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Guatemala Justice

En Español

Lake Atitlán is sacred to the Maya

Slate US researchers infected Guatemalans with syphilis & gonorrhea, then left without treating them. Their families are still waiting for help.

Everyone agrees the experiments were unethical—the legal question is who should be held responsible. No one wants to pay up.

Federico Ramos was 22 when he left his home in San Agustín Acasaguastlán, Guatemala, in 1948 to serve in the country’s military. . . . Once his service was complete, Ramos moved to La Escalera, a tiny village of 400 people near his hometown where he could plant beans and corn and start his own family. Soon after settling down, he began suffering from what he refers to as “bad urine”—he felt extreme strain when he relieved himself. Over the years it got much, much worse and extended beyond his genitals to his appendix and other organs. He consulted doctors who prescribed medicines that didn’t work. . . . As his eight children grew up, they too started to have similar health problems. And later on, so did their children. . . .

For years, the family didn’t know what they were suffering from. A friend of theirs, who was studying at a university in the city, eventually looked up their symptoms and said it seemed like gonorrhea. . . .  Federico is now 91 years old. Sitting on a chair outside his son Benjamin’s small home, the frail veteran tells me how in October 2010, he heard from friends about recent news reports in which the government announced that several members of the Guatemalan military had been secretly and intentionally infected with gonorrhea by American researchers in the 1940s. Other groups—mental patients and prisoners—had additionally been exposed to syphilis and chancroid. The experiments were in the news because then–Secretary of State Hillary Clinton had issued a public apology to the government of Guatemala for violating its citizens’ human rights. Álvaro Colom, president of Guatemala when Clinton made reconciliation efforts, announced an investigation into the matter. Then-President Barack Obama asked the Presidential Commission for the Study of Bioethical Issues to commence a report investigating how these horrifying experiments came to be. The report has been completed, the apology long since issued. But for families like Frederico’s, compensation and treatment has still not come.

Thank you to Slate for this important update to the struggle for restorative justice. The following points bear correction.

Judge Marvin Garbis ruled the US experiments on Guatemalan victims are illegal, in violation of customary international law prohibiting medical experiments on human subjects without consent under the leading case of Abdullahi v. Pfizer, Inc., 562 F.3d 163, 187 (2d Cir. 2009). Judge Garbus did not rule the experiments were simply “unethical.” Indeed, the government of Guatemala issued its own presidential report analyzing the experiments as crimes against humanity. Slate ignores the report, and should not.

In addition, human victims sued the US in the 2011 case dismissed on sovereign immunity grounds. Sovereign immunity based on the archaic and unfair English concept “the king can do no wrong” should not shield the US for these human rights violations. The article states immunity protects against suits by foreign governments; that is not at issue here.

This is why we represent the Catholic Archdiocese of Guatemala seeking restorative justice for the victims before the Inter-American Commission on Human Rights. Individual and collective memory, truth, and reconciliation require more than an apology by the US. The US must be held accountable on these undisputed facts for human rights violations and crimes against humanity. We also keep the cited documents publicly available at www.cityprojectca.org/guatemala-justice, and not behind a pay wall. This is especially important if the US scours this history from official sites, as the article suggests.

Guatemala_syphilis_experiments_2017

Third amended complaint, Giron Alvarez v Johns Hopkins University, Rockefeller Foundation, Bristol-Myers Squibb Co., and others

Congressman Raul Grijalva Justice for STD Experiment Victims in Guatemala, Strengthen the Common Rule HuffPost

Grijalva 2016

En Español

FOR IMMEDIATE RELEASE
April 14, 2016
Press Contact
Dan Lindner (Grijalva) – (202) 225-2435

Justice for STD Experiment Victims in Guatemala

Rep. Raúl M. Grijalva | Ranking Member of the House Natural Resources Committee

Doctors see us at our most vulnerable. When we are sick or wounded, in our infancy, and in our final days, they are admitted to our bedside to bring comfort and healing. So there is perhaps no betrayal greater than when a medical practitioner inflicts deliberate harm. Yet it has happened throughout the past century.

