AN ALLY FOR OVERWEIGHT AMERICANS?

Alli can help overweight Americans shed extra pounds, but should not be considered a miracle drug, said Malesia Dunn, a GlaxoSmithKline spokesperson. Consumers will also have to follow a reduced-calorie diet and commit to regular exercise to see results, she said.

"Now, instead of [losing] 10 pounds, by including Alli in that program, you will potentially lose up to 15 pounds," Dunn said. "And for a lot of people that becomes very meaningful."

The drug's active ingredient decreases the body's absorption of fat by about 25 percent per meal -- meaning that dieters do not absorb those fat calories. The undigested fat passes through the body and can cause unpleasant side effects, including gas, oily spotting and loose stools. The FDA recommends that users follow a low-fat diet to reduce these side effects.

"If you eat a lot of fattening, high-fat products, you're still going to have a lot of that in your body," Dunn said. "The product only blocks a percentage."

Dunn said GlaxoSmithKline has spent a great deal of time and marketing to educate consumers about how Alli works. Even the drug's website, www.myalli.com, tells potential customers that losing weight "won't be easy -- nothing worth it ever is -- but greater weight loss is possible."

"Alli's just going to help you with that payoff," Dunn said.

GlaxoSmithKline has also funded the production of a new book to educate overweight consumers about weight loss, according to an April 30 GlaxoSmithKline press release. The book, titled Are you Losing it? Losing Weight Without Losing Your Mind, provides dieters with weight-loss strategies, low-fat menu ideas and advice on how to make lifestyle and behavioral changes, according to the press release. The company's website for Alli also includes a Body Mass Index calculator and "Alli readiness quiz" that helps potential consumers determine whether they should use the drug. Only people ages 18 and older who have BMI of 25 or higher should take Alli.

If taken three times per day, Alli will block about 100 to 200 calories daily, Dr. Caroline Apovian, a Boston University medical professor said. Apovian endorsed the drug on its website and contributed to GlaxoSmithKline's weight-loss strategies book.

"I decided to endorse Alli because it is the safest and most effective FDA-approved weight-loss drug to go over the counter," she said.

Although the FDA considers the drug to be a safe and effective weight-loss aid, some people said Alli's intestinal side effects make the pill an unattractive option for weight loss.

"I just would never want to use it," said Donna Devlin, an administrative secretary at BU's Office of Career Services. "I wouldn't want to have the side effects. It doesn't seem worth it."

Alli: Is This the Magic Pill That’ll Drop Down Your Dress Size in Weeks?

People have been waiting for years for some sort of a magic pill that could help them lose weight without any effort. The FDA has approved the first over the counter(OTC) weight loss pill Alli which means you don’t need any prescription to buy them.

The makers of the pill, Glaxo Smithkline claim that the drug apparently cuts weight by 5 per cent in only four months and also improves the overall health by reducing blood pressure and cholesterol levels.

How does it work? According to the website- The Alli capsule works by preventing your body from absorbing some of the fat you eat. When you take the capsule with meals, Alli prevents the enzymes in your intestines from digesting about one-fourth of the fat in your foods. Undigested fat can’t be absorbed and passes through your body naturally. Which means your body can’t store it as fat. If you could lose 10 pounds through dieting alone, you could lose 15 with alli.

All weight loss pills come with side effects; according to the makers, you may have gas with oily spotting,loose stools and more frequent stools that may be hard to control.

Taking a Pill to Make Eating Fat Painful

If you remember Olestra (a fat that was unabsorbed by the body) and its side effects, you will know what the deal is with Alli. In February this year, the FDA approved GlaxoSmithKline’s “Alli” an over-the-counter version of prescription orlistat (Xenical). It is a drug that blocks enzymes that break down fat, preventing the body from absorbing fat from ingested foods. The side effects of the drug are the extremely uncomfortable effects of not absorbing fat: fatty stools, fecal urgency and gas. Obviously these side effects are triggered by ingestion of fats, so the Alli Web site (www.myalli.com) encourages users to think of these “treatment effects” as an “incentive to keep from eating too much fat.”

What I don’t understand is, if the idea is to prevent you from eating fat, isn’t that just a diet? Moreover, the Web site also has a “readiness quiz” for the drug regimen. You are deemed ready to go on Alli if you are willing to commit to the hard work it takes to lose weight, eat smaller portions, eat a reduced-calorie and low-fat diet, and be more active. If you are doing these things, you are on a diet, so why would you want Alli and all its unpleasant effects?

