New study of Chantix in comparison with NRT

Recently there has been some concern over side-effects experienced by a minority of people using Chantix (varenicline). Although Chantix had a remarkably good safety and efficacy record in the clinical trials conducted prior to its launch, those trials excluded patients with complex medical or psychiatric problems (normal practice in pre-approval clinical trials). So when a number of patients (albeit a tiny proportion of the millions who have used Chantix) have reported unpleasant and serious mood disturbances or even suicidal thoughts and acts while taking Chantix since it was launched, this has led to a concern that perhaps Chantix may have more serious side-effects in regular patients with complex medical and psychiatric problems.

A new study by John Stapleton and colleagues was published this week in the journal, Addiction, that addressed this issue. The study reports on the clinical outcomes of 412 patients being treated at a tobacco dependence clinic in London, UK. 204 patients were treated with nicotine replacement therapy (NRT) between May and November, 2006 (prior to Chantix being launched in the UK), and 208 patients were treated with Chantix from January to April 2007. Although the two groups were not randomly allocated to treatments, they were very similar on a number of baseline measures - for example 47% of those treated with NRT were men and 50% of those treated with varenicline were men. The daily cigarette consumption of the two groups was 21 and 22 cigarettes per day respectively. The only signs of baseline differences between the groups were that 69% of those treated with NRT were white, compared with 79% of those treated with Chantix. Those treated with Chantix also rated themselves as being slightly more “determined to quit” at baseline. All of the patients were treated in weekly stop-smoking groups for 7 weeks, with the target quit date coming at the third group meeting. Some of the patients using NRT used “combination” NRT (typically the patch plus either nicotine gum, lozenge, nasal spray or inhaler). At the end of group treatment (i.e. four weeks after the target quit date), 66% of those using a single NRT, 75% of those using combination NRT and 80% of those using Chantix were no longer smoking (not a puff in the previous two weeks). So Chantix produced higher quit rates than a single NRT product, but similar to combination NRT.

111 of these patients were receiving treatment for a mental illness, and the pattern of results for those patients was similar to that of the group as whole, with higher quit rates for those using Chantix. In the whole sample, those using Chantix reported significantly lower craving scores, with no differences on ratings of withdrawal symptoms (e.g. irritability, poor concentration, etc).

An analysis of adverse drug reactions found only one that was more commonly reported with NRT than with Chantix (skin irritation related to patch use). However, 12 symptoms were reported more frequently among those using Chantix. Those symptoms were, nausea (38%), disturbed sleep (30%), vivid dreams (13%), drowsiness (12%), constipation (11%), headache (10%), dyspepsia (8%), dry mouth (7%), bad taste (7%), depression/low mood (5%), diarrhoea (5%), and disorientation/confusion (5%). 7 patients reported moderate/severe anxiety/panic while on Chantix, compared with only one on NRT. Two patient had adverse reactions while using Chantix that were of sufficient severity to be reported to the Medicine’s Regulatory Authority in the UK. One of these was for a “severe psychological reaction likened to a bad LSD trip, including anxiety, paranoia, and confusion.”

It should be noted that around 80% of the patients in this study had previous experience trying to quit smoking using NRT. It is possible that those taking the new drug (Chantix) would have a stronger tendency to note side effects than those using an NRT that they were familiar with.

Overall, these results are broadly consistent with the evidence from clinical trials and post-launch clinical experience with Chantix. They are consistent with the ideas that (a) Chantix may result in slightly higher chances of success in quitting smoking than another single medicine/NRT (b) Quitting success rates on Chantix are broadly similar to those with combination NRT, (c) Chantix results in more side effects than NRT, of which some are common (e.g. nausea, disturbed sleep and vivid dreams) and some less common (<5%) – including depressed mood, disorientation and anxiety. The single patient experiencing a severe psychological reaction while using Chantix may be an indication that such reactions can occur but are rare (<1%).

