Human Subject Experimentation

1. Human Subject Experimentation The Nazis Lessons for Contemporary Research The Role of the Physician in Society Martin Donohoe

2. “When a doctor [goes] wrong, he is the first of criminals. He has nerve and he has knowledge.” - Sherlock Holmes to Dr. Watson, Arthur Conan Doyle

3. Nazi Medicine • Guiding philosophy = Hegelian (rational utility) • Social Darwinism - parallels in American and British Eugenics Movement • medical journals relatively silent • Ethics reduces morality to efficiency, economics, and aesthetics

4. Nazi Medicine • An arm of state policy • Focus on racial purity • from eugenic sterilization (370,000) • to involuntary euthanasia (70,000) • to large-scale genocide (over 6 million)

5. Nazi Medicine • Individual worth stated in economic terms; propaganda re obligations to the state • “I Accuse” • “Mathematics in the Service of Political Education”

6. Nazi Medicine • Doctoring the nation more important than doctoring individuals - Nazism as “applied biology” (Rudolph Hess) • Focus on preventive medicine and public health: anti-tobacco and anti-alcohol campaigns, environmental toxins, organic farming -to improve Aryan stock • Nazi soldiers given anabolic steroids to increase aggresiveness

7. Nazi Physicians • 52,000 physicians • National Socialist Party Members • Jews ostracized; replaced by young Aryans • today 0.2% of German physicians are Jews, c/w 17% pre-Nazis • 5% of non-Aryans committed suicide; 25% murdered

8. Nazi Physicians • Economic hard times, physicians salaries rise, academic perks • Blutkitt (“blood cement”) • Rare resistance • Catholics • Marxists • Dutch

9. Nazi “Physician-Researchers”(Torturers) • Dr. Sigmund Rascher - coagulation/amputation studies; hypothermia experiments • Dr. Karl Gebhart: heteroplastic transplantation experiments • c.f. Stalin’s attempts to create interspecies (half-men/half-apes) “super-warriors” • Drs. Karl Clausberg and Viktor Brack: X-irradiation/sterilization

10. Nazi “Physician-Researchers” • Drs. Joachim Mrugowsky, Erwin Ding-Schuler, and Waldemar Hoven: IV phenol and gasoline executions • Dr. Friedrich Wegener (“Wegener’s Granulomatosis”): German pathologist, Nazi party member, autopsied a prisoner with oxygen injected into his bloodstream in an embolism study; may have participated in experiments on concentration camp inmates

11. Nazi “Physician-Researchers” • Dr Hans Conrad Reiter (formerly “Reiter’s Syndrome”, now “reactive arthritis”): senior Nazi official • Dr. Joseph Mengele: Septicemia/twin vivisection studies • Dr. Hans Eppinger - “father of modern hepatology”

12. “Indirect Participants” • Prof. J Hallevorden: “Look here now, boys, if you are going to kill all these people at least take the brains out so that the material could be utilized … the more (brains) the better….I accepted these brains of course. Where they came from and how they came to me was really none of my business.”

13. Doctors and Resistance • German invasion of Poland (1939) • Drs Eugene Lazowski and Stanislaw Matulewicz created a fake typhus epidemic, using a harmless bacterium to innoculate non-Jews, knowing that infected Jews would be summarily executed • Germans fooled, quarantined area, many Jews escaped death

14. Nuremberg Doctors’ Trial • 23 German physicians tried • 16 found guilty • 7 hanged (incl. Gebhardt, Brack, Hoven, and Mrugowsky) • Rascher died before trial; Mengele fled for Argentina (remains verified 1985); Hallevorden committed suicide before trial

15. Nuremberg Code • Voluntary consent is absolutely essential • Avoidance of unnecessary physical and mental suffering • Option to quit/responsibility to terminate • Other safeguards

16. Declaration of Geneva • “I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient” • “I will not use my medical knowledge contrary to the laws of humanity.” • “It is unethical for physicians to employ scientific knowledge to imperil health or destroy life.”