While the Tuskegee Study that left untreated black men in Alabama who were already infected with syphilis is infamous, it is just a single instance in a deplorable history of non consensual human experiments. The same doctor that led the Tuskegee Study was responsible for a series of STD experiments in Guatemala beginning in the 1940’s that involved more than 5,000 people, including children, orphans, child and adult sex-workers, Guatemalan Indians, leprosy patients, mental patients, prisoners, and soldiers. The study was funded by the U.S. Public Health Service.

More than 5,000 innocent Guatemalan people were purposely infected with syphilis, gonorrhea, and chancroid without their informed consent. Very few were treated, and the rest were left to suffer almost without purpose, since the results were virtually abandoned before the researchers could pursue their purported goal of testing whether penicillin could be used for treatment or prevention. Victims were left untreated and uncompensated to the present day.

This shameful experiment has left a devastating legacy, since untreated syphilis also infects children, passing from one generation to the next. The Guatemalan Government’s report on the study called it a crime against humanity, and noted that racism and discrimination permeated the experiments. The US government report concedes that the experiments were unethical, but offers no relief for the victims. The facts are not disputed.

While money cannot right the wrongs inflicted on these innocent people, it is imperative that we do everything in our power to treat and compensate the surviving victims and their descendants. When the Tuskegee Study came to light, a fund was established to find the survivors and their offspring and provide treatment and payments. Furthermore, the U.S. Congress passed the National Research Act of 1974, mandating the establishment of ethics committees to review federally funded human research. The US has guidelines that govern research involving human subjects, known as the Common Rule.

The Common Rule needs to be stronger in defining informed consent for medical human experiments, and it is virtually silent on the unique questions of such research in developing countries, including whether consent can be truly voluntary in regions with autocratic governments that benefit from the money and prestige that come from hosting research sponsored by nations like ours.

The result is that experiments that would never be approved in the United States are outsourced to places where there is less scrutiny. At present, such studies can be carried out in Central and South America, Eastern Europe, or Africa. To this very day, the medical professionals we trust to care for us can instead treat human beings like lab rats, for example, administering placebos to sick people when a known cure exists.

We must find the public and political will needed to seek out every Guatemalan family that has been impacted by this horrible experiment and ensure they are treated and compensated. The Archdiocese of Guatemala has filed a petition with the Inter-American Commission on Human Rights seeking relief for the victims against the U.S. and the Republic of Guatemala. We support relief. Furthermore, we must strengthen Common Rule and international health policy to ensure that neither the United States nor any other country can again perpetrate such crimes against humanity and human rights violations in the name of medicine. The U.S. government is studying proposed revisions to the Common Rule now. The world over, people must be able to trust the doctors and medical professionals that keep them healthy. We must take every step necessary to ensure the United States never undermines that trust again.

Archdiocese Human Rights Petition US Sex Experiments Word Cloud & Text Links

Guatemala petition word cloud 105

The Word Cloud and Text Links analyze the Archdiocese of Guatemala’s petition before the Inter-American Commission on Human Rights against the US and Guatemala over the US sex experiments. The US intentionally infected innocent Guatemalan victims including children with sexually transmitted diseases beginning in the 1940s, leaving them untreated and uncompensated to the present day.

The Word Cloud shows the top 105 words in the petition. The Text Links shows the links between words (co-locations). The petition has 15,986 total words and 2,668 unique word forms.

The top ten words in the petition include rights (137); states (124); Guatemala (118); American (115); united (98); experiments (97); human (94); article (89); victims (78); and medical (70).

Guatemala petition text links 30

Click on the Word Cloud and Text Links for a larger image.

Voyant Tools courtesy of Stéfan Sinclair and Geoffrey Rockwell.

Archdiocese of Guatemala Human Rights Petition against US and Guatemala for STD Experiments

En español

guatemala std

Overdue Justice for Guatemalan Victims of Venereal Disease Experiments

A petition for the victims of U.S. and Guatemalan experiments that infected vulnerable Guatemalans with venereal diseases was filed today in the Inter-American Commission on Human Rights by the Office of Human Rights for the Archdiocese of Guatemala, represented by the UC Irvine School of Law International Human Rights Clinic and The City Project of Los Angeles.

