2 replies to this topic

[doug123]

wistv.com: News Source



Pills could help weight loss - but with side effects

June 15, 2007 01:56 PM PDT

NATIONAL (NBC) - Americans are constantly trying to find a "magic" pill that will help them lose weight - and they may soon have two options, although a little work is required.

Wednesday an FDA advisory panel will review information on the drug Rimonabant - already marketed in Europe under the brand name Acomplia.

Studies found obese patients with at least one heart risk factor lost 15 pounds over a year while taking the pill and keeping a healthy diet and exercise routine.

Another pill, called Alli, is set to hit store shelves this week. This pill is available over-the-counter and works by stopping fat from being absorbed by the body.

Registered dietician Cindy Moore says, "This diet pill is going to help reduce the absorption of fat, when someone eats a meal that contains fat. About one-quarter or 25 percent of the fat won't be absorbed by the body."

Both pills only work when combined with diet and exercise, and they come with side effects.

Alli can cause loose stools and diarrhea when consumers eat foods high in fat. Rimonabant may increase suicidal thoughts and behavior - a topic that will be reviewed extensively at Wednesday's panel meeting.

Posted by Chantelle Janelle

[doug123]

Here's an update on this story:

Orlando Sentinel: News Source



FDA-approved weight-loss pill not wonder drug, maker says
The fact that Alli works best with diet and exercise -- and comes with unpleasant side effects -- could dampen sales.
Linda Shrieves
Sentinel Staff Writer

June 16, 2007

Customers across Central Florida and the nation flocked to drugstores Friday to buy Alli -- the first over-the-counter weight-loss drug approved by the Food and Drug Administration.

"It's been flying off the shelves," said Nathan Taylor, executive assistant at a Walgreens Drugstore in Oviedo, where the introductory packets sold out Friday -- the day stores nationwide unveiled the drug. "I've never seen a product launch like this."

The drug, the over-the-counter cousin of prescription Xenical, works by blocking the absorption of fat in the intestines.

But Alli's maker, GlaxoSmithKline, has taken a unique marketing approach. Rather than promote Alli (pronounced "ally") as a wonder drug, the manufacturer is telling people that the drug is designed to work with diet and exercise.

"It is for committed individuals, people committed to a low-fat, reduced-calorie diet," said Malesia Dunn, a company spokeswoman. "It's not for people trying to lose a couple of pounds for a high-school reunion or trying to fit into a bathing suit."

The company says the drug, which costs about $50 for a one-month starter pack of 90 pills, will help dieters lose 50 percent more weight than dieting alone -- so dieters who lose 10 pounds through diet and exercise could conceivably lose 15 pounds by taking the drug with their regimen.

University of Florida pharmacy professor Paul Doering applauded GlaxoSmithKline's sensible marketing approach, but he wonders whether Alli's unpleasant side effects could torpedo sales.

"If you eat a big fatty meal, and it's not being absorbed, there's only one place for it to leave the body -- by flatulence, bloating and oily leakage," says Doering.

Even the downside, Doering said, has been given a positive spin. "The company says if you find you have excess flatulence and leaking, that's God's way of telling you you're eating too much fat," Doering said. "If you eat less fat, it will work better."

For many dieters, it could be worth the gamble.

Linda Shroll, who was at Walgreens on Friday, heard the manager talking about the product and grabbed the store's last box.

"I've tried a zillion ways to lose weight," said Shroll, 39. "I'm still trying to lose the last of the baby weight" -- though her youngest is now 4 years old.

"It just goes to show that everybody's looking for a miracle," Shroll said. "But the miracle is: It only works with diet and exercise."

Linda Shrieves can be reached at lshrieves@orlandosentinel.com or 407-420-5433.
Copyright © 2007

[sick]

[doug123]

Another outlook:

InsideBayArea.com: News Source



Experts wary of new diet pill
Oily anal leakage a side effect of Alli
By Barbara Feder Ostrov and Saqib Rahim, MEDIANEWS STAFF
Inside Bay Area
Article Last Updated:06/16/2007 02:53:30 AM PDT

Vivian Cota leaned on her shopping cart in the diet aisle of a San Jose Walgreens, eyeing the thick, locked plastic case labeled "Alli."

She has tried numerous other boxes on this shelf — the green tea supplements, the 10-day Hoodia diet. And now it's time for something new.

