Wednesday, September 29, 2010

Does Dual Use Jeopardize Smokeless Tobacco’s Role in Harm Reduction? Absolutely Not

One year ago, I briefly discussed the “dual use” of cigarettes and smokeless tobacco by men in the U.S. (post here). Dual use is the object of persistent complaints by American tobacco control extremists. For example, in 2002, Dr. Jack Henningfield, currently a member of the FDA tobacco products scientific advisory committee, was first author of a commentary describing theoretical adverse consequences of dual use (citation here). Despite his concerns, Henningfield acknowledged that “There are virtually no data that currently exist on the safety of such use or the degree to which such use will foster the perpetuation of smoking or contribute to reduced overall smoking…The issue warrants further study.”

That study has now been done, and the results have been published online in Nicotine & Tobacco Research (abstract available here). In a review of 17 published research studies that had data on the health risks from dual use versus those from smoking, almost all of which have appeared since 2002, Kimberly Frost-Pineda and colleagues conclude that “…there are not any unique health risks associated with dual use of smokeless tobacco products and cigarettes, which are not anticipated or observed from cigarette smoking alone.” The authors further commented that “some data indicate that the risks of dual use are lower than those of exclusive smoking.”

Frost-Pineda and colleagues also found evidence from both American and Swedish longitudinal studies that dual users were more likely than exclusive smokers to quit smoking, but less likely to become completely tobacco-abstinent. For example, one American study (abstract here) found that 11% of dual users were tobacco-abstinent after 4 years of follow-up, compared with 16% of exclusive smokers. However, 80% of exclusive smokers were still smoking at the 4-year follow-up, while only 27% of dual users were smoking; 44% were still dual users and 17% were exclusive smokeless users. The differences between smokers and dual users in Swedish follow-up studies are even more impressive.

This excellent review will present major problems for Henningfield and other FDA panelists, including Greg Connolly, Dorothy Hatsukami, Jonathan Samet and Neal Benowitz, because they have established solid records opposing tobacco harm reduction. Samet, the panel’s chair, summed up this opposition in a 2009 article in the Journal of the American Medical Association (citation here ): “Snus, a moist snuff that is low in tobacco-specific nitrosamines, has received particular attention because it has been widely used in Sweden, apparently with little increase in risks for cancer and cardiovascular disease. However, there is concern that strategies to introduce lower-risk products will diminish efforts to promote prevention and cessation.”

For over 40 years, “prevention and cessation” efforts have largely failed. But tobacco prohibitionists continue to focus on those objectives, while raising a host of largely theoretical concerns about the substitution of smokeless tobacco for cigarettes. Now, scientific research shows that the “problem” of dual use is not a problem at all.

A final note: The authors of the dual use study are employees of Altria Client Services, which is owned by the parent company of Philip Morris and U.S. Smokeless Tobacco. They should be complimented for this contribution to the scientific literature on tobacco harm reduction. The editors of Nicotine and Tobacco Research deserve kudos for reviewing and publishing this manuscript.

Wednesday, September 22, 2010

Tobacco Harm Reduction: Not During Pregnancy (Revisited)

In May, I discussed a 2003 Swedish study reporting that pregnant women who use snus are at risk for slightly smaller babies, and have modestly elevated risks for premature delivery and preeclampsia (read the post here). Two new studies from Sweden also document that snus use has risks for the developing baby and should be avoided.

Both studies are based on over 600,000 pregnancies documented in the Swedish Medical Birth Register from 1999 to 2006, and both are authored by Anna-Karin Wikström and colleagues from the Karolinska Institute.

The first study, published in the British Journal of Obstetrics and Gynaecology (sic) (abstract here), examined the effect of tobacco use on the risk for very premature (less than 32 weeks) or moderately premature (32-26 weeks) births. It showed that snus users had a modestly elevated risk for a very premature birth (adjusted odds ratio, aOR = 1.38, 95% confidence interval = 1.04 – 1.83). The risk among light smokers (1-9 cigarettes per day) was 1.60 (CI = 1.42 – 1.81), and the risk among heavy smokers (10+ cigarettes) was 1.90 (CI = 1.61 – 2.25). The study also showed that snus users had an elevated risk for a moderately premature birth of 1.25 (CI = 1.12 – 1.40), which was intermediate between light smokers (aOR = 1.18, CI = 1.12 – 1.24) and heavy smokers (aOR = 1.45, CI = 1.35 – 1.56).

The second study, published in Epidemiology (abstract here ), examined the effect of tobacco use on the risk for stillbirth, which is the death of a baby during pregnancy. It showed that women who were snus users had a modestly elevated risk (aOR = 1.57, CI = 1.03 – 2.41), which was again intermediate between light smokers (aOR = 1.15, CI = 0.91 – 1.45) and heavy smokers (aOR = 1.85, CI = 1.39 – 2.46).

