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 The methodology section of SAMMEC states that it ‘uses unpublished age-adjusted RR estimates for persons aged 35 years and older from the second wave of the American Cancer Society's Cancer Prevention Study (CPS-II), 6-year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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