History and Legal Regulation Of Medicine

1. History and Legal Regulation Of Medicine

2. Shamanism • Oldest Medicine • Primitive Tribes • Alternative Medicine • Integrates Religion And Medicine • Persists Even Today In So Called Modern Cultures

3. Explicitly Ministers To The Psyche And The Body • Often Sophisticated Rituals And Herbals • Driven By Myths • Trial And Error And Careful Observation • Some Cure, Most Do Not • Leviticus • Public Health Code • Rules Reduce Food Poisoning

4. Useful Pharmacopeia • Ethnobotany • Study Of Plants Used By Ritual Healer • Many Drugs Have Been Discovered This Way • Witches Used Foxglove - Digitalis • Medicinal Chemists • Refine And Modify Botanicals

5. Greco-Roman Rationalism • Galen And Successors • Driven By Rational Theories • Religion Is Left To Priests • Observations Forced To Fit Into The Theory • Plato Was Terrible About This • Mistakes Are Not Corrected • Persisted Until 16th Century

6. Hospitals as Religious Institutions • Started in Europe in the Middle Ages • Some of the Oldest Institutions in Continuous Operation • Run by Nursing Sisters • For the Poor • More Egalitarian in the United States

7. Nursing Only • Church Did Not Sanction Medical Care • Goal Was to Alleviate Suffering • Ease the Transition to Heaven • Most Died From Their Illnesses • Only the Very Sick Entered • Excellent Environment for Infectious Diseases • Changed With Technology in the 1880s

8. Scientific Medicine • Not The Philosopher's Scientific Method • The Imperative To Disprove Theories • The Full Disclosure Of Information • Science Is Constantly Questioning And Rethinking

9. Paracelsus • Philippus Aureolus Theophrastus Bombastus Von Hohenheim • Early 16th Century • Transition From Alchemy • Experiments And Systematic Observations • Antimony

10. Anatomy And Function • Andreas Vesalius • Mid 16th Century • Accurate Anatomy • William Harvey • Early 17th Century • Flow Of The Blood And Operation Of The Heart

11. Edward Jenner • Smallpox • Major Killer • Wiped Out The Indigenous Peoples • 1798 – Published His Book On Cowpox

12. John Snow • Cholera In London • Broad Street Pump • Proved Cholera Is Waterborne • 1854

13. Ignaz Philipp Semmelweis • Childbed Fever • Fellow Medical Student Died • Controlled Studies • 1849

14. Louis Pasteur • Scientific Method • Germ Theory • Vaccination For Rabies • Pasteurization • 1860s-1880s

15. William Morton • Dentist • Ether Anesthesia • 1846

16. Joseph Lister • Antisepsis • 1867-1880s • Listerine

17. Koch - 1880s • Koch’s Postulates • Agent Must Be Present In Every Case; • Agent Must Be Isolated From The Host And Grown In Vitro [In A Lab Dish]; • Agent Must Cause Disease When Inoculated Into A Healthy Susceptible Host; And • Agent Must Be Recovered Again From The Experimentally Infected Host. • Limitations

18. Organic Chemistry – 1880s • German/Swiss Dye Industry • Bayer • Hoffman La Roche • Ciba • Became Drug Chemistry

19. Sanitation Movement in Public Health • Food Sanitation • Water • Sewage • Life Expectancy Goes from 25 – 50+ fast • Slowly Rises to 76.5

20. Tuberculosis Control - 1900 • The Major Killer • Koch And Pasteur • Sanatoria • Pasteurization Of Milk • Disease Control Of Dairy Herds • Effective Drugs Came Later

21. Antibiotics • Sulfa Drugs In The 1930s • Penicillin • Alexander Flemming – 1928 • Purified By Chain And Florey In 1939 • Streptomycin – 1944 • First Antituberculosis Drug • Selman Abraham Waksman – 1944 • (Coined The Term Antibiotic

22. State Regulation of Medical Practice

23. Pre-Constitutional Period • Limited Occupational Licensing • NY Passed Licensing Law in 1760s • Not Enforced • Extensive Public Health Regulation • Old Notion of Dirt • Nuisance • Managing Fear • People Terrified of Epidemic Disease • Yellow Fever and the Constitution

24. Constitution - Post Civil War • Jacksonian Populism and Distrust of Institutions • Decline of Occupational Licensing • Existing Laws Were Rescinded • Doctors • Lawyers • Continued Growth of Public Health Regulation • Driven by Snow’s Discoveries • Shattuck Report – Boston - 1850

25. Schools of Practice – Mid 1800s • Allopathy • Opposite Actions • Toxic and Nasty • Homeopathy • Same Action as the Disease Symptoms • Tiny Doses • Less Dangerous • Naturopaths, Chiropractors, Osteopaths, and Several Other Schools

26. Legal Consequences of Schools of Practice • No Testimony Across Schools of Practice • Different from Medical Specialties • Surgery, Internal Medicine, Pediatrics • All Same School of Practice - Allopathy • All Same License • Cross-Specialty Testimony Allowed

27. Locality Rule • Medicine was judged based on the community you were in • If you were in the sticks, you had to show that the care was below the standard for the sticks, not for Boston • Made it almost impossible to bring claims • Provided little inventive to improve practice • Still applies to hospitals in some situations

