PSY 2311st Edition Lecture 23Outline of Last LectureI. Question and Answer DayOutline of Current LectureII. Research Guidance of Public Policy: An ExampleA. Understanding Minamata DiseaseIII. Example of Research Driven Policy: Drug RegulationIV. Research Can Inform Public Policy IfCurrent LectureResearch Guidance of Public Policy: An Example● Public policy-- actions taken by groups in the public interest○ laws○ policies govern the behavior of the government○ regulations= rules that are not laws but law says you have to follow them● Minamata disease (1955)○ 3000+ cases○ neurological problems■ muscles weakness and tremors■ deathUnderstanding Minamata Disease● Description of medical symptoms● Detailed victims histories● Epidemiology: similarities among victims○ other observations: cats and birds were getting the disease● Experiments○ Chisso fed their waste to animals and found their factory waste was the sole cause of Minamata Disease● Direct observation of○ IV-- accumulation in the body○ DV-- health changes● Validated the point that you observe the thing you want to learn about● Control/manipulation of○ components of Chisso waste○ prior health○ methylmercury dose○ time of exposure: prenatal vs. postnatal○ type of exposure: ingested vs. inhaled● Experiments are artificial in a good wayExample of Research Driven Policy: Drug Regulation● Psychoactive drugs○ act on central nervous system○ change mood and behavior○ treatment of some psychological disorders● Drug development○ research on effectiveness and safety○ 10-12 years and up to $1 Billion per drug● Pre-clinical testing○ non humans○ DV■ safety■ drug interactions○ possible effectiveness■ animal “models” of disorder● Phase 1 Clinical testing○ healthy humans○ DV pharmacokinetics■ how quickly absorbed, eliminated?○ safety■ side effects, drug interactions?● Phase 2 Clinical testing○ RCTS w/ clinical patients○ DV■ clinical effectiveness (presence/absence)■ lowest effective dose■ safety● Phase 3 Clinical testing○ bigger RCTS (n=1000s)○ effect size and nonresponders○ safety: rare side effects● FDA decides based on research ○ sale allowed?○ by prescription?○ doses?○ what disorders?○ Warnings on label?■ side effects, drug interactions, who should not take itResearch Can Inform Public Policy If● Good research exists (Minamata)● Right kind of research exists● Decision makers value and understand research● Non Research forces (politics) do not
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