Wednesday, July 27, 2011

Snus Use and Gum Disease: No Association

Swedish investigators have just published a study in the Journal of Clinical Periodontology documenting “no significant association between gingivitis, [periodontal pockets] and periodontal disease experience and snus use.” (abstract here). The authors are Anders Hugoson from Jönköping University and Margot Rolandsson from Karlstad University.

The study was based on 1,500 residents of Jönköping who took part in detailed dental health exams in 1983, 1993 and 2003. Hugoson and Rolandsson supervised teams of dentists who collected information on the number of teeth, plaque index, presence of inflammation of the gingiva (gum tissue), periodontal pocket depth, gum recession, calculus, and x-ray examination. The findings were used to classify participants according to the presence and severity of gum, or periodontal, disease. The results were adjusted for factors that might influence the development of periodontal disease, such as age, gender, and socioeconomic class (education, employment and marital status).

In comparison to nonusers of tobacco, smokers were more likely to have severe periodontal disease (odds ratios, OR = 3.0 – 6.5, which were statistically significant). The authors note, “Numerous epidemiological studies have demonstrated that of all the risks identified, cigarette smoking may be the most strongly associated with periodontitis.”

Severe periodontal disease among snus users was about as common as among nonusers of tobacco (OR = 0.8, not statistically significant). This is in essential agreement with a comprehensive review published by Kallischnigg and colleagues in BMC Oral Health in 2008 (available here). Furthermore, it suggests that the federally mandated smokeless tobacco warning, “This product can cause gum disease and tooth loss,” is not relevant to snus, if it is scientifically credible at all.

Hugoson and Rolandsson provide information on tobacco use for each year of the study. Following is the breakdown for men:


Proportion of Men in Jönköping Who Are Snus Users, Smokers and Nonusers
Year Snus Users (%) Smokers (%) Nonusers (%)
198392962
1993131770
2003171469

The prevalence of snus use among men doubled from 9% in 1983 to 17% in 2003, while the prevalence of smoking was cut in half, from 29% to 14%.

This study provides more evidence that use of snus by Swedish men has resulted in real benefits to their general and oral health.

Wednesday, July 20, 2011

Switchers: Profiles of Pioneers

The scientific rationale for switching from cigarettes to smokeless tobacco was indisputable in 1994 when I published my first two articles on tobacco harm reduction (here and here). But had anyone ever made the switch from combustible to smoke-free tobacco?

The answer, according to a 1993 report from the federal Centers for Disease Control and Prevention (available here), was a resounding YES. The report estimated that there were 5.3 million smokeless users in the U.S., and that one-third of them, or 1.7 million, were former smokers.

My research group established contact with a small number of switchers, and in 1995 we published a manuscript about them (citation here). Their average age was 50, but some were as young as 27, and some as old as 77. They were blue and white collar, women and men. Their cigarette smoking experience varied considerably, with an average smoking history of 48 pack-years. (A pack-year is a measure of exposure to cigarettes obtained by multiplying the number of packs smoked daily by the number of years smoked). Some had recognized early on that cigarette smoking was a future health threat -- they had only 3 pack-years; others made the switch with an astounding 156 pack-years behind them.

In my book, For Smokers Only (link), I shared the stories of switchers we had met. The following is an excerpt.

The people depicted below are real pioneers. They are former smokers who, for various and sometimes very personal reasons, decided on their own, without any medical assistance or support, that smokeless tobacco was a safer alternative to cigarette smoking. These profiles in courage can serve as models for those of you who may be impressed by the facts, the stats and the logic in this book, but who need a personal touch to bring the book's message to heart.

Each one of the former smokers below has shared his or her medical and personal story with researchers in my program.

Clint

Clint is a 55 year old manager of maintenance operations for a national transportation firm. He started smoking when he was 17 years old and consistently smoked a pack of cigarettes a day for the next 34 years. Clint had occasionally tried to quit. In 1985 he successfully quit smoking for an extended period of time, but soon found himself again smoking up to two packs per day.

In August 1988 Clint started experiencing pain in his lower chest and stomach area. When it did not go away, he decided to drive to the hospital for evaluation. To calm his nerves on the way, he had what turned out to be his last cigarette. Clint was suffering a heart attack.

