Freedom from Smoking

Goodbye from Freedom From Smoking (at least for now)

2010-04-30T20:18:00.000-07:00

Dear Readers,

We have been informed that technical changes will mean that Healthline will soon be unable to support the capabilities required to continue the current format for "Freedom From Smoking" and the other HealthLine Experts blogs. But, we have also been reassured that access to past posts should still be available once the transition to a new format has taken place.

We have also been told that the "Comments" sections under the posts has been disabled, which is a pity, but in truth it has not been working perfectly for some time. I have received many copies of readers’ submitted comments that never made it onto the site. So if you were one of many readers who attempted to post a comment that never appeared, I'm sorry but this is outwith my control.

Each of the Healthline Bloggers has been told that it may take some time to develop Healthline’s new blogging system, and I don’t believe that firm decisions have been made regarding its format. So just in case this is my last post as a Healthline blogger, I’d like to thank all those who have read my posts, made comments, or told me that you have appreciated the posts in one way or another.

I have tried to make it a mixture of commentary on current research and policy on tobacco and health, and straightforward information and advice for the tobacco user or their family…hopefully in a manner that might help them to stop using tobacco and live a longer healthier life.

While all of the Healthline blogs will cease for the time being, I hope that tobacco users will still be able to find useful information contained in the blog posts that currently exist. You should still be able to search for specific topics using the “Search Health Experts” box on the upper right side of the page. Typing keywords such as “smoking” and “youth” should bring up all Health Experts blog posts that mention the keywords.

I also want to wish all existing smokers out there all the best in their attempt to quit. It remains the single best thing a smoker can do for their health. Remember that there are some very useful websites out there aim to help smokers to quit. Some of the best are:

www.becomeanex.org
www.quitnet.org
www.smokefree.gov

Also don’t hesitate to make use of free telephone quitlines which are available in many countries. In the USA the toll-free number to call is: 1-800-QUITNOW (1-800-784-8669).

Best of luck and best of health to you.

Jonathan Foulds, PhD.

10,753 young children poisoned by cigarettes, 3 by novel smokeless products.

2010-04-30T14:02:00.000-07:00

A number of colleagues recently mentioned to me that they had heard that new smokeless tobacco products are very dangerous because they cause a lot of poisonings to children. When I checked the internet, sure enough, there were plenty of news headlines along the lines of, “Tobacco mints tied to poisoning in kids” and “Tobacco candy poisoning kids, study shows.” I thought this looked interesting, particularly as I was unaware of any “tobacco candy”.

On looking into it, I found that the source article was one recently published by Professor Greg Connolly at Harvard University and colleagues. The study examined data on all accidental poisonings resulting from ingestion of tobacco products by children under 6 years old, that were reported to poison control centers around the United States.

The study found that over the years 2006-8 there was a total of 13,705 cases reported for all tobacco products, of which the type of tobacco used was unknown in 1197 cases (8.7%). Of the 13705 cases, 10,573 (77%) were caused by consuming cigarettes. 167 were caused by consuming cigars, and 1768 (12.9%) were caused by consuming (presumably traditional forms of) smokeless tobacco.
The new varieties of snus and other novel tobacco products (Camel Orbs, Sticks and Strips) were not widely available in the United States during the period under study, but the authors mentioned that they had heard of 2 cases of mild poisoning of children aged 2 and 3 who had ingested some snus, and a single case of a 3 year-old who was believed to have ingested Camel Orbs in 2009.

The paper serves a useful purpose in quantifying the number of accidental poisonings of young children (primarily less than 2 years old) by tobacco products. Clearly this points to the need for greater awareness among tobacco users to not leave these products where children can access them. It also points to the potential need for childproof containers for all tobacco products.

The thing that struck me as rather odd about this paper was that it focused so much on the harmfulness of the novel smokeless tobacco products. The paper included a photograph of Camel Orbs alongside a packet of tictacs (candies), and certainly they are similar. One difference is that whereas tictacs are contained in easily opened flip-top containers, the new smokeless tobacco products are contained in containers that are not only childproof but are psychologist-proof and actually extremely difficult to open by anyone who tries. I suspect that one reason kids may be poisoned by these products is that it is so difficult to get the product out, and almost impossible to put it back in, leading consumers to leave the loose product laying around.

But the data contained in the report found at least 10,573 cases of children poisoned by cigarettes, as compared with one poisoned by Orbs. It seemed rather strange, given that data, for all the focus and media coverage to be on Orbs. Why no call for all cigarettes to be packaged in childproof containers, rather than flimsy cardboard boxes?

The core message here should be that tobacco is a poison and should never be left accessible to the hands of children.

Reference:
Connolly et al. Unintentional child poisonings through ingestion of conventional and novel tobacco products. Pediatrics, April 2010.
http://www.ncbi.nlm.nih.gov/pubmed/20403932

CBS 60 Minutes documentary on snus smokeless tobacco (2)

2010-04-04T18:33:00.000-07:00

This evening the respected CBS documentary news show “60 Minutes” included a feature on smokeless tobacco, focusing on the recent launch of snus in the United States. The show was relatively balanced in focusing on the main potential risks and benefits of snus.

It started by featuring a young man who enjoys using snus in places where he cannot smoke, while continuing with a pack-a-day smoking addiction. The interviewer gave him the bad news, “You are a dual user!”

It then had a segment with the widely respected Swedish nicotine addiction expert, Dr Karl Fagerstrom, who stated that snus is 90-99% less harmful than smoking (while admitting some risks, including of pancreatic cancer).

A tobacco control advocate in Indiana expressed concerns about many tobacco users becoming dual users, and also mentioned the concern that children may become addicted to these products. She was particularly concerned that some of the new dissolvable tobacco products look like candy and appear to be designed with kids in mind.

The counterpoint was an interview with a Swedish TV presenter whose mother died of lung cancer, and who himself had been an addicted smoker. He was only able to quit smoking by switching to snus.

The show did not give much explanation about why Swedish snus contains fewer toxins than traditional American smokeless tobacco, and the claims about nicotine delivery of the new dissolvable products may be inaccurate. But it presented the main issues in an interesting and informative manner.

Overall, I suspect this show may be relatively good publicity for snus. The tobacco companies are not allowed to tell the public that snus is much less harmful than cigarettes (its primary benefit), and this show got that information into the public domain. The companies have also been trying hard to draw a distinction between traditional “spit tobacco” and this new more discrete “spitless” form of smokeless tobacco. Again, the show got that message across fairly clearly, without playing down the main potential problems…dual use, addiction and use by youth.

The full section on smokeless tobacco that was shown this evening can be viewed online at:
http://www.cbsnews.com/video/watch/?id=6362540n&tag=contentMain;cbsCarousel

Note also that 3 additional “extra” segments that were not shown on TV can also be viewed at the CBS 60 minutes site. Two of these include interviews with an Indiana University medical professor, Dr Stephen Jay, on use of smokeless tobacco for smoking cessation. The other addresses the same topic with Dr Karl Fagerstrom.

I’d be interested to read your comments on the show and other excerpts from the CBS website.

Going Smokeless on CBS 60 minutes

2010-04-03T23:12:00.000-07:00

60 Minutes will broadcast a story on smokeless tobacco this Sunday, April 4th. It is available on your local CBS station at 7 p.m. or earlier, depending on time zone. The story will also be available in its entirety on the internet after the show. The website is www.60Minutes.com

“As cigarette sales plunge, tobacco companies are marketing smokeless products to skirt smoking bans and keep customers. Lesley Stahl investigates the pros and cons, Sunday, April 4, at 7 p.m. ET/PT.”

See full preview at:
http://www.cbsnews.com:80/video/watch/?id=6353825n&tag=contentMain;cbsCarousel

At the time of writing I don’t know what angle this show will take. If you watch it and have an opinion, feel free to comment here.

IF you want to learn more about snus, enter the word as a search term and click on the “search health experts” box on the right.

State Medicaid Expenditures Attributable to Smoking

2010-03-31T22:55:00.000-07:00

In the United States there is an ongoing debate relating to the rapidly-increasing costs of healthcare and the apparent inadequacy of current systems of health insurance to provide quality healthcare to the US population.

At the same time as this debate is taking place at a national level, each state is facing its own major challenges in balancing its budget during the current economic recession. In the United States, each state is partially responsible (Federal government covers just over 50% of expenses,) for its own expenditures on Medicaid, the health insurance system designed to cover low-income Americans. As a percentage of state budgets, Medicaid expenditures increased from 8% in 1985 to 21.5% in 2006, surpassing elementary and secondary education as the largest single budget item. In 2007 the total Medicaid expense for each of the 50 states was over $144 billion. A recent study by Dr Brian Armor and colleagues at the US Centers for Disease Control (CDC) calculated the proportion of Medicaid expenditure on smoking-caused disease. They reported that smoking prevalence in the adult Medicaid population is approximately 53% greater than that of the overall US adult population (34.5% vs 22.6% in 2006). Overall, about 11% ($22 billions) of Medicaid expenditure is on smoking-attributable costs (e.g. treating smoking-caused cancer, heart disease and respiratory diseases etc in Medicaid patients).

