“The mere mention of experimental medical research on incapacitated human beings - the mentally ill, the profoundly retarded, and minor children - summons up visceral reactions, with recollections of the brutal Nazi experimentation...

Even without the planned brutality, we have had deplorable instances of over-reaching medical research in this country.”
Justice Edward Greenfield

T.D. v. NYSOMH, 1995

 

Contents

 

 

 

 

 

 

 

 

 

 

 

 

 

A Chronology of Human Research

from AllianceForHumanResearchProtection Website

  1. 6th century B.C.: Meat and vegetable experiment on young Jewish prisoners in Book of Daniel.
     

  2. 5th century B.C: “Primum non nocere” (“First do no harm”), medical ethics standard attributed to Hippocrates. This Oath became obligatory for physicians prior to practicing medicine in the 4th century AD
     

  3. 1st century B.C. Cleopatra devised an experiment to test the accuracy of the theory that it takes 40 days to fashion a male fetus fully and 80 days to fashion a female fetus. When her handmaids were sentenced to death under government order, Cleopatra had them impregnated and subjected them to subsequent operations to open their wombs at specific times of gestation. [http://www.jlaw.com/Articles/NaziMedExNotes.html#1]
     

  4. 12th century: Rabbi and physician Maimonides’ Prayer: “May I never see in the patient anything but a fellow creature in pain.”
     

  5. 1796: Edward Jenner injects healthy eight-year-old James Phillips first with cowpox then three months later with smallpox and is hailed as discoverer of smallpox vaccine.
     

  6. 1845-1849: J. Marion Sims, “the father of gynecology” performed multiple experimental surgeries on enslaved African women without the benefit of anesthesia. After suffering unimaginable pain, many lost their lives to infection. One woman was made to endure 34 experimental operations for a prolapsed uterus. http://www.coax.net/people/lwf/jm_sims.htm
     

  7. 1865: French physiologist Claude Bernard publishes “Introduction to the Study of Human Experimentation,” advising: “Never perform an experiment which might be harmful to the patient even though highly advantageous to science or the health of others.”
     

  8. 1896: Dr. Arthur Wentworth performed spinal taps on 29 children at Children’s Hospital, Boston, to determine if the procedure was harmful. Dr. John Roberts of Philadelphia, noting the non-therapeutic indication, labeled Wentworth’s procedures “human vivisection.”
     

  9. 1897: Italian bacteriologist Sanarelli injects five subjects with bacillus searching for a causative agent for yellow fever.
     

  10. 1900: Walter Reed injects 22 Spanish immigrant workers in Cuba with the agent for yellow fever paying them $100 if they survive and $200 if they contract the disease.
     

  11. 1900: Berlin Code of Ethics. Royal Prussian Minister of Religion, Education, and Medical Affairs guaranteed that:

     

    • “all medical interventions for other than diagnostic, healing, and immunization purposes, regardless of other legal or moral authorization are excluded under all circumstances if,

       

      1. the human subject is a minor or not competent due to other reasons;

      2. the human subject has not given his unambiguous consent;

      3. the consent is not preceded by a proper explanation of the possible negative consequences of the intervention.” http://www.geocities.com/artnscience/00berlincode.pdf
         

  12. 1906: Dr. Richard Strong, a professor of tropical medicine at Harvard, experiments with cholera on prisoners in the Philippines killing thirteen.
     

  13. 1913: Pennsylvania House of Representatives recorded that 146 children had been inoculated with syphilis, “through the courtesy of the various hospitals” and that 15 children in St. Vincent’s House in Philadelphia had had their eyes tested with tuberculin. Several of these children became permanently blind. The experimenters were not punished.
     

  14. 1915: A doctor in Mississippi, working for the U.S. Public Health Office produces Pellagra in twelve Mississippi inmates in an attempt to discover a cure for the disease
     

  15. 1919-1922: Testicular transplant experiments on five hundred prisoners at San Quentin.
     

  16. 1927: Carrie Buck of Charlottesville is legally sterilized against her will at the Virginia Colony Home for the Mentally Infirm. Carrie Buck was the mentally normal daughter of a mentally retarded mother, but under the Virginia law, she was declared potentially capable of having a “less than normal child.”

     

    By the 1930s, seventeen states in the U.S. have laws permitting forced sterilization The settlement of Poe v. Lynchburg Training School and Hospital (same institution, different name) in 1981 brought to an end the Virginia law. It is estimated that as many as 10,000 perfectly normal women were forcibly sterilized for “legal” reasons including alcoholism, prostitution, and criminal behavior in general.
     

  17. 1931: Lubeck, Germany, 75 children die in from pediatrician’s experiment with tuberculosis vaccine.
     

  18. 1931: Germany adopts “Regulation on New Therapy and Experimentation” requiring all human experiments to be preceded by animal experiments. This law remained in effect during the Nazi regime.
     

  19. 1931: Dr. Cornelius Rhoads, a pathologist, conducted a cancer experiment in Puerto Rico under the auspices of the Rockefeller Institute for Medical Investigations. Dr. Rhoads has been accused of purposely infecting his Puerto Rican subjects with cancer cells. Thirteen of the subjects died. A Puerto Rican physician uncovered the experiment an investigation covered-up the facts.

     

    Despite Rhoads’ hand written statements that the Puerto Rican population should be eradicated, Rhoads went on to establish U.S. Army Biological Warfare facilities in Maryland, Utah, and Panama, and was later named to the U.S. Atomic Energy Commission. Rhoads was also responsible for the radiation experiments on prisoners, hospital patients, and soldiers. The American Association for Cancer Research honored him by naming its exemplary scientist award the Cornelius Rhoads Award.
     

  20. 1932-1972: U.S. Public Health Service study in Tuskegee, Alabama of more than 400 black sharecroppers observed for the natural course of untreated syphilis.
     

  21. 1932: Japanese troops invade Manchuria. Dr. Shiro Ishii, a prominent physician and army officer begins preliminary germ warfare experiments.
     

  22. 1936: Japan’s Wartime Human Biowarfare Experimentation Program.
     

  23. 1938: Japan establishes Unit 731 in Pingfan, 25 km. from Harbin. Unit 731, a biological-warfare unit disguised as a water-purification unit, is formed outside the city of Harbin.
     

  24. 1939: Third Reich orders births of all twins be registered with Public Health Offices for purpose of genetic research.
     

  25. 1939: Twenty-two children living at the Iowa Soldiers’ Orphans’ Home in Davenport were the subjects of the “monster” experiment that used psychological pressure to induce children who spoke normally to stutter. It was designed by one of the nation’s most prominent speech pathologists, Dr. Wendell Johnson, to test his theory on the cause of stuttering.
     

  26. 1940: Poisonous gas experiments at Unit 731. One experiment conducted September 7-10, 1940, on 16 Chinese prisoners who were exposed to mustard gas in a simulated battle situation.
     

  27. 1940-1941: Unit 731 used aircraft to spread cotton and rice husks contaminated with the black plague at Changde and Ningbo, in central China. About 100 people died from the black plague in Ningbo as a result.
     

  28. 1940’s: In a crash program to develop new drugs to fight Malaria during World War II, doctors in the Chicago area infected nearly 400 prisoners with the disease. Although the Chicago inmates were given general information that they were helping with the war effort, they were not informed about the nature of the experiment. Nazi doctors on trial at Nuremberg cited the Chicago studies as precedents to defend their own research aimed at aiding the German war effort.
     

  29. 1941: Sterilization experiments at Auschwitz.
     

  30. 1941-1945: Typhus experiments at Buchenwald and Natzweiler concentration camps.
     

  31. 1941: Dr. William c. Black inoculated a twelve month old baby with herpes. He was criticized by Francis Payton Rous, editor of the Journal of Experimental Medicine, who called it “an abuse of power, an infringement of the rights of an individual, and not excusable because the illness which followed had implications for science.” Dr. Rous rejected outright the fact that the child had been “offered as a volunteer.”
     

