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Healthy Skepticism Library item: 16157

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: news

Comer B.
DDMAC warns Abbott on Kaletra promo
Medical Marketing & Media 2009 Jul 31
http://www.mmm-online.com/DDMAC-warns-Abbott-on-Kaletra-promo/article/141016/


Notes:

Link to warning letter:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM173184.pdf


Full text:

FDA warned Abbott about a patient testimonial DVD for its HIV drug Kaletra, starring Earvin “Magic” Johnson.

The DVD, titled “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 of the program, “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 The DVD also featured outdated product labeling.

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.

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.

In other FDA correspondence news, ViroPharma, a Pennsylvania-based biotech, received an untitled letter in June regarding branded panels and sales aids for Cinryze, a product indicated for a rare type of swelling called hereditary angioedema. Those materials were deemed “false or misleading because they present efficacy claims for Cinryze but fail to reveal, and they minimize, material facts; they make unsubstantiated comparative claims; and they overstate the efficacy of Cinryze,” according to a letter signed by Robert Sausville, director, division of case management at the Office of Compliance and Biologics Quality (OCBQ). That division is part of the Center for Biologics Evaluation and Research (CBER).

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909