During his hospitalization the doctors were blunt. Smoking was a big factor in the attack. To continue to smoke was to run the risk of another attack -- one that might not be as mild. For Clint this was enough of an incentive to quit for good. However, the need to smoke persisted. He seemed to be longing for nicotine every minute of every hour of every day. Finally, after a year and a half of continuous craving, he started using smokeless tobacco.

Clint's story is not uncommon from several standpoints. First, a health problem resulting from smoking made a sudden appearance. Second, he continued to experience craving long after he quit, long after the physical effects of nicotine were out of his system. This is not unusual. Many smokers enrolled in our program have quit in the past for as many as several years, but the need for nicotine did not subside. Smokeless tobacco had completely satisfied that craving.

Carl

Carl is a retired machinist who remembers smoking when he was 10 years old. For forty years he averaged two packs a day. He smoked unfiltered Camel cigarettes for 30 years, but switched to a filtered brand when he started to experience breathing problems. When his breathing started to get considerably worse, Carl consulted a doctor. The diagnosis: emphysema. The solution: stop smoking. The outcome if he didn't: a maddeningly slow death by suffocation. Carl made the decision to quit. He tried prescription nicotine gum, but it was of no help. He knew he had to try something else soon or he would break down and resume smoking. He tried smokeless tobacco.

That was twelve years ago. His lung deterioration was slowed, and, most importantly, he is convinced that without smokeless tobacco he would still be smoking, or be six feet under.

Marian

Marian is a 77 year old who smoked a pack of cigarettes every three or four days for decades. When she was 72 she developed a cough that scared her. Looking for a way to continue enjoying tobacco without harming her grandchildren (even by bad example), she hit upon the idea of trying discreet little packets of moist snuff. For the past five years Marian has been successfully substituting smokeless tobacco for cigarettes.

Wendell

Wendell is a 50 year old farm manager. He had smoked non-filtered cigarettes for 14 years when, at the young age of 35, he started experiencing severe shortness of breath, a bad cough, and numerous sinus infections. Wendell thought he could beat these problems by switching to a pipe. However, he fell into a common trap for cigarette smokers who switch to cigars or a pipe. Because a cigarette smoker gets used to the nicotine jolt obtained through inhaling the smoke, the tendency is to continue inhaling when smoking a cigar or pipe. NO SMOKE IS HEALTHY, and cigar and pipe smoke can be very irritating when inhaled.

After six years of pipe smoking, Wendell decided he'd better quit altogether. After just one week of climbing the walls, he went back to the tobacco aisle and tried smokeless tobacco. Today, 15 years later, Wendell remains smoke-free and cough-free.

Rick

Rick is 52 years old and works as a technician for a major electronics manufacturer. He started smoking when he was 20, and for the next 29 years he consistently consumed between two and four packs daily. Rick had several close calls with another "occupational risk" of the habit. He had dozed off several times with a cigarette in his hand, coming very close to starting a major house fire. (Each year in the United States, smoking is the cause of fires that kill one thousand, three hundred people.)

Rick tried to quit tobacco altogether when he quit smoking. But he frequently craved the nicotine he was missing, even though he got over the queasy disorientation of the physical withdrawal symptoms within the first week.

After three months of constant craving, he started using smokeless tobacco. For the past three years he has been sleeping better, knowing that he won't wake up with a problem in his lungs or a burning cigarette in his hand.

Dan

Dan is a 38 year old non-commissioned officer in the army. He started smoking when he was 16 years old. After smoking 2 packs per day for 12 years, Dan started developing shortness of breath. He saw the handwriting on the wall and made an overnight switch to smokeless tobacco.

Like many successful participants in my quit-smoking program, Dan did not experience a moment of physical or psychological withdrawal after giving up his cigarette habit. He had not read about the relative safety of smokeless tobacco, but he intuitively knew that it had to be healthier than pouring fumes into his body.

