Will DDMAC’s July 14th warning letter to Abbott send shivers down the spines of MLRers, reinforcing the notion that the FDA doesn’t approve of the use of celebrities?
Let’s look at the facts:
DDMAC cites Abbott’s promotional DVD, titled "I Know What's Important," for clumping the risk information in a dull section of at the end of the video and suggesting that Kaletra (lopinavir/ritonavir) has broader utility in treatment-experienced patients than the label supports. The “I” is non other than Ervin “Magic” Johnson.
In the Kaletra DVD, the first 111/2 minutes are devoted to an "engaging and lively" discussion with Johnson about the benefits he has experienced from the drug. "In contrast," DDMAC writes, "the presentation of serious risks associated with Kaletra is relegated to the end of DVD after the interview is over, where it is unlikely to draw the viewer's attention, and is displayed as a running telescript."
The only risk information included during the interview is a brief acknowledgement by Johnson that he experiences "fatigue sometimes" and disclosures in SUPERs that Kaletra "is not a cure for HIV infection," that "the most commonly reported side effects of moderate severity that are thought to be drug-related are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache, and nausea, " and that "children taking KALETRA may sometimes get a skin rash."
DDMAC argues that while Johnson's claims may be an accurate reflection of his own experience, "inclusion of the SUPER stating 'Individual results may vary' ... does not mitigate the misleading impression created by the promotional DVD that all or most treatment-experienced patients taking Kaletra can expect to survive and be healthy for at least five years."
"FDA is not aware of substantial evidence or substantial clinical experience to support effectiveness for five or more years of treatment with Kaletra in treatment-experienced adults," DDMAC wrote, and the "personal experience of a Kaletra patient such as Magic Johnson does not constitute such evidence."
"These claims misleadingly overstate the efficacy of Kaletra by suggesting that the usual outcome of treatment with Kaletra is the preservation and continuance of a 'normal life,' including activities of daily living, work productivity, and social, emotional, and physical functioning," DDMAC wrote.
Note: No claims were made to infer that use of Kaletra helps to enhance one’s baby sky hook.
