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martes, 12 de octubre de 2010

VIOLACION A LA ETICA EN INVESTIGACION


Early Release Article: posted October 11, 2010 JAMA
Intentional Infection of Vulnerable Populations in 1946-1948
Another Tragic History Lesson
Thomas R. Frieden, MD, MPH; Francis S. Collins, MD, PhD
JAMA. Published online October 11, 2010. /jama.2010.1554


Unethical uses of humans as research subjects represent appalling chapters in the history of medicine.1 To ensure that effective protections against such abuses continue to evolve and improve, it is essential to continue to learn from historical examples. Sadly, a new example has recently come to light.
While conducting research on the Tuskegee study of untreated syphilis,2 Wellesley College Professor Susan Reverby recently reviewed the archived papers of John Cutler, a US Public Health Service (PHS) medical officer and a Tuskegee investigator. Instead of finding Tuskegee records, however, Reverby found the records of another unethical study. In this study, vulnerable populations in Guatemala—mentally incapacitated patients, prison inmates, sex workers, and soldiers—were intentionally exposed to sexually transmitted infections (syphilis, gonorrhea, and chancroid).
The work was directed by Cutler and was done with the knowledge of his superiors, including then Surgeon General Thomas Parran Jr. Funded with a grant from the National Institute of Health (NIH) to the Pan American Sanitary Bureau (which became the executive arm of the Pan American Health Organization), the study was conducted in cooperation with Guatemalan investigators by the USPHS Venereal Disease Research Laboratory, which 10 years later became a part of the Centers for Disease Control and Prevention (CDC).
As described by Reverby,3 the study's initial syphilis experiments used female sex workers, intentionally infected with Treponema pallidum, as a source of infection to male prison inmates. At that time, sex workers were allowed into Guatemalan prisons. When the rates of female-to-male transmission proved to be low, the research approach changed to the direct inoculation of prison inmates and patients in the Guatemalan mental hospital. Most inoculation experiments involved subcutaneous injection of T pallidum or exposure of the penile foreskin to infectious material. The majority of study subjects were treated with penicillin, although available study records do not document therapy or completion of therapy for all subjects and some received only partial treatment.4
One study subject, a patient with a history of severe epilepsy, died of status epilepticus during treatment with penicillin. Although additional deaths occurred during the conduct of the study in the mental hospital, they were most likely related to the high rates of underlying disease, such as tuberculosis. The investigators provided some items for institutional support, such as anticonvulsant medications and refrigerators to store vaccines, and offered cigarettes as an incentive to study subjects. The archives provide no indication that individuals understood that they were participating in research.
Most of the gonorrhea and chancroid experiments were conducted with Guatemalan soldiers. While the initial studies involved sexual contact of soldiers with female sex workers who had been infected with gonorrhea, subsequent subjects were infected through intraurethral inoculations of Neisseria gonorrhoeae and cutaneous inoculations of Haemophilus ducreyi, and then treated with penicillin and sulfathiazole, respectively.

Ethical Violations
Ethical violations in this study clearly include the following: (1) study subjects were members of vulnerable populations including institutionalized and mentally disabled persons, prison inmates, and soldiers (who could not give valid informed consent); (2) individuals were intentionally infected with pathogens that could cause serious illness; and (3) deception was used in conducting the experiments. Correspondence between the investigators and their superiors also recognized the unethical nature of the work. A letter from Cutler's supervisor, R. C. Arnold, written in 1948, notes that, "I am a bit, in fact more than a bit, leery of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody organization got wind of the work, they would raise a lot of smoke."4 The study was never published.
Unfortunately, such studies were not rare at the time. For example, intentional infection of prison inmates with gonorrhea and syphilis was conducted in Terre Haute, Indiana, and Sing Sing prison, respectively.5-6


Safeguards
Over the past 60 years, regulations safeguarding humans participating in research have been enacted7 (Table). The Nuremberg Code, which articulated the requirement for voluntary consent of research participants, was issued in 1947, in response to Nazi human experimentation. The Declaration of Helsinki, the first international set of ethical principles for medical research involving human research participants, was adopted in 1964 by the World Medical Association. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created following the revelation of the Tuskegee study, issued the landmark Belmont Report on ethical principles and guidelines for research involving humans in 1979.8 In 1981, these guidelines were embodied in Health and Human Services (HHS) regulations to protect research participants (45 CFR 46).9 In 1991, Subpart A of these regulations ("The Common Rule") was adopted by an additional 16 federal agencies.

