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Diet Drug Acomplia Sales Dwarfed by Initial Sales of Diet Pill alli

Add comment August 2nd, 2007

Just how badly sales of diet drug Acomplia (rimonabant) have been set back by Sanofi’s inability to bring it to the U.S. market was dramatically illustrated July 25th when GlaxoSmithKline revealed initial launch results for over-the-counter diet pill alli (low-dose Xenical).

Sales of non-prescription alli totaled a surprising $156 million in the weeks after its U.S. launch in mid-June — a sales surge that dwarfs the monthly sales of Acomplia in all the countries where it is on the market in the European Union.

If most of the alli sales were to people initially buying a one-month supply of the over-the-counter diet pill, the sales figure would suggest that more than 1 million Americans decided to try these non-prescription weight-loss product in its first weeks on the market.

By contrast, in the European Union, where Acomplia was approved for sale last summer, somewhere between 100,000 and 200,000 are believed to have tried it over the course of a year.

Sanofi had initially hoped that Acomplia — which was to be sold in the United States as Zimulti — would be a blockbuster drug with sales that could even exceed $5 billion worldwide.

But without the U.S. market, it appears that Sanofi will be fortunate if sales in Europe and other countries where it has been approved total one-tenth of that.
Glaxo, in announcing sales results for alli as part of its report on second-quarter earnings, said its big advertising and promotion campaign paid off with more than 2.4 billion.

Glaxo also said that it had recorded more than 4.5 million visits to its website — myalli.com — making it the third-most visited website for any over-the-counter pharmaceutical product.

Acomplia is currently marketed in 13 European Union nations as well as in Argentina, Mexico and a handful of other countries.

Gastric band weight loss surgery now being performed on underage teenagers

Add comment July 19th, 2007

With the increase in obesity among children, some parents are turning to a relatively unexplored solution with their offspring: stomach stapling. Stomach surgeries have been around for years, and its popularity has surged among adults in recent years – going from 12,775 to 70,256 surgeries in the U.S. from 1998 to 2002, according to the monthly Archives of Surgery journal. More recently, that number has increased to more than 120,000 a year.

But what about children? In 2004, only 350 kids in America had such an operation, according to federal statistics. Doctors have been hesitant to do the surgeries for more than one reason: for one, most stomach surgeries cut the stomach to make it operate as smaller “pouch,” which has unknown health risks to a developing child — the death rate among kids who do the surgery is around 1 in 50, which is twice the death rate among adults who have bariatric surgery.

As well, childhood obesity was not nearly as prevalent in American society compared to today. However, while bellies have grown, so has interest in the surgeries.

Mike Adams, a consumer health advocate who has written numerous health books, says the increase in bariatric surgery is a disappointing barometer regarding the future of America’s health.

“It’s disgusting that surgeons are now targeting young teens for bariatric surgeries, given that the real solution to childhood obesity can never be addressed by maiming a child’s digestive system,” Adams said.

“The way to deal with obesity is to teach nutrition, ban junk food advertising, remove vending machines from schools and end the manipulation of our children’s health by food and soda companies.”

In July, the federal Agency for Healthcare Research and Quality hat said four in 10 weight-loss surgery patients develop problematic complications within six months after the surgery.

Incidentally, with the increase in surgeries comes an increase in cost to private health insurance companies – according to the University of Michigan Health System, in the year 2002 hospitals charged roughly $2 billion for the cost for more than 70,000 surgeries. Health insurers picked up the tab for 80 percent of that cost.

These costs are then often spread to other policyholders covered by the insurer.

Going to a hospital for stomach surgery costs an average of $29,000, a study by the UMHS showed.

Weight-loss drugs and supplements can have side effects

Add comment July 18th, 2007

Question: I have heard a lot about a new over-the-counter weight-loss drug. Is it safe and how do I know if I am a good candidate?

Answer: The new drug on the market is Alli. It is the first over-the-counter weight-loss drug.

However, this new drug has been tested. I still warn you to be cautious since many drugs have side effects and interactions that are not found until the drug has been used for some time.

The drug, Alli, claims to help you lose 50 percent more weight than what you would lose on just exercise and diet alone. It is not suggested for use by those who need to lose only a few pounds. Alli is a drug that blocks the absorption of fat by the body. This can lessen the amount of calories that your body absorbs and thus, helps you lose weight.

