The sneaky trick Pfizer tried to play on Chantix users

FDA finally tells Pfizer to take a hike

When Tina turned 47 she decided, once and for all, to quit smoking.

She had tried to stop several times before. But this time, she promised herself, it would be for good.

So Tina turned to someone she trusted…her doctor. And she got a prescription for Chantix.

But that’s not all she got.

Several months later she ended up in a psychiatric ward. Just to get her transported to the hospital took 5 EMT’s and several firemen. She was paranoid, aggressive, totally confused, and having hallucinations.

Tina calls Chantix a “mind-altering drug with serious consequences.” And she implores people to pay serious attention before it “happens to you or someone you love.”

While she isn’t getting any help from Pfizer, she may have found an unlikely ally…the FDA.

Last month I told you how Pfizer was doing everything in its power to remove that black box warning on the Chantix package.

And that could have had terrible consequences. Many people who were thinking of using Chantix wouldn’t have had a clue about its horrific side effects. And healthcare professionals may think that new research showed that the drug is actually safer than it was.

But this isn’t about science, it’s about sales.

Pfizer wants to remove the language that starts with: “WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS.”

That certainly gets your attention. Especially right there on the label’s first page — a place where people might actually read it.

It continues to say the drug might make you hostile, agitated, depressed and even cause “suicidal ideation or suicidal behavior.”

Of course that’s one of the reasons that Chantix sales have been dropping. Pfizer only made a paltry $648 million last year on the drug, which is why they were pulling out all the stops.

Fortunately, experts, consumer groups, and people, like Tina, who suffered these side effects were up in arms about what the drug maker was asking the FDA to do.

Even FDA staffers told Pfizer it should wait until it had completed (another) one of its psychiatric risk studies before asking the agency for any change.

But the company was so sure the FDA would give it what it wanted, as is usually the case. So it insisted on making its presentation.

The FDA’s Advisory Committee, however, wasn’t impressed.

Out of 18 voting members, 11 favored keeping the black box warning. Another 6 said it needed to be made even stronger.

Just one lone panelist voted on Pfizer’s side. That was Dr. Andrew Saxon who works with VA hospitals. His reason was that the VA has strict rules against giving out an Rx for black box drugs, and that the Chantix warning “does deter” some people from using it.

Exactly, Dr. Saxon! Isn’t that what warnings are supposed to do?

Now when Pfizer officials smugly strutted into the meeting last month, they came with what’s called “observational data” and “meta-analyses.” The drug maker also had its own interpretation of adverse event reports sent into the FDA.

But one FDA staffer said that many of the side effects people are having can’t be easily “coded” as a symptom. And because of that they wouldn’t end up on Pfizer’s “official” reports.

These included “feeling like a zombie.” Or not being able to get out of bed in the morning. That one, the FDA doctor said, somehow got “coded” as a problem with “social function” in Pfizer’s study.

And Pfizer even got caught using a similar drug to test Chantix against. It was a way of ensuring that the “placebo” would cause the exact same side effects.

It’s not often the FDA sends one of the major drug companies packing.

So if all the other warnings haven’t convinced you that Chantix is a terribly dangerous drug, the FDA’s response here should.

Sources:
“FDA panel: Chantix boxed warning should stay” John Gever, October, 17, 2014, Medpage Today, medpagetoday.com