Historic Examples

 

What are some historical examples of unethical biomedical research and what lessons has society learned?

 

Answer: There are several historical examples of unethical biomedical research over the past century, which have common threads with embryonic stem cell research. These examples of unethical biomedical research ultimately led to the formation of guiding bioethical principles called the Nuremberg Code, the Declaration of Helsinki and the 1974 National Research Act.

 

Example 1

 

• On December 9, 1946, an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for crimes against humanity (USA vs Karl Brandt or Doctor Trial).

• German physicians planned "Euthanasia Program," the systematic killing of those they deemed "unworthy of life." The victims included the mentally retarded, the institutionalized mentally ill, and the physically impaired.

• German physicians conducted pseudoscientific medical experiments utilizing thousands of concentration camp prisoners without their consent. Most died or were permanently crippled as a result. Most of the victims were Jews, Poles, Russians and Gypsies.

• Sixteen of the doctors were found guilty. Seven were sentenced to death. They were executed on June 2, 1948.

 

The following are the types of unethical experiments that were conducted:

 

• A) High-Altitude Experiments

• B) Freezing Experiments

• C) Malaria Experiments

• D) Mustard Gas Experiments

• E) Sulfanilamide Experiments

• F) Bone, Muscle, and Nerve Regeneration and Bone Transplantation Experiments

• G) Sea-Water Experiments

• H) Epidemic Jaundice Experiments

• I) Sterilization Experiments

• J) Spotted Fever (Fleckfieber) Experiments

• K) Experiments with Poison

• L) Incendiary Bomb Experiments

 

An important principle from the Nuremberg trial was the formation of the Nuremberg Code that human subjects should receive informed consent and that research should not be conducted on subjects when there is the potential for harm. For details of the Nuremberg Code see link. In the 1964 the World Medical Association reaffirmed bioethical research standards in the Declaration of Helskinki.

 

Example 2

 

• Between 1945-1966 the NIH funded 2,000 research projects, and none of them used informed consent.

• Thalidomide was being developed at the time to prevent miscarriages. The head of the Food and Drug Administration did not want to approve the drug for use because she was unsatisfied with test results.

• 200,000 American women were given the drug without knowing that it had not been approved. These women were essentially taking part in a drug trial without knowing it. They were not warned of the risks.

• Many babies of women taking this drug were born with extreme birth defects.

• Congress passed an amendment to the Food, Drug and Cosmetic Act that required doctors to tell patients if they were taking a trial drug.

 

Example 3: The Beecher Report of 1966

 

Dr. Henry Beecher wrote a landmark article in the June 16, 1966 issue of the New England Journal of Medicine exposing many clinical research trials that had been funded by the government that were very highly unethical.

 

• He gave 22 examples of unethical research.

• One of the examples was that mentally retarded children at a state school were infected with a hepatitis virus. The researcher who carried out this experiment eventual became head of the pediatrics department at New York University. He felt that he was justified because a cure for hepatitis would help many more people.

• Beecher cited other clinical trials done on marginal members of society such as the poor, developmentally disabled and senile who couldn't decide to participate in these trials.

• In July 1966, NIH called for an independent Institutional Review Board to review all research done by an institution. These Review Boards examined risks and benefits of research and how the researcher intended to obtain informed consent.

• Shortly after the FDA created rules for obtaining informed consent of investigations of new medicines.

 

Example 4: The Tuskegee Study

 

• The United States Public Health Service conducted the study.

• The Tuskegee study began in 1932 and continued until 1972, when it was revealed to the public.

• The purpose of the study was to examine the long-term affects of syphilis. The subjects of the study were 400 African-American males who were primarily poor sharecroppers. These men all had syphilis, but were unaware of it.

• They were also unaware of the true nature of the experiment. The most horrifying aspect of the experiment was in the 1950 penicillin was proved to be effective at curing syphilis. The researchers did not treat the men's syphilis and even prevented other doctors who saw the participants from treating the syphilis.

• As many as one hundred men died from complications from their untreated syphilis.

• The study was revealed in 1972 by a researcher who had worked on the project. His newspaper article shocked the country and caused the project to be shut down.