They found that estimated annual smoking-attributable expenditure per state per year varied from $40 million (Wyoming) to $3.3 billion (New York). In my own home state (New Jersey), despite having the lowest proportion of smoking-attributable Medicaid expenditure (6% of Medicaid expenditure), NJ smoking-attributable Medicaid costs totaled $309 million in 2004.

Im partly bringing this up because it links to the building evidence from Massachusetts that covering all evidence-based smoking cessation treatments is effective in helping smokers to quit (see previous blog post). The one published study on the Masshealth smoking cessation benefit showed it was widely used, highly successful and reduced smoking prevalence by 26%. In addition, the Massachusetts Department of Public Health reported heart-attack hospitalizations were down 38 percent, asthma visits dropped 17 percent, and complications in childbirth declined 17 percent for Medicaid clients in the smoking cessation program. It is clear that once they have worked out the cost benefit from the smoking cessation program, it will have an excellent return on investment, both in terms of improved health and reduced healthcare costs.

Other states, including my own, should be looking to quickly improve health and reduce healthcare costs such as Medicaid, by providing good smoking cessation benefits/treatment like Massachusetts.

Rapid reduction in smoking prevalence due to Massachusetts Medicaid smoking cessation benefit.

2010-03-30T07:10:00.000-07:00

In July 2006, the Massachusetts health care reform law mandated tobacco cessation coverage for the Massachusetts Medicaid population. The new benefit included behavioral counseling and all medications approved for tobacco cessation treatment by the U.S. Food and Drug Administration (FDA). With the implementation of this benefit, MassHealth subscribers are allowed two 90-day courses per year of FDA-approved medications for smoking cessation, including OTC medications like nicotine replacement therapy, and up to 16 individual or group counseling sessions. Medications require written prescriptions following an office visit. Prior authorization is not required to prescribe the nicotine patch, gum, lozenge, Chantix, or bupropion/Wellbutrin. With prior authorization, the nicotine inhaler and nasal spray may also be covered. The co-payment is minimal at $1.00 or $3.00. Detailed information on the benefit design and reimbursement rates is available at www.makesmokinghistory.org/quitworks/mas shealth.html . Between July 1, 2006 and December 31, 2008, a total of 70,140 unique Massachusetts Medicaid subscribers used the newly available benefit, which is approximately 37% of all Massachusetts Medicaid smokers.

Smoking prevalence was evaluated pre- to post-benefit using 1999 through 2008 data from the Massachusetts Behavioral Risk Factor Survey (BRFSS). The smoking rate decreased from 38.3% in the pre-benefit period compared to 28.3% in the post-benefit period, representing a decline of 26 percent. A demographically adjusted smoking rate showed a similar decrease in the post-benefit period. Trend analyses reflected prevalence decreases that accrued over time. Specifically, analysis of smoking prevalence among Massachusetts Medicaid benefit-eligible members (age 18–64) from 1999 through 2008 found a decreasing trend that was coincident with the implementation of the benefit. The trend in smoking decreased significantly from July 1, 2006 to December 31, 2008.

Interestingly, these results were not due to more Medicaid smokers making a quit attempt, but rather because those who did make attempt were more likely to successfully quit (6.6% pre-benefit vs. 19.1% post-benefit).

This was the first published analysis of the MassHealth study, and shows absolutely fantastic results in terms of utilization, quit rates and impact on smoking prevalence. The authors have also initiated and verbally reported analyses of the impact on health outcomes such as ER visits due to respiratory diseases and found significant improvements in these, coinciding with the smoking cessation benefit implementation.

These findings suggest that a tobacco cessation benefit that includes coverage for medications and behavioral treatments, has few barriers to access, and involves broad promotion can significantly reduce smoking prevalence.

The full article by Dr Thomas Land and colleagues is freely available online at:
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0009770#pone-0009770-t001

New Jersey tobacco control is a good investment and should not be cut

2010-03-24T11:22:00.000-07:00

The Centers for Disease Control (CDC) identified tobacco use as the single biggest cause of premature death in every state in the USA. They recommended in 2007 that New Jersey state government should spend $120 million per year on tobacco control ($13.75 per person per year, and 12% of total tobacco-related revenue to the state).

Here in New Jersey, our Comprehensive Tobacco Control Program (CTCP) started in 2000, with annual funding of just over $30 million via the Master Settlement Agreement (MSA). The program was set up to follow CDC guidelines to have components for media, evaluation, community activities, youth prevention, and smoking cessation. With the post 9/11 recession causing severe budget problems for the state, funding was drastically cut by 66% to $11 million in 2004 and then in 2009 it was cut again to around $8m. The state brings in approximately $1 billion per year from tobacco sources (MSA plus tobacco taxes) and so New Jersey has recently been spending around 1% of tobacco revenues on tobacco control.

Despite being drastically underfunded, the New Jersey CTCP has had many noteable achievements. Just a few of these are:

- The number of cigarettes smoked by New Jersey youth was cut by 50% from 1999 to 2006 (i.e. from around 180 million to around 90 million cigarettes per year).

- Adults cigarette smoking fell from 21% during the mid 1990s to under 17% since 2007

- A national report released in 2009 found that New Jersey has the highest proportion of ex-smokers of any state in the nation (62% of smokers have quit, compared with 52% nationally and 41% in West Virginia).

So there is no doubt that New Jersey’s tobacco control program has been doing an excellent job.

Some point to the successes in reducing smoking and seem to be under the misguided impression that smoking is so rare nowadays that there is no longer a need for robust tobacco control programs. The reality is that according to our latest data (2006), New Jersey’s 7th through 12th graders smoke 90 million cigarettes a year. This does not include the significant proportions smoking cigars and bidis, or chewing tobacco.

In 2009, 283 million packs of cigarettes were sold in New Jersey, (providing $730 million in tax revenue to the state treasury).

To put New Jersey’s current investment in tobacco control into perspective, on an annual basis it is less than the amount of revenue the state receives in excise taxes from illegal cigarette sales to kids ($11.5 million)!

Yet in that scenario of incredible success despite serious underfunding, New Jersey’s Comprehensive Tobacco Control Program is currently threatened with complete elimination. In his proposed budget for the year ahead, Governor Christie proposed cutting all of the CTCP funding.

I don’t think we can really say that with New Jersey’s youth smoking 90 million cigarettes per year, and with 43 packs being consumed annually for every person in the state, that the work for tobacco control is done. We are only beginning to see the return on investment in terms of reduced health effects from tobacco. For example, the number of admissions to New Jersey hospitals for heart attacks was 24278 in 2000, but dipped below 22,000 in 2004 and has continued to fall to below 20,000 since 2006. To cut the program now would result in a reversal of the progress, and directly cause more heart attacks, more cases of lung cancer and emphysema, and more premature babies.

Tobacco control spending provides an excellent return on investment, and it is for this reason that CDC recommends that New Jersey should spend $120 million, rather than be considering cutting from $11m. Even in tough financial times, a dollar spent on tobacco control is a dollar well spent on improving health and reducing healthcare costs.

Full details and evaluation of New Jersey’s Comprehensive Tobacco Control Program can be found at: http://www.nj.gov/health/as/ctcp/research.htm

For details on what a New Jersey Quitcenter does to help smokers quit, click on:
http://www.healthline.com/blogs/smoking_cessation/2008/02/what-does-tobacco-treatment-clinic-do.html

For more details on the toll of tobacco in New Jersey, click on:
http://www.tobaccofreekids.org/reports/settlements/toll.php?StateID=NJ

For the CDC’s best practices for Comprehensive Tobacco Control (2007), click on:
http://www.cdc.gov/tobacco/tobacco_control_programs/stateandcommunity/best_practices/

Submit Comments to FDA on 2 Tobacco Issues.

2010-03-14T13:44:00.000-07:00

The FDA is accepting comments from the public on two tobacco control issues:
 • Nicotine Replacement Therapy (NRT): Two years ago, New York State Health Commissioner Richard Daines submitted a petition to the FDA to make nicotine replacement therapy more readily available and encourage more quit attempts. Two groups, the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT), recently submitted a similar but more detailed petition. The ATTUD-SRNT petition seeks action on the following issues:

1) Comparison of Health Risks: The FDA must recognize and use as a guiding principle that tobacco dependence is a chronic disease, one that causes other grave illness and often death in smokers. The magnitude of the risk of continued smoking should be considered at all phases of review of NRT products. On NRT products approved as safe and effective, product labeling should reflect the potential health risks associated with use of NRT as compared to the significant negative health risks caused by smoking. This comparison is the appropriate measure, as it should be assumed that the consumer considering NRT is currently smoking and plans to reduce or quit smoking by using NRT.

