Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 261

1932: The Tuskegee Scandal
The Tuskegee study was carried out to study the evolution of patients with
syphilis. Although by that time it was known that penicillin was effective
against syphilis, the researchers decided not to give penicillin to patients in
order to continue with the study. This study is still today a matter of discus-
sion and a critical call to conduct clinical research ethically [6].
1950: The Jewish Chronic Disease Hospital Study
In studying the rejection process that takes place in transplantation, cancer
cells were inoculated in immundepressed patients to observe the effect of
cancer spreading with a depleted immunological system (nowadays a method
used in animal models to recreate tumorigenesis). Most of the subjects of the
study were elderly people with an impaired mental status. No informed con-
sent was required from the helpless patients and when they asked about the
study they were told that “the study was a simple skin test” [6].
1960: The Thalidomide Tragedy
Thalidomide is a drug that was prescribed to pregnant women due to its
potential use in morning sickness caused during pregnancy. Soon it was
realized that thalidomide was related to deformities in newborns (embry-
opathies) such as focomelia, heart defects and cranial nerve palsies, among
others. Almost 8,000 cases of abnormalities in newborns were reported in
Europe whereas only 17 cases were reported in the United States (in clini-
cal trials).This was because the drug was not approved in the United States
due to concerns regarding potential neuropathy related to the drug (but not
because of the potential embryopathies) (Rice, 2008). This tragedy resulted
in an amendment of the Food and Drug Cosmetic Act by including the
informed consent of the patient as a primary document to conduct human
subject research [46].
1970s: The Dalkon Shield Case and Intrauterine Devices
One of the most important scandals in the history of medical devices was
that of the Dalkon Shield, an intrauterine contraceptive, designed with
nylon-6 and with a multifilament tail, which was withdrawn from the mar-
ket in 1974 after several cases of Pelvic Inflammatory Disease and Sepsis
were reported. The problem was blamed on the design of the device where
multifilament tails were incorporated to allow the physician to have access
FIGuRE 10.7
Historical tragedies involving biomedical research in human subjects.