Ethics and Professionalism: The Integrity of Medicine

2. Ethics and Professionalism:The Integrity of Medicine Richard L. Elliott, MD, PhD, FAPA Professor and Director, Medical Ethics Mercer University School of Medicine Adjunct Professor Mercer University School of Law

3. Goals • Week one • Review first year ethics • Research and ethics • “The purpose of Community Medicine II is to introduce the concept of evidence-based medicine” • Tuskegee, IRBs • Small group discussions (exam material!) • Week two • Research ethics II: Conflicts of interest • Medical student abuse and impaired colleagues • Medical malpractice • Exam (14 multiple choice questions)

4. ObjectivesAt the end of the phase you should be able to: • Distinguish aspects of the TSUS which were ethical and unethical • Discuss the ethics of duplicate publication, ghost writing, disclosure of potential conflicts of interest and the nature of publication bias (publication of negative results)

5. Objectives • Discuss the role of patient assent and parental informed consent in the enrollment of minors in clinical research trials • Discuss ethical issues in the enrollment of patients in double-blind, placebo-controlled clinical trials

6. Objectives • Discuss ethical aspects of enrolling subjects in phase 1, phase 2, and phase 3 clinical trials • Describe vulnerable populations in clinical trials

7. Objectives • Describe the 4 Ds of medical malpractice • Describe the role and ethical duties of an expert witness in a medical malpractice case • Discuss the appropriate response after an adverse medical incident

8. Objectives • Describe the primary reasons why patients sue after an adverse medical incident • Describe factors associated with the awarding of damages in a malpractice suit • Discuss appropriate documentation after a medical error

9. Objectives • Describe the relationship between medical injuries and malpractice claims

10. Resources • http://medicine.mercer.edu/ • Go to Programs • Go to Ethics and Professionalism • Schedule on Community Medicine curriculum guide • Cases under “Preparation” • For exam review PowerPoints, Studdert, cases

11. Review • Four ethical principles • Autonomy • Primum non nocere (nonmaleficence) • First do no harm • Beneficence • Social justice • Rule #1 • We are doctors – think clinically

12. USMLE #1 • A 72-year-old man with prostate cancer had surgery and felt well for two years before bone metastases were discovered. He begins to suffer pain and nausea. He is clear-minded and fully understands his medical condition, prognosis, and treatment options. The patient consistently tells you orally and in writing that he does not want further treatment and wants his physicians to focus on pain relief. With the patient’s agreement, a DNR order is in place. In the hospital, the patient loses consciousness, and his family requests that the DNR be reversed.

13. You should: • Agree with the family and change his DNR status • Tell the family you cannot change his DNR status • Ask for an Ethics Committee consultation • Attempt to build a relationship with the family, to educate them, and to help them accept the patient’s decision and their grief

14. MR and Leukemia • Ms. Smith is a 39-year-old woman with severe mental retardation. Her parents have died and no information is available about other living relatives. She lives at a long-term care facility and a court-appointed guardian has been appointed to make health care decisions for her. She has never been able to express preferences of her own concerning these decisions. She has developed leukemia. Treatment involves significant risk and discomfort and only a small chance of prolonging her survival.

15. On what basis should you proceed? • Substituted judgment? • Best interests?

16. What should be done about her treatment? • Proceed with the chemotherapy • Withhold chemotherapy • Confer an “expert panel” to determine therapy • Discuss options and likely outcomes with the guardian and ask the guardian what is in the best interests of the patient

17. Ethics in Research Richard L. Elliott, MD, PhD Professor and Director Medical Ethics and Professionalism Mercer University School of Medicine

18. Medical Research and the Clinician • Many physicians participate in formal research • Most physicians will use the results of clinical research • All physicians will have contact with research derived from the pharmaceutical or medical device industries

19. Goals • Describe common research situations posing ethical issues • Historical • Current • Describe application of ethical reasoning to research • List important resources for ethics in research • Describe ethical issues in our relationships with the pharmaceutical industry • Analyze cases involving clinical research

20. Common Areas of Concern • How “informed” is informed consent in research? • Clinical risks and benefits, use of results for profit • Research in vulnerable populations • Poor, children, poorly educated, mentally ill/MR • Research in special settings • Intensive care units, emergency rooms, prisons • Funding and conflicts of interest • Publication bias, stifling negative results • Publication issues • Authorship, plagiarism, fraud • Animal rights • Use of placebos

22. Background to TSUS • Jenner vaccinated boy, exposed him to smallpox • 1840s J. Marion Sims - surgical experiments on enslaved women and infants without anesthesia • 1874 MD opened skull of woman with tumor and stimulated cortex with electricity until she died • 1896 LPs done on children at Children’s Hospital in Boston without parental consent to see if LP harmful • 1900 US Army infected prisoners with bubonic plague • Many other examples of deliberate infections with syphilis, tuberculosis, cholera, . . . • Informed consent not well developed until 1960s

