Will Pfizer's Stop-Smoking Drug Hurt Big Tobacco?

Pfizer (NYSE: PFE  ) recently completed its first clinical test of varenicline, the company's smoking-cessation product, on patients who were unable or unwilling to abruptly quit smoking within a month. Results were good for Pfizer, and the drug met its primary and secondary endpoints. This is great news for Pfizer, but is it going to be bad news for Altria Group (NYSE: MO  ) , Reynolds American (NYSE: RAI  ) , or Philip Morris International (NYSE: PM  ) ?

Not as bad as it seems
Now, I ask is it bad news because Pfizer's stop-smoking Chantix drug, which has been on the market since 2006 and is one of the two ingredients of varenicline, has not had that much success. Granted the drug has been given to 20 million patients and has a 22% success rate, but it also has some pretty dire side effects.

For example, during the past five years, 544 suicides and 1,869 attempted suicides have been reported to the U.S. Food and Drug Administration as "adverse events" in connection with Chantix. In addition, numerous "acts of violence" have been reported, most of which have been described as "inexplicable and unprovoked." So far, 2,700 lawsuits have been filed against Pfizer relating to these side effects, and the company has paid out nearly $300 million in settlements -- around 50% of Chantix's annual sales.

After taking all of that into account, I do not believe that big tobacco is likely to be worried by Chantix. Actually, Altria, Philip Morris, and Reynolds are all working on their own 'reduced-risk' tobacco products, which are likely to be more popular as an aid in the quest to quit smoking rather than a drug with dangerous side effects.

Safer alternatives
For a start, Philip Morris recently signed an agreement with Altria whereby the two companies will share the technology for electronic cigarettes, or e-cigs, and 'reduced-risk' products under several licensing, supply, and cooperation agreements.

Altria is also set to benefit from Philip Morris' donation of 'reduced-risk' products to the company's arsenal of products for sale within the United States. Reduced-risk products are, according to Philip Morris, products that reduce the risk of tobacco-related illnesses. Altria already has several of these products on the market, such as the company's Verve chewable nicotine product and Denmark, a type of gum containing tobacco.

Internationally, Philip Morris is also working on driving sales of 'low-risk products.' The company recently invested $680 million in a reduced-risk product-manufacturing facility in Italy, ahead of the full commercialization of one of its reduced-risk products in the second half of 2014. According to Philip Morris, once fully operational, the factory's combined annual production capacity is expected to reach 30 billion units by 2016. Commenting on the development of reduced-risk products, management said:"The development and commercialization of reduced-risk products...a potential paradigm shift for the industry, and an important growth opportunity for PMI..."

Reynolds American is also active in the not-tobacco nicotine sector. Reynolds' subsidiary, Niconovum USA, has entered its first lead market in the United States with Zonnic, a nicotine replacement therapy gum, while another subsidiary, R.J. Reynolds Vapor, has introduced electronic cigarette Vuse, which currently has limited distribution.

Foolish takeaway
So overall, Pfizer's attempt to try and profit from smokers trying to kick the habit is a great move. However, it is unlikely that this treatment will ever gain enough support to present a serious threat to big tobacco. Indeed, the side effects of Pfizer's new treatment are more than enough to put many prospective users off, and this is without considering the cost.

For example, within many developing economies, where the number of smokers is still rising, Pfizer's drug may prove too expensive for many. Meanwhile, Altria, Philip Morris, and Reynolds are all working together on 'reduced-risk' products that are more likely to attract customers who are trying to quit smoking thanks to their lower cost and lack of nasty side effects.

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  • Report this Comment On January 31, 2014, at 8:08 AM, petpirhana wrote:

    Fortunatey or not, this pill will be no more effective the the medication used to stop alcohoics from drinking. I am a alcoholic (40 years sober) and an x-smoker (off 25 years). I went through AA and 12 DETOX facilities without any success. In the end , it was will power and the heath requrement that caused me to stop along with a lot of praying!

  • Report this Comment On January 31, 2014, at 9:49 AM, BMan wrote:

    Mr Hargreaves

    You know niothing about this rea..please become more informed

    http://medicalletter.wordpress.com/2014/01/16/safety-of-vare...

    Safety of Varenicline

    January 16, 2014 by Mark Abramowicz, M.D.

