Alli slimming pill safety under question

A new over-the-counter weight-loss drug called Alli may give people with eating disorders another tool to harm themselves, therapists fear.

Alli — pronounced “AL-eye” — is the only weight-loss medicine on the market approved by the federal Food and Drug Administration. It’s half the dose of the prescription drug orlistat, trade name Xenical, which is used to fight morbid obesity.

Dr. Randall Flanery, head of the Eating Disorders Program for the St. Louis Behavioral Medicine Institute, said the new drug is ripe for abuse because young people with eating disorders find the side effects of intense diarrhea and other gastrointestinal problems that empty the digestive system inviting.

People who use diet products to bolster their eating disorders “tend to take them at much higher dosages than recommended, as much as 10 times,” Flanery said. “It’s analogous to laxatives. People with eating disorders take 10 to 50 (laxative pills) at a time. They become dependent and take higher and higher dosages.”

Another danger is that the medicine is approved by the FDA “and people will believe that because it’s over-the-counter and FDA-approved, it must be safe,” Flanery said. “It’s not.”
The drug should be kept behind counters and monitored for distribution to make sure that at least teens don’t have access to it, Flanery said.

What is it?

The FDA approved Xenical nearly 10 years ago. It limits the absorption of fat so that the fat doesn’t enter the bloodstream as triglycerides. Triglycerides are used for fuel and are stored in fat cells. In excess, they clog the blood vessels and help cause heart attack, stroke and organ failure. They can elevate because you eat too much fat or because you have a disease such as diabetes.

The FDA approved Alli in February at 60 milligrams. (prescription-strength Xenical is sold in 120 mg capsules.) The manufacturer, GlaxoSmithKline, said in its advertising literature that the drug can increase weight loss by 50 percent if it’s used along with a reduction of fat intake and an increase in exercise.

But you can experience oily diarrhea, flatulence and other intestinal side effects.

Not unanimous

A weight-loss specialist said anything Alli can do can be done for a tiny fraction of the cost by medications that are easier to purchase by minors.

“There are a lot of cheaper ways to get diarrhea,” said Dr. Samuel Klein, head of the Weight Management Program at Washington University in
St. Louis. “This medication is $60.” That’s for 90 pills.

“It’s half the dosage (of the prescription version), and the manufacturer is marketing it responsibly as something that needs a change in lifestyle to work,” Klein said.

Also, he said, the gastrointestinal problems are bothersome enough that even someone with an eating disorder wouldn’t want to face them, especially with easier alternatives.

Eating disorders

Flanery’s concern is that people with anorexia nervosa and bulimia — about 1 percent of the female population younger than 24 and a growing number of men — use a bunch of tricks to get thinner.

The tricks include faking eating, taking laxatives, purging (vomiting a meal), isolating themselves and taking amphetamines to reduce appetites.

Debbi Kuehnel, a counselor and owner of the Eating Disorder Recovery Center, wants the drug to be taken off the market. People with eating disorders are as prone to trends as anyone, and Alli’s newness could be its attraction, she said.

“We already had a client who stole a bottle,” Kuehnel said. “She took 10 pills. They don’t care about the side effects.

“Putting this drug on the market was ridiculous,” she continued. “The ads say eat right, exercise and change your lifestyle and use the drug. You’ll lose weight if you eat right, exercise and change your lifestyle; you don’t need the drug.

“The prescription dose was meant for people who are morbidly obese; there’s no need to make it over-the-counter.”

Via http://www.holmencourier.com/articles/2007/08/23/news/drug.txt

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Alli executive promoter lost over 60 pounds with Alli

There will be no need to audition models for an ad campaign when Britain's largest drugs company launches its "next big thing" in America's $15bn (£8.4bn) diet industry.

The executive in charge of promoting GlaxoSmith-Kline's slimming wonderdrug, Alli, can supply his own "before and after" photos. He's been taking the pills for three years and has slimmed down by 60 pounds from his original 275 pounds. Steven Burton hopes the story of his personal battle with obesity will help Glaxo make money in a market that is unpredictable and prone to fads.

The drug works by preventing the body from absorbing about a third of the fat in meals and, as that fat has to go somewhere, users are prone to multiple visits to the loo and incontinence, it is claimed. Now, the Public Citizen, a consumer health group, argues that Alli could cause colon cancer. GSK denies the claim.

But they admit the side-effects may be off-putting. "I'll never forget having a fish sandwich and loading it up with tartar sauce and having French fries," says Mr Burton. The result was "a classic oops" and a dash home for a change of clothes.

But, as Mr Burton says: "I had a doctor who was telling me pretty bluntly that it was time to do something about my blood pressure and high cholesterol for the sake of my kids. That's pretty motivating."

GSK is making Mr Burton's warts-and-all account of the drug available at the start of a marketing campaign that will accelerate over the summer. That is when the company is expected to win approval to launch Alli over-the-counter in US pharmacies. The pill is currently available only on prescription, under the brand name Xenical.

GSK paid $100m for the US rights to Alli, so Mr Burton is under pressure.

The company knows that dieters swap their experiences of the latest pills, potions and meal-time strategies, so that the success of a new weight-loss aid will be determined more by word-of-mouth than by a traditional corporate marketing machine.

GSK is also experimenting with new viral marketing techniques. It is already trying to create an online community of dieters at its QuestionEverything.com website. This currently provides information and invites discussion on healthy lifestyles and existing dieting techniques, but when regulators give Alli the go-ahead, it will certainly start guiding them towards considering the product.

Public Citizen has put GSK on notice that its marketing techniques will be under scrutiny. The group wants Xenical banned.

