The Centers for Disease Control and Prevention report that 440,000 Americans
die from smoking-related illnesses every year. However, even this enormous
number does not adequately describe the extraordinary burden that cigarette
smoking imposes on American society. Our research provides additional
perspective: If smoking-related lung cancer did not occur, cancer mortality
rates in the United States would have declined continuously since 1950 (Figure
1)(1). Thus, for the past 50 years the American cancer "epidemic" has
primarily consisted of one disease, cancer of the lung, and has been due to one
dominant lifestyle factor, cigarette smoking. It is compelling evidence that the
anti-smoking campaign in the United States, now nearly 40 years old and of
ever-increasing intensity, has failed to help adult smokers to quit.
Conventional approaches to cessation have failed because they offer smokers only
behavioral therapy. An excellent example is a 1993 NCI smoking cessation manual,
How to Help Your Patients Stop Smoking, which advises physicians to recommend
coping tips such as "Keep your hands busy -- doodle, knit, type a
letter;" "Cut a drinking straw into cigarette-sized pieces and inhale
air;" "Keep a daydream ready to go."(2) Such advice has little
effect on adult smokers because they need nicotine. Conventional programs also
fail because they offer adult smokers only temporary nicotine replacement. But
these products are expensive and provide low doses of nicotine at doses too low
to prevent craving and withdrawal. A recent review of over-the-counter nicotine
medications revealed that their success rate is 7% (3). The authors
characterized this result as "efficacious" and "modest." We
characterize programs with 7% "success" rates as abject failures.
All these programs are failures because they require smokers to quit nicotine
completely. This is incorrect, as well as ineffective. Over the past decade we
published epidemiologic and clinical studies that provide the scientific
foundation for a new smoking cessation strategy. It involves permanent nicotine
maintenance using products other than cigarettes (4,5,6,7,8). Our strategy is
based on the fact that nicotine, while addictive, is about as safe as caffeine,
another widely consumed addictive drug. It is tobacco smoke, with its thousands
of toxic agents, that leads to cancer, heart disease and emphysema. Eliminate
the smoke, and you eliminate virtually all of the risk.
We recommend many types of nicotine delivery systems, including smokeless
tobacco (SLT) products. These products are well suited to replace cigarettes
because they have four key characteristics: 1) They provide nicotine levels
similar to those from smoking; 2) They are vastly safer than smoking; 3) They
are socially acceptable and are cost-comparable to cigarettes; and 4) there is
evidence that they help smokers quit. No other products have this combination of
features to help smokers quit now.
Nicotine Delivery: SLT rapidly delivers a dose of nicotine comparable to that
from smoking (Figure 2). Thus, smokeless tobacco satisfies smokers, a necessary
criterium for any agent intended as a permanent substitute. In comparison,
nicotine medications provide only about one-third to one-half the peak nicotine
levels of tobacco products, which is unsatisfying for many smokers.
Safety: SLT use has been the subject of intensive research for over 50 years.
The only consequential adverse health effect from long-term SLT use is oral
cancer. However, more than twenty epidemiologic studies over the past 50 years
have established that this risk is very low (9). Our research documents that SLT
use imposes only about 2% of the mortality risk of smoking (4,7). We found that
the average reduction in life expectancy from SLT use is only 15 days (5). In
contrast, the average smoker loses almost 8 years. For further context, the risk
of death from long-term use of smokeless tobacco (12 deaths in every 100,000
users per year) is about the same as that from automobile use (15 deaths in
every 100,000 users per year) (10).
Social Acceptability: Opponents of our strategy often argue that smokers will
never use disgusting "spit" tobacco. That term is insensitive and
inappropriate when used by health professionals. First, it is demeaning and
degrading both to current SLT users and to smokers who may wish to try this
strategy. Second, and more importantly, the term is incorrect, because new SLT
products can be used invisibly and are more discreet than chewing gum.