Table. Evolution of Human Subjects Research and Guidelines
Could such unethical studies happen today? For research funded or conducted by the US government, the answer is no. All federally funded research projects in which human participants are exposed to more than minimal risk must be reviewed by an institutional review board (IRB) before proceeding, and, as described in the Common Rule, must involve written, signed informed consent of research participants or their legally authorized representative (except in rare cases). Federal regulations instruct IRBs to be " . . . particularly cognizant of the special problems of research involving vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons."9 For institutions violating these regulations, sanctions are imposed by the HHS Office for Human Research Protections. Furthermore, the HHS Office of Research Integrity takes administrative action against individual investigators for whom a determination of research misconduct has been made.
As clinical research increases in volume and complexity and more frequently crosses country borders—often to reach the most affected populations—continued scrutiny of guidelines governing research involving human subjects remains critical. As technologies evolve, it is essential to continuously consider what new risks—physical, psychological, or informational—might be raised by research, and how investigators can best inform, engage, and protect research participants.
While effective protections against unethical research continue to evolve across the world, the past exploitations of vulnerable populations, including the subjects of the study in Guatemala in the 1940s, are regrettable and deeply saddening. For them, the basic ethical principle of respect for persons was flagrantly violated. The NIH and CDC are committed to ensuring that lessons drawn from the past help shape actions to protect all future research participants, no matter where studies are conducted. The 1946-1948 inoculation study should never have happened, and nothing like it should ever happen again.

Author Affiliations: Director, Centers for Disease Control and Prevention, Atlanta, Georgia (Dr Frieden); and Director, National Institutes of Health, Bethesda, Maryland (Dr Collins).
REFERENCES
1. Lederer SE. Subjected to Science: Human Experimentation in America Before the Second World War. Baltimore, MD: The Johns Hopkins University Press; 1995.
2. Reverby SM. Examining Tuskegee: The Infamous Syphilis Study and Its Legacy. Chapel Hill: University of North Carolina Press; 2009.
3. Susan M. Reverby faculty page. http://www.wellesley.edu/WomenSt/fac_reverby.html. Accessed October 6, 2010.
4. Information on the 1946-1948 United States Public Health Service STD Inoculation Study. US Department of Health & Human Services Web site. http://www.hhs.gov/1946inoculationstudy. Accessed October 5, 2010.
5. Mahoney JF, Van Slyke CJ, Cutler JC, Blum HL. Experimental gonococcic urethritis in human volunteers. Am J Syph Gonorrhea Vener Dis. 1946;30:1-39.
6. Magnuson HJ, Thomas EW, Olansky S, Kaplan BI, De Mello L, Cutler JC. Inoculation syphilis in human volunteers. Medicine (Baltimore). 1956;35(1):33-82. PUBMED
7. National Institutes of Health, Office of Human Subjects Research. Regulations and ethical guidelines. http://ohsr.od.nih.gov/guidelines/index.html. Accessed August 15, 2010.
8. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979. http://ohsr.od.nih.gov/guidelines/belmont.html. Accessed October 6, 2010.
9. Code of Federal Regulations, Title 45 Public Welfare: Part 46, Protection of Human Subjects. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed October 6, 2010.


