Alli slimming pill safety under question

A new over-the-counter weight-loss drug called Alli may give people with eating disorders another tool to harm themselves, therapists fear.

Alli — pronounced “AL-eye” — is the only weight-loss medicine on the market approved by the federal Food and Drug Administration. It’s half the dose of the prescription drug orlistat, trade name Xenical, which is used to fight morbid obesity.

Dr. Randall Flanery, head of the Eating Disorders Program for the St. Louis Behavioral Medicine Institute, said the new drug is ripe for abuse because young people with eating disorders find the side effects of intense diarrhea and other gastrointestinal problems that empty the digestive system inviting.

People who use diet products to bolster their eating disorders “tend to take them at much higher dosages than recommended, as much as 10 times,” Flanery said. “It’s analogous to laxatives. People with eating disorders take 10 to 50 (laxative pills) at a time. They become dependent and take higher and higher dosages.”

Another danger is that the medicine is approved by the FDA “and people will believe that because it’s over-the-counter and FDA-approved, it must be safe,” Flanery said. “It’s not.”
The drug should be kept behind counters and monitored for distribution to make sure that at least teens don’t have access to it, Flanery said.

What is it?

The FDA approved Xenical nearly 10 years ago. It limits the absorption of fat so that the fat doesn’t enter the bloodstream as triglycerides. Triglycerides are used for fuel and are stored in fat cells. In excess, they clog the blood vessels and help cause heart attack, stroke and organ failure. They can elevate because you eat too much fat or because you have a disease such as diabetes.

The FDA approved Alli in February at 60 milligrams. (prescription-strength Xenical is sold in 120 mg capsules.) The manufacturer, GlaxoSmithKline, said in its advertising literature that the drug can increase weight loss by 50 percent if it’s used along with a reduction of fat intake and an increase in exercise.

But you can experience oily diarrhea, flatulence and other intestinal side effects.

Not unanimous

A weight-loss specialist said anything Alli can do can be done for a tiny fraction of the cost by medications that are easier to purchase by minors.

“There are a lot of cheaper ways to get diarrhea,” said Dr. Samuel Klein, head of the Weight Management Program at Washington University in
St. Louis. “This medication is $60.” That’s for 90 pills.

“It’s half the dosage (of the prescription version), and the manufacturer is marketing it responsibly as something that needs a change in lifestyle to work,” Klein said.

Also, he said, the gastrointestinal problems are bothersome enough that even someone with an eating disorder wouldn’t want to face them, especially with easier alternatives.

Eating disorders

Flanery’s concern is that people with anorexia nervosa and bulimia — about 1 percent of the female population younger than 24 and a growing number of men — use a bunch of tricks to get thinner.

The tricks include faking eating, taking laxatives, purging (vomiting a meal), isolating themselves and taking amphetamines to reduce appetites.

Debbi Kuehnel, a counselor and owner of the Eating Disorder Recovery Center, wants the drug to be taken off the market. People with eating disorders are as prone to trends as anyone, and Alli’s newness could be its attraction, she said.

“We already had a client who stole a bottle,” Kuehnel said. “She took 10 pills. They don’t care about the side effects.

“Putting this drug on the market was ridiculous,” she continued. “The ads say eat right, exercise and change your lifestyle and use the drug. You’ll lose weight if you eat right, exercise and change your lifestyle; you don’t need the drug.

“The prescription dose was meant for people who are morbidly obese; there’s no need to make it over-the-counter.”

Via http://www.holmencourier.com/articles/2007/08/23/news/drug.txt

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TrimSpa in trouble after Smith's death

Marketing experts say TrimSpa's close association with its spokeswoman could spell disaster for the business.

NEW YORK (CNNMoney.com) -- The death of sassy spokeswoman Anna Nicole Smith coupled with growing doubts about TrimSpa's controversial slimming products may prove too much for the closely held company, marketing experts said Thursday.

"Given the double whammy of who their spokesperson was and the other tangential difficulties, I don't think they're going to come back," said Robert Passikoff, a New York brand consultant.
Anna Nicole Smith had been a spokeswoman for TrimSpa since 2003.