It works as an enzyme that attaches to the fat molecules that enter your body. It blocks about a quarter of the amount of fat absorbed as calories.

What isn’t absorbed is carried out of the body. Therefore, if you eat too much fat in your diet, the excess fat can leave your body in a not-too-pleasant way.

There are side effects to this weight-loss plan. These are some of the side effects that lists: Gas with oily spotting, loose stools and more frequent stools that may be hard to control.

Those effects may not be worth the added weight loss. So I highly recommend that you try a reduced-calorie diet and a healthy dose of exercise first. The Alli weight loss plan includes daily pills as well as tailored eating plan found on the Web site.

Once you purchase the package, you will be able to register for myalliplan for free. You can also take a quick quiz on the Web site to see if you are a good candidate.

General questions are if you are: willing to try to lose weight gradually, committed to eating a low-calorie, low-fat diet (15 grams or less a day), committed to eating smaller portions, understand the possible side effects, make more time to be physically active and if you will read the label and follow directions properly. It is also recommended that you only do this program if you have significant weight to lose.

As with any weight-loss program, you should consult with your physician before starting.

There are other fat blocking-supplements and drugs, including Orlistat, that you have to get through a prescription, and chitosan, which is derived from shellfish. Do your research and remember that many weight-loss supplements are not tested and have a greater risk for side effects and improper ingredients.

Another thing to consider is the cost. You can take up to three capsules a day and the starter pack contains 90 capsules. The starter pack costs roughly $60 and the refill container contains 60 capsules at about $50. That between $2 and $2.50 a day.

If you decide to try this plan, then make sure you change your lifestyle habits so that when you quit the program, you can maintain your weight loss and control the things that got you where you are.

It is imperative that you find ways to change lifestyle habits and if a program like this can help you lower your calories and fat intake, then it is helping you gain some control and balance. Make sure that the program leads you be to a healthier person inside and out.

Alli Can’t Do It All: Pills May Increase Unhealthy Behavior

Add comment July 16th, 2007

On one hand, GlaxoSmithKline really, really wants you to take their new over-the-counter diet pill, alli. On the other hand, they don’t want you to abandon healthy habits in favor of pill popping.

Unfortunately, according to a recent study, that’s what happens: Consumers considering taking a drug for a condition are likely to give up on the healthy habits that are also necessary to change that condition. They tend to think that they needn’t bother with a healthy lifestyle because the pill will do the job for them.

Even worse, the idea of drugs appears to weaken their conviction that they can actually manage a healthy lifestyle. (Oddly enough, health supplements don’t cause the same erosion of healthy habits, apparently because people take them on faith and see them as natural, not as scientific panaceas.)

So while the company wants to convince you that their pill’s a wonderful thing, they dare not market it as a cure-all for fear that consumers will just rest on the pill’s laurels and head for McDonald’s. They are addressing this by describing alli as a “pill with a plan,” a whole program that “requires a commitment to living your life in a new way as you learn to change your eating and activity habits.”

The study authors, from the Pennsylvania School of Medicine and the Wharton School of Business, believe that other pharmaceutical companies may follow Glaxo’s lead, playing up the role of lifestyle changes as a necessary companion of drug-taking instead of marketing their pills as the magic solution to every problem. We’ll see.

Being overweight ups risk of colon cancer

Add comment July 9th, 2007

For men, the risk of colon cancer increases with body weight in a nearly linear manner, a study shows. For women, the risk is more variable but still trends upward, particularly for those younger than age 67.

The findings highlight the importance of weight control for colon cancer prevention, Dr. Kenneth F. Adams, of the National Institutes of Health in Rockville, Maryland, and colleagues conclude in a report in the American Journal of Epidemiology.

They examined the association between body mass index (BMI) and colorectal cancer incidence in 307,708 men and 209,436 women enrolled in the NIH-AARP Diet and Health Study. BMI, a standard measure to determine obesity, is calculated using weight and height. A BMI of more than 25 is considered overweight, and more than 30 is obese.

The men and women were followed from 1995 to 2000. During that time, a total of 2,314 men and 1,029 women developed colorectal cancer. An association was observed between BMI and an increased risk of colon cancer, but not rectal cancer, for both men and women.

