Category Archives: Ethics

The Tuskegee Experiment

The Tuskegee Experiment (From Truth-The Hemorrhage of Pigs!)

Tuskegee Syphilis Experiment

by Truth on Wednesday, December 28, 2011 at 3:00am

The Tuskegee syphilis experiment (also known as the Tuskegee syphilis study or Public Health Service syphilis study) was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S. government.

The Public Health Service, working with the Tuskegee Institute, began the study in 1932. Investigators enrolled in the study a total of 600 impoverished, African-American sharecroppers from Macon County, Alabama; 399 who had previously contracted syphilis before the study began, and 201 without the disease. For participating in the study, the men were given free medical care, meals, and free burial insurance. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for “bad blood,” a local term used to describe several illnesses, including syphilis, anemia and fatigue.

The 40-year study was controversial for reasons related to ethical standards; primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease they were studying. Revelation of study failures by a whistleblower led to major changes in U.S. law and regulation on the protection of participants in clinical studies. Now studies require informed consent (with exceptions possible for U.S. Federal agencies which can be kept secret by Executive Order), communication of diagnosis, and accurate reporting of test results.

By 1947, penicillin had become the standard treatment for syphilis. Choices available to the doctors involved in the study might have included treating all syphilitic subjects and closing the study, or splitting off a control group for testing with penicillin. Instead, the Tuskegee scientists continued the study without treating any participants and withholding penicillin and information about it from the patients. In addition, scientists prevented participants from accessing syphilis treatment programs available to others in the area. The study continued, under numerous US Public Health Service supervisors, until 1972, when a leak to the press eventually resulted in its termination. The victims of the study included numerous men who died of syphilis, wives who contracted the disease, and children born with congenital syphilis.

The Tuskegee Syphilis Study, cited as “arguably the most infamous biomedical research study in U.S. history,”  led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections (OHRP). It also led to federal laws and regulations requiring Institutional Review Boards for the protection of human subjects in studies involving human subjects. The Office for Human Research Protections (OHRP) manages this responsibility within the US Department of Health and Human Services (HHS).

http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment

The Public Health Service Act of 1944 structured the United States Public Health Service (PHS) as the primary division of the Department of Health, Education and Welfare (HEW), which later became the United States Department of Health and Human Services. The PHS comprises all Agency Divisions of Health and Human Services and the Commissioned Corps. The Assistant Secretary for Health (ASH) oversees the PHS and the United States Public Health Service Commissioned Corps.

Mission

The mission of the U.S. Public Health Service Commissioned Corps is to protect, promote, and advance the health and safety of the United States. According to the PHSCC, this mission is achieved through rapid and effective response to public health needs, leadership and excellence in public health practices, and advancement of public health science.

Tuskegee Study of Untreated Syphilis in the Black Male

In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks. It was called the “Tuskegee Study of Untreated Syphilis in the Negro Male”.

The study initially involved 600 black men – 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients’ informed consent. Researchers told the men they were being treated for “bad blood,” a local term used to describe several ailments, including syphilis, anemia, and fatigue. In truth, they did not receive the proper treatment needed to cure their illness. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years. It has been called “arguably the most infamous biomedical research study in U.S. history.”

Note that a USPHS physician who took part in the Tuskegee program, John Charles Cutler, was in charge of the US government’s syphilis experiments in Guatemala, in which Guatemalan prisoners, soldiers, orphaned children, and others were deliberately infected with syphilis and other sexually transmitted diseases from 1946-1948 in order to study the disease, in a project funded by a grant from the National Institutes of Health. President Obama apologized to Guatemala for this program in 2010.

http://en.wikipedia.org/wiki/U.S._Public_Health_Service

Diseases with which the CDC is involved in other than the Tuskegee Experiment is:

Influenza

The CDC has launched campaigns targeting the transmission of the flu, including the swine flu (H1N1). The CDC has launched websites including [flu.gov] to educate people.

Other infectious diseases

The CDC’s website (see below) has information on other infectious diseases, including smallpox, measles, and much more.

Non-infectious disease

The CDC also combats non-infectious diseases, including obesity.

http://www.cdc.gov/Features/Tuskegee/

 

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Tuskegee Syphilis Experiment PART II

The Tuskegee Experiment II (From Truth-The Hemorrhage of Pigs!)

