Public Citizen: Celebrex Ad Is ‘Illegal’
4 CommentsBy Ed Silverman // April 9th, 2007 // 10:23 am
Just one week after Pfizer’s new Celebrex ad debuted, Public Citizen is calling on the FDA to order the drugmaker to “immediately stop its misleading” ad, which runs for an unusual 2-1/2 minutes and tries to harp on the painkiller’s associated risks. Take a look.
Public Citizen, however is having none of that. In a letter to FDA commish Andy von Eschenbach, the advocacy group’s Sid Wolfe writes:
“The ad violates FDA law and regulations because it contains several false or misleading statements that will lead many viewers to underestimate the cardiovascular and gastrointestinal risks of Celebrex and use it in preference to equally effective, safer alternatives such as OTC naproxen. He goes on to criticize Pfizer for:
* Asserting, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are no greater than those of any of the other non-steroidal anti-inflammatory (NSAID) painkillers; and
* Claiming that there are overall gastrointestinal benefits with Celebrex over two popular, over-the-counter painkillers, while trying to downplay the risk of serious stomach and intestinal problems such as bleeding and ulcers that applies to Celebrex and all other NSAIDS.
You can read Public Citizen’s letter here.[tags]Celebrex, DTC Ads, FDA, Pfizer, Public Citizen[/tags]
Lew
Given the controversy surrounding Celebrex, I strongly suspect that Pfizer pre-cleared the ad with the FDA. Thus, I doubt that it violates FDA law and regulations. This is typical of Sidney “Cry” Wolfe.
ed
Hi Lew,
Yes, I believe Pfizer did clear it with the FDA. And it is typical of Public Citizen to go to the FDA and demand the agency review its actions.
If nothing else, this is the first time I’ve come across debate over the substance of the new Celebrex ad. So far, all the attention paid has been to the form and length.
I’m curious to see whether the ads are effective. Now that the ad has been out a week, what do you think?
thanks for stopping by,
ed
Pharm Aid
I love Sid Wolfe. I really do. This guy can be counted on to take the contrarian position on anything. A drug company could say, “we’re canceling the trial because the drug lacked efficacy.” And there would be Sid, arguing the drug is effective.
Subscriptions to his newsletter must have really dropped off because he’s been hitting the circuit a lot lately.
Anybody else remember Sid Wolfe’s position on the risks of bottled water from the late 1970’s and early 1980’s? I’m still shaking my head to figure out how we went from ’serious health risks’ to ‘it’s no better than tap water and you’re wasting your money.’
Cry Wolfe Sid is right.
ed
Hi PharmAid,
Nice to hear from you. I can’t say I remember that episode, although I do remember enjoying the Watergate hearings and the Knapp commission. That was real excitement. But I’ve been drinking tap water my whole life and feel fine. Evian spelled backward is naive, you know.
Anyway, I think a more interesting issue is commercial free speech. At some point, you know, drugmakers are going to fight back if FDA restrictions on ads become too onerous. They may win, they may lose. But that’s a battle the FDA probably would like to avoid. That said, the agency has to prove it can do a good job here. I know they don’t take the Celebrex ad lightly; it’s an opportunity to get something right.
Can’t blame Sid for trying, though. As a contrarian, I confess to enjoying others ask contrarian questions. And why not? If we all agreed, things would be dull.
cheers
ed