumer Healthcare

Pills or Surgery for Weight Loss?

Lap-Band is short for laparoscopic adjustable gastric banding. It's an operation. Through small incisions in the abdomen, a surgeon inserts a viewing scope (laparoscope) and instruments with which he or she can encircle the top of the stomach with an adjustable band. That creates a small pouch for a stomach. People cannot eat large quantities of food. They fill up quickly. They lose weight.

The "pros" of this operation include a considerable weight loss, which brings protection against diabetes, high blood pressure and arthritic knees and hips. Cholesterol almost always drops.

The "cons" are the fact it is an operation, and all operations have the potential for complications. It requires anesthesia, another possible risk. The band might need readjusting down the road. There's always a threat of infection from any surgical procedure.

Orlistat has been around for some time and is sold as the prescription drug Xenical. Alli can be obtained without a prescription. It contains a smaller dose of orlistat. This medicine inhibits the intestinal enzyme lipase, which breaks up fat so that it can be digested. Less fat is absorbed. Weight is lost. A major "pro" for Alli is not having to undergo surgery. Some "cons" are possible loose stools, an increase in gas and a decreased absorption of vitamins A, D, E and K, which require fat to pass into the blood. That can be remedied by taking those vitamins in pill form.

Alli Diet Pill (Low-Dose Xenical) to Go on Sale June 15th

Diet pill alli (low-dose orlistat) will officially go on sale on June 15th, according to distributor GlaxoSmithKline Consumer Healthcare.

While the pricing of the drug has not been officially announced, a starter pack that includes 60 alli capsules (enough for three weeks assuming that you take one before each meal), the alli Shuttle (a carrying case for your pills), and several booklets including a calorie and fat counter and a daily journal is expected to cost between $50 and $60.

An alli starter pack that includes 90 alli capsules (enough for a month assuming that you take one before each meal) is expected to cost between $65 and $70.

An alli refill package -- consisting solely of 120 alli capsules (enough for 40 days) -- is expected to cost between $75 and $85.

Glaxo, meanwhile, has released the first two television commercials of what is ultimately expected to be a $100 million plus first-year blitz for the first FDA-approved over-the-counter diet drug.

Both of the first two commercials can be viewed by those who have missed them on television via the video sharing website YouTube.

As part of the prelaunch educational campaign for the diet pill that Glaxo agreed to at the insistence of the FDA, the first two commercials are very slick but soft-sell and are designed to push people to Glaxo's internet website, myalli.com, which is expected to play a major role in the company's marketing.

Sweden Girls waiting for Alli Diet Pill Arrival

Sweden is facing a surprising statistic: its girls are more likely to be overweight than are the boys. A study found that 4-year-old girls are six times more likely to be obese than they were 20 years ago, which is a much bigger jump than boys of the same age had. In 1982, 1 percent of all 4-year-olds were obese, compared to 2 percent of boys and 6 percent of girls in 2002. A similar discrepancy is found in 10-year-olds, but researchers don’t know why more girls are heavy

Researchers in America are looking at a new way to slow the rate of obesity by interviewing parents using a method popular for dealing with substance abuse. The technique, known as motivational interviewing, was used in a pilot program with 91 children of varying weights, all of whom had at least one obese parent. Some parents received a motivational interviewing session, while others received handouts or more intensive sessions with pediatricians or nutritionists. The difference in weight loss between the groups was not significant, but 94 percent of parents involved in the interviews said they helped them think about changing eating habits

One town in Massachusetts has recently completed a program to combat childhood obesity there. The Shape Up Somerville program was designed by researchers at Tufts University and involved a communitywide effort to make kids healthier. Initiatives included training school food service personnel, offering after-school cooking and physical activity classes, in-class nutrition and physical activity, and more. Students on average were prevented from gaining about a pound in an eight-month period, which doesn’t sound like much, but researchers say such small changes could have a big impact across the community

Alli, the new over-the-counter weight-loss pill from GlaxoSmith Kline that’s set to hit shelves next month, is not a miracle pill, nor is it being marketed like one. Ads and the website for the drug emphasize that people need to work to see results with the pill. The company wants people to know Alli is not intended to be another diet drug that’s heavy on promises but doesnt actually work

Finally, it seems a group of female students at Framingham State College thought better of their plan to wear tank tops and shorts to a women’s lacrosse game while sporting a player’s name spelled out on their bellies. The women are accused of stealing 1,000 copies of the school newspaper in which a picture of them appeared, apparently because they thought they looked fat. The adviser for the newspaper said the incident “is the most stupid reason the paper has been stolen.”

Alli Diet Pill needs no prescription but won't work without exercise and healthy eating

For many overweight Americans, the battle of the bulge didn't begin with great drama. Too many fast food dinners and long work hours that squeezed out time for exercise led to gradual weight gain and, eventually, a weight problem with serious health risks.

Within weeks, some of those pudgy Americans may reach for Alli, the nation's first over-the-counter diet remedy approved by the Food and Drug Administration. The manufacturer, GlaxoSmithKline Consumer Healthcare, has been strategically placing 1 million copies of self-help diet books that will sit on store shelves until late June, when they'll be replaced with packages of Alli as the diet pill goes on sale nationwide.