Tuskegee Syphilis Experiment PART II

by Truth on Wednesday, December 28, 2011 at 3:17am
From: http://www.rbs2.com/humres.htm (There are many experiments on this site)

 

tuskegee-syphillis-experiment-101007-02

Tuskegee syphilis experiment

The deliberate failure to treat a group of male Negroes in Macon County (near Tuskegee), Alabama who had syphilis begun in 1932 and ended, by unfavorable publicity, in 1972. This experiment is difficult to discuss, because so much was wrong with it. In my opinion, there are three major mistakes. Page citations are to Bad Blood by James H. Jones, a historian and scholar in bioethics.

  1. The U.S. Public Health Service (PHS) began using penicillin to treat syphilis in 1943 (p. 178) and penicillin became generally available in 1953 (p. 211). Despite this safe and effective treatment, which would have halted the progression of syphilis in the subjects, penicillin was deliberately withheld from the subjects. Not only did the PHS not give penicillin to their subjects, but the PHS (1) repeatedly distributed lists of names of subjects to local physicians and instructed the physicians not to give penicillin to these subjects (pp. 144-45, 162-63) and (2) supplied sham “treatments” (e.g., aspirin at p. 147, 160) to subjects, in an attempt to discourage subjects from seeking treatment elsewhere. The failure to treat this communicable disease violated Alabama law. (pp. 178, 212) In 1950-51, the PHS knew “that we have contributed to their ailments and shortened their lives.” (p. 182) In the 1970’s, the PHS offered the pretexual and lame excuse that penicillin would have harmed the participants if it had been given (pp. 8, 195), but when penicillin was given in 1973, there were no adverse reactions (p. 215). If, indeed, there were legitimate doubts about the safety and efficacy of penicillin in patients with long-term syphilis, administration of penicillin to these subjects would have made a worthy experiment in the late 1940’s or early 1950’s.
  2. Dr. Vonderlehr, of the PHS, practiced a fraud on the subjects by offering a painful lumbar puncture as a “special free treatment”, when, in fact, the procedure was purely diagnostic and only for the benefit of the researchers.
  3. The subjects were not informed that they had syphilis (pp. 71-74, 219). Admittedly, informed consent would be extraordinarily difficult, because of the lack of education of the subjects: most were illiterate and many did not know their last name (pp. 4, 218). One of the best educated subjects had completed only eight years of school. To the extent that the subject’s lack of education made informed consent impossible, these people should never have been allowed to suffer for the benefit of the physicians. It would have been a different matter if the subjects had been treated benevolently, for example, given penicillin prior to 1954.

To me, the most important question about the Tuskegee experiment is:

“Why was this experiment begun and continued?”

The project was begun in 1929 as a syphilis control program, using the standard therapy of 1929-33: a series of at least twenty IM injections of arsenic compounds, supplemented by topical applications of mercurial ointment. (pp. 45-90) However, there was not enough money for full treatment, despite the application of the PHS to private foundations. The subjects received only eight injections, which cured only 3% of them (p. 119).

There was a very high incidence of syphilis among Negroes in Macon County: 36%, which should be compared to the national average for Caucasians of only 0.4%. Given that these black men were living in distressing poverty (pp. 61-62, 83, 107, 201) and ignorance, it was easy to get them to follow orders from white physicians. When it was not financially possible to treat these subjects, the physicians may have looked for other things that they could do with this docile and relatively immobile group of people. In 1933, the long-term complications of syphilis were well known in Caucasians, but the common view amongst physicians was that Negroes responded differently to disease than Caucasians. So, apparently, the physicians decided to study the progression of untreated syphilis in Negroes, ending only when all of the subjects had been autopsied. I say “apparently”, because with all of the bureaucratic obfuscation in the 1970’s, it is not clear what the motivation really was in 1933.