It should be noted that all of the patients in this study were being treated in a specialist tobacco treatment clinic, within the context of support groups facilitated by experienced clinicians. In that context adverse effects of medications can be monitored, and if necessary patients promptly switched to different medications. Many of the psychological side effects were 3-5 times more common among patients using Chantix than among patients using NRT.

The research continues to show that Chantix is an effective drug for smoking cessation, that offers renewed hope for those who have tried and failed with other treatments. However, I think patients who are not planning on maintaining regular contact with an experienced clinician during their quit attempt (i.e. a clinician who can monitor side effects and provide supportive advice on a regular basis) should give serious consideration to using combination NRT (patch plus one other NRT) as a first choice. This treatment has the advantage that the patient is not taking a “new drug” – just the same one (nicotine) they have been taking, but without the 4000 other toxic chemicals.

Labels: Chantix, cigarette smoking, foulds, nicotine, NRT

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Chantix (varenicline) safety being reviewed by FDA

The issue of Chantix safety and particularly its potential psychiatric side effects have been previously discussed on this blog with many informative comments from Chantix users and their family members:
"Chantix: how does this new stop smoking medicine work?” 4/15/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html
“Chantix and mental illness: what are the facts?” 08/12/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html
“Two new studies of Chantix (varenicline)”. 8/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html
"Does Chantix cause mental health problems?" 9/20/07: http://www.healthline.com/blogs/smoking_cessation/2007/09/does-chantix-cause-mental-health.html
Immediate and delayed quitting. 10/14/07: http://www.healthline.com/blogs/smoking_cessation/2007/10/immediate-and-delayed-quitting.html

On November 20th, the US Food and Drug Administration issued an announcement regarding an ongoing safety review of Chantix, focusing on potential effects on suicidal thoughts, aggressive behavior and drowsiness. The full text of yesterday’s announcements by FDA are attached in quotes below.
This will likely get some more headlines in the media and it is important that consumers and patients understand what this announcement means, and don’t over-react.
This “early communication” is simply stating that FDA are analyzing additional data on the potential link between Chantix and these potential side-effects. It has not concluded that there is any causal relationship and FDA is not recommending that doctors stop prescribing Chantix, nor that patients stop taking it, unless they have reason to believe that they are starting to experience potentially dangerous side effects of the medication,. In that case patients should discuss this with their doctor, bearing in mind that irritability and depression are nicotine withdrawal symptoms that commonly occur on stopping smoking without any medication. The FDA announcements are inside the quotation marks below:

“Chantix (Varenicline)
Audience: Healthcare professionals, consumers[Posted 11/20/2007]
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking. Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them. [November 20, 2007 - Ongoing Safety Review: Varenicline (marketed as Chantix) - FDA][November 2007 - Prescribing Information - Pfizer] :”

“This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.
FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product.
Suicidal Thoughts
The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior. FDA currently is reviewing these cases, along with a number of recent reports in the popular press and internet sites. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.
Aggressive and Erratic Behavior
FDA is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request.
Drowsiness
FDA is evaluating reports from Pfizer of drowsiness in patients taking Chantix. Reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.
FDA recommends the following:
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes. Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA is working with Pfizer, Inc., 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. FDA is working to complete the analysis of the materials submitted by Pfizer. As soon as this analysis is completed, FDA will communicate its conclusions and recommendations to the public.

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
online at www.fda.gov/medwatch/report.htm
by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
faxing the form to 1-800-FDA-0178
by phone at 1-800-332-1088 “

Labels: Chantix, cigarette smoking, foulds, varenicline

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Effects of smoke-free workplace legislation on heart attacks

There is no doubt whatsoever that exposure to other people’s tobacco smoke pollution, over a long period of time, can cause various diseases (as summarized in a previous posts):
Health effects of Tobacco Smoke Pollution. 8/6/07 http://www.healthline.com/blogs/smoking_cessation/2007/08/health-effects-of-tobacco-smoke.html
Sidestream cigarette smoke more toxic than mainstream smoke. 8/8/07 http://www.healthline.com/blogs/smoking_cessation/2007/08/sidestream-cigarette-smoke-more-toxic.html
Make yours a smoke-free home. 08/10/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/make-yours-smoke-free-home.html

Since the growing implementation of workplace smoking bans (with bars restaurants etc being workplaces) there have been a number of reports from around the world finding that the rate of hospitalizations for acute myocardial infarction (MI: a “heart attack”) decreases significantly in areas where these smoking bans are implemented.