Contact information:

Robert Garcia, The City Project (213) 977-1035
Hannah Robinson, Consultant for the Oficina de Derechos Humanos de Arzobispado de Guatemala (785) 312-4533
Catherine Sweetser, Co-Director, UC Irvine School of Law International Human Rights Clinic (646) 549-6817

First there was silence, then investigation, and then denial of a remedy. Now, over 70 years later, may come international justice. Today, the Office of Human Rights for the Archdiocese of Guatemala filed a petition in the Inter-American Commission on Human Rights on behalf of the victims of the U.S. and Guatemalan governments’ scientific experiments that infected vulnerable Guatemalan people with syphilis, gonorrhea, and chancroid. At least 5,000 Guatemalans were purposefully infected, and only a small fraction received treatment. The rest were left to suffer, almost without purpose; though the experiments were well-documented, the results were virtually abandoned before the research team pursued their purported aim: the discovery of whether penicillin could be used as a preventive treatment, or prophylaxis.

The experiment were motivated by the government’s desire to stamp out sexually transmitted infections that were ravaging soldiers during the Second World War. Similar experiments were started in the 1930s in rural Alabama with African American men with syphilis, known as the Tuskegee Experiments. The experiments were conducted with a team of researchers from the US Public Health Services. Dr. John Cutler, who directed the Guatemala experiments, also took part in the Tuskegee experiments. Other similarities between the Tuskegee and Guatemala experiments include the lack of individual consent to the experiments, lack of treatment for infected victims, and deception of victims and the public. In Guatemala, researchers intentionally infected the victims and generally left them without treatment or compensation for the remainder of their lives. In Tuskegee, the nearly 400 victims were already infected but were left without treatment for nearly 30 years while U.S. government researchers observed the progress of their infections. The United States eventually provided treatment and compensation for victims, families, and heirs in Tuskegee, including funding to locate the victims and pay attorneys’ fees.

In Guatemala, experiments were conducted beginning in the 1940s and continuing through at least the 1950s on some of the most vulnerable populations in Guatemala: mental health patients, prisoners, soldiers, prostitutes, and even orphans. There is no documentation that orphans were ever purposefully infected, but orphans already infected with syphilis did receive experimental treatment options in exchange for medical supplies given to the orphanages. The rest of the vulnerable populations were infected through injections and the topical application of infected material, usually transmitted by causing an abrasion on the victims’ genitals. These experiments were conducted without the victims’ consent and without any compensation — sometimes, the research team gave the victim a pack of cigarettes afterward.

The drastic effects of the experiments have been passed down through generations, since untreated syphilis also infects children. The petitioners in the case before the Inter-American Commission are children and grandchildren of the infected population, who suffered from birth defects such as blindness, paralysis, and still-birth. The victims are petitioning with the Office of Human Rights for the Archdiocese of Guatemala, one of the leading non-governmental organizations for human rights in Guatemala City.

Petitioners are legally represented by the International Human Rights Clinic at the University of California-Irvine Law School, directed by international human rights attorneys Paul Hoffman and Catherine Sweetser. The petition has been filed against the U.S. and Guatemala at the Inter-American Commission on Human Rights in Washington, D.C., claiming violations of the rights to life, health, freedom from torture, and crimes against humanity under both the American Declaration of the Rights and Duties of Man, and the American Convention on Human Rights.

To the governments’ credit, both the U.S. and Guatemala later apologized and issued reports about the unethical medical experiments. Under the direction of President Barack Obama, the U.S. established a Commission to investigate and expose the crimes, publishing a report in 2011 on the findings called “Ethically Impossible: STD Research in Guatemala from 1946 to 1948.” However, the petitioners’ attempts to hold the perpetrators accountable in U.S. civil courts was unavailing — the District of Columbia Court of Appeals decided that the victims were too late, since the accountable governmental authorities had already left office. Jessenia Ovalle, an attorney in Guatemala working for the Office of Human Rights for the Archdiocese of Guatemala, states that the ultimate goal of the petition is “truth and justice for the Guatemalan victims’ families of these experiments through comprehensive and dignified reparations.” Another federal case is pending in Baltimore against the private entities involved, but not against the government entities.

