What can one say about a judge who decides that her opinion on matters medical and scientific outweighs the facts?  Not much.  What can one say about a legal system that enshrines the judge's ignorance?  It obviously needs an overhaul.  Dr. Dunn doesn't waste time in name calling but instead cooly examines a decision that chills scientific inquiry and stifles dissent.

August 17, 2006 Federal District of Columbia District Court,  Judge Gladys Kessler published her opinion and orders in the case brought by the United States Department of Justice (DOJ) against the tobacco manufacturers United States of America and Interveners v. Phillip Morris USA Inc., et al., United States District Court Civil Action No. 99-CV-02496 (GK).

Judge Kessler’s order and opinion of more than 1600 pages included the following:

The tobacco companies were liable, but not under RICO (Racketeer Influenced and Corrupt Organizations Act (18 US Code Sec. 1961) for asserting that health effects from secondhand smoke were not proven, and that low tar and nicotine cigarettes have lesser toxic health effects.  The Judge adopted all the opinions and testimony of the government scientific witnesses.     

RICO penalties claimed in the lawsuit were $280 billion dollars and included criminal penalties of 20 years in prison and forfeiture of all ill-gotten gains and interest but apparently the DOJ overreached and no RICO penalties were imposed.

No further research is allowed on the position of the tobacco companies that secondhand smoke was not a toxin. 

Forbidden are descriptors such as  ‘low tar,’ ‘light,’ ‘ultra light,’ ‘mild,’ ‘natural,’ for any tobacco ads or any use of those words “that could be expected to result in a consumer believing that smoking the cigarette brand using that descriptor may result in a lower risk of disease. . . ” 

Tobacco companies will pay to publicize her orders and her version of public health education widely in newspapers and on the web.

Tobacco defendants pay the government’s extraordinary legal fees, more than 5 years, tallying in the tens of millions of dollars, including costs of experts and discovery.

Defendants are “prohibited from representing directly, indirectly, or by implication. . .  that low-tar, light, ultra light, mild, natural, or low-nicotine cigarettes may result in a lower risk of disease or are less hazardous to health than other brands of cigarettes.”

Judge Kessler ignored basic scientific rules of toxicology and epidemiology and evidentiary admissibility promulgated in the United States Federal Judicial Center’s Reference Manual on Scientific Evidence (2^nd Edition 2000, West Publishing).

She adopted government witness testimony, even when the testimony violated rules set out in the Manual in chapters on epidemiology and toxicology by renowned scientists Leon Gordis and Bernard Goldstein, respectively, that recite the rules on relative risk as evidence of proof and the basic Bradford Hill rules of toxicology.  Government witnesses like Jon Samet, from Johns Hopkins, impressed Judge Kessler and encouraged the sympathetic judge to ignore the problem of studies with low relative risks and toxicology studies with linear modeling and no threshold.  He also convinced the good judge to ignore the problem of no threshold toxicology and a lack of proof of toxicity in low ranges of exposure.

Judge Kessler also ignored the 1998 opinion of Federal Judge William Osteen in  Flue-cured Tobacco Cooperative, Phillip Morris Inc. v. United States Environmental Protection Agency (4 F.Supp.2d 435 (M.D.N.C.1998).

At the end of that 5 year case Judge Osteen ruled that the 1992 Environmental Protection Agency Report on secondhand smoke was rife with junk science and scientific misconduct and that the EPA asserted invalid and unsupported conclusions that ETS was a proven carcinogen and had toxic effects. Judge Osteen found that the EPA had cherry picked research on ETS; ignored studies that didn’t support its position, and tortured the data analysis or even bent the rules on basic statistics to strengthen its weak findings on ETS.  (See footnotes 36 and 37 and pages 64-80 of the opinion that recite EPA scientific misconduct.) 

Judge Osteen’s findings of fact and evidentiary commentary on EPA misconduct were not nullified by the fact that the 4^th Circuit Court of Appeals vacated his decision on the narrow  jurisdictional conclusion by the 4^th Circuit that the EPA Report was not a regulatory action.   Flue Cured Tobacco et al v United States Environmental Protection Agency 313 F 3d 852 (4^th Cir. 2002).

Judge Kessler’s order that no further research is allowed that might contradict her opinions on tobacco or second hand smoke censors honest epidemiologic research on tobacco toxicology, unless it agrees with the opinions of the government sponsored experts presented and supported by the judge.  Her opinion reaches into the offices of the British Medical Journal and other medical or scientific journals that have in the past, and may, in the future, review  articles on ETS and might suggest that Judge Kessler is not speaking infallibly ex cathedra. 

