Doctor: Diet Pill Approval Is A "Mistake"
Health Research Advocate Calls FDA's OK For Over-The-Counter Drug "The Height Of Recklessness"
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Play CBS Video Video New Over-The-Counter Diet Drug The food and drug administration has approved the prescription diet drug Xenical to be sold over-the-counter as "Alli." Dr. Emily Senay speaks with Hannah Storm about the drug's pros and cons.
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Video Are Diet Pills Worth It? The FDA is set to approve a new diet pill, but do these drugs really work and are the potential drawbacks worth it? Emily Senay discussed the topic with Julie Chen.
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Video High Hopes For New Diet Pill An experimental anti-obesity drug has helped some patients lose weight and keep it off. Dr. Lou Aronne, who helped test the drug, spoke to The Early Show about the promising pill.
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The FDA announced on Feb. 7, 2007, that an over-the-counter version of the diet drug Xenical has been approved for sale. (AP / file)
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Interactive Diet And Nutrition Are you eating right? See the government's guidelines, calculate your body mass index and quiz yourself on healthy food choices.
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Quiz Are You Food Savvy? Have you consumed myths about diet and nutrition? Take these quizzes to find out.
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Quiz Fact Or Fiction? Do you have a healthy knowledge of common medical misconceptions? Take this quiz to find out.
Dr. Sidney Wolfe says studies have linked the prescription version of the drug, called Xenical, with pre-cancerous lesions of the colon.
The director of Public Citizen's Health Research Group says the plans to market a non-prescription version are a "dangerous mistake" in light of what he calls the product's "marginal benefits." He also says the diet pill can have "bothersome adverse reactions."
The Food and Drug Administration announced Wednesday that it had approved sales of a lower-dose version of Xenical. The non-prescription version is called "alli."
Officials stress that it needs to be used in combination with a diet and exercise program — and that using the pill alone isn't likely to do any good.
The FDA said the fat-blocking weight-loss pill orlistat, which has been available by prescription, can be sold in a reduced-strength version over the counter.
The new version will be sold as "alli" by GlaxoSmithKline PLC. Xenical, the prescription version, is made by Roche Holding AG.
GlaxoSmithKline chose the name "alli" because it's supposed to be "allied" with a weight-loss program, including exercise and healthy eating, reports CBS News correspondent Dan Raviv.
The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise.
Dr. Charles Ganley, the FDA's director of nonprescription products, stressed that the drug is intended for use along with diet and exercise programs. "Using this drug alone is unlikely to be beneficial," Ganley said.
Ganley said in trials, for every five pounds people lost through diet and exercise, those using orlistat lost an additional two to three pounds.
When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects.
The agency recommended users take a multivitamin when using this drug.
The new drug would contain half the dose of Xenical prescription capsules. The price has not been set but is expected to run $1 to $2 a day, company officials said. The company estimates that 5 million to 6 million Americans a year would buy the drug over the counter.
The Food and Drug Administration said the most common side effect of the product is a change in bowel habits including loose stool and some oily spotting. Eating a low-fat diet will reduce the likelihood of this side effect.
FDA said people who have had organ transplants should not take OTC orlistat because of possible drug interactions. In addition, anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat, the agency said.
© MMVII, CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
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The secrets of tennis legend 
How about instead of cursing large companies like GSK, Pfizer, etc. you thank them?!?! Do yo realize how much $$$ these companies invest each year in order to research diseases such as Diabetes, Cancer, Alzheimers and so on? Sure, they make a profit off their products...name one company that doesn't!! You should realize that each time a drug gets approval by the FDA a pharmaceutical company has invested 800+ MILLION dollars into research and development! I can only hope that these 'monsters' you all speak of continue to do what they are doing so that some day my children don't have to experience Alzheimers, cervical cancer, breast cancer, colon cancer, diabetes, heart failure....do I need to keep going?!?!
hint: IF this drug works for you, YOU ARE CONSUMING TOO MUCH FAT.
Working on a HIGH???, or weight loss????
When I started it, my friend kept saying it was like a free ticket to eat what I wanted... I think that is probably the biggest appeal to it. The drug itself doesnt help you lose weight in any form other than give you a push to change your eating habits. My closest description is to compare it to Antabuse (the drug that makes you extremely sick if you drink alchohol)
Acetaminophen is an incredibly dangerous drug, and I absolutely guarantee you that it's killed more people than all diet pills combined. Should the FDA pull its approval?
I agree that the FDA seems to act in the best interest of big pharmacetical companies. No question. However, by approving a drug with known risks, the FDA is not accepting responsibility for patients' using those drugs/supplements/whatever. It's still up to the patient (or, in the case of a prescription drug, the prescriber) to ***** the risk and take responsibility.
Nothing is free. No one's going to force anyone to buy Alli.
Never been big, have you? Did not think so.
The add says "DIET PILL " you, and so many others go off on the deep end. Oh bad it is a bad pill, keep it away from the kids, bad bad pill.
Get a grip ***----. Anything is bad for you if not taken in moderation. Too many sterol-types. If it helps a fat person, I%u2019m all for it.
A drug is proven to cause CANCER in clinical trials, so the FDA removes it, right? WRONG! The money men say repackage it and sell it in lower doses with a new name!
Cha-Ching!
My heart goes out to the desperate people who will spend good money on this pill, hoping to lose weight. They may lose, they may not... but we'll all lose out in the end: More cancer patients, more profits to the drug companies... more payoffs to the FDA.
WAKE UP AMERICA.
A small benefit at best, with a 50/50 chance of developing gastrointestinal side effects,(I think we know what that is)
As always it should be a personal decision
just the typical type of mentality drug companies enjoy....
What are you going to do about it?
- by reel-crazy February 8, 2007 6:22 PM EST
- This story hit on my original comment and set me ablaze again, so I will repeat my comment from the initial story, but will emphasize it stronger this time. If the FDA has it's concentration on a diet pill instead of cancer cures, their priorities are askew. Huge drug companies can get anything they want done, however fast they want it done:
- Reply to this comment
See all 20 CommentsThe only reason this got FDA approval was because of a powerhouse company like GSK getting it rammed through the system.
Cel-Sci ( www.cel-sci.com ) has an anti-cancer drug that will continue to be placed on the back burners and require more lengthy clinical trials unless a company like Pfizer, GSK, Merck, King, or Astra Zeneca gets a hold of them.
What's more important here...a diet pill or a cancer cure?
Posted by Reel-Crazy at 05:58 PM : Feb 07, 2007