Is a 14% Chantix success rate worth risking death?
While nearly all Pfizer Chantix marketing boasts a 44% success rate, a new clinical trial found that only 1 in 7 Chantix quitters were still not smoking at 6 months. This comes as Chantix adverse reaction reports to the FDA surpass a whopping 35,000.
A June 7, 2011 study in the journal Nicotine & Tobacco Research found that only 14% of Chantix users were still not smoking at 24 weeks. Headed by University of Vermont physician-professor John Hughes, ironically, it arrives as New England news headlines tell of a Vermont Chantix user's shotgun slaying of his mother.
The Hughes study comes on the heels of a May 19, 2011 report by the Institute for Safe Medication Practices (ISMP) revealing that the FDA has now received a total of 272 reports of completed suicides by Chantix users.
According to the ISMP, Chantix ranks first in reported deaths, more than twice as many as any other monitored drug. Total adverse event reports now exceed 35,000, of which roughly 10,000 were classified as serious, disabling or fatal, with 1,055 serious events being reported during the 3rd quarter of 2010.
So how do we explain the substantial difference between Pfizer's 44% advertised success rate and this study's disturbing 14% finding? One major difference is that Pfizer's 44% rate declares quitting victory at 12 weeks, the end of treatment, a day when many study participants were still under varenicline's influence (24 hour elimination half-life).
The Hughes paper's 14% figure is a six-month rate following 8 weeks of treatment. It was established three months after most users had stopped using Chantix, and had adjusted to living with natural dopamine pathway stimulation.
The 44% advertised rate reflects continuous cessation (zero smoking lapses) and was generated in a July 2006 drug approval study published in the Journal of the American Medication Association (Gonzales 2006 - free full text).
There, the more comparable six-month (24-week) 7-day point prevalence rate (no smoking within the prior 7 days of the smoking assessment point) was 33.5 percent. But that's a rate 239% higher than Hughes' six-month (24-week) 7-day point prevalence rate of 14%.
The level of formal counseling and support provided in generating the 44% advertised rate was more than twice the level seen in the Hughes study. Pfizer's 2006 drug approval studies provided participants with 19 counseling/support sessions by the 24-week mark. The Hughes study involved just 8 provider contacts: 4 counseling sessions and 4 follow-up telephone calls seeking data.
What's concerning is that according to the June, 2000 U.S. Guideline for Treating Tobacco Use and Dependence, Pfizer knew when it designed the original Chantix studies that counseling and support program contacts are highly effective at helping prevent relapse to smoking.
According to the Guideline, quitting programs involving 4 to 8 sessions generate an average 24 week quit smoking rate of 20.9 percent. What's not yet known is whether the Hughes study's dismal 14% rate suggests that Chantix is worthless as a quitting aid.
Surprisingly, the FDA allowed Pfizer to bring Chantix to market without any study showing quitting rates when unaccompanied by formal counseling and support, the manner used by the vast majority of smokers trying to quit.
According to the U.S. Guideline, the record levels of counseling and support seen in Chantix's 2006 drug approval trials - up to 25 sessions, each lasting up to ten minutes - could account for nearly all of the 44% quitting rate boasted by Pfizer.
Still a bit high on the number of provider contacts, the Hughes trial is the closest yet to mimicking real-world use conditions. Real-world users often are not highly motivated, but decide to give a new quitting product a try following recommendation by a physician, marketing, family or friend.
The level of participant cessation motivation may have contributed to the Hughes 14% rate. Study inclusion criteria required all participants to state that they eventually wanted to stop smoking but that they had no planned intention to quit within the next month.
Smokers were recruited to the study via advertising which stated, "Smokers, not quite ready to quit? We are testing a new medication to help you reduce and control your smoking and be less addicted. Compensation up to $75 provided. This is a study conducted by the University of Vermont."
The Hughes study's average participant smoked 19 cigarettes per day, was 42 years old, started smoking about age 16, and rated their addiction at 8.5 on a 10 scale.
What Pfizer marketing continues to fail to adequately advise smokers is that unless Chantix use is accompanied by effective and ongoing counseling or support that the user's odds of success are not good. In fact, they're horrible. What Pfizer fails to make clear is that its 44% advertised rate was generated by participants who looked forward to receiving professional face-to-face counseling during every week of treatment.
