FDA To Advertise Fake Blood Pressure Pill
18 CommentsBy Ed Silverman // August 5th, 2008 // 6:11 pm
Why? So the agency can determine whether the images in the ads actually distract consumers from paying attention to required safety warnings. After the ads run, the FDA plans to survey 2,400 consumers who 40 years and older to gauge their responses.
The FDA intends to create several ads for the fictitious high blood pressure drug using different images and text on the screen while a narrator reads risk info. Some visuals will focus on benefits to determine if that diverts attention from safety warnings, Bloomberg News writes, adding participants will be asked questions about the ads and their attitudes toward what will appear to be a new med.
You may recall that, last May, the House Energy and Commerce Committee held a hearing on direct-to-consumer advertising in which Duke University linguist Ruth Day, who lectures on the psychology of language, testified that drugmakers use various tactics to highlight a drug’s benefits and downplay risks, including matching fast speech to visual effects.
The example she cited: an ad for Schering-Plough’s Nasonex allergy drug that featured a bumble bee flying around as side effects were listed, but hovered when benefits were discussed. “All of these wing flaps and wing flashes and sparkly things essentially divided the attention of the viewers…and thus led to decreased knowledge” of possible risks, Day testified.
The FDA is “responding to criticism of many of us that the risk information is underplayed” in ads, said Steve Findlay, a health-care analyst at Consumers Union, the publisher of Consumer Reports, tells Bloomberg. “It’s unfortunate that this has taken so long, but I think we’ll probably learn some valuable things from this.”
Justice in Michigan
Good grief. Well, I suppose there is some logic to this, but doesn’t announcing it kinda blow the experiment?
In any event, will be interesting to see what they name it. My suggestions:
Woodcoxx
Blackboxx
Preemptort
Pdufix
Cdersinai
or maybe just
Andy
why not?
M Helm, MD
Seems to me that an alternative approach would have been to have sampled a larger number of veiwers about actual current ads to see if real viewers of real advertisements accurately received both information on approved uses, benefits and risks.
If those aren’t all equally recalled, the actual advertising would seem not to meet the standard of “fair balance.”
This approach would 1) save money (no fake advertising development costs, and no need for an artificial viewing lab environment - I’m assuming the advertising would not actually be broadcast), 2) help to “build a dataset” identifying the kinds of ads which do better than others in providing balanced information, and 3) potentially result in some reasonable enforcement action relating to the balance in the advertising.
If manufacturers know that there are expectations set by the FDA about what percent of those exposed can report benefits and risks, and that the expectation is that these percentages should be the same, the advertising development and testing processes will begin to take care of themselves. What I mean is that advertising pre-tests by the manufacturers will begin to document the percentage recall of both stated benefits and risks.
To mix a metaphor, seems that the FDA is trying to go around their elbow” to reinvent the wheel.
Lisa Van S
Justice,.. If we could vote!.. I would select Pdufix.
Austin Lee
I hope they run this using focus groups. Seems to me it would be wasteful to actually broadcast a phony ad (as if it were real), then go hunt down folks to survey.
Austin
http://drughealth.blogspot.com/
Anon
If you think this is bad take a look at what’s been occuring in the package inserts over the last couple of years in anticipation of preemption. Also what the new format is really resulting in.
Justice in Michigan
Agree, Anon. I don’t know if you’ve seen the threads on this, but there has been a fair amount of discussion here about the relationship between the new labeling “guidelines” and preemption. Of course, the famous/infamous preemption preamble was to FDA’s 2006 revised labeling guidelines. Part of the Trojan war.
Bob Freeman
Years ago a fellow Ph. D. student did a related study: varying efficacy and safety information contained in print drug ads for a mock drug (I don’t remember the therapeutic area). Very interesting research design. What he found is that the provision of negative information in a drug ad makes the efficacy claims more believable. Increase the level of “negative” information leads to an increase in believability.
Now, his study was performed on physicians, not patients, but it brought back memories. This was done back in the mid-70s and was published but I don’t have the citations.
Jim Edwards
I’d like to hear more about label changes and pre-emption. Please email me at jimedwards123@hotmail.com
Scott Lawrence
This is a non-story. Back in Aug/Sept of last year the FDA made this plan public and solicited comments from the public and industry.
Ed Silverman
Hi Scott,
Actually, the study was first proposed by the agency last August as a survey of 1,020 consumers in shopping malls. And since then, the agency made changes to the methodlogy. So this is an update of that story.
Hope this helps,
ed
Justice in Michigan
Jim Edwards - If you just google “preemption preamble” you will find a lot of sources and views on the issue.
James
Bob,
that’s fascinating–I would love to see the specifics of that study.
Very anecdotally, I (and I certainly wouldn’t consider myself representative of the general population) remember very clearly one DTC ad in particular. It was for Zyban. The spokesperson started the warnings pertion with a very dramatic change in voice:
“There’s a risk of SEEEIZURE associated with Zyban.”
At that point I decided that, even if I did smoke, and even if I wanted to quit said smoking, I would be very reluctant to take Zyban.
So, chalk up at least one point for soft pedaling the risk section–or at least not going out of your way to draw attention to it.
Nathan
I’m still confused: Is this ACTUAL advertising (as the title of the article suggests) or is this FOCUS GROUPS? If it’s the former, it seems that the FDA will violate many of its own guidelines!! If it’s the later, the title of this article needs to be changed.
atlex
Nathan,
This is a study. It’s not clear whether they are using focus groups or one-on-ones, but I don’t think they are not going to actually advertise over the airwaves or cable.
Atlex
Bob Freeman
James, I’ll see if I can track it down but since it was done in the 70s I’m not sure it will be found easily.
The lead author was Lon N. Larson. I’ll see what I can find via Google Scholar.
The dissertation should be available through The University of Michigan, but, again, I imagine a paper copy would have to be purchased.
Sorrowful
I watched Ruth Day’s fascinating presentation to a Congressional committee and this summer, when I can bring myself to stand it, I watch DTC ads. The variety of tricks used to make your eyes glaze over when the risk section is presented is mind-boggling, and heartbreaking. People will die because they won’t get the truth, from the ad OR from their doctor (example: neither the ads NOR the doctors are telling people they put on SSRIs of the danger during starting or ending the drug of suicide or homicide).
Soon I will go home and return to my preferred way of watching - Netflix.
Just A Thought
Strikes me strange that they chose a blood pressure medication for this. I would have chosen something that people might be lured to ask for from their doctors, something that piqued interest. Blood pressure medications are not ‘one size fits all’ drugs and it’s hard to imagine anyone requesting a certain BP drug for their treatment. If you’re going to test the effect of these ads, doesn’t it seem more appropriate to use a fake product that would tempt the population- to see what they might choose to ingnore for the amazing product?
Maybe I’m missing the point but a beta blocker, for instance, is not the answer to everyone’s BP woes. Do most people know what kind of med they need and if this fake will fit their needs? BP meds would be a hard sell. Just sayin’.
Bob Freeman
James2 and others: I was able to find some of Larson’s work on the believability of prescription drug ads. He’s done research on both patients and physicians using randomized exposure of variable ad content.
I’m going to try to post a link: if it doesn’t come through I can forward the links via e-mail:
http://www.haworthpress.com/store/ArticleAbstract.asp?sid=Q9PX01CC954V8JGUMBJSS2R4GH6H9726&ID=75221
(Ah, I see it worked.) Anyway, use google scholar and the name “Lon N. Larson”. You’ll get some but not all of his citations.