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Wednesday, December 16 2009
World
Headlines
Common medical =91myths=92 = exposed in new=20 book | See Latest = News=20 |
US drug company warned over ad featuring =91Magic=92 Johnson
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In the video Magic Johnson was interviewed about the = benefits=20 of Kaletra Photo: Getty Images
=
Thursday July 23 2009
Abbott= =20 Laboratories was warned by US = regulators over a=20 promotional DVD where basketball Hall of Fame member Earvin "Magic" = Johnson=20 discusses his experience with the HIV treatment Kaletra.
The consumer-directed video =93minimizes the serious risks=94 and = =93overstates the=20 efficacy=94 of the medicine, the Fo= od and=20 Drug Administration said in a warning letter posted today on the = agency=92s=20 website.
Abbott stopped using the DVD earlier this year and will work with the = FDA to=20 address its concerns, according to Michelle = Johnson, a=20 company spokeswoman.
Abbott was warned in 2004 over a print advertisement for Kaletra that = failed=20 to include risk information and implied that patients can expect to be = healthy=20 for at least five years, which hasn=92t been proven, according to the = letter.
The FDA said it is concerned that the drugmaker is continuing to use=20 promotions for the drug that are misleading and in violation of federal = law.=20
=93The violations described above are serious,=94 Thomas = Abrams,=20 director of the FDA=92s division of drug marketing, wrote in the letter. =
Abbott was ordered to submit to the agency a plan to =93disseminate = truthful,=20 non-misleading, and complete corrective messages about the issues = discussed in=20 this letter.=94
Johnson video interview
In the video Magic Johnson was interviewed about the benefits of = Kaletra for=20 the first 11 1/2 minutes, according to the letter.
A discussion of the drug=92s risks was left until the end of the DVD = as a=20 running telescript, =93where it is unlikely to draw the viewer=92s = attention,=94 the=20 FDA said.
The agency also took issue with implication that all patients fare as = well as=20 Johnson, a 49-year-old retired professional basketball player who = announced that=20 he had HIV in 1991.
In the DVD, Johnson said his disease has been undetectable in the = five years=20 since he started taking Kaletra.
=93FDA is not aware of substantial evidence or substantial clinical = experience=20 to support effectiveness for five or more years of treatment with = Kaletra in=20 treatment-experienced adults,=94 the FDA said in the letter.
=93The personal experience of a Kaletra patient such as Magic Johnson = does not=20 constitute such evidence.=94
Johnson was a five-time National=20 Basketball Association champion with the Los Angeles = Lakers and a three-time league Most Valuable Player.
Kaletra is Abbott=92s second biggest drug, accounting for $1.47bn = (=801.03bn) in=20 2008 sales, or 5pc of the company=92s revenue, according to data = compiled by=20 Bloomberg.
(Bloomberg)
- Catherine Larkin
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