These studies have sometimes been based on very small geographic regions and a relatively small number of MIs. For example, a widely reported study published in the BMJ in 2004 found that in Helena, Montana, the number of hospitalizations for MI fell from 40 per half-year before the workplace smoking ban to 24 in the six months the law was in effect. The MI hospitalization rate increased slightly in a part of Montana outside Helena, and increased again (to 38) in Helena when the workplace smoking ban was lifted http://www.bmj.com/cgi/content/full/328/7446/977 .

This month a much larger study found that there were 3814 fewer hospital admissions (an 8% drop) for MIs in New York state in 2004 than would have been expected without the smoke-free workplace legislation implemented in 2003 in New York. http://www.ajph.org/cgi/content/abstract/97/11/2035

One question raised by these findings is whether the effects are caused primarily by fewer MIs in smokers who reduce or quit smoking because of the ban on smoking in workplaces, or whether it is primarily caused by fewer MIs in non-smokers who are no longer having to breath air polluted by tobacco smoke.

Another study published this month suggests that the effect is almost exclusively in non-smokers. This study by Drs Seo and Torabi of Indiana University carefully compared the number of hospitalizations in one Indiana county (Monroe) that implemented increasingly strict smoke-free workplace legislation, with another very similar county that did not pass such legislation (Delaware county). They found that in Monroe county the number of non-smoking MI admissions fell from 17 to 5, whereas it fell from 18 to 16 over the same time period in Delaware. The number of smokers admitted with MIs stayed about the same in both counties. This suggests that the reductions in MIs following these smoking bans is due to the reduction in the cardiotoxic effects of inhaling tobacco smoke pollution in non-smokers (For some reason the authors excluded MIs in people with other pre-existing risk factors such as high BP or cholesterol. I’m not sure why, so if you know, please explain it to me).

While none of the studies finding reduced MIs following smoke-free workplace legislation are perfect, and many are based on a very small number of cases, they are telling a fairly consistent story. The only way the data could fall this way by chance (rather than due to a “real” effect) would be if there was a systematic publication bias (i.e. people doing similar studies with different results not publishing them) or a systematic bias in the research process (e.g. researchers “cherry-picking” the time-frames chosen for comparisons to exclude “data blips” that don’t fit with the claimed results). While such biases do sometimes enter into the research process my inclination is to believe the results when they are almost all pointing in the same direction. So if you are aware of any studies of this issue that found different results, please let me know. But in the mean time the main conclusions appear to be:

1. Non smokers exposed to other people’s tobacco smoke pollution have increased risks of suffering a heart attack.

2. Implementing comprehensive smoke-free workplace legislation not only allows people to work in a safer workplace, it results within a year in a reduced number of non-smokers suffering from heart attacks.

3. If making workplaces smoke-free reduces heart attacks, making homes smoke-free will likely have the same effect.

Have a happy and smoke-free Thanksgiving.

Labels: ETS, foulds, myocardial infarction, tobacco smoke pollution

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Helping Latino Smokers To Quit

Spanish speakers, primarily originating in Central and South America, are the fastest growing segment of the U.S. population. In the city where I work, (New Brunswick, New Jersey, USA) approximately 50% of the population is Latino – from a number of countries with Mexico being the largest subgroup. For various reasons, Latino smokers have been less inclined to make use of treatment services to help them quit. Here in New Brunswick we have worked at making our service more culturally competent, with the help of funding from the Robert Wood Johnson Foundation. This has included adding basic features (e.g. Spanish speaking staff), and doing more systematic outreach into the Latino community. In so doing the proportion of our patients who are Latino has increased from 3% in 2001 to over 15% in 2006. The website for this project includes resources for both smokers and clinicians at: http://proyectovidanofume.org/

Latino smokers are also even less inclined to use medication (like nicotine patches or Zyban) than the rest of the population, even when factors like health insurance coverage are the same. It seems that this is because some of the common misconceptions are even more prevalent in Latino smokers (e.g. “I should be able to quit on my own” or “These medicines may be as harmful as smoking”). In order to try to help remedy this situation we have translated guidance for consumers on the use of nicotine replacement therapy to Spanish. This and other documents are available at:
http://proyectovidanofume.org/espanol/publication-span.htm

Whether you live in Mexico, Manchester or Minneapolis, the message for smokers is the same: “The single best thing you can do for your health is to quit smoking. Help is available from your doctor, your pharmacist, and online and you should do whatever it takes to succeed in becoming tobacco free.”

Labels: cessation, cigarette smoking, latino, proyectovida

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Thanks to “Dr Anonymous” for Grand Rounds 4.9.

Thank you Doctor Anonymous for publishing Grand Rounds 4.9 and including my post on “Why do some doctors not treat tobacco dependence?”. Grand Rounds is a compilation of medical blogs for the week. There are usually some interesting reads, so check it out.
http://doctoranonymous.blogspot.com/2007/11/grand-rounds-volume-4-number-8.html

Labels: Dr Anonymous, grand rounds

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Its Great American Smokeout

Tomorrow (November 15th, 2007) is the Great American Smokeout 2007 – a day on which smokers across the country are encouraged to try to go the whole day without using any tobacco - and then to consider staying that way.

There is usually a reasonable amount of media activity encouraging people to quit smoking and there is a national peak in quit attempts on this day. It is therefore an excellent day for smokers who have been contemplating quitting to have a go. If you are a regular reader of this blog, you’ll know that we’ve previously given a lot of advice on methods for stopping smoking. Some of the links are provided here to help you recap:

How bad is smoking for your health? 2/18/07
http://www.healthline.com/blogs/smoking_cessation/2007/02/how-bad-is-smoking-for-health.html

Ten tips for coping with nicotine withdrawal. 3/7/07
http://www.healthline.com/blogs/smoking_cessation/2007/03/ten-tips-on-coping-with-tobacco.html

Nicotine addiction: how it can trick you into “absent-minded” smoking. 4/13/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/nicotine-addiction-how-it-can-trick.html

How to tell if a smoking cessation aid works. 4/29/07
http://www.healthline.com/blogs/smoking_cessation/2007_04_01_smoking_cessation_archive.html

Get rid of all your tobacco. 6/16/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/get-rid-of-all-your-tobacco.html

Is nicotine replacement therapy effective in the “real world”? 6/21/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/is-nicotine-replacement-therapy.html

When is the best time to quit smoking? 6/29/07
http://www.healthline.com/blogs/smoking_cessation/2007/06/when-is-best-time-to-quit-smoking.html

A year of smoking takes 3 months off your life. 7/9/07
http://www.healthline.com/blogs/smoking_cessation/2007/07/last-friday-july-6th-new-paper-was.html

The American cancer Society Website for Great American Smokeout is also worth a visit at: http://acsf2f.com/gaso/

I’d like to encourage all smokers out there to really have a go at lasting the whole of tomorrow without a smoke, whether you use a smoking cessation aid or not. Then if you can do it for one day, why not another?
I’d also love to hear from those who are going to try, what method you used, and how it went. Feel free to post your stories on this site for others to learn from. Best of luck.

Labels: cessation, cigarette smoking, great american smokeout

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Why do some doctors not treat tobacco dependence?

