Thursday, March 29, 2012

Indiana General Assembly Urges Study of Tobacco Harm Reduction

A year ago, Indiana became the second state in the U.S. to codify tobacco harm reduction as a rational basis for excise tax policy (discussed here). This year, the Indiana legislature passed resolutions urging the Legislative Council (comprised of eight representatives and eight senators) “to establish an interim study committee for the purpose of assisting the legislature in considering the inclusion of tobacco harm reduction strategies to reduce smoking-attributable death and disease.”

The resolutions note that “Numerous public health organizations, such as the Institute of Medicine, the American Council on Science and Health, the Royal College of Physicians, and the World Health Organization, have all recognized that there is a continuum of risk among tobacco product types, and that the risks associated with cigarette use are substantially higher than those associated with the use of smokeless tobacco.” And, they add, “abstaining from all tobacco is clearly the best and most effective way for smokers to reduce their risk of disease and premature death (no tobacco product has shown to be safe)…”

The rationale for the resolutions is rock solid: “…it is appropriate to consider whether those who will not abstain can substantially reduce their risk of disease and premature death by switching from cigarettes to smokeless tobacco products that present less risk.”

These resolutions indicate growing awareness among legislators about the public health impact of tobacco harm reduction.

If the interim study committee is approved by the Legislative Council, discussion of tobacco harm reduction will take an important and exciting first step in Indiana.

Tuesday, March 20, 2012

The Surgeon General on Teen Tobacco Use: Is She “Shocked,” or Shocking?

Surgeon General Regina M. Benjamin on March 8 released a report on teen tobacco use with the comment, “The numbers are really shocking.” What is truly shocking is that Dr. Benjamin apparently released the report only to a select group of media outlets that published unchallenging stories, precluding any immediate intelligent analysis of this important public health screed.

Stories published shortly after 12 am that day in the Washington Post (here) and USAToday (here) read like tobacco prohibition press releases. Wendy Koch distilled the theme in her USAToday lead: “Many of America's teens smoke cigarettes as well as use smokeless tobacco, and the tobacco industry's marketing fuels their addiction.”

The Surgeon General incorrectly stated in the report’s preface that “today nearly one in four high school seniors … smoke.” That was true eight years ago. According to the authoritative Monitoring the Future Survey, last year only 19% of high school seniors had smoked in the past 30 days, and only 10% smoked daily (here). These are the lowest numbers in the survey’s 36-year history. Before Dr. Benjamin uses the Surgeon General’s bully pulpit, she should get her facts right.

On tobacco industry marketing, the Surgeon General’s allegations strained scientific credibility.

Tobacco manufacturers have been prohibited from targeting children since the 1998 Master Settlement Agreement with 46 states (here). They cannot “take any action, directly or indirectly, to target Youth within any Settling State in the advertising, promotion or marketing of Tobacco Products, or take any action the primary purpose of which is to initiate, maintain or increase the incidence of Youth smoking within any Settling State.” If Dr. Benjamin can make a case against the industry, she should contact state attorneys general, who have expedited processes for policing and enforcing MSA provisions regarding children.

The FDA has said there is virtually no evidence that tobacco manufacturers are marketing to children through retailers. The agency’s extensive multi-state monitoring program shows that 96% of retailers are compliant (discussed in my blog here). Retailers in several states, including Alabama, Idaho, Kansas, Maryland and Maine, have compliance rates of at least 99%.

If the Surgeon General holds the tobacco industry responsible for the 19% of high school seniors who smoke, then what industry does she blame for the 23% of high school seniors who use marijuana (evidence here)? Does she blame the alcohol industry for the 40% of seniors who use alcohol, or for the 25% of high school seniors who had been drunk in the past 30 days (evidence here)?

According to Dr. Benjamin, “Cigarette smoking by youth and young adults is proven to cause serious and potentially deadly health effects immediately…” This appears to be a new line of attack aimed at teens: If you smoke, you are now at risk for disease and death. Dr. Benjamin should reconsider the veracity of this statement. While teen smoking is unacceptable and troubling, it is not a death sentence.

To put the numbers in context: Every year, there are 33,000 deaths among U.S. teenagers and young adults (age 15-24 years); 25,000 of those are due to “external causes,” including 11,000 road accidents, 5,300 homicides and 4,100 suicides. Illnesses of all kinds account for 8,000 deaths.

The Surgeon General has an obligation to focus on the real and tragic causes of death among our youth. She would be wise to adhere to the facts.

Tuesday, March 13, 2012

Could Obama Administration Ban Tobacco?

The Orange County Register on March 12 published my commentary on the theme of tobacco prohibition in federal agencies. The column appears below (OC Register link here).

Could Obama Administration Ban Tobacco? Prohibition seems to have support within the Department of Health and Human Services

By Brad Rodu

“Ending the Tobacco Epidemic: A Federal Plan” is the startling title of a speech scheduled for March 14 by Dr. Howard Koh, Assistant Secretary for Health in the U.S. Department of Health and Human Services (HHS). He will be keynoting the annual meeting of the Society for Research on Nicotine and Tobacco in Houston. Will the Obama Administration actually pursue tobacco prohibition?

The “tobacco epidemic” theme is not new. In November 2009, Health Secretary Kathleen Sebelius named Koh chair of an HHS working group tasked to develop a strategic action plan. Their report (here), published a year later, was titled “Ending the Tobacco Epidemic.”

