Thursday, September 8, 2016

American Cancer Society & CDC Withheld Evidence on Safer Smokeless Products

The Centers for Disease Control (CDC) and the American Cancer Society (ACS) have a long history of suppressing information about the relative risks of smokeless tobacco (ST) products. (CDC example here)

CDC and ACS researchers in 2007 jointly published a mortality study of smokers who had switched to ST (here).  Using data from the ACS 2nd Cancer Prevention Survey (CPS-II), they reported that smokers who switched to ST had slightly higher risks than smokers who became abstinent.  However, the authors omitted a critically important comparison group: smokers who continued smoking. 

The ACS and the CDC had always avoided direct comparison of smokers with ST users because they knew that ST users incurred vastly lower risks.  This time, their omission was glaring.   

In February 2007, I filed a federal Freedom of Information Act request for access to the ACS dataset.  The CDC denied my request seven months later, claiming that the CDC authors had not had access to the data.

A month later, in October 2007, I filed an appeal with the HHS Deputy Assistant Secretary for Public Affairs, raising two issues:

  • CDC co-authors would not willingly violate the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, a mandate that authorship be based on substantial contribution to the conception and design, acquisition of data, or analysis and interpretation of data.  My position was that CDC authors were effectively co-owners of the data.

  • There was incontrovertible evidence that the CDC possessed or had access to the CPS-II Dataset.  I noted, “The CDC maintains the SAMMEC website, which ‘calculates annual smoking-attributable deaths, years of potential life lost, smoking-attributable expenditures, and productivity losses for adults in the United States, individual states, and user-defined populations.’  The methodology section of SAMMEC states that it ‘uses unpublished age-adjusted RR estimates for persons aged 35 years and older from the second wave of the American Cancer Society's Cancer Prevention Study (CPS-II), 6-year follow-up.’”

More than two years later, in June 2010, HHS denied my appeal, asserting, “These primary data are in the possession of the ACS. CDC did not have any role in collecting or defining these data and never had possession of it. ACS never sent CDC its CPS-II primary data and it never allowed CDC to access the data or to submit computer programs to access the data. The ACS never showed any intent to relinquish control over the data.”

For 30 years, the CDC has been the source for smoking-related U.S. and global mortality estimates (discussed here).  Critical measures used to generate these numbers are the relative risk estimates from CPS-II, which are apparently the private property of the ACS and which have never been validated by external experts, even those at the CDC. 

I wrote ACS CEO John Seffrin in 2010: “I urge the ACS to release comparable risk estimates for male smokers, smokeless tobacco users and switchers in CPS-II…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 pointed out, “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 (here). 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.’”

I explained, “When FDA officials characterize all tobacco products as equally lethal, they are effectively denying smokers lifesaving information about safer cigarette substitutes…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.”

ACS Chief Medical Officer Otis Brawley denied my information request, writing, “We 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.”  Both letters were copied to Deyton, Sharfstein and Hamburg.

I described the ACS correspondence in my blog (here), where I noted, “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.”

This is how the CDC and ACS have for years ignored and buried evidence documenting that smokeless tobacco use is vastly safer than smoking.

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