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.
Hi John, actually DDMAC has indicated through its enforcement actions - namely, the 9 untitled and warning letters it has issued on the subject of patient testimonials in the past 2 and 1/2 yrs - what it means by "typical" patient. These letters make clear that the benefits claimed in testimonials must be consistent with the safety and efficacy demonstrated in pivotal trials and included in the product's label. In addition, the FTC has issued guidance on patient testimonials as well that talks about the "typical" patient.
ReplyDeleteCindy,
ReplyDeleteThanks for pointing that out.
Cindy, what you say doesn't change the fact that the average viewer of these ads will likely assume, that the women speaking are actual or real patients. That Amgen doesn't just state this outright, but instead chooses to allow women to 'trust' these paid actors, tells me Amgen is doing whatever it can without violating the letter of the law, to get folks to take Prolia, a drug that has many serious side effects, has not been tested on subpopulations, and has no post-marketing safety record. Heck, the 17 miserable pages in their prescribing information is sufficient to make one aghast that FDA ever approved this drug. So let us not mince words here. Drug companies have huge advertising budgets for the sole purpose of getting an ever-widening pool of patients to take their drugs. Prolia was slow to make it through the approval process and it's the new kid on the block, so patient beware--Pharma has THEIR pocketbooks in mind, NOT the interests of patients.
ReplyDeleteThe reason actual patients are typically not used by drug companies are because of legal reasons, ie. HIPPA. Additionally, every drug has side effects. Before you discuss Prolia having serious side effects you need to look at the package insert of the product. You will notice that the patients who received placebo (a water injection) experienced the same side effects. It also mentions that overall, the serious side effects were no different than placebo. I point this out because the way the FDA reports side effects is very different than in the past. Statistical differences used to be the only side effects reported, but now all side effects are reported whether or not they are proved to be caused by the drug or not. Business statistics shows that hypothesis' are void if statistic difference is not proven. The FDA, however, does not adhere to this and therefore you have every single event reported in clinical trials. Prolia, being one of the few 'first in class" drugs approved by the FDA in recent years is an example of this new reporting system. Even so, similar side effects were reported in the earlier approved medicines for Osteoporosis. They were not required to report side affects as stringently as Prolia because they fell under the old reporting system. These changes will be mainstay for all new drugs moving forward.
ReplyDeleteAnon,
ReplyDeleteThanks for the information and insight regarding drug side effects.
Point of clarification: HIPAA applies to covered entities (ie, doctors) revealing patient information, not to patients themselves who are free to tell anyone about their medical history and give others permission to use the information.