17. Post-WW II • Over 700 Nazi rocket scientists and their families brought to the U.S. (including Werner von Braun) to help build nuclear missile program • Operation Paperclip • Japanese scientists brought to Fort Detrick, MD, to help establish U.S. biological/chemical weapons program

18. Post-WW II Human Subject Experimentation • Tuskegee Syphilis Study • Willowbrook Hepatitis Experiments • Henry Beecher • U.S. govt.-sponsored radiation expts.

19. Post-WW II Human Subject Experimentation • Ongoing sterilization programs • WI, NJ, CA, IN, OR, others • Alabama’s Governor Graves vetoed law in 1930s law citing “hazard to personal rights • Oregon governor Kitzhaber apologized in 2002 for the over 2500 state-forced sterilizations that occurred between 1917 and 1983

20. Post-WW II Human Subject Experimentation • Elementary school race experiment (good or bad?) • Milgram’s obedience studies • Soviet psychiatry • US military/pharmaceutical vaccine and medication trials in the developing world

21. Research on Prisoners • 1905: cholera experiments on “volunteers” • 1915: Joseph Goldberger – pellagra studies • Parole in exchange for participation • WW II: gonorrhea, gas gangrene, dengue fever, malaria

22. Research on Prisoners • >90% of pharmaceutical industry research in early 1970s • Rapidly curtailed by state/federal laws and new university regulations • 2006: IOM approves with safeguards

23. Contemporary Issues and Ethical Dilemmas • 90% of research dollars spent on diseases affecting 10% of the world’s population • Research on special populations (cultural minorities, prisoners, developing world, etc.) • Contract Research Organizations • Role of institutional and for-profit IRBs

24. Contemporary Issues and Ethical Dilemmas • Use of placebo controls • Uninsured become research subjects to receive needed care • Informed consent for treatment – physician/patient negotiation vs. unilateral decision-making when treatment options limited

25. Contemporary Issues and Ethical Dilemmas • 2003: Ban on industry experiments testing safety of pesticides/other potentially toxic chemicals in humans lifted by NAS • Physician participation in “War on Terror,” Abu Ghraib, Guantanamo • “Basic Science Consultation Teams” • Co-optation of anthropologists in Iraq, Afghanistan • Nurses injecting psychotropic drugs to forcibly sedate deportees

26. What to do with data acquired via unethical means? • Eduard Pernkopf’s Atlas; Dachau Hypothermia Experiments; Phosgene gas experiments; biological weapons data (offensive vs. defensive) • Japan’s Unit 731 and biological warfare experiments

27. What to do with data acquired via unethical means? • Move to rename “Hallevordan-Spatz syndrome”: “pantothenate kinase-associated degeneration” or “neurodegeneration with brain iron accumulation” • Breast cancer cure scenario

28. What to do with data acquired via unethical means – AMA Policy E-2.30 – Adopted 1998 • All proposed experiments using human subjects should undergo proper ethical evaluation by a human studies review board before being undertaken. • Responsibility for revealing that the data are from unethical experiments lies in the hands of authors, peer reviewers, and editors of medical texts that publish results of experimental studies.

29. What to do with data acquired via unethical means – AMA Policy E-2.30 – Adopted 1998 • Each publication should adopt a standard regarding publication of data from unethical experiments. • If data from unethical experiments can be replaced by existing ethically sound data and achieve the same ends, then such must be done.

30. What to do with data acquired via unethical means – AMA Policy E-2.30 – Adopted 1998 • If ethically tainted data that have been validated by rigorous scientific analysis are the only data of that nature available, and such data are necessary in order to save lives, then the utilization of such data by physicians and editors may be appropriate. • Should editors and/or authors decide to publish an experiment or data from an experiment that does not reach standards of contemporary ethical conduct, a disclaimer should be included. Such disclosure would by no means rectify unethical conduct or legitimize the methods of collection of data gathered from unethical experimentation.