  32. 1942 - 1945: Unit 731. Ishii begins “field tests” of germ warfare and vivisection experiments on thousands of Chinese soldiers and civilians. Chinese people who rebelled against the Japanese occupation were arrested and sent to Pingfan where they became human guinea pigs; there is evidence that some Russian prisoners were also victims of medical atrocities.

     

    • “I cut him open from the chest to the stomach and he screamed terribly and his face was all twisted in agony. He made this unimaginable sound, he was screaming so horribly. But then finally he stopped. This was all in a day’s work for the surgeons, but it really left an impression on me because it was my first time.” NYT

     

    These prisoners were called ‘maruta’ (literally ‘logs’) by the Japanese. After succumbing to induced diseases - including bubonic plague, cholera, anthrax - the prisoners were usually dissected while still alive, their bodies then cremated within the compound. Tens of thousands died. The atrocities were committed by some of Japan’s most distinguished doctors recruited by Dr. Ishii.
     

  33. 1942: High altitude or low pressure experiments at Dachau concentration camp.
     

  34. 1942: Harvard biochemist Edward Cohn injects sixty-four Massachusetts prisoners with beef blood in U.S. Navy-sponsored experiment.
     

  35. 1942: Japanese sprayed cholera, typhoid, plague, and dysentery pathogens in the Jinhua area of Zhejian province (China). A large number of Japanese soldiers also fell victim to the sprayed diseases.
     

  36. 1942-1943: Bone regeneration and transplantation experiments on female prisoners at Ravensbrueck concentration camp.
     

  37. 1942-1943: Freezing experiments at Dachau concentration camp.
     

  38. 1943: Refrigeration experiment conducted on sixteen mentally disabled patients who were placed in refrigerated cabinets at 30 degree Farenheit, for 120 hours, at University of Cincinnati Hospital., “to study the effect of frigid temperature on mental disorders.”
     

  39. 1942-1943: Coagulation experiments on Catholic priests at Dachau concentration camp.
     

  40. 1942-1944: U.S. Chemical Warfare Service conducts mustard gas experiments on thousands of servicemen.
     

  41. 1942-1945: Malaria experiments at Dachau concentration camp on more than twelve hundred prisoners.
     

  42. 1943: Epidemic jaundice experiments at Natzweiler concentration camp.
     

  43. 1943-1944: Phosphorus burn experiments at Buchenwald concentration camp.
     

  44. 1944: Manhattan Project injection of 4.7 micrograms of plutonium into soldiers at Oak Ridge.
     

  45. 1944: Seawater experiment on sixty Gypsies who were given only saltwater to drink at Dachau concentration camp.
     

  46. 1944-1946: University of Chicago Medical School professor Dr. Alf Alving conducts malaria experiments on more than 400 Illinois prisoners.
     

  47. 1945: Manhattan Project injection of plutonium into three patients at Billings Hospital at University of Chicago.
     

  48. 1945: Malaria experiment on 800 prisoners in Atlanta.
     

  49. 1946: Opening of Nuremberg Doctors Trial by U.S. Military Tribunal.
     

  50. 1945: Japanese troops blow up the headquarters of Unit 731 in final days of Pacific war. Ishii orders 150 remaining “logs” (i.e., human beings) killed to cover up their experimentation. Gen. Douglas MacArthur is named commander of the Allied powers in Japan.
     

  51. 1946: U.S. secret deal with Ishii and Unit 731 leaders cover up of germ warfare data based on human experimentation in exchange for immunity from war-crimes prosecution.
     

  52. 1946-1953: Atomic Energy Commission sponsored study conducted at the Fernald school in Massachusetts. Residents were fed Quaker Oats breakfast cereal containing radioactive tracers.
     

  53. 1946: Patients in VA hospitals are used as guinea pigs for medical experiments. In order to allay suspicions, the order is given to change the word “experiments” to “investigations” or “observations” whenever reporting a medical study performed in one of the nation’s veteran’s hospitals.
     

  54. 1947: Colonel E.E. Kirkpatrick of the U.S. Atomic Energy Commission issues a secret document (Document 07075001, January 8, 1947) stating that the agency will begin administering intravenous doses of radioactive substances to human subjects.
     

  55. 1947: The CIA begins its study of LSD as a potential weapon for use by American intelligence. Human subjects (both civilian and military) are used with and without their knowledge.
     

  56. 1947: Judgment at Nuremberg Doctors Trial sets forth “Permissible Medical Experiments” - i.e., the Nuremberg Code, which begins: “The voluntary consent of the human subject is absolutely essential.”
     

  57. 1949: Intentional release of radiodine 131 and xenon 133 over Hanford Washington in Atomic Energy Commission field study called “Green Run.”
     

  58. 1949: Soviet Union’s war crimes trial of Dr. Ishii’s associates.
     

  59. 1949-1953: Atomic Energy Commission studies of mentally disabled school children fed radioactive isotopes at Fernald and Wrentham schools.
     

  60. 1940s-1950s: “psychic driving” and “mental departterning” experiments conducted by Dr. Ewen Cameron, depriving patients of sleep, using massive ECT combined with psychoactive drugs such as, LSD. After his “treatments” patients were unable to function. In the 1950’s Dr.Cameron’s experiments were sponsored by the CIA.
     

  61. 1950: Dr. Joseph Stokes of the University of Pennsylvania infects 200 women prisoners with viral hepatitis. 1950: U.S. Army secretly used a Navy ship outside the Golden Gate to spray supposedly harmless bacteria over San Francisco and its outskirts. Eleven people were sickened by the germs, and one of them died.
     

  62. 1951-1960: University of Pennsylvania under contract with U.S. Army conducts psychopharmacological experiments on hundreds of Pennsylvania prisoners.
     

  63. 1952-1974: University of Pennsylvania dermatologist Dr. Albert Kligman conducts skin product experiments by the hundreds at Holmesburg Prison; “All I saw before me,” he has said about his first visit to the prison, “were acres of skin.”
     

  64. 1952: Henry Blauer injected with a fatal dose of mescaline at New York State Psychiatric Institute of Columbia University. U.S. Department of Defense, the sponsor, conspired to conceal evidence for 23 years.
     

  65. 1953 Newborn Daniel Burton rendered blind at Brooklyn Doctor’s Hospital due to high oxygen study on RLF.
     

  66. 1953-1957: Oak Ridge-sponsored injection of uranium into eleven patients at Massachusetts General Hospital in Boston.
     

  67. 1953-1960: CIA brainwashing experiments with LSD at eighty institutions on hundreds of subjects in a project code named “MK-ULTRA.”
     

  68. 1953-1970: U.S. Army experiments with LSD on soldiers at Fort Detrick, Md.
     

  69. 1954-1974: U.S. Army study of 2,300 Seventh-Day Adventist soldiers in 157 experiments code named “Operation Whitecoat.”
     

  70. 1950s - 1972: Mentally disabled children at Willowbrook School (NY) were deliberately infected with hepatitis in an attempt to find a vaccine. Participation in the study was a condition for admission to institution.
     

  71. 1956: Dr. Albert Sabin tests experimental polio vaccine on 133 prisoners in Ohio.
     

  72. 1958-1962: Spread of radioactive materials over Inupiat land in Point Hope, Alaska in Atomic Energy Commission field study code named “Project Chariot.”
     

  73. 1962: Thalidomide withdrawn from the market after thousands of birth deformities blamed in part on misleading results of animal studies; the FDA thereafter requires three phases of human clinical trials before a drug can be approved for the market.
     

  74. 1962 to 1966, a total of 33 pharmaceutical companies tested 153 experimental drugs at Holmesburg prison (PA) alone.
     

  75. 1962-1980 Pharmaceutical companies conduct Phase I safety testing of drugs almost exclusively on prisoners for small cash payments.
     

  76. 1962: Injection of live cancer cells into 22 elderly patients at Jewish Chronic Disease Hospital in Brooklyn. Administration covered up, NYS licensing board placed the principal investigator on probation for one year. Two years later, American Cancer Society elected him Vice President.
     

