GSK ads for Avodart are misleading, says FDA

Share this article:
GSK ads for Avodart are misleading, says FDA
GSK ads for Avodart are misleading, says FDA

Consumer ads in support of GlaxoSmithKline's prostate drug Avodart overstate its efficacy and present misleading claims, the FDA said in a letter to the company.

The specific ad in question—a 60-second TV spot titled Planetarium—depicts artists working on planetary models, with one artist having to leave for the bathroom. Afterward, the actor recounts a conversation with his doctor: "Avodart is different because, over time, it actually shrinks the prostate, so I go less often. Other medicines, they don't treat the cause, because they don't shrink the prostate.”

“The TV ad misleadingly suggests that Avodart is superior to other drug therapies when this has not been demonstrated by substantial evidence or substantial clinical experience,” DDMAC's Cynthia Collins, consumer safety officer, said in the letter, citing Merck's Proscar, another drug approved for the treatment of symptomatic benign prostatic hyperplasia.

FDA also took issue with a graphic showing a large planet and a small planet—used to represent the actor's prostate. “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,” the letter said. “In fact, the approximately 20-25% reduction in volume corresponds to a difference in diameter of less than 10%."

The untitled letter requested that GSK immediately cease dissemination of the ad, and submit a written response to the letter by March 4.

Sarah Alspach, a GSK spokesperson, told the Associated Press on Friday that the ad had not aired since last fall, and that GSK “is committed to responsible marketing.”

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.