UPDATE: Following on an apology released today by the U.S. government for its involvement in supporting research that included the intentional infection of hundreds of disenfranchised Guatemalans with syphilis and gonorrhea, the Pan American Health Organization has also released a statement apologizing for its role. The statement reads in part (and is copied in full below in the comments):

This research was conducted by the Venereal Disease Research Laboratory of the Public Health Service and venereal disease experts from Guatemala, with funds given to the Pan American Sanitary Bureau (PAHO’s precursor) by the U.S. Institutes of Health, and with some cooperation by Guatemalan authorities. Dr. John Cutler, who conducted these experiments and worked on the infamous Tuskegee experiments, was then a Public Health Service medical officer.

We are just learning details of these experiments, and the US Institute of Medicine is now conducting an investigation. The Organization has established strong ethical standards for research it sponsors or is associated with to prevent such abuses for many years now. Currently, research ethics in PAHO is overseen by the PAHO Ethics Review Committee (PAHOERC), an interdisciplinary group of up to 13 professionals. The PAHOERC review process ensures that all research with human subjects in which PAHO is involved meets international ethical standards in accordance with three basic ethical principles: respect for persons, beneficence, and justice. We deeply regret the past ethical violations revealed this week and we are committed to cooperating fully with Member States, particularly the United States and Guatemala, to clarify these events and to ensure that such ethical violations are never allowed to take place again in the name of public health.

ORIGINAL ARTICLE:

The United States Government today apologized for funding a study in the 1940s in which U.S. government medical researchers intentionally infected hundreds of people in Guatemala–including institutionalized mental patients and prisoners–with gonorrhea and syphilis without their knowledge or permission. Secretary of State Clinton also personally apologized to Guatemalan President Alvaro Colom. The public apology was directed to Guatemala and to Hispanic residents of the United States, according to the State Department.

The experiments involved 696 subjects — male prisoners and female patients in the National Mental Health Hospital. Many of those infected were encouraged to pass the infection onto others as part of the study.  The researchers were trying to determine whether the antibiotic penicillin could prevent early syphilis infection, not just cure it, according to an analysis of the research. Subjects were infected with the syphilis bacteria — through visits with prostitutes who had the disease and direct inoculations. About one third of those who were infected never got adequate treatment and it is unclear whether those who did were later cured.

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.”

The study, funded by the National Institutes of Health through the Pan American Sanitation Bureau (now the Pan-American Health Organization), was carried out by the late John Cutler, a medical doctor and then an employee of the United States Public Health Service (USPHS).

Cutler later led the infamous “Tuskegee” Syphilis Study in which the USPHS monitored the progression of late-stage syphilis in hundreds of African American men for forty years (1932-1972), without ever offering them treatment.

Evidence of the Guatemala study was uncovered by Dr. Susan Retherby, a medical historian, professor of Gender and Women’s Studies at Wellesley College, and an expert on the Tuskegee study. According to Wellesley, Retherby first found material on the Guatemala study while “digging” in the archives at the University of Pittsburgh where she was conducting research on her book about the history and myths surrounding the the Tuskegee Syphilis.

“She did not expect what she finally wrote up to make it to the White House, through the State Department and to Guatemala,” says a release by Wellesley.

The book, Examining Tuskegee, was published in November 2009.

After finishing the book, Retherby wrote an historical analysis about the medical research study in Guatemala between 1946 and 1948. Men and women were purposely infected with syphilis in the Guatemala study, but were also offered a penicillin cure. However, it appears, not everyone was cured and “the research should never have been done this way,” notes Wellesley. She alerted HHS and the State Department to her findings.

On a call today, Dr. Francis Collins, director of the National Institutes of Health (NIH) and Arturo Valenzuela, Assistant Secretary of State for Western Affairs underscored the serious nature of the human rights and ethical violations that occurred in the Guatemala study and explained efforts to ensure increasing vigilance over the ethics involved in bio-medical research involving human subjects.

Collins called the episode “deeply disturbing” and “an appalling example from a dark chapter in medicine.” He complimented Retherby on her work, and stated that “today we have protections [in place] to prohibit such unethical conduct.”

“In the forties, there were no formalized regulations in place to protect human subjects in research,” said Collins. “Today there are regulations in place that would absolutely prohibit this type of study. And NIH, DHHS, and the entire US govt are committed to protecting persons in research.”

Nevertheless, bioethicists must remain vigilant in ensuring that these types of violations never occur again, he said. The United States is commissioning two studies, one domestic and one international, to look into violations of research ethics and to ensure international consensus on continued evolution in and application of ethical norms in biomedical ethics.

Collins pointed to four violations evident in the Guatemala study:

• Conducting research on one or more vulnerable populations
• Lack of any evidence of informed consent of the participants
• Deception by the researchers in telling participants about the implications for their health and lives of the research in which they were being used as subjects
• No understanding or consent by participants that they were being intentionally infected.

Asked whether there might be other examples of such ethical breaches not yet uncovered, Dr. Collins said that “when one considers that ethical standards at the time were inadequate, we can identify at least 40 other studies that were done domestically with intentional infections.”

While researchers must now go through ethics reviews of their proposed protocols and be cleared by Institutional Review Boards at the colleges and universities at which they are doing their research, or through NIH, for example, Collins underscored that the U.S. government was committed to investigating these issues further and is setting up two commissions to do so.

The U.S. government is asking the Institutes of Medicine to convene a committee of experts to study and issue a report on all facts of this study. And the Presidential Commission for the Study of Bioethical Issues will convene an international commission to ensure that all human research meets rigorous ethical standards throughout the world. No timeline has yet been set for completion of the work of these commissions.

Next week, says William Smith, Executive Director of the National Coalition of STD Directors, “the nation’s leaders in combating sexually transmitted diseases will be gathering in Texas for our annual meeting, and we do intend to move a resolution condemning this experience and calling on our government to ensure transparency on all ongoing studies on STDs.”

What is clear is that this new discovery also further highlights the ways in which racism and discrimination completely infected the white-dominated medical and research establishment at the time, such that people of color, black, brown, poor, vulnerable, were treated as less than human, and fair game for unethical practices that at the time weren’t even considered unethical.

A transcript of the press call with Collins and Valenzuela, which became available at 5:36 pm on Friday, October 1. 2010, can be found here.