  77. 1962: Stanley Milgram conducts obedience research at Yale University.
     

  78. 1963: NIH supported researcher transplants chimpanzee kidney into human in failed experiment.
     

  79. 1963-1973: Dr. Carl Heller, a leading endocrinologist, conducts testicular irradiation experiments on prisoners in Oregon and Washington giving them $5 a month and $100 when they receive a vasectomy at the end of the trial.
     

  80. 1964: World Medical Association adopts Helsinki Declaration, asserting “The interests of science and society should ever take precedence over the well being of the subject.”
     

  81. 1965-1966: University of Pennsylvania under contract with Dow Chemical conducts dioxin experiments on prisoners at Holmesburg.
     

  82. 1966: Henry Beecher’s article “Ethics and Clinical Research” in New England Journal of Medicine.
     

  83. 1966: U.S. Army introduces bacillus globigii into New York subway tunnels in field study.
     

  84. 1966: NIH Office for Protection of Research Subjects (“OPRR”) created and issues Policies for the Protection of Human Subjects calling for establishment of independent review bodies later known as Institutional Review Boards.
     

  85. 1967: British physician M.H. Pappworth publishes “Human Guinea Pigs,” advising “No doctor has the right to choose martyrs for science or for the general good.”
     

  86. 1969: Judge Sam Steinfield’s eloquent dissent in Strunk v. Strunk, 445 S.W.2d 145, the first judicial suggestion that the Nuremberg Code should influence American jurisprudence.
     

  87. 1969. Milledgeville Georgia, investigational drugs tested on mentally disabled children. No institutional approval.
     

  88. 1969: San Antonio Contraceptive Study conducted on 70 poor Mexican-American women. Half received oral contraceptives the other placebo. No informed consent.
     

  89. 1973 Ad Hoc Advisory Panel issues Final Report of Tuskegee Syphilis Study, concluding “Society can no longer afford to leave the balancing of individual rights against scientific progress to the scientific community.”
     

  90. 1974: National Research Act establishes National Commission for the Protection of Human subjects and requires Public Health Service to promulgate regulations for the protection of human subjects.
     

  91. 1975: The Department of Health, Education and Welfare (DHEW) raised NIH’s 1966 Policies for the Protection of Human subjects to regulatory status. Title 45 of the Code of Federal Regulations, known as “The Common Rule,” requires the appointment and utilization of institutional review boards (IRBs).
     

  92. 1976: National Urban League holds National Conference on Human Experimentation, announcing “We don’t want to kill science but we don’t want science to kill, mangle and abuse us.”
     

  93. 1978: Experimental Hepatitis B vaccine trials, conducted by the CDC, begin in New York, Los Angeles and San Francisco. Ads for research subjects specifically ask for promiscuous homosexual men.
     

  94. 1979: National Commission issues Belmont Report setting forth three basic ethical principles: respect for persons, beneficence, and justice.
     

  95. 1980: The FDA promulgates 21 CFR 50.44 prohibiting use of prisoners as subjects in clinical trials shifting phase I testing by pharmaceutical companies to non-prison population.
     

  96. 1981: Leonard Whitlock suffers permanent brain damage after deep diving experiment at Duke University.
     

  97. 1986: Congressional subcommittee holds one-day hearing in Washington, called by Rep. Pat Williams of Montana, aimed at determining whether U.S. prisoners of war in Manchuria were victims of germ-warfare experimentation. Hearing is inconclusive.
     

  98. 1981-1996: Protocol 126 at Fred Hutchinson Cancer Center in Seattle.
     

  99. 1987: Supreme Court decision in United States v. Stanley, 483 U.S. 669, holding soldier given LSD without his consent could not sue U.S. Army for damages.
     

  100. 1987:” L-dopa challenge and relapse” experiment conducted on 28 U.S. veterans who were subjected to psychotic relapse for study purposes at the Bronx VA.
     

  101. 1990: The FDA grants Department of Defense waiver of Nuremberg Code for use of unapproved drugs and vaccines in Desert Shield.
     

  102. 1991: World Health Organization announces CIOMS Guidelines which set forth four ethical principles: respect for persons, beneficence, non-maleficence and justice.
     

  103. 1991: Tony LaMadrid commits suicide after participating in study on relapse of schizophrenics withdrawn from medication at UCLA.
     

  104. 1993: Kathryn Hamilton dies 44 days after participating in breast cancer experiment at Fred Hutchinson Cancer Center in Seattle.
     

  105. 1994. The Albuquerque Tribune publicizes 1940s experiments involving plutonium injection of human research subjects and secret radiation experiments. Indigent patients and mentally retarded children were deceived about the nature of their treatment.
     

  106. 1994. President Clinton appoints the Advisory Commission on Human Radiation Experiments (ACHRE) The ACHRE Report 
     

  107. 1995. U.S. Department of Energy (DOE) published Human Radiation Experiments, listing 150 plus an additional 275 radiation experiments conducted by DOE and the Atomic Energy Commission, during the 1940s-1970s
     

  108. 1995: 19-year-old University of Rochester student Nicole Wan dies after being paid $150 to participate in MIT-sponsored experiment to test airborne pollutant chemicals.
     

  109. 1995. President Clinton appoints the National Bioethics Advisory Commission.
     

  110. 1995: NYS Supreme Court rules (TD v NYS Office of Mental Health) against the state’s policy of conducting non-therapeutic experiments on mentally incapacitated persons - including children - without informed consent. Justice Edward Greenfield ruled that parents have no authority to volunteer their children: “Parents may be free to make martyrs of themselves, but it does not follow that they may make martyrs of their children.”
     

  111. 1995: Thirty-four healthy, previously non-aggressive New York City minority children, boys aged 6 to 11 years old, were exposed to fenfluramine in a non-therapeutic experiment at the New York State Psychiatric Institute. The children were exposed to this neurotoxic drug to record their neurochemical response in an effort to prove a speculative theory linking aggression to a biological marker.
     

  112. 1996. Cleveland Plain Dealer investigative report series, ‘Drug Trials: Do People Know the Truth About Experiments,’ December 15 to 18, 1996. The Plain-Dealer found: of the “4,154 FDA inspections of researchers testing new drugs on people [since 1977]... more than half the researchers were cited by FDA inspectors for failing to clearly disclose the experimental nature of their work.”
     

  113. 1996: Yale University researchers publish findings of experiment that subjected 18 stable schizophrenia patients to psychotic relapse in an amphetamine provocation experiment at West Haven VA.
     

  114. 1997. President Clinton issues a formal apology to the subjects of the Tuskegee syphilis experiments. NBAC continues investigation into genetics, consent, privacy, and research on persons with mental disorders.
     

  115. 1997. Researchers at the University of Cincinnati publish findings of experiment attempting to create a “psychosis model” on human beings at the Cincinnati VA. Sixteen patients, experiencing a first episode schizophrenia, were subjected to repeated provocation with amphetamine. The stated purpose was to produce “behavioral sensitization. This process serves as a model for the development of psychosis, but has been little studied in humans. Symptoms, such as severity of psychosis and eye-blink rates, were measured hourly for 5 hours.”
     

  116. 1997. U.S. government sponsored placebo-controlled experiment withholds treatment from HIV infected, pregnant African women. NY Times, Sept. 18.
     

  117. 1997. Victims of unethical research at major U.S. medical centers - including the NIMH - testify before the National Bioethics Advisory Commission, Sept. 18.
     

  118. 1997. FDA Modernization Act gives pharmaceutical companies a huge financial incentive - a 6 month patent exclusivity extension - if they conduct drug tests on children. The incentive can yield $900 million.
     

  119. 1998. National Bioethics Advisory Commission (NBAC) Report. Research Involving Subjects with Mental Disorders That May Affect Decision-making Capacity. November 12, 1998 
     

  120. 1998: The Japanese government has never formally apologized for Unit 731’s activities, and did not even admit to its existence until August 1998, when the Supreme Court ruled that the existence of the unit was accepted in academic circles.
     