Although the US Public Health Service Clinical Practice Guideline for the Treatment of Tobacco Use and Dependence recommends that all patients should be asked about their tobacco use, and all smokers offered an approved medication to help them quit, it is clear that this is not happening (1). An analysis of the 2001-2 national Ambulatory Care Survey (2) found that tobacco counseling occurred in 22.5% of visits by tobacco users, and cessation medications were prescribed on only 2.4% of occasions (with the odds being 15 times higher if the patient requested it). These rates are no higher than were found in this survey in 1991. A study involving direct observation of physician encounters with patients (3) found that of 244 smokers identified, physicians provided assistance with smoking cessation for 38% (range among practices = 0%-100%). Bupropion and nicotine-replacement therapy were discussed with smokers in 31% and 17% of encounters, respectively. Numerous other studies have documented poor adherence of physicians to the basic recommendations in the 1996 and 2000 Tobacco Treatment Guidlines (1) regarding the “5 As” (Ask, Advise, Assess, Assist, Arrange), with particularly low rates of “assisting” on use of medications and “arranging” follow-ups (4,5,6). This partly relates to lack of familiarity with the Guideline (7), but time constraints and the perception that smokers are unreceptive to counseling were the two most common barriers cited by both physicians and office managers in one study (8). Thorndike et al (9) reported that there has been a small increase in physicians' rates of patients' smoking status identification and a small decrease in rates of counseling smokers over the decade 1993-2003. This lack of progress may reflect barriers in the US health care environment, including limited physician time to provide counseling.

A National Commission on Prevention Priorities, led by dormer US Surgeon General Dr David Satcher ranked 25 preventive healthcare interventions for their population impact and cost-effectiveness (10). 3 interventions achieved the top ranking on both of these measures (total score=10): Daily aspirin for people over 40, childhood immunizations, and brief counseling and pharmacotherapy for tobacco use. Of all the interventions evaluated, the tobacco intervention was estimated to have by far the biggest impact on Quality-Adjusted Life Years saved if widely implemented (1.3 million annually). Undertreatment of tobacco dependence therefore represents a major failure in the US healthcare system. So what are the causes and potential remedies? Here are my thoughts:

Causes
1. Although very thorough evidence-based reviews and clinical practice guidelines are available, most clinicians are unaware of them and few healthcare systems require that they be followed in the same way that guidelines on the treatment of other comparable disorders (e.g. hypertension) are followed. If the healthcare system (whether that be the hospital system or the health plan) does not explicitly value tobacco treatment one should not be surprised that busy clinicians are not going out of their way to find and follow clinical guidelines on this issue.

2. Clinicians have found that it is not simple to get paid for tobacco treatment interventions. Where these are covered by health plans there may be high copays or deductibles, and frequently payments are low and certain effective treatment components are not covered (e.g. OTC NRT or group treatment). So for both clinicians and patients there is uncertainty about what (if any) treatment components are covered and this itself is a barrier to treatment provision.

3. Clinicians are unsure about the effectiveness of tobacco treatment. Their experience is that of 50 patients counseled and offered a medication, 40 will still be smoking when they are seen a year later. This can seem unrewarding compared to some other clinical interventions.

Solutions
1. We need to make all the effective components of tobacco treatment covered benefits of all health plans. Model benefit designs have already been described and widespread adoption of these would take away that doubt/barrier. http://www.tobaccoprogram.org/cftfkinsurance.htm
This will require patients and employers to ask for it, as well as insurance companies to offer and provide it.