The study I discussed in May found that snus use was associated with preeclamsia, but Wikström and colleagues did not report a statistically significant elevated risk. In addition, they reported that snus users did not have elevated risks for bleeding or for infants who were small for their gestational age, both of which are seen in light and heavy smokers.

In general snus use is vastly safer than smoking, but pregnant women should refrain from using all tobacco products.

Wednesday, September 15, 2010

The American Heart Association Has No Compassion for Smokers

On September 13, the American Heart Association released a policy statement opposing the use of smokeless tobacco (ST) to quit smoking. The statement (available here), based on a selective review of the literature, warns that ST might have risks for cardiovascular disease.

The Heart Association’s rejection of tobacco harm reduction is contradicted by the evidence presented in its review.

Here are the diseases that were reviewed, and the authors’ assessment of the risks among ST users:

Hypertension (high blood pressure): “In summary, data from the majority of studies in this section do not support an increase in the incidence or prevalence of hypertension in ST product users.”

Myocardial Infarction (heart attack): “In summary, data derived from the majority of studies conducted in Sweden, whereby snuff/snus is the major ST product used, have not demonstrated a significant increase risk of nonfatal or fatal MI…Data derived from predominately US populations are equivocal…More research is needed in the United States with currently marketed ST products to assess the potential relationship between ST product use and MI risk in the US population.”

Stroke: “In summary, data from 2 studies (1 from the United States and 1 from Sweden) suggest that ST product use is associated with a slight increase in the risk of stroke mortality…More research is needed in the United States regarding currently marketed ST products to assess the potential relationship between ST use and stroke risk in the US population.”

Other Cardiovascular Risk Factors: “Although the data are limited, most studies have found no relationship between ST use and other biochemical risk factors for [cardiovascular diseases].”

Diabetes and Metabolic Syndrome (a complex disorder involving increases in blood sugar, blood lipids, blood pressure and weight): “Based on data from two of the above studies conducted solely in Swedish populations, heavy use of moist snuff appears to increase the odds of developing [metabolic syndrome] and type 2 diabetes.” This interpretation should be placed in perspective. One Swedish study (abstract here) found that heavy users of snus (5+ cans per week) had modestly elevated risks for metabolic syndrome (odds ratio = 1.5 – 2.0), but moderate users (4 cans or fewer) had no risk. With respect to type 2 diabetes, one Swedish study (here) found an increased risk in users of 3+ cans per week (OR = 2.7, CI = 1.3 – 5.5), while two other studies (here and here) found no risk in snus users; the second study was not included in the Heart Association review. In summary, if the risks are real, they are modest and only present in heavier users.

So, after a comprehensive review, the authors concluded that there were no markedly increased risks for any cardiovascular disease. Yet, on the basis of very limited evidence, “the American Heart Association does not recommend the use of ST as an alternative to cigarette smoking or as a smoking cessation product.”

Each year 118,000 Americans die from cardiovascular diseases attributed to smoking. Why is the Heart Association denying these smokers a vastly safer alternative?

The authors were unable to find any substantially elevated risks related to ST use, yet the Heart Association press release and other materials are decidedly prohibitionist. Here is a media sound bite by first author Mariann Piano: “[Health professionals] need to respond by continuing to emphasize that none of their patients should be using any kind of tobacco product. So that does include all forms and types of ST products. And so they need to absolutely emphasize that their patients should never begin smoking and that smoking cessation, for those who do use cigarettes, or cessation of ST products. We again don’t advocate the use of any tobacco products.”

Piano’s prohibitionist rhetoric is surprising, because in 2001 she was on a Heart Association panel that delivered a balanced message on the impact of alcohol on heart diseases (available here). That report concluded:

“Moderate intake of alcoholic beverages (1 to 2 drinks per day) is associated with a reduced risk of [coronary heart disease] in populations…Although moderate use of wine and other alcohol-containing beverages does not appear to lead to significant morbidity, alcohol ingestion, unlike other dietary modifications, poses a number of health hazards…The American Heart Association maintains its recommendation that alcohol use should be an item of discussion between physician and patient.”

The Heart Association could have issued a similar policy with respect to ST as a substitute for cigarettes, but tobacco prohibition prevailed. The list of authors includes several prohibitionists, most prominently Neal Benowitz, who I discussed previously (here). He has established a clear position against tobacco harm reduction, which is especially disturbing since he is on the FDA’s tobacco products scientific advisory committee.

The Heart Association has rejected ST; what does it recommend for smokers? Its quit smoking website (here) offers smokers these tips, among many others:

• Lie back in a comfortable chair and relax for 10 to 15 minutes. Use a relaxation tape. If you don't have time for a full session, breathe in deeply and slowly while you count to five. Then breathe out slowly for 5 counts.
• Take a short walk.
• Start a hobby that calms you, such as making models, sewing or doing jigsaw puzzles.
• Warn your family and friends that you may be in a bad mood for a few weeks.
• Do something to improve your self-image. For example, shop for clothes to go along with the "new" you, or get a new haircut.