  121. 1998. Complaint filed with OPRR about experiments that exposed non-violent children in New York City to fenfluramine to find a predisposition to violence.
     

  122. 1998: Boston Globe (four part) series, “Doing Harm: Research on the Mentally Ill” shed light on the mistreatment and exploitation of schizophrenia patients who have been subjected to relapse producing procedures in unethical experiments.
     

  123. 1999: Nine month-old Gage Stevens dies at Children’s Hospital in Pittsburgh during participation in Propulsid clinical trial for infant acid reflux.
     

  124. 1999: 18-year-old Jesse Gelsinger dies after being injected with 37 trillion particles of adenovirus in gene therapy experiment at University of Pennsylvania.
     

  125. 1999: Director of National Institute of Mental Health suspends 29 clinical trials that failed to meet either ethical or scientific standards.
     

  126. 2000: University of Oklahoma melanoma trial halted for failure to follow government regulations and protocol.
     

  127. 2000: OPRR becomes Office of Human Research Protection (“OHRP”) and made part of the Department of Health and Human Services.
     

  128. 2000: President Clinton implement the Energy Employees Occupational Illness Compensation Act of 2000, which authorized compensation for thousands of Department of Energy workers who sacrificed their health in building the nation’s nuclear defenses.
     

  129. 2000: The Washington Post (6 part) series, “Body Hunters” exposes unethical exploitation in experiments conducted by U.S. investigators in underdeveloped countries. Part 4 dealt with U.S. government funded, genetic experiments conducted by Harvard University in rural China. 
     

  130. 2001: A biotech company in Pennsylvania asks the FDA for permission to conduct placebo trials on infants in Latin America born with serious lung disease though such tests would be illegal in U.S.
     

  131. 2001: Ellen Roche, a healthy 27-year old volunteer, dies in challenge study at Johns Hopkins University in Baltimore, Maryland.
     

  132. 2001: April 4, Elaine Holden-Able, a healthy retired nurse, consumed a glass of orange juice that had been mixed with a dietary supplement for the sake of medical research. This Case Western University Alzheimer’s experiment, financed by the tobacco industry, wound up killing her in what was called a “tragic human error.” Federal Office of Human Research Protections did not interview hospital staff, mostly accepted hospital’s internal report, imposed no penalty, and closed the case and did not mention the death in its letter of determination
     

  133. 2001: Maryland Court of Appeals renders a landmark decision affirming “best interest of the individual child” as a standard for medical research involving children. The Court unequivocally prohibited non-therapeutic experimentation on children. (Higgins and Grimes v. Kennedy Krieger Institute). The case involved exposure of babies and small children to lead poisoning in EPA funded experiment.

Back to Contents

 

 

 

A History of US Secret Human Experimentation

2000 - Health News Network
3-25-2003

from Rense Website

  1. 1931 Dr. Cornelius Rhoads, under the auspices of the Rockefeller Institute for Medical Investigations, infects human subjects with cancer cells. He later goes on to establish the U.S. Army Biological Warfare facilities in Maryland, Utah, and Panama, and is named to the U.S. Atomic Energy Commission. While there, he begins a series of radiation exposure experiments on American soldiers and civilian hospital patients.
     

  2. 1932 The Tuskegee Syphilis Study begins. 200 black men diagnosed with syphilis are never told of their illness, are denied treatment, and instead are used as human guinea pigs in order to follow the progression and symptoms of the disease. They all subsequently die from syphilis, their families never told that they could have been treated.
     

  3. 1935 The Pellagra Incident. After millions of individuals die from Pellagra over a span of two decades, the U.S. Public Health Service finally acts to stem the disease. The director of the agency admits it had known for at least 20 years that Pellagra is caused by a niacin deficiency but failed to act since most of the deaths occurred within poverty-stricken black populations.
     

  4. 1940 Four hundred prisoners in Chicago are infected with Malaria in order to study the effects of new and experimental drugs to combat the disease. Nazi doctors later on trial at Nuremberg cite this American study to defend their own actions during the Holocaust.
     

  5. 1942 Chemical Warfare Services begins mustard gas experiments on approximately 4,000 servicemen. The experiments continue until 1945 and made use of Seventh Day Adventists who chose to become human guinea pigs rather than serve on active duty.
     

  6. 1943 In response to Japan's full-scale germ warfare program, the U.S. begins research on biological weapons at Fort Detrick, MD.
     

  7. 1944 U.S. Navy uses human subjects to test gas masks and clothing. Individuals were locked in a gas chamber and exposed to mustard gas and lewisite.
     

  8. 1945 Project Paperclip is initiated. The U.S. State Department, Army intelligence, and the CIA recruit Nazi scientists and offer them immunity and secret identities in exchange for work on top secret government projects in the United States.
     

  9. 1945 "Program F" is implemented by the U.S. Atomic Energy Commission (AEC). This is the most extensive U.S. study of the health effects of fluoride, which was the key chemical component in atomic bomb production. One of the most toxic chemicals known to man, fluoride, it is found, causes marked adverse effects to the central nervous system but much of the information is squelched in the name of national security because of fear that lawsuits would undermine full-scale production of atomic bombs.
     

  10. 1946 Patients in VA hospitals are used as guinea pigs for medical experiments. In order to allay suspicions, the order is given to change the word "experiments" to "investigations" or "observations" whenever reporting a medical study performed in one of the nation's veteran's hospitals.
     

  11. 1947 Colonel E.E. Kirkpatrick of the U.S. Atomic Energy Commission issues a secret document (Document 07075001, January 8, 1947) stating that the agency will begin administering intravenous doses of radioactive substances to human subjects.
     

  12. 1947 The CIA begins its study of LSD as a potential weapon for use by American intelligence. Human subjects (both civilian and military) are used with and without their knowledge.
     

  13. 1950 Department of Defense begins plans to detonate nuclear weapons in desert areas and monitor downwind residents for medical problems and mortality rates.
     

  14. 1950 I n an experiment to determine how susceptible an American city would be to biological attack, the U.S. Navy sprays a cloud of bacteria from ships over San Francisco. Monitoring devices are situated throughout the city in order to test the extent of infection. Many residents become ill with pneumonia-like symptoms.
     

  15. 1951 Department of Defense begins open air tests using disease-producing bacteria and viruses. Tests last through 1969 and there is concern that people in the surrounding areas have been exposed.
     

  16. 1953 U.S. military releases clouds of zinc cadmium sulfide gas over Winnipeg, St. Louis, Minneapolis, Fort Wayne, the Monocacy River Valley in Maryland, and Leesburg, Virginia. Their intent is to determine how efficiently they could disperse chemical agents.
     

  17. 1953 Joint Army-Navy-CIA experiments are conducted in which tens of thousands of people in New York and San Francisco are exposed to the airborne germs Serratia marcescens and Bacillus glogigii.
     

  18. 1953 CIA initiates Project MKULTRA. This is an eleven year research program designed to produce and test drugs and biological agents that would be used for mind control and behavior modification. Six of the subprojects involved testing the agents on unwitting human beings.
     

  19. 1955 The CIA, in an experiment to test its ability to infect human populations with biological agents, releases a bacteria withdrawn from the Army's biological warfare arsenal over Tampa Bay, Fl.
     

  20. 1955 Army Chemical Corps continues LSD research, studying its potential use as a chemical incapacitating agent. More than 1,000 Americans participate in the tests, which continue until 1958.
     

  21. 1956 U.S. military releases mosquitoes infected with Yellow Fever over Savannah, Ga and Avon Park, Fl. Following each test, Army agents posing as public health officials test victims for effects.
     

  22. 1958 LSD is tested on 95 volunteers at the Army's Chemical Warfare Laboratories for its effect on intelligence.
     

