Lessons taught by Miss Evers' Boys: the inadequacy of benevolence and the need for legal protection of human subjects in medical research.

• Author: Hermann, Donald H.J.

Legal regulation and ethical constraints on medical research are again at the forefront of public policy concerns. The reported deaths of a volunteer in a gene therapy research program at the University of Pennsylvania and of a participant in an asthma experiment at the Johns Hopkins Medical Center have raised issues of the adequacy of government surveillance of medical research and the adequacy of current practices eliciting voluntary informed consent from research participants. (2)

The recognition of the need for legal constraints on medical research and for protection of human subjects was greatly influenced by the reports of the research conducted by Nazi doctors and scientists. (3) While no one denies the atrocities committed under the guise of medical research in the Third Reich, there has also been recognition of the significant abuse of research subjects in the United States, most recently in the reports of the Federal Advisory Committee on Human Radiation experiments. (4) Perhaps the most publicized research involving failure to protect human subjects in medical research is the Tuskegee Syphilis Study (5) which provides the subject matter of the film Miss Evers' Boys. (6)

The movie Miss Evers' Boys is a fictionalized narrative based on the Tuskegee Study of Untreated Syphilis in the Negro Male, a project sponsored by the United States Public Health Service that was initiated in 1932 to determine whether the effects of syphilis in black men paralleled the reports of the effects of this venereal disease in Caucasian men in a Norwegian study conducted in Oslo between 1891 and 1910. (7)

The Tuskegee Syphilis Study was authorized by the United States Public Health Service to observe a number of black men infected with syphilis who were living in Macon County, Alabama. (8) The purpose of the project, which was run through a clinic associated with the Tuskegee Institute, was to determine the natural course of untreated syphilis in black males and "the difference in historical and clinical course of the disease in black versus white subjects." (9) Four hundred men with syphilis were initially enrolled in the project, along with 200 uninfected men who served as controls. (10) The first published report of the study appeared in 1936 (11) followed by reports provided every four to six years until 1960. (12) Although penicillin became generally available in 1950, the infected subjects were not given penicillin. (13) As late as 1969, the Centers for Disease Control recommended continuation of the study without any treatment for syphilis being provided to the research subjects. (14) The study was halted in 1972 and those subjects still living were given penicillin following publication of newspaper stories critical of the Tuskegee Study in the various newspapers, including the New York Times. (15)

The film Miss Evers' Boys portrays the transformation of a government sponsored syphilis treatment program .into a clinical research project in 1932 in which existing treatments were to be withheld and later discovered treatments were not offered to the research subjects. (16) The program continued until 1972 despite the widespread acknowledgment of the effectiveness of penicillin in treating the disease by the late 1940's. (17)

A 1973 Senate hearing provides the background setting for the film's principal character, nurse Eunice Evers' testimony about the history of the project and her view of the ultimate justification of the role she played, along with that of the directing physicians. (18) In the film, Miss Evers recalls her initial recruitment into the treatment program in 1932. (19) Dr. Eugene Brodus, an African-American physician working in the clinic at the Tuskegee Institute, was himself invited to join in the research project by Dr. John Douglas, a white physician who was assigned by the Public Health Service to administer a private foundation financed syphilis treatment program. (20) The Tuskegee Institute was selected because of its stature in the black community and because of epidemiological evidence of widespread syphilis infection among African American men in the surrounding geographical area. (21) However, according to the film narrative, within less than a year, the effects of the depression on dissipating the sponsoring foundation's assets necessitated a decision to discontinue treatment with the collateral consequence of nurse Evers termination from the initial treatment project. (22)

Meanwhile, in Washington, D.C., officials at the Public Health Service developed a proposal to fund a research project to study the course of untreated syphilis in black males by replacing the existing treatment being provided to the patients with a placebo. (23) The project involved transforming patients into a research project, without informing them of the change in their status from patient to research subject. (24)

In the film, Public Service officials, including Dr. Douglas, justify their action on the ground that the research could undermine social prejudice by showing that the course of syphilis is no different in black men than in white. (25) Moreover, proponents of the research point out that the alternative for the patients would be not only no treatment for syphilis, but the loss of all medical treatment at the clinic. (26) By their unknowing participation as research subjects, it was argued by the researchers and government officials that these men would at least receive care for their other medical needs. (27)

Dr. Brodus, who is generally portrayed as dismayed by the elimination of the treatment program, initially is outraged by the proposal to replace existing treatment with a placebo since the studies on white men done over a quarter of a century before had not only traced the cause of the disease, but had led to successful treatments. (28) Dr. Brodus, however, is a pragmatist who becomes convinced that his participation in this research program will not only result in subsequent reinstitution of funding for treatment, but will also establish that human diseases have the same effect whatever the race of the infected person. As he assumes the mantle of research scientist, Dr. Brodus insists the project be called "The Tuskegee Study of Untreated Syphilis in the Negro Male." (29)

Eunice Evers begins her testimony at the Senate hearing with the words of her ethical pledge as a nurse:

I solemnly pledge myself before God and in the presence of this assembly; To pass my life in purity and to practice my profession faithfully; To hold in confidence all matters revealed to me in the practice of my calling; To abstain from knowingly administering any harmful medicine; To do all in my power to maintain the standard of the nursing profession; To endeavor with loyalty to aid the physician in his work; To devote myself to the welfare of those patients committed to my care. (30) This oath, based on Florence Nightingale's Pledge of 1 $93, embodies the main tenets of the oath of Hippocrates that governs the provision of medical treatment as well as research involving patients, including participation of all human subjects in medical research projects. (31) This pledge provides the ethical background against which the viewer is asked to judge Miss Evers.

Much of the significance of this film is the interpretation of the words of this oath by nurse Evers as a justification for participation in medical research involving withholding of available treatment and lack of voluntary informed consent by patients. From the outset, in the film, Miss Evers is aware and troubled by the nature of the research project when she is asked to return to work at the clinic as a member of the staff of the research study. She questions the direction that arsenic injections and mercury backrubs be replaced by the placebo of heat liniment. (32) She is disturbed that patients are not told of this withholding of treatment, and that a procedure involving obtaining spinal taps, to obtain research specimens, is passed off as "backshot" treatment. (33)

Initially, nurse Evers accepts the pragmatic view that her engagement in the research project is a temporary expedient necessary to obtain restored funding for treatment which will be available to all infected patients. (34) An apparently significant underlying factor in nurse Evers continued participation in the project is her deference to the judgment of physicians about the appropriateness of the project.

With the passage of months and years, new justifications or rationalizations are sought by Nurse Evers by which she sought to find, within her understanding, what was necessary to care for the men who were participating in the study. Throughout her participation in the research project, Nurse Evers accepts the idea that not telling the men that they are participating in a study and not receiving treatment is justified by their lack of education and likely misplaced fear if they were informed. (35) However, it is the experience of Caleb Humphries, a research subject with whom Eunice Evers, establishes a romantic attachment that becomes a central issue in the film. Caleb Humphries places himself before Miss Evers as a patient who has been cured of syphilis by penicillin injections. (36) This evidence of an available cure of syphilis with penicillin treatment creates a significant question for Nurse Evers' mind about the propriety of continuing the study of the effect of untreated syphilis. Again, Miss Evers, however, defers to the physicians conducting the experiment when they assert that penicillin injections would provide a significant danger of death to the research subjects because of their advanced stage of the disease. (37) The film epilogue points out that when the project was halted in 1972, the remaining research subjects were given penicillin treatment without any significant side effect. (38)

Miss Evers also testifies to her awareness that Dr. Douglas at some time avowed the...