The FDA has known for decades that smokers generally do not like attending or participating in quitting programs. In the future, the FDA should not approve any quitting product without a stand-alone study requiring the product to stand on its own two feet, unsupported by counseling or support. Sadly, it's a study that, if the pharmaceutical industry has its way, as here, will never be conducted.
Ten thousand serious adverse events, a six-month rate of just 14 percent, and no statistically significant advantage in generating successful quitters by six months or one year when pitted against the nicotine patch (see Aubin 2008). Before the death toll climbs higher, it's time for the FDA to engage in serious and immediate risk-benefit analysis as to whether or not Chantix should remain on the market.
Share this Chantix article
PDF copy for saving or printing
Related Links and Articles
- Cold turkey clobbers e-cigs, NRT and Chantix, John R. Polito, 07/18/18
- JNCI study finds pharmaceutical stop smoking aids ineffective, John R. Polito, 12/22/17
- Nicotine cessation: lost in the deserts of Abu Dhabi, John R. Polito, 03/16/15
- 10 studies screaming "leave replacement nicotine alone!" John R. Polito, 01/01/15
- The Surgeon General's Reports: 50 years of cessation ignorance, John R. Polito, 01/20/14
- Australia's half-baked quit smoking campaign, John R. Polito, 11/30/11
- The Great American quit smoking sham, John R. Polito, 11/18/13
- BMJ's non-publication policy should extend to pharma's nicotine, John R. Polito, 10/19/13
- Gallup Poll: cold turkey 48 times smarter than Nicorette, John R. Polito, 08/26/13
- Cold turkey quitting still king, John R. Polito, 07/15/13
- Pharma bias destroys ITC quit smoking medication study, John R. Polito, 08/20/12
- Potent warnings, horrible quitting advice: what's the CDC smoking? John R. Polito, 03/17/12
- Replacement Nicotine's Killing Fields, John R. Polito, 02/11/12
- Chantix study joins negative findings omissions club, John R. Polito, 12/22/11
- Dying truths about quitting smoking methods, John R. Polito, 11/14/11
- Bias against cold turkey quitting apparent in literature, Dr. Michael Siegel, 11/03/11
- Suicidal behavior and depression in smoking cessation treatments, Moore TJ et al, 11/03/11
- Study finds cold turkey quitting more effective but concludes opposite, Dr. Michael Siegel, 11/01/11
- Tar wars over smoking cessation, BMJ Link, Professor Simon Chapman, 08/08/11
- Is a 14% Chantix success rate worth risking death?, John R. Polito, 06/14/11
- Chantix fails to defeat nicotine patch, John R. Polito, 03/30/11
- Chantix serious injuries exceed 8,500, John R. Polito, 01/28/11
- Champix - Chantix worth questioned - John R. Polito, 01/06/11
- GlaxoSmithKline Continues Defrauding Smokers - John R. Polito, 11/02/10
- Little communication in failed war against smoking - John R. Polito, 08/08/10
- Smokefree.gov really Buymeds.now - John R. Polito, 03/24/10
- Five facts Chantix ads keep hidden - John R. Polito, 12/29/09
- Pfizer's Chantix Continues Killing Quitters - John R. Polito, 10/22/08
- Chantix and Champix mental health safety assurances contrary to evidence - John R. Polito, 06/12/08
- Strong Safety Signal Seen for New Varenicline Risks - ISMP, 05/21/08
- U.S. quit smoking policy integrity drowns in pharmaceutical influence - John R. Polito, 05/13/08
- FDA pulls video clip admitting Chantix suicide link - John R. Polito, 04/03/08
- New FDA Chantix suicide risk video clip raises concerns - John R. Polito, 04/02/08
- FDA Chantix Handling Betrayed Public Health - John R. Polito, 02/08
- Windows media clip of WhyQuit's candid views on Chantix & Champix: 18mb video for dial-up users | high res 53mb format | and 7mb audio only format, length 48 minutes, recorded 10/19/07 by Joel Spitzer
- Flawed research equates placebo to cold turkey - John R. Polito, 03/07
- Nicotine Fix - Behind Antismoking Policy, Influence of Drug Industry - Kevin Helliker, 02/07
- WSJ Highlights Financial Conflicts of Chair of Federal Guidelines Panel - Michael Siegel, MD 02/07
- Nixing the Patch: Smokers quit cold turkey - Ken Millstone, 02/07