Naming the drug to sound like a cute little girl’s name makes it all too transparent who GlaxoSmithKline is targeting. Where orlistat was only suggested for prescription to the extremely obese, half-strength Alli can be snatched up by any woman who is unhappy with her body image. Although Alli is only suggested for those above a certain BMI, the potential for abuse seems pretty blatant. On the other hand, obesity is a real and growing health threat in America. Anti-obesity drugs are sometimes viewed as tools to psychologically empower people to lose weight. If Alli can produce results and sustain them, then more power to it. My inner skeptic says loose stools and fecal urgency does not seem like a sustainable option.

Drugs sold over the counter present dangers

Over-the-counter drugs offer a variety of cures for what ails the average college student, including problems such as coughs, yeast infections and headaches.

But college-aged students, especially women, need to be careful and critical of emerging OTC drugs, health officials warn. Some could have negative consequences, despite the fact that the Food and Drug Administration deems them safe for use without the consent of a doctor.

The FDA has no systematic way of tracking negative effects of OTC drugs yet, so patient responsibility is important, said David Brushwood, University of Florida professor in pharmacy health-care administration.

Concerns arise, for example, when looking at the new OTC drug, Alli, made available this summer. Alli, pronounced "ally," is the first FDA-approved, OTC weight-loss drug.

The drug, taken with meals, blocks intestinal enzymes from digesting one-fourth of food's fat.

"Let's face it. There is pressure in our society to be thin," said Mary Ann Burg, associate professor of Community Health and Family Medicine and former director of UF's Women's Health Research Center.

Weight-loss pills may seem like one route to get to that socially acceptable norm.

Yet, research shows that college-aged women diagnosed with bulimia can be frequent abusers of laxatives, or OTC stimulants that treat constipation, as a means to increase weight loss, Burg said.

Drugs treating more overt female concerns and problems have also made transitions from prescription to OTC, sometimes only after political pressure, said Phylis Craigcq, nurse practitioner at the Women's Clinic at the Student Health Care Center.

In 1991, women were allowed buy treatment for yeast infections over the counter. And last fall, the morning-after pill, or Plan B contraception, won approval for OTC use after the FDA duked it out with Congress and its own advisory board.

"We have a lot less girls sitting on our doorstep Monday morning, and our emergency calls sure have gone down," Craig said. "I don't miss those 2 a.m. phone calls."

Morning-after pills became available upon request in January, after the manufacturer re-packaged and re-labeled the drug - a major concern of the FDA, Craig said.

"The FDA is a label-oriented organization," health administration professor Brushwood said. "They say, 'Can we write a label so clear, so easy to understand that a consumer can use it without medical assistance?'Â "

Clear labels describing safe usage are one of the primary factors the FDA uses to decide if a drug should be offered over the counter, Brushwood said. If the drug company can't provide a legible label, its product becomes prescription only.

It has to have adequate directions, warnings and advice that consumers could understand and follow, he said.

Yet, even after precautions have been taken, the FDA could still have a problem on their hands.

"The truth is, every drug has side effects and the potential to cause harm," said Earlene Lipowski, an associate professor in the College of Pharmacy.

Both Lipowski and Brushwood agree that the FDA has no concrete, systematic method of catching abuse of OTC drugs.

The system in place now is completely voluntary, Brushwood said.

Here's how it works:

A patient takes a cough medicine, which gives him hives all over his body. Shocked and surprised, he goes to his doctor, explains what cough medicine he took and what happened to him.

The patient goes home, and the doctor has a choice. He can go about his day, or he can send a "moderator report" to the FDA, describing the patient's situation.

The FDA - if the patient isn't the only one with hives from this cough syrup - develops an aggregate of similar cases and if it becomes large enough, goes to the drug manufacturer to investigate what is happening.

Further research interprets whether that cough syrup stays on the market.

"You see, though, patients have a responsibility in all this as well. They have a responsibility to report adverse reactions" to a doctor, nurse, pharmacist or other health-care provider, Brushwood said.

The best way to use any drug - prescription or over the counter - is to check with a doctor first, women's health researcher Burg said.

Sometimes, going to a health practitioner, even if you know what you need, can help you in the future, as well, Craig said.

For instance, when the morning-after pill was only available by prescription, the Women's Clinic staff used to have ways of counseling sexual assault victims or setting up prescriptions for oral contraceptives so patients wouldn't need to use the morning-after pill again.

