Mass Tort Litigation Blog

Pfizer Begins Public Relations Campaign to Counter Chantix Concerns

Article in the Wall Street Journal -- Pfizer Seeks to Counter Chantix Concerns, by Alicia Mundy and Avery Johnson.  Here's an excerpt:

Pfizer Inc. is preparing an advertising and public-relations campaign to counter concerns about its antismoking drug Chantix, once trumpeted as a potential billion-dollar-a-year blockbuster.

Chantix is drawing scrutiny from federal regulators and a tough congressional critic of the pharmaceutical industry following revelations about potentially dangerous adverse events such as heart irregularities, seizures and more than 100 accidents linked to use of the drug.

An important issue is whether Chantix is effective at dosage levels that are safe for its users. This was a concern for FDA researchers prior to the drug's approval, according to agency records.

BGS

FAA Bans Chantix Use By Pilots and Air Traffic Controllers

Article on cnnmoney.com -- FAA bans Pfizer anti-smoking drug.  Our initial Chantix blog post in November 2006 has so far lead to 178 comments, most of them describing physical and mental problems occurring in people using Chantix.  Here's an excerpt from today's article:

Pfizer Inc.'s once-promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group's report about serious physical side effects prompted the Federal Aviation Administration to ban the drug's use by pilots and air traffic controllers.

The report, from the Institute for Safe Medication Practices, points out hundreds of serious problems reported since the popular drug was approved in May 2006, including dizziness, loss of consciousness, seizures, and abnormal spasms and movements.

BGS

FDA Says Connection Between Chantix & Serious Psychiatric Problems "Increasingly Likely"

Article on cnn.com -- FDA wary of Pfizer anti-smoking drug.  Here's an excerpt:

Government regulators said Friday the connection between Pfizer's anti-smoking drug Chantix and serious psychiatric problems is "increasingly likely."

The Food and Drug Administration said it has received reports of 37 suicides and more than 400 of suicidal behavior in connection with the drug. In November, the agency began investigating reports of depression, agitation and suicidal behavior among patients taking the popular twice-daily pill.

The agency's announcement comes two weeks after Pfizer added stronger warnings to the drug. In doing so, the company stressed that a direct link between Chantix and the reported psychiatric problems has not been established, but could not be ruled out.

These findings come as no surprise to me, given the over 140 comments on my original post about Chantix in November 2006.  Those comments detail terrible tales of people's difficulty with this drug.  No other post on the Mass Tort Litigation blog has generated so much feedback from potential plaintiffs.  And those posts started nearly immediately and have continued steadily nearly every day. 

BGS

FDA Investigates Chantix Link to Suicidal Thoughts, Aggressive Behavior, and Drowsiness

The FDA is looking into possible links between Pfizer's anti-smoking drug Chantix and various mental or emotional effects.  In its announcement yesterday -- Early Communication About an Ongoing Safety Review: Varenicline (marketed as Chantix) -- the agency summarized the reports it has received about side effects of Chantix.  The FDA is working with Pfizer "to further evaluate the potential association between Chantix and suicidal thoughts, aggressive and erratic behavior, and impairment that affects one’s ability to drive or operate machinery," and will report its conclusions and recommendations as soon as it completes its analysis.  In the meantime, "The FDA urges both healthcare professionals and patients to report side effects from the use of Chantix to the FDA's MedWatch Adverse Event Reporting program."

Here's an excerpt from today's Wall Street Journal article:

The Food and Drug Administration has received reports of "suicidal thoughts and aggressive and erratic behavior" in people taking Chantix, the smoking-cessation drug sold by Pfizer Inc., but it is too soon to say whether the drug is clearly linked with such problems, the agency said yesterday.

Pfizer said yesterday that it had updated the drug's label to include "reports of depressed mood, agitation, changes in behavior, suicidal ideation, and suicide in patients attempting to quit smoking while taking Chantix."

... The agency said it is reviewing reports of drowsiness in some people taking the drug, and it recommended that patients taking Chantix be careful driving and operating machinery until they know how the drug affects them. Patients should tell their doctors if they have mood or behavior changes while taking the drug.

Pfizer denies proof of causation.  The WSJ article quotes a Pfizer medical director who emphasized that quitting smoking can cause nicotine-withdrawal symptoms regardless of whether an anti-smoking drug is used.  At Pharmalot, Ed Silverman wrote about this yesterday in Up in Smoke?  Pfizer's Chantix and Suicidal Thoughts, and reports Pfizer's reaction:

A Pfizer spokesman e-mailed us to say that Chantix labeling has been updated to reflect the various reports, but emphasized that “there is no scientific evidence establishing a causal relationship between Chantix and these reported events…In clinical trials involving more than 5,000 patients, adverse events related to changes in behavior or psychiatric symptoms, including suicidal ideation, were rare and occurred at a rate comparable to placebo-treated patients. There were no suicides in patients taking Chantix in our clinical trials.”

