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WEIGHTY SIDE EFFECTS

The Baltimore Sun

There's no such thing as a free lunch. Not even if you take alli, the latest, hottest FDA-approved diet pill.

Brendon Sadowski, 24, knows this well. The 290-pound, 5-foot-10-inch Army veteran says he's "always been a big guy."

So he was excited when the Food and Drug Administration approved alli for over-the-counter sale in June. He picked some up and lost 6 pounds within a week, with little change in his diet and almost no exercise.

But the gastric side effects - a detailed description of which could well ruin your breakfast - eventually persuaded him to take a break from the pill. Ever hopeful, Sadowski started the medication again two weeks later. "If it's something that's gonna work, I'm willing to do it," he said.

What makes alli something less than a miracle drug for the overweight? Medically, the drug prevents 25 percent of the fat that users consume from being digested. That's the good part.

But that excess fat has to go somewhere. Ultimately, it "passes through as poop," said Dr. Jonathan Rich, a Mercy Medical Center internist.

For users, that means potential side effects that include diarrhea and "oily discharge," which explains why alli was available only by prescription after it was first approved in 1999.

The FDA finally approved a low-strength version for over-the-counter sales in June, amid protests from watchdog groups such as Washington-based Public Citizen.

Consumers ignored the warnings in droves and rushed to pharmacies to purchase the pricey pill (a 30-day supply is $60).

Rich has seen Xenicol, alli's prescription predecessor, help patients lose weight, but he warned that it is hardly a wonder drug. It only works well when a patient is committed to healthy eating and exercise. "You can't just take it and lose weight," he said.

For users like Libbie Schlather who are willing to make lifestyle changes, alli may work well. "The whole reason why I'm doing this is because I'm getting married in October," said Schlather, who was part of a trial group that received a free six-month supply of alli.

Schlather, a 5-foot-3-inch program manager at Fannie Mae, has been able to drop from 152 pounds to 139 in two months with a combination of alli, exercise and healthy eating.

She was well motivated. Shortly after she bought her wedding dress more than a year ago, she started gaining weight. "Unfortunately, I became more sedentary," she said.

The dress, which fit like a glove when she bought it, could not be made larger. So alli seemed well worth a try.

Given her low-fat diet, the side effects hardly troubled her. "Until I went to brunch one day and had everything on the table," she said in a call monitored by employees of GlaxoSmithKline, the drug's makers. "The cause-and-effect relationship was pretty clear."

On average, research has shown that the pill can help dieters lose 50 percent more weight than they otherwise would.

But the drug must be taken with a multivitamin tablet because many fat-soluble vitamins get washed out of the body with the blocked fat, GlaxoSmithKline recommends.

The company also recommends staying at home or at least near a bathroom during the first few days of use.

Bathroom access

Sadowski is a part-time musician who works at Aberdeen Proving Ground. While he said he can't talk about his job, which is classified, the important thing is that he has "easy access to a bathroom there."

He kept track of some of his alli experiences in a video journal on YouTube, where he described the pill's not-so-attractive side effects in detail. "Yes, there was gas with oily spotting, but you just do what you got to do," he said.

Sadowski has cut the bacon and eggs from his breakfast, sticking to fruit, coffee with cream and sugar and an occasional pastry. Lunch and dinner are less controlled: He buys a sandwich or sub for lunch and eats his dinners at casual dining chain restaurants or orders takeout Chinese food.

Experts and critics of American dining habits say a culture of oily food with high fat content has helped lead the country down the path to an obesity epidemic. For example, an order of kung pao chicken can contain as much as 76 grams of fat, according to the Center for Science in the Public Interest.

More than two-thirds of American adults and nearly 20 percent of children between ages 6 and 10 are overweight or obese, the National Center for Health Statistics found in a 2004 survey. Maryland's collective waistline mirrors the national average, while the nation's most obese states are in the South.