    An article and accompanying editorial in the December 1, 2013 issue of the American Journal of Psychiatry offer strong support for the safety of varenicline (Chantix), which appears to be the most effective drug available as an aid in smoking cessation. First reviewed in The Medical Letter in 2006, varenicline was the second non-nicotine drug to gain FDA approval for treatment of tobacco dependence. Soon after its approval, as happens with many new drugs, the FDA began to receive reports of adverse events. In this case, the agency incorporated some of those reports into warnings in the Chantix package insert, stating that serious symptoms, including agitation, changes in behavior, depressed mood, suicidal ideation, and suicidal behavior had occurred in patients who took varenicline.

    In a review of drugs for tobacco dependence, published in the September 2008 issue of Treatment Guidelines from The Medical Letter, we pointed out that smoking itself has been associated with psychiatric disease and that psychiatric symptoms including suicidal ideation and completed suicide have been associated with both smoking and smoking cessation.

    The recent article in the American Journal of Psychiatry by Robert D. Gibbons and J. John Mann, was an analysis of 17 randomized controlled trials conducted by the manufacturer (Pfizer) in a total of more than 8000 patients and data on rates of neuropsychiatric adverse events compiled by the Department of Defense from more than 35,000 patients receiving varenicline or nicotine replacement therapy. In the randomized controlled trials, varenicline increased the risk of nausea (a known adverse effect of the drug), but not of aggression, agitation, depression, or suicidal events. In the Defense Department study, the rate of neuropsychiatric disorders was significantly lower with varenicline than with nicotine replacement products.

    The accompanying editorial, by A. Eden Evins, points out that adverse event reports like these put us (investigators, editors and, most importantly, prescribers) in the difficult position of trying to prove the absence of an association between a useful drug and adverse events known to occur in the condition the drug is treating. There is no easy answer to this problem, and it is certainly not limited to varenicline and smoking.

    http://ajp.psychiatryonline.org.proxy1.athensams.net/data/Jo...

    Reassessing the Safety of Varenicline

    In this issue, in a meta-analysis of 17 randomized placebo-controlled clinical trials involving over 8,000 participants, Gibbons and Mann (1) report that varenicline improved tobacco abstinence rates and was not associated with increased rates of neuropsychiatric adverse events. The incidence of depression, aggression/agitation, or suicidal thoughts and behavior was no greater in study participants who received varenicline than in those who received placebo, whether or not they had a past or present comorbid psychiatric illness. Those who received

    varenicline had higher rates of nausea than those who received placebo, indicating that the analysis was sensitive enough to identify emergent adverse events associated with the treatment. Of note, smokers with a past or current comorbid psychiatric illness were more likely than those without to report a neuropsychiatric adverse event, but this effect did not differ between those who received varenicline and those who received placebo. The authors also report on an expanded analysis of an observational study of over 35,000 smokers treated in the Military Health System with varenicline or nicotine replacement therapy for smoking cessation. In this retrospective cohort study, in the overall sample and the subsample with a comorbid psychiatric or addictive disorder, smokers who received varenicline had fewer diagnoses of anxiety,depression,drug-inducedmental

    disorder, episodic mood disorder, other psychiatric disorder, posttraumatic stress disorder, schizophrenia, suicide attempt, or transient mental disorder in the subsequent 60 days than those who received nicotine replacement therapy. There is no signal in either of these large samples with active or placebo controls for varenicline to be associated with new or worsening neuropsychiatric symptoms. This is consistent with another large observational study in over 80,000 people with nicotine replacement therapy and bupropion comparators (2) and with other randomized placebo-controlled clinical trials of varenicline in stable outpatients with schizophrenia (3, 4) and major depressive disorder (5). In our group’s experience with varenicline for smoking cessation in outpatients with stable, treated serious mental illness, 25%230% of patients report generally mild to

    moderate transient symptoms of anxiety, irritability, agitation, or excitement that seldom lead to treatment discontinuation or need clinical intervention, although they may lead to resumption of smoking (6). Interestingly, study clinicians in a recent trial at our site performed no better than chance when guessing whether study participants were taking varenicline or placebo. To my knowledge, there is no published trial that shows a difference between varenicline and placebo in ratings of positive, negative, or depressive symptoms over the course of treatment, and rates

