Questions for Discussion - University of Pittsburgh

Questions for Discussion - University of Pittsburgh

Chinese Benzene Cohort Study 74,828 exposed and 35,805 unexposed workers Leukemia deaths: RR 2.3, 95% CI 1.1-5.0 Malignant lymphoma deaths: RR 4.5, 95% CI 1.3-28.4 No deaths from multiple myeloma in either population TABLE IV. Results of Studies Reporting on Benzene and Total Leukemia First Author (year) Girard (1970)a Ishimaru (1971)b Linos (1980) Thorpe (1974) Rushton (1981) Tsai (1983)

Decoufle (1983) Bond (1986) Austin (1986) Wong (1987a) Study setting Community Community Community Industry Industry Industry Industry Industry Industry Industry

Yin (1989) Hurley (1991) Paxton (1994) Greenland (1994) Industry Industry Industry Industry Exposed cases 30 24 4 8 18 0

3 4 15 6 1 25 5 14 NA NA Relative risk 2.9 1.8 3.3 1.2 2.3

0 6.8 1.9 NA 1.4 0.7 5.7 0.4 3.6 0.9 1.4 95%CI 1.1-7.4 0.9-3.7 0.6-27.6 0.5-2.4 1.0-5.0

0.0-8.7 1.4-19.9 0.5-4.9 NA 0.5-3.0 0.0-3.7 4.0-8.0 0.1-1.0 2.0-6.0 0.3-3.1 0.6-3.2 Wong and Raabe, 2000 Meta-Analysis of Risk of Multiple Myeloma in Petroleum Workers 22 cohort studies of >250,000 workers

220.93 deaths expected; 205 observed SMR 0.93; 95% CI 0.81-1.07 Bergsagel et al; Blood, 1999 Nested Case Control Study of Multiple Myeloma and AML >18,000 petroleum distribution workers Up to 5 controls for each of 11 cases with multiple myeloma and 13 with AML Cumulative mean exposure (ppm-yrs THC): MM 672; controls 800 AML 773; controls 837 Wong, Trent & Harris, 1999 Why is it harder to find an elevated SMR for MM than for AML in benzene-exposed cohorts?

Benzene does not cause MM Benzene is a relatively less potent myelogen than it is a leukemogen Benzene is as or more potent a myelogen than it is a leukemogen, but the background incidence of MM is less than AML The latency period for MM is longer than for AML MORTALITY OF DISTRIBUTION WORKERS EXPOSED TO GASOLINE Cause of death (ICDA-8)B All causes of death (1-999) All malignant neoplasms (140-209) Cancer of digestive organs and peritoneum (150-159) Cancer of respiratory system (160-163) Cancer of lung (162-163) Cancer of kidney (189) Leukemia and aleukemia (204-207)

Cancer of other lymphatic tissue (203-203, 208) All lymphopoietic cancer (200-209) Allergic, endocrine, metabolic, nutritional diseases (240-279) Diabetes mellitus (250) All diseases of circulatory systems (390-458) All respiratory diseases (460-519) Cirrhosis of liver (571) Motor vehicle accidents (810-827) Suicide (950-959) OBSERVED 2066 520 151 173 165 12 27

18 55 30 20 1039 150 31 35 26 SMR 51.3** 66.4** 69.4** 65.8** 66.2** 65.4 89.1

91.9 75.4* 44.6* 35.0** 48.9** 56.5** 36.5** 44.9** 39.4** Healthy Worker Effect: Reasons Specific to Hematopoietic Cancer Acute Myelogenous Leukemia Downs syndrome, Fanconis anemia, etc Status post cancer chemotherapy Non-Hodgkins Lymphoma HIV AIDs

Immune suppression diseases or therapies Exposure Dose Relationships in Determining Causality Is this a useful approach when there are only small numbers and borderline statistical significance? Challenges to Epidemiological Identification of Environmental Causes of Cancer

Cancer as a final common pathway Unknown susceptibility factors Uncertain exposure levels Powerless negative Cluster fallacy Different Levels of Certainty Required for Decisions SCIENTIFIC (p < .05) TORT (p < .50) REGULATORY (p = whatever) Is Relative Risk Greater Than Two Required for Proof of Causation? (Carruth and Goldstein, 2001)

Threshold: Required to support inference of causation 12 Threshold: Determinative of ultimate issue 2 Not required for inference of causation 14 Sufficient for inference of causation (not clear if required) 1

Total # of published decisions 29 Is Relative Risk Greater Than Two Required for Admissibility? (Carruth and Goldstein, 2001) Required for admissibility 10 Not required for admissibility 11 Total # of published cases

21 Cases Before and After Daubert II Addressing Whether Relative Risk Greater Than Two is Required for Admissibility of Causation Opinion Before Daubert II Daubert II and After Required Not Required 0 10

5 6 Not Considered 9 1 Shortcomings of Occupational Epidemiology for Establishing an Odds Ratio for a Specific Risk Healthy worker effect Inadequate exposure data Dilution of high risk group Appropriateness of time period

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