The US government "apologizes" for a criminal human experiment--PHS Sexually Transmitted Disease Inoculation Study, 1946-1948.   The experiment was conducted on 696  Guatemalan mental patients who were INTENTIONALLY infected with gonorrhea and syphilis.

Many of those infected were encouraged to pass the infection onto others as part of the study. About one third of those who were infected never got adequate treatment.

Does an "apology" suffice for criminal experimentation designed to cause harm?

This experiment demonstrates that a medical culture which deviates from Hippocratic medical ethics--"First, do no harm"--is likely to descend into criminal medicine.

That's what the Nuremberg Nazi Doctors Trial were about.

The attempt by Francis Collins, the current Director of NIH,  to downplay the culpability of those involved demonstrates a shocking lack of appreciation for the essence of medical ethics.

It is clear that independent oversight is needed to ensure that the medical research enterprise does not cross the boundaries of acceptable medicine.

 Vera Hassner Sharav

 U.S. apologizes for Guatemala STD experiments

Government researchers infected patients with syphilis, gonorrhea without their consent in the 1940s

Chief science and health correspondent

NBC News NBC News

updated 10/1/2010 9:25:42 AM ET

U.S. government medical researchers intentionally infected hundreds of people in Guatemala, including institutionalized mental patients, with gonorrhea and syphilis without their knowledge or permission more than 60 years ago.

Many of those infected were encouraged to pass the infection onto others as part of the study.

About one third of those who were infected never got adequate treatment.

On Friday, Secretary of State Hillary Clinton and Health and Human Services Secretary Kathleen Sebelius offered extensive apologies for actions taken by the U.S. Public Health Service.

"The sexually transmitted disease inoculation study conducted from 1946-1948 in Guatemala was clearly unethical," according to the joint statement from Clinton and Sebelius. "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."

Secretary Clinton called Guatemalan president Alvara Cabellaros Thursday night to reaffirm the importance of the U.S. relationship with the Latin American country.

"The people of Guatemala are our close friends and neighbors in the Americas," the government statement says. "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."

During a conference call Friday with National Institutes of Health Director Francis Collins and Assistant Secretary Arturo Valenzuela, officials noted that there were no formalized regulations regarding protection of human studies during the 1940s.

In addition to the apology, the U.S. is setting up commissions to ensure that human medical research conducted around the globe meets "rigorous ethical standards." U.S. officials are also launching investigations to uncover exactly what happened during the experiments.

The episode raises inevitable comparisons to the infamous Tuskegee experiment, the Alabama study where hundreds of African-American men were told they were being treated for syphilis, but in fact were denied treatment. That U.S. government study lasted from 1932 until press reports revealed it in 1972.

The Guatemala experiments, which were conducted between 1946 and 1948, never provided any useful information and the records were hidden.

They were discovered by Susan Reverby, a professor of women's studies at Wellesley College in Massachusetts and were posted on her website.

According to Reverby’s report, the Guatemalan project was co-sponsored by the U.S. Public Health Service, the NIH, the Pan-American Health Sanitary Bureau (now the Pan American Health Organization) and the Guatemalan government. The experiments involved 696 subjects — male prisoners and female patients in the National Mental Health Hospital.

The researchers were trying to determine whether the antibiotic penicillin could prevent syphilis infection, not just cure it, Reverby writes. After the subjects were infected with the syphilis bacteria — through visits with prostitutes who had the disease and direct inoculations — it is unclear whether they were later cured or given proper treatment, Reverby notes.

The STD experiments were conducted with the cooperation of the Guatemalan government. During that time, the U.S. -- which had a long association with the Guatemalan military -- exerted a powerful influence in the Latin American country, largely in order to protect the interests of the American-based United Fruit Company. In 1954 the U.S. CIA helped overthrow Guatemala’s democratically elected president because of land reforms that opposed the multinational corporation.

Reverby, who has written extensively about the Tuskegee experiments, found the evidence while conducting further research on the Alabama syphilis study.

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FOR IMMEDIATE RELEASE Friday, October 1, 2010

Contact: HHS Press Office 202-690-6343

Joint Statement by Secretaries Clinton and Sebelius on a 1946-1948 Study

Following is a joint statement by Secretary of State Hillary Rodham Clinton and Secretary of Health and Human Services Kathleen Sebelius on the U.S. Public Health Service Sexually Transmitted Disease Inoculation Study of 1946-1948:

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.

TEXT IN SPANISH:

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 estadounidenses 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.