Even though she supports the drug being over the counter, it's harder to provide further help to patients who come in, pick up the drug and leave after only a minimal interaction with a pharmacist, Craig said.

Diet Pill alli May Also Be Available Over-the-Counter in Europe by Late 2008

Diet pill alli, which is scheduled to go on sale in the United States in mid-summer, may also be available as an over-the-counter diet drug in Europe by the end of next year, according to GlaxoSmithKline.

The company said on April 1st that it plans to seek European approval before the end of this year to sell alli, a low-dose version of prescription diet drug Xenical (orlistat), and hopes to launch the drug in Britain and other European countries by late 2008.

The U.S. Food and Drug Administration gave the go-ahead to alli in February, making it the first weight-loss pill ever approved for over-the-counter sale in the United States.

In Europe as in the United States, hundreds of unregulated products are sold as diet aids in pharmacies and supermarkets, and Glaxo is counting on the blessing by regulators to set alli apart and lead to its use by millions of dieters.

"Consumers spend billions each year on fad diets, unproven miracle pills and potentially unsafe weight loss supplements that may not work," a Glaxo spokesperson said.

"alli is the clinically-proven alternative to these hyped quick-fix products that mislead overweight adults away from weight-loss strategies that are backed by medical science."

"My concern is that it should not be seen as a panacea for people who want to get into a smaller-sized bikini," said Dr. Colin Waine, chair of Britain's National Obesity Forum. "It may also be unpleasant - if you eat a high fat diet you will experience the effects. But if used sensibly with the right sort of dietary back-up then this could help some people."

Wonder weight loss drug to go on sale in UK next year

The battle of the bulge is soon to get a drug-fuelled boost. The first over-the-counter weight loss pill has been licenced in the US and is expected to be approved for use in Britain next year.

Alli, marketed by GlaxoSmithKline, will join dozens of other slimming aids sold in chemists and supermarkets. But unlike them, Alli has been proved to work.

Clinical trials have shown that when combined with a low fat diet and exercise regime over six months, Alli can increase weight loss by 50%, Jean Paul Garnier, head of Glaxo said.

In the US, the Food and Drug Administration gave the go-ahead to Alli last month, triggering a marketing campaign which the company hopes will reap five to 6mn US customers a year.

At a price between $12 and $25 a week (£5-£12), the drug could have annual sales of $1.5bn.
Glaxo said it planned to apply for a European licence by the end of the year with the launch of the drug expected to follow within 12 months. Alli is an over-the-counter version of Xenical, the prescription weight loss remedy launched by the Swiss pharmaceutical company, Roche, in 1999.

Alli contains half the dose of Xenical and will be packaged with guides giving advice on meal planning, what to order when eating out, a fat and calories counter and a journal to record daily food intake.
Two thirds of adults are overweight or obese and the numbers are continuing to rise. Experts believe diet and discipline are not alone sufficient to prevent waistlines expanding and that extra help is required.

The drug works by blocking the absorption of fat from food that is eaten. About one quarter of the fat is blocked with prescription-strength Xenical, but the effect will be reduced in lower strength Alli.
However, the unabsorbed fat has to go somewhere and dieters using it are prone to diarrhoea, its least attractive side effect.

Steve Burton, the Glaxo executive in charge of promoting Alli in the US, has used the drug himself and describes in painful detail the embarrassment it caused when he ate a fish and chip meal with tartare sauce.
The result was a “classic oops” and a dash home for a change of clothes, he told reporters last year.
On the other hand, the drug’s effect provides a powerful incentive to stick to a low fat diet - because the consequences of doing otherwise will be too unpleasant.

Burton, 48, is a walking advertisement for the drug’s success - he lost 65lbs over three years, cutting his weight from 275lbs to 210lbs.
But he warned he had done better than the typical user will do because he had been particularly faithful to his diet and exercise regime. Evidence from trials of Xenical also show that weight loss is temporary - and tends to be re-gained once the drug is stopped.

A spokeswoman for Glaxo in the UK said: “Alli is a fantastic drug if taken alongside a low fat diet and you have a lot of willpower. But it is not a wonder pill and it won’t achieve weight loss on its own. It will be marketed in a very similar way to our smoking control programme where NiQuitin (nicotine gum and patches) comes with advice on giving up smoking, a website and regular messages of support.” – The Independent