Sunday, October 3, 2010

Apology / disculpa

The apology given for U.S. tests done six decades ago on unknowing Guatemalans was profuse.
Among the words in the bilingual, joint statement of apology, reprinted in full below, that Secretary of State Hillary Clinton (below left) (credit) and Health and Human Services Secretary Kathleen Sebelius (bottom left) (credit) issued on Friday:
► unethical / antiético
► outraged / indignados
► reprehensible / reprochable
► regret /disculpas
► abhorrent / abominables
► sad / triste
► appalling / atroz
None overstates the significance of a recent finding by Susan M. Reverby (right), the the Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies at Wellesley College. Reverby unearthed what a research team, funded by a grant from the United States' National Institutes of Health, did from 1946 to 1948. As stated by Dr. Francis S. Collins, current director of NIH, a D.C. briefing Friday, the team

intentionally infected vulnerable populations, including prisoners and mentally ill patients, with sexually transmitted diseases, including syphilis, gonorrhea, and chancroid. The purpose of the study was to test the effectiveness of penicillin, which was relatively new at the time.
Notwithstanding that "the intention was to provide treatment, and the evidence supports that the vast majority were adequately treated," Collins identified 4 "primary ethical violations":
► Experimentation on vulnerable populations;
► Apparent absence of informed consent;
► Deception respecting what what the team was doing to the subjects; and
► Intentional infection of potentially harmful pathogens.
A federal investigation is under way.
One hopes that investigators ask a question reporters at the briefing did not:
What does it mean that these tests took place at the same time that Americans were prosecuting Germans for medical experimentation -- in the same year, 1947, that a physician advising American war crimes prosecutors drafted what would come to be known as the Nuremberg Code, the keystone of current safeguards for human subjects?
While awaiting answer, ponder the Clinton-Sebelius apology:
The sexually transmitted disease inoculation study conducted from 1946-1948 in Guatemala was clearly unethical. Although these events occurred more than 64 years ago, we are outraged that such reprehensible research could have occurred under the guise of public health. We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices. The conduct exhibited during the study does not represent the values of the United States, or our commitment to human dignity and great respect for the people of Guatemala. The study is a sad reminder that adequate human subject safeguards did not exist a half-century ago.
Today, the regulations that govern U.S.-funded human medical research prohibit these kinds of appalling violations. The United States is unwavering in our commitment to ensure that all human medical studies conducted today meet exacting U.S. and international legal and ethical standards. In the spirit of this commitment to ethical research, we are launching a thorough investigation into the specifics of this case from 1946. In addition, through the Presidential Commission for the Study of Bioethical Issues we are also convening a body of international experts to review and report on the most effective methods to ensure that all human medical research conducted around the globe today meets rigorous ethical standards.
The people of Guatemala are our close friends and neighbors in the Americas. Our countries partner together on a range of issues, and our people are bound together by shared values, commerce, and by the many Guatemalan Americans who enrich our country. As we move forward to better understand this appalling event, we reaffirm the importance of our relationship with Guatemala, and our respect for the Guatemalan people, as well as our commitment to the highest standards of ethics in medical research.

Declaraciones de la secretaria de Estado Hillary Rodham Clinton y la secretaria de Salud y Servicios Sociales Kathleen Sebelius sobre el Estudio de inoculación de enfermedades de transmisión sexual del Servicio de Salud Pública de Estados Unidos de 1946 a 1948:
El estudio de inoculación de enfermedades de transmisión sexual que se llevó a cabo de 1946 a 1948 en Guatemala claramente fue antiético. Aunque estos sucesos ocurrieron hace más de 64 años, estamos indignados de que tal investigación reprochable haya ocurrido bajo el pretexto de la salud pública. Lamentamos profundamente que esto haya sucedido y ofrecemos nuestras disculpas a todas las personas que resultaron afectadas por esas abominables prácticas de investigación. La conducta demostrada durante el estudio no representa los valores de Estados Unidos ni nuestro compromiso con la dignidad humana y el gran respeto hacia el pueblo de Guatemala. El estudio es un triste recordatorio de que las garantías adecuadas para la investigación en seres humanos no existían hace medio siglo.
En la actualidad, los reglamentos que gobiernan la investigación médica en seres humanos financiada por Estados Unidos prohíben este tipo de violaciones atroces. Estados Unidos es inquebrantable en su compromiso de garantizar que todos los estudios médicos en seres humanos que se realizan en la actualidad, cumplan con las rigurosas normas legales y éticas de Estados Unidos e internacionales. Bajo el espíritu de este compromiso con la ética investigativa, estamos iniciando una minuciosa investigación con respecto a los detalles de este caso de 1946. Además, mediante la Comisión Presidencial para el Estudio de Asuntos de Bioética, convocaremos también a un cuerpo de especialistas internacionales para que revise e informe sobre los métodos más eficaces para asegurar que toda investigación médica en seres humanos que se realice en el mundo en la actualidad cumpla con rigurosas normas éticas.
El pueblo de Guatemala es uno de nuestros amigos cercanos y vecinos en las Américas. Nuestros países son socios en una variedad de asuntos y nuestros pueblos están vinculados por valores compartidos, comercio y por los muchos stadounidenses de origen guatemalteco que enriquecen nuestro país. A medida que avanzamos para comprender mejor este atroz suceso, reiteramos la importancia de nuestra relación con Guatemala y nuestro respeto por el pueblo guatemalteco, así como nuestro compromiso con las normas éticas más exigentes en la investigación médica.


Patrick S. O'Donnell said...

And yet clinical trials on human subjects remains a sordid business, literally: please see Carl Elliott’s review essay, “The Mild Torture Economy,” in the London Review of Books, Vol. 32, No. 18 (September 2010):

Diane Marie Amann said...

See too the commentary by our colleague Kevin Jon Heller at