Shire Pharmaceutical received an FDA Warning letter as a result of a YouTube video by Extreme Makeover (Home Edition) host Ty Pennington. You can see the full letter here at the FDA website.
Shire acknowledged that it was aware of the YouTube video posted by Pennington, and helped promote the content. Here’s part of the script:
“Now once I got on medication it’s just amazing the transformation I made. I -It literally changed my life, and gave me the confidence to achieve my goals, like being an artist. As a kid, I never could have imagined I could do it. But with the medicines like Adderall XR, it’s truly a transformation. I mean talk about an Extreme Makeover, I’m like living it. Now growing up with ADHD can be a little difficult. It’s not easy to communicate with people, including your own family. So you become kind of alienated. You feel like you’re different, and you don’t really fit in. And that, well, can kind of cause you to feel different, and nobody likes to feel different. So as someone who has had ADHD, and is overcoming it, proper treatment has truly changed my life and made an amazing difference.”
The video has been removed from YouTube, and the FDA is claiming it overstates the efficacy of Adderall XR by implying that this product will “transform” patients’ lives and improve their “confidence.”
This is a reminder that even an informal videos on YouTube is an advertisement, and subject to state and government laws pertaining to accuracy and “fair balance” required by pharmaceutical manufacturers.
This means language like this, which is from Adderall’s “prescribing information”: AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.”
Well I suppose that ADHD boy (see video below) isn’t likely to get that pharma sponsor he was hoping for…