2) Combined Use: Package labeling should allow for combined use of NRT products. Current labeling strongly warns against the combined use of NRT products yet sound research shows that combined use is safe and highly effective. Labeling should reflect that certain NRT products may be used safely and effectively in combination rather than that such use is prohibited or discouraged.

3) Term of Treatment: NRT users should not be discouraged from using the product beyond the currently recommended 10 to 12 weeks. Research supports that use well beyond 12 weeks is safe and may be more effective in achieving full and permanent smoking cessation for some individuals than the standard shorter course of treatment. Current labeling instructing that NRT
use stop at 10 or 12 weeks should be amended.

4) Package Size: To enhance accessibility, the FDA should permit the sale of NRT in one-day packages that can be priced affordably. Currently the FDA prohibits such packaging. The high price of NRT under current packaging standards, particularly as compared to the much lower price of a package of cigarettes, discourages quit attempts and smoking cessation.

5) Continued Smoking and NRT: Package labeling strongly warning against continued smoking and use of NRT should be amended such that consumers are encouraged to use NRT to treat the symptoms of nicotine withdrawal during temporary smoking abstinence or to assist consumers

The full ATTUD-SRNT petition is available here:
http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2010-P-0089.

To submit a comment to the FDA on this issue, go to
http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480aa6675.

   • E-Cigarettes: Since last year, the FDA has sought to regulate e-cigarettes as drug delivery devices, citing the lack of published studies on product safety. However, a federal judge recently ruled that the FDA cannot regulate e-cigarettes as such. An appeal is expected. Click here to read more. The American Association of Public Health Physicians recently submitted a petition to request that the FDA classify and regulate e-cigarettes as tobacco products instead of drug delivery devices, noting the potential for harm reduction. The petition can be found at http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2010-P-0095.
To submit a comment on this petition, go to
http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480aa84a7.    

The Future of the Tobacco Industry

2010-03-13T14:54:00.000-08:00

The tobacco industry and its products (primarily cigarettes) has caused the premature deaths of over 13 million people in the United States since the 1964 Surgeon General’s Report which concluded that cigarette smoking causes lung cancer. Those health professionals, who are familiar with these statistics, and with the great lengths the industry has gone to to try to cover them up, have little sympathy for the industry’s current decline in the U.S. Many want nothing more than the annihilation of the tobacco industry. This is all the more understandable for those people who have seen patients and loved ones suffer and die from a smoking-caused illness. Some may feel that the tobacco industry and those in it do not deserve to continue to make money from such a deadly business.

It is quite appropriate that the emotions evoked by these aspects of the tobacco industry inspire many public health professionals to strive harder to oppose everything the tobacco industry does. However, these emotions may also cause some in public health to take their eye off the ultimate goal, which is the reduction of tobacco-caused harm. It is an unfortunate fact that the tobacco industry is not only a legal business; it is a very profitable one that has existed and gained in power and influence since the very birth of the United States.

Through that history and those massive financial resources the tobacco industry has been able to have enormous influence on elected and appointed public officials, continuing to this day. In addition, the dramatic increase in both federal and state cigarette taxes over the past 15 years has led to a situation in which the states have become dependent on those taxes as a source of revenue to balance their budgets. Recently total state revenues from tobacco taxes have been in the region of $20 billion per year.

Meanwhile, tobacco companies have a duty to maximize profits for shareholders. They are not going to stop selling cigarettes just because it would be good for public health.

This situation is part of the reason why I believe the best strategy for public health is one that forces/encourages the tobacco industry to morph from an industry that predominantly sells products that cause the premature deaths of half of its consumers (cigarettes), to one that sells products that do not cause lung cancer or respiratory diseases at all.

I believe the most practical way for this to happen is for tobacco companies to switch their focus away from cigarettes and towards other less harmful tobacco products such as smokeless snus tobacco. This is more realistic than total annihilation of the industry, partly because it would allow the companies to remain in business as tobacco companies, and for governments to continue to tax these products in order to balance their budgets.

For more details on the rationale for this, check out a presentation I gave to the Tobacco Merchants’ Association Annual Meeting in 2007:
http://www.tobaccoprogram.org/fouldstma.htm

For a summary of recent changes in tobacco taxes check out:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a2.htm

For an article on the implications of state tax revenues for policy, check:
http://www.medicalnewstoday.com/articles/120076.php

Could FDA reduce nicotine levels in cigarettes?

2010-03-01T04:58:00.000-08:00

In the previous posting I discussed the possibility of FDA requiring that no tobacco products be allowed to emit Carbon Monoxide. While appealing in its simplicity, such a strategy may have problems in that it could be interpreted as a ban on a whole class (or classes) of tobacco products, which the legislation does not allow.

Another strategy might be to reduce the harm from tobacco by lowering the nicotine content/delivery of cigarettes down to the level at which they are no longer addictive. A form of this strategy was proposed in the 1990’s by leading tobacco researchers Professor Neal Benowitz, and Professor Jack Henningfield. The FDA legislation singles out nicotine as the only chemical that cannot be reduced to zero, but this allows FDA the right to reduce the nicotine delivery of tobacco products down to a level just above zero at which they would no longer be addictive.

Although people could debate and study precisely what level of nicotine delivery is non-addictive, in reality it would not be at all difficult to define a level that would be so lacking in reinforcement as to be insufficient to perpetuate addictive use. For example, one could require that no cigarettes are capable of providing the user with a venous blood nicotine level higher than 4 ng/ml, whether from chain-smoking a number of cigarettes, or from smoking a whole pack throughout the day. For cigarettes to meet this criterion would not require them to be nicotine-free, but it would require them to deliver a per-cigarette boost in venous blood nicotine of less than 2 ng/ml (as compared to a typical boost of 10-20 ng/ml from a typical cigarette). This low level of nicotine delivery would not be sufficiently reinforcing for the vast majority of users. If alternative nicotine delivery products such as nicotine replacement therapy, smokeless tobacco products and possibly e-cigarettes were allowed to remain on the market with their normal (or possibly even increased) nicotine delivery then highly addicted smokers would transition onto these products as the nicotine delivery of their cigarettes is cut.

One of the primary aims of this strategy is to get to the point where young people will no longer become addicted to cigarettes.

So long as very low nicotine delivery cigarettes remain available, this strategy should be consistent with the legislation, and so long as plenty of smoke-free nicotine delivery products remain available it should not cause major problems of nicotine withdrawal, even if it is implemented relatively swiftly.

Of course, although in these days of FDA regulation there is talk that now tobacco policy can be driven by science rather than politics. While there is now a much more direct role for science than we had before the legislation, that does not mean that politics do not play a part. In the end, money counts, and right now the federal government and the states have become somewhat reliant on revenue from tobacco (primarily cigarette) taxes to come close to balancing budgets. If that revenue source was suddenly taken away (or even gradually) then there is a risk that the political world may interfere with the science-based public health strategy. For that reason I would recommend that the same nicotine reduction strategy not be applied to smokeless tobacco products. Rather, these should be regulated with a toxin reduction strategy to ensure they are minimally harmful, while maintaining the ability to deliver adequate amounts of nicotine to satisfy smokers’ addiction. These products would continue to be taxed at a relatively high rate and would take on the tax burden vacated by smoked products (which would no longer deliver adequate amounts of nicotine to be the lead product). In this way, the financial consequences for the states need not be so severe that the cigarette nicotine reduction strategy would be called to a halt. This dual track strategy also allows the tobacco industry to stay in business. There will be a greatly increased demand for low-toxin medium-high nicotine-delivery smokeless tobacco products, along with a greatly reduced demand for very-low-nicotine cigarettes and cigars. The companies will have to change fairly drastically to producing products that no longer cause hundreds of thousands of cases of lung cancer and COPD each year. But this is precisely the purpose of the FDA legislation: to regulate tobacco in a manner that prioritizes public health.

Could FDA require tobacco companies to cease selling products emitting carbon monoxide?

