Sunday, September 21, 2014

Rest of the Story Announces Fund-Raising Campaign for Research on Effectiveness of Electronic Cigarettes

As we've discussed here for the past several months, there’s a great debate about electronic cigarettes right now, involving consumers, public health officials, scientists, and doctors. The basic question is this—Do e-cigarettes help people fight their addiction to cigarettes, or do they actually make it more difficult for smokers to cut back or quit?

For the past 25 years, I have conducted nearly 100 published studies about smoking, and as both a researcher and a physician, I have struggled to find effective ways to help smokers fight this powerful addiction. Along comes a product that—for the first time—might be able to help smokers overcome their biological addiction to nicotine, but also address their psychological addiction to the act of smoking.

How has the public health community reacted to e-cigarettes? As you would expect, opinions differ. Some public health officials have gone so far as to call for a complete ban on these products, but other experts believe that e-cigarettes should be embraced as a method to help smokers cut back or quit. Unfortunately, as it stands now, we don’t have the data we need to determine the changes in smoking behavior that result from the use of electronic cigarettes.

The FDA has proposed “deeming regulations” which would require virtually every electronic cigarette on the market to file an application demonstrating that product’s benefit to the public health. To be clear, with these regulations in place, every one of these applications will require data that demonstrates the effects of e-cigarettes on smoking behavior. Many independent e-cigarette companies cannot afford to conduct this research on their own—but we are confident that, if the e-cigarette community will join forces, we can raise enough money to conduct a rigorous study that will provide the data that the FDA needs

That's why today, I am announcing the start of a fund-raising campaign to help us conduct what we hope will be the most rigorous research conducted to date on the effect of e-cigarettes on smoking behavior. The research is called BSCiTS (The Behavioral Study of Cigarette and Tobacco Substitution).

In BSCiTS, we hope to conduct a six-month, randomized study that looks at changes in smoking behavior over time when smokers who wish to quit or cut down are offered a free, ten-week supply of either nicotine patches or electronic cigarettes.

While two trials have been conducted in other countries, none have yet been reported in the U.S. However, we believe that the FDA will require research from the U.S. in the new product applications.

Three things make this study different from prior research conducted in other countries. First, we will be working with smokers who actually want to cut back or quit. Second, we will be testing the most up-to-date e-cigarette products on the market. Third, our study - if funded a the desired level - will involve the largest sample of smokers to date, making it the most rigorous and scientifically important study yet conducted.

There are two important disclaimers. First, our research team reserves the right to alter the scope of the proposed research project to keep it in line with the funds raised. This might mean reducing how many smokers can be enrolled in the study, or how long we can follow them over time. Alternatively, if the funds we raise are insufficient, we might choose to conduct a survey study to answer these questions. Whatever the case, the purpose of our research will remain the same: to examine changes in smoking behavior associated with the use of electronic cigarettes, in comparison to the nicotine patch.

Second, we are unable to accept donations from tobacco companies or electronic cigarettes companies that are owned or affiliated with tobacco companies.

We need your help to accomplish this. By donating to this study, you will have a direct impact on one of the most critical public health questions of our time.  Let’s put an end to the debate about e-cigarettes and find out, once and for all, exactly how they impact the behavior of smokers.

To donate to this research, please see our BSCiTS web site

All donations are considered gifts to Boston University and are tax-deductible.

No comments: