Israeli scientist develops new slimming drug

It's no secret that obesity statistics are on the rise, and along with them the likelihood of many more people developing heart disease and diabetes. And while the late Anna Nicole Smith helped to popularize the slimming pills in America, these pills are known for having side effects that can wreak havoc with one's health.

In response to this dilemma, Israeli researcher Dr. Nir Barak has developed what could be a weight-loss wonder drug. Working with drug company Obecure, Barak has developed a new formulation called Histalean which is based on betahistine, an approved drug marketed worldwide for the treatment of vertigo. Betahistine has been available to health authorities for over 30 years and is therefore already FDA-approved.

Histalean has been found to quell the desire to consume fatty foods, particularly in women under the age of 50. The pill works by activating chemical agents that reduce appetite. The most recent double-blind placebo-controlled study included 281patients, men and women aged 18-65, with a BMI ranging from 30 to 40. This study revealed the effects of gender and age on the pill's response.


Now, says Obecure CEO Dr. Yaffa Beck, studies of the drug will focus primarily on women under 50, since this approach seems to work best due to the presence of estrogen.


Barak is a physician in Beilinson Hospital in Petah Tikva and an instructor at Tel Aviv University's Sackler School of Medicine. While one of Barak's areas of expertise is internal medicine, he is also a US certified expert in clinical nutrition, which he practiced for two years in the University of Chicago Hospital.

"I treat people with obesity, and I also treat people who can't eat anything and rely on intravenous feedings," says Barak. "I see both ends of the spectrum."

Barak explains that Histalean is unique in comparison to other diet pills because it focuses on the histamine system, which scientists associated for years with the immune system. It's only recently that scientists began to connect the histamine system with dietary behavior, and Histalean is the only drug of its kind that has been tested safely on humans.

Barak also cautions that while he has high hopes for Histalean, there may be a long road ahead to developing an encompassing cure for obesity, because dietary behavior is more complex than it appears on the surface.

"I don't think there's one magic pill," he says. "Every individual probably has a mixture of certain mechanisms that drive them to overeat... Once we have an arsenal of four or five drugs that work on different mechanisms, then we'll be able to start managing people more efficiently when it comes to diet."

Another area that excites Barak is the possibility that Histalean can prevent weight gain in schizophrenic patients who take the anti-psychotic drug Zyprexa. This powerful medication has significant results for schizophrenia, but also causes devastating weight gain in patients, to the extent that they may sometimes gain as much as a kilo per week. Histalean activates the same appetite-reducing chemicals which are blocked by Zyprexa, leading Barak to believe that Histalean can be developed to prevent this side effect of the drug.

"The patients are gaining weight to the degree that they develop diabetes," says Barak. "This is really a very urgent problem. Schizophrenia is among the most debilitating diseases that there are-it affects every aspect of life." Coping with this debilitating illness and obesity simultaneously can be a cruel ordeal for patients, who often opt to go off their medication or switch to an older medication which causes a Parkinson's-like disease. "They would rather have Parkinson's than be obese," comments Barak.

This chance to ease the lives of people who are already under tremendous strain is attractive to Barak. "As a physician, it's very appealing for me," he says. "There's a real need here to solve an urgent medical problem-a real problem, not a cosmetic one."

www.israel21c.org

Proactol VS Alli

Most effective weight loss pills

What about Alli side effects?

How badly do you want to be skinny? Is it worth soiling your underwear?

Those questions will likely confront users of the new Alli, the first over-the-counter slimming pill approved by the U.S. Food and Drug Administration.

Its marketing effort makes an impression by telling users to wear dark pants and carry extra clothes in case they soil themselves.

"Well, that sounds attractive, doesn't it?" Jay Leno cracked June 25 on "The Tonight Show." "You lost a couple of pounds, and you're on a date with that special girl. 'Excuse me while I change my pants. "

NBC's Conan O'Brien also spoke up to pooh-pooh Alli, suggesting that "the drug comes in three forms: pills, capsules and chimichangas."

The slimming pill's backers say that the embarrassment is exaggerated and that the effects can be managed by a low-fat diet.

Only half of all users had "fecal urgency" or related effects in clinical trials, and just 5 percent quit for those reasons, said Vidhu Bansal, director of medical affairs for GlaxoSmithKline's consumer health division.

"They actually served as a positive feedback tool," she said. "It reminded them that they cheated on their diet."

Caroline Apovian, a Boston physician who wrote "The Alli Diet Plan," which shows how to minimize problems by eating low-fat foods, said she did not understand the shame people might feel over losing bowel control. "It's also embarrassing to be obese," said Apovian, who was a paid consultant to GlaxoSmithKline in getting Alli approved for over-the-counter sales. "It's embarrassing to be dead."

GlaxoSmithKline executives are pitching Alli as part of a lifestyle change, which includes a commitment to eat better and exercise more. Users can log in their progress on the slimming pill's Web site www.myalli.com and interact with other customers or ask questions of a pharmacist, a nutritionist, a chef and a fitness specialist.

The firm, with a U.S. headquarters in Philadelphia, paid $100 million to Xenical's maker, Roche, for the rights to sell Alli over the counter. GlaxoSmithKline is spending an additional $150 million in a marketing campaign that includes a 60-second television ad and print ads appearing this month in most major magazines, read by 33 million people.

Bill Trombetta, professor of pharmaceutical marketing at St. Joseph's University in Philadelphia, said the comedians' attention has an initial upside. "They got your attention. This is on everyone's lips," he said. "You can't buy this kind of publicity."

But will the exposure move people to try it?

Maybe at first, said Kelly Brownell, who directs the Yale Center for Eating and Weight Disorders. But he predicts "sales will tail off fairly quickly."

"The people who will try it won't lose much weight and won't provide very good word-of-mouth," he said.

"Both the benefits and the side effects are overstated," Brownell added. "It's not going to hurt many people, and it's not going to help many people."

Marion Nestle, a nutrition professor at New York University and a frequent critic of the food industry, noted that many users may replace fat calories by eating more carbohydrates. "A lot of Alli takers will do that and wonder why they aren't losing weight," she wrote in an e-mail.

The early results are sketchy.

In the California beach town of Santa Monica, a Los Angeles Times reporter found that Alli bottles were flying off store shelves.

But in Philadelphia, once dubbed the nation's fattest city, Alli's arrival appeared to be less of a sensation.

"We do have it in stock. No one has inquired about it," pharmacist Maria Taylor at Narberth Pharmacy, said last week, echoing several other Philadelphia-area pharmacists. "Maybe it should come with a coupon for Depends," the adult diaper.

Alli contains 60 milligrams of orlistat - half the amount found in prescription Xenical. The over-the-counter version is taken three times a day with meals and costs from $60 to $67 for a month's supply. A year's worth costs at least $720.

The prescription drug's U.S. sales have been fading, from $135 million in 2002 to $93 million last year.

Despite the fact that obesity rates are surging, an effective slimming pill remains elusive. "Eating is so fundamental for human existence that the body has multiple redundant systems," said Gary D. Foster, who directs Temple University's Center for Obesity Research and Education and was a consultant to GlaxoSmithKline for its Alli Web site. "So if you block one pathway, it's evolutionarily smart to have a backup."

Alli works by blocking the digestive enzyme lipase, which aids in fat absorption. The firm estimates that Alli blocks about 25 percent of the fat that reaches the gut.

But too much fat can cause oily discharges. "You may recognize it as something that looks like the oil on top of a pizza," an Alli brochure says cheerily.

That is what happened to Paula Miguel, 35, of Hopatcong, N.J. She was one of 400 people picked by the drug firm to receive a six-month supply of Alli for free.

She said it was hardest the first week to establish her routine to walk more and eat better.

She felt a strong urge to go after downing some greasy crab cakes at a friend's house. "When I went to the bathroom, it was orangey, like an oil," she said.