Ética e investigación médica
Arnoldo Kraus


LA JORNADA,13 DE OCTUBRE 2010
Hace pocos días la prensa informó acerca de violaciones éticas en humanos por parte de la medicina estadunidense. Infectó EU con gonorrea y sífilis a guatemaltecos”, anunciaba La Jornada el 2 de octubre. El asunto, muy delicado por su naturaleza, tiene varias aristas. Una es peor que otra. Las disculpas ofrecidas por Barack Obama al gobierno de Guatemala no alcanzaron la luz motu proprio, es decir, por honestidad del sector salud o del gobierno; el perdón se expresó porque Susan M. Reverby, profesora de historia médica, quien seguía el affaire Tuskegee, informó, a fuentes gubernamentales, sus hallazgos sobre experimentos realizados en Guatemala. Esa falta de arrepentimiento, y esa incapacidad de asumir la culpa, debe ser la razón por la cual la medicina estadunidense siguió, después de Guatemala, violando la ética médica.
Los experimentos efectuados por médicos estadunidenses en Guatemala se llevaron a cabo entre 1946 y 1948. Con la intención de estudiar el comportamiento de la sífilis y de la gonorrea, así como el posible efecto terapéutico de la penicilina, médicos del servicio de salud pública estadunidense inyectaron los agentes causales de esas enfermedades venéreas a cientos de presos, soldados y pacientes siquiátricos.
La insanidad del asunto fue terrible: A) Se utilizaron prostitutas enfermas de gonorrea o sífilis para contagiar al grupo de estudio. Cuando se comprobó que la frecuencia del contagio era baja, se decidió inyectar el Treponema pallidum o la Neisseria gonorrhoeae directamente en el pene o en los brazos de las personas. B) Los sujetos elegidos, verdaderos conejillos de indias, no tenían, por supuesto, noción de la investigación. C) Al terminar la Segunda Guerra Mundial, se llevaron a cabo los Procesos de Nuremberg (1945-1946), donde se sancionó a los colaboradores del régimen nacionalsocialista. En forma paralela se llevaron a cabo otros juicios, entre ellos el Juicio de los Doctores (diciembre 1946), cuya finalidad fue exponer la actividad de médicos nazis acusados de experimentar, asesinar o torturar a judíos, gitanos o polacos enfermos de tuberculosis. El Juicio de los Doctores fue presidido por el distinguido abogado estadunidense Telford Taylor. D) La penicilina se empezó a utilizar con éxito en el tratamiento de la sífilis desde 1943. Los cuatro incisos previos ilustran la brutalidad del experimento así como la relación temporal entre la investigación, las denuncias éticas y la eficacia de la penicilina.
Durante los años en los cuales se llevaron a cabo los experimentos en Guatemala, las atrocidades de la medicina nazi habían alertado al mundo acerca de los cruciales vínculos entre ética y medicina. Debido a la participación de Taylor, y al uso de la penicilina como tratamiento de la sífilis y otras infecciones es imposible aceptar la doble moral y la falta de apego a las reglas médico-éticas: la medicina estadunidense violó la ética médica en Guatemala. El silencio y la falta de autocrítica de la elite médica estadunidense fue la semilla para que algunos doctores continuaran realizando experimentos alejados de normas morales.
En el primer párrafo mencioné la ciudad de Tuskegee (Alabama); allí se llevó a cabo, entre 1932 y 1972 el Estudio Tuskegee sobre la sífilis no tratada en hombres negros. Ese estudio es uno de los ejemplos más contundentes de investigación mal hecha y de conductas éticas inadecuadas. Con tal de no interrumpir las observaciones sobre la evolución natural de la sífilis –pacientes sin ningún tratamiento– en negros pobres, el Servicio de Salud Pública de Estados Unidos decidió no administrar ningún tratamiento a la población estudiada. El protocolo se realizó en 399 hombres negros. La idea fundamental consistía en no ofrecer ninguna de las terapias disponibles, ya que la población afectada representaba una “oportunidad única” para conocer la evolución natural de la sífilis.
A los enfermos se les explicaba que recibirían tratamientos contra la “sangre mala” (bad blood), término local utilizado para describir problemas como anemia, sífilis, fatiga. Contra toda ética, los sujetos no recibieron ningún tratamiento; a cambio, se les ofreció exámenes médicos gratuitos, alimentos sin costo y seguro funerario. Inicialmente la investigación duraría seis meses; se prolongó 40 años. Lo grave del asunto es que el estudio no fue interrumpido motu proprio; la publicación de una noticia en 1972 en The New York Times fue la razón para finalizarlo. En 1997 Bill Clinton pidió disculpas a los supervivientes.
Además de Guatemala y Tuskegee, prestigiosas revistas médicas estadunidenses han develado que en algunos países africanos, los sujetos en los cuales se experimenta un fármaco firman consentimientos informados en idiomas que no comprenden por no ser el propio. Versiones paralelas en los medios médicos han subrayado que, hace no muchos años, los sujetos de investigación en Latinoamérica o en otros países no recibían el mismo cuidado que sus pares en Estados Unidos.
Las disculpas de Obama, en relación con el asunto guatemalteco, y de Clinton por Tuskegee, son, por supuesto, bienvenidas. Sin embargo, las disculpas no provienen de un mea culpa sincero del gobierno o de las autoridades sanitarias de Estados Unidos; son la respuesta obligada a lo publicado en la prensa. Es muy probable que en el futuro los medios de comunicación informen de nuevos sucesos.