The working group’s vision, “a society free of tobacco-related death and disease,” morphs into an argument for prohibition. For example, the group quoted a 2007 study by the Institute of Medicine (here) which discussed “the ultimate goal of ending the tobacco problem in the United States.” They also cited a chapter in the 2007-2008 President’s Cancer Panel report (here) titled “The Scourge of Tobacco in America Must End.” The chapter’s topline message is clearly abolitionist: “Ridding the nation of tobacco is the single most important action needed to dramatically reduce cancer mortality and morbidity. There is no substitute for this action if we are to eliminate the sickness and death caused by tobacco use.”

Tobacco prohibition is a shared theme throughout HHS. The National Cancer Institute’s Tobacco Control Research Branch envisions “a world free of tobacco use and related cancer and suffering” (here), while CDC’s Office on Smoking and Health yearns for “a world free from tobacco-related death and disease.” (here)

In a relentless and unscientific bid to “end” the “tobacco epidemic,” federal government officials are deliberately misapplying causation from smoking, a legitimate risk factor for many diseases, to tobacco in general. This prohibition crusade ignores the enormous life-saving potential of tobacco harm reduction, the substitution of smoke-free tobacco products for cigarettes.

Tobacco prohibitionists treat all tobacco products as equally dangerous; this is factually incorrect and dangerously unethical. Smoke-free products, including smokeless tobacco and e-cigarettes, are vastly safer than cigarettes. Britain's prestigious Royal College of Physicians reported that “consumption of non-combustible tobacco is on the order of 10-1,000 times less hazardous than smoking.” The College concluded that “smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.” (here)

A study funded by the National Cancer Institute addressed the ethical considerations: “[smokeless] products pose a substantially lower risk to the user than do conventional cigarettes. This finding raises ethical questions concerning whether it is inappropriate and misleading for government officials or public health experts to characterize smokeless tobacco products as comparably dangerous with cigarette smoking.” (abstract here)

Congress has already endorsed the legality of tobacco and has given the FDA regulatory authority over the manufacture, marketing and distribution of tobacco products. It is unacceptable, at this stage, for HHS, “the principal agency for protecting the health of all Americans,” to spend taxpayer funds in pursuit of tobacco prohibition. Rather, the agency should embrace the compelling scientific foundation for tobacco harm reduction and educate the nation’s 45 million smokers about its significant health advantages.

Monday, March 5, 2012

FDA Study: Menthol Smokers Have Lower Lung Cancer Risk

FDA Center for Tobacco Products scientist Brian Rostron has published a study finding “evidence of lower lung cancer mortality risk among menthol smokers compared with nonmenthol smokers at ages 50 and over in the U.S. population.” His research is available online in the journal Nicotine & Tobacco Research (abstract here).

Dr. Rostron first examined the Cancer Control Supplement of the 1987 National Health Interview Survey. Of 6,073 current smokers, 1,417 reported that they smoked menthol cigarettes and 3,690 were nonmenthol smokers (the menthol preference for the other 966 smokers was undetermined). Using a computerized mortality file developed specifically for these survey participants, Dr. Rostron then determined how many smokers died from lung cancer over the next 20 years, through 2006. Comparisons were made using hazard ratios (HRs), which can be interpreted similarly to relative risks.

Compared with nonmenthol smokers, menthol smokers age 50+ years had a significantly lower risk of dying from lung cancer (HR = 0.59, 95% Confidence Interval, CI = 0.37 – 0.95). The lower risk for menthol smokers was also seen at all ages (HR = 0.69), in both men and women (HR = 0.71 and 0.70 respectively), and especially in blacks (HR = 0.41). This indicates that the results were consistent across many smaller subgroups of smokers, although the HRs were not significant because of the smaller numbers.

Dr. Rostron’s results were in agreement with two previous epidemiologic studies. The first, published last year by Vanderbilt University’s William Blot and colleagues (abstract here), found that the incidence of lung cancer among menthol smokers was 65% of that among nonmenthol smokers (CI = 0.47 – 0.90).

The second study, published in 2003 by Steven Stellman at the American Health Foundation along with investigators at several other research institutions, also found that menthol smokers had lower lung cancer risk than nonmenthol smokers (abstract here). Dr. Stellman’s conclusion that “Smokers of menthol flavored cigarettes were at no greater risk for lung cancer than were smokers of unflavored brands” was a gross understatement. His data show that white men and white and black women who smoked menthols all had lower lung cancer risks than nonmenthol smokers. While the lower risks were not statistically significant for any subgroup, the odds ratio for all menthol smokers was 0.68, which is perfectly consistent with Dr. Rostron’s findings. It was highly unconventional for Dr. Stellman not to report that result.

It is interesting to consider these findings when reading last year’s FDA Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol (available here). It appears that TPSAC deliberately downplayed the Blot lung cancer findings, while discussing other findings in detail. The Stellman study was not even mentioned.

In his new article, Dr. Rostron writes, “The reasons for [lower lung cancer risks among menthol smokers] are not clear at the present time.” There is little evidence that menthol smokers have higher quit rates than nonmenthol smokers. Dr. Rostron suggests that the mortality differences “may be due in part to differences in inhalation caused by product design and not necessarily to menthol itself.”

Does this mean that menthol cigarettes carry reduced risk? Dr. Rostron notes, “Smoking of any kind of cigarette is known to profoundly harm individual and population health…”, but he suggests that further research on menthol cigarettes “could potentially identify ways to decrease the individual risk of cigarettes.”

The importance of this newest research should not be underestimated. Last year, FDA Commissioner Margaret Hamburg emphasized that “Science underlies everything we do at this agency…” (here). Dr. Rostron and the Center for Tobacco Products should be commended for producing this analysis. One hopes it will be used appropriately by the FDA in development of science-based tobacco regulation.