The Tuskegee Syphilis Study. Dr. Joseph Costa, D.H.Sc., PA-C. Health Policy and Management MPH 525. Dr. Adeniyi Mofoluwake Adijolola

Transcription

1 The Tuskegee Syphilis Study Dr. Joseph Costa, D.H.Sc., PA-C Health Policy and Management MPH 525 Dr. Adeniyi Mofoluwake Adijolola June 2013

2 1 Introduction The United States Public Health Service collaborated with the Tuskegee Institute in 1932 to study and record the natural history of syphilis with the aim of achieving evidence based treatment programs for blacks. This was called the "Tuskegee Study of Untreated Syphilis in the Negro Male (CDC, 2011). It was conducted in Tuskegee, Macon County, Alabama. It turned out to be a scandal in American medicine in the twentieth century (Brandt, 1978). This unethical study was conducted using six hundred African American men as subjects; three hundred and ninety- nine had syphilis while, the two hundred and one men who did not have syphilis were used as controls. The study was projected to last for 6 months but it lasted forty years (CDC, 2011). The Tuskegee Syphilitic study was not beneficial in any way. Forty years after the study started nothing was learnt to prevent, find or cure infectious syphilis or bring the United States closer to controlling venereal diseases (Brunner, 2007). It revealed more about the pathology of racism than the pathology of syphilis (Brandt, 1978). Why Public Health Went Wrong With The Study? The study was deceitful and it violated standard research procedures (Brandt, 1978). The subjects were deceived; though they agreed to participate in the study of their own free will, informed consents were not obtained from them (Heintzelman, 2003). They knew neither the details of the study nor its real purpose. The researchers told them that they were on treatment for bad blood, a local term used to describe several ailments, including syphilis, anaemia, leukaemia and fatigue. The men who had syphilis were not properly treated to cure them of the syphilis infections (CDC, 2011). The researchers gave the subjects mercurial ointment, inadequate dosages of neoarsphenamine and performed spinal taps on them to convince them they were being treated (Brandt, 1978). The control subjects that became syphilitic were transferred to the test group (Brandt, 1978). In 1927, Alabama passed a law requiring the reporting and treatment of several venereal diseases including syphilis, by medical personnel.

3 2 At the commencement of the study every textbook of syphilis advocated for syphilis therapy even in its latent stages. The USPHS sponsored and published a paper written by 7 experts on syphilis in 1932 when the Tuskegee Syphilis study began that strongly argued for treating syphilis (Brandt, 1978). Despite the law and the evidence of the need treat syphilis, treatment was withheld for the purpose of research (Heintzelman, 2003). When penicillin became the drug of choice for treating syphilis in 1947 and was made available by nationwide campaigns to eradicate venereal disease in Mason County; everything was done to ensure the men did not get treatment (Brunner, 2007). In 1934, the USPHS ensured even the local black doctors did not treat these men if they sort care (Brandt, 1978). The researchers intentionally chose poor, illiterate sharecroppers and tenant farmers as subjects. At that time there was an African American health deficit ; most of these men had never accessed a physician (Washington, 2007). They were pleased at the prospect of free meals, free medical care, free transportation to and fro the clinics, free medical treatment for minor ailments and burial insurance in exchange for taking part in the study (Brunner, 2007; CDC, 2011). The African American staffs that assisted the Tuskegee experiments were also deceived. They were made to believe that being part of the medical experiment was an opportunity to act in the best interests of poor black residents of Tuskegee (Brandt, 1978). The men were not offered an option of quitting the study at any time (CDC, 2011). The researchers wanted to autopsy the corpse of the subjects who developed tertiary syphilis and its complications. They wanted to collect data for experiments believing the experiments will scientifically confirm the findings study (Brunner, 2007). The USPHS collaborated with Tuskegee Institute Hospital by giving the hospital s director an interim appointment. This helped the USPHS deceive the men to have their corpse autopsied by having them die at the hospital (Brandt, 1978). Accurate records were not kept. The number of study participants that died from syphilis was not known. (Heintzelman, 2003). Though, no comprehensive