- New Study Challenges Thinking on Use of NRT During Pregnancy - Michael Siegel, MD, 02/07
- Nicotine for the Fetus, the Infant and Adolescent - H.K. Ginzel, MD, 02/07
- The secret to quitting smoking - John R. Polito, 01/07
- Financial Ties Between Guideline Panels and Big Pharma Run Deep - Michael Siegel, MD, 01/07
- Chantix - an 8 in 10 failure rate or worse? - John R. Polito, 12/06
- Do physician's have a legal duty to ignore Guideline Recommendation 7? - John R. Polito, 12/06
- Is the U.S. government's quitting policy killing smokers? - John R. Polito, 10/06
- Will Chantix really help me quit smoking? - John R. Polito, 08/06
- It's unlikely this NRT study was blind - John R. Polito, 08/06
- Conference Sponsorship by Pharma Precludes Objective Symposium - Michael Siegel, MD 07/06
- 13th World Conference on Tobacco or Health Drenched in Nicotine - John R. Polito, 07/06
- Cold Turkey Twice as Effective as NRT or Zyban - John R. Polito, 05/06
- Nicotine Not Medicine, Its Use Not Therapy - John R. Polito, 04/06
- How to use behavorial findings to sell NRT - John R. Polito, 01/06
- GlaxoSmithKline Attacks Cold Turkey Quitting - John R. Polito, 12/05
- UK Guidance for NRT use in pregnancy and by children - ASH London, 12/05
- June 2000 Guideline Chairman Michael Fiore's Testimony - see PDF pages 14 & 15, 05/05
- The Nicotine Patch, Gum and Lozenge - Mounting Evidence of a Sham - John R. Polito, 04/05
- 40 Years of Progress? - Joel Spitzer, 10/04
- Widespread Blinding Failures Put NRT Studies in Serious Question - John R. Polito, 06/04
- Nicotine Gum Maker's Concern Raises Concerns - John R. Polito, 05/04
- A Quitter's Dilemma: Hooked on the Cure - New York Times, 05/04
- Quebec CT Quitters Disprove "Double Your Chances" NRT Assertion - John R. Polito, 04/04
- Are nicotine weaning products a bad joke? - John R. Polito, 10/03
- Is CT Quitting More Productive & Effective than NRT? - John R. Polito, 07/03
- Are Teens Getting Hooked on NRT? - John R. Polito, 06/03
- March 2003 OTC NRT Meta-Analysis Finds 93% Midyear Relapse Rate - John R. Polito, 03/03
- Quitting Methods - Who to Believe? - Joel Spitzer, 2003
- JAMA Study Concludes NRT is Ineffective - John R. Polito, 09/02
- Real-World Nicotine Patch and Gum Rates - John R. Polito, 06/02
- Does the OTC Nicotine Patch Really Double Your Chances of Quitting? - John R. Polito, 04/02
- Is Nicotine Replacement Therapy The Smoker's Last Best Hope? - John R. Polito, 11/00
- Financial Disclosures for June 2000 Guideline Panel - U.S. Public Health Service, 06/00
- June 2000 Guideline Recommendation 7 - pharmacotherapy use by all quitters - 06/00
How to Quit Smoking
Our Free E-books
Read both & destroy fear driven anxieties!
Discover Smart Turkey Quitting
- WhyQuit.com - WhyQuit is the Internet's oldest forum devoted to the art, science and psychology of cold turkey quitting, the stop smoking method used by the vast majority of all successful long-term ex-smokers.
- Nicotine Addiction 101 - WhyQuit's basic guide to understanding nicotine dependency.
- Nicotine Cessation Topic Index - An alphabetical subject matter index to more than a thousand nicotine cessation articles, videos and support group discussions.
- Joel's Library - Joel Spitzer began presenting stop smoking clinics and seminars in 1976. WhyQuit's education director since 2000, Joel's Library is home to his life's work. It includes Joel's "Daily Quitting Lesson Guide," more than 100 original stop smoking articles, his free ebook "Never Take Another Puff," and to his ever growing collection of more than 400 stop smoking videos.
- "Freedom from Nicotine - The Journey Home" - Written by John R. Polito, a former 30-year heavy smoker and WhyQuit's 1999 founder, Freedom from Nicotine shares the science underlying nicotine dependency and successful abrupt nicotine cessation.
- Turkeyville - Imagine surrounding yourself with more than 10,000 cold turkey quitters. Turkeyville is a Facebook support group exclusively for cold turkey quitters.
- Freedom - Freedom was WhyQuit's original 1999 stop smoking support group. No longer accepting members, its 453,000 archived posts continue to share recovery insights.