Pill is not free pass to buffet
The FDA-approved diet aid requires users to stick to a good eating plan - or else.
By REBECCA CATALANELLO
Published June 14, 2007
The first over-the-counter diet pill approved by the U.S. Food and Drug Administration debuts on store shelves this week, promising to help already "committed" dieters lose 50 percent more weight than they otherwise would.
The key word is "committed."
Here's why: The drug, called Alli, can bring embarrassing gastrointestinal side effects if you stray from a low-fat diet. The drug's maker touts them as a potential weight loss motivator, though some think they will hurt sales of the latest entry into the multimillion-dollar weight loss industry.
"No one likes experiencing treatment effects, " Alli's drug literature admits, "but they might keep you honest and avoid anything questionable for fat content. If you think of it like that, Alli can act like a security guard for your late night cravings."
Alli blocks about 25 percent of fat from being absorbed in the body by attaching to enzymes that usually break down fat, stopping their work.
The downside is the fat that is not absorbed must go somewhere. So it passes out of the body - sometimes in the form of loose, frequent or explosive stools, gas and oily discharge.
Such side effects are more intense the more fat one ingests. If you eat more than 15 grams of fat per meal, watch out.
Available at about $50 for a three-week starter pack, the 60-milligram Alli tablet is a lower-dosage version of the 120 milligram prescription Xenical the generic name is orlistat, which has been on the market since 1999.
"There's no way I'm taking that!" said Beth Martin, 41, of Tampa, a dieter who has heard about orlistat. "I mean, I'd rather just watch what I eat."
Though Martin has had success with Adipex, a prescription appetite suppressant, she says a key factor in staying on that drug was that she didn't experience any of its jittery side effects.
Unlike many herbal remedies and other supplements that claim weight loss miracles, Alli bears the safe-and-effective label that comes with FDA approval.
But that approval came over objections by Public Citizen, a Washington, D.C.-based advocacy group that testified before the FDA and also warned consumers about the dangers of the pain reliever Vioxx before it was pulled from the market.
Besides blocking absorption of fat, Alli (pronounced AL-eye) also limits the body's intake of fat-soluble vitamins A, D, E and K. It can be dangerous for anyone on a blood-thinner.
Additionally, tests found the drug caused precancerous lesions on rats' colons.
"It's a drug that should never have been approved, " said Dr. Sidney Wolfe, director of health research for Public Citizen.
GlaxoSmithKline acquired the over-the-counter rights to the drug from prescription drug maker Roche earlier this year.
In the United States, prescriptions for Xenical dropped from 1.5-million in 2002 to just 623, 000 in 2006, according to figures provided by IMS Health, a health care information company. In the same time, sales plummeted 31 percent.
Seeking FDA approval for over-the-counter sales, Wolfe says, was a way for the drug manufacturer to put an end to eroding sales. "It's a business decision, " he said.
GlaxoSmithKline representatives did not return phone calls for comment this week.
But Steven. L. Burton, the company's vice president for weight control, told the New York Times about entering the $15-billion annual market for weight loss drugs: "Even a small percentage of that market is going to be a significant commercial opportunity."
Burton referred to the side effects as the drug's "oops" factor, but noted the company is going out of its way to advise people on how best to use Alli to maximize results while avoiding its socially awkward consequences.
Kathy Moorman, director of pharmacy at University Community Hospital in Tampa, doesn't expect the drug to become a long-lasting bestseller. Any initial flurry of activity, she predicted, will probably slow when users experience the urgent need to frequent the bathroom.
For Mary Bell, 37, a single mother of four teenagers in St. Petersburg, the drug offered hope. Bell has struggled for years to shed pounds, but working three jobs, seven days a week leaves little time for exercise or healthy meal planning.
She's tried Trim-Spa, Slim-Quick, fen-phen. "After you get off of it, the weight just comes back, " she said.
In March, at 183 pounds, her doctor gave her a prescription appetite suppressant. She lost about 13 pounds. But when her weight loss plateaued, her doctor prescribed Xenical.
Bell liked it at first. But after the third pill, the side effects were startling enough that Bell resolved to take it only when she knows she won't be going outside the house.
The first time she had to run to the bathroom at work, she said, "I had to go home and take a bath before I came back."
"I know people who have taken it, but I don't know anyone who has used it long-term, " said Karen Miller-Kovach, chief scientific officer at Weight Watchers International.
Kovach and Jessica Bruzzichesi, a registered dietitian with Community Health Centers of Pinellas Inc., agreed Alli's side effects might be motivation for some to stick to the low-fat diet.
While medication as part of a weight-loss program is accepted practice for obesity treatment, Kovach stressed patients should always check with a doctor.
"I don't think Alli should be an impulse buy, " she said. "It's absolutely not for the young 20-year-old who wants to lose five pounds because she wants to look good in her bikini."
But she said Alli could be a useful complement to the Weight Watchers plan, which promotes the old-fashioned, low-fat diet and regular exercise.
At least one lifelong weight loss warrior, Missy Covington, 38, of St. Petersburg said if she's learned anything in her dieting trials and tribulations, it is that there is no magic pill.
In the year since joining Weight Watchers, Covington has lost 68 pounds, more than half-way to her goal weight. She's learning how to do it herself by eating reasonably and becoming more physically active.
"When it comes off really fast, " she said, "I don't know that you've learned enough."
Asked about Alli, Covington said the drug is not for her, even if has the FDA's approval.
"I would say my first thought is, if you're committed to a low-fat diet and exercise, then why do you need the pill?"
Times researcher John Martin contributed to this report. Rebecca Catalanello can be reached at rcatalanello@sptimes.com or (813) 226-3383.
Panel rejects drug
Federal health advisers unanimously rejected a weight-loss drug Wednesday after hearing testimony that it increases the risk of suicidal thoughts.
Manufacturer Sanofi-Aventis SA failed to show the drug rimonabant is safe, the panel said.
The back-to-back, 14-0 votes by the panel made it unlikely that the Food and Drug Administration will approve the drug. The FDA is to make a final decision on the drug by July 27.
Is Alli for you?
- Maintaining a balanced, low-fat diet is essential to its effectiveness. Failure to do so could result in messy, uncomfortable, embarrassing side-effects involving loose bowels.
- For every five pounds you lose from diet alone, Alli can help you lose two to three more. In studies, most people lost five to 10 pounds over six months.
- Price at Publix is $46.99 for a 60-pill starter pack. At Walgreens, it's $49.99 for a 60-pill starter pack, $59.99 for a 90-pill starter pack and $69.99 for a 120-pill refill. Recommended dose is one capsule three times a day with meals containing fat.
- Recommended only for people 18 or older who are considered obese with a body mass index of 27 or higher. To calculate your BMI, go here: www.cdc.gov/nccdphp/dnpa/bmi
- Take a daily multivitamin to combat loss of fat-soluble vitamins A, D, E and K.
Source: U.S. Food & Drug Administration, GlaxoSmithKline, Walgreens, Publix