Most of all, though, Mr Burton needs users to get to know how Alli works and how to use it in order to reduce the likelihood of unpleasant side-effects. He thinks that is done better through online discussions.

"If you don't stay with the program, you're at risk for things like having to go to the restroom more frequently. We don't want people to be surprised," he says.

Via news.independent.co.uk

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Alli clinical studies showed moderate weight loss efficacy

Orlistat, known by the brand name Alli, works by decreasing the amount of fat absorbed by the body. It is the OTC version of Xenical, a prescription weight loss pill. The good news: Orlistat has been tested and the prescription version has been used since 1999.

Last fall Dr. James Anderson, head of the UK College of Medicine Metabolic Research Group, and his colleagues examined the effects of OTC strength (60 mg) orlistat on mildly to moderately overweight individuals. The study was the first of its kind. Previously, the slimming pill's effects had only been studied in obese individuals. Study participants took either orlistat or a placebo three times daily with meals for 16 weeks. Results of that study showed those taking OTC-strength orlistat did lose more weight than those taking the placebo.

"Our research showed that people taking orlistat and following low-fat diets lost almost five percent of their initial body weight, about seven to15 pounds, over four months," Anderson said. "While two to four pounds a month isn't dramatic, steady weight loss of this amount can have major health benefits. For example, the reduction in LDL-cholesterol, the bad-guy cholesterol, of 10 percent can reduce risk of heart attack by 20 percent."

Any successful dieter knows that long-term weight loss is about lifestyle changes not quick fixes. While taking Alli slimming pill may help you lose weight, it won't do all of the work for you. Anderson stresses a healthy diet and exercise plan are absolutely necessary to lose the weight and keep it off.

"This is the first over-the-counter slimming pill that has proven effectiveness. It is my hope that people will take one capsule before each regular meal, breakfast, lunch, and supper, and alter their fat and calorie intake," Anderson said. "If they commit to exercise six days a week, most people can lose weight steadily. All of us are in this for the long haul and need to keep up healthy behaviors, not for days or weeks, but for months and years. Doing regular physical activity and making good food choices will help us be trimmer and give us more energy."

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Many doctors are not loyal to Alli

The recent debut of Alli, the first over-the-counter slimming pill approved by federal regulators, no doubt has some dieters dashing to drugstores and supermarkets. But shortly thereafter, critics warn, they'll be dashing to the bathroom.

Alli is a lower-dose version of the prescription drug Xenical, which blocks about 25 percent of fat from being absorbed into the body by attaching itself to fat-dissolving enzymes. Problem is, the unabsorbed fat then may exit forcefully and frequently.

"We have the makings of some very embarrassing moments," says Jeffrey Novick, nutrition director for the Pritikin Longevity Center & Spa in Aventura. "This is not new news. Just old news repackaged."

Dr. Andrew Larson, bariatric surgeon at JFK Medical Center in Atlantis, isn't an Alli fan, either.

"I think it's going to be a total flop," he says. "Some people might expect a little buzz, like you'd get with Dexatrim or other diet pills. But with this, you're not going to feel anything — except the side effects."

Alli literature states: "While no one likes experiencing treatment effects, they might help you think twice about eating questionable fat content. If you think of it like that, Alli can act like a security guard for your late-night cravings."

An article in last week's Wall Street Journal, meanwhile, gives potential buyers some math to chew on:

A half-cup serving of Häagen-Dazs ice cream has about 320 calories and 19 grams of fat. Alli, which is taken with meals, would stop the body from absorbing about 4.75 fat grams or about 43 calories.

If you consume 2,000 calories a day and eat 30 percent fat, the fat-blocking benefits of Alli would translate to approximately 150 calories a day. A pound of weight loss equals 3,500 calories.

Critics insist that if you're committed to healthier eating and exercise, like Alli recommends, you don't need the drug.

"Why bother?" says Dr. Kenneth Woliner, a family practitioner in Boca Raton. "The only advantage of this pill is if you can't stop yourself from eating regular cheese or the skin off a chicken. You'll quickly regret it. But if you cut out the fat, you're doing what you need to do anyway."

Xenical (generically known as orlistat) has been available in 120-milligram pills since 1999, with prescriptions falling from 1.5 million in 2002 to 623,000 four years later. GlaxoSmith Kline acquired the over-the-counter rights from Roche in February and spent $150 million aggressively marketing Alli, which hit stores June 14.

There's an Alli book, Are You Losing It?, with diet tips and low-calorie recipes. And www.myalli.com offers a message board and personalized action plan.

GlaxoSmithKline says dieters can lose 50 percent more weight with Alli (pronounced AL-eye) than with dieting alone. The 60-milligram pill, taken three times a day, doesn't suppress appetite or affect the brain.

But doctors are concerned that Alli, approved by the U.S. Food and Drug Administration for adults 18 and older, also may block absorption of fat-soluble vitamins, such as A, D, E and K.

"Low vitamin D can push you toward dry skin, psoriasis, depression and cancer," Woliner says, adding that the drug doesn't distinguish between "bad" fats and "good" ones, such as the essential fatty acids found in fish oil.

Insufficient vitamin D also may raise the risk of brittle bones, gum disease and diabetes.

Woliner predicts that consumers will buy Alli only once or twice, which still means a hefty payday for GlaxoSmithKline.

Walgreens and CVS, for example, charge $49.99 for a 60-pill starter pack and $59.99 for 90 pills. Publix charges $46.99 for the starter pack and $69.95 for 120 pills.

"I don't think it's going to be a success," Larson says, advising people to eat more fiber and choose healthier foods instead. "I personally don't like it at all. It's a weak pill."

Via www.palmbeachpost.com