Yesterday, I posted a notice about FDA sending GSK a warning letter citing a violative Avodart "Planetarium" TV commercial for exaggerating the benefit of the drug to shrink enlarged prostate glans (see "FDA Warns GSK About Enlarged Avodart Ad Imagery").
One piece of evidence cited by FDA was the imagery used in the ad. Looking back over previous posts I have made, I find a post I made back in January, 2008, about an Avodart PRINT ad, which, as it turns out, ALSO exaggerates the amount of prostate gland shrinkage attributed to Avodart. See the following images:
The top image shows the whole ad, while the bottom image shows an enlarged area of the ad plus an optical illusion I added (see a previous post for an explanation).
Note that the enlarged illustration suggests that Avodart shrinks the prostate whereas "Other Drugs" do not (the ad copy says so outright -- click the ad image to enlarge IT). The image also shows a shrinkage of 19% in the diameter of the prostate, whereas the FDA says clinical trials only show a decrease of 10%.
Seems that the FDA missed this ad. Why don't they read this blog? It would save them a lot of time!
It is not that the FDA missed the ad, it is that pharmaceutical companies can still air DTC and print advertisements before submitting them to DDMAC. That is why there are close to 100 warning letters to pharmaceutical companies every year.
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