4 3 report was ever published, medical journals reported the study for almost forty years and no one in the medical community protested. Though physicians checked on the progress of the study periodically, the morality or usefulness of the study was never seriously scrutinized (Brandt, 1978). The USPHS disregarded the consequences of untreated syphilis on the subjects, their wives and or sexual partners (Heintzelman, 2003; Brunner, 2007). The health of the Macon County, Alabama was exposed to an enormous risk by not treating an infectious disease (Brandt, 1978). Why the Medical Profession Pursued the Study The medical profession pursued the study knowing that they were taking advantage of these men because of their vulnerability and racism. Doctors; the Tuskegee Institute Hospital; county and state health departments; draft boards; the Centres for Disease Control and Prevention; the National Medical Association; American Medical Association and the USPHS collaborated to ensure this study commenced and continued. It would have lasted for more than forty years had the press not got wind of it (Brandt, 1978). The researchers did say; we must remember we are dealing with a group of people who are illiterate, have no conception of time, and whose personal history is always indefinite" (Brandt, 1978). The USPHS assumed African Americans were promiscuous, lustful and were not likely to seek or continue therapy. They felt it was natural for them to have untreated syphilis presuming they would never be treated (Brandt, 1978). In 1960, the USPHS evaluated the status of the study and rationalized its racial aspects but forged ahead with the experiment and concluded they would answer to questions saying that the subjects were at a point that therapy would no longer help them and they were getting better medical care than they would under any other circumstances (Brandt, 1978). Though Dr. Lucas (Assistant Chief of the Venereal Disease Branch), stated in a memo he prepared that; "nothing learned will prevent, find, or cure a single case of infectious syphilis

5 4 or bring us closer to our basic mission of controlling venereal disease in the United States", he concluded that the study should be continued "along its present lines". In 1950, Dr. Wenger said that; "we now know, where we could only surmise before, that we have contributed to their ailments and shortened their lives. The study was still allowed to continue. In 1969, at the CDC, a group of physicians met to decide if the study should be terminated. At the meeting, Dr. Smith said; "you will never have another study like this; take advantage of it". There was a consensus that it should continue (Brandt, 1978). African Americans were called names that depicted racism in the speech and letters wrote to each other by the medical team. The study continued without treating the subjects twenty-five years after a cure for syphilis was discovered (Chadwick, 2002). What I would have changed about the way this study was run and why? This author would have ensured a purposeful study by changing the purpose and manner it was run. The purpose of the study would have been to control, prevent and find a cure for syphilis. Subjects would have being selected across all or several races and not the African American race alone. An informed consent would have been obtained from the subjects. African Americans that participated in the study would be made aware of the purpose and details of the study. Laws mandating treatment of all venereal diseases including syphilis and evidence based researches instructing the treatment of syphilis at any and all stages would have been obeyed. Syphilis therapy would not have been withheld for the purpose of the study. Controls would have remained controls and if they developed syphilis during the duration of the study, they would have been treated and opted out of the study. Records would have been properly kept according to the records of the medical profession. Comprehensive reports would have being published and would have been subjected to serious scrutiny. Informed consents would have been obtained for autopsy.

6 5 This would have prevented withholding treatment for the purpose of research; made the research ethical; non-racial; non-deceitful and standard research procedures would not have been violated. This would have prevented the violation of human rights- the right to health and the right to life that defined the Tuskegee Syphilis study. This would not have posed a risk to the men, their wives and or sexual partners, their unborn babies and Mason County. Informed consent Informed consent is a process of obtaining permission before conducting research or a healthcare intervention on an individual according to the research or medical ethics respectively. According to Burke & Friedman (2011); the legal dimensions of consent in health services are based on the concept that liberty rights prohibit any intervention unless the individual agreed to it. For consent to be ethical, it must be informed and given voluntarily by a competent person. Before consent is obtained adequately understood information about the facts, benefits, risks and alternatives to the services to be rendered should be communicated. A physician or someone authorised to act for a physician can obtain consent. Policies and procedures should be established to ensure that the clinical staff can ascertain that the person being served understands perfectly well what is happening (Burke & Friedman, 2011). Individual Autonomy The need to obtain consent for therapy and the way public health organizations and its staff view and interact with people it serves is governed by autonomy. According to Friedman & Burke 2011); autonomy requires that one acts towards others in a way that enables them to be self-governing. It is a liberty right, the right to be free from interference. It is inviolable except if its exercise interferes with other s rights. Exceptions to liberty rights occur in public health. An example is mandatory vaccination of school children. Autonomy also means that everyone should be accorded the respect, time and opportunity needed to make ones decision.