31. What to do with data acquired via unethical means – AMA Policy E-2.30 – Adopted 1998 • This disclaimer should: • (1) clearly describe the unethical nature of the origin of any material being published • (2) clearly state that publication of the data is needed in order to save human lives • (3) pay respect to the victims • (4) avoid trivializing trauma suffered by the participants • (5) acknowledge the unacceptable nature of the experiments • (6) endorse higher ethical standards.

32. What to do with data acquired via unethical means – AMA Policy E-2.30 – Adopted 1998 • Based on both scientific and moral grounds, data obtained from cruel and inhumane experiments, such as data collected from the Nazi experiments and data collected from the Tuskegee Study, should virtually never be published or cited. • In the extremely rare case when no other data exist and human lives would certainly be lost without the knowledge obtained from use of such data, publication or citation is permissible. • In such a case, the disclosure should cite the specific reasons and clearly justify the necessity for citation.

33. What to do with data acquired via unethical means – AMA Policy E-2.30 – Adopted 1998 • Certain generally accepted historical data may be cited without a disclaimer, though a disclosure of the ethical issues would be valuable and desirable.

34. Ethical Perspectives on Scientific Research and War • Denial of moral responsibility for consequences • Recognition of moral responsibility but competing obligations • Recognition of moral responsibility and refusal to participate • Responsibility to inform or lead public opinion

35. Scientists and War Research • Archimedes, da Vinci, Galileo, Haber, Fieser • Farraday • Nobel, Einstein, Szilard

36. Doctors as Terrorists • George Habas – founder of Popular Front for the Liberation of Palestine • Behind aircraft hijackings of Black September • Mohammed al-Hindi – founder of Islamic Jihad • Ayman Al-Zawahiri - #2 in Al Qaeda

37. Doctors as Terrorists • Ikuo Hayashi – chief of circulatory medicine at a leading Japanese hospital • Pleaded guilty to planting sarin gas on Tokyo subway • Radovan Karadzic (psychiatrist)

38. Primo Levi “A country is considered the more civilized the more the wisdom and efficiency of its laws hinder a weak man from becoming too weak or a powerful one too powerful.” (US – largest maldistribution of wealth of any industrialized country)

39. The role of the doctor in society • Public health versus individual health • Roles, responsibilities, and obligations • patients • society • institutions • families • government • world

40. The role of the doctor in society • Theodore Billroth: • “If the whole of Social Medicine needs to be part of the curriculum of the medical student, it must not take more than two hours per semester … during the last two semesters; otherwise, it will surely be detrimental to his other studies”

41. The role of the doctor in society • Rudolph Virchow: • “Doctors are natural attorneys for the poor … If medicine is to really accomplish its great task, it must intervene in political and social life…”

42. The role of the doctor in society • World Health Organization: • “The role of the physician … in the preservation and promotion of peace is the most significant factor for the attainment of health for all.”

43. Ethical Issues Relating to Mixed Agency of Military Physicians • Triage and return to combat • Confidentiality • Communication • Loyalties/Command • Experimentation • “The Sea and Poison”

44. Medical Education Lacking • 2007 survey: 5,000 medical students at 8 medical schools, 35% response rate (Int J Hlth Serv 2007;37(4):643-50) • 94% received < 1 hr. instruction on military medical ethics • 3.5% aware of legislation already passed making a “doctors’ draft” possible • 34% did not know Geneva Conventions require physicians to treat the sickest first, regardless of nationality

45. Medical Education Lacking • 34% not aware Geneva Conventions prohibit ever threatening or demeaning prisoners or depriving them of food or water • 34% could not state when they would be required to disobey an unethical order (answer = always)

46. Ethical Issues Relating to Mixed Agency of Civilian Physicians • Physician participation in torture and executions • Pharmaceutical company provision of agents used in lethal injection executions

47. Contact Information Public Health and Social Justice Website http://www.phsj.org martindonohoe@phsj.org