2010-02-28T17:12:00.000-08:00

Carbon monoxide (CO) is a clear, odorless gas that is produced by burning any carbon-based substance. So when tobacco is burned and inhaled, one of the 4,000 or more chemicals that enters the body is CO. When the smoke is inhaled into the lungs, CO is rapidly absorbed into the blood stream. CO binds to the hemoglobin in the red blood cells 200 times more effectively than oxygen does. The result is that many of these blood cells that were designed to carry oxygen to different parts of the body, instead bind to the CO, forming carboxyhemoglobin (COHb). This means that the heart has to do more work to supply the necessary amount of oxygen to the body. There is good evidence that high levels of carbon monoxide in the blood of smokers is one of the main factors causing smokers to have increased rates of cardiovascular diseases (such as angina and heart attacks). Other factors include platelet aggregation increasing the “stickiness” in the blood, stimulated by oxidant gases in cigarette smoke, and increased myocardial oxygen demand caused by nicotine. But it is clear that the reduced oxygen supply caused by carbon monoxide is a major factor. For example, increasing blood CO levels (either by smoking non-nicotine cigarettes or inhaling CO) has been shown to reduce the amount of exercize required to cause angina (chest pain) in patients with a history of angina.
(see: http://circ.ahajournals.org/cgi/content/abstract/61/2/262 )

Tobacco smoking is by far the largest determinant of CO levels in the blood, with smokers typically having blood COHb levels around ten times higher than non-smokers. So the idea that you might as well smoke because there is so much pollution in the air anyway is just nonsense. See this link for a study of this in a population sample:
http://www.biomedcentral.com/1471-2458/6/189

The legislation that was passed 8 months ago giving the US Food and Drug Administration the right to regulate tobacco products, allows FDA to require tobacco product manufacturers to take out any chemical (except nicotine) that appears to be harmful to public health. This can include not only chemicals IN the product, but also chemicals emitted by the product and absorbed by the user during normal use. Given the kind of evidence described above, it would seem highly likely that if it were to be reviewed by the FDA scientific advisory committee, it would conclude that CO is a chemical emitted by cigarettes that is harmful to the individual consumer, and also that limiting the industry to selling products that do not emit carbon-monoxide would be very likely to improve public health. I don’t believe there would be any controversy over the scientific evidence on CO from cigarettes and cigars, or the benefits of banning CO-emitting products.

However, the controversy would arise over whether or not the FDA legislation really empowers FDA to do this. It is highly likely that such a move would immediately result in tobacco company lawyers claiming that such a requirement is in effect a ban on at least 2 classes of products (cigarettes and cigars), and that the legislation does not give FDA the right to ban whole classes of products. This is something that would be decided by lawyers and possibly ultimately by politicians. But here is another view of the possibilities:

The legal definition of a cigarette in the United States is as follows:

“Any roll of tobacco wrapped in paper or in any substance not containing tobacco; and any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette.”

By this definition, electronic cigarettes (e-cigarettes) could be classified as cigarettes. In fact just last month a U.S. judge ruled that e-cigarettes were cigarettes and not drug delivery devices (actually over-ruling the claims of FDA). For more details on this, cut and paste the following link:

http://www.e-cig.org/2010/01/19/what-does-judge-leons-ruling-against-the-fda-mean-for-electronic-cigarettes/

So if e-cigarettes are judged to be cigarettes, and they don’t emit carbon-monoxide (which they don’t), then FDA requiring tobacco companies to cease selling CO-emitting products would NOT in fact be a ban on a class of products. It would simply be a sensible way of reducing the harm to health from certain tobacco products, just as the legislation was intended to do. Of the big smoked tobacco manufacturers want to stay in business they could (and should) switch to focus exclusively on making and selling products that deliver nicotine without simultaneously delivering carbon-monoxide, such as e-cigarettes and smokeless tobacco.

At that point FDA could require the companies to minimize the amount of harmful chemicals being emitted by these products, even although over 90% of the harms from tobacco would already have been eliminated by taking out the burning part of the process. Some people reading this may think it sounds naïve or even crazy. But maybe its not. The federal government and the states would likely ramp up the taxes on e-cigarettes and smokeless tobacco to make sure their revenue is not affected too much, and cigarette and cigar manufacturers would focus on exports and on sales to sources they know will smuggle them back into the country. So in reality, traditional cigarettes would still exist, but they just wouldn’t be used nearly as widely in the United States, just as marijuana is still smoked, but not as regularly as cigarettes.

Citizens’ Petition To FDA on Regulation of Tobacco Treatment Medicines.

2010-02-17T18:09:00.000-08:00

On Friday February 12th 2010 two of the leading organizations concerned with reducing the harm to health from tobacco submitted a petition to the US Food and Drug Administration, requesting changes in the way tobacco treatment medicines are regulated. The Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT) were co-petitioners, with the final petition being reviewed and approved by the relevant committees within these organizations. At SRNT this included review by a sub-committee consisting entirely of members who have no links with pharmaceutical companies. The petition was accompanied and supported by a review paper, entitled “Barriers to Use of FDA-Approved Smoking Cessation Medications: Implications for Policy Action”, which was funded by the Robert Wood Johnson Foundation.

The review paper sought to identify barriers to consumer demand for effective FDA-approved tobacco treatment medications, and to suggest potential policy solutions. It identified widespread misconceptions about the harms and benefits of nicotine replacement therapy, characterized by an exaggerated concern about the safety of NRT and skepticism about the effectiveness of NRT. Many of the recommended solutions are consistent with those that have previously been recommended to reduce tobacco consumption generally. In addition, broadening indications and access conditions, and altering labeling on tobacco treatment products may enable these products to help more tobacco users to become tobacco-free. There is an urgent need for this policy action, because every additional year that hundreds of billions of cigarettes are smoked in this country results in hundreds of thousands of premature deaths and millions of cases of avoidable illness.

The mission statement of the FDA states that:
╥The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health╙.

The Citizens Petition from ATTUD and SRNT requests that FDA regulate tobacco treatment medicines in a manner that is consistent with this mission. Specifically, it requests that the following actions be taken. Support for these actions and further explanation is provided in the body of the Petition and in the Barriers Report.

1) Comparison of Health Risks: The FDA must recognize and use as a guiding principle that tobacco dependence is a chronic disease, one that causes other grave illness and often death in smokers. The magnitude of the risk of continued smoking should be considered at all phases of review of NRT products. On NRT products approved as safe and effective, product labeling should reflect the potential health risks associated with use of NRT as compared to the significant negative health risks caused by smoking. This comparison is the appropriate measure, as it should be assumed that the consumer considering NRT is currently smoking and plans to reduce or quit smoking by using NRT.

2) Combined Use: Package labeling should allow for combined use of NRT products. Current labeling strongly warns against the combined use of NRT products yet sound research shows that combined use is safe and highly effective. Labeling should reflect that certain NRT products may be used safely and effectively in combination rather than that such use is prohibited or discouraged.

3) Term of Treatment: NRT users should not be discouraged from using the product beyond the currently recommended 10 to 12 weeks. Research supports that use well beyond 12 weeks is safe and may be more effective in achieving full and permanent smoking cessation for some individuals than the standard shorter course of treatment. Current labeling instructing that NRT
use stop at 10 or 12 weeks should be amended.

4) Package Size: To enhance accessibility, the FDA should permit the sale of NRT in one-day packages that can be priced affordably. Currently the FDA prohibits such packaging. The high price of NRT under current packaging standards, particularly as compared to the much lower price of a package of cigarettes, discourages quit attempts and smoking cessation.

5) Continued Smoking and NRT: Package labeling strongly warning against continued smoking and use of NRT should be amended such that consumers are encouraged to use NRT to treat the symptoms of nicotine withdrawal during temporary smoking abstinence or to assist consumers

You can access the Citizens Petition and the report on barriers to the use of FDA-approved smoking cessation medicines on the ATTUD website at:
www.attud.org

and on the SRNT website at:
http://www.srnt.org/about/policies.html

I believe these documents will shortly be posted on the FDA website and at that point will be available for comment.

E-cigarettes deliver almost no nicotine.

2010-02-12T08:58:00.000-08:00

E-cigarettes continue to create a lot of media buzz and chatter among smokers and smoking cessation experts alike. Today, Professor Thomas Eissenberg of Virginia Commonwealth University published an important study demonstrating that E-cigarettes, despite claims on the packaging and advertising, deliver almost no nicotine to the user.

The study is published in the latest edition of the journal, Tobacco Control. Professor Eissenberg had 16 smokers abstain overnight, then come to the lab. on different days and (a) smoke two of their usual cigarettes (b)puff on two unlit cigarettes or (c) “smoke” 2 leading brands of E-cigarette using their “high nicotine” cartridge (16mg), each brand on a separate occasion. On each occasion he measured the blood nicotine levels before, during and up to 45 minutes after using the products.

As expected, the smokers started off with very low nicotine blood levels (around 2 ng/ml) and went up to around 17 and 20 ng/ml after smoking the usual cigarettes. However, when the smokers used 2 E-cigarettes their blood nicotine levels hardly budged, peaking at 3.5 ng/ml (i.e. not significantly different from before they used the E-cigarette or puffing on an unlit cigarette). Similarly, unlike smoking real cigarettes, the E-cigarettes did not affect heart rate and had a relatively small (but observable) effect of reducing craving for a smoke.

