Glaxo targets U.S. minorities with launch of weight-loss drug in supersized market

[Al-khiyal]

Concerns over messy and dangerous side-effects

May 23, 2007 -- A new over-the-counter diet pill from Britain's biggest drugs company, GlaxoSmithKline, is to be specifically targeted at the high proportion of overweight people in the US's black and Hispanic communities.

At a ceremony in New York yesterday, Glaxo launched Alli - the only weight-loss treatment to be approved by the US food and drug administration for use without a prescription.

The company is hoping to secure some of the $1bn (£500m) spent annually by Americans on "quack" tablets, herbal potions and unproven laxatives in efforts to lose weight.

Glaxo is going to great lengths to reach out to minority groups by providing a Spanish-language website, bilingual materials at the point of sale and a variety of recipes for low-fat versions of Mexican cuisine and deep south-style "comfort" food.

According to government figures, 76% of black and Hispanic people in the US are overweight. Dr Valentine Burroughs, a specialist in obesity-related complaints who practices in Harlem, said: "There's a lack of recognition in minority populations of the connection between being overweight and the health complications that arise."

Dr Burroughs said a mixture of economic deprivation and cultural factors contributed to the problem: "In African-American communities, there's a cultural acceptance of the full physique - it's often preferred to the lean physique."

Historically, Dr Burroughs said, immigrant communities had access only to poor-quality foods and tended to over-season it with salt and other fatty additives. He added that first-generation arrivals who did heavy manual work developed a taste for large energy-rich helpings which they passed on to their often less active children.

Alli is a lower-dose version of a prescription drug, Xenical. It works by inhibiting the body's lipase enzymes, which break down fat in the digestive system. Tests have shown that it can increase the amount of weight lost by dieters by as much as 50%.

The drug increases the amount of fat that passes through the body unabsorbed, but unless users combine it with a strict low-calorie diet they risk unpleasant side-effects, including severe and unexpected bowel movements.

Steven Burton, head of Glaxo's weight-loss division, said that about half of users never experienced these side-effects. He cited personal experience: "I have used the prescription version of product for three years and I've had only one surprise. That was very early on and it was when I'd been very foolish with eating fatty foods."

Linda Bannister, a healthcare analyst at the stockbroking firm Edward Jones, has estimated that Alli could generate US sales of $200m annually. Glaxo intends to apply for over-the-counter approval in Britain by the end of the year.

Many obesity experts have welcomed Alli as a new weapon that could help tackle an obesity crisis, which has led to a diabetes epidemic and has put immense strain on the US healthcare system.

But Alli has its critics. The pressure group Public Citizen has called the FDA "reckless" for granting approval, saying Alli offers only marginal benefits given its side-effects. The group has raised concerns about animal trials of the prescription version, Xenical, which showed a high incidence of pre-cancerous lesions developing in the gut.

Glaxo targets U.S. minorities with launch of weight-loss drug in supersized market

[Al-khiyal]

June 15, 2007 -- At 9:30 a.m. on Thursday, 12 boxes of alli, the first FDA-sanctioned diet drug to be sold without a prescription, were placed on the top shelf of a Santa Monica Walgreens' diet section. Four hours later, all but one had been sold.

"I have never in my life experienced anything like this," store manager Roe Love, a pharmacist for 20 years, said as she eyed the empty space next to the last box of 90 capsules selling for $59.99.

The fact that the product is kept with the rest of the diet drugs under locked glass on the shelf — to prevent theft — didn't deter people from requesting it.

The only comparable phenomenon Love could think of was the frenzy over the antibiotic Cipro during the post-9/11 anthrax scare. "You couldn't fill those prescriptions fast enough," she said.

The latest diet pill is being rolled out across the country this week by manufacturer GlaxoSmithKline. The company's website, myalli.com, and literature offer the potential for greater weight loss than dieting alone if you do everything right and a warning of extraordinarily unpleasant and embarrassing side effects if you don't.

Not all merchants have alli (pronounced "ally") in stock yet — a spokeswoman for Longs Drugs says all stores should have it by Saturday — but among those that do, the buyers have overwhelmingly been women.

"And they're not fat," Love said of the women she saw buying the drug at her store.

In Los Angeles, where thinness is the Holy Grail and people will do just about anything to get there — including risking some rather unfortunate intestinal distress — buyers didn't flinch at possible side effects.

The drug was introduced as the stronger, prescription-only Xenical several years ago.

