Healthy Skepticism Library item: 18879

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
One Too Many: Alkermes & Promotional Hyperbole
Pharmalot 2010 Nov 16
http://www.pharmalot.com/2010/11/one-too-many-alkermes-and-promotional-hyperbole/

Full text:

Sometimes, people with a drinking problem may have difficulty focusing on certain things. But Alkermes seems to have almost guaranteed that important risk info would escape most anyone by the way the drugmaker produced a consumer DVD and brochure for its Vivitrol alcohol-dependency med, which is approved only for people who have managed to avoid drinking before seeking treatment.
How so? Well, Alkermes stuck the risk info for the injectable after testimonials and toward the end of the videos where, as the FDA notes in a warning letter, it is “unlikely to draw the viewer’s attention.” Moreover, the risk info appears in the form of fast-moving, movie-style credits displayed in small type. Still more curious, there is no accompanying narration, but music is playing, which can be distracting.
In similar fashion, a 24-page patient brochure presents numerous efficacy claims on the first 19 pages, the FDA writes, but fails to include any risk info until page 20. Once again, Alkermes stacked the deak by relegating important info to the tail end of informational material and, in the process, minimized the risk info. On the other hand, Alkermes didn’t pull any punches when it came to overstating efficacy.
In fact, the videos and brochures are replete with hyperbole designed to create the impression that Vivitrol is a wonder drug that can help you sleep better (even though sleep disorder is a common side effect); improve tattered relationships with family and friends; reduce problems on the job and experience spiritual growth.
“The money was going towards alcohol and not the kids. I couldn’t go to their functions at school or their baseball games ‘cause I was always too buzzed,” says Tina S. in one testimonial. “Couldn’t even crawl out of bed and now I’m back to work…My life has changed so much in the past year. I’ve gotten remarried. We’re working on the house and everything’s going pretty good.”
Of course, finding a way to stay on the wagon is a good thing and should not be minimized. With this laundry list, though, everyone should get a shot – and we do not mean a shot of whiskey. As far as the FDA is concerned, Alkermes went too far by implying the usual outcome of Vivitrol treatment is “a positive effect on a patient’s interpersonal relationships, emotional functioning, work productivity, productivity in general, and overall quality of life.”
The agency writes that it is not aware of substantial evidence or substantial clinical experience to support the notion that Vivitrol can do such things. Even simple math is off base and creates a disingenuous impression. In one testimonial, an alleged patient says he has had 10 shots, although Vivitrol is administered every four weeks and was evaluated for no more than six months (10 × 4 = 40 weeks, which is more than six months).
Alkermes execs would do well to drown their sorrows in an intensive seminar on how to develop promotional materials that offer vulnerable patients all of the info they need to know – and in a proper and meaningful way. That might even call for a toast.