FDA warned Abbott about a patient testimonial DVD for its HIV drug Kaletra, starring Earvin “Magic” Johnson.
The DVD, I Know What’s Important, minimizes the risks, overstates efficacy and includes unsubstantiated claims, DDMAC said in a warning letter dated July 14.
At the beginning of the DVD, Johnson answers questions in an interview-style format, although “the only risk information included during the interview are a brief acknowledgement by Johnson that he experiences ‘fatigue sometimes,’” with other risk information superimposed in text, according to the letter.
DDMAC contends that the interview portion omits “any discussion of serious risks,” and relegates that information to the end, “where it is unlikely to draw the viewer’s attention, and is displayed as a running telescript.”
Additionally, DDMAC took issue with several statements made by Johnson during the interview that overstated the efficacy of Kaletra: “While these statements may be an accurate reflection of Magic Johnson’s own experience…this promotional testimonial suggests that Kaletra has been shown to allow all or most antiretroviral treatment-experienced individuals…to live a ‘normal life’…for five or more years.” Evidence is lacking for that claim, the letter said. The DVD also featured outdated product labeling.
DDMAC’s warning letter to Abbott follows an untitled letter on the subject of Kaletra promotion in 2004—that letter questioned a print ad and poster that overstated effectiveness and omitted risk information.
Johnson has been associated with Abbott and Kaletra for several years as a spokesman, having previously served as a pitchman for GlaxoSmithKline’s Combivir.
In 2008, Shire was warned over a patient testimonial video featuring celebrity Ty Pennington, after he discussed his experience with Adderall XR —and inadvertently expanded the drug’s indication.