Celebrex Dangers

This is a partial transcript from "Your World with Neil Cavuto," December 20, 2004, that was edited for clarity.

NEIL CAVUTO, HOST: What is behind all of this? With us right now is the man who runs Pfizer (search), its chairman and CEO Hank McKinnell.

Dr. McKinnell, good to have you with us.

HANK MCKINNELL, CEO, PFIZER: Neil, thank you.

CAVUTO: What happened here?

MCKINNEL: Well, we learned last evening at 5 p.m. — I learned about 8 p.m. — that we had safety reports, cardiovascular safety reports on two very large, well-controlled cancer trials, one at two to four times the recommended osteoarthritis dose, the other at four to eight times the cardiovascular dose, dosed continuously over three years.

One of the studies showed cardiovascular risk no different from placebo. The second study, also large and well controlled, did show a higher risk than placebo in the study.

Now, those results are inconsistent with the first study. They’re also inconsistent with everything else we know about the safety and efficacy of Celebrex (search) when used as recommended.

But we felt it was important to get the information to regulators in the United States and Europe and prescribing physicians.

CAVUTO: Let me ask you something, Doctor, then. If I’m looking in my medicine chest and I take Celebrex and I’ve heard this news, should I pause?

MCKINNEL: If you’re concerned, you should talk to your prescribing physician. That’s the best source of medical information available to you.

CAVUTO: As you know, sir, a lot of doctors say if there’s risk, don’t bother. What if so many doctors across the country start telling their patients, you know, "This Celebrex thing, it could be another Vioxx (search) thing. Avoid it"?

MCKINNEL: Well, we have to remember why this class of drugs was discovered in the first place. It’s a tragic fact that more people in this country die from gastrointestinal complications of the traditional non-steroidals, about 16,500, than die from AIDS, about 15,000.

There’s a major medical need for these products. In fact, it’s interesting that the study — the cancer studies we were doing at four to eight times the recommended dose than osteoarthritis, continuous dosing for three years, could not have been done with any other traditional non-steroidal.

CAVUTO: Do you find it surprising, Hank, that this occurs, you know, only a few months after the whole Vioxx issue? People ran to Celebrex as, supposedly, a safe alternative.

Your stock zoomed for awhile in response to that. Your stock was hit hard early today, rebounded later today on the belief that maybe you’ve got problems, too. What do you think is the real scoop?

MCKINNEL: Well, after the events of September 30, we worked with the National Cancer Institute (search) to empanel a body of specialists, cardiovascular specialists, to look at the safety data. They did, and they concluded in one study, the risks were equal to placebo and that in the other study, they were higher than placebo.

CAVUTO: But therein likes just the slight difference in studies. Enough, some would say, just pull the drug until this is all ironed out. What do you say?

MCKINNEL: Well, there’s no other alternative. The alternative is to go on to the traditional non-steroidals, and they bring with them a very significant gastrointestinal risk which affects toleration. It also affects the safety of the medicine.

CAVUTO: But as part — I’m sorry, Hank, but as part of that decision — I don’t want to sound so jaded here — of pulling the drug and avoiding pulling a drug, the fact that once you do that, you expose yourself to just a legal nightmare?

MCKINNEL: Well, what really matters here is the interest of the patient that by pulling the drug, we would be exposing more patients to the older agents, which bring with them greater cardiovascular risk. These are really hard decisions.

CAVUTO: But how do you know you’re doing that? By keeping it on the market now, you might be exposing them to risks that this one study — and you’re right, only one study — seems to think that it could be greater.

MCKINNEL: Well, the key, of course, is full information to the prescribing physician. And the patient — the physician and the patient can have a discussion of benefits and risks of the various alternatives. We all need to take responsibility for our own medical care here.

CAVUTO: What if there is a follow-up study that confirmed what this one worrisome study said? Would you pull this drug?

MCKINNEL: Depends on the circumstances. If it was a similar, continuous dosing, long-term two to four times the recommended dose, it would be concerning.

But there still are many, many patients who benefit from treatment with Celebrex. And maybe that risk, in the judgment of the physician and the patient, would maybe be acceptable.

But we are not in that position. This was a piece of information that doesn’t fit with everything else we know.

CAVUTO: All right. Dr. McKinnell, thank you very much. We appreciate it.

MCKINNEL: Thank you, Neil.

CAVUTO: Hank McKinnell, the man who runs Pfizer, under the spotlight today.

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