  23. 1960 The Army Assistant Chief-of-Staff for Intelligence (ACSI) authorizes field testing of LSD in Europe and the Far East. Testing of the European population is code named Project THIRD CHANCE; testing of the Asian population is code named Project DERBY HAT.
     

  24. 1965 CIA and Department of Defense begin Project MKSEARCH, a program to develop a capability to manipulate human behavior through the use of mind-altering drugs.
     

  25. 1965 Prisoners at the Holmesburg State Prison in Philadelphia are subjected to dioxin, the highly toxic chemical component of Agent Orange used in Viet Nam. The men are later studied for development of cancer, which indicates that Agent Orange had been a suspected carcinogen all along.
     

  26. 1966 CIA initiates Project MKOFTEN, a program to test the toxicological effects of certain drugs on humans and animals.
     

  27. 1966 U.S. Army dispenses Bacillus subtilis variant niger throughout the New York City subway system. More than a million civilians are exposed when army scientists drop lightbulbs filled with the bacteria onto ventilation grates.
     

  28. 1967 CIA and Department of Defense implement Project MKNAOMI, successor to MKULTRA and designed to maintain, stockpile and test biological and chemical weapons.
     

  29. 1968 CIA experiments with the possibility of poisoning drinking water by injecting chemicals into the water supply of the FDA in Washington, D.C.
     

  30. 1969 Dr. Robert MacMahan of the Department of Defense requests from congress $10 million to develop, within 5 to 10 years, a synthetic biological agent to which no natural immunity exists.
     

  31. 1970 Funding for the synthetic biological agent is obtained under H.R. 15090. The project, under the supervision of the CIA, is carried out by the Special Operations Division at Fort Detrick, the army's top secret biological weapons facility. Speculation is raised that molecular biology techniques are used to produce AIDS-like retroviruses.
     

  32. 1970 United States intensifies its development of "ethnic weapons" (Military Review, Nov., 1970), designed to selectively target and eliminate specific ethnic groups who are susceptible due to genetic differences and variations in DNA.
     

  33. 1975 The virus section of Fort Detrick's Center for Biological Warfare Research is renamed the Fredrick Cancer Research Facilities and placed under the supervision of the National Cancer Institute (NCI) . It is here that a special virus cancer program is initiated by the U.S. Navy, purportedly to develop cancer-causing viruses. It is also here that retro-virologists isolate a virus to which no immunity exists. It is later named HTLV (Human T-cell Leukemia Virus).
     

  34. 1977 Senate hearings on Health and Scientific Research confirm that 239 populated areas had been contaminated with biological agents between 1949 and 1969. Some of the areas included San Francisco, Washington, D.C., Key West, Panama City, Minneapolis, and St. Louis.
     

  35. 1978 Experimental Hepatitis B vaccine trials, conducted by the CDC, begin in New York, Los Angeles and San Francisco. Ads for research subjects specifically ask for promiscuous homosexual men.
     

  36. 1981 First cases of AIDS are confirmed in homosexual men in New York, Los Angeles and San Francisco, triggering speculation that AIDS may have been introduced via the Hepatitis B vaccine
     

  37. 1985 According to the journal Science (227:173-177), HTLV and VISNA, a fatal sheep virus, are very similar, indicating a close taxonomic and evolutionary relationship.
     

  38. 1986 According to the Proceedings of the National Academy of Sciences (83:4007-4011), HIV and VISNA are highly similar and share all structural elements, except for a small segment which is nearly identical to HTLV. This leads to speculation that HTLV and VISNA may have been linked to produce a new retrovirus to which no natural immunity exists.
     

  39. 1986 A report to Congress reveals that the U.S. Government's current generation of biological agents includes: modified viruses, naturally occurring toxins, and agents that are altered through genetic engineering to change immunological character and prevent treatment by all existing vaccines.
     

  40. 1987 Department of Defense admits that, despite a treaty banning research and development of biological agents, it continues to operate research facilities at 127 facilities and universities around the nation.
     

  41. 1990 More than 1500 six-month old black and Hispanic babies in Los Angeles are given an "experimental" measles vaccine that had never been licensed for use in the United States. CDC later admits that parents were never informed that the vaccine being injected to their children was experimental.
     

  42. 1994 With a technique called "gene tracking," Dr. Garth Nicolson at the MD Anderson Cancer Center in Houston, TX discovers that many returning Desert Storm veterans are infected with an altered strain of Mycoplasma incognitus, a microbe commonly used in the production of biological weapons. Incorporated into its molecular structure is 40 percent of the HIV protein coat, indicating that it had been man-made.
     

  43. 1994 Senator John D. Rockefeller issues a report revealing that for at least 50 years the Department of Defense has used hundreds of thousands of military personnel in human experiments and for intentional exposure to dangerous substances. Materials included mustard and nerve gas, ionizing radiation, psycho-chemicals, hallucinogens, and drugs used during the Gulf War .
     

  44. 1995 U.S. Government admits that it had offered Japanese war criminals and scientists who had performed human medical experiments salaries and immunity from prosecution in exchange for data on biological warfare research.
     

  45. 1995 Dr. Garth Nicolson, uncovers evidence that the biological agents used during the Gulf War had been manufactured in Houston, TX and Boca Raton, Fl and tested on prisoners in the Texas Department of Corrections.
     

  46. 1996 Department of Defense admits that Desert Storm soldiers were exposed to chemical agents.
     

  47. 1997 Eighty-eight members of Congress sign a letter demanding an investigation into bio-weapons use & Gulf War Syndrome.

Back to Contents

 

 


Human Experimentation  Before the Nazi Era and After

by Roberta Kalechofsky, PhD.
from MicahBooks Website

"First animals, then orphans, then the mentally retarded."
David J. Rothman

Strangers At The Bedside.

In 1907, Dr. Albert Leffingwell concluded his booklet, Illustration of Human Vivisection, with this chilling prophecy:

"At the beginning of a new century we are confronted by great problems. One of these is human vivisection in the name of scientific research. We appeal, then, to the medical press of America to beak that unfortunate silence which seems to justify or, at least, to condone it.

 

Now and henceforth, will it not join us in condemning every such vivisector of little children, every such experimenter upon human beings? We make this appeal to it in the name of Justice and Humanity and for the sake of millions yet unborn."

The intellectual and philosophical rationalizations, as well as much of the practice of human experimentation, was well advanced by the end of the nineteenth century, and presents a continuing danger to human rights today, particularly when faced with the stimulus of crisis and war.


The history of human experimentation in the West is usefully divided into two eras: before the Nazi era and after. Human experimentation neither arose with the Nazis, nor ended with them. But the Nazi era, to paraphrase Samuel Johnson's famous statement that "Nothing concentrates a man's thoughts so much as the knowledge that he is to be hanged on the morrow" - the Nazi era concentrated our thoughts about human experimentation and, to some extent, halted its momentum. But it did not end the practice of what Dr. Leffingwell called at the beginning of the century, "the secret creed."


Vivisection was practiced in the Roman era on gladiators and slaves. But this vivisection, monstrous to the living victim, was sporadic.

 

The real history of vivisection begins in the nineteenth century with the rise of the experimental method in science, and subsequently in medicine. It arises from and accompanies animal experimentation which, with the work of Claude Bernard in the mid-nineteenth century, became the standard methodology in modern medicine. As soon as animal vivisection became standard practice, the question arose about experimental research on human beings.

 

Animal researchers recognized that an inescapable problem had been created: the only way animal research could really be validated for human medical problems was to finally conduct the experiment on human beings, for there is no assurance from animal research itself that a given drug would be valid for human application.

 

A famous example is the fact that aspirin kills rabbits, and if researchers had been guided in their use of aspirins by this laboratory research, human beings would have been denied a valuable drug.

 

Michael Krater summarizes the process in his book, Doctors Under Hitler.

"One of the prerequisites that turned into a sort of fetish of this exact-scientific attitude was the experiment--it, too, a child of rationalization in the past century. At the universities, the theories had to be validated by experiments.