But, she said, that happened only once since she began April 18. Overall, she said, she has lost 23 pounds, falling to 170 pounds on her 5-foot-3 frame. "It's not as bad as they say," said Miguel. "I eat better ... I'm more active. For me, it works fine."

The company said users could expect to lose an average of 10 pounds in a year. But that's high, independent experts say. The more potent prescription version helped participants lose an average of 6.3 pounds by the end of a year, according to researchers who analyzed 50 studies for a 2005 article in the Annals of Internal Medicine.

Paul Woolf, chairman of the department of medicine at Crozer-Chester Medical Center in Chester, Pa., was on the FDA advisory committee that in 2006 recommended that Alli be freed from prescription status.

He called Alli "a real niche product" that causes modest weight loss.

"No one is going to abuse it," he said. "They're going to be very unhappy if they do."

Via South Bend Tribune

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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

Best weight loss pills article

Alli slimming pill hits stores - experts warn of side effects, misuse

For two years, George Hegedus has avoided expensive diet plans and made it to the gym barely three times a week. At 270 pounds, the Coconut Creek, Fla., resident said he needs something to help combat the fat calories.

So when alli, the first federally approved over-the-counter slimming pill, hit South Florida drugstore shelves Thursday, he drove to a Walgreens store on his lunch hour and bought a starter pack: 90 pills at $59.99.

"I hope it helps take calories off, but it's not a magic pill," said Hegedus, 42, a structural engineer.

South Florida drugstores reported growing consumer interest in the new slimming pill, which is being rolled out nationwide this week with an unprecedented $150 million marketing campaign. Although the drug has been available at greater strength by prescription since 1999, this is the first time it is available over the counter to overweight adults.

The pill works by blocking about 25 percent of the body's absorption of fat in the digestive system by attaching to natural enzymes that would otherwise break down fat.

Alli's London-based manufacturer, GlaxoSmithKline, recommends taking it along with a low-fat diet and exercise. Consumers who don't stick to a low-fat diet can experience some unpleasant side effects, such as oily discharge, diarrhea and gas.

The Food and Drug Administration approved the pill in February, at half the strength of its prescription version, sold under the name Xenical. GlaxoSmithKline is promoting the pill with books, a TV commercial and educational CDs.

Drugstore representatives said many consumers were putting in pre-orders for the drug before it hit the shelves Thursday.

"We've been getting a lot of calls and we've taken a number of pre-orders through the Web site," said Carol Hively, a spokeswoman for Walgreens. "We expect this to be a big product."
But dieticians and pharmacists say that, despite the buzz, it does not change the classic formula for weight loss: eating less and moving more.

Jan Schuman, a pharmacist at Boca Pharmacy, said the key to losing weight is behavior modification.

"I'm on a diet now. I'm exercising and can do without alli," Schuman said. "I don't eat that much fat."

Schuman said taking alli and having a high calorie intake is like diabetics eating sugary foods and injecting more insulin into their bodies. He urges people not to "play a game" with themselves by thinking the pill will solve their problem, and instead focus on a good diet and exercise.

GlaxoSmithKline mailed fliers and educational material to drugstores, but Schuman said he has not heard from the company on counseling those who buy alli.

Via SunHerald.com

Actually alli is half strengh of Xenical slimming pill which is well known and proved efficacy although many people noticed side effects. Alli does have the same side effects like Xenical.

Here they are:

• loose stools
• too-frequent stools
• uncontrollable bowel movements
• gas with an oily discharge

Natural fat binder Proactol showed approximately the same efficacy in blocking fats like alli, except for no side effects noticed from testers who took it.

People using Proactol since February 2007 (the month it's become available for public) also noticed no side effects and increased weight loss rate as compared to routines without taking Proactol.

It seems natural because Proactol active ingredient is based on Opuntia Ficus Indica fiber, known for thousands of years for it's strong binding capacities. Scientific researches by Bio Serae Laboratories discovered great fat binding power of Neopuntia (made from the fiber) and several clinical studies proved that it can be used for safe weight loss.

So make your choice towards natural and safe weight loss aid and please remember that if other people reach weight loss success it's available for you too!

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