Littlewood & Fennell, P.A.
Independent Public & Health Policy Research [1] ______________________________________________________________________
February 8, 1999

Dr. Larry Hart
National Toxicology Program (NIEHS)
111 T.W. Alexander Drive, Building 101, South Campus
Research Triangle Park, NC 27709-2233

Dr. Hart,

Enclosed are our public comments on the National Toxicology Program's decision to list environmental tobacco smoke (ETS) as a Class A carcinogen.

We find NO convincing evidence that ETS should be so listed. We do find convincing evidence of statistical manipulation, misrepresentation of data and, as Lewis Carroll so charmingly put it "having the verdict before the trial." We have no affiliation with either industry or government. Indeed, this was a labor of our love for sound science and intelligent public health policy. Specifically:

We own no stock or stock options or other financial instruments of companies whose products are discussed in these comments,

Have not been paid consultants with either industry or government in this matter,

Have not been employed by either industry or government in this matter,

Have received no fee or honorarium for these comments, nor for conducting research related to this material,

Have received no speakers fees or educational grants or travel assistance from industry or government regarding this matter.

Considering the thinly veiled contempt expressed by members of the subcommittee, we felt it quite important to make these points.

Sincerely,

Anne Fennell

Encl. Comments on listing ETS as a carcinogen, "No convincing evidence. . ." 63 pages.

Phone: Withheld [1]----Fax: Withheld[1]----e-mails: Withheld[1]


_________________________


Environmental Tobacco Smoke
NO CONVINCING EVIDENCE OF CARCINOGENICITY

Table of Contents 4. POINT-BY-POINT DISCUSSION OF TRANSCRIPT
Summary 2
No convincing argument for ETS carcinogenicity 3
Key Messages 3
1. OVERVIEW & BACKGROUND 4
Vol I
Vol II
Transcript
2. GENERAL COMMENTS & OBSERVATIONS 5
Bradford Hill criteria
 5
Nature of ETS
 5
Measuring ETS
 5
Realistic exposure levels
 6
Minimum threshold
 7
Epidemiological assessment
 7
Trend analysis
 7
Confounders & publication bias
 8
Statistical malpractice
 8
Inconsistent assessments of significance
 8
Science v advocacy
 9
Scientific misconduct
 9
Law of unintended consequences
 10
3. QUALITY OF MATERIALS 11
Vol I
 12
------Only 16.6% of studies show any significance
 14
------Data from Fontham
 15
Vol II
 16
------Biomarkers
 16
------Confounders ignored
 17
------------Diet inadequately considered
 17
------------Beta-carotene
 18
------------Heredity
 18
------------Socioeconomic status
 18
------------Physical activity
 19
------------Alcohol
 19
Animal studies
 20
Transcript 21
Biological criteria: plausibility/experimental evidence
 22
------Analysis by analogy
 22
------Direct smoke & condensates
 23
------ "4,000" chemicals
 23
------Hecht
 23
------Witschi studies
 23
Epidemiological criteria: strength,
------biological gradient,
------consistency, specificity
 23
------90% confidence interval
 23
------Fontham
 24
------Publication bias
 24
------Workplace exposure & Wells
 24
------Hackshaw/Wald
 25
------IARC/Boffetta
 25
------Willemsen
 26
------Biases
 27
------Diet
 27
------Publication bias
 28
------Bero
 28
------Biased publications
 28
------Biased research
 28
Biological plausibility
 29
Temporality & coherence
 29
5. EPIDEMIOLOGY & META-ANALYSIS
Rule 1: RRs of less than 2.0 are small/weak
 31
Rule 2: Biological plausibility has precise standards
 34
Rule 3: Consistent dose-response is required
36
Rule 4: Epidemiology is easily confounded
 36
Rule 5: Association is not causation
 37
------Fresh look at Brownson & Fontham
 39
Rule 6: Publication bias must be accurately factored
 44
Industry v government/institutional bias
 46
6. SPECIAL COMMENTS
Seventh Day Adventists: Unscientific control group
 48
7. GENERAL COMMENTS
Rush to judgement: a disturbing pattern for ETS
 50
Witchfinding
 50
Misrepresentation of facts and data
 51
U.S. Rep. Bliley testimony on EPA/ETS misconduct
 51
------SAB Exec Committee, April 1990
54
------2nd Draft of risk assessment
55
Distaste & skepticism
58
8. CONCLUSION 58
Endnotes 59-63


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[1] FORCES has withheld phones, faxes and e-mail addresses to protect the Authors from the harassment of the anti-tobacco cartel operatives, known resort to intimidation, slander, ad hominem attacks, and other expedients to induce silence in the opposition.

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