For example, men who were overweight with a BMI of 25 to less than 27.5 had a 22 percent increased risk of developing colon cancer, compared to men of normal weight. Overweight men with a BMI of 27.5 to less than 30 had a 44 percent increased risk of colon cancer.

In obese men with BMIs of 30 to 32.5, 32.5 to less than 35, 35 to less than 40, and 40 or more, the risk of colon cancer was 53 percent, 57 percent, 71 percent, and more than 2-fold higher, respectively, relative to normal weight men.

For women, being overweight with a BMI of 25 to less than 27.5 was associated with a 29 percent increased risk of colon cancer. Overweight women with a BMI of 27.5 to less than 30 had a 31 percent increased risk of developing colon cancer.

In obese women with BMIs of 30 to 32.5, 32.5 to less than 35, 35 to less than 40, and 40 or more, the risk of colon cancer was 28 percent, 13 percent, 46 percent and 49 percent higher, respectively, relative to normal weight women.

“Age did not significantly modify the BMI-colon cancer association for men,” Adams and colleagues report. “By contrast, colon cancer was associated with BMI in women aged 50 to 62 and 63 to 66 years, but not in those aged 67 to 71 years,” they note.

The association was not modified by hormone replacement therapy in women, or by physical activity in men or women — “indicating the importance of weight control as a prevention strategy for this very common malignancy.”

Diet pill’s icky side effects keep users honest

Add comment July 7th, 2007

Sometimes, you can’t stop your weight-loss secrets from leaking out.

Dieters have been flocking to drugstores to pick up Alli, the first over-the-counter weight-loss pill to be approved by the Food and Drug Administration, despite the scary warning: Stray too far from your low-fat diet and you just might poop your pants.

Still, it seems there’s no shortage of people willing to risk public humiliation to shed a few pounds. At one Los Angeles-area Walgreens, pharmacist Susie Uyu’s seen customer after customer march directly through the store toward the prominent Alli display. “I think they’re excited that it’s an over-the-counter product,” Uyu says. And even though pharmacist Miyuki Anderson, who works at a Bartell Drugs in Seattle, warns everyone who eyes the Alli display about the messy side effects, it doesn’t stop most of them from buying the diet pill.

The drugmaker states very clearly that it’s no miracle drug, and only promises to help people toward moderate weight loss. For example, if someone were to lose 10 pounds from dieting, they’d lose 15 by combining their diet with Alli.

The diet pill works by blocking 25 percent of fat from being digested. Alli users take one pill with every meal, and to avoid an “Alli oops,” they should eat less than 42 grams of fat a day, or about 15 grams per meal. But those fat grams can be sneaky. One grande Starbucks Caramel Frappuccino contains 15 grams of fat, and if an Alli user adds even a low-fat muffin to that meal, it could get icky.

“It’s so important to understand that you must adopt a low-fat, healthy lifestyle,” Jones says. “We call them treatment effects — that’s a signal for you that you’re not staying in the guidelines. What Alli will not do is make up for not living a healthy lifestyle.”

Some Alli enthusiasts have been conscientious enough to avoid any side effects. Carole McMahan, who’s trying to lose 10 pounds, started taking Alli the day the product hit drugstore shelves on June 15, and has been careful to follow the low-fat diet.

“No pun intended, but I’m very anal about it,” says McMahan, who’s 44 and lives in Greensboro, N.C. She appreciates the way Alli holds her accountable to her eating habits.

“I started very cautiously, and I’ve just grown more and more comfortable with it,” McMahan says. “I just follow the diet. I knew I couldn’t go out and order hot fudge cake.”

But some Alli fans, like 25-year-old Rachelle Beaini, are just asking for it. Beaini, who lives in Henderson, Nev., and wants to lose 20 pounds, has lost 6 pounds in two weeks without a single side effect. Inspired by her success, last week she dared to eat a meal of chicken nuggets — while wearing white pants. (Still no unpleasant consequences, she swears.)

 

 

Could Nerve-Snipping Spur Weight Loss?

Add comment July 3rd, 2007

An old ulcer operation is getting new attention as a possible alternative obesity surgery: a quick snip of a nerve that helps control hunger.

