In
1933, the U.S Public Health Service in Macon county, Albama began an investigation
to chart the succession of phases syphilis
exhibits
when left to itself, uncomplicated by other morbid processes and unmolested
by active treatment. 399 African-American men with latent syphilis and
201 men without disease were enrolled in the study based on the results
of a 1930 venereal diseases control projects survey. This survey had identified
Macon County to have the highest prevalance of syphilis of the six southern
States examined. The rural setting of Tuskegee - a deprived socioeconomic
status,high rates of illiteracy and especially a paucity of medical
care - were exploited by the investigators of the syphilis study who led
the poor sharecroppers to believe they were being treated for "bad blood,"
a euphemism for syphilis. The study, which lasted for 40 years included 
only
sporadic clinical reexaminations when a Public Health physician came to
Tuskegee and denied the individuals any form of anti-syphilitic therapy.
In fact, in 1942 when it was brought to the attention of the then Assistant
Surgeon General, Vonderlehr that some of the syphilitic subjects were being
called for examination prior to induction into the Armed Forces and were
being directed to undergo treatment systematic steps were taken to preserve
the investigation. To prevent the draftees from receiving anti-syphilitic
treatment, the investigators provided the Macon County Selective Service
Board with a list of 256 names of men under the age of 45 years who were
to be excluded from the list of draftees needing treatment. The Board agreed
to exclude these men. Furthermore, when the modern-era of anti-syphilitc
therapy began in 1943 with the introduction of penicillin as an effective
drug, the Public Health Service did not use the drug on the Tuskegee participants
unless they asked for it. The rationale published by the investigators
for their decision regarding the lack of treatment provided to the infected
"Negro" population was,
"...Such individuals seemed to offer an unusual opportunity to study the untreated syphilitic patients from the beginning of the disease to the death of the infected person. An opportunity was also offered to compare the syphilitc process uninfluenced by modern treatment, with the results attained when treatment had been given."(6)By the time the study was exposed in 1972, and ended on November 16th of the same year, 28 men had died of syphilis, 100 others were dead due to syphilis related complications, at least 40 wives had been infected and 19 children had contracted the disease at birth.
On July 23rd, eight months after the Tuskegee syphilis study was abandoned, a $1.8 billion class action suit was filed against the institutions and individuals involved. Prominent civil rights lawyer, Fred Gray, demanded $3 million in damages for each living participant and the heirs of the deceased. The case, however, never came to trial and in December 1974 and out of court settlement was made. The government agreed to the distribution of $10 million, whereby each survivor received $37,500 in damages and the heirs of the deceased received $15,000.
The most vociferous criticism of the Tuskegee Study has been that the subjects were not provided with the adequate information needed to willingly consent to participating. The subjects were not consulted about the research project, its consequences to them and the alternatives available to them. A program that promised little inconvience and substantial rewards to the impoverished society of Tuskegee necessarily appealed to the participants of the study.
Bearing in mind the low educational status of the patients and the tendency of the average African-American man to willingly agree with a perceived authoritarian figure such as the Public Health Service physician the men from Tuskegee became the unassuming victims of an unethical scientific undertaking."...various methods were used to maintain and stimulate their interest. Free medicines, burial assistance or insurance, free hot meals on the days of examination, transport to and from the hospital and an opportunity tp stop in town on the return trip...all helped." (7)
This was stated in the venereal disease law enacted by the Alabama Legislature in 1927. Notwithstanding the law the officials of a Federal Agency, the Public Health Service, were successful in withholding therapy from the participants of the Tuskegee Study, and the physicians did not detect an ethical dilemma."...The county health officer shall require persons infected with venereal disease to report for treatment to a reputable physician and continue treatment until such disease, in the judgement of the attending physician is no longer communicable..." (8)
Altough there were no guidelines in 1930 to influence the formulation of a prospective study of patients with an untreated chronic disease, when the Judiciary Council of the American Medical Association issued a report, on December 10th, 1946, on the ethics of experiments involving human subjects the investigators of the Tuskegee Study took no steps to revise or terminate their investigation. The Tuskegee Syphilis Study was in violation of all three requirements proposed by the Judiciary: (1) the voluntary consent of the person on whom the experiment is to be performed must be obtained, (2) the danger of each experiment must be previously investigated by animal experimentation, (3) the experiment must be performed under proper medical protection and management. <see also The Nuremberg Code>
In the aftermath of the Tuskegee Study the government reevaluated its research practices to prevent another Tuskegee. The National Research Act was signed in 1974, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The group identified the basic principles of research conduct and suggested ways to ensure those principles were followed. <see also The Belmont Report>
Furthermore,
regulations were passed that required all studies using human subjects
be reviewed by an Institutional Review Board, which read the study protocols
and decided whether they met ethical standards.
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REFERENCES
(1) Benedek TG : The 'Tuskegee
Study' of Syphilis: Analysis of Moral versus Methodological Aspects. J
Chronic Dis 31: 35-50, 1978
(2) Kampmeier RH : Final Report on the 'Tuskegee
Syphilis Study.' Southern Medical Journal 67(11): 1349-1353, 1974
(3) MaDonald CJ : The Contribution of the Tuskegee
Study to Medical Knowledge. J Na'tl Medical Association 66(1): 1-7,
1974
(4) Curran WJ, Hyg SM : Law-Medicine Notes The
Tuskegee Syphilis Study. NEJM 289(14): 730-731, 1973
(5) Cheever DW : The value and the fallacy of
statistics in the observation of disease. Boston Med Surg J 63,
1861
(6)
Vonderlehr RA, Clark T, Wegner OC et al : Untreated syphilis in
the male Negro. Ven Dis Inform 17: 260-265, 1936
(7)
Rivers E, Schuman SH, Simpson L et al: Twenty year follow-up experience
in a long-range medical study. Publ Hlth Rep 68: 391-395, 1953
(8)General
laws of the legislature of Alabama. Session of 1927. Montgomery : Brown
716, 1927
(9) The Tuskegee Syphilis Study Legacy Committee
Report : http://www.med.virginia.edu/hs-library/historical/apology/report.html
(10) How Tuskegee Changed Research Practices
: http://www.nih.gov/sigs/bioethics/IRB.html