Citizens Freedom Alliance, Inc. Complaints Against Carmonas 2006 Report

Citizens Freedom Alliance, Inc.
	On October 8, 2008, the Citizens Freedom Alliance joined with Opponents of Ohio Bans, the Hawaii Smokers Alliance, and Ban the Ban Wisconsin in filing four separate and distinct complaints with the Federal Office of Research Integrity, Health and Human Services (ORI) against Ex-Surgeon General Carmona's 2006 Report. Each complaint is unique and separate, detailing four different charges of misconduct, misrepresentation, data manipulation and omission, and general statistical sloppiness. The four complaints are not related in any direct way to an earlier complaint filed by FORCES, but will serve to remind the ORI that all such complaints must be dealt with seriously and expeditiously under the law, and will reinforce the fact that the overall Report has serious deficiencies that need to be properly addressed and rectified. Below is the text of the joint Press Release that was published on October 8th, as well as the text of the CFA's complaint itself. Citizens Freedom Alliance, Inc. Chris B. Pascal, JD Director Office of Research Integrity US Department of Health and Human Services 1101 Wootton Parkway, #750 Rockville, MD 20852 215.453.8200 http://ori.dhhs.gov/ 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[1] have arisen. We know that Forces International , Opponents of Ohio Bans and the Hawaii Smokers Alliance have filed formal complaints with the Office of Research Integrity (ORI). Moreover, many outstanding researchers, such as those who work with the Heartland Institute[2], have publicly pointed out 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[3], 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.” Funding Jurisdiction 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/ , "The 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[4] 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. Changing and Omitting Data In a meta-analysis, each study essentially represents a point of data. Some studies carry more weight due to sample size and/or methodology. In the Surgeon General’s words on page 21 of his report (page 40 of the PDF file), “[m]eta-analysis refers to the process of evaluating and combining a body of research literature that addresses a common question.” So, in his own words, his meta-analysis is an analysis of the results of studies in the relevant field. The Enstrom/Kabat study, which was a thirty-eight-year research project funded by and analyzing data from the American Cancer Society and published in the well-respected British Journal of Medicine, was such a data point and should have been both included and given relatively substantial weight. However, a simple search on “Enstrom” in the entire 727 pages of the 2006 Surgeon General’s report yields only one instance, namely that on page 691, “Enstrom JE, Kabat GC. Environmental tobacco smoke and tobacco related mortality in a prospective study of Californians, 1960–98. British Medical Journal, 2003;326(7398):1057.” The citation is a reference for Chapter 7, “Cancer Among Adults from Exposure to Secondhand Smoke”. As reported by the Heartland Institute[5]: Carmona mentions the Enstrom study just once, in an appendix listing studies too recent to include in the report. But Enstrom's study was published four years ago, and Carmona cites more recent studies. In fact, Carmona's principal "findings" were taken from a 2005 report--not a scientific study, merely another report--from California's Clean Air Resources Board, mostly citing the very studies the federal judge rejected in 1993. Another study (Maria Blettner, Hajo Zeeb, Ingo Langner, Gaël P. Hammer and Thomas Schafft, “Mortality from Cancer and Other Causes among Airline Cabin Attendants in Germany, 1960-1997," American Journal of Epidemiology, Vol. 156, No. 6, p. 564) states: We found a rather remarkably low SMR [Standardized Mortality Ratio] for lung cancer among female cabin attendants and no increase for male cabin attendants, indicating that smoking and exposure to passive smoking may not play an important role in mortality in this group. Smoking during airplane flights was permitted in Germany until the mid-1990s, and smoking is still not banned on all charter flights. This study came from the Department of Epidemiology and Medical Statistics, School of Public Health-WHO Collaborating Center, University, Bielefeld, 33501 Bielefeld, Germany and can be found at http://www.wispofsmoke.net/PDFs/WHO_2.pdf