What this suggests is that regardless of how much nicotine is supposed to be contained in the E-cigarette cartridge, almost none of it is transferred via the vapor and absorbed in the human body. As I have previously suggested, the E-cigarettes appear to be a good idea, with intuitive appeal, but ultimately have the status of a neat theatre prop which mimics rather well the appearance of smoking.
Given that it delivers almost no nicotine, it follows that the E-cigarette is unlikely to be effective in reducing nicotine withdrawal symptoms and helping addicted smokers to quit in the long run. Although on initial use, the smoker will likely get some conditioned effects (like Pavlov’s dog salivating on hearing the bell), after repeated use it is likely the smoker will learn that that ‘something is missing”, and notice that it doesn’t really help with their withdrawal symptoms and cravings (like Pavlov’s dogs salivate less and less as the bell is rung and no food appears).

I’ve no doubt that some people will continue to feel that they are ‘getting something” from the E-cigarette and that it helps them nonetheless. And of course many would prefer a product that doesn’t give them any nicotine. However, the lack of nicotine delivery casts doubt on this product’s usefulness for smoking cessation, and also poses questions as to the accuracy of the claims of those who market the product.

To find out more about the E-cigarette or other ways of quitting smoking, type in "smoking" and the relevant terms in the "Search Health Experts" box on the right side and click on return.

The reference for the study is:
Eissenberg T. Electronic nicotine delivery devices: ineffective nicotine delivery and craving suppression after acute administration. Tobacco Control 2010: 19, 87-88

To access online, cut and paste this link:
http://tobaccocontrol.bmj.com/content/19/1/87.full

Is Unassisted Quitting The Most Successful Method?

2010-02-10T19:07:00.000-08:00

Once again, my Australian tobacco control colleague, Professor Simon Chapman, has courted controversy by publishing another article railing against smoking cessation treatment for smokers and suggesting that the most successful method is unassisted quitting.

I am truly puzzled as to what Professor Chapman is trying to achieve by this and his earlier similar articles, and also by his rationale. For example, he cited a study by Shiffman and colleagues showing that of all the smokers in the US who tried to quit in 2003, two thirds made their quit attempt with no form of assistance, about a third used a smoking cessation medication and under 9% received some kind of behavioral support. Over three quarters of those making unassisted quit attempts had returned to smoking, but that’s not surprising. The point here is that Professor Chapman appears to think we need to draw more attention to recommending unassisted quitting when it has always been and remains by far the most common form of quit attempt. So to me the very data he cites does not support his basic premise that pharmacological treatment has an undue domination of the smoking cessation landscape.

Professor Chapman also seems to be concerned with the fact that despite most smokers who quit doing so without assistance, (albeit a small minority of those attempting to quit unassisted), most research on cessation focuses on forms of assistance! Well knock me down with a feather…..researchers aren’t doing so much research studying people trying to quit the same remarkably unsuccessful ways they’ve been trying for decades, are instead doing research trying to develop more effective methods! Surely Professor Chapman can’t really be surprised by this any more than he’d be surprised that most research on hypertension focuses on interventional treatments rather than on observing whether people’s hypertension just goes away.

Another odd thing is that Professor Chapman acknowledges that, “Accumulated evidence from clinical trials shows unequivocally that those who use NRT (nicotine replacement therapy) in trials have 50%–70% greater success than those using placebo.” But he appears to doubt that this efficacy transfers into the “real world”. Well Im not sure what constitutes his “real world” but there are now plenty of studies showing that NRT increases quit rates versus no NRT outside of clinical trials, whether it be in naturally occurring quit attempts (West & Zhou, 2007)), situations where the NRT was mailed to the public via a quitline (Miller et al, 2005), or among patients attending a smokers clinic for treatment (Steinberg et al, 2006).

But I’m most puzzled about his willingness to ignore the very clear evidence from prospective clinical trials that smoking cessation treatments work, and recommend an emphasis on (demonstrably inferior) unassisted quitting. If one had to cite a single study that makes the point Id probably choose the US Lung Health Study. This study randomly allocated a large cohort of middle-aged smokers to either “usual medical care” or an intensive smoking cessation treatment consisting of nicotine gum and group counseling. 36% of those given treatment were quit a year later, compared with 9% of those not given treatment (who were free to quit “cold turkey”). One of the key results was that when they did the 15 year follow up they found that significantly more people who had been randomized to receive the smoking cessation intervention were still alive, as compared to those who were randomized to “usual medical care”. So if you want proof that intensive smoking cessation treatment saves lives, this is the study that proves it.

There are some things I agree with in Simon Chapman’s article. I agree that no smoker should be discouraged from making an unassisted quit attempt (nor any serious quit attempt). I agree that we may gain useful information from more research on unassisted quit attempts.

But on the question of whether cold turkey is the most successful quitting method he is simply wrong. Most ex-smokers who have quit have quit that way, yes, and most current smokers who continue smoking have already failed that way as well. The evidence is really crystal clear that smoking cessation treatment consisting of counseling and medication is more successful (the Lung Health Study suggests four times more successful) than no treatment.

My question to Simon would be this: If you had a close relative who you loved very much, who smoked 20 cigarettes per day, and had tried to quit a number of times before but never succeeded, and they asked you to recommend what method would give them the best chance of successfully quitting, what would you say?

If your answer to your relative is “cold turkey”, then you truly believe the message of your paper. Personally, Id rather my loved ones had the best chance of avoiding a premature death, and the same goes for people I educate about quitting smoking.

If you want to read Simon Chapman’s article you can find it at:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000216

If you want to read a previous comment I made about one of Simon Chapman’s other papers, you can find it at (March 4th, 2009):
http://www.healthline.com/blogs/smoking_cessation/2009/03/should-health-care-services-provide.html

If you want to read an earlier summary of the Lung Health Study (October, 29th, 2009) you can find it at:
http://www.healthline.com/blogs/smoking_cessation/2009/10/classic-study-lung-health-study.html

Other studies showing the “real world” effects of NRT are:

Miller N, Frieden TR, Liu SY, Matte TD, Mostashari F, Deitcher DR, Cummings KM, Chang C, Bauer U, Bassett MT. Effectiveness of a large-scale distribution programme of free nicotine patches: a prospective evaluation. Lancet. 2005 May 28-Jun 3;365(9474):1849-54.

Steinberg MB, Foulds J, Richardson DL, Burke MV, Shah P. Pharmacotherapy and smoking cessation at a tobacco dependence clinic. Prev Med. 2006 Feb;42(2):114-9.

West R, Zhou X. Is nicotine replacement therapy for smoking cessation effective in the "real world"? Findings from a prospective multinational cohort study.Thorax. 2007 Nov;62(11):998-1002. Epub 2007 Jun 15.

For the record, I have done work that was funded by companies that market smoking cessation medicines. I’ve published research on smoking cessation medicines (including papers reporting poor results for the medicine under study) as well as on studies of non-pharmacological smoking cessation methods. Some of this is mentioned in my profile.

Where can you get cheap nicotine replacement therapy?

2010-02-07T12:38:00.000-08:00

One of the main reasons motivating smokers to quit is money. A pack a day smoker in my home state of New Jersey who is purchasing his or her cigarettes on a daily basis is likely paying around $8 per pack. That’s $56 per week, $243 per month, or just under $3,000 per year.

So it clearly makes sense to quit for health and financial reasons. But as I’ve discussed on this site previously, your best chance of successfully quitting will be to get counseling support and to use at least one FDA-approved smoking cessation medicine. If you don’t want to have to go to the doctor for a prescription, your choices will be limited to the “Over-The-Counter” products: nicotine patch, gum or lozenge. When you go to a local pharmacy you will often find that the sticker price for a branded box of NRT, which typically last around 2 weeks (e.g. a 14-day supply of nicotine patches) is around $50, and possibly slightly higher. That sticker shock can put some people off. So are there less expensive ways of obtaining NRT?

One thing you should be aware of, is that all the major pharmaceutical manufacturers have programs that enable them to supply free medicines to people on very low incomes and no other way to pay (e.g. insurance). You can find out about these via the companies website. It typically involves completing a reasonable amount of paperwork, supplying some verification of financial situation, and I think requires a doctors office to ship it to. But it does work, and is a way for people on a very low income to get the medicines they need.

If you are fortunate enough to live in a state with a good/comprehensive tobacco control program, it is possible that the smoking cessation services can provide free or low cost medicine (e.g. free nicotine patches via the quitline or face-to-face counseling services). In some states, people covered by Medicaid can get their medicines covered. Similarly some private insurance policies cover the medicines. Some cover them all, and some just cover the prescription-only products (nicotine inhaler, nasal spray, and bupropion or varenicline). So if you have insurance, call your policy number and inquire about what is covered.

