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Read Original Story

Nonprescription diet drug gets OK

Rating

4 Star

Nonprescription diet drug gets OK

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

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story mentioned alli would cost between $2-$3 per day.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

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.

Does the story adequately explain/quantify the harms of the intervention?

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.

Does the story seem to grasp the quality of the evidence?

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.

Does the story commit disease-mongering?

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.

 

Does the story use independent sources and identify conflicts of interest?

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

Does the story compare the new approach with existing alternatives?

Not Satisfactory

This story did not discuss other treatment options for the loss of comparable amounts of weight

Does the story establish the availability of the treatment/test/product/procedure?

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.

Does the story establish the true novelty of the approach?

Satisfactory

The story was clear that alli is an over-the-counter strength of a medication that has previously been available by prescription only.

Does the story appear to rely solely or largely on a news release?

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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