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Chantix: For people who are dying to quit smoking

Rages that make no sense at all



The headline proclaimed "Anti-smoking drug Champix does not raise risk of suicide or depression." This was a reference to a study published last September by Daniel Kotz and his colleagues in Lancet Respiratory Medicine, which compared the cardiovascular and neuropsychiatric risks of Chantix with two other stop smoking drugs: bupropion (trade name Zyban) and nicotine replacement therapy, or NRT. The generic name for Chantix is varenicline. Outside the United states, varenicline is marketed as Champix.
Part 1: A fantastic individual Part 2: Quitting can be different this time Part 3: Is suicide an expected event? Part 4: Unnecessary public alarm Part 5: Rages that make no sense at all The study compared all patients in the QResearch database, which holds data from 753 general practices in England. All patients who had received a prescription for Chantix, bupropion, or NRT between January 1 2007 and June 30 2012 were identified. Patients were excluded if they had used any of these three drugs within the 12 months before the study period began, or if they had received prescriptions for more than one of these drugs. All study subjects were followed for six months to compare the incidence of cardiovascular events (ischemic heart disease, cerebral infarction, heart failure, peripheral vascular disease, and cardiac arrhythmia) and neuropsychiatric events (depression and self-harm). The analysis revealed no significant differences in the rate of cardiovascular or neuropsychiatric events for patients taking Chantix as opposed to those getting NRT. The authors concluded "Our findings suggest an opportunity for physicians to prescribe varenicline even more broadly, and therefore help more smokers to quit successfully than do at present." Professor Aziz Sheikh, one of the study authors, told the Telegraph "On the basis of our extensive analysis, we believe it is highly unlikely that varenicline has any significant effects on cardiac or mental health. Regulators such as the United States Food and Drug Administration should review its safety warning in relation to varenicline as this may be unnecessarily limiting access to this effective smoking cessation aid." So does this settle the matter? Perhaps not. First of all, there is the matter of funding. Three of the study authors have received research grants from Pfizer, the manufacturer of Chantix. The study itself was funded, in part, by Cancer Research UK. That organization's annual report does not provide a list of donors, but the website pfizer.co.uk proudly boasts that the company is "working in partnership with Cancer Research UK." In addition, under the category of "neuropsychiatric events," the study looked at two types of events: depression and self-harm. They did not look at other reported toxic effects of Chantix, which include but are not limited to hostility, aggression, paranoia, suicidal ideation, suicidal behavior, and completed suicide.

