Does Sydney Wolfe Have a Secret FDA Source Who Tipped Him Off Regarding the Celebrex Ad?

Much has been made recently of Pfizer’s new Celebrex ad, launched a few days ago. It’s long, confusing, feels like it’s written by lawyers, and earlier this week became the subject of a complaint to the FDA by Dr. Sydney Wolfe, director of Public Citizen’s health issues division.

“The overall purpose of the ad is to make it appear, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are not greater than those of any of the other NSAID painkillers,” Wolfe told the FDA.

That’s because, among other things, the ad states, “"You may think some prescription NSAID pain relievers like ibuprofen and naproxen don't have any cardiovascular risks. But based on available research that's not clear."

But the most interesting part of Wolfe’s letter comes in the second-to-last paragraph: “Although the company has stated that this ad is the result of long-term consultation with the FDA, it is clear that the final version of the ad was not seen by the agency until very shortly before it started to air last week.”

So I called Wolfe this morning to chat about the ad and ask him how he knows that the ad “was not seen” by the FDA until right before it aired.

Isn’t it the case that the ad makes it quite clear that Celebrex results in death? How much more dangerous did you want it to sound? “If you read the first few paragraphs, the overall impression is that it's no more dangerous than any other NSAID and that’s absolutely false…they’re taking out an ad to clearly lead people into thinking ‘it’s just not clear,’ … it’s absolutely not true. It’s an extremely misleading statement.”

But didn’t the FDA see this ad before it aired? “That’s not correct. The FDA had discussions with Pfizer. But only shortly before the ad ran did the FDA see it for the first time. Not in time, as far as I can tell, to say, ‘wait a minute, you need to change this.’ It’s currently undergoing intensive review at the FDA. The FDA told the New York Times that.”

How do you know that the FDA didn’t have time to look at the ad properly before it was aired? “I can’t comment on that.”

Why not? “I just can’t. You know that that means.”

Actually, I’m not entirely sure what Wolfe means, but one natural assumption is that Wolfe has a source inside the FDA who tells him interesting things. When Wolfe says “you know that means,” it felt to me that he was suggesting that as a reporter I would know what it means because I also have sources whose identities I conceal. Whatever, Wolfe clearly believes he knows the FDA was ambushed with this long, complicated ad.

It’s even more interesting because Pfizer has given the media the impression that it gave the ad to the FDA in plenty of time. According to this MarketWatch story:

“Gail Cawkwell, Pfizer's senior medical director, said Pfizer consulted with the FDA while developing the commercial and then submitted the final television spot to the FDA in late February for review. The company also developed new print ads with questions and answers about Celebrex's risks and benefits.”

“Kimberly Rawlings, an FDA spokeswoman, confirmed Pfizer submitted the television ad to the agency prior to its airing. She said the agency would review Public Citizen's request and ‘will take the appropriate action, if needed.’”

Obviously, Pfizer and Wolfe can’t both be right. One of them has got this wrong. (Update on April 12: I chatted with Pfizer rep Jack Cox today and he reiterated that "a final version was sent in February" and that the FDA made "no specific comments after receiving the ad." Pfizer is confident that the FDA is not going to yank the ad, he said.)

Wolfe and I continued talking:

Is there anything the ad gets right? “I never said there’s nothing in the ad that’s legit. That’s not the point. If 15 or 17 claims are legit and several aren’t, and the several are misleading there’s no reason the FDA should give credit. It’s like if someone doesn’t crash a red light 17 times and one time they do …. The laws apply to the whole ad. … the frisbee that turns into a warning is my favorite part. I wonder how much that ad cost to make?”

Would it be acceptable to you if these Cox-2 drugs were marketed as long as the risks and disclaimers were properly disclosed, or do you just want them off the market? “That is a question behind which is the attitude which is that as long as everyone is informed—this is the Wall Street Journal editorial page’s position, the market uber alles—you can put anything on the market as long as there’s a warning. Then why bother having an FDA? You could put anything on the market. The FDA has a responsibility not to approve drugs that have serious dangers and no unique benefits like this one... [He noted that there were warnings about Vioxx as far back as 2002]. Simply allowing increased risks by informing people is just unacceptable because it doesn’t work. You’re condemning people to die with no unique benefit.”

You’re testifying tomorrow to the FDA about whether Merck’s Arcoxia, another Cox-2 should be back on the market. What are you going to say? [He initially declined to tell me, but as we continued to chat said this:] “There is no information for Arcoxia that there is a group of patients for whom there is some unique benefit. No unique benefit and unique risks and as the FDA pretty much stated 2 years ago, any new Cox-2 would have to have some identifiable unmet need. What’s the unmet need? Anecdotes about ‘I have a patient that likes it’; that’s not evidence.”

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