History of fads

The epidemic of obesity has been mirrored by a willingness to pursue an endless supply of fads, diets, drugs, toys and tricks targeting consumers who want to knock off a few pounds - or more than a few. The country's history with diet pills, in particular, is long and storied.

In the 1930s, Stanford University researchers found that a chemical called dinitrophenol seemed to speed up metabolism, causing users to lose weight rapidly. But overdoses resulted in death, and the drug was quickly pulled off the market.

In the 1950s, doctors began prescribing amphetamines to curb the appetite, but the drugs also kept users awake and increased alertness - which led to addiction in many cases. Most similar drugs are banned today.

Then came fen-phen, the infamous diet drug of the 1990s - a combination of fenfluramine and phentermine. It seemed like a miracle at first, helping patients lose up to 200 percent more weight than they otherwise would have.

But the drug also demonstrated that it could increase heart rates to fatal levels.

"It was basically a mild version of speed," said Dr. Paul Rivas, an internist who specializes in weight management at the Greater Baltimore Medical Center.

Now it is alli's turn in the spotlight. GlaxoSmithKline confirmed that it has put at least $150 million into sales and marketing of the drug. Sales since the drug was released in June have surpassed $150 million, according to the company's quarterly report.

'Huge thumbs down'

But some critics, including Rivas, say the drug is a gimmick. "It just doesn't work," he said. "All of the over-the-counters are pointless, and I have to give this one a huge thumbs down."

Rivas prescribed the prescription version of alli, known as Xenical, when it was approved eight years ago. But too many patients found the side effects to be intolerable, he said. In fact, the uncontrollable diarrhea from the pill forced some of his patients to begin wearing diapers - which he found unacceptable.

In addition, Rivas said, the pill doesn't always work as claimed, and it doesn't work for everybody. "The weight issue is a genetic problem, and much more complicated than a simple pill that blocks fat," he said.

Weight, Rivas said, has always been tied to genetics. About 50 percent of us are predisposed to gaining weight, he said, even if we are not overeating. Combine that with the near-universal availability of cheap, fat-laden food in America and the result is an obesity epidemic, he said.

"If you live in Ethiopia and you have the genetic tendency toward gaining weight, you're still probably not going to gain weight," he said.

Losing weight is a complex proposition that may involve medication, diet and exercise. "I would say if you have family history and are more than 20 pounds overweight, and diet and exercise are not working, you should see your doctor."

Rivas still prefers what he calls the "safe half of fen-phen," or phentermine, to treat patients. The appetite suppressant hit the market in the 1950s and is still one of the best, Rivas said. It also raises metabolism, so it works well, he said. He has prescribed it regularly for the past 15 years and has seen positive changes in his patients.

But Marion Nestle, a nutrition professor at New York University who runs a blog called whattoeatbbok.com, disagreed.

"Genes matter, of course. Not everyone who overeats gains weight. But rates of overweight started to zoom up just in the past 25 years or so, too recently for genetics to have changed," she wrote in her blog.

"While the science types are working hard to find a magic and highly-profitable bullet, people need to find ways to handle a food environment that encourages overeating."

Sadowski, the ex-Army man, doesn't buy the genetic argument, either.

"My sisters are 120 pounds and 5 feet 6 inches. In my family, it's just me."

He's back on alli again, and after two weeks he has lost a couple more pounds. This time he's determined to stay off the oily food and hit the gym.

"When I was in basic training, I ate like a pig every day, and I lost 40 pounds. I know you can eat a lot of food and lose weight if you're doing PT," he said.

sindya.bhanoo@baltsun.com

Tips for taking alli

People considering the over-the-counter medication should be prepared to:

Get regular exercise.

Eat low-fat foods, calculating each meal at 15 grams of fat or less.

Take a multivitamin to replenish fat-soluble vitamins.

Stay at home or near a bathroom to cope with side effects.

Consult a doctor before starting alli in case of potential complications from conditions, such as pancreatitis, listed on safety materials and on the Web site myalli.com.

[SUN RESEARCH]

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