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Patients who died within six months of receiving a prescription were "censored" from the study. Were any of these deaths due to suicide? The paper doesn't say. Perhaps most important, the study design provided no way to compare Chantix users with patients attempting to quit smoking without the aide of drugs. The cardiotoxic effects of both nicotine and bupropion are well-known. When we say the rate of cardiovascular events with Chantix is no worse than with either of two known cardiotoxins, have we really said anything at all? What about the neuropsychiatric effects? The same ISMP study that demonstrated a shockingly high rate of violence case reports associated with Chantix also showed a shockingly high proportion of violence case reports associated with bupropion. Moreover, a 2003 meta-analysis by psychiatrist David Healy and statistician Chris Whittaker looked at randomized clinical trials for nine antidepressants (including bupropion) and found that their use was correlated with a whopping four-fold increase in the incidence of completed suicides, compared to placebo. Or as Doctor Healy put it, graphically and succinctly, "When it comes to dead bodies in current psychotropic trials, there are a greater number of them in the active treatment groups than in the placebo groups. This is quite different from what happens in penicillin trials or trials of drugs that really work." Looking at the bupropion trials alone, we find there were three suicides in treatment arm, as opposed to zero suicides in the placebo arm. In a telephone interview, Dr. Healy declined to comment specifically on the meta-analysis by Kotz et al., but he did say as a general matter "If you're comparing a drug with other agents that can cause the same problem, then clearly you can't say for sure the drug isn't itself causing the problem" He also cautioned against drawing conclusions from any meta-analysis of trials for which the raw data is not available for inspection. "If you take the Study 329 that I and my colleagues reported on in BMJ, it was clear that in the first published article the company had included only slightly more than one-third of the serious episodes of children becoming suicidal in the course of the trial. And the rate at which these things had actually happened was far far higher. If we don't have access to the raw data we can't tell whether the reporting is faithful or not." Despite all this, Chantix remains on the market. Moreover, guidelines published by the US Department of Health and Human Services explicitly state that, in the absence of specific contraindications, individuals should not try to quit smoking without pharmaceutical assistance. The question is, Why? After all, over 46 million Americans have quit smoking. 90% of those who quit did so cold turkey. Part of the answer may lie in the fact that at the time the HHS guidelines were issued, Doctor Michael Fiore, Chair of the panel that issued the guidelines, held an endowed professorship at the University of Wisconsin funded by GlaxoSmithKline, the makers of Wellbutrin, Commit lozenges, Committed Quitters, NiQuitin/Nicoderm/Nicabate, and Nicorette -- all stop-smoking drugs whose use is recommended by the panel guidelines. "These products aren't doing anything," John Polito, founder and director of whyquit.com, asserted in a telephone interview. "Most people quit without them. The vast majority. The FDA will allow me, to this day, to come in there with a new product and wrap it in as many counseling sessions as I want to prove it works. We don't know how good the product is until it gets used out in the street. In the real world, Chantix users aren't getting 20 counseling sessions. What Pfizer did is the biggest bait-and-switch in history." Dr. Healy had a different take on matters. "I think there are clearly people for whom it helps. I've seen some friends who have used it and have problems, so I'm clear that the drug can cause problems, but I have every reason to think it can be helpful. "The condition they're treating is serious, you know. People smoke and they are much more likely to get heart attacks, they are much more likely to get cancers, and all things equal we need treatments that will help people stop smoking. So I'm in favor of having things that will help, but in favor of them coming with the right warnings." Mr. Krystynak says he had no idea Chantix was associated with neuropsychiatric effects. As a nurse, his wife almost certainly did know, but he says she never shared this information with him. On December 2 of this year, the Therapeutic Goods Administration (the Australian equivalent of the FDA) approved new product information for Champix with stronger warnings, including new warnings about the effects of combing Champix with alcohol. In a telephone interview, Thomas Moore of the Institute for Safe Medication Practices summed up matters thusly: "I think our society and our legal system are not ready to think about and understand that drugs are capable of making people suicidal and violent. This drug as well as other drugs can cause people to think about homicide, to explode into rages that make no sense at all, and we like to think that people are responsible for their own acts. Society isn't ready to realize that we have drugs that in some individuals can cause suicidal or violent behaviors." As for Nora Krystynak: authorities were able to re-trace her movements the night she disappeared. She drove to nearby Fairview Hospital, where she asked to see her son (who was in Florida at the time). The staff informed her that her son was not there, but they did not recall anything unusual about her demeanor that night. Nora then went to the nearby Lorain Road Bridge, which spans Rocky River, a notorious local spot for suicide attempts. Authorities found her lifeless body at the bottom of the ravine. The medical examiner initially ruled her death a suicide, Mr. Krystynak says, but later changed cause of death to "unknown." List of Sources
  1. 1. Donnelly, L. 2015. Study: Anti-smoking drug Champix does not raise risk of suicide or depression. Telegraph 7 September 2015.
  2. Kotz, D. et al. 2015. Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study. Lancet Respiratory Medicine 3:761-768.
  3. Cancer Research UK 2014/2015. Beating Cancer Sooner.
  4. Pfizer 2007-2015. Working in partnership with Cancer Research UK.
  5. CDC 1992. Public health focus: Effectiveness of smoking-control strategies -- United States. Morbidity and Mortality Weekly Report 41(35);645-647, 653.
  6. CDC 2006. Tobacco use among adults -- United States 2005. Morbidity and Mortality Weekly Report 55(42); 1145-1148.
  7. US Department of Health and Human Services 2008. Treating tobacco use and dependence: 2008 update.
  8. Dr. Michael Fiore, UW-CTRI Director, personal statement regarding potential conflicts of interest.
  9. Australian Associated Press 2015. Safety info upgraded for anti-smoking drug.
  10. Associated Press 2004. Metroparks scene of 10 suicides this year.
  11. Short, J.A. 2014. Police respond to two separate suicides on Lorain Road Bridge.
  12. Miady, B. 2015 Heartbroken mother appeals to Fairview officials for suicide barriers on Lorain Road Bridge.


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Patrick D Hahn -- Bio and Archives

Patrick D Hahn is the author of Prescription for Sorrow: Antidepressants, Suicide, and Violence (Samizdat Health Writer’s Cooperative) and Madness and Genetic Determinism: Is Mental Illness in Our Genes? (Palgrave MacMillan). Dr. Hahn is an Affiliate Professor of Biology at Loyola University Maryland.



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