 

It was unquestioned that advances in medicine (as in natural science) could be achieved only through the inductive method of formulating a hypothesis and testing it, by subjecting it to revision and verification in a controlled series of empirical observations."

However, Michael Krater's further statement is only partially true:

"Throughout the 1920s and well into the Third Reich, German medical scientists were ruled by a consensus that as desirable as human experiments were, for moral reasons animals had to suffice as objects of empirical experimentation."

That was the desideratum, but by the turn of the century experimentation on human beings was on its way to becoming respectable. The famous chemist, E.E. Slosson wrote on Dec. 12th,1895, in the New York Independent,

"A human life is nothing compared with a new fact in science....the aim of science is the advancement of human knowledge at any sacrifice of human life....We do not know of any higher use we can put a man to."

Professor Starling of University College, London, openly declared in 1906 to Britain's Parliament at its investigation into vivisection practices, "The last experiment must be on man."


What animal research does is to provide a seemingly safety net and guidelines for procedure with human beings. Sometimes this safety net works, sometimes it doesn't; sometimes it's misleading, but it is standard procedure, so that animal and human experimentation are two sides of the same coin.

 

An article in The New Republic (April 26 and May 2, 1999) by Jerome Groopman, quixotically entitled "Merciful Medicine," describes the system very well:

"After extensive testing in small animals, drugs are tested for toxicity in human beings during what is known as Phase I trials. This first phase is designed to gauge the side effects of the drugs, usually on groups of three or four people that get very low doses of the drug, followed by groups that receive successively higher doses until intolerable toxicity is reached [like LD50 drug testing in animals].

 

There is no expectation of clinical benefit in this first phase. Furthermore, Phase I studies take virtually all comers."

Groopman goes on to describe Phase II and Phase III of human experimentation, in an article intended as a plea to allow those who wish to to volunteer for human experimentation.

 

It was only a matter of time until medicine would arrive at this point where the need for volunteers for human experimentation would become inescapable and would mandate a "merciful plea."

 

As Michael Krater describes the escalation under Nazi Germany,

"Because animal experimentation was known to be a poor substitute for experiments on humans, for only analogous inferences could be drawn, the crossover to human experimentation during the war became a logical consequence of prior practices that had been fettered."

The evolution from animal experimentation to human experimentation is a logical consequence of laws governing the experimental process, whether in Nazi Germany, or elsewhere, and not the result of preferring humans to animals.

 

As Krater writes,

"...the often-encountered theory that Nazis spurned human life in preference for that of animals, in particular house pets, is without basis in fact--non-suspect societies love pets also."

The Weimar law passed in 1931 with respect to animal and human experimentation required that German and, subsequently Nazi, doctors must first conduct their experimental procedures on animals before proceeding to human beings.

 

This law was never abrogated in Nazi Germany and is similar to laws in the United States today. All experiments with human beings are and were first conducted on animals, and experimenters in and out of Nazi Germany had to validate this procedure.

 

Thus, when Dr. Karl Rascher made his request on May 15, 1941 to the Reich Leader Himmler, "for two or three professional criminals," for high altitude test experiments of eighteen thousand meters, he pointed out that this experiment had been tried on monkeys, but that monkeys outlived their usefulness at 12,000 meters, and he now had to proceed to the use of humans. Research on animals does not protect human beings from becoming experimental guinea pigs.


The literature of the nineteenth century illustrates a continuing increase in the use of human beings for medical experiments, beginning in the last two decades of that century. With the rise of the germ theory and of the pharmaceutical companies, testing on both animals and humans proliferated at dizzying speeds.

 

In her book, Subjected to Science: Human Experimentation in America Before the Second World War, Susan Lederer writes:

"The science of bacteriology engendered substantial experimentation on human beings and animals....Isolating and identifying a disease germ under the microscope was the first step. After growing the microorganism in a pure culture, the physicians needed to use the germ to produce the disease in a healthy organism.


"The use of human beings to confirm that a microbe caused a particular disease to demonstrate the mode of transmission was a harsh legacy of the germ theory of disease. Unable to find a suitable animal model in which to study the disease, physicians turned to human subjects. Before the discovery that monkeys could be infected with syphilis and gonorrhea, the search for microbes of venereal disease prompted more than forty reports of experiments in which individuals were inoculated with the suspected germs of gonorrhea and syphilis.

 

In 1895 New York pediatrician Henry Heiman... described the successful gonorrheal infection of a 4-year-old boy ("an idiot with chronic epilepsy"), a 16-year-old boy (an "idiot") and a 26-year-old man in the final stages of tuberculosis"

This information is in the medical journals of its time, The American Journal of Syphilis of 1943, and the Journal Cut. Genito-Urinary Diseases of 1895.

 

It is germaine to the problem of informed consent that two of the subjects are described as "idiots," therefore presumably incapable of giving informed consent. Who then gave it for them, and should others have the right to give such consent for others? Should a parent in need of money have the right to give consent for a child to be experimented upon? Would this be considered "selling" a child to science. These are problems that degrade the integrity of the concept of informed consent.


Usually the human beings used for experimental purposes were--and are-- the disenfranchised, populations of prisoners, orphans, the mentally retarded, charity patients of all kinds. Dr. Leffingwell's study uncovered decades of experiments on human beings in charity wards and on children in orphan asylums. None of these experiments were as horrific as those conducted by the Nazis, but they were quite serious enough.

 

Leffingwell documented experiments by Dr. Sydney Ringer of University Hospital of London, who experimented with poisons, such as overdoses of salicin, nitrate of sodium, gelseminum and other toxic agents, often on children under the age of ten. Due to the experiments, the children suffered from severe headaches, vomiting, twitching of limbs, burning sensations in the eyes, and other painful symptoms.

 

Dr. Leffingwell commented:

"A distressing feature of many of these experiments is the fact that the men and women upon whom they were performed were not only ignorant, but under constraint. In this horrible case certain patients in the hospitals were not merely poisoned once, but were obliged 'on compulsion' to undergo the convulsive paroxysms and all the other agonizing symptoms a second time"

Dr. Ringer's experiments were published in a book called Handbook of Therapeutics. Far from receiving criticism for his experiments on children, Dr. Ringer's book went through eight editions and was regarded as a respectable medical book.


In 1906, the British Parliament conducted The Second Royal Commission into Vivisection Practices. H.H. Levy, the Honorable Secretary of the Personal Rights Association, told the Commission,

"These experiments are not confined to animals and never have been confined to animals; they have always been performed on human beings, as well as on animals."

Indeed, the Commission uncovered decades of evidence of routine human experimentation.

 

Some of these experiments were published in 1949 in E. Westacot's book, A Century of Vivisection and Anti-Vivisection. Westacott's book describes the experiments of Professor Neisser of Vienna who, on March 29, 1899, reported in the Medical Press of Vienna, how he had inoculated eight healthy children with syphilis.

 

Three of the children developed symptoms of the disease, and a fourth suffered later in life from a cerebral tumor. While Professor Neisser was condemned and fined by the disciplinary court of Breslau, he was rewarded by the West London Chirurgical Society in England in 1911, with the Cavendish Gold Medal for his research, and a reception was held in his honor. Apart from the Nazi doctors, it is hard to find a single doctor who was seriously punished for human experimentation, and who was not in fact professionally rewarded.


In the United States, in 1913, the Pennsylvania House of Representatives recorded that 146 children had been inoculated with the syphilis virus, "through the courtesy of the various hospitals" and that 15 children in St. Vincent's House in Philadelphia had had their eyes tested with tuberculin. Several of these children became permanently blind.

 

The experimenters were not punished. Moreover, this case further illustrates that the doctrine of "informed consent" proves to be practically inoperable in the case of institutionalized people, particularly children, because in most of these circumstances it is the institution's supervisor who is responsible for giving "informed consent" and usually gives it.