But if you are going to have to go to the pharmacy and purchase your own NRT, there are still some bargains to be had out there. Many pharmacies have vouchers giving $5 or $10 off branded NRTs. The other thing to do is to get an idea of what is available is to go to the online store of one of the leading chains and see what they have. I just went on the Walmart website and typed on the search words “smoking cessation”, and among the 91 “hits” were some interesting options. Among the best value were:
1. A box of 170 pieces of 4mg original flavor nicotine gum “Equate” for $30, which can be shipped to my home for 97cents.
2. A box of 20 pieces of 4mg Mint flavor “Equate” nicotine gum was only $8! That truly equated one for one with the cost for cigarettes!
3. 14 day supply of Equate 21mg nicotine patches for $26.
So if you were a heavy smoker and wanted to combine the nicotine patch with 4mg gum, an adequate 2-week supply would cost $56. That’s still half as expensive as buying a pack of cigarettes per day for 2 weeks in New Jersey.

There were numerous other options of brands, flavors and prices available on that site. I was a bit surprised to find that a form of e-cigarette also came up on my search. I did not realize until recently that Walmart were selling e-cigarettes and I think it is inappropriate for them to be sold as “smoking cessation aid” when they are not approved by FDA for that purpose. Interestingly, however, the user feedback in response to a question was quite positive.

A Smokefree Future: Comprehensive Tobacco Strategy

2010-02-07T11:16:00.000-08:00

Last week the UK Government announced a new comprehensive tobacco control strategy for England. This document should be of interest to other countries around the world as England has been at the cutting edge of tobacco control and smoking cessation over recent years. Adult smoking prevalence fell from 28% in 1998 to 21% in 2008, and youth smoking rates fell from 11% to 6% following the previous tobacco control strategy announced in 1998. During that time frame a nationwide network of smoking cessation services was set up, comprehensive smoke-free workplace legislation was implemented (including bars and restaurants), tobacco advertising severely restricted, and large pictorial health warnings introduced on packs. In 2006 the UK ratified the World Health Organization Framework Convention on Tobacco Control.

The UK government has set ambitious targets to be reached by 2020:
1. To reduce the proportion of 11-15 year-olds to 1% (currently 6%)
2. To reduce adult smoking prevalence to 10% (currently 21%)
3. To have two-thirds of households in which parents smoke be smoke-free by 2020 (i.e. even smoking households having a policy of not smoking indoors).

One of the main components of the strategy for England is to motivate and assist every smoker to quit. Over the past 10 years the UK smoking cessation service have helped arrange over 4 million quit attempts. These services are unique in international comparisons in that they are based on a network of locally based face-to-face tobacco treatment services.

The new strategy plans to expand these services by using an expanded marketing campaign, but perhaps the most radical aspect is the plan to broaden the number of routes to cessation by encouraging smokers to (a) cut down their smoking, perhaps over a long period, by substituting cigarettes with nicotine replacement therapy (e.g. nicotine gum (b) encouraging smokers to use safer nicotine delivery products like nicotine gum in places where they are not allowed to smoke and (c) encouraging all smokers to reduce the amount of environmental smoke they emit, by replacing smoking of cigarettes to use of nicotine replacement therapy.

In order to fit in with these new pathways to cessation, the UK government plans to change the way the face-to-face smoking cessation services work, such that longer courses of behavioral and pharmacological support will become available to suit the needs of those smokers who are not yet ready to quit completely.

This last part is a fairly radical step for a government. Most countries don’t even have a government funded smoking cessation service, never mind one that also serves to help smokers reduce their smoking. Overall, so long as scarce resources are not diverted away from smokers who are seeking help to quit completely, I think the UK has broadly got it right, and many other countries should take a look at what is being achieved there and consider adopting a similar approach.
You can access the details of the strategy at:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_111749

New study shows that longer duration nicotine replacement leads to better quit rates

2010-02-01T17:20:00.000-08:00

A new study was published in Annals of Internal Medicine this week, showing that having access to nicotine patches for 24 weeks leads to higher quit rates at 24 weeks (32%) that using the patch for the more typical duration (8 weeks), which led to only 20% being quit at 24 weeks. This study, by Dr Robert Schnoll and colleagues at University of Pennsylvania, recruited 568 healthy adult smokers (smoked an average of 21 cigarettes per day). They were all given a standard treatment consisting of 8 counseling sessions over 6 months, and a 24 week supply of patches. Half of the participants had full strength 21mg nicotine patches for 24 weeks (extended duration) and half had full strength nicotine patches for 8 weeks, and 16 weeks of placebo patches that were packaged to be identical to the nicotine patches. The study was conducted in a double-blind manner meaning neither the researchers not the participants were aware of who received the extended duration treatment, until after the study was completed.

This study examined a range of outcome measures, and produced some interesting findings. For example, while the quit rates were similar between the two groups up to week 8, , from weeks 9 to 24, the relapse rate was slower among those still using the nicotine patches. Then from weeks 24 to 52 (when all participants had ceased patch use), the relapse rates were again similar, although slightly higher in those who had extended duration nicotine patches up to week 24. From weeks 9 through 24, those smokers who continued to have access to nicotine patches but had a lapse cigarette were more likely to recover abstinence, than those using placebo patches.
The authors defined abstinence as either “point prevalence” (no tobacco use in prior 7 days at a point in time) “prolonged abstinence” (allows some smoking during first 14 days, then a period of abstinence, ending with 7 consecutive days of smoking…a relapse) and “continuous abstinence” (not a puff from the quit date to a follow-up point). Extended duration patch treatment led to higher rates of prolonged abstinence at one year (29% v 21%). It was noteworthy that only 1% of each group achieved continuous “not a puff” abstinence for 52 weeks!

There were a few odd aspects to this study. The researchers attempted to estimate the costs of the treatment as well as the additional medical costs incurred by participants as a result of participation in the study. It seems very unlikely that these were fully and/or accurately measured. For example, the total estimated cost for counseling was $120. No details were provided on how this estimate was arrived at, but its hard to see how the TOTAL cost of the behavioral part of the intervention would be so low. Even if only the 8 counseling sessions were included, that would imply that a counseling session costs $15. This is clearly an underestimate of true staff costs, and of course doesn’t take into account the potential impact/cost of the additional recruitment/assessment and follow-up procedures, which although strictly a part of the research process, likely influenced outcome.

One other thing that was slightly odd was that the discussion section of the paper began with the statement that “smokers who received extended therapy with transdermal nicotine were about twice as likely as those who received standard therapy to achieve abstinence 24 weeks after their quit date.” Given that the point prevalence quit rates were 32% vs 20%, neither this nor any other outcome measure was twice as likely in those receiving extended duration patches. Presumably the authors were referring to the “odds ratio” (1.8) but that is not a straightforward “likelihood” in the sense that most people understand it.

One other weakness of the study was that only healthy smokers were included in the study. For example, all volunteers who were already taking any medication or had a psychiatric disorder were excluded. As a result, of 3276 smokers who were screened, only 575 (18%) were included in the study. However, although that limits generalizability of the findings, I have some confidence in the result, partly because here at UMDNJ a research study by Dr Michael Steinberg and colleagues focusing on smokers with medical illness obtained a similar finding (extended duration treatment with patch plus bupropion plus nicotine inhaler gave better outcomes at 6 months than standard duration nicotine patch).

However, despite these minor quibbles, this was an excellent study yielding some very interesting results. These results are consistent with the view we that tobacco dependence is best treated as a chronic illness, and for some smokers, that means continuing the medication for as long as is necessary.

Reference
Schnoll et al (2010). Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Annals of Internal Medicine, 153: 144-151

Classic paper: health consequences of smoking1-4 cigarettes

2010-01-30T10:38:00.000-08:00

The journal Tobacco Control has on its website a list of the top 10 most read articles each month. One paper that has been near the top ever since it was published in 2005, was written by Dr Kjell Bjartveit and his colleague Dr Tverdal, on “Health consequences of smoking 1-4 cigrettes per day.”

The study included 23 521 men and 19 201 women, aged 35–49 years when they were initially screened for cardiovascular disease risk factors in the mid 1970s and followed them up to 2002. The researchers calculated the total risks of death and relative risks adjusted for confounding variables, of dying from ischaemic heart disease, all cancer, lung cancer, and from all causes, and examined the effects of regular smoking of only a few cigarettes per day.

The study found that both men and women who smoked 1-4 cigarettes per day were about 3 times as likely as people who never smoked of dieing from a heart attack, 3-5 times as likely of dieing from lung cancer, and overall about 50% more likely to have died from any cause during the study period.

As in many other studies, the risks were greater the more the participants smoked. For example, people who smoked over 25 cigarettes per day were 37 times more likely to die of lung cancer than people who never smoked.
The study was important in that it showed that there really isn’t a threshold of cigarette consumption below which its safe to smoke.

The full version of this paper and many other influential tobacco research papers can be found by cutting and pasting this link:
http://tobaccocontrol.bmj.com/reports/most-read

If you would like to find blog posts on other topics, try typing the subject words into the “Search Health Experts” box on the right. If your interest is in smoking, be sure to enter a relevant key word, e.g. smoking, nicotine, etc.