But for all of Glaxo's marketing might, Alli won't work unless consumers who buy it also commit to lifestyle changes. That means choosing healthy, low-fat diets and exercising. The trio maximizes weight loss: For every 10 pounds the overweight consumers would lose, adding Alli would increase that weight loss to 15 pounds. Alli alone won't do the job.

Ruth Tenofsky has already learned that lesson. The Jamaica Plain woman is working on losing an extra 10 pounds, on top of the 35 she's already shed. Tenofsky knows exactly how she put on that extra weight. After her son moved out of the house, Tenofsky, a real estate broker, and her husband frequently went out for dinner.

It didn't stop there. "I am a grazer by nature," she said. "I sort of figure if you eat it standing up, it doesn't count. I would eat a cracker. Only it wouldn't be a cracker, it would be the whole box."

A few months after those excess pounds dampened her enthusiasm for a vacation trip to the beach, she resolved to take action last fall with the assistance of Dr. Caroline Apovian , director of the Nutrition and Weight Management Center at Boston Medical Center.

"I said, 'I've got to learn to eat properly,' " recalled the 62-year-old. "Like a lot of women my age, we lose sense of what a portion size is." She lost the weight through a combination of improved diet, a commitment to exercise, and Xenical -- a prescription version of the drug that will be sold over the counter, at a lower dose, as Alli.

But Tenofsky does not credit swallowing a magic bullet for her magical transformation. She's on the treadmill two or three times a week and takes Pilates another two or three times a week. She's banished crackers and pretzels and replaced them with fresh fruit. She and her husband still eat out, but "grilled, steamed, broiled, sauce on the side" has become her mantra.

GlaxoSmithKline's gamble is that over-the-counter users will be as committed to lifestyle changes as Tenofsky is.

At 60 cents per pill, Alli helps burn 150 to 200 calories, about what you'd down in a quarter-cup of Ben & Jerry's New York Super Fudge Chunk ice cream. It's also the amount of calories one could burn for free, by taking a brisk walk for 15 minutes and gardening for another 15 minutes.

People will take Alli three times a day, with meals that contain about 15 grams of fat. (That's the amount of fat in two tablespoons of peanut butter.) Alli works by blocking fat absorption. Eat too much fat, however, and the drug's dreadful side effects can kick in: oily gas and such sudden, uncontrolled bowel movements. Glaxo suggests that new Alli users wear dark apparel and have a change of clothes ready.

Still, Edward Jones analyst Linda Bannister projects that Alli will carve out $200 million in annual sales, because Americans are hyper weight-conscious. "It's not for everyone," Apovian cautions. "It is certainly not for the person who wants to lose 10 pounds tomorrow -- no way."

Alli Diet Pill Book Launched

The makers of the first government-approved non-prescription weight loss drug have launched a book to help consumers maximize their weight loss potential by taking on a healthier lifestyle.

The book, Are You Losing It? Lose Weight Without Losing Your Mind, was born out of an agreement between GlaxoSmithKline, the nutritional supplement company that created the diet pill Alli, and the United States Food and Drug Administration. The federal food and drug regulator voiced concerns about the misconceptions consumers might have about how the pill actually works. The book, on supermarket and pharmacy shelves across the country, is meant to educate Alli users about the need for exercise and adopting a low-calorie diet.

Alli is expected to be available to the public this summer. The drug is designed to work by blocking the absorption of fat by the body and limiting the number of calories that are absorbed. Alli users are expected to lose up to 10 percent of their body weight when they use the pill in combination with a reduced calorie diet and an exercise program.

Book on Alli Diet Pill (Low-Dose Xenical) Now Appearing on Stores

The long anticipated launch of diet pill alli (low-dose Xenical) has now been preceded by launch of the new official alli book -- called "Are You Losing It? Losing Weight Without Losing Your Mind" -- which began making a May debut on shelves of grocery stores and pharmacies all across the country.

The book is part of the premarketing educational campaign for the diet pill agreed to by Glaxo Smith Kline before the Food and Drug Administration okayed alli as the first and only FDA-blessed weight-loss product that will be available to consumers without a prescription.

The FDA was insistent that consumers not be led to view alli as a "magic pill" but be educated to the need to combine it with a reduced-calorie diet and exercise program, and the book gives practical advice on behavioral changes, provides low-fat menu ideas and offers physical activity tips.

The book retails for $5.99 and Glaxo said consumers will find it -- as long as supplies last -- in the weight loss product aisle at stores nationwide including CVS, Walgreens, Kroger, Target and Wal-Mart.

"This book provides a much needed educational tool that takes you on a thoughtful journey about simple lifestyle changes that may deliver big health benefits," says Gary Foster, Ph.D., contributing author, director for the Center for Obesity Research and Education and professor at Temple University.

Other experts contributing to the book are:

• Dr. Caroline Apovian, director of the Center for Nutrition and Weight Management at Boston Medical Center .
• Kathleen Daelemans, a professional chef who focuses on healthy eating.
• Dr. Madelyn Fernstrom, director of the Weight Management Center at the University of Pittsburgh Medical Center .