It works in the digestive system by blocking the absorption of about 25% of fat that is consumed.

In a theoretical 3,000 calorie-a-day diet with about 100 grams of fat, the drug would eliminate about 225 calories.

But it can also result in what the manufacturer describes as loose stools and gas with an oily discharge. "It's probably a smart idea to wear dark pants, and bring a change of clothes with you to work," the drug's official website says. (The drug maker's literature and website say side effects can be minimized with a low-fat, reduced-calorie diet.)

But the women buying alli Thursday were unfazed by the warnings.

At a San Fernando Valley Walgreens that had sold 10 boxes — with one man among the buyers — no one was asking the pharmacist about side effects. " 'Will it work?' That's the only question they're asking," said the store's pharmacy manager, who spoke on condition of anonymity.

At a prominent display in a Rite Aid drugstore in Santa Monica, prospective buyers clutched the big alli starter kit and shared war stories from the diet battleground.

"I've tried so many other things," said Monique Brown, a Santa Monica legal secretary who says she's been through Metabolife, CortiSlim and various products, some of which made her jittery. She dreams of losing 30 pounds.

At least, alli won't make her jittery, she said. "I'm just willing to give it a try. There are side effects to a lot of things…. I work in an office and I sit all day. There's a bathroom right there. We've all worked together a long time. If you have to go, you have to go."

Wendy Reid, a 57-year-old Tallahassee, Florida, resident visiting Southern California, said she had no qualms about taking alli. "I've read about it completely," said Reid, carrying her purchase out of the Rite Aid in Santa Monica.

Deeply tan from her daily regimen of tennis, she nonetheless has 15 extra pounds she says she gained since she hit menopause. She shrugged off the possibility of side effects. "I thought I would just deal with them," Reid said. "So far it's been proven safe."

Tall and athletic, she said it's not about what other people think of her frame. "My husband thinks I'm silly, everyone thinks I'm silly. But I want to be the skinny self I always was."

Media outlets nationwide reported on the pill's introduction Thursday, interviewing dieters eager to try something new; the manufacturer predicted that 5 million to 6 million Americans a year would buy the drug. About 130 million Americans are considered overweight.

The materials that accompany alli and are posted on the website stress that people should eat a low-fat, reduced-calorie diet.

If dieters can stick to that discipline, they "can lose about 50% more weight than dieting alone," according to the drug brochure, which many stores displayed. They can also allay some of the side effects. And the manufacturer notes that awareness of possible side effects acts as a disincentive to overeat fatty foods.

Not all buyers seemed to have grasped that concept. Love said one woman mentioned, as she bought the drug, "that if she was going to have cheesecake, she'll take one. That's ridiculous."

Alli is intended for overweight people 18 and older, according to the manufacturer. However, the controls were unclear.

At some stores, it could simply be picked up off the shelf and taken to a cashier for purchase. But at a Walgreens in the San Fernando Valley, the drug was being held behind the pharmacy counter, according to the pharmacy manager. As sales were rung up, "the register prompts us to check for I.D. for a birth date," said the pharmacy manager, who added that she would not sell it to someone under 18.

Earlier this year, Dr. Adrienne Youdim, a weight-loss specialist at Cedars-Sinai Medical Center, said alli has a good safety record and has helped people lose an average of 10 to 16 pounds.

Not everyone, however, welcomes the product or the hype. New York-based nutritionist Oz Garcia, who treats clients on both coasts, said: "There is no real advantage to using alli unless you're doing what you're supposed to do — working out, eating a well-balanced diet, all the things you have to pay attention to."

Garcia noted that a fat-blocking drug does no good for those gulping down cookies and pasta and other carbohydrates.

"A lot of the weight gain that has occurred in the last decade is because people are already eating low-fat but they're eating high carbs," Garcia said.

On the Westside, where some of Los Angeles' most toned bodies reside, there was some scorn for alli.

"Let's eat a salad and go to the gym. I don't need anal leakage," said wardrobe stylist Luisa Dalmagro, nursing a coffee drink and sharing a piece of cake with Melissa Shapiro, an interior decorator, at a Starbucks in Brentwood.

The two had just finished a workout at the Burn 60 gym, which specializes in interval training.

"If there were a miracle pill, everyone would be skinny," Shapiro said.

"We're women. We've all been concerned with weight half our lives," she added. "But the bottom line is nothing is better than watching calories in and calories out."

New diet drug touches off a feeding frenzy