The Dissolvable Deficit: FDA and CDC Must Fill Data Void

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) held a public hearing January 18-20 on dissolvable smokeless tobacco products. The information gleaned there will help inform a congressionally mandated report on the subject, due March 23.

The proceedings (agenda here) underscored the dearth of information on dissolvable tobacco use. Committee members repeatedly observed that there is no reliable data on who uses these products and in what context. Are dissolvables temporary or permanent substitutes for cigarettes? Do they promote tobacco initiation among teenagers?

These are legitimate questions for which we need definitive answers. One problem is that dissolvables from major manufacturers have only been in limited markets since 2009, when RJ Reynolds test-marketed Camel Orbs, Strips and Sticks in Indianapolis, Columbus and Portland, Oregon. Testing was discontinued early last year, but Reynolds later launched the products in Denver and Charlotte. In 2011, Altria introduced Skoal and Marlboro Sticks in Kansas. A smaller player, Star Tobacco, has sold Ariva dissolvable tobacco since 2001.

It is not surprising that we know next to nothing about dissolvable tobacco use; little is known about smokeless tobacco use generally, despite the fact that some 6 million U.S. adults consume these products. This information deficit can be blamed on the federal government, and specifically on the Centers for Disease Control and Prevention (CDC).

Each year, the CDC publishes detailed information on U.S. smoking prevalence, based on the annual National Health Interview Survey. What about smokeless tobacco? It turns out that the CDC has only produced detailed smokeless tobacco information twice in the last decade, in 2000 and in 2005, when the NHIS included a special supplement sponsored by the National Cancer Institute. There is a lot of information in these supplements, as I documented in 2009 publication (abstract here).

There has been growing discussion over the past decade about smokeless tobacco as a substitute for cigarettes. The U.S. House of Representatives in 2003 held a hearing titled “Can Tobacco Cure Smoking: A Review of Tobacco Harm Reduction” (my testimony here). It should have been a wakeup call for government officials to collect more information on smokeless tobacco use. Instead, there is evidence that NHIS staff decided to collect less.

In addition to smokeless tobacco information, the 2000 NHIS also collected information on the techniques used by smokers during their last attempt to quit. This data proved that tobacco harm reduction with smokeless tobacco was working. As I noted in a published study (abstract here):

“An estimated 359,000 men switched to smokeless tobacco in their most recent quit attempt. This method had the highest proportion of successes among those attempting it (73%), representing 261,000 successful quitters (switchers)… Switching to ST compares very favorably with pharmaceutical nicotine as a quit-smoking aid among American men, despite the fact that few smokers know that the switch provides almost all of the health benefits of complete tobacco abstinence. The results of this study show that tobacco harm reduction is a viable cessation option for American smokers.”

If the 2000 NHIS survey proved that tobacco harm reduction was viable, what did the 2005 NHIS survey show? Absolutely nothing. NHIS removed the switch-to-smokeless option from the 2005 survey, despite the huge explosion in awareness of and discussion about tobacco harm reduction.

Today, the TPSAC committee is preparing to make important decisions concerning tobacco harm reduction... lacking basic information about smokeless tobacco use and with no current data about transitions between cigarettes and smoke-free products.

This information deficit is unacceptable. The FDA Center for Tobacco Products, generously funded by fees from tobacco manufacturers, must act. At a minimum, it should fund annual use of the 2000 NHIS smokeless tobacco supplement – with appropriate revisions for e-cigarettes – in every annual survey, in order to collect unbiased information about use of smoke-free tobacco products.

British and Australian Smokers Attracted to Smoke-Free Substitutes

A study published in Harm Reduction Journal (here) concludes that there is “an untapped interest in the use of substitutes to reduce the harmfulness of smoking…The greater the range of products on offer, the more smokers are likely to try a product to quit.”

The study’s lead author is Ron Borland at Australia’s VicHealth Center for Tobacco Control. His coauthors are from the University of Nottingham in the UK, and Roswell Park Cancer Institute in Buffalo, New York.

Thirty-four smokers in the UK and 31 in Australia were recruited; each received a variety of smoke-free substitutes for “short term use (less than 1 week).” In the UK, 15 smokers preferred nicotine lozenges, 9 preferred Oliver Twist (here), one liked both products and 8 liked neither. Smokers in Australia were sent more products, and 17 tried all of them. Six favored Oliver Twist, 5 liked nicotine lozenges, 2 preferred Swedish snus (here) and one favored Stonewall/Ariva dissolvables (here); three smokers didn’t like any of the smoke-free alternatives.

Borland and colleagues reported that there was “considerable interest in using [pharmaceutical nicotine and smokeless tobacco] as a means of quitting smoking or as a long-term substitute for smoking.” They added that “the greater range of options provided, the more likely we are to find one that will be acceptable to any given smoker, thus increasing the potential pool of those who might be helped” and they advocated sampling to get “the participant to choose the product they wanted to use longer term” as a “sensible and viable approach for encouraging more than minimal use of substitute products.”

The authors reasonably write that smokers should try a variety of smoke-free substitutes, but they add an unrealistic caveat -- “we should not allow for-profit companies to directly market them to consumers, rather they should be available from a not-for-profit source.”

Borland and colleagues conclude that “…many smokers are interested in reducing the harmfulness of their smoking behaviour. Smokers deserve to know what the differential risks of potential alternatives are, and to be supported to make the choices that are in their long-term best interests, which is to quit nicotine altogether, but failing that use the least harmful form of nicotine they find acceptable.”

Many smokers are interested in harm reduction, but too many are dying every year – 15,000 in Australia, 80,000 in the UK and 400,000 in the US – because they don’t have truthful information about vastly safer cigarette alternatives.

Evidence That Dissolvable Tobacco Works for American Smokers

Researchers from the Department of Psychiatry at the Medical University of South Carolina have published a small, but persuasive, study documenting that dissolvable tobacco products “led to a significant reduction (40%) in cigarettes per day, no significant increases in total tobacco use, and significant increases in two measures of readiness to quit, either in the next month or within the next 6 months.”

The study was funded by the National Institute on Drug Abuse, a U.S. government agency, and it was published by Matthew Carpenter and Kevin Gray in the online edition of Nicotine and Tobacco Research.

Carpenter and Gray randomly assigned 31 smokers who were uninterested in quitting to receive Ariva or Stonewall, dissolvable smokeless products from Star Tobacco (that I have recommended to smokers for many years here and here), or to continue smoking cigarettes. Smokers were given “minimal instructions on how to use” these products and were “told that there is no safe tobacco product and that the best thing they can do for their health is to quit entirely.”

Carpenter and Gray wrote that their findings suggest “that Ariva and Stonewall are effective products to curb withdrawal and craving.” In other words, these products satisfy smokers.

Perhaps the researchers’ most important conclusion was that there is “no evidence that smokeless tobacco (Ariva or Stonewall) undermines quitting. To the contrary, readiness to quit (in the next 1 month and within the next 6 months) significantly increased among smokers who used a smokeless tobacco product relative to those who continued to smoke conventional cigarettes.”

This is important because tobacco prohibitionists have complained that telling smokers about vastly safer smokeless substitutes will “undermine quitting.” Never mind that this puts their dream for a tobacco-free society ahead of the health of people who smoke. The new research shows that tobacco harm reduction is completely consistent with both the health of smokers and broader public health goals.

Had Carpenter-Gray successfully completed a lung cancer vaccine trial, it would have made international headlines. Instead, their monumental study on smokeless tobacco, with major implications for immunizing smokers against lung cancer, has gone unnoticed. With the lives of millions of smokers at stake, their work deserves greater attention.