Healthy Skepticism Library item: 18433

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
How Not To Create A Patient Brochure
Pharmalot 2010 July 20
http://www.pharmalot.com/2010/07/how-not-to-create-a-patient-brochure/

Full text:

The general idea behind a patient brochure is to sell a drug, but the FDA, as you know, also wants a drugmaker to include comprehensive, easy-to-find, readable info about safety and effectiveness, too. So omitting or minmizing such things should be avoided. And drugmakers ought to know, but sometimes – you can confess – a company may forget, or maybe push things a little too far.
That’s what Jazz Pharmaceuticals did with a brochure that was submitted to the agency for its Luvox CR pill used to treat social anxiety disorder and obsessive-compulsive disorder. The agency staff took a close look and, lo and behold, the drugmaker received a warning letter that reads like a grade-school primer for pharma marketers who need lessons on how to include the correct info.
The bottom-line – important safety info was minimized or omitted entirely, and efficacy info was overstated. For instance, warnings about potentially fatal serotonin syndrome and serious drug interactions were not stated. The brochure claimed the pill caused “a low incidence of sexual side effects.” But the labeling notes Luvox caused an “appreciable incidence” of sexual side effects compared with placebo, such as abnormal ejaculation, delayed ejaculation and decreased libido. Ironically, those side effects might just make one socially anxious or obsessed with performance.
Meanwhile, the FDA notes the only risk info is located at the end of each patient profile, but the actual patient profiles omit the same info, including warnings found in product labeling about increased suicidality in children, adolescents, and young adults ages 18 to 24. And while the rest of the info in the brochure is written in consumer-friendly language, the risk info is in medicalese “that is not likely to be understood by consumer audiences.”
Then there’s the bragging about efficacy. The brochure depicts the fictitious Ana, a 19-year-old student, who says: “The knots would form in my stomach weeks ahead of anything social…So I made excuses as to why I couldn’t go out. I’d sit alone in my dorm room feeling nervous and sick to my stomach. I stopped going to class. My grades were suffering. If it kept up, I would flunk out of school. I knew other people who were anxious. They went to see a psychiatrist and took medication.”
But after taking Luvox, her world was much better: “Recently, I got a B on my bio midterm and I’ve been playing flute in a jazz quartet after classes. Small steps, but everything is starting to go well. My psychiatrist is really pleased and thinks I’m doing better.”
The FDA, however, isn’t buying it. The agency argues the brochure creates the impression the pill will “markedly improve” social functioning and academic performance – patients will go from sitting “alone in (a) dorm room feeling nervous and sick to (their) stomach” and being in danger of flunking out of school to “playing flute in a jazz quartet after classes” and getting good grades. “We are not aware of substantial evidence or substantial clinical experience to support the implication that patients treated with Luvox XR will experience such improvements in social functioning or academic performance,” the agency writes.
You can read the entire letter yourself, of course. Meanwhile, Jazz execs must come up with a comprehensive plan for designing and distributing brochures that tell the truth – the whole truth and nothing but the truth. This is not the first time a brochure has been tagged by the agency, or the most eggregious example one might find. But this is not a new issue either. Brochures like the one for Luvox are not close enough to jazz to satisfy the FDA. Nor should they be.