7 6 It requires that vulnerable persons (children, elderly, mentally ill, prisoners) are protected (Burke & Friedman, 2011). Beneficence Beneficence is acting with charity and kindness. It obligates public health to protect the public s wellbeing. It comprises of conferring benefits and balancing benefits and harms. In medical and public health practice, it is ethical to provide beneficence by doing all that is possible to help and benefit those being served (Burke & Friedman, 2011). According to Burke & Friedman (2011); beneficence anchors one end of a continuum, at the opposite end of which is the principle of nonmaleficence, defined as refraining from actions that aggravate a problem or cause other negative results. Beneficence balances the benefits and harm of an action; the concept of utility, the philosophical basis for cost-benefit and risk-benefit analysis. In public health decision making, utility is considered (Burke & Friedman, 2011). Current Policies Governing Informed Consents Current policies governing informed consents are listed below. The Federal Policy for the Protection of Human Subjects published in 1991, it is also called the Common Rule and it has 4 subparts. Subpart A, also known as the Federal Policy or the Common Rule. Subpart B, additional protections for pregnant women, human foetuses, and neonates. Subpart C, additional protections for prisoners and subpart D, additional protections for children (US DHHS, 2013). The National Research Act which was signed into law in July, It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research which develops guidelines for human subject research, defines what informed consent is in each setting, assesses the risks and benefits of the appropriateness of research involving human subjects oversees, and regulates the use of human experimentation in medicine (The President's Council on Bioethics, 1998).

8 7 In 1978, the National Commission for the Protection of Human Services of Biomedical and Behavioural Research released the Ethical Principles and Guidelines for the Protection of Human Subjects of Research and published it in 1979 in the Federal Register. It is also called the Belmont Report. It emphasizes on the protection of participants in clinical trials and research studies using 3 fundamental ethical principles for research (autonomy, beneficence and justice) and obtaining informed consents (Sims, 2010). The Nuremberg Code which lays an emphasis on obtaining consent (US DHHS, 2005). Scenarios Where Informed Consent Is Not Needed Informed consent is not needed in the scenarios listed below. In the event of an emergency when a person cannot communicate. If there is a need to administer healthcare that has no significant risk to an adult who lacks the capacity to consent for example, administering artificial nutrition or hydration, tetanus injection e.t.c. (Burke & Friedman, 2011 pg 96). When screening is done through a phone call initiated by the participant, it doesn t involve extensive or intrusive questions and identifiable information is not recorded. In studies conducted by or subjected to the approval of state or local government officials designated to study, evaluate or examine public benefit of service programs; procedures for obtaining benefits or services under those programs; possible changes in alternatives to those programs or procedures and possible changes in methods or levels of payments for benefits or services under those programs (University of Connecticut, n. d.). It will be unethical to waive consent for any area of clinical investigation. It will lead to taking advantage of vulnerable populations. If informed consents are waived for any area of clinical investigation, the society will lose its trust in both medicine and public health. There will be no proof that the standard offered is recognised as the standard of acceptable professional practice. Individuals will be subjected to investigations they are not aware of its

9 8 purpose, intent, benefit, risk and alternatives. This will result in an increase in litigation in medical and public health fields. It is ethically unacceptable especially with regulations like the Nuremberg code which emphasizes obtaining an informed voluntary consent from human subjects (US NIH, 2012). The Belmont report is a leader in ethics and health care research. It emphasizes on protection of subjects in clinical trials and research studies and considers it unethical to waive consent for any area of clinical research (Sims, 2010). Recommendation All medical and public health institutions should put in place measures to ensure informed consents is obtained from all patients and research participants as recommended by the common rule and the national research act. Medical and public health ethics which an emphasis on obtaining informed consent should be taught as a core course in all medical and public health schools. At all medical and public health institutions and organizations refresher courses should be organized and attended by physicians and everyone authorized to obtain informed consent in the place of a physician annually. To ensure attendance at the refresher courses, attendance of the course can be used as a pre-requisite to practising in the organization the following year. References

10 9 Centres for Diseases Control and Prevention, (2011). United States public health service syphilis study at Tuskegee. Retrieved from: Chadwick, A., (2002). Remembering the Tuskegee experiment. Retrieved from Brandt, M., (2007). Racism and research: The case of the Tuskegee syphilis study Retrieved from dash.harvard.edu/bitstream/handle/1/ /brandt_racism.pdf?...1 Brunner B., (2007). The United States government's forty year experiment on black men with syphilis Retrieved from: Heintzelman, C., (2003). The Tuskegee syphilis study and its implications for the twenty-first Century, The new social worker, 10(4) Sims, J., (2010). A brief review of the Belmont report. Dimensions of critical care Nursing, 29(4), The President's Council on Bioethics (1998) Retrieved from: United States Department of Health and Human Services, (2005). The Nuremberg code Retrieved from United States Department of Health and Human Services, (2013). Federal policy for the protection of human subjects (common Rule) Retrieved from United States National Institute of Health, (2012). The Nuremberg code Retrieved from: University of Connecticut, (n. d.) Informed consent Retrieved from: Washington, H., (2007). Medical apartheid: The dark history of medical experimentation on black Americans from colonial times to the Present Retrieved from Colonial/dp/ #