also found at http://www.data-yard.net/39/cabin.pdf and an abstract found at http://aje.oxfordjournals.org/cgi/content/abstract/156/6/556 ). This study included 16,014 women and 4,537 men employed in 1953 or later with a mortality follow-up completed through December 31, 1997. In addition, the effect of duration of employment was evaluated with Poisson regression. Therefore, this is a long-term, large study of various diseases on people exposed to SHS/ETS. Yet, this study was not mentioned once in the 2006 Surgeon General’s meta-analysis. We also note that the Wu-Williams study (Wu-Williams AH, Dai XD, Blot W, Xu ZY, Sun XW, Xiao HP, Stone BJ, Yu SF, Feng YP, Ershow AG, et al. Lung cancer among women in north-east China. British Journal of Cancer 1990;62(6):982–7.), which is another large study yielding a significant negative result, was dismissed as “anomalous” on page 514 of the PDF file of the 2006 Surgeon General’s report. The exact words of the Surgeon General are, “[t]his observation should be considered anomalous as this result differs from the collective evidence of studies conducted in other Chinese populations as well as from the overall evidence.” Yet, this is followed by studies in the Chinese population with variable results—and many of the results are below unity. We note that the Boffetta study (Boffetta P, Agudo A, Ahrens W, Benhamou E, Benhamou S, Darby SC, Ferro G, Fortes C, Gonzalez CA, Jöckel K-H, et al. Multicenter case-control study of exposure to environmental tobacco smoke and lung cancer in Europe. Journal of the National Cancer Institute 1998;90(19):1440–50.), which is also one of the larger studies, yielded only one statistically significant result and the result was a negative correlation, again agreeing with the other larger studies. We recall the lack of damaging results—and one statistically significant negative correlation—in the Enstrom Kabat study and the Blettner study. Therefore, the Surgeon General’s dismissal of the Wu-Williams study was incorrect and amounts to omitting data in a meta-analysis. One study that was discussed at-length in the 2006 Surgeon General’s report was the 1992 U.S. Environmental Protection Agency (EPA) report, Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders. Although the Surgeon General acknowledged the court ruling to vacate the 1992 EPA meta-analysis and the subsequent ruling to overturn the first ruling, he did not mention the gross criticisms made by the federal judge. To quote the Surgeon General’s report from page 21 (page 40 of the PDF file): In a lawsuit brought by the tobacco industry against the EPA, the 1998 decision handed down by Judge William L. Osteen, Sr., in the North Carolina Federal District Court criticized the approach EPA had used to select studies for its meta-analysis and criticized the use of 90 percent rather than 95 percent confidence intervals for the summary estimates (Flue-Cured Tobacco Cooperative Stabilization Corp. v. United States Environmental Protection Agency, 857 F. Supp. 1137 [M.D.N.C. 1993]). In December 2002, the 4th U.S. Circuit Court of Appeals threw out the lawsuit on the basis that tobacco companies cannot sue the EPA over its secondhand smoke report because the report was not a final agency action and therefore not subject to court review (Flue-Cured Tobacco Cooperative Stabilization Corp. v. The United States Environmental Protection Agency, No. 98-2407 [4th Cir., December 11, 2002], cited in 17.7 TPLR 2.472 [2003]). However, as the Heartland Institute[6] observed in Osteen’s ruling, “[t]he judge said EPA cherry-picked studies to support its position, misrepresented the most important findings, and failed to honor scientific standards.” The actual ruling by Judge Osteen actually entailed numerous serious criticisms, as preserved by Forces International[7] (note that, as per a previous decision[8] from Osteen, he was not what one might call a "tobacco shill." Not at all.) His decision was overturned on the grounds that the EPA is not a "reviewable action agency," (see “FLUE-CURED TOBACCO COOPERATIVE v. EPA”[9]). In other words, other agencies can use the report to justify antismoker laws because the EPA doesn't use the report to enact laws. Yet, the Surgeon General extensively used the circumspect conclusions of this report and devoted an entire chapter to recommending policy actions in “Chapter 10: Control of Secondhand Smoke Exposure.” In fact, in his press release associated with the report[10], he is