Tobacco surely was designed to poison and destroy mankind

2010-01-30T07:21:00.000-08:00

Tobacco surely was designed 
To poison and destroy mankind
Philip Freneau (1752–1832)

This is the most famous excerpt from a poem by Philip Freneau. I don’t think I’m allowed to copy the whole poem here, but he was clearly ahead of his time in identifying (a) that tobacco, whether smoked or chewed is harmful to the body and (b) that it was very hard to give up once you have started (i.e. in modern language, addictive).

Freneau was quite an interesting man. His father was a French wine merchant and his mother was Scottish. He was raised in Monmouth County, New Jersey and attended Princeton University (then called College of New Jersey) in 1768. As a patriot, he was imprisoned by the British and both James Madison and Thomas Jefferson enlisted his help as an editor of various publications which aimed to further the cause of independence for the Americans from the British. He was never afraid to speak his mind and apparently became strongly disliked by people in power, including President George Washington, whose policies he had criticized.

He died at the age of 80, apparently freezing to death after trying to walk home from a tavern while drunk and getting lost in the forest. He and his family were buried in Matawan, New Jersey. The Matawan Post Office on Main Street, New Jersey, has a sculpture on the wall of Freneau. It features him with black slaves as he became strongly opposed to slavery later in life.

Early test-marketing of snus in the United States.

2010-01-28T17:00:00.000-08:00

Snus is a relatively new smokeless tobacco product in the United States, and is modeled after the Swedish moist snuff product that is heat-treated rather than fermented, resulting in lower concentrations of certain toxins, (carcinogenic tobacco-specific nitrosamines).

The major tobacco manufacturers in the United States have each test-marketed snus-like products in a few US cities over the past 5 years, but so far only Camel Snus is available nationally. This week a new report was published in the journal, Nicotine & Tobacco Research, which analyzed the marketing strategy for these products in these test markets in 2008. The researchers, led by Dr John Rogers of University of Massachusetts surveyed 165 stores in 4 test markets (Columbus Ohio, Dallas Texas, Indianapolis Indiana and Portland Oregon). They found that a snus product was available in 64% of the stores, with big differences in availability of the brands. Marlboro Snus (Philip Morris) and Triumph Snus (Lorillard) were available in just over 60% of stores, but Camel Snus (Reynolds) was available in only 37% of stores. Grand Prix and Tourney Smus (Liggett) were only available in 2 and 4 of the stores respectively. Overall, at least one snus product was available in 80% of the stores.

Camel Snus was more expensive ($4.98) than its comparable cigarette brand, whereas Marlboro snus ($4.01) and Triumph (3.37) were less expensive than their same brand cigarettes. Despite this, 42% of stores reported “medium or high perceived demand” for camel Snus whereas only 12% did for Marlboro or Triumph (both medium, with no ratings of “high demand”). The products tended to be placed near cigarettes rather than other smokeless products, and there were other signs that the marketing was targeting cigarette smokers (e.g. in 25% of stores had “onsert” coupons attached to Camel cigarette packs).

So far, snus has not been flying off the shelves in the United States. Part of this is likely due to the fact that a large proportion of US smokers believe it is just as harmful as cigarettes (in reality it is much less harmful, estimated to be about 90% less, with no excess risk of lung cancer or respiratory diseases).

You can find out more about snus by entering the word in the “health experts” search box on the right.

Reference:
Rogers J, Biener L, Clark PI. Test marketing of new smokeless tobacco products in 4 US cities. Nicotine & Tobacco Research, 12: 69-72

Can quitting smoking after lung cancer diagnosis improve survival?

2010-01-23T16:26:00.000-08:00

Most smokers dread lung cancer. They are aware that by continuing to smoke the chances of developing lung cancer are increased 20 times, and that once it has developed the treatment is unpleasant and prognosis poor. Many patients (and unfortunately many clinicians) assume that once you have lung cancer it is too late to quit.

This week a new report was published in the BMJ, based on a review of the evidence that smoking cessation after diagnosis of a primary lung tumour affects prognosis. The study, by Drs Parsons, Daley and Aveyard at the UK Centre for Tobacco Control Studies, combined the data from 10 studies. They found that those who quit smoking after diagnosis were significantly less likely to develop another tumor and significantly more likely to still be alive 5 years later. For example, it was estimated that among 65 year-old patients newly diagnosed with early stage non-small cell lung cancer who continue to smoke, 33% will survive for 5 more years, whereas for those who quit smoking, 70% will survive for at least 5 years.

There are a few pieces of information contained in this paper that are quite striking. The first is the proportion of patients who quit after lung cancer diagnosis. Of 1295 smokers newly diagnosed with lung cancer in this study, only 4640 (49%) quit smoking post diagnosis. If anything, that is likely to be an overestimate of the quit rate, as abstinence was generally based on self-report with no biochemical verification. It is remarkable that less than half of the smokers with lung cancer managed to quit.

The other amazing fact mentioned in the paper was that the authors could not find a single randomized controlled trial testing the effect of smoking cessation on prognostic outcomes in lung cancer. Billions of dollars have been spent on (largely fruitless) new drug development and evaluation for lung cancer, and in the past 50 years not one single cancer research center was funded to do a proper trial to find out whether tobacco dependence treatment improved clinical outcomes! Amazing.

But the good news from this study is that smoking cessation has relatively large clinical benefits even after lung cancer diagnosis.

I wonder what proportion of newly diagnosed smokers with early-stage lung cancer are provided with state-of-the-art smoking cessation treatment?

You can access the full research paper by Parsons and colleagues by cutting and pasting this link into your browser:

http://www.bmj.com/cgi/content/full/340/jan21_1/b5569

If you want to find out more about smoking and smoking cessation, type your search terms into the “Search Health Experts” box on the right.

Can glucose tablets help you quit smoking?

2010-01-18T14:57:00.000-08:00

Professor Robert West, at University College London, has an interesting theory which suggests that glucose tablets can help smokers to quit. It is well known that when smokers quit smoking they put on weight, and that nicotine appears to act like a mild anorectic drug…it dulls the appetite. It has also been noted that smokers often crave high carbohydrate foods when they quit smoking. So it seems as though smoking dulls the hunger for carbohydrates. The glucose theory (or at least one version of it) suggests that when an addicted smoker quits smoking they experience a strong hunger/craving sensation, sometimes located in their stomach. When trying to interpret that sensation they think, “what am I craving? I just gave up cigarettes, it must be that.” But part of the renewed craving is actually craving for carbohydrates (which had previously been dulled by nicotine). So if the recent ex-smoker takes some glucose tablets, it will satiate their craving for carbohydrates, and also help the person feel less severe overall cravings. In addition, there is fairly solid experimental evidence that glucose tablets and drinks can improve feelings of stress, irritability and improve mental performance and memory. Many of the things that glucose improves are also nicotine withdrawal symptoms, so it should be no surprise that glucose tablets may help a recent ex-smoker to cope with withdrawal.

But this is more than just a theory. Professor West has published a series of studies supporting the role of glucose tablets in reducing cigarette cravings and helping smokers to quit. These have included fairly large randomized placebo-controlled trials (which found that glucose tablets were at least as effective as the nicotine patch for smoking cessation), and placebo-controlled experimental studies which found that the glucose tablets reduced cigarette cravings. The data on glucose has not all been totally consistent. For example, a colleague and I published a paper a few years ago showing no significant effect of glucose tablets on cigarette cravings.

But just this month, Professor West published his biggest trial of glucose tablets for smoking cessation, in the journal, Psychopharmacology. In this study 928 smokers were randomly allocated to receive either glucose tablets or sorbitol (placebo) tablets to help them quit. During this study in the UK, the UK government approved the used of NRT and bupropion as covered medicines in the UK National Health Service. As a result, about half of the people in the study also used an approved smoking cessation medicine. So when the results were analyzed they examined those who only used counseling plus glucose/sorbitol tablets, and separately analyzed those who used another medicine (plus counseling), plus either glucose or sorbitol. The results were a little puzzling.

The 6-month quite rate was no higher for those receiving glucose tablets only (10.7%) as compared to those who only received sorbitol tablets (14.3%). However , among the 474 smokers who received NRT or bupropion (mainly nicotine patch or gum), those who were also given glucose tablets had a significantly higher quit rate (18.2%) as compared with those given placebo tablets, (12.2%). These results are puzzling to me, as I might have expected the effects of glucose to be higher when the person had no other medications, when they were the opposite.

So what does all this mean? First of all, it seems likely that any effect of glucose in helping a smoker to quit may be quite small…it is no wonder-cure. But my view is that there are enough studies out there with evidence of a clinically useful effect of glucose on cigarette craving and cessation, to warrant further studies. Part of the reason this could be useful is that glucose tablets are so cheap compared to most medicines. Another is that for some medicines it would be useful to have an adjunct that could be added on if craving became a severe problem.

