Wednesday, January 25, 2012

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.

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