John

John is a 66 year old who owns a small business. He had been smoking 3 packs of cigarettes per day for 52 years. Four years ago doctors told him that he had hardening of the arteries, a blood vessel condition that is complicated by smoking. He switched to smokeless tobacco as soon as he realized, to his surprise, that dipping snuff gave him the same satisfaction he got from cigarettes.

Dr. Lee R.

Dr. Lee R. is a health professional in rural Alabama. He started when he was 20 years old, smoking one and a half packs per day for 26 years. Like many other smokers, his entire breathing apparatus started to rebel. Dr. R. started wheezing, especially at night. In addition, he had shortness of breath, a persistent cough, and irritated sinuses and eyes. Dr. R.'s medical training had not been forgotten; these were ominous signs of more serious problems ahead if he didn't quit. He quit for 3 months, suffering continuous craving like so many other former smokers. Then he discovered smokeless tobacco, and for the last ten years he has been looking and feeling better.

Dr. R. tried to convince smoking friends and relatives to make the switch. He worked on his brother for years, but was not able to convince him to make the transition. His brother has since died from lung cancer.

If you’re a switcher, share your story. It might inspire other smokers who are struggling to manage one of the most powerful of human addictions. Submit a comment to this post, or send me an email -- brad.rodu at louisville.edu

Tuesday, July 12, 2011

Anti-Harm Reduction Tactics By The American Dental Association

On June 24 the American Dental Association (ADA) continued its long assault on tobacco harm reduction in a news article on FDA cigarette warning labels (here). The dental group repeated its 2009 statement about smokeless tobacco substitution: “As a matter of public health, we have become increasingly alarmed by recent attempts to market smokeless tobacco as a healthier (or less harmful) alternative to cigarettes. Smokeless tobacco is not a healthy alternative to cigarette smoking; both products pose health risks.”

Under the guise of “public health,” the ADA continues to deny smokers information that smokeless tobacco is a satisfying and vastly safer substitute.

The ADA has a long history of undermining this lifesaving strategy. In 1994 I published the first two articles in the medical and scientific literature proposing that smokers switch to smokeless tobacco (here and here). At the time I was chairman of the oral pathology department at the University of Alabama at Birmingham School of Dentistry, and I was a member of the ADA. Nevertheless, the organization aggressively worked to destroy my reputation and my career.

On August 17, 1994 the president of the ADA wrote to the dean that my proposal was “naïve at best and irresponsible at worst,…a disservice to the faculty and the public at large. He called the “notion that smokeless tobacco is a safe alternative to smoking tobacco” a “deception,” and he urged the dean to “repudiate the advice being promulgated by Dr. Rodu in the strongest possible manner.”

The ADA letter was a thinly veiled request to silence me. I do not know if the dean responded, but I know that the ADA expanded its destructive campaign by trying to convince the local dental society to condemn me. However, in November 1994 Dr. Alvin Stevens, the local society’s president, published a letter supporting me in the nationally distributed ADA News. Dr. Stevens wrote that “Dr. Rodu’s message is simple and is backed up by published medical and dental data…statistically, the morbidity of smokeless tobacco use is dramatically and significantly less than the use of cigarettes…Dr. Rodu’s proposal is a viable and realistic option.”

Dr. Stevens concluded that “we think that it is a disservice to call a fellow dentist ‘irresponsible’ without acknowledging, recognizing or listening to his total message…”

The ADA encouraged my professional organization, the American Academy of Oral and Maxillofacial Pathology, to condemn me and my proposal. The president replied that “…it is not the role of the AAOMP to make public statements in support of or disagreement with any individual research that has been appropriately reviewed…”

The ADA also collaborated with the American Association of Oral and Maxillofacial Surgeons, which contacted all of their members, suggesting that they send a form letter under their signature to the local newspaper. The letter contained the false punchline: “Suggesting this switch is like telling someone to use a rifle instead of an Uzi.” In retrospect, we know now that the analogy would have been more accurate if the substitute was a water gun.

In the seventeen years since 1994, approximately 6.8 million Americans have died from diseases attributable to smoking. Yet, there is no evidence that officials at the ADA, or at other national health organizations, have even considered the hundreds of scientific and medical studies documenting the benefits of tobacco harm reduction.

