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39501 - Screening Pharmaceuticals for Possible...

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Screening Pharmaceuticals for Possible Carcinogenesis: Three Decades of Experience Supercourse Lecture April 2, 2010 Gary D. Friedman, M.D., M.S. Adjunct Investigator and Former Director Kaiser Permanente Division of Research Consulting Professor of Epidemiology Department of Health Research and Policy Stanford University School of Medicine
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Pharmaceuticals and Cancer Study: Current team of investigators Laurel A. Habel, Principal Investigator Gary D. Friedman Charles P. Quesenberry, Jr. James Chan Natalia Udaltsova Ninah Achacoso Kaiser Permanente Division of Research
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Other contributors Hans Ury Donna Wells Joe V. Selby Bruce Fireman Stephan Van Den Eeden Sheng-Fang (Sophie) Jiang Lisa Herrinton Nina Oestreicher Tamirah Haselkorn Elizabeth (Dawn) Flick Alice Whittemore Kristin Sainani Stephan Woditschka Christopher Rowan* Christine Iodice* *Pending as of August 2010
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History FDA-supported drug reaction monitoring system at Kaiser Permanente 1-3 Initial data sources: pharmacy and clinics. Initial (1977) and subsequent NCI grant support for our screening-for-carcinogenesis studies
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Initial Kaiser Permanente surveillance Drugs: 1969-1973 San Francisco KP pharmacy records: cohort of 143,574 subscribers who received prescribed drugs. Cancers Pre-existing: 1968-9 manual SF hospital files Incident Tumor registry: 1969- Hospitalizations: 1971- All manually confirmed, then only hospital Later: total tumor registry coverage
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Initial Kaiser Permanente surveillance (cont’d) Users of 215 most commonly dispensed drugs carefully followed up for cancer compared to non-users, adjusted only for age and sex. >=500 prescriptions or >=300 recipients
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Initial Kaiser Permanente surveillance (cont’d) Biennial analyses: each site, all combined Lag analyses: 1-year, 2-year (to avoid associations due to treatment of pre- diagnostic cancer symptoms) Optional dose-response, crudely based on number of dispensings
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Initial Kaiser Permanente surveillance (cont’d) Associations found are just clues Most due to chance or confounding Select interesting ones for more detailed study, mostly chart review of exposed cases, some comparisons with non-exposed cases, exposed non-cases
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Evolving view of screening for associations “Hypothesis-seeking” “Data-dredging” “Hypothesis-free research”
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Some accomplishments of our non-drug hypothesis-seeking Alcohol and coronary heart disease (1974) 4 Alcohol and blood pressure (1977) 5 Leukocyte count and coronary heart disease (1974) 6 Obesity and multiple myeloma (1994) 7
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