For now, the evidence may not be sufficient to start advising smokers routinely to use glucose tablets. However, it seems clear that going on a low calorie weight loss diet when trying to quit smoking is probably not the best combination.

Reference
West R et al (2010). A randomized trial of glucose tablets to aid smoking cessation. Psychopharmacology, 207, 631-637.

Avoid Relapsing Back To Smoking

2010-01-18T00:37:00.000-08:00

At this time of year, less than a month after many smokers initiated their “new year” quit attempt, there will be a significant number of recent ex-smokers who are trying hard not to relapse.

Back in April 19th, 2009 I wrote about some things you can do to avoid relapse.

http://www.healthline.com/blogs/smoking_cessation/2009/04/concerned-you-might-relapse-to-smoking.html

Since that time a few new studies on relapse have been published. One recent study examined the predictors of relapse in ex-smokers who had used varenicline (Chantix) successfully to be smoke-free after 12 weeks on the medicine. The study by Heffner and colleagues (University of Cincinatti) assessed the factors that predict relapse by 52 weeks among those who were abstinent at 12 weeks.

The main finding was that those who only achieved abstinence (by 12 weeks) relatively recently were 5 times more likely to relapse than those who remained completely abstinent from their quit date. This is not very surprising, but it underscores the importance of getting off to a good start when you quit smoking. That means getting rid of all your cigarettes and other tobacco at least the day before the Target Quit Date, and making sure you take your smoking cessation medications as prescribed. Of course in the study by Heffner and colleagues the ex-smokers ceased use of varenicline at week 12, so this study was primarily of smokers who had recently stopped using varenicline. There is growing evidence that using a smoking cessation medicine for longer than suggested by the labeling can help prevent relapse. Varenicline is the only smoking cessation medicine that actually states on the labeling that some may benefit from continuing the medicine for another 12 weeks (making a total of 24 weeks). But as discussed in previous articles, there is fairly consistent evidence supporting the longer term use of nicotine replacement therapies beyond the first few months.

The study by Heffner and colleagues also had an unexpected finding, namely that people who had achieved over 30 days of abstinence in the previous year were MORE likely to relapse in subsequent months. It is unclear why this might be the case, although it could simply be a sign that some smokers are better at achieving an initial quit, but poorer at maintaining it.

Another new study by Herd and colleagues (2009) found that people who believed that smoking provided certain psychological benefits were more likely to relapse back to smoking after an initially successful quit attempt. So it may be that the little devil on your shoulder saying things like “Just have one, it will make you feel less stressed,” really is a major part of the problem. It is therefore important to focus on the positive reasons for quitting, and not entertaining any thoughts of benefits of smoking.

So if you are currently an ex-smoker, well done. Don’t jeopardize all the effort it took to get this far, and keep your focus firmly on staying completely abstinent. An extra 10 healthy years of life is a pretty big benefit. Add on all the money saved, illnesses avoided, etc etc and its a no-brainer.

References

Heffner JL, Lee TC, Arteaga C, Anthenelli RM.
Predictors of post-treatment relapse to smoking in successful quitters: Pooled data from two phase III varenicline trials.
Drug Alcohol Depend. 2010 Jan 11. [Epub ahead of print]

Herd N, Borland R, Hyland A.
Predictors of smoking relapse by duration of abstinence: findings from the International Tobacco Control (ITC) Four Country Survey Addiction. 2009 Dec;104(12):2088-99.

Study finds smokers prefer Snus and Zonnic over Nicotine Gum

2010-01-16T23:51:00.000-08:00

A study was just published comparing the effects of nicotine gum, snus (smokeless tobacco sachets) and Zonnic (new synthetic nicotine replacement sachets) for reducing smoking. The study by Drs Caldwell, Burgess and Crane was conducted with 63 cigarette smokers at University of Otago in New Zealand.

During the study, participants were allowed to use each product for 2 weeks each to reduce their cigarette smoking. The researchers also measure nicotine withdrawal symptoms, cravings for a cigarette, and side effects.

The smokers reduced their smoking by 33% while using nicotine gum, by 37% while using snus and by 42% while using Zonnic sachets. The smokers also had fewer cravings for a cigarette and side-effects while using snus and Zonnic than while using nicotine gum. Overall they said they preferred using snus and Zonnic to using nicotine gum. The researchers concluded that more studies are needed of snus and Zonnic as replacements for cigarette smoking.

This study was interesting in that it took place in a country where neither snus nor Zonnic (both developed in Sweden) are available. Since the time the study took place, the Zonnic manufacturer (Niconovum) has been purchased by the large US tobacco company, Reynolds American. Although not a smoking cessation study, and clearly not definitive, it does provide some evidence that some smokers outside of Scandanavia may prefer these new alternative products as a way to stop smoking.

Zonnic is the brand name for Niconovum’s range of nicotine-delivery products including a sachet or pouch product (like a little white tea-bag) used in this study, an oral spray product, and a gum product. The Zonnic products are currently on the market only in Scandanavian countries. You can find out more about these products at:
http://www.niconovum.se/Products.aspx?id=5142993720952767944

Snus (moist snuff tobacco) is now more widely used by Swedish men than cigarettes, and has recently been launched in other countries, including the United States.

You can access my previous blogs about snus by typing it into the “Search Health Experts” box on the right.

Reference:
Caldwell B, Burgess C, Crane J. Randomized crossover trial of the acceptability of snus, nicotine gum, and Zonnic therapy for smoking reduction in heavy smokers. Nicotine & Tobacco Research..(available online Jan 11, 2010).

Philip Morris Ask for Tobacco Risk Comparison

2010-01-10T10:47:00.000-08:00

The Wall Street Journal reported Jan. 6 that Philip Morris and U.S. Smokeless Tobacco Co., both parts of the Altria Group Inc., wrote to the FDA suggesting that tobacco products be ranked on their harmfulness to health. This would most likely result in smokeless tobacco products being ranked as markedly less harmful than cigarettes. Philip Morris apparently claimed the plan would have "a significant public-health benefit." (assuming smokers took the rankings at face value and switched from more to less harmful products).

Now at face value, this sounds reasonably sensible. But when we consider that Philip Morris USA makes the vast majority of its profits from cigarette sales, and the plan would apparently reduce those sales as smokers switched to smokeless products, it is reasonable to wonder what they are playing at.

Firstly, we need to be realistic and accept that all private tobacco companies have a legal duty to maximize fields for shareholders. Public health is neither their business nor primary concern. So what are they up to? The first thing to note is that the recent FDA legislation outlines in some detail the procedures that have to be followed before a tobacco company is allowed to make a claim that one of its products is less harmful to health than an alternative tobacco product (i.e. make a comparative risk claim). The legislation appears to require a significant amount of evidence, not only regarding the relative risks to individual users, but also regarding the total population impact (including for example, estimates of whether the claim or product may result in more tobacco users and potentially greater total harm). Not everyone agrees that this is a fair or reasonable evidential barrier to require before being permitted to make a claim, but this is what the legislation requires. The recent request to FDA may be seen as an attempt either to circumvent some of these procedures, or at least to initiate the process.

The next question is why would tobacco companies want this, if their current profits come mainly from cigarettes (particularly Philip Morris who have the largest market share for cigarettes in the USA)?

Those who are skeptical about tobacco companies motives (and with very good reason) suspect that the companies do not really intend that smokers switch from extremely harmful cigarettes to much less harmful smokeless tobacco. Rather they may see smokeless as providing smokers with a bridge product to use in situations where smoking is not allowed. As smoke-free air legislation sweeps across the United States and the rest of the world, many smokers will find it is just too much hassle to be a smoker and will try to quit. But if these smokers can use smokeless tobacco when in a smoke-free environment, and then return to smoking when they are outside or at home, this could keep people smoking who would otherwise have quit.

The current marketing for smokeless tobacco products has an emphasis on the “for when you cant smoke” message. Skeptics see this as the gameplan. On the other hand, one can see that if you want to tempt smokers into trying a different product, that is the most obvious selling point to get them to try.

My view is that the smokeless tobacco products are clearly much less harmful than cigarettes to the individual user. Even within the category of “smokeless tobacco” the products contain and deliver markedly different amounts of toxins and nicotine. Products that deliver a moderate to high dose of nicotine, with a low dose of toxins (which do exist and are very popular in some countries) have great potential for replacing smoking. But this will only have a significant positive impact on health if the smoker switches completely to the smokeless tobacco product, and quits smoking completely. Of course in this discussion we should not forget that people use these products primarily for the effects of (addiction to) nicotine. A better way to quit smoking is to get some advice and support and use a product (or 2 or 3) that has been demonstrated to be safe and effective for smoking cessation.