2. We need to ensure that a new tier of healthcare provider can be trained and eligible for reimbursement for tobacco treatment. MDs and other prescribers’ time is valuable and the counseling component is best provided by counselors who have been trained to specialize in that work. In large hospitals or high population densities this tobacco counseling can be provided face-to-face in specialist clinics, but in more rural areas this can best be provided via telephone quitlines and interactive websites. This will require that more tobacco treatment counselors be trained, and approved for reimbursement by health plans. Standards for Practice for Tobacco Treatment Specialists have been developed by the Association for the Treatment of Tobacco Use and Dependence (ATTUD):
http://www.attud.org/public/survey.php

3. Steps 1 and 2 above will enable MDs to move to a model where they routinely ask patients about tobacco use, advise them to quit and offer to prescribe a med but then refer on to a local counselor or quitline (ideally via an electronic or “fax-to-quit” service). The MD intervention needn’t require more than one or two 15 minute appointments, and the counselor’s intervention would consist of 4-8 30-minute sessions.

I’d be interested to hear from clinicians regarding what they think could be done to improve tobacco treatment provision. For the patients, I think the advice has to be to ask your clinicians for help. Most clinicians see it as part of their role (even without adequate reimbursement) and are happy to help, but are currently working in a reactive rather than proactive mode.

1. Fiore MC, Bailey WC, Cohen SJ, Dorfman SF, Goldstein MG, Gritz ER et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Public Health Service, 2000.
http://www.surgeongeneral.gov/tobacco/tobaqrg.htm
2. Steinberg MB, Akinciquil A, Delnevo C, et al. Gender and age disparities for smoking cessation treatment. Am J Prevent. Med. 2006 May;30(5):405-12. http://www.tobaccoprogram.org/staffarticles.htm
3. Ellerbeck EF, Ahluwalia JS, Jolicoeur DG, Gladden J, Mosier MC. Direct observation of smoking cessation activities in primary care practice.J Fam Pract. 2001 Aug;50(8):688-93.
4.Thorndike AN, Rigotti NA, Stafford RS, Singer DE. National patterns in the treatment of smokers by physicians. JAMA. 1998 Feb 25;279(8):604-8.
5. Longo DR, Stone TT, Phillips RL, Everett KD, Kruse RL, Jaen CR, Hewett JE. Characteristics of smoking cessation guideline use by primary care physicians.Mo Med. 2006 Mar-Apr;103(2):180-4.
6. Cokkinides VE, Ward E, Jemal A, Thun MJ. Under-use of smoking cessation treatments: results from the National Health Interview Survey, 2000. Am J Prev Med 2005;28:119--22.
7. Ward MM, Vaughn TE, Uden-Holman T, Doebbeling BN, Clarke WR, Woolson RF. Physician knowledge, attitudes and practices regarding a widely implemented guideline. J Eval Clin Pract. 2002 May;8(2):155-62.
8. Marcy TW, Skelly J, Shiffman RN, Flynn BS. Facilitating adherence to the tobacco use treatment guideline with computer-mediated decision support systems: physician and clinic office manager perspectives. Prev Med. 2005 Aug;41(2):479-87.
9. Thorndike AN, Regan S, Rigotti NA. The treatment of smoking by US physicians during ambulatory visits: 1994 2003. Am J Public Health. 2007 Oct;97(10):1878-83.
10. Maciosek MV, Edwards NM, Coffield AB, Flottemesch TJ, Nelson WW, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: methods. Am J Prev Med. 2006 Jul;31(1):90-6. Review
http://www.prevent.org/content/view/130/163/

Labels: counseling, pharmacotherapy, tobacco

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Snus use in Norway.

Snus is a form of smokeless tobacco that is widely used – primarily by men – in Sweden. It is characterized by being relatively low in toxins but delivers about as much nicotine as a cigarette. It is not harmless (causes gum erosion, and pancreatic cancer) but has been estimated to be about 90% less harmful than smoking cigarettes (no lung cancer, oral cancer, or chest diseases).

In Sweden more men now use snus on a daily basis than smoke, and about a quarter of Swedish men who quit smoking did so by switching to snus. Consequently Sweden is just about the only country in the world in which it is consistent that fewer men smoke than women. As I’ve previously discussed, multinational tobacco companies are now test-marketing their own snus products, including in then US. However, some doubt remains as to whether this product (which is banned in the European Union, Australia and New Zealand) could become popular in another country.

