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Crestor: No Truth in Advertising?

Reeling from all the scrunity from outside (namely Congress) and within (Dr. David Graham, my hero who keeps fighting the good fight), the FDA took a stand yesterday to protect what's left of its sagging public image in a strong letter to AstraZeneca. Seems the makers of Crestor made false statements partly attributed to the agency in an ad that appeared in newspapers shortly after Dr. Graham's scathing testimony in which he named Crestor as one of the current on-market drugs that pose grave safety concerns.

The misleading statements in question:

  • "A medication can be more effective and just as safe." (comparing Crestor to other statins)
  • "The FDA has confidence in the safety and efficacy of Crestor."

The FDA believes the first claim minimized the risks of taking Crestor while the latter suggests the agency has no concerns about Crestor's safety with AstraZeneca even citing the FDA's Web site in the ad. Fact is, a FDA spokesperson cited a late November Washington Post story in which Steven Galson, acting director of the FDA's drug division, said the agency "has been very concerned about Crestor since the day it was approved, and we've been watching it very carefully."

AstraZeneca stopped running the advertisements in November, well before receiving the drug agency's letter, according to a company spokeswoman.

The interesting statistic: The FDA has sent NINE letters warning drugmakers about false claims, and has rarely criticizes a company for misrepresenting the agency itself.

All this nonsense merely takes your eyes off the real issue: Taking a potentially toxic drug as a "stopgap" measure to lower your cholesterol rather than taking proactive steps to retool your lifestyle to solve the problem. If lowering your cholesterol is your goal, try a healthier diet with little to no grains and sugars. This will work in the majority of cases.

USA Today December 23, 2004

New York Times December 23, 2004

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