here). The ACS is also withholding important information that has profound implications for FDA regulation of smokeless tobacco.
I wrote to ACS president John Seffrin in September 2010, asking the organization “to fully and publicly disclose important information from its Cancer Prevention Study II (CPS-II) regarding the health risks associated with tobacco use. Notwithstanding the fact that this information has been in the possession of the ACS for years, it has not been made public. The tobacco regulatory and research community, as well as the American public, need access to this information in order to validate significant differences in the health risks associated with smokeless tobacco use compared with smoking in the U.S.”
I noted that the ACS has released highly selective bits of information about smoking and smokeless tobacco use:
“The ACS has provided the Centers for Disease Control and Prevention (CDC) with risk estimates for cigarette smokers, which are derived from a 6-year follow-up of CPS-II. For many years the CDC has used these risks to estimate that smoking kills 400,000 Americans every year. Although these estimates serve as the cornerstone for federal government actions regarding smoking, there is no way to validate them, because the ACS has never published the risks or released the CPS-II data on which they are based.
“In addition to smoker risk estimates, the ACS must release complete risk estimates for smokeless tobacco users and smokers who switched to smokeless tobacco. Previous ACS releases have been highly selective and incomplete, and none are directly comparable because the ACS used different follow-up intervals. As I noted, the ACS provided unpublished risk estimates derived from a 6-year follow-up of CPS-II for smokers. For smokeless tobacco users, ACS investigators have published risk estimates using an 18-year follow-up of CPS-II; for switchers, ACS and CDC investigators have together published risk estimates using a 20-year follow-up.”
I explained why this information was important for FDA regulation:
“There are compelling reasons why the ACS should release this information. Officials at the U.S. Food and Drug Administration (FDA), which now has regulatory authority over tobacco products, may not be aware that the health risks from smokeless tobacco use are vastly lower than those from smoking. Earlier this year, Lawrence Deyton, director of the FDA Center for Tobacco Products, Principal Deputy Commissioner Joshua Sharfstein and Commissioner Margaret Hamburg authored a commentary about tobacco regulation for the New England Journal of Medicine, in which smoking and tobacco use were used synonymously. These physicians wrote that ‘tobacco use causes more than 400,000 deaths in the United States annually…,’ and they described ‘tobacco products’ as ‘the leading cause of preventable death in the United States.’ If the ACS and the FDA are committed to reducing the morbidity and mortality from tobacco use, the first critical step must be to recognize that all forms of tobacco use are not equally risky. That critical issue was overlooked in the New England Journal of Medicine commentary.
“When FDA officials characterize all tobacco products as equally lethal, they are effectively denying smokers lifesaving information about safer cigarette substitutes. A 2004 study, in which ACS Vice President Emeritus Michael J. Thun participated, concluded that ‘…smokeless tobacco 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.’ ”
I strongly urged the ACS to end its misinformation campaign by releasing ALL of its risk data:
“The public health is not well served when information that can save lives is buried and/or ignored. The selective and incomplete provision of risk information by the ACS is contrary to its public health mission and will only serve to hamper the FDA from undertaking an independent assessment of this issue in pursuit of its overarching mission: reducing the harm associated with tobacco use.
“I urge the ACS to release comparable risk estimates for male smokers, smokeless tobacco users and switchers in CPS-II for all three follow-up periods, 6-years, 18-years and 20-years. In addition, the ACS should release the CPS-II data, so that the risk estimates for all tobacco users can be validated by external scientists. I would be happy to meet with ACS officials to discuss this request.
“Dr. Deyton has confirmed that the FDA’s ‘objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products.’ I strongly urge you to release these data and risk estimates, which constitute the best available science distinguishing the health risks related to smoking from those related to smokeless tobacco use. Because this matter has implications for future regulatory actions by the FDA, I have sent copies of this letter to relevant FDA officials.”
The ACS response was written by Chief Medical Officer Otis W. Brawley on December 1, 2010. He explained why the ACS would not share its data:
“[The ACS] have not found it productive to share the CPS-II data with researchers supported by the tobacco industry, because of their repeated misuse and misrepresentation of the data.”
I have conducted research on tobacco harm reduction for almost 20 years; published numerous studies in professional journals; written dozens of articles in the general media; and given hundreds of lectures. No one has ever accused me of misusing or misrepresenting any data.
The ACS continues to misinform Americans, and especially American smokers, about the vast difference in health risks related to smoking versus smokeless tobacco use. This is vitally important because the CPS-II survey is the only source for comparable information about the health risks from smoking and smokeless tobacco use.
FDA regulation of tobacco should not compromised by the withholding or selective release of critical data by the American Cancer Society.