Evidence that SLT products work: In 1998 we published the first trial assessing
SLT substitution as a quit-smoking method (11). After one year 25% of inveterate
smokers, most of whom had failed repeatedly to quit even with prescription
nicotine gum or patches, had successfully substituted SLT for cigarettes. We
have followed this group for seven years, and our results suggest that SLT
substitution is sustainable (manuscript submitted).
Data from Sweden support the role of SLT in harm reduction at the population
level. For 50 years men in Sweden consistently have had the lowest smoking rate
and the highest SLT usage rate in Europe. The result: Rates of lung cancer - the
sentinel disease of smoking - among Swedish men have been the lowest in Europe
for 50 years. World Health organization statistics reveal that Swedish men have
the lowest rates of lung cancer among 20 European countries (Figure 3). Not so
for Swedish women, whose lung cancer rate ranks fifth highest in Europe (Figure
4). One of us (BR) is very familiar with tobacco use patterns in Sweden. He
lived there for six months last year conducting research on this subject,
resulting in two published studies with Swedish colleagues that demonstrate that
SLT was primarily responsible for a decline in smoking among men from 19% in
1986 to 11% in 1999 (12,13)(Figure 5). This figure reveals the lower rate of
smoking among men than among women for the entire period of study. We emphasize
that this is the reverse of the pattern seen in virtually every other society in
the world, where men invariably have higher smoking rates than those of women.
Our strategy has evoked criticisms that are inaccurate, irrelevant or both. The
usual complaint is that providing risk information about SLT to adults will
prompt children to use these products. We painstakingly point out that our
strategy is tailored to adult smokers. This is not a children's issue.
Eliminating children's access to tobacco is important, but the 10 million
Americans who will die from smoking over the next two decades are now adults.
Withholding life-saving information from these adults, in the name of children,
is shortsighted, even immoral.
An extension of the children's theme is that SLT could serve as a gateway to
smoking. This notion never had a sound basis, and current research shows it to
be wrong. Furthermore, and most unfortunately, for twenty years the dominant
public health message has been that SLT use and smoking are equally risky. In
fact, this erroneous message is reinforced by the mandated warning on packages
of SLT ("This product is not a safe alternative to cigarettes").
Regrettably, surveys show that 80% of smokers believe that smokeless tobacco is
as dangerous as smoking, and continue to smoke. This message may also cause some
SLT users to switch to cigarettes, an unfortunate and lethal behavior.
Finally, for ten years we have been portrayed as lone advocates of a flawed
public health strategy. But now good company has joined us. Last year Britain's
Royal College of Physicians, one of the world's most prestigious medical
societies, issued a report on tobacco regulation in the United Kingdom called
"Protecting Smokers, Saving Lives"(14). This report marked the first
time a major health organization acknowledged that products like smokeless
tobacco are safer than cigarettes. The report stated "As a way of using
nicotine, the consumption of non-combustible [smokeless] tobacco is on the order
of 10-1,000 times less hazardous than smoking, depending on the product."
The report continued with an even bolder statement, acknowledging that some
smokeless tobacco manufacturers may want to market their products "as a
'harm reduction' option for nicotine users, and they may find support for that
in the public health community."
A growing number of public health experts now agree with our harm reduction
strategy, because the antiquated quit-or-die strategy is increasingly recognized
as a failure. Cigarette smoke is the problem for 48 million adult smokers. To
answer the question posed by this hearing, smokeless tobacco can be part of the
solution.
#
References
1. Rodu B, Cole P. The fifty-year decline of cancer in America. Journal of
Clinical Oncology, Volume 19: pp 239-241, 2001. UAB-TRF
2. Glynn TJ, Manley MW. How to help your patients stop smoking: a National
Cancer Institute manual for physicians. NIH Publication No. 93-3064. Bethesda,
MD; 1993.
3. Hughes JR, Shiffman S, Callas P, Zhang J. A meta-analysis of the efficacy of
over-the-counter nicotine replacement. Tobacco Control, Volume 12, pp 21-27,
2003.
4. Rodu B. An alternative approach to smoking control. The American Journal of
the Medical Sciences, Volume 308, pp 32-34, 1994.
5. Rodu B, Cole P. Tobacco-related mortality. Nature, Volume 370, p 184, 1994.
6. Rodu B, Cole P. The rewards of smoking cessation. Epidemiology, Volume 7, pp
111-112, 1996.
7. Rodu B, Cole P. Nicotine maintenance for inveterate smokers. Technology,
Volume 6, pp 17-21, 1999.
8. Rodu B. For Smokers Only: How Smokeless Tobacco Can Save Your Life. Sumner
Books, Los Angeles, ISBN 0-9666239-0-8.
9. Rodu B, Cole P. Smokeless tobacco use and cancer of the upper respiratory
tract. Oral Surgery, Volume 93, pp 511-515, 2002. UAB-TRF.
10. National Highway Traffic Safety Administration. Traffic Safety Facts 2001.
Available at: http://www-nrd.nhtsa.dot.gov/pdf/nrd-30/NCSA/TSFAnn/TSF2001.pdf
11. Tilashalski K, Rodu B, Cole P. A pilot study of smokeless tobacco in smoking
cessation. The American Journal of Medicine, Volume 104, pp 456-458, 1998.
12. Rodu B, Stegmayr B, Nasic S, Asplund K. Impact of smokeless tobacco use on
smoking in northern Sweden. Journal of Internal Medicine, Volume 252, pp
398-404, 2002. UAB-TRF
13. Rodu B, Stegmayr B, Nasic S, Cole P, Asplund K. Evolving patterns of tobacco
use in northern Sweden. Journal of Internal Medicine, Volume 253, pp 660-665,
2003. UAB-TRF
14. Royal College of Physicians. Protecting Smokers, Saving Lives. Available at:
http://www.rcplondon.ac.uk/pubs/books/protsmokers/index.asp
15. Sullum J. For Your Own Good: The Anti-Smoking Crusade and the Tyranny of
Public Health, pp 67-70, The Free Press, New York, 1998.
Financial Support
During the period 1993-1999 all of the developmental work for this
harm-reduction strategy was completed with limited financial support from
general university accounts and no external support. During that time Drs. Rodu
and Cole established the scientific foundation of the strategy with publications
in professional medical journals and in the general-interest press. Dr. Rodu's
book, For Smokers Only: How Smokeless Tobacco Can Save Your Life, was published
in 1995.
The publication of the first two articles in medical journals was followed by
strong negative reaction from organizations that traditionally provide funding
for tobacco related research. For example, in 1994 Dr. Rodu and colleagues sent
a letter of inquiry to the National Cancer Institute with regard to obtaining
support for tobacco harm reduction research ( Reference 15, above). The letter
was never answered, but Dr. Rodu and the University of Alabama at Birmingham (UAB)
were accused of possible ethical, legal and medical malpractice violations by
the acting director of the NCI. This resulted in a year-long investigation of
research by Rodu and others at UAB by the NIH Office for Protection from
Research Risks. This investigation concluded that the research was on a solid
ethical and legal foundation, but the broad message was clear: The NIH and other
organizations would not fund research in the area of tobacco harm reduction.
In 1999 the University of Alabama at Birmingham received a five-year $1.25
million unrestricted research grant from the United States Smokeless Tobacco
Company (USST) of Greenwich, Connecticut. The award supports the UAB Tobacco
Research Fund (UAB-TRF), and the principal investigator is Brad Rodu.
The agreement between the USST and UAB broke new ground with regard to
industry-sponsored university research. The award is completely unrestricted;
the agreement specified that UAB has no obligation to USST regarding
consequential work products. USST has no scientific input or other influence
regarding the nature of the research projects or activities and does not have
access to research reports prior to their publication. In fact, this agreement
exceeds UAB's guidelines with regard to financial support from external sources,
and it imposes no restrictions on academic freedom in the undertaking and
communication of the research. A scientific advisory board oversees the program.
The board consists of a former UAB associate dean, and a cancer center director
and an epidemiologist from other universities.
Research publications cited in this document that were supported by the Tobacco
Research Fund are clearly marked by the notation (UAB-TRF).