28. The Profession - 1870s • Most Medical Schools are Diploma Mills • No Bar to Entry to Profession • Small Number of Urban Physicians are Rich • Most Physicians are Poor • Cannot Make Capital Investments • Training • Medical Equipment and Staff • Physicians Push for State Regulation

29. The Role of Legal Regulation in Professionalizing Medicine • Protection of Licensees • Quality of Care • Availability of Care • Fair Pricing • Governmental Interests

30. Protection of Licensees • Critique from the Left • Paul Starr - Social Transformation of American Medicine • Critique from the Right • Milton Friedman • “Hostile” v. “Friendly” Licensing • Not Incompatible with Other Goals

31. Quality and Availability of Care • Require Training • Exclude Unorthodox Practitioners • Discipline Incompetent or Impaired Docs • Subsidize Indigent Care with Required Treatment Mandates • EMTALA • Medicare/Medicaid Non-Discrimination Rules

32. Fair Pricing • Sustain Prices to Assure Supply • Prevent Monopoly Pricing • Prevent Gouging Based on Patient’s Limited Bargaining Position • Emergency Conditions • Emotional Vulnerability • Lack of Knowledge • This never worked very well

33. Governmental Interests • Cross-Subsidize Government Programs • Tax the Profession • Political Influence of Professionals • Draw on Professional Expertise • Traditional Public Health • Traditional Mental Health

34. Medicine and Surgery • Medicine Starts to Work • Surgery Can Be Precise • Patients Do Not Get Infected • Professionalism Starts to Matter • What is a Quack if Nothing Works? • Why Train if Training Does Not Matter?

35. Authority to Regulate Medical Care and Public Health - The Police Power • Historical Right of Societal Self-Defense • Central Colonial Function • Not Police Forces • Public Health and Safety • Left to the States by the Constitution • Can Be Preempted by Federal Legislation • Tobacco Labeling • Medical Device Labeling

36. Constitutional Attacks on State Regulation of Medicine • Equal Protection/Due Process • Discriminating Based on Training • Discriminating Based on Theory of Practice • License as Property Right • Inception of Licensing Laws • Discipline of Licensees • All Trumped by Police Power

37. Constitutional Limits on the Police Power • Civil Rights • Chinese Laundry Cases • Other Shams for Discrimination • Contraception • Sterilization and Abortion • Access to Adequate Pain Relief?

38. Licensing and Education • Mid to Late 1800s • Physicians are Solo Practitioners • Most Make Little Money • Have Limited Respect • Effective Medicine Drives Licensing • Licensing Limits Competition • Physicians Start to Make Money • Makes sense to invest in training

39. Consolidation of Power • American Medical Association Gains Power • Linked State and Local Societies to the National Society • Linked Medical Staff Membership to Local and State Society Members • Exclusionary Politics • Blacks • Women • Jews

40. Reform of Medical Education • Schools with High Standards Could not Compete • Degree Cost More • Took More Time • Did not Affect Entry to Practice or Success • Race to the Bottom • Schools Were Closing • Curriculum was Weakening

41. Outside Forces • Carnegie Foundation • “Flexner Report” • Most Schools Failed • Not Like US News and World Report Rankings • Incentives to Change • Foundation Money • Student Selection Pressures

42. Effect of Licensing • State Required Training in Approved Programs • Some Programs Were Not Approved • Some Unorthodox Practitioners Had Their Own Schools so They Cooperated • Students Had an Incentive to Attend a Better School

43. How Did Medical Schools Change? • Professionalism of Faculty • Full-Time Salaried Positions • Education Requirements • Emphasis on Research • Driven by Outside Money • Reinforced by the Success of the Research • Development of Modern Residency Training

44. What Happened to Unorthodox Practitioners? • Homeopaths and Osteopaths • Homeopathic Schools Closed • Osteopathic Schools Evolved to be Much the Same as Other Medical Schools • Osteopaths are Now Licensed and Treated the Same as Other Physicians • Chiropractors • Politically Very Powerful • Got Their Own License and Allowed to Keep Practicing

45. Where Are We Now? • All States Require A Medical School Degree • Most Require One Year Post-Graduate Residency Training • No States Have Separate Licenses for Specialties • Private Certification of Medical Specialties • Required by Most Hospital and Health Plans • Extra Training and Examinations

46. Hospital-Based Medicine • Started With Surgery • Medical Laboratories • Bacteriology • Microanatomy • Radiology • Services and Sanitation Attract Patients • Internal Medicine • Obstetrics Patients

47. Reformation of Hospitals • Paralleled Changes in the Medical Profession • Began in the 1880s • Shift From Religious to Secular • Began in the Midwest and West • Not As Many Established Religious Hospitals • Today, Religious Orders Still Control A Majority of Hospitals

48. Post WW II Technology • Ventilators (Polio) • Electronic Monitors • Intensive Care • Shift From Hotel Services to Technology Oriented Nursing • Became capital intensive

49. Post World War II Medicine • Conquering Microbial Diseases • Vaccines • Antibiotics • Shift to Chronic Diseases • Better Drugs • Better Studies • Leukemia • Chronic Diseases are much more lucrative

50. Hospitals Shift From Nuns to Paid Staff • Advantages of Nuns • Work Cheap • Work Long Hours • Well Organized and Disciplined • Keep Physicians In Line • Supply Plummets • Replaced With Paid Staff • Not Many Nuns Even In Religious Hospitals