Honesty in Drug Advertising: Some rare examples

“In patients with multiple risk factors for heart disease, LIPITOR REDUCES RISK OF HEART ATTACK BY 36%* If you have risk factors such as family history, high blood pressure, age, low HDL (‘good’ cholesterol) or smoking.”

The noteworthy part of this New York Times ad is the asterisk and this explanation of the 36% statistic: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.”

Take a moment to appreciate the significance of this rare finding of candor in one of those ubiquitous Lipitor ads featuring Dr. Robert Jarvik, “inventor of the Jarvik Artificial Heart and Lipitor user.” Most drug ads would rather proclaim a “36% reduction” and leave it at that, but this version shows exactly what it means. Take Lipitor for years and your risk of having a heart attack drops 1%. Granted, the explanation is in much smaller type than the 36%, but at least it’s there.

Another Jarvik/Lipitor Times ad proclaims: “In patients with type 2 diabetes, LIPITOR REDUCES RISK OF STROKE BY 48%* If you also have at least one other risk factor for heart disease…” The explanation: “That means in a large clinical study, 2.8% of patients taking a sugar pill or placebo had a stroke compared to 1.5% of patients taking Lipitor.”

It’s rare to see ads with drug benefits expressed in what statisticians call absolute risk terms, which are more understandable to the public as well as doctors. Tom Abrams, director of the FDA Division of Drug Marketing, Advertising and Communications, explained in a telephone interview that the FDA encourages drug companies that provide quantitative information (e.g., 36% reduced risk of heart attack) in their ads to show what it means. In other words, the ad must answer the question: 36% of what?

Whether quantitative information goes into an ad is up to the drug companies, but once it does, the FDA wants them to put in the explanation, Abrams said, though only the most egregious non-compliers get a warning letter. Why no explanation of the quantitative information in all TV versions of these ads? “This is a quicker media and companies believe that people can’t process the information?” he said.

Well, honesty in some print ads is better than nothing. The next thing to look for is the quantification of the drug’s severe adverse effects…in absolute risk terms.

Maryann Napoli, Center for Medical Consumers ©
May 2007