quoted as saying, “[s]econdhand smoke contains more than 50 cancer-causing chemicals, and is itself a known human carcinogen.” This is despite the fact that this conclusion of the 1992 EPA report has been repeatedly invalidated. To add insult to injury in this gross misrepresentation, although the judicial proceedings were briefly mentioned on page 576 (page 595 of the PDF file), no mention was made of the three congressional committees that had denounced the report prior to judicial proceedings as scientifically unsound and politically-motivated— House Committee on Agriculture[11], the House Committee on Energy and Commerce[12], and the Congressional Research Service[13]. In fact, the House Committee on Energy and Commerce said: EPA's risk assessment on ETS released in January of this year claims that ETS exposure is responsible for approximately 3,000 lung cancer cases per year in the United States. Analysis of the risk assessment reveals, however, that EPA was able to reach that conclusion only by ignoring or discounting major studies, and by deviating from generally accepted scientific standards. The ORI should note the similarity between the problems previously cited with regard to the 1992 EPA report and the problems we are currently noting in the 2006 Surgeon General’s report. In addition to relying on the discredited 1992 EPA report, the Surgeon General also relied on studies with questionable results. For example, on page 560 of the report (page 579 of the PDF file) the Surgeon General said: Another study (Sandler et al. 1989) determined the causes of death for White residents of Washington County, Maryland (United States), who had died between 1963 and 1975. The researchers examined associations with secondhand smoke exposure among 10,799 residents who had reported in 1963 that they were lifetime nonsmokers with household smoking exposures. There was an increased risk of death from emphysema and bronchitis in women (RR = 5.7 [95 percent CI, 1.2–26.8], n = 13) but not in men (RR = 0.9 [95 percent CI, 0.2–5.3], n = 6). In this instance, the study had very small sample sizes, very wide confidence intervals and one result less than unity. Again referring to the enclosed table, one can easily see that the 2006 Surgeon General’s report is replete with such examples. To summarize, the SG omitted two of the largest studies, The Enstrom/Kabat study and the airline study, one of which demonstrated the opposite of harm from SHS/ETS and the other failed to show any significant association. He discounted the largest study, the Wu-Williams study, as "anomalous" because its results largely agreed with one large study that he had omitted as well as the Boffetta study, i.e. showed the opposite of harm. In addition, he relies on a report that has been repeatedly discredited by experts, including three congressional committees and a federal court. Moreover, he relies on comparatively small and unreliable studies for generalization to the whole population. In the context of a meta-analysis, this is omitting or changing data. § 93.103 Research misconduct defines research misconduct as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results” and further defines falsification as “manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.” Therefore, by omitting relevant long-term, large studies as well as relying heavily on discredited reports, the Surgeon General both changed and omitted data in his meta-analysis of research on secondhand smoke (SHS)/environmental tobacco smoke (ETS), which did indeed ensure that the research is not accurately represented in the research record. He, therefore, committed “research misconduct” as defined by the “falsification” according to the “Public Health Service Policies on Research Misconduct”. For your convenience and easy reference, we provide a copy of this letter on the website at http://www.citizensfreedomalliance.org .The hyperlinks provide easy access to the discussed reports, quotes and judicial proceedings. We look forward to your reply. Regards, Gary Nolan Citizens Freedom Alliance, Inc. http://www.citizensfreedomalliance.org/ ec: 110^th United States Congress [1] http://www.surgeongeneral.gov/library/secondhandsmoke/report/ [2] http://www.heartland.org/policybot/results.html?artId=22150 [3] http://ori.dhhs.gov/documents/42_cfr_parts_50_and_93_2005.pdf [4] http://www.surgeongeneral.gov/news/speeches/06272006a.html [5] http://www.heartland.org/policybot/results.html?artId=22150 [6] http://www.heartland.org/policybot/results.html?artId=22150 [7] http://www.forces.org/evidence/epafraud/files/osteen.htm [8] http://www.usdoj.gov/civil/cases/tobacco/decision.htm [9] http://pacer.ca4.uscourts.gov/opinion.pdf/982407.P.pdf [10] http://www.hhs.gov/news/press/2006pres/20060627.html [11] http://www.archive.org/stream/tobaccoprogramhe00unit/tobaccoprogramhe00unit_djvu.txt (July ,1993) [12] http://www.pipes.org/Articles/Bliley.html (July, 1993) [13] http://findarticles.com/p/articles/mi_m1594/is_n5_v5/ai_15794308/pg_2 (November, 1995) Four Groups File Complaints Against Carmona's 2006 Report COLUMBUS, Ohio, Oct. 8, 2008 /PRNewswire-USNewswire/ -- In June, 2006, then Surgeon General Carmona released his report titled "The Health Consequences of Involuntary Exposure to Tobacco Smoke". Since that date, his report has drawn criticism from Scientists and Epidemiologists worldwide. Four separate groups have filed complaints with the Office of Research Integrity, Health and Human Services against Ex-Surgeon General Carmona's 2006 Report. Opponents of Ohio Bans filed a complaint against the scientific misconduct (manipulation of research) of the economic assessment/impact of smoking bans. According to Carmona's report, smokefree policies do not harm business. Two thirds of the studies in Carmona's report were either authored or co-authored by Stanton Glantz, Director of the Center for Tobacco Control Research and Education at the University of California San Francisco School of Medicine, who is not an economist. He and his university have profited heavily by anti-tobacco funding and grants. Absolutely no studies or reports conducted by economists or trade organizations were cited in Carmona's report, although many sources were available at the time. For example, the highly regarded Deloitte and Touche reported a study for the National Restaurant Association study (2004), the Ridgeway Economic Associates New York Nightlife Association/Empire State Restaurant and Tavern Association Study (05/12/2004), and Terry L. Clower, Ph.D. & Bernard L. Weinstein, Ph.D. completed a study for Dallas Restaurant Association Study (10/01/2004). "This is a glaring and obvious attempt to stack the deck in favor of anti-tobacco versus the real damage done to the hospitality industry. How was it even possible that the highest medical authority in this country got away with this?" asks Pam Parker of Opponents of Ohio Bans. The Hawaii Smokers Alliance filed a complaint against the public statement "there is no safe level of exposure". In addition to violating the basic tenets of toxicology, this actually crosses the line of fabricating results because the SG is the highest healthcare authority in the United States of America and his press release to announce the results of his meta-analysis truly is his report to the American public. "We are committed to holding those who have chosen to misinform or misrepresent information to the general public accountable for such reckless and egregious behavior. Such misrepresentations are solely responsible for the destruction and incalculable financial harm to businesses both large and small across the nation," states Jolyn Tenn of Hawaii Smokers Alliance. Ban the Ban Wisconsin's complaint cites the haphazard use of RRs or "relative risks". Coupled with the fact that the larger studies not included in Carmona's report would have diminished the already unacceptably low RRs, questionable studies inflated the appearance of RRs. Moreover, the relative risks don't appear to be discussed with respect to absolute risks. In the ORI's terms, this is a significant departure from accepted practice in the relevant field. Early in Carmona's report, a brief subsection stated that, "The quantitative results of the meta-analyses, however, were not determinate in making causal inferences in this Surgeon General's report." Clearly, in the absence of hard evidence, the Surgeon General chose to pontificate according to his pre-determined results. Carmona couldn't have deviated any further from accepted practice in the relevant field without stepping in something. Citizens Freedom Alliance's complaint is centered on "changing and omitting data". The data for a meta-analysis is the studies collected from the body of research, but the SG's meta-analysis omits relevant studies such as the Enstrom/Kabat study, belittles other large relevant studies, includes highly questionable studies, and relies heavily on the thoroughly discredited 1992 EPA report (which