It’s far from clear if cutting the vagus nerve really helps _ initial pilot studies in a few dozen patients have just begun. Skeptics abound, and even proponents say it wouldn’t lead to nearly as much weight loss as more traumatic operations that shrink the stomach and reroute intestines.

It’s part of a hunt for middle-ground options for people scared of today’s surgery, or those not quite fat enough to qualify for it.

“By no means do I think this is a panacea,” cautions Dr. Robert Lustig of the University of California, San Francisco, who is studying the method along with University of Rochester surgeons.

“But I think this will be a rational alternative for a cadre of patients that are sort of in the middle there. With as much obesity as we have in this country, that’s a big middle.”

More than 177,000 people underwent obesity surgery last year, according to the American Society for Metabolic and Bariatric Surgery. The most popular method is gastric bypass, stapling the stomach to create a tiny pouch. Options include placing an adjustable band around the stomach, or cutting off the stomach’s side and rerouting the intestines.

Surgery can produce life-altering weight loss, if recipients adhere to diet and exercise advice, but each method comes with varying degrees of pain and risk, including a rare chance of death. So doctors are searching for alternatives.

Enter the vagus nerve, which snakes from the brain to the abdomen, with fibers reaching into multiple organs with different effects. Among them: The nerve spurs gastric acid production, and in the 1970s, surgery to cut where it attaches to the front and back of the stomach brought ulcer sufferers great relief _ after they recovered from open-abdominal surgery. Once better acid-reducing medications came along, this arduous operation was abandoned.

Yet surgeons at the time noticed, and subsequent animal studies confirmed, that these vagotomies could trigger weight loss. In addition to a less acidic stomach’s slower digestion, the vagus helps control appetite-stimulating brain hormones and signals our bodies to store more fat, Lustig explains.

Since doctors today can snip the nerve far less invasively, through just five pencil-sized cuts in the abdomen, it was time to test in the obese.

Thirty patients had a vagus snip at UCSF or the University of Rochester. The study isn’t complete. But of the 11 who are a year past surgery, all but one are shedding pounds, losing an average of 18 percent of excess weight so far, Lustig and Rochester’s Dr. Thad Boss reported at last month’s bariatric society meeting.

They suffered no serious side effects, and went home hours later with little pain.

“Every patient who had the vagus nerve cut says they’re not hungry,” adds Lustig _ although the one who didn’t respond got hungry again six weeks after surgery, perhaps because the nerve healed.

That’s less than half the weight loss of standard surgeries, warns Dr. Neil Hutcher of Bon Secour St. Mary’s Hospital in Richmond, Va., and a past president of the bariatric society.

“I have my doubts that vagotomy alone is going to be a significant weapon,” says Hutcher, who often cuts the nerve during standard gastric bypasses for a different reason _ to help those patients avoid the side effect of heartburn-causing acid buildup.

But, when Greensboro, N.C., surgeons added a vagotomy to 25 patients getting bands on their stomachs, the nerve-snip seemed to make that usually more modest operation about as effective as a gastric bypass _ with 43 percent loss of excess weight at six months, and counting.

For a more rigorous study, Rochester’s Boss is about to recruit 60 more patients headed for band surgery, giving half a vagotomy as well.

The pilot studies were funded by a startup medical device company called EndoVx Inc. that hopes one day to further simplify vagotomies, cutting the nerve by beaming high-intensity ultrasound waves down the throat.

Other doctors are testing if implants that treat epilepsy by stimulating the vagus nerve also might trigger weight loss, with mixed results so far.

For now, Boss stresses that vagus nerve-snipping remains highly experimental. He and Lustig will track their 30 patients for 18 months to check if ultimate weight loss is enough to warrant further study, and who responds best.

The goal is to help people like Garth Michaels of Walnut Creek, Calif., who twice backed out of standard obesity surgery, fearful of side effects and a long recovery. Thirteen months after he volunteered for the vagotomy experiment, he has dropped 66 pounds, to 246.

That’s a much more gradual loss than with regular surgery, but Michaels says having his hunger curbed help him finally learn to exercise. He spends a half-hour on an exercise bike most days. And he learned to avoid former diet saboteurs _ french fries, sweets _ that caused foul burping after his vagotomy, in favor of fruits and vegetables.

“I will lose more, there’s no doubt about it,” says Michaels, 56, whose goal is 175 pounds. “It has given me such hope.”