Experimentation on human beings was not confined to bacteriological research. J. Marion Sims, the "father of gynecology" performed experimental surgery, before the days of anesthesia, on several slaves, and performed thirty-four experimental operations on a single black female slave for a prolapsed uterus.
 

One of the most famous cases in human experimentation involves an Irish servant girl, Mary Rafferty, who entered Good Samaritan Hospital in Cincinnati in 1874, with an ulcerated tumor on the side of her head, which had been caused by a bad burn.

 

Mary Rafferty's case demonstrates the characteristics usually inherent in cases of human experimentation: the ambiguity involved in determining whether informed consent had been obtained, the shadow land between experimentation and therapy, the fact that only the attending physicians really know the truth of what occurred.

 

Her physicians diagnosed the ulcer on her scalp as cancerous and apparently attempted to treat her condition surgically. When they believed that her situation could not be remedied, they proceeded to experiment on her. One of Mary's physicians, Roberts Bartholow was interested in experiments Dr. David Ferrier had made with dogs using electric shock to determine the localization of epilepsy.

 

The experiments with Mary are described as follows:

"When the needle entered the brain substance, she complained of acute pain in the neck. In order to develop more decided reaction, the strength of the current was increased by drawing out the wooden cylinder one inch. When communication was made with the needles, her countenance exhibited great distress, and she began to cry.

 

Very soon, the left hand was extended as if in the act of taking hold of some object in front of her; the arm presently was agitated with chronic spasm; her eyes became fixed with pupils widely dilated; her lips were blue, and she frothed at the mouth; her breathing became stertorus; she lost consciousness and was violently convulsed on the left side.

 

The convulsion lasted five minutes, and was succeeded by a coma. She returned to consciousness in twenty minutes from the beginning of the attack, and complained of some weakness and vertigo."

The Mary Rafferty Case illustrates a persistent pattern in issues of human experimentation: she died a few days later, and her death certificate stated that she died from cancer.

 

There was criticism of Dr. Bartholow's experiment: it was condemned by the American Medical Association, but Dr. Bartholow did not suffer professionally. Indeed, he advanced professionally. Scandal arises, then scandal subsides, and the researcher is rewarded.


The second issue is that while Dr. Bartholow conceded that his experiment had perhaps gone too far, he asserted emphatically that Mary had given informed consent and that his experiments did not cause her death. But even if the experiments did not cause her death, she was entitled to die without unnecessary pain. The argument that "the patient was going to die anyway" is a gross argument, and one that was used by the Nazi doctors. Bad enough the patient is going to die; it is no excuse for the patient to be tortured while dying.

 

We do not permit condemned prisoners to be tortured on the excuse that they're going to die anyway. (However, there are constant proposals from research medicine that prisoners on death row be used for experimental purposes. Would such "experiments" constitute torture or not?)


The third issue is that of Mary Rafferty's consent. Dr. Bartholow argued that she was not feeble-minded and understood his questions to her. There is a contradiction in this argument. If Mary Rafferty really understood Dr. Bartholow's description of what he was about to do, common sense tells us she would not have consented. This is the crux of the issue with most "informed consent" problems.

 

Examination of particular experiments invariably suggests that the patient did not understand what he or she was consenting to. "Informed consent" proves to be a treacherous deception in many cases.

 

At a conference on "The Nazi Doctors and the Nuremberg Code" at Boston University in 1989, Dr. Arthur Caplan stated that the principle of informed consent, which is the cornerstone of protection for human rights in a medical context, is now so eroded that it has evolved into "protection of the researcher" and a license to experiment.


"Informed consent" does not respond to the more common types of experimentation on human beings, where the area between therapy and experimentation is blurred, and where it is difficult to pass judgment on medical procedure. An article in The New York Times (Nov., 1996) by Gina Kolata, demonstrates the ubiquity of the problem. The Food and Drug Administration gave permission to lift the requirement of informed consent for patients who have been brought into a hospital, suffering from a head injury which has rendered them unconscious, and who have no identification. Who is to give consent in this case?

 

Though this step marks a grave departure from the Nuremberg Code, it has aroused little public reaction. Of course, the argument in defense of the lifting of this ban is the necessity to treat a patient, even experimentally, who cannot speak for him or herself.

 

But how many people are wandering about without any identification? The population of "unidentifiable" people is immediately identifiable: the homeless and probably illegal immigrants.


Even with alert and identifiable patients, as Jay Katz observed at the Boston University Conference, informed consent is meaningless unless the patient is educated and medically very knowledgeable, but most sick people, as Dr. Katz pointed out, are not in a position to argue with their physicians: they are "coerced by disease," by pain, by fear of death, and often by ignorance.


In real practice--not theoretical practice - the concept of "informed consent" has led to the duplicitous practice of what Bradford H. Gray calls in his book, Human Subjects in Medical Experimentations, "the engineering of consent."

 

His study unsurprisingly reveals that "informed consent" is often a mirage, often coerced from frightened people who are in too much pain and confusion to withstand a request from a doctor.

 

In the introduction to Gray's book, Bernard Barber exposes the myth of medical experimental outrages as the aberration of a "few bad doctors."

"There is a mistaken belief held by some medical researchers, and even by those who deplore the defects in present practices in this field, that the shortcomings and scandals that occur can be traced to a handful of individuals who lack the requisite personal qualities. They recommend that 'the honest, conscientious, compassionate physician' be the ultimate safeguard of the human research subject. But Gray's book shows that 'honest, conscientious, compassionate' physicians have been led into bad practice by a bad system."

Experimentation on human beings is not the work of a few aberrant doctors; it is systemic, because it is the system by which modern western medicine works.

 

Exposés of outrageous experiments, such as Dr. Henry Beecher's book, Research and The Individual, written in 1966, often endorse research on human beings. Dr. Beecher wrote,

"The well-being, the health, even the actual or potential life of all human beings, born or unborn, depend upon the continuing experimentation in man. Proceed it must; proceed it will. 'The proper study of mankind is man.'"

The Nuremberg trials brought to light the horrors of medical experimentation on human beings, and tried to articulate a restraining formula by stressing the concept of "informed consent," but the trials also recognized that

"Medical science cannot, unless it is to be brought to a standstill, dispense with the application in suitable cases of new remedies and procedures not yet fully tested. Nor can it do entirely without scientific experiment on human beings itself."

In 1931, Germany already possessed a good bioethical code which contained almost all the points of the Nuremberg Code.

 

Yet it failed to curb the rapacious desire to experiment. By the time of the Nazi experiments, the legal procedure and conduct of experimentation with human beings had been laid down in Germany, the United States and England. Experimentation on human beings was not condemned. What was condemned in Germany was the political and racial uses of human experimentation, and its excesses.

 

The defense of the Nazi doctors rested on the argument that their procedure was standard Western medical practice, and they submitted cartons of documentation of experiments on human beings in Western hospitals to prove their case, including an exhaustive volume, entitled, Experiments on Human Beings in World Literature, by Dr. Erich H. Hahlbach, which describes such experiments as those conducted on "eight hundred convicts from three American prisons" artificially infected with malaria, who presumably volunteered for this experiment, prisoners in Turkey sentenced to death, infected with typhus, prisoners sentenced to death infected with plague, etc.

 

The defense pointed out that,

"Out of fifty-three printed sources quoted, seventeen state that the subjects consented. In thirty-six the matter was not mentioned in any way and in several of these cases it appeared that the subjects might not have presented themselves willingly."

The defense's argument was that experimentation with human beings had been accepted medical procedure.

 

The question, they asked, is whether "medical experimentation can be considered a crime." The prosecution did not argue this, but condemned the experiments because they had been used for political and racial purposes. A half hour's reading in The Encyclopedia of Bioethics , under "human experimentation," "minority subjects," reveals that it had been thus for half a century. The Encyclopedia documents cases of experimentation on human beings of minority populations and Third World populations.


