Monday, April 4, 2011

Amgen's Prolia Website Features Stories from "Typical" But Not "Actual" Women Like You

Posted by Princess Eva Angelica at 6:00 AM
You've probably been seeing DTC TV ads for several different osteoporosis drugs these days. No longer does Sally Field dominate the airwaves hawking Genentech's Boniva. AMGEN's twice-per-year injectable Prolia, for example, is now competing with once-per-month injectable Boniva.

Unlike Boniva, however, Prolia does not have a celebrity spokeswoman. What it has are "Women Like You."

The Prolia website prominently displays the option titled "Stories from women like you." Below is a screen shot of that option showing Karen, 71, who talks about Prolia.


Unfortunately, neither Karen nor any of the other "women like you," is an actual patient. Their stories, AMGEN claims, are "examples of typical patients--not the experiences of actual patients." Maybe it's difficult to get real patient stories for a new drug. I've heard from posts on CafePharma that sales of Prolia suck big time because few GPs want to prescribe a new, unproven biologic that remains in the body for a whole year. Plus there are re-imbursement issues.

Karen tells her story AS IF she were a real patient and provides details of how she fractured her left wrist. "I should be glad it wasn't my right [wrist]," says Karen. "My doctor said, 'Karen, you didn't get a fracture from being clumsy. You got a fracture from weak bones.'"

[BTW, I love the new age music in the background!]

Karen mentions that she is doing "everything my doctor told me to do to strengthen my bones." At first -- within the first two minutes of the video -- she only mentions getting a "shot every six months," which she "likes" and says"works for me." Later on, Karen does mention calcium pills, exercise, etc.

While Karen doesn't mention specific side effects, some specific side effects do pop up in the video frame in mouse-sized type that is difficult to read -- especially, I imagine, for older women. The last 2 minutes of the video highlights the important safety information using a scrolling text screen and a voiceover.

Perhaps, over time AMGEN will collect stories from ACTUAL patients to replace Karen and other "not actual patients" on its website. Meanwhile, I remain queasy about actors portraying "typical" patients in drug ads. Has the FDA issued any guidelines regarding what constitutes a "typical patient" in drug ads? FDA has issued warning letters about actors whose dialogue overstates benefits or downplays risks, but I don't recall any letter that questioned whether or not the portrayal is "typical."

Suppose, instead of a typical patient, AMGEN had a video of a "typical" physician? Would the FDA (or AMA for that matter) rise up and challenge the concept of a typical physician?

It seems to me that allowing drug marketers to use actors to portray what is labeled a "typical patient" is worse than using actual patients who tell real stories stories, even if those stories are not typical. At least we can challenge the veracity of "real" stories versus "typical" stories.

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