FDA, last week, posted a letter sent to GlaxoSmithKline requesting that the firm stop running a television spot for its prostate treatment Avodart (dutasteride). 

The campaign in question is a 60-second testimonial-style commercial featuring an “employee” at an air and space museum. The man claims to be a diorama designer who creates scaled-down models of the solar system; the commercial plays off the shrinking of the planets, using the props as a metaphor for taking Avodart to shrink the prostate and to reduce overactive bladder problems.

No Superiority
FDA’s big complaint: one of those convoluted statements found in many drug ads that suggest superiority while avoiding a clear-cut statement. “Avodart is different because over time it actually shrinks the prostate, so I [urinate] less often,” says the diorama designer. “Other medicines, they don’t treat the cause, because they don’t shrink the prostate.”

The agency saw two problems. First, it’s not true that Avodart is the only drug to reduce prostate size; Merck’s Proscar (finasteride) does the same thing. Though someone along the line may have thought calling the drug “different” rather than “better” would keep the ad safe, that outcome just wasn’t in the stars—or the planets.

“In indentifying Avodart as the only drug that ‘treats the cause’ by shrinking the prostate, the TV ad clearly suggests that Avodart works better than other medications, presumably including drugs with different mechanisms of action that ‘don’t treat the cause,’ but also including finasteride, which has the same mechanism of action,” read the FDA letter. “Avodart is indicated to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. Other products are also indicated to treat the symptoms of BPH, and nothing in the labeling for Avodart suggests any specific advantage. FDA is not aware of any comparative clinical trials of Avodart monotherapy and other products approved for the treatment of BPH to support the implication that Avodart is superior to such other products.”

Shrinking Claims
And to clinch it, the eagle eyes at DDMAC examined the size of the “before” and “after” planets. Their conclusion: “The visual of the planet shrinking in size represents a reduction in prostate volume that is much greater than the reduction actually achieved with Avodart therapy in clinical trials [about 25 percent]. In fact, the approximately 20–25 percent reduction in volume corresponds to a difference in diameter of less than 10 percent”

“When it comes to the FDA, the bottom line is this—what the FDA advises and what the FDA thinks is ultimately what counts,” said Robert Perry, spokesperson for GSK’s men’s health division. “The ad is not running any longer, and we are going to make sure that future advertising for Avodart integrates [FDA’s direction] into the advertisements.”

The ad ran from March 2008 to September 2008, and was not pre-approved by FDA. Perry told Pharm Exec on Wednesday that GSK traditionally only screens advertisements for new drug launches with FDA. 

“I’ve been in the marketing communications group for four years and we always pay [attention] to legal and regulatory guidelines. There is a process for reviewing all advertisements, and the bulk of our material is filed with the FDA,” Perry said. “This is something that [we] are inherently aware of as [we] develop the promotional pieces, but no one is infallible.”