A report has just been published on tobacco use in Norway (which is not a member of the EU), which shows a fairly dramatic increase in snus use among young men.
http://www.shdir.no/publikasjoner/faktahefter/tall_om_tobakk_1973_2006_13509

This report found that in the period 2004-6 10% of men used snus on a daily basis and 7% on an occasional basis (compared to 7% and 6% in 2001-3). However, the proportion of users is much higher in young men, with 17% using daily and 17% occasionally in the 16-24 age group. Overall the proportion of daily snus users among men aged 16-44 has more than quadrupled from 1985 to 2006. It remains to be seen what the effects of this expansion of snus use is on smoking rates and health effects. Figure 24 in the report shows that of 631 men who successfully quit smoking during the period 1990-2006 and were surveyed in 2004-6, 17% quit smoking by using snus – a proportion equal to the number who quit by using the nicotine gum (10%), patch (4%) and Zyban (3%) added together. Most Norwegan male ex-smokers quit without any assistance, and 1% used the national telephone helpline. This suggests that a meaningful proportion of men are quitting smoking by switching to snus in Norway. Clearly no tobacco use is preferable to use of smokeless tobacco, and approved medicines are preferable as smoking cessation aids. But anything that gets people to quit smoking has the potential to reduce the harm to health in then population.

If you are interested in learning more about snus, and the effects it has had on smoking in Sweden, click on this link: http://www.tobaccoprogram.org/staffarticles.htm, scroll down to the papers by Foulds and colleages (2003) on “The Effect of smokeless tobacco (snus) on smoking and public health in Sweden” and the paper by Ramstrom & Foulds (2006). These are both available as pdfs for free from this site.

Labels: nicotine, smokeless, snus, tobacco

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One Cigarette Wouldn’t Do Any Harm – Would It?

Just over half of the “ever-smokers” (those who ever became regular smokers) in the United States are now “ex-smokers”. Of course for all ex-smokers, the possibility of relapse is real, and the shorter the time since your last smoke the greater the risk of going back. As many as 40% of those who go a whole year without a smoke will lapse and have another cigarette or more in the next few years, while for those who havn’t smoked for five years or more the chances of going back to smoking are much lower.

I suspect that most visitors to the Healthline.com website are not current smokers, but that a sizeable proportion will be ex-smokers, many of whom gave up long ago (5 years or more). Most long-term ex-smokers are very happy and relieved to have successfully quit, but many will admit to getting occasional urges to smoke. Being in situations where you previously smoked (e.g. a bar) or doing an activity that was associated with smoking (e.g. walking the dog) or even just being in a certain mood state can trigger thoughts about smoking, even if you hadn’t thought about it at all for weeks or months. On many of these occasions you won’t have any tobacco available and the thought will pass in a matter of a few seconds. But certain things seem to be associated with stronger cravings and relapse risks. Some of these things are very obvious practical factors, such as the availability of cigarettes. Some are factors that serve to lower our inhibitions or lead us to believe that we “deserve” a smoke (e.g. drinking alcohol, being at a celebration or being on vacation). Even though alcohol can trigger cravings directly, sometimes I suspect that consuming alcohol also causes an indirect effect whereby the ex-smoker believes that being intoxicated somehow gives them an acceptable excuse.