Passikoff said news that Smith died in Florida Thursday could spell disaster for the small business.

In fact, TrimSpa had suffered from sinking sales figures for the past three years. Right after Smith came on board, TrimSpa sales ballooned 172 percent to $43 million in 2004 from close to $16 million in the year earlier.

But by 2006, sales had shrunk to $19.5 million, according to Information Resources, Inc., a data-tracking firm.

A spokeswoman for TrimSpa said the company did not know if Smith was taking the slimming pill, which does not require a prescription, at the time of her death.

Authorities said they retrieved a "large amount" of prescription medicine from Smith's hotel room, according to CNN.

"The company was in trouble with or without Anna Nicole," said a source familiar with the company.

"When you mention TrimSpa, the image that came to mind was Anna Nicole Smith and that's the difficulty with being so closely tied to a celebrity," Passikoff said.

"You've just pulled the rug out from under what the brand was standing on," he added.

The former Playboy Playmate and reality TV star became a spokeswoman for TrimSpa in October 2003, after losing a reported 60 to 70 pounds.

But Smith and TrimSpa have faced repeated legal difficulties over allegations that advertisements for the slimming pills were misleading.

"It's a matter of making reasonable and moderate claims that are backed by real substantiation," said Ralph Fucetola, former lawyer for the company.

Last month, the Federal Trade Commission said it fined the marketer of TrimSpa and other over-the-counter slimming drugmakers $25 million for false advertising.

The government agency said that the company's weight control claims were not supported by scientific evidence.

"While TrimSpa disagreed with the FTC it made a business decision by consenting to a $1.5 million payment in order to end the FTC's over two-year investigation," a spokeswoman for TrimSpa told CNNMoney Friday.

The company still contends that its slimming pill, along with diet and exercise, can yield successful results.

"TrimSpa has some major challenges given the loss of credibility about their product and [now] losing their spokesperson," said Britt Beemer, the chairman of strategic marketing firm America's Research Group.

"It's a one-two punch and it does damage their marketing position dramatically."
TrimSpa, which is owned by privately held Goen Technologies, is based in Cedar Knolls, N.J.
TrimSpa founder Alex Goen expressed regret at Smith's death.

"Today, Anna Nicole Smith's grief-stricken and tumultuous personal life came to an end. Anna came to our company as a customer, but she departs it as a friend," Goen said in a brief statement.

"While life for Anna Nicole was not easy these past few months, she held dear her husband, Howard K. Stern, her daughter, Dannielynn Hope, her most cherished friends, beloved dogs, and finally, her work with TrimSpa," he said.

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Consumers who bought Xenadrine EFX slimming pills expecting to lose weight will get refunds of up to $30, the Federal Trade Commission said Monday.

The government isn't requiring you to prove that you bought the pills.

You do have to sign and mail a form swearing, under penalty of perjury, that you bought Xenadrine EFX between Feb. 1, 2002, and May 22, 2006, and were not satisfied with it.

Promoters of the slimming pill advertised heavily on TV and in People, TV Guide, Men's Fitness and other publications. The ads claimed the slimming pills caused rapid and substantial weight and fat loss, without dieting or exercise.

Some customers claimed to have lost more than 100 pounds. The FTC says they were paid up to $20,000 for their testimonials.

According to the FTC, promoter Robert Chinery Jr. commissioned several studies of the slimming pills, none of which showed substantial weight loss. One study showed an average loss of 1.5 pounds over 10 weeks, while those who took placebos lost an average of 2.5 pounds.

A 120-tablet bottle — a one-month supply — sold for about $40. Sales topped $160 million.

The amount of refund per consumer depends upon how many others apply. Depending upon the number, the promoters will pay between $8 million and $12.8 million to settle the FTC's complaint.

The settlement bars the promoters from making any health claims not substantiated by scientific evidence.

Download the claim form at http://www.xenadrineefxsettlement.com/ or call 1-800-560-6435. The deadline is Sept. 15.

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