Chris.B. Pascal, JD
Office of Research Integrity
US Department of Health and Human Services
October 6, 2008
Many concerns about errors in the 2006 Surgeon General’s report, The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General have arisen. We know that Forces International and Opponents of Ohio Bans have filed formal complaints with the Office of Research Integrity (ORI). Moreover, many outstanding researchers, such as the Heartland Institute, have aired rather serious flaws in the report. According to § 93.402 ORI allegation assessments (part a) of the "Public Health Service Policies on Research Misconduct; Final Rule", Federal Register, Vol. 70, No. 94, P. 28392, concerning Rules and Regulations, the ORI “may conduct an initial assessment or refer the matter to the relevant institution for an assessment, inquiry, or other appropriate actions.”
As stated in § 93.402 ORI allegation assessments part (b), the ORI “considers whether the allegation of research misconduct appears to fall within the definition of research misconduct, appears to involve PHS supported biomedical or behavior research, research training or activities related to that research or research training, as provided in § 93.102, and whether it is sufficiently specific so that potential evidence may be identified and sufficiently substantive to warrant an inquiry.” In short, the ORI is responsible for investigating scientific misconduct in research, reports and studies funded by the Public Health Service (PHS). According to http://www.surgeongeneral.gov/ , "[t]he Office of the Surgeon General, under the direction of the Surgeon General, oversees the operations of the 6,000-member Commissioned Corps of the U.S. Public Health Service and provides support for the Surgeon General in the accomplishment of his other duties.” Therefore, given a considerable allegation, the ORI should investigate whether the 2006 Surgeon General’s report exhibits research misconduct as defined by the ORI. In particular, as per § 93.403 ORI review of research misconduct proceedings, “ORI may conduct reviews of research misconduct proceedings. In conducting its review, ORI may (a) Determine whether there is HHS jurisdiction under this part.” The launch of the 2006 Surgeon General’s report was given by “Vice Admiral Richard H. Carmona, M.D., M.P.H, FACS, United States Surgeon General, U.S. Department of Health and Human Services.“ The jurisdiction is clear and verified.
We refer to the ORI’s Rules and Regulations, specifically § 93.103 Research misconduct.
“[r]esearch misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” In this instance, we specifically refer to the case of fabrication in reporting research results. Part (a) of § 93.103 states, “[f]abrication is making up data or results and recording or reporting them.” Although we have found various instances of misreporting results within the 2006 Surgeon General’s report, we choose to recall only the most egregious instance.
The Press Release associated with the 2006 Surgeon General’s report states:
“The health effects of secondhand smoke exposure are more pervasive than we previously thought,” said Surgeon General Carmona, Vice Admiral of the U.S. Public Health Service. “The scientific evidence is now indisputable: secondhand smoke is not a mere annoyance. It is a serious health hazard that can lead to disease and premature death in children and nonsmoking adults.”
This is the report of the results of the 2006 Surgeon General’s report to the public, despite the fact that the 2006 Surgeon General’s report contains quite a bit of contradictory and/or inconclusive evidence. Several of his comments by the Vice Admiral of the U.S. Public Health Service appear to have made up the conclusions and results of his report when he reported those results to the public.
We also note that the press release beings with, “U.S. Surgeon General Richard H. Carmona today issued a comprehensive scientific report which concludes that there is no risk-free level of exposure to secondhand smoke.” Clearly, the conclusions of the 2006 Surgeon General’s report are a far cry from this dramatic statement, which means that the Surgeon General misreported the actual conclusions to the public.
We reiterate the words of Dr. Elizabeth Whelan:
The SG report is on target in that it systematically dismisses (or says there is insufficient evidence) for many of the oft-claimed hazards of ETS (although that part of the report received no media coverage): for example, there is, according to the SG, no established causal relationship between ETS and breast or cervical cancer, congenital malformations, behavioral development, or childhood cancers.
That brings us to the most important concepts of all: dose and length of exposure. Both the Surgeon General's and the CDC report completely omit any reference to these critical variables. The CDC motto here is "It hurts you; it doesn't take much; it doesn't take long," and they note that "even a little (ETS) can be dangerous." The SG goes even further, with this totally outrageous statement: "the scientific evidence indicates that there is no risk-free level of exposure to secondhand smoke." This leaves us with the clear impression that if we merely walk through a smoke-filled room, we have put our health in irreversible jeopardy.
These statements violate the basic tenet of toxicology: "only the dose makes the poison." What is most alarming here is that the top doctor in the land is communicating a message that anything that is harmful at high dose can be lethal at low dose -- when that is simply not true.
We also reiterate the words of Dr. Michael Seigel:
The rest of the story, then, is that the Surgeon General's misrepresentation of the scientific evidence regarding secondhand smoke in his own report has led to a gross distortion of the science to the public. This has occurred almost a year and a half following the release of the initial report. And it is likely to continue to occur.
From these two experts, one cannot help but surmise that whoever wrote the 2006 Surgeon General’s report is not the same person who wrote the press releases for the report. Whatever the case, Surgeon General Carmona fabricated the results and even violated the basic tenets of toxicology in reporting the results to the American public. We believe that the Office of the Surgeon General is the highest health authority and should be held in great esteem. For a Surgeon General to violate the trust of the American people is, therefore, a serious transgression.
For your convenience and easy reference, we provide a copy of this letter at [http://….] .The hyperlinks provide easy access to the discussed reports, quotes and judicial proceedings. We look forward to your reply.
ec: 110th United States Congress