One other psychological factor that increases relapse risk is the thought that, “one cigarette won’t do any harm.” This type of thought is very seductive because on the surface it may seem like a very reasonable point. One cigarette on its own is very unlikely to trigger a serious illness. Ex-smokers entertaining this train of thought often find themselves thinking further rationalizing thoughts such as, “and if I hang out in that smoky bar all evening I’ll probably breath in a whole cigarette’s worth of smoke just from other people’s smoke…so whats the difference?”. But the important thing to remember is that the biggest risk from smoking a single cigarette, is that it greatly increases the risks that you will smoke another and then another and so on. We don’t fully understand the mechanism for this type of relapse but some of it likely occurs at a neurobiological level. Even laboratory rats that have learned to press a lever for nicotine may get a sudden reinstatement of bar pressing if they are given a single injection of nicotine. But there is also a cognitive component to it, that is referred to as the “abstinence violation effect”. This is the process whereby an ex- smoker who has a lapse cigarette then finds him/herself thinking, “oh well, I’ve broken my good record now…I may as well finish the pack” (something that the lab. rat probably doesn’t think).

So it is far better to be very clear in your mind that one cigarette could do a great deal of harm, (by prompting a return to pack-a-day smoking) and that “not-a-puff” abstinence is the way to go.

Labels: cigarette, relapse, smoking cessation

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Lung Cancer

November is lung cancer awareness month – aiming to increase awareness of lung cancer, and its causes and to stimulate activities aimed at preventing and treating lung cancer.

Most people are aware that by far the biggest cause of lung cancer is tobacco smoke, whether it be via active smoking of cigarettes or cigars, or exposure to environmental tobacco smoke pollution (secondhand smoke). Many people are still surprised to learn that lung cancer kills more women than breast cancer. The risks of lung cancer increase dramatically with age and years of tobacco smoking. Men who continue to smoke are over 20 times more likely to die of lung cancer compared with men who have never smoked. At age 75, never smokers have a cumulative risk of lung cancer of less than one percent. Those who smoked but quit at age 50 have a cumulative risk of lung cancer by age 75 of 6%. Those who continue smoking have a cumulative risk of lung cancer by age 75 of over 16%. So it is clear that quitting smoking reduces the risks of lung cancer, even if you have smoked for decades. However, the risks do not return to those of a never smoker and it takes about 15 years without smoking for the increased risks to be cut in half.

Environmental tobacco smoke pollution also causes lung cancer. This cause accounts for a significant proportion of the never smokers who get lung cancer. So living with someone who smokes in the home, or working in an environment where people smoke (e.g. a bar, restaurant or casino) will significantly increase your lung cancer risks even if you never smoked yourself. This is part of the reason why many countries and states have passed laws to prevent smoking in workplaces (and remember, bars, restaurants and casinos are workplaces too). Its also part of the reason that many homes have also become smoke-free – requiring family, friends and guests who smoke to take it outside rather than pollute the air inside the home with carcinogens.

Unfortunately the 5-year survival rate for lung cancer remains very low – around 15%, and so far there has not been very convincing evidence that going for CT scans is particularly effective in detecting curable lung tumors at an early stage (without giving false-positives causing unnecessary treatment).

On the positive side, lung cancer is largely preventable on an individual level by not smoking and by avoiding smoky places. On a national level too, we know how to prevent most lung cancer, by implementing comprehensive tobacco control policies including smoke-free workplace legislation, increasing cigarette taxes, hard-hitting mass media educational campaigns, and providing effective smoking cessation treatments. For reasons not entirely unrelated to political campaign contributions from tobacco companies, successive governments have chosen not to adequately fund these effective lung cancer prevention efforts – even though they happen to prevent heart disease, respiratory disease and numerous other illnesses at the same time.

At this moment the President of the United States has promised to veto legislation that has been approved by both the Senate and Congress to increase cigarette taxes to pay for health insurance for poor families. Protecting the tobacco industry in this way leads directly to many more cases of lung cancer.

The symbol for lung cancer awareness is a clear ribbon – symbolic of the “invisible cancer” that receives far fewer dollars for prevention and treatment or public attention than other types of cancer.

For those wishing to learn more about the ways that tobacco harms health, some colleagues and I have just published a fairly detailed review of the health effects of tobacco as a chapter in a new book . You can access the pdf of this chapter via the following link:
http://www.tobaccoprogram.org/staffarticles.htm

Labels: lung cancer, Smoking

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