23. “To know syphilis is to know medicine”Sir William Osler 1849-1919

24. Early Treatments for Syphilis Julius Wagner-Jauregg, MD 1857-1940 Paul Ehrlich, MD 1854-1915

25. Syphilis - 1930 • Widespread (leading cause of mental illness) • Treatment dangerous • Mercury, arsenicals, bismuth, malaria • But a previous study of course of syphilis in whites showed treatment preferable to no treatment • Some thought a study was needed to compare outcomes in treated vs. untreated syphilis in blacks

26. Tuskegee Study of Untreated Syphilis • 1932-1972 US PHS • 600 subjects • 399 with syphilis, 201 controls • To determine course of untreated syphilis in African American men • Julius Rosenwald Fund

29. Eunice Rivers

30. Treatment!

31. Penicillin and Syphilis • Penicillin available 1943 • Treatment of venereal diseases mandatory in Alabama • Henderson Act of 1943 required treatment of venereal diseases • Subjects received notices from draft boards ordering treatment

33. Nuremberg Code (1947) • Voluntary consent of competent individual • Benefits society, not obtainable by other means • Sufficient scientific basis to justify experiment • Avoids unnecessary suffering and injury • Avoid disabling injury or death unless MDs are subjects • Degree of risk proportional to societal benefit • Facilities and preparations to protect subjects • Conducted by qualified investigators • Subject can terminate participation • Investigator should terminate if unsafe to participant

34. World Medical Association Declaration of Helsinki • 1964, most recently clarified 2013 • Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care. • Questions use of placebos

35. Tuskegee Study 1968 Peter Buxtun voices concerns 1969 CDC, AMA, NMA reaffirm support for TSUS 1972 Buxtun approaches AP, expose published 1973 HEW Report critical of Study

36. Ethical Problems with TSUS • Failure to inform subjects of nature of study and their illness • Deception regarding LP “treatment” • Failure to inform subjects of penicillin • Failure to offer penicillin • Failure to inform partners of risks • Was failure to offer Rx at outset unethical?

37. Retrospective Ethical Assessments • Some things are always right (or wrong) • Categorical imperative • Deceiving patients for Study purposes • Some things are right or wrong only in a culturally realtive sense • Informed consent • AMA 1847 unethical telling patients bad news

38. Was Tuskegee An Isolated Incident? • 1946-48 Guatemala syphilis study • 1956-70 Hepatitis and Willowbrook State School • 1961 Milgram Yale study • 1963 Cancer and Jewish Hospital for Chronic Diseases • 1960-72 Cincinnati radiation exposure experiments • 1971 Zimbardo Stanford prisoner experiments • 1993-95 Johns Hopkins lead study • 2011 Las Vegas MD indicted for infusing stem cells

39. Aftermath of Tuskegee • Widespread distrust among blacks of clinical studies • National Research Act of 1974 • Institutional Review Boards • Belmont Report

40. IRB • National Research Act of 1974 (Title 45 CFR Part 46) • Risks to research subjects are minimized and are reasonable in relation to anticipated benefits • Welfare and human rights of subjects are protected and informed consent is sought from each prospective subject or the subject’s • Provisions for monitoring data collection are in place to assure the safety, and physical, emotional, and mental well-being of research subjects • Confidentiality of data/privacy of subjects are assured • Researchers are qualified to conduct the research

41. Composition of IRB • At least 5 members, including one scientist, one non-scientist, one community member. • Members must not have conflict of interest • If study involves vulnerable population, must have member familiar with this group • Children, pregnant women, fetuses, neonates,prisoners, mentally disabled, students, minorities, poor, terminally ill, AIDS/HIV (Mercer website – ethics - research)

42. Exempt Studies • Use of educational materials in educational settings • Subjects cannot be identified • Review of existing data • Subjects cannot be identified • Evaluation of public service programs • Should still submit to IRB to determine study is exempt

43. Belmont Report - 1979 • Ethical Principles and Guidelines for the Protection of Human Subjects of Research • (1) respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent; • (2) beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and • (3) justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits.)

44. If you participate in a research project • What are you being asked to do? • Is it something for which are qualified or will receive training? • Have you discussed use of results? • Publication/poster • Authorship • Funding or other potential conflicts of interest? • Is consent (if required) meaningful? • Have you reviewed other ethical issues?

45. Examples of Application of Ethical Principles to Research • Autonomy • Inform subjects of purpose of study, risks, benefits, alternatives, right to withdraw • Consent from competent, voluntary subjects - consider vulnerability • Beneficence • Value to patient should outweigh risks • Stop trial if arms no longer equally beneficial (clinical equipoise) • Non-maleficence • Protect confidentiality • Social justice • Access to benefits from research • Ensure compensation not so great as to expose poor to excess risk

46. Research Case Analysis • Clinical and Study Information • Medical background, including prognosis, alternative treatment, risks of non-research treatment • Nature and purpose of study, risks/benefits to patient, conflicts of interest, nature of informed consent (competence, assent, voluntariness, quality of information), vulnerable population or special setting

47. Case Analysis • What are the ethical issues? • How do important documents and reports address these issues? • What do propose as a solution?

48. Groups • Medical ethics site, Second Year, Preparation • Read and analyze cases • Discuss • Exam includes questions from cases