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Food and Drug Act 1906 Dr. Harey WIley's "poison squad". 5 year experiments leading to law limiting interstate commerce but not banning of adulterated foods. Eugenics Selection of the best traits. Looking at physical characteristics to see if you are healthy. Nazi-like study. Positive eugenics Improving the race through selective breeding. Still practiced in dating. Negative eugenics Finding "bad" stock and eliminating them. Restrictive immigration, sterilization, genocide. Buck vs. Bell 1927 Individual forced sterilization and commited to Viginia Colony for epileptics. Supreme court favored sterilization to prevent crime and other social ills. Food, Drug, Cosmetic Act 1938 Allowed removal of "foods" from shelves but to safety concerns. Initially started with Sulfanilamide laced with antifreeze for taste. Joseph Mengele "Angel of Death". Twin experiments for military experimentation. Nuremberg Code 1947 Informed voluntary consent without coersion. Experiments should be useful and necessary. Degree of risk should not exceed humanitarian importance. Kefauver-Harris Amendments 1962 Drugs required to have proven efficacy. Initially involved thalidomide given to pregnant women resulted in phocomelia in children. Tuskegee Syphilis Study 1932-1972 Individuals studied without giving medication. Investigators took advantage of poor socioeconomic and educational status of subjects. Holmesburg Prison Philidelphia 1950-1970 Dow chemical experiments with dioxin. Individuals paid a large sum of money for participation. Took advantage of subject's status. Declaration of Helsinki 1964 WHO Statement of ethical principles. Definied rules for therapeutic and non-therapeutic research. William T Summerlin Faked results of skin transplants. He claimed mental exhaustion and pressure to publish. Belmont Report 1979 Promoted a reliable study group, respect for persons (informed consent), beneficence (good study design), and justice (fairness with equitable selection of subjects). Stephen E. Breuning Fabricated data on the treatment of hyperactivity. IND Rewrite of Regulations 1987 Protection of subjects in clinical trials. FDA approval must be based on data. Phase I "First in Human." Closely monitored patients or normal volunteer subjects. Study increasing dosage of drug. Phase II "Small Sample." Effectiveness of the drug for indication or indications. Patients with disease or condition. Phase III "Larger Population." Additional information about effectiveness and safety. Benefit-risk relationship of the drug. Phase IIIb Separate side study to evaluate special populations. i.e. geriatrics. Forms additional indications and safety data. Phase IV Epidemiology. Long-term safety indications. Familiarize prescribers with product or changes to product. Off-label use Using a medication for another use than what it is officially approved for by the FDA. Key Opinion Leaders (KOL) Chosen as experts in subspecialties. Often recruited by management firms. Internal validity Integrity in the experimental design, performance of the experiement. External validity Appropriateness and extent in which results can be applied to non-study patients or populations. Bias Threats to internal validity. Any factor arising from the design or conduct of a study that skews data. Selection Bias Patients are preselected based on a particular feature and assigned to a "random" group based on that feature. Observer Bias Person taking the measurements of the study knows the status of the patient. Subconsciously encourages patient based on that status. Participant Bias Participant allocated to no treatment takes some other form of medication anyway. Withdrawel Bias Greater than 20% of participants withdraw from the study, should raise questions into the design of the study. Recall Bias Participants in the study tend to recall only the things that are negative and don't remember the positive. Instrument Bias Equipment used in the study skews the data. Invalid calibration or improper equipment used. Reliability: Test-Retest Consistent repeated measurements. Reliability: Intra-rater Consistent single rater. Reliability: Inter-rater Consistent between different raters. Reliability: Intra-subject Consistency of a single subject.