    of psychotic or depressive exacerbation have not differed between varenicline This article is featured in this month’s AJP Audio Why do we find ourselves in the nearly impossible position of trying to prove the absence of an association between a medication and an important

    category of adverse events? Am J Psychiatry 170:12, December 2013 ajp.psychiatryonline.org 1385 and placebo arms. It is not that there were no psychiatric adverse events in people who received varenicline to help them quit smoking; there were quite a few, most

    transient and mild, but the rate is no higher with varenicline than with placebo in the randomized controlled trials or with nicotine replacement therapy and bupropion in observational studies. Why do we find ourselves in the nearly impossible position of trying to prove the

    absence of an association between a medication and an important category of adverse events? The large initial trials of varenicline excluded smokers with concurrent psychiatric or addictive disorders. Varenicline was found to be extremely effective and well tolerated in these trials, with few psychiatric adverse events. However, by excluding smokers with psychiatric illnesses, these trials had no opportunity to evaluate, with the aid of a control group, the psychiatric adverse event rate with varenicline in smokers with comorbid psychiatric illness. When

    varenicline came into use in the general population of smokers and particularly worrisome events such as agitated, aggressive, suicidal, or violent behavior and new-onset psychosis and mania in stable outpatients were observed, the medication

    was blamed, and the alarm bell sounded with sensationalism in the press, warnings by regulatory agencies, restriction of varenicline by many formularies, and reluctance on the part of many physicians to prescribe varenicline. Case reports and postmarketing pharmacovigilance reports are critical sentinels that identify adverse events possibly associated with medical treatments in realworld practice, not seen in carefully selected samples in randomized controlled trials, that could change the risk-to-benefit assessment of a treatment in general practice. But because of reporting bias, confounding, multiple reporting, and the uncertain denominator inherent in these reports, controlled trials are essential to determine whether a causal association exists. Attempting to understand the association between neuropsychiatric adverse events and smoking cessation aids

    provides a classic example. The underlying diagnosis of nicotine dependence is strongly, independently associated with an increased risk for suicide attempts (7). A large proportion of smokers have a comorbid psychiatric or addictive disorder and are at risk for psychiatric adverse events independent of smoking cessation treatment. The nicotine withdrawal syndrome reliably includes transient and usually mild anxiety, irritability, difficulty concentrating, and depressed mood. So it is not surprising that uncontrolled postmarketing reports alerted us to psychiatric

    adverse events with varenicline treatment that may have been due to nicotine withdrawal, underlying nicotine dependence, or other psychiatric illness. Our task now as clinicians is to weigh the known consequences of continued smoking against the risks of pharmacologic cessation aids. Smokers who don’t quit have a 50% chance of dying prematurely, on average 10 years prematurely, from a smoking-related illness. The good news is that those who quit smoking in middle age avoid the bulk of the excess mortality in later life; for example, those who quit before age 40 avoid 90% of the excess risk for premature mortality from smoking. Thus, the risk of continued smoking is high, and the benefit of cessation is clear. Too many of our patients who smoke have not had a single aided cessation attempt, although a majority will have tried to quit on their own. But we now know that a

    substantial proportion of smokers with and without comorbid psychiatric and addictive disorders can quit smoking with available cessation aids and that psychiatric illnesses, by and large, remain stable during and after the cessation attempt (8, 9). Treatment guidelines recommend pharmacotherapy for every smoker willing to try quitting (10). Nicotine dependence is defined as a chronic, relapsing disorder;

    1386 ajp.psychiatryonline.org Am J Psychiatry 170:12, December 2013 EDITORIAL

    the average smoker makes five cessation attempts before attaining sustained abstinence, so multiple cessation attempts following relapses to smoking should be expected and encouraged. Clinicians should advise their patients who smoke to quit, prescribe a pharmacologic

    cessation aid, refer them to the telephone quit line in their area, and provide or refer them to any other behavioral support that is available. They should ask their patients to set a quit date and plan what to do that day, and advise them that

    they may experience craving, anxiety, irritability, agitation, excitement, and insomnia but that these are likely to be relatively mild and time limited. With varenicline, patients are also likely to experience nausea and vivid dreams. The

    trend from several studies is to see improvement in mood with varenicline. Varenicline doubles to triples the likelihood of quitting smoking over placebo, and its most common side effects are nausea and vivid dreams. With the Gibbons

    and Mann report joining other published studies finding no increased incidence of psychiatric adverse events with varenicline over placebo or active controls, it is time to unring the alarm bell on varenicline and use this effective medication on

    a larger scale.