was not only discredited by a Federal Judge, but by three congressional committees). By omitting relevant long-term, large studies as well as relying heavily on discredited reports, the Surgeon General both changed and omitted data in his meta-analysis of research on secondhand smoke (SHS)/environmental tobacco smoke (ETS), which did indeed ensure that the research is not accurately represented in the research record. He, therefore, committed "research misconduct" as defined by the "falsification" according to the "Public Health Service Policies on Research Misconduct". According to Gary Nolan, U.S. Regional Director for Citizens Freedom Alliance, "Americans should be angry about this waste of tax payer dollars. I truly believe this study was released for purely political reasons and is an insult to every honorable scientist in the world. The result of Carmona's ETS study was to needlessly ruin business, cost jobs and harm the economies of local communities and states across the country. He should be ashamed of his actions." Dr. Michael Siegel is a prominent doctor specializing in Preventative Medicine and Public Health. From his commentary on Carmona's 2006 report, he is quoted as saying, "The Surgeon General is publicly claiming that brief exposure to secondhand smoke increases risk for heart disease and lung cancer. But there is absolutely no evidence to support this claim. Certainly, no evidence is presented in the Surgeon General's report to support this claim. And certainly, the Surgeon General's report draws no such conclusion." http://tinyurl.com/5fq7r6 Many researchers and prominent organizations have written about the powerful influences of the anti-tobacco activists. Dr. Carl Phillips, University of Alberta School of Public Health, Edmonton, Canada wrote "Warning: Anti-Tobacco Activism May Be Hazardous to Epidemiological Science". http://www.epi-perspectives.com/content/pdf/1742-5573-4-13.pdf . Other articles such as "Science and Secondhand Smoke: the Need for a Good Puff of Skepticism" by Sidney Zion (Skeptic, Volume 13, Number 3, 2007), "Where's the Consensus on Second Hand Smoke?" by Joseph Bast of Heartland Institute, and "Did Carmona Read His Own Report?" by Jacob Scullum with Reason Magazine 06/29/2006 http://www.reason.com/blog/show/114497.html are but a small representation of the articles that give a glimpse of how damaging the epidemic of anti-smoking is. The fact is, the Surgeon General title is one that is held in highest esteem. It is the medical authority in this country. When, for whatever reason, that position is compromised into producing a report that wreaks the damage his report has had on this country, that authority should be held accountable. Carmona's 2006 report is the sole reason given for several smoking bans, Ohio's ban for one. These bans have had devastating financial impacts on businesses. The worst offense is the offense against the American People and the Scientific Community. People will no longer be able to trust the word of the person holding the Surgeon General title. The damage to the science of Epidemiology is irreversible. The good news is many ethical doctors and scientists can no longer remain silent about the abuses of Epidemiology and are starting to speak out. "Because they've committed a huge fraud on the American public. And because they should be held accountable for that. They should be held accountable to the same rules of corporate and individual behavior as everybody else. It's very simple." This is a quote by Stanton Glantz during a PBS interview about Big Tobacco. Shouldn't the same apply to the Surgeon General? Related Web site: www.opponentsofohiobans.com SOURCE Opponents of Ohio Bans Four Groups File Complaints Against Carmona's 2006 Report Scientific Misconduct as Reasons for Complaints Against Ex-Surgeon General October 8, 2008 http://www.cnbc.com/id/27085565/ AAPS (Association of American Physicians and Surgeons) Newsletter October, 2008 Cover page http://kuneman.smokersclub.com/PDF/AAPScover.bmp Page 3 article http://kuneman.smokersclub.com/PDF/AAPSpg3.JPG Also read: IPCPR Joins Challenge of Surgeon General's 2006 Report http://wispofsmoke.net/ORI.html Citizens Freedom Alliance, Inc. http://www.citizensfreedomalliance.org BanTheBan-Wisconsin http://banthebanwisconsin.com/oriletter.pdf Opponents of Ohio Bans http://opponentsofohiobans.com/news.aspx Hawaii Smokers Alliance https://www.hawaiismokersalliance.com/

Citizens Freedom Alliance, Inc.

Funding Jurisdiction