"I'm very interested in this," said the 65-year-old San Jose woman, unhappy that the drug couldn't be purchased until Friday. "You reach a plateau, and then you have to try something else."

As Alli, the first FDA-approved diet drug cleared for over-the-counter sale, arrived Friday in drugstores nationwide, doctors and nutritionists were trying to counter that intense consumer interest and a marketing juggernaut with some spin of their own, arguing that the drug's high cost and limited effectiveness may not be worth its notably unpleasant side effects.

Alli (pronounced "ally"), sold by GlaxoSmithKline, is a half-dose of the prescription drug orlistat. The drug has been marketed in prescription form by Roche Holding AG under the brand name Xenical since 1999, but it never turned out to be a blockbuster.

GlaxoSmithKline, however, expects Alli ultimately to rake in at least $1.5billion in annual sales, and the company is expected to spend $150million on marketing the drug in its first year. Television and magazine ads are running. E-tailers Amazon.com and Drugstore.com report that the drug, which has been pre-sold, already is a top seller — even at a cost of $50 to $60 for a month's supply.

Alli blocks enzymes that digest fat, preventing the body from absorbing about a quarter of the fat eaten. The undigested fat is then excreted. One study of Alli showed that dieters who took the drug along with diet and exercise over a year lost about three pounds more than people who only dieted and exercised.

The company's message is that the pills are not a "magic bullet," and officials urge users to use Alli only along with exercise and a reduced-calorie, low-fat diet.

Because Alli can interfere with vitamin absorption, it can affect how medications act in the body. The drug is not recommended for children under 18, people with kidney disease, patients on blood thinners and certain other medications, and pregnant or breast-feeding women.

Then there are the side effects, which can include oily discharge, diarrhea and uncontrollable bowel movements significant enough for the company to recommend carrying an extra pair of pants until users have acclimated to the drug. The side effects alone can force users to eat less.

"We're skeptical about something like this going over the counter," said Dr. Rohini Ashok, a Kaiser Permanente-Santa Teresa physician and a leader of the HMO's new, doctor-supervised weight loss program. "It's not an unsafe drug, but it's not benign. The side effects are pretty gross."

Ashok says that while the drug may be helpful for a small group of people, many Kaiser Permanente patients who have taken the prescription version of Alli generally do not refill their first prescription because they can't tolerate the side effects.

For now, Kaiser will not sell Alli as an over-the-counter product in its pharmacies, she said.

As the American population grows ever fatter — about 65 percent of adults are either overweight or obese — pharmaceutical firms have tried to create a diet pill that is safe and effective, with only minimal success. A previous drug combination popularly known as fen-phen was pulled from the market in 1997 after reports of heart valve damage.

Earlier this week, an advisory committee to the U.S. Food and Drug Administration recommended against approval of the diet drug Acomplia, which has been approved in Europe but increases the risk of suicidal thoughts.

At a Weight Watchers meeting in San Jose on Thursday, Stephanie Vose, 23, said that she and her friends had tried numerous diet fads over the years, only to experience strange side effects such as shaking or bursts of energy.

"It's not like it taught you how to eat right," Vose said. "So it all comes right back."

Was Alli worth a try, given its unpleasant side effects? No way, Vose said. "That's disgusting," she said. "I would not take that."

Doctors and nutritionists wish more of their patients shared Vose's attitude and willingness to try dieting the hard way: The Weight Watchers program emphasizes portion control, exercise and slow, long-term weight loss.

"I'm sure (Alli) is not the solution to the obesity epidemic," said Christopher Gardner, a Stanford University Medical School nutrition researcher.

He painted a glum picture of how a stint with Alli might go:

The dieter starts out taking the drug, but doesn't change her diet. Gradually, she begins to lose weight, because her body isn't absorbing all of the fat she eats. Eventually, she achieves her goal and stops taking the drug. But she's in for a surprise — since she never changed her diet, her body will now absorb the fat that Alli helped reject, and her weight will balloon to where it was before.

This trap looks a lot like the ones from previous drugs, which have often worked for a small group of people and failed for everybody else, he said.

"If we had a great way for everybody to lose weight, we wouldn't need to have any of these discussions," Gardner said.

His suggestion? The usual: "Just eat less and exercise more."

Barbara Feder Ostrov can be reached at (408) 920-5064.

Oh, and here's a...well...messier version of the story:

FDA approved diet pill known to cause “Exploding Hershey Squirts.” Enjoy.

This still deserves the nasty emotion though. [sick]