Our Review Summary
This is a story crafted around the news that the FDA has approved the sale of a lower dose, over-the-counter (OTC) version of the diet medication orlistat. The story insinuates that the OTC version would have a similar effect on weight loss as does the prescription strength. Although both are likely to be associated with weight loss, the data suggest that the weight loss is dose dependent, so the anticipated weight loss should be about half of that seen with the prescription version. Although the story alluded several times to a 10-20 pound weight loss, it failed to provide a time frame for this weight loss or any indication that weight regain was common after cessation of the drug.
Quotes from several clinicians, FDA officials, and the makers of the medication were included in this piece. Some sources expressed appropriate caveats about safety and about efficacy of the new OTC product.
Although the story lists some of the gastro-intestinal unpleasantries that occur with the use of this medication, a quote from a paper put out by the FDA (http://www.fda.gov/bbs/topics/ANSWERS/ANS00951.html ) on the prescription strength form of the drug really says it better: "The most common side effects of orlistat are oily spotting, gas with discharge, fecal urgency, fatty/oily stools and frequent bowel movements."
Criteria
Satisfactory
The story mentioned alli would cost between $2-$3 per day.
Not Satisfactory
The claim for this over-the-counter version of this medication was that it will have similar effect on weight loss as the dose available by prescription. However, data from the original studies designed to examine effectiveness of this medication show that the weight loss observed was dose dependent. These data suggest that the anticipated weight loss should be about half of that seen with the prescription version.
Although the story alluded several times to a 10-20 pound weight loss, it failed to provide a time frame for this weight loss or any indication that weight regain was common after cessation of the drug.
Satisfactory
Although the story lists some of the gastro-intestinal unpleasantries that occur with the use of this medication, a quote from a paper put out by the FDA (http://www.fda.gov/bbs/topics/ANSWERS/ANS00951.html ) on the prescription strength form of the drug really says it better: "The most common side effects of orlistat are oily spotting, gas with discharge, fecal urgency, fatty/oily stools and frequent bowel movements."
The story also included concerns regarding the potential for deficiency of fat-soluble vitamins occuring with the use of this medication.
The story did not include a warning for organ transplant recipients for whom this medication could cause serious problems. But it did mention concerns regarding the potential for deficiency of fat-soluble vitamins occuring with the use of this medication.
The story included a quote from the director of health research at Public Citizen regarding concerns about "precancerous lesions of the colon" derived from a single study in rats. There is currently no published data supporting similar concerns about use of this drug in humans.
Not Satisfactory
The story included information from one weight loss specialist that the use of this product results in an average weight loss of 10-16 pounds. It did not mention that this was with the use of the prescription strength product, in the setting of a weight loss practice which likely included supportive interactions with health care professionals as well as reduction in calories consumed and increased exercise.
Near the end of the story, there was information ("..eating a low-fat diet containing no more than 15 grams of fat per meal would reduce the risk of the side effect.") attributed to the FDA. This sentence is actually a direct quote from the www.myalli.com website.
Satisfactory
No overt disease-mongering about obesity; about two thirds of the way through it mentions that ~130 million Americans are overweight, and that about half of these would be considered obese.
Satisfactory
There were many clinicians, FDA personnel, and company spokesperson quoted for this story. The views from clinicians included those who said that this product will not result in weight loss on its own.
It might have been helpful to include a link to the information released by the FDA on this product. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01557.html
Not Satisfactory
This story did not discuss other treatment options for the loss of comparable amounts of weight
Satisfactory
This story is about a new product, alli, which has been approved by the FDA for sale without a prescription. The story reported that it will be available this summer.
Satisfactory
The story was clear that alli is an over-the-counter strength of a medication that has previously been available by prescription only.
Satisfactory
Several sources were used, so it appears unlikely the story relied solely or largely on a news release.
Total Score: 7 of 10 Satisfactory
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