Eileen Welsome's book, "The Plutonium Files," (Dial Press, 1999), documents radiation experiments on human beings in the United States from the 1940s, after the exposure of Nazi experiments and the articulation of the Nuremburg Code. Some of the doctors who conducted these experiments and were later interviewed about them, confessed that they knew of the Nuremberg Code, but did not think it applied to them--that code was for the barbarian Nazis.

 

William Silverman of Columbia University, said:

"'The connection between those horrendous acts and our every day investigation was not made for reasons of self interest, to be perfectly frank. As I see it now, I'm saddened that I didn't see the connection, but that's what was sone. We wrapped ourselves in the flag....'" (p. 214.)

Welsome writes,

"Physicians performed experiments on healthy people and sick patients without informing them of what was going on or getting their consent. Sick patients were preyed on most frequently. They were convenient, plentiful, and vulnerable, since non-therapeutic procedures could be administered easily under the guise of medical treatment...

 

Terminally ill patients were perhaps the most vulnerable group of all... Women, children, unborn fetuses, minorities, the mentally retarded, schizophrenics, prisoners, alcoholics, and poor people of all ages and ethnic groups were targets." (p. 214-215)

There are examples of experimentation on human beings that is more democratic. Ed Regis' book, "The Biology of Doom: The History of America's Secret Germ Warfare Project," ( Henry Holt & Co., 2,000) writes of those experiments when U.S. Nay ships,

"without, it seems the knowledge of Congress, sprayed the Virginia coastal communities of Norfolk, Hampton and Newport News with BG (bacillus globigii--used to stimulate the spread of anthrax) [and] 800,000 people around San Francisco ay were exposed to clouds of these microbes."

("The New York Times Book Review, Jan. 22, 2,000).

Prior to this, in October, 1940,

"Japanese planes dropped a mixture of grains and fleas over Chinese towns, causing two major outbreaks of bubonic plague south of Shanghai." (Ibid)

The race to develop genetic medicine has opened new temptations for doctors to experiment on human beings.

 

The death of Jesse Gelsinger, 18 years old, who suffered from a non-threatening liver ailment, and was induced to undergo genetic treatment for it at the University of Pennsylvania, has exposed appalling practices that are now a century old: the cavalier behavior of the experimenters, the hasty patched-together "informed consent" form --after his death--- other procedural misconduct. ("The New York Times, Jan. 27, 2,000, page. 1, " Youth's Death Shaking Up Field of Gene Experiments on Humans.)


The philosopher Hans Jonas proposed that experimentation on human beings must be reserved not for the disenfranchised, but for the scientists and intellectuals themselves -- both for scientific and moral reasons. Scientifically, because the class that designs the experiments can best report on the probity and results of the experiments.

 

There were outstanding examples of this procedure in the nineteenth century, and occasionally one still hears of a medical doctor experimenting on himself (or a member of his family), but as human experimentation went from what David Rothman called "a cottage industry" in the nineteenth century to its present dimensions as an indispensable part of modern medicine requiring ever larger populations, "voluntary science martyrs" disappeared.

 

The reasons for this are not hard to find: If Mary Rafferty had understood what she presumably was consenting to, she would not likely have consented. Some who do consent are usually those in desperately dependent positions.


Jerome Stephens offers another, more chilling reason why the medical research community does not seek out "volunteers' from the higher socio-economic brackets.

 

Researching on the ignorant and the disenfranched allows the researchers to maintain control of the research process.

"Medical researchers, of course, are quite aware of the social, economic, and political backgrounds of those who serve as subjects, and while the researchers are interested in developing an ideology that does imply societal authority for experimentation, the primary goal seems to be to maintain their power over the neglected.

 

It is highly unlikely, for example, that researchers would even want to include large numbers of educated and affluent individuals as subjects, because to do so would almost certainly threaten the status quo by requiring that more information be imparted, and by requiring research to be better designed to avoid the completely useless experiments now conducted.

 

It is also obvious that more stringent regulations would emerge to control experimentation if groups with well-defined and powerful constituencies were used. At the present, the researchers, by confining their experiments primarily to the neglected, are potentially useful to the more affluent in that they may discover new knowledge, and the researchers provide no threat to the middle class.

 

Tacit consent to exercise power, then, does reside in researchers, but it is the exercise of power, not individual choice to submit to experimentation or overt societal authority that is the core to understanding the whole process of human experimentation."

Not quite.

 

Animal experimentation is "the core to understanding the whole process of human experimentation," for if the poor, the mentally retarded, the homeless, the orphaned and the imprisoned have little voice, the animals have no voice, and it is voicelessness and rightlessness that invests the whole procedure from animal to orphan to the mentally retarded.


We are not done with Auschwitz and Nuremberg. Their shadows are long.

 

The silence of the medical communities in Germany and the United States after the Second World War revealed the desire of the medical communities to distance themselves from the outrages of Auschwitz, by silence and by spreading the myth that the German experiments was the work of deranged scientists.

 

In his anthology, When Medicine Went Mad, Arthur Caplan asks why bioethics has so little so say about the Holocaust:

"There has been almost no discussion of the roles played by medicine and science during the Nazi era in bioethic literature. Rather than see Nazi biomedicine as morally bad, the field of bioethics has generally accepted the myths that Nazi medicine was either inept, mad, or coerced.

 

By subscribing to these myths, bioethics has been able to avoid a painful confrontation with the fact that many who committed the crimes of the Holocaust were competent physicians and health care professionals acting from their moral convictions.... A fog of excuses, lies, and exculpation has been laid over the crematoria and laboratories of the concentration camps."

When the Nazi doctors were asked in the Nuremberg trials how they could have brought themselves to perform such experiments, they responded that they had been trained by doing them on animals.

 

Time is exposing the desperate myth that animal experimentation replaces or disposes of the need for human experimentation, and that the work of the Nazi doctors was that of "mad scientists." Some of it was bad science, but some of it wasn't, and the work of the Nazi doctors has been entering mainstream Western medicine for decades.

 

The Columbus Dispatch in 1984 revealed that a researcher in British Columbia had been using the information from Nazi experiments on hypothermia. The Jerusalem Report of Feb. 22, 1996 revealed that Dr. Howard Israel, an oral surgeon at Columbia Presbyterian Medical Center in New York was dismayed to discover that his valuable and trusted book, Pernkopf's Topographical and Applied Human Anatomy contained illustrations that may be based on the cadavers of concentration camp victims.

 

Caplan's question in When Medicine Went Mad, "Should Nazi data from the experiments be used?" has been answered: Nazi data has been used by many scientists from many nations.


Our moral horror at the Nazi medical experiments was dissipated by our government's decision not to prosecute the Japanese for almost identical experiments on an almost identical number of victims, three thousand (many of whom were American prisoners), in exchange for the information from those experiments.

 

As Raoul Hillburg wrote in The Destruction of the European Jews,

"If the world was so shocked at what it discovered to be the extremes to which experimental medicine would go, it has yet to condemn the method or find the means to control it."

Back to Contents

 



The Nuremberg Code (1947)
Permissible Medical Experiments
from CircumcisionReferenceLibrary Website
 

 

BRITISH MEDICAL JOURNAL

No 7070 Volume 313: Page 1448,
7 December 1996

 
CIRP Introduction

The judgment by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human subjects in a new code that is now accepted worldwide.

This judgment established a new standard of ethical medical behavior for the post World War II human rights era. Amongst other requirements, this document enunciates the requirement of voluntary informed consent of the human subject. The principle of voluntary informed consent protects the right of the individual to control his own body.

This code also recognizes that the risk must be weighed against the expected benefit, and that unnecessary pain and suffering must be avoided.

This code recognizes that doctors should avoid actions that injure human patients.

The principles established by this code for medical practice now have been extended into general codes of medical ethics.


The great weight of the evidence before us to effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally.

 

The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study.

 

All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts:

  1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

     

    This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

    The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
     

  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
     

  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results justify the performance of the experiment.
     

  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
     

  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
     

  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
     

  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.
     

  8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
     

  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
     

  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

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