The American Heart Association has rejected tobacco harm reduction for the thinnest of reasons. Yet it wants smokers to manage one of the most powerful of human addictions with a jigsaw puzzle, a relaxation tape or a new haircut. The Heart Association should be expected to take a more positive and compassionate role in preventing the 118,000 cardiovascular disease deaths that result each year from smoking.

Wednesday, September 8, 2010

Is “Never Recommend A Carcinogen” An Appropriate Policy? Apparently Only For Tobacco

The Wall Street Journal’s “Numbers Guy” Carl Bialik blogged in April on the scientific debate about promoting smokeless tobacco as a substitute for cigarettes (read it here). Bialik’s well-balanced article included expert comments on the science of tobacco harm reduction, in addition to quotes from the usual array of individuals and organizations opposed to offering smokers safer options.

On re-reading Bialik’s article, I was struck by one passage in particular:

“‘We wouldn’t recommend anybody using a product that causes cancer,’ said Cathy Backinger, chief of the tobacco control research branch at the National Cancer Institute.”

At first glance, the comment sounds perfectly reasonable. Surely no one at the NCI would recommend that ANYBODY use a product that causes cancer. Well, it turns out that this is completely false. In fact, the NCI recommends routinely that women take a medication that is known to cause two forms of cancer.

The medication is tamoxifen, which, according to an NCI website (available here), “interferes with the activity of estrogen, a female hormone that can promote the development of cancer in the breast.” The NCI states that “Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for the prevention of breast cancer and for the treatment of breast cancer, as well as other types of cancer.”

In other words, the NCI endorses the use of tamoxifen by women who don’t have breast cancer but who are at risk of developing it.

But there’s a problem. The NCI acknowledges that “Tamoxifen increases the risk of two types of cancer that can develop in the uterus: endometrial cancer, which arises in the lining of the uterus, and uterine sarcoma, which arises in the muscular wall of the uterus.” The NCI says tamoxifen doubles the risk for endometrial cancer; the magnitude of the sarcoma risk is not specified. The NCI also cautions that “women who took tamoxifen had an increased chance of developing blood clots and an increased chance of stroke.”

The NCI justifies the use of tamoxifen with a straightforward rationale: “The benefits of tamoxifen as a treatment for breast cancer are firmly established and far outweigh the potential risks. Patients who are concerned about the risks and benefits of tamoxifen or any other medications are encouraged to discuss these concerns with their doctor.”

There are legitimate reasons to recommend tamoxifen for women who are at risk for developing breast cancer. Similarly, there is a rock-solid scientific and medical foundation for recommending smokeless tobacco – with cancer risks that are barely measureable by modern epidemiologic methods – to smokers who otherwise face far higher risks of developing a plethora of medical illnesses.

If the Backinger principle was adopted by physicians, they would withhold tamoxifen from women at risk for breast cancer on the grounds that it may cause cancer of the uterus. That application would violate principles of public health and condemn thousands of women to a life with – and perhaps death from – breast cancer. Dr. Backinger’s refusal to consider tobacco harm reduction similarly violates public health principles and condemns millions of inveterate smokers to a disease and death.

Public health policies should be consistent in using scientific evidence of relative risk to promote legitimate life-saving strategies.

Wednesday, September 1, 2010

Outstanding News Report On Smokeless Products

KMSP Fox 9 in Minneapolis-St. Paul recently aired an excellent news report on new smokeless tobacco products, including dissolvable Camel Orbs, Sticks and Strips and Camel snus (Click on the image above to see the video).

The station focused on a new Minnesota law that puts all tobacco products behind the counter and out of the reach of children. Kelly Valen, a 43-year-old smoker who blames her addiction on easy cigarette availability, is excited about the law but sadly oblivious to what the rest of the story delivers: information about vastly safer smokeless alternatives.

Discussing types of “tobacco you may not even heard of yet,” the station turned to Mike Sheldon of Clearway Minnesota as an authority on “more innovative and new tobacco products.” He presents an informative display of orbs, sticks, strips and snus, saying “they’re smokeless and spitless, and that’s trying to take away the social stigma of smokeless tobacco products of the past” -- an accurate description of the advantages of these new cigarette substitutes.

KMSP says that while these products aren’t for sale yet in Minnesota, the dissolvables are available in test market cities Indianapolis, Portland, Oregon and Cincinnati. (Actually, they’re available in Columbus, not Cincinnati.) Camel snus is sold nationwide.

It is important for smokers to learn about safer, satisfying, spitless smokeless products, but FDA regulations severely restrict what manufacturers can tell smokers about these innovative new products. Clearway Minnesota and KMSP have contributed to public health with this informative new feature.