--addresses how well drug ads in major medical journals adhere to FDA guidelines, and whether, secondarily, the ads tell physicians what they need to know to prescribe properly. Is the glass half empty or half full? You be the judge.
The authors looked at 83 unique ads appearing in 9 high-impact medical journals during November 2008. They found that only 18% clearly met all the FDA criteria, 49% were clearly nonadherent in at least one criterion, and the rest were uncertain due to missing information. (half empty) But the articles that were clearly nonadherent failed, on average, to meet only 1-2 of 21 FDA guidelines. (half full)
Where were the ads most likely to fail? The chief deficiencies identified by the authors were:
- Unbalanced literature citations making the drug sound better than the evidence shows
- Misleading use of headlines or pictures
- Implying doses recommended for one class of patients also safe and effective for other classes
The authors went on to assess whether the ads provided important prescribing information. They found few ads that met this goal, mostly due to failure to quantify either safety or efficacy. (half empty)
So, what's the take-home message? The ads may be deficient according to FDA guidelines but most ads seem adherent to most of the guidelines. On the other hand, any physician trying to figure out how to prescribe drugs for patients should never trust drug ads to tell what she needs to know. On the other other hand, who didn't know that?
A few comments. First: the FDA is probably always destined to be toothless regarding ads unless it were to be equipped with SWAT teams. Ads have a natural and limited life cycle, somewhere just upward of the May fly. They are run for a few weeks or months and then replaced by a new round of ads. Almost always, by the time the FDA gets wind of a major violation in an ad and can gather itself to take formal action, the ad has already run its course and the damage is done.
Second: As I tried to describe in HOOKED, drug companies never market a drug in just one way. A drug marketing campaign is a carefully orchestrated symphony. Not only are there a lot of sections, but great care is taken to precisely coordinate the timing of all the different elements. So looking only at one section of the orchestra--the journal ads, the TV DTCA ads, the drug rep visits, the dinner talks, etc.--is almost certainly to miss the forest for the trees (to mix metaphors shamelessly).
Third, having said all that, it would be wrong to blow off journal ads as not worth powder and shot. Korenstein et al. cite industry data to show that the drug companies estimate return on investment for journal ads at $5 in drug sales for every $1 spent on ads, making this one of the best returns in any area of marketing.