Chantix Is Still a Risk

Here we go again, baking the same old muffin. The recipe’s on a well-thumbed index card from your grandma-editor’s recipe box:

Take one press release about a health-related research study, add one busy editor and one heavy helping of “We Need Traffic” (any brand will do). Stir and place in copy oven. After half-baking, you’ll have a nice puffy headline and a heavy bottom that no one will read.

Today the muffin in question is a story about the smoking-cessation drug Chantix:

• New York Daily News: Anti-smoking drug Chantix not linked to psych problems: FDA
• Medpage Today: Psych Risks No Higher With Chantix, FDA Says
• USA Today: FDA: Chantix not linked to mental problems
• Wall Street Journal: FDA: studies do not tie Chantix to psych problems

That last headline comes from the AP, so it’s been reproduced extensively, from the El Paso Times to the York Daily Record (and, apparently, the WSJ online).

Chantix has been the subject of thousands of lawsuits against its maker, Pfizer. The majority of those had to do with psychological side effects, including rage, hostility and, most notably, increased incidences of self-harm and suicide.

In February 2008, the FDA issued a Public Health Advisory about those side effects after receiving 227 domestic reports of suicidal acts, thoughts or behaviors; 397 cases of possible psychosis; and 525 reports of hostility or aggression in one year. The totals, according to the Institute for Safe Medication Practices, “included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination.”

The FDA required Pfizer to add a so-called “black box” warning to “highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts.” Airlines prohibit Chantix use in pilots, and its use is strictly regulated in the military.

As of May of this year, England’s Daily Mail reported:

Hundreds of reports of suicides and violent reactions tied to the stop-smoking drug Chantix were left out of a crucial government safety review. The reports were missing because the drug’s manufacturer Pfizer Inc. submitted years of data through ‘improper channels’, according to the Food and Drug Administration.

Serious problems—such as people killing themselves, trying to kill themselves, depression and unprovoked attacks on others—were mixed among 26,000 records of non-serious side effects such as nausea and rashes dating back to 2006 …

The FDA requested that Pfizer resend the records that, due to improper formatting, could not been added to the agency’s Adverse Events Reporting System—a. k. a., the place where pesky suicides are tracked. When the submissions were corrected, the number of suicides jumped almost twofold.

But wait, you say. That was just a few months ago. What about those terrific headlines? Don’t they imply the FDA has cleared Chantix? They do, but they shouldn’t.

The two FDA-sponsored studies were conducted with veterans and active service members who were offered Chantix or nicotine replacement therapy (NRT). The only thing measured was whether they were subsequently admitted to psych hospitals. That’s all. For this reason, the study only concludes that Chantix users aren’t any more likely than NRT users to end up in mental hospitals.

Those are rather narrow findings. Most people who experience agitation, hostility, mood swings, depression and suicidal thoughts don’t go to psychiatric hospitals. (If they did, half the people you know would be wearing straitjackets right now.)

The FDA is very clear about the studies’ constraints:

… both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events … Although these two studies did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with Chantix. …

Overall, FDA has determined that the current warnings in the Chantix drug label, based on postmarketing surveillance reports, remain appropriate. FDA is continuing to evaluate the risk of neuropsychiatric adverse events with Chantix.

In other words, little has changed, yet the 44 percent of people who just scan headlines will believe otherwise.

Given Pfizer’s troubles, these headlines must have been greeted with hosannas at the company’s PR headquarters. No one loves a good muffin top more than Big Pharma—and for that reason alone media leaders have to be vigilant to keep the empty calories to a minimum.