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By Susan Perry | Published Fri, Feb 5 2010 10:21 am
Forbes magazine has put up a must-see slide show of “Ten Misleading Drug Ads.”
These are among the 41 advertising and promotional campaigns that generated warning letters in 2009 from the apparently newly energized U.S. Food and Drug Administration (FDA), which regulates such advertising. (Hat tip: Gary Schwitzer’s HealthNewsReview blog.)
As Forbes reporter Rebecca Ruiz notes, the FDA issued twice as many enforcement letters in 2009, under President Obama’s administration, than it did the previous year under President George W. Bush’s watch. (I posted on Monday about FDA warning letters sent to pharmaceutical companies last year regarding online ads.)
But that's still way below the 142 that were sent out in 1997, the year, as Ruiz puts it, when the "FDA issued new rules for direct-to-consumer advertising, opening the floodgates for drug companies to advertise on television."
As one source quoted by Forbes said (with considerable understatement), during the Bush administration "FDA leadership made it clear they were not going to be zealous in keeping the industry's feet to the fire on such ads."
We'll have to wait and see exactly how zealous the agency will be under President Obama.
Pharmaceutical chutzpah
The misinformation that appears in some drug ads is quite remarkable. Writes Ruiz:
Sometimes companies egregiously exaggerate how well their drugs work. In a brochure given to doctors and nurses last year, the Japanese drug company Eisai claimed that its Dacogen drug helped 38% of patients with a rare blood cell disorder in a clinical study. This figure was false, the FDA said in a November 2009 warning letter. In fact, the figure was taken from a tiny subgroup of patients who responded well to the drug. When all patients in the study were included, the real response rate was a much less impressive 20%, the FDA noted.
"It’s almost impossible for the public to actually parse the ads and come to their own independent conclusions," says Cleveland Clinic cardiologist Steven Nissen, a fierce critic of drug ads.
But Nissen is suspicious of most drugs that are advertised because he thinks that the marketing campaigns distract and mislead consumers. His advice: avoid the most heavily advertised drugs and stick to generics.
Each of the 10 ads featured in the Forbes article comes with a brief explanation of the FDA’s concerns — things like not fully reporting a drug’s side effects, or exaggerating its benefits, or suggesting that it be used “off-label” (for a purpose that hasn’t been approved by the FDA). For readers who want more details, the article also includes links to the actual warning letters that the agency sent to manufacturer of the drug or medical device.
Here’s a list of the products in the ads featured by Forbes:
Like Gary Schwitzer, I, too, wish Forbes hadn't decided to stop at 10.
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