Pharma Testimonial Videos Overstate Efficacy More Often Than Other Ads

Mark Senak over at Eye On FDA Blog has analyzed 235 Warning Letters (WLs) and Notice of Violation (NOVs) letters issued by FDA's Office of Pharmaceutical Drug Promotion (OPDP) since 2005. He cataloged 600 violations, including:

• risk omission or minimization, 
• superiority claims, 
• overstatement of efficacy, 
• unsubstantiated claims and
• broadening of indication

When Senak specifically looked at letters regarding pharma marketing videos (excluding TV DTC ad videos), he found that 80% of the violations concerned risk minimization (40%) or overstatement of efficacy (40%). Below is the remake of his pie chart of these data (for the original data see "Viewing Video’s Regulatory Profile").

What's interesting is that these videos -- mostly patient and physician testimonials -- overstate efficacy at TWICE the average for all kinds of promotions (40% for videos vs. 21% for all ads, including video). Senak postulates that "when people talk about their own experiences with a treatment, [they] may include reference to outcomes that is not typical or supported by clinical data."

An example of a video that overstated efficacy was a video testimonial featuring Ty Pennington posted on youtube.com by Shire. FDA said "Both the webpage and video overstate the efficacy of Adderall XR; the video also omits important information regarding the risks associated with Adderall XR use."

The problem with FDA letters is they usually are sent well after the cow has walked through the open barn door! See, for example, "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!"

Will FDA Cite this Vyvanse Web Image as Off-Label Promotion?

If an image is worth a thousand words, then this image found on the Vyvanse Web site home page is shouting off-label promotion.

Is it a coincidence that this image, showing a woman ("Fran") with a measuring tape and a dress, evokes weight loss, which is one of the common side effects of Vyvanse and similar stimulant dextroamphetamines?  (Vyvanse is a "prodrug"; it gets converted to stimulant dextroamphetamine in the body). Thanks to "Chad" who pointed this out to me via the "Contact Us" link above.

Other drugs have been promoted off-label for weight loss. Just yesterday I reported that Johnson & Johnson was fined $81.5 million for misbranding and illegally marketing Topamax for weight loss, among other things (see "Trouble in the House that McNeil Built: Why Drug Company Silos are Useful").

Compared to the Topamax off-label case, the Vyvanse off-label imagery is pretty subtle and perhaps only people like me (and "Chad") would even think it was more than a coincidence. Images in direct-to-consumer (DTC) ads, however, are carefully chosen by pharma marketers and the FDA does pay close attention to them as part of the overall message. An example is the shrinking planet Avodart ad that received an FDA letter because the image showed too much shrinkage (see "FDA Warns GSK About Enlarged Avodart Ad Imagery"). Other critics have even pointed out things like the speed of flapping bee's wings in some DTC ads (see "Ruth Day and the Bees Repeat Performance at House DTC Hearing").

These days, the FDA is paying more attention to subtleties in Rx drug promotions. For example, FDA recently sent Novartis warning letters about two unbranded Web sites that it said illegally promoted Gleevec even though the brand name was not mentioned on the sites (see "FDA Warns Novartis Over Gleevec Internet Sites").

Maybe the FDA reads this blog and will take a look at the Vyvanse Web site. If it decides to send Shire a letter, it may not happen for several months, by which time "Fran" may have been replaced by "Frank," a trucker having a late night meal at a truck stop. Pretty stimulating image, eh?