A post on Chantix on the Mass Tort Litigation Blog one year ago has generated 100 comments, mostly by Chantix users discussing side effects they have experienced.  To our surprise as blog editors, the comments page to that post has become something of a chat room for worried Chantix users.  Is this the first stages of the sort of mass tort networking about which Byron Stier has written?

I understand that neither Chantix users nor Pfizer looks at this from an academic perspective.  I also understand that, for them, this is not (or at least, one hopes, not primarily) about tort liability and litigation.  For users, this is about personal health, and for Pfizer, it's about both corporate responsibility and a product that is critical to the company's revenue. 

But for those of us who try to understand the development of mass tort litigation, it's fascinating to watch the seeds of potential litigation at a point when we know that some litigation is inevitable but do not know whether the lawsuits will flourish and replicate.  Four million U.S. patients took Chantix.  There are plaintiffs' attorneys advertising for Chantix clients.  But it's very early.  Beck and Herrmann, in their Anatomy of a Mass Tort (which I think was right on target), described how mass torts begin:

A mass tort does need a trigger. We'll bet the mortgage that one of these five events started the avalanche: (1) bad press -- Connie Chung or Mike Wallace said something nasty, (2) regulatory action -- the FDA added a black box warning to a drug or the National Highway Traffic Safety Administration recalled a car, (3) a voluntary recall -- although no government agency demanded it, a manufacturer took its product off the market, (4) a big jury verdict -- nothing catches the eye of the plaintiff's' bar like money, or (5) a critical article in the scientific literature -- historically, we didn't see this trigger too often, but it's becoming increasingly common.

Even as we watch a potential endgame in Vioxx with Merck's settlement offer, and follow asbestos litigation in its over-mature stage, it's interesting to look at yesterday's FDA announcement when we don't yet know whether that announcement will turn out to be a mass tort trigger, and to look at the informal networks developing among Chantix users when we don't yet know whether the chat room will become a litigation plaintiff network.

HME

Anti-Smoking Pill Chantix May Be Used to Curb Drinking

Article in the New York Times -- Anti - Smoking Pill May Help Curb Drinking, by the Associated Press.  A prior post on Chantix on the Mass Tort Litigation Blog lead to numerous posted comments noting negative health effects from taking Chantix.  Here's an excerpt:

A single pill appears to hold promise in curbing the urges to both smoke and drink, according to researchers trying to help people overcome addiction by targeting a pleasure center in the brain.

The drug, called varenicline, already is sold to help smokers kick the habit. New but preliminary research suggests it could gain a second use in helping heavy drinkers quit, too.

Much further down the line, the tablets might be considered as a treatment for addictions to everything from gambling to painkillers, researchers said.

Several experts not involved in the study cautioned that there is no such thing as a magic cure-all for addiction and that varenicline and similar drugs may find more immediate use in treating diseases like Alzheimer's and Parkinson's.

Pfizer Inc. developed the drug specifically as a stop-smoking aid and has sold it in the United States since August under the brand name Chantix. Varenicline works by latching onto the same receptors in the brain that nicotine binds to when inhaled in cigarette smoke, an action that leads to the release of dopamine in the brain's pleasure centers. Taking the drug blocks any inhaled nicotine from reinforcing that effect.

BGS

WSJ on Pfizer's Chantix Antismoking Pill

Article in the Wall Street Journal -- Marketing New Antismoking Pill Poses Challenges for Pfizer, by Scott Hensley:

For Pfizer Inc., the easiest part of marketing its new antismoking pill may have been winning Food and Drug Administration approval for the drug in May.

Chantix, the first medicine in a decade to help smokers quit, would seem a surefire blockbuster. Smoking remains the leading preventable cause of death in the U.S., and about 70% of the nation's 45 million smokers say they want to quit, according to government estimates. In addition, existing treatments work poorly, and Chantix got speedy FDA approval in large part because of its superior performance.

But in launching the drug, Pfizer has had to negotiate a marketing obstacle course that illustrates some of the challenges facing the industry, as well as the idiosyncrasies of the huge antismoking market. Aware of increased consumer cynicism and unfulfilled promises made for smoking treatments in the past, Pfizer has adopted a softer sell that it hopes will build Chantix steadily over time. Meanwhile, because insurers are slow to cover smoking treatments, it has priced Chantix so that consumers will be willing to pay for it themselves.

BGS