One of the most frequently asked questions about tobacco harm reduction is: “Why don’t all health professionals recommend that smokers switch to smoke-free alternatives?” In addition to the widespread misperception about risks (documented here), health professionals are reluctant to draw the wrath of powerful national organizations that believe that the destruction of the tobacco industry is more important than the health of America’s smokers.

Tuesday, July 5, 2011

Taking Chances on Chantix

The smoking cessation drug Chantix (generic name varenicline) has been associated with several potentially serious side effects. In 2009, the FDA issued a “boxed warning” for the product, based on this rationale: “Some people who have taken Chantix or Zyban to help them quit smoking have reported experiencing unusual behavior changes, have become depressed or have had their depression worsen, or have had thoughts about suicide or dying; some have attempted suicide either while using one of these drugs or after they stopped taking them.” (FDA advisory here).

Now a bigger warning flag has been raised. On July 4 a meta-analysis, published in the Canadian Medical Association Journal (available here), concluded that Chantix was associated with “an increased risk of serious adverse cardiovascular events,” based on an odds ratio of 1.72 (95% Confidence Interval = 1.09 – 2.71).

The FDA may have been aware of the new analysis; on June 16, 2011, the agency issued a drug safety announcement under this headline: “Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease.” (read it here ). It is a fascinating document.

First, what is a “certain cardiovascular adverse event”? The answer is important: a nonfatal heart attack (myocardial infarction). It is strange that the FDA titled the announcement so vaguely, when the report was primarily about the risk of heart attacks. The first time myocardial infarction is mentioned is halfway through the notice.

The announcement’s “Data Summary” section contains information upon which the FDA based its decision. The agency reviewed a clinical trial involving over 700 patients, about half of which (n = 355) received Chantix for 12 weeks, while the other half (n = 359) received a placebo. All had been previously diagnosed with stable cardiovascular disease (other than high blood pressure). Both groups “received smoking cessation counseling throughout the study,” so it appears that they got the best treatment available. The follow-up was complete at one year.

Of patients getting the placebo, only three, or 0.86%, suffered heart attacks. Seven, or about 2%, of the patients in the Chantix group had heart attacks. The numbers are small, so this result is not statistically significant. But the relative risk of heart attack in the Chantix group is 2.3, which was undoubtedly worrisome to FDA officials.

So what were the quitting rates? In the placebo group, only 7% were continuously abstinent at one year. That’s 26 out of the 359 who enrolled. This means that an astounding 93%, or 333 smokers, did not respond to “smoking cessation counseling.” In other words, the claim that safer tobacco substitutes are not needed because smoking cessation counseling works is utter nonsense.

In the Chantix group, the abstinence rate at one year was 19%. That represents 68 of the 353 smokers who started the study. Although the FDA says that this is “significantly higher” than the placebo group, 285 participants were still smoking. Tobacco harm reduction could help them, too.

Strangely, it appears that the FDA was trying to downplay the announcement; they did not identify the research source. In fact, the study was published in 2010 in Circulation (abstract here ), by first author Nancy Rigotti (Harvard) and, among others, co-author Neal Benowitz, who is a member of the FDA Tobacco Products Scientific Advisory Committee. The study was conducted in 15 countries. Pfizer, manufacturer of Chantix, sponsored the research and paid consultation fees to Rigotti and Benowitz.

Another oddity: the authors of the study were not concerned about the adverse cardiovascular events related to Chantix. Although they acknowledged that “trial size and duration preclude a definitive conclusion about [safety],” they asserted that “this study provides reassurance to physicians that varenicline appears to be safe to use in smokers with stable cardiovascular disease.” Given its June 16 warning, the FDA clearly disagrees with Rigotti and colleagues about the potential risks of Chantix.

In a previous post I discussed the American Heart Association’s rejection of smokeless tobacco as a substitute for cigarettes (here), based on almost no significant research findings; that position was also co-authored by Neal Benowitz. It is evident that some health professionals who reject tobacco harm reduction are willing to tolerate serious adverse events associated with the medicines they prescribe. If they accept relative risk for prescription drugs, why reject relative risk for tobacco products?