Fewer than half of the claims in advertisements that appear in leading medical journals aimed at ear, nose and throat specialists are actually supported by data referenced by the advertisers, according to a new study in Archives of Otolaryngology. And the finding suggests that doctors may be misled by the content of the ads.
The researchers chose a sample of 50 claims from 23 ads that ran in four leading journals and sent them to five specialists, who were asked to compare the claims to references listed in the ads. The upshot? Only 28 percent of the claims were strongly supported by the referenced data, but 12 percent of the time, the data actually contradicted the claims (here is the abstract).
The issue is troublesome, the lead researcher says, if busy docs may rely on one-line glossy ads rather than pouring through lengthy articles. "The fact is that the scientific literature is copious and much of it is somewhat obscure," Jeffrey Spiegel, a head and neck surgeon at Boston University, tells Reuters. "It doesn't have to lead to actual harm, but it can still be wasted time and effort."
The results underscore an ongoing debate over the value of ads in medical journals. As Reuters notes, drugmakers are believed to generate from $2 to $5 in sales for each dollar spent on advertising in medical journals. And ads are lucrative to journals as well, although some have begun banning them from their pages. Earlier this year, for instance, Emergency Medicine Australasia took this step (read here).
However, Richard Rosenfeld, editor of Otolaryngology - Head and Neck Surgery, one of the journals that was reviewed, believes ads alert docs to meds that may not otherwise know about. And he says the results are not clear cut. "The fact that (the five reviewers) can't agree reflects the nature of what an ad is," he tells Reuters. "The problem is that we're attempting to provide a level of precision to something that was never intended to be precise. Ads are intended to attract interest."
Although the FDA reviews promotional materials from drug and device makers, Reuters writes that Spiegel suggests the system might be overwhelmed, since there is no requirement for claims to be vetted before they're published. "Perhaps it would be appropriate for the medical journals to go the extra distance and help its readers by rating the ads," he offers.
Paul Levine, editor of Archives of Otolaryngology - Head & Neck Surgery, which contributed ads for the review, says he is uncertain about the best approach. "We need to figure out a methodology to better evaluate the veracity of these ads," he tells Reuters. "What is implied in the study is that it's everybody's responsibility to ensure that claims of any type are in fact true."
Rosenfeld, whose journal is the official publication of the American Academy of Otolaryngology - Head and Neck Surgery Foundation, does review ads. "When I sign off what I'm saying is I feel that the advertisers are providing a reasonable and fair representation of their product," he tells Reuters, adding that he also rejects some. "They are obviously looking to spin their product in the best light possible. I think the bottom line from this study is caveat lector, let the reader beware
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6 Comments
If I was a physician I would consider that a very big problem! I would never know what to believe. FDA reviews less than 2% of the adds and usually only after receiving complaints. ToTally overwheled is correct. TALK TO ANY OF THEM!
FDA approves every detail that can be said about any promotional effort on the part of company. So how long do you think it would take for a competitor to report mis-labeleing to FDA when published in an ad. As fast as they can type is the answer. And then the lawyers get their chance if a false claim is made with liability suits.
The academic world seems to forget that survey after survey makes journals a leading source of medical information in all specialties and in most every instance, journal advertising is a part of what makes journals possible at a reasonable cost to the physician. The one Australian journal mentioned in the write-up as abandoning advertising is not exactly a trend.
I would appreciate seeing the full report. I have seen a couple of similar studies over the years and they all are filled with protocol miscues that would make "False Claims" very easy to justify.
My suggestion is to the authors is to report their specific findings to FDA rather than casting a shadow over an industry that is the most regulated in the world.
No offense to all the head & neck specialists out there, but this journal is not running ads about major, widely prescribed products. Just looking at examples of claims reviewed in this article, it was clear that these ads were for very specific, narrowly targeted products. More significant research would involve a major, broad-based journal, eg, JAMA, New England Journal.
Sorry Industry veteran, but the FDA does not approve of any adds. THat is the idea of the Bad add campaign. THey do not have the people to look at all the material. THe advertizer is only required to give the FDA a copy of the material. Most of that material is never reviewed. THe FDA gets thousands of adds a month and does not have the staff to look at all of them. I've talked to some of the FDA employees that look at adds and they only have time to look at a very few.
Insider-It is true, as Industry Veteran says, that competitors often narc on each other to DDMAC. And the risk of getting a warning letter can create an effective moral hazard.
But it's fair to say that, after the pre-clearance review window (6 months post-approval) there isn't a whole lot of attention given to the promotional materials filed with DDMAC.
The Bad Ad campaign is basically crowd-sourcing this process, which seems fine as far as it goes. The plaintiffs bar is also clearly more than happy to step into the breach.
First, it's spelled "ad", as in short for advertisement. Second, there are lies, damn lies, and statistics. As someone working in healthcare advertising for 25 years, I find the face value plausibility of these claims questionable at best.The entire paper needs to be skeptically examined before we accept these sorts of alarmist accusations as Truth. I strongly suspect the news articles emanating from this paper and press release don't include a prior thorough reading of the full paper. Even if the Abstract is the basis, there is plenty of anecdotal data that Abstracts don't always reflect the true central findings of a paper. And don't get me started on press releases. The fact is, all promotion is reviewed rather stringently by a team of medical, legal, and regulatory folks from the company sponsoring the ad. These folks take their job seriously and prize their integrity and independence. They are not in cahoots with Marketing. Depending on the company, they can arguably be overly conservative. I speak from considerable experience. The "value" of ads? Ads are not an educational service, and are not designed to provide "value" to the reader unless that is a conscious strategic decision by the ad's authors. They drive awareness and keep brands top of mind. They can make a topline point or 3 about the advertised brand at best. The "value" is to the sponsoring company and the journal. Feel free to turn the page, but let's stop pretending ads are something they're not and never will be unless it serves the purpose of the sponsor company.