    References

    1. Gibbons RD, Mann JJ: Varenicline, smoking cessation, and neuropsychiatric adverse events. Am J Psychiatry

    2013; 170:1460–1467

    2. Gunnell D, Irvine D, Wise L, Davies C, Martin RM: Varenicline and suicidal behaviour: a cohort study based on

    data from the General Practice Research Database. BMJ 2009; 339:b3805

    3. Shim JC, Jung DU, Jung SS, Seo YS, Cho DM, Lee JH, Lee SW, Kong BG, Kang JW, Oh MK, Kim SD, McMahon RP,

    Kelly DL: Adjunctive varenicline treatment with antipsychotic medications for cognitive impairments in

    people with schizophrenia: a randomized double-blind placebo-controlled trial. Neuropsychopharmacology

    2012; 37:660–668

    4. Hong LE, Thaker GK, McMahon RP, Summerfelt A, Rachbeisel J, Fuller RL, Wonodi I, Buchanan RW, Myers C,

    Heishman SJ, Yang J, Nye A: Effects of moderate-dose treatment with varenicline on neurobiological and

    cognitive biomarkers in smokers and nonsmokers with schizophrenia or schizoaffective disorder. Arch Gen

    Psychiatry 2011; 68:1195–1206

    5. Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C: Effects of varenicline on smoking

    cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med

    2013; 159:390–400

    6. Pachas GN, Cather C, Pratt SA, Hoeppner B, Nino J, Carlini SV, Achtyes ED, Lando H, Mueser KT, Rigotti NA,

    Goff DC, Evins AE: Varenicline for smoking cessation in schizophrenia: safety and effectiveness in a 12-week,

    open-label trial. J Dual Diagn 2012; 8:117–125

    7. Bolton JM, Robinson J: Population-attributable fractions of axis I and axis II mental disorders for suicide

    attempts: findings from a representative sample of the adult, noninstitutionalized US population. Am J

    Public Health 2010; 100:2473–2480

    8. Tsoi DT, Porwal M, Webster AC: Interventions for smoking cessation and reduction in individuals with

    schizophrenia. Cochrane Database Syst Rev 2013; 2:CD007253

    9. van der Meer RM, Willemsen MC, Smit F, Cuijpers P: Smoking cessation interventions for smokers with

    current or past depression. Cochrane Database Syst Rev 2013; 8:CD006102

    10. Fiore FC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ: Treating Tobacco Use and Dependence: 2008

    Update: Clinical Practice Guideline. Rockville, Md, US Department of Health and Human Services, Public

    Health Service, May 2008

    A. EDEN EVINS, M.D., M.P.H.

    From the Department of Psychiatry, Harvard Medical School, Boston; and the Center for Addiction Medicine,

    Massachusetts General Hospital, Boston. Address correspondence to Dr. Evins (a_eden_evins@hms.harvard.

    edu). Editorial accepted for publication September 2013 (doi: 10.1176/appi.ajp.2013.13091257).

    Dr. Evins has received research grants from Pfizer and Envivo and is an advisory panel member for Pfizer.

    Dr. Freedman has reviewed this editorial and found no evidence of influence from these relationships.

  • Report this Comment On February 03, 2014, at 10:32 AM, FoolChecker wrote:

    Kudos to BMan for calling out the author of this article for substandard journalism. I agree that he (Hargreaves) demonstrates little knowledge or insight into this subject and, in a matter of such importance to public health, the uninformed would be wise to become more informed before publishing such an article.

    An investment advisor's ignorance of actual clinical data is concerning, but not surprising. Also alarming is Mr Hargreaves tobacco-industry-serving references to Altria and Philip Morris as separate entities.

    We should never forget that 'Altria' emerged from Philip Morris in a rebranding strategy designed to switch its image from bad people selling addictive carcinogens to a company of altruism and other lofty values.

    An informed public won't fall for that strategy unless complicit parties like Mr. Hargreaves contribute to the camouflage. For shame, Fool.

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