I get the impression that the PHS saw these subjects as a wonderful opportunity for an experiment, when the PHS’s first choice – a treatment program – was denied for lack of financial support, they found another experiment to do with this group of subjects. Support for my view is given by the continuation of the experiment in 1951: “the widespread use of … [penicillin] had practically eliminated the possibility of finding another large group of syphilitic patients”. (p. 179)

Given the unethical aspects of this experiment, why was it allowed to continue until stopped by public outcry in 1973? Apparently, the long-term experiment was never seriously questioned – as a matter of bureaucratic inertia – since it had continued for such a long time and was allegedly valuable. Further, when new managers were appointed, these new managers were reluctant to rescind decisions of their mentors. (p. 178, 180)

Bad Blood (at p. 190) alleges that the first physician objected to the experiment only in 1965. In 1966 a social worker at a PHS VD clinic in San Francisco objected to the study, and, in 1972, he tipped a reporter at Associated Press. (pp. 191-193, 203-205). The initial reaction of the PHS was that they had a public relations problem on their hands, but they had done nothing unethical. (p. 201) Remember, the Tuskegee experiment was no secret among physicians who worked on sexually transmitted diseases: results from this experiment were published in medical journals. I think it remains an important and unanswered question of why the entire medical establishment was so blind to ethics for more than forty years.

Other points of Tuskegee experiment

From the viewpoint of 1996, it is shocking that women were omitted from the study. But, by not treating the men in the study and by not informing the men of the nature of the disease, the PHS permitted many women to become infected with syphilis and many infants to acquire congenital syphilis. (pp. 104, 165, 215) Around 1930, 62% of the men in the study had congenital syphilis (p. 76), so the PHS simply allowed the disease to continue, nonetheless, one would expect better of the PHS.

A study of nearly 2000 untreated syphilitic in Oslo, Norway from 1891-1910 had been published and a follow-up study of them was published in 1929. (pp. 10, 92-3, 167, 183) Why did the PHS need to repeat the Oslo experiment? The common view amongst physicians in the 1930’s was that Negroes responded differently to disease than Caucasians.

Some commentators mention that the PHS paid for the subjects’ funeral expenses as a way of inducing consent to autopsy. I see nothing wrong with such compensation.

Finally, despite the suffering of the participants, it is uncertain how much valid, new medical knowledge was published as a result of this study. A 1933 review by the American Heart Association said the results of X-ray examinations of syphilitic hearts had “very little, if any, value”. (p. 139) No one knew the exact number of subjects. (p. 181) Twelve of the two hundred controls acquired syphilis in the first six years of the study. (p. 176) Some of the subjects may have received penicillin for other infections. (p. 202) The autopsies were conducted until 1952 with “high-grade Neanderthal equipment”. (p. 184) And, of course, these supposedly untreated subjects had received some treatment in the 1930’s, which cured about 3% of them and had unknown effects on the progression of disease in the remainder. (pp. 119, 131, 173-76, 182, 202) I am also concerned that chronic malnutrition might induce pathologies of comparable severity to partially treated syphilis. So, in the end, this ghastly experiment tells us nothing about untreated syphilis. And since penicillin is an effective cure for syphilis, we have no reason to know about the progression of untreated syphilis.

There was also little valid medical knowledge from the so-called experiments in Nazi concentration camps. This parallel raises the question “Are unethical studies also likely to be invalid?”. While I acknowledge that technical skills in biology and statistics are entirely different from knowledge of morality and ethics, I nevertheless maintain that a competent scientist is zealous about both technical and ethical concerns. In particular, I don’t see how a physician can work amongst suffering people without being aware of, and concerned about, their suffering. The moment that the physician sees subjects (as if they were a inanimate object), instead of patients or people, the physician has lost some of his humanity. If the physician can’t see suffering, how much else can he not see?

At least 28, perhaps more than 100, of the 399 subjects had died from syphilis. (pp. 1-2) Litigation against the PHS, et al., was settled in Dec 1974, 18 months after suit was filed, for $ 37,500 to each surviving participant and $ 15,000 to each decedent’s estate. (p. 217) As yet another piece of exploitation of the subjects, the attorney who brought the suit received 1/8 of the settlement, which gave approximately one million dollars to the attorney – quite a nice income in 1974 for a case that did not go to trial. (p. 217) Interestingly, this black attorney included neither any predominantly black institution nor any black physicians or nurses as defendants (pp. 216), although the Tuskegee Institute and a number of black physicians had been involved in the experiment, which was operated from the beginning until 1965 by one black nurse. While one might be reluctant to blame a black nurse for following orders of white physicians, especially during the 1930’s and 1940’s (pp. 151-169), “following orders” was not an acceptable excuse for German war criminals.