Pfizer’s asks FDA to ditch Chantix suicide warning

For many, trying to quit smoking has turned into a nightmare beyond their wildest dreams.

Take Chris Kunkel, for example. One night, the happily married Army IT specialist had an idea pop in his head while watching TV: “I’m going to kill myself.”

Kunkel, who had recently gone cold turkey after a pack-a-day habit, went to the bathroom and choked down a whole bottle of Tylenol PM.

Then there’s journalist Derek De Koff. When he stopped smoking he got the idea of leaping in front of a bus.

These are just two out of thousands of examples of quitters who all had something in common — they were taking Chantix, the Pfizer stop-smoking aid.

And now — once again — Pfizer is trying to convince the FDA to strip that black box warning about suicidal thoughts from the Chantix package.

Only this time, a funny thing happened on the way to the FDA meeting.

Money talks

You could say Chantix is unique among prescription drugs.

I mean, what other drug has the distinction of being linked to so much violent behavior, and yet stays on the market?

Over the years I’ve been warning you about the horrible ordeals Chantix users have gone through. Like Chris, who was found by his wife in time to save his life, or Derek, who wrote a feature story on his Chantix experience for New York magazine.

And as I said, there are thousands of other cases, many that ended in tragedy.

So you would think that Pfizer would be happy that this drug is still selling at all.

Yeah, you would think.

But apparently Pfizer wants the whole ball of wax. And the biggest thorn in its side is that darn black box warning — the one that starts with “WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS.”

The drugmaker tried to get rid of it two years ago, but the plan backfired. Instead of going along with Pfizer’s request to ditch it, the FDA made the company add an additional one about drinking and taking Chantix.

Well, it looks like this latest try could backfire as well.

In an attempt to get the agency’s blessings to do away with the warning about “hostility, agitation, depressed mood (and) suicidal thoughts or actions,” Pfizer conducted a big study. One intended to show the “real-world” risks of Chantix.

But instead, it was the drugmaker that discovered some real-world risks.

To begin with, the FDA advisory panel didn’t like Pfizer’s study. The data looked inconsistent, they said.

Then the committee dropped a bombshell on the pharma giant.

On page 63 of its briefing document, it questioned whether some big payments made to doctors conducting this study had influenced its outcome. And I’m not just talking about one or two researchers, either.

When the FDA panel dissected Pfizer’s financial disclosures, it found that numerous investigators at 32 sites where the trial was being conducted were paid $25,000 or more by Pfizer. Plus that, many were paid multiple times. And — get this — some were given money to conduct talks about Chantix!

There were payments to 39 more doctors at 27 more trial locations as well. But they were below the $25,000 threshold and didn’t even get counted.

All in all, the locations where Pfizer-paid investigators were located reported fewer problems with Chantix, especially those annoying neuropsychiatric ones that the study was all about.

What a surprise!

Pfizer has been trying for some time now to get those scary warnings off its Chantix box. And while it succeeded in doing that in Europe, surprisingly it hasn’t yet with the FDA.

Will it finally get its way with the agency this time? It just might.

Unbelievably, despite everything that was revealed about Pfizer’s study, 10 out of 19 of the advisory committee members voted to dump the black box warning. If the FDA agrees, that would set an “ominous precedent” said the head of a consumer group.

What we do know for sure is that yes, you should definitely quit smoking. Only don’t risk going from the frying pan to the fire by trying to do it with Chantix.

Sources:
“FDA suggests Pfizer’s payments to Chantix trial doctors may have skewed the data” Tracy Staton, September 14, 2016, FiercePharma, fiercepharma.com