As an example of her censorious attitude,  Judge Kessler maligns the 2003 Enstrom/Kabat Study, on pages 1380-1383 of her opinion, and includes it as part of the illegal tobacco defendant’s conduct, even though it was a robust and long term mortality study, published after being properly peer reviewed for methods and analysis, and no errors have ever been shown to invalidate the findings, even  by the inflamed anti-smoking opponents and critics of the study (see the BMJ email responses online, which sometimes have the look of religious screeds.) 

The editor of the BMJ has repeatedly stood behind the decision to publish the Enstrom/ Kabat  paper, even after a storm of vilification and intimidation descended on the offices of BMJ.

To address the criticism and vilification,  Enstrom has responded on the BMJ rapid response web site, and on October 10, 2007 Enstrom published a detailed and thorough defense of his BMJ paper, entitled “Defending legitimate epidemiologic research: combating Lysenko pseudoscience."

Moreover, the null findings of “The Enstrom/Kabat Study,” are consistent with the null findings of other studies, including  a major study sponsored by the World Health Organization--Boffetta P Agudo A, Ahrens W et. al.  Multimember case-control study of exposure to environmental tobacco smoke and lung cancer in Europe.  Journal of NCI 1998; 90:1440-50, a large nationwide 1995 American Cancer Society study  and a 2006 Western New York State study.

Enstrom and the other researchers were lumped together with opinion essayists and accused by the US DOJ attorneys of being part of the tobacco company condemned conduct, labeled in the petition as criminal and subject to RICO.   Question is, would the BMJ and its editors and reviewers now be considered liable for misconduct for reviewing and publishing the article, given the overreaching and aggressive censorship of Judge Kessler? 

The Department of Justice recruited Judge Kessler to its zealous prosecutorial misconduct and inappropriate accusations of legitimate and honest scientists.  The prosecutorial misconduct castes a pall or a chilling effect on conduct of scientific research and even journal publishing in areas where politics prevails and debate has been squelched.  Drs. Enstrom and Kabat followed the scientific method in conducting their research and published their findings in a respected peer-reviewed journal, the proper forum for scientific reports.  The BMJ  provided the data and the study for evaluation and no serious and professional critique has legitimately or effectively condemned or even discredited or disproved the study. 

The DOJ accused Enstrom and Kabat, and even columnists and opinion essayists of complicity in the alleged racketeering for disagreeing with the government position that second hand smoke was a carcinogen and must be banned from public areas.   Judge Kessler made no effort in her opinion to exonerate or immunize legitimate opinion or research.  She now acts like a recruit to the cause and an advocate instead of an objective occupant of the bench.  

Does this opinion mean that Judge Kessler might determine that the Federal Judicial Center publication that sets out the rules, or the Osteen opinion that shows how the EPA violated the rules should be on some new Index Librorum Prohibitorum.   Should scientists worry about doing research in areas where the government has a position, an agenda or pretends a “consensus”? 

The US government agencies already influence research and publishing on hot political issues by funding and political power, is this the end of independent and vigorous inquiry?  Should the Medical Journal Editors just check with the judicial case reports or agency guidance, and all influential political entities before evaluating research on controversial or hot spot subjects?  How should journals decide to publish on research in air, water, or heavy metal toxicology when the EPA agenda is designed to panic the public?

The tobacco companies appealed Judge Kessler’s decision to the District of Columbia Circuit Court of Appeals and a stay of her orders was granted on October 31, 2006.  However, as late as March 2007 Judge Kessler refused a defendant’s request to use the words light and low tar in cigarette adds outside the United States. 

The British and American traditions of free speech and inquiry cannot endure or thrive with too much of this “consensus” science and judicial tyranny.  It may be that journals in other countries also treasure the value of open inquiry.  The old saying about the blood of tyrants and patriots may be a little strong on freedom of scientific inquiry, but tyranny by one little judge or many, by one agency or many, is still a blow struck against liberty and freedom.

John Dale Dunn MD JD

Emergency Medicine Civilian Faculty, Carl R Darnall Army Medical Center, Fort Hood, TX
Science and Policy Board, American Council on Science and Health,New York, NY
Policy Advisor, Heartland Institute, Chicago, IL

jddmdjd@web-access.net