Cancer risk or risk of losing your mind -- the FDA will make that choice for you

Smoker’s choice

It’s one of those questions we all hope we’ll never be faced with…and we shouldn’t have to be:

Would you rather risk cancer or literally going crazy?

It would be agonizing to actually have to make that choice. Who would ever want to put themselves at risk of either outcome? Nobody, of course.

Fortunately, the FDA has made the choice for millions in the form of a new recommendation concerning one of the most outrageous drugs I’ve ever seen — and as you know, I’ve seen MANY of those.

I’m talking about Chantix, Pfizer’s smoking cessation drug. If you take it and it works you’ll quit smoking, which could reduce your risk of getting cancer. But whether it works or not, you’re opening yourself (and your loved ones and complete strangers) to a wide range of shocking and dangerous psychological problems.

Tough choice? Well, not for the FDA!

It seems that agency officials have gone well above and far beyond to help protect this drug from the reputation that it might turn mild- mannered folks into raging psychos.

Spinning the message

Here’s the chain of events the FDA set in motion that ended up whitewashing this dangerous and only mildly effective drug.

First, the agency sponsored two Chantix studies. Each evaluated risk of neuropsychiatric adverse events linked to the drug.

Second, the FDA issued a “Safety Announcement,” to tell us this: “Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy.”

Third, the media responded with headlines like this one from MSNBC: “FDA: Studies do not tie Chantix to psych problems.”

Mission Accomplished!

So if you were feeling a bit wary about trying Chantix because you heard that some people have extreme adverse events ranging from rage to suicide, well don’t you worry about a thing, because these studies (according to many different headlines) do not tie Chantix to psych problems. No worries!

Unless…

Here’s the catch…

The key word in the FDA announcement is the word “hospitalizations.”

You see, both of the studies examined the numbers of neuropsychiatric hospitalizations linked to Chantix. So, for instance, if there had been a man enrolled in this study who committed murder-suicide (this is just one actual tragedy linked to the drug, outside the study), there would be no hospitalization involved so his outcome wouldn’t be included in the results.

Is that clever, maneuvering by the people who designed this study, or what?

But here’s the truly amazing thing: In the Safety Announcement, the FDA actually ADMITS that the study is fundamentally flawed, stating that the results “do not rule out an increased risk of other neuropsychiatric events with Chantix.”

And yet, even with that disclaimer, the media rushed in with those positive, reassuring headlines, completely ignoring this warning on the Chantix website: “If you…develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia, or confusion, stop taking CHANTIX and call your doctor right away.”

Call your doctor? You mean, if you decide to murder your wife and commit suicide, you should wait and call your doctor instead? Good advice!

And the same goes for the young woman who beat up her boyfriend in his sleep and then attempted suicide, or the middle-aged man who punched a stranger in a bowling alley, or the woman who became enraged while driving and struck her daughter in the mouth. (All of these are actual reported events that may have been triggered by Chantix use.)

That’s right — don’t do any of those things! Just pick up the phone and call your doctor. Hopefully you won’t be hallucinating that your phone is an animal trying to attack your face.

The FDA announcement concludes with this: “The Agency continues to believe that the drug’s benefits outweigh the risks.”

Which leads ME to continue to believe that someone at the Agency may be experiencing neuropsychiatric events.

Sources:
“FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events” FDA Safety Announcement, 10/24/11, fda.gov