The petition also alleges the denial of a right to a remedy for human rights violations, as the victims have never been compensated. According to Citlalli Ochoa, a law student at UC Irvine School of Law who wrote the international petition with the International Human Rights Clinic: “Given that U.S. courts have denied victims a remedy, it was important for us to seek international avenues to hold the governments accountable. Keeping this issue in the public eye within a legal context is crucial for ensuring government accountability and preventing similar events from happening again.”

According to Robert García, a civil rights attorney with The City Project / Proyecto del Pueblo, who is co-counsel on the petition and who was born in Guatemala, “Intentionally infecting Guatemalan people without their knowledge or consent, and leaving them untreated to the present day, is a crime against humanity. It violates international law, and domestic laws against rape and assault. Apologies are not good enough. Truth and reconciliation require treatment, compensation, and restorative justice. This can never happen again to anyone anywhere.” The City Project / Proyecto del Pueblo is based in Los Angeles, CA.

Resources

There are two additional reports in Spanish, which explicitly describe the violations of domestic and international law and provide background for the report by the Guatemalan Presidential Commission.

  • The technical report Experimentos en Seres Humanos: el Caso Guatemala 1946-48 (Abril 2011), by Comisión Técnica, Comisión Presidencial para el Esclarecimiento de los Experimentos en Humanos en Guatemala 1946-48. Click here for the discussion under domestic and international laws in the technical report in English. The technical report states: “Given the applicable laws during that period, all directly responsible committed crimes punishable by law and its cover up suggests knowledge of criminal responsibility.” Page 96.
  • The archival report Investigación archivística sobre experimentos practicados en seres humanos en Guatemala, 1947-1948 (Mayo 2011) by Archivo General de Centro América (AGCA), el Archivo Histórico de la Policía Nacional (AHPN), y la Dirección de los Archivos de la Paz (DAP) de la Secretaría de la Paz. Click here for the discussion under domestic and international laws in the archival report in English. The archival report concludes: “It is evident that people responsible for these experiments took advantage of the conditions and vulnerability of these groups to carry out these practices which were a crime against humanity and a clear violation of the Nuremberg Code.” Page 165.

These two reports are not available in English, except for the translated excerpts above. The U.S. Presidential Commission on Biotethics should publish these reports in English to ensure justice for Guatemalan people by including Guatemalan perspectives on the STD atrocities.

According to reports by the Catholic Church and the United Nations, 200,000 Guatemalan people were killed or disappeared, most of them Mayan, with countless more kidnapped and entire communities displaced.

“Migration of the Golden People” CARECEN 2002 © Judy Baca Courtesy of SPARC www.sparcmurals.org

Click here for this press release.

Síga este enlace para leer el resumen en español.

 

American Journal of Public Health – First, Do No Harm: US Sexually Transmitted Disease Experiments in Guatemala

Q & A with Michael Rodriguez and Robert Garcia: First, Do No Harm. AJPH Talks.

EnglishEspañol

First, Do No Harm, a commentary piece written by Michael A. Rodriguez and Robert Garcia, examines the unethical practices and procedures practiced by the U.S. Government during the 1940s, when U.S. doctors and medical researchers infected vulnerable populations with bacteria that caused sexually transmitted diseases without their informed consents. This week, the authors sit down with AJPH Talks to discuss the experiment’s ramifications and results.

Q: Can you describe the Guatemalan STD Experiments?

Rodriguez and Garcia: Beginning in 1946, U.S. Public Health Service investigators in Guatemala, funded by the National Institutes of Health, engaged in immoral, unethical, and illegal experiments infecting victims with bacteria that cause sexually transmitted diseases, without the victims’ informed consent. The U.S. has left the victims untreated and uncompensated to the present day.

Q: Who was affected?

Rodriguez and Garcia: The STD experiments involved at least 5,128 vulnerable people, including children, orphans, child and adult prostitutes, Guatemalan Indians, leprosy patients, mental patients, prisoners, and soldiers. Health officials intentionally infected at least 1,308 of these people with syphilis, gonorrhea, and chancroid, and conducted serology tests on others.

Dr. John Cutler, who was later responsible for the Tuskegee experiments that left African American men untreated for syphilis for decades, led the STD experiments in Guatemala. U.S. officials worked with the cooperation of Guatemalan authorities – which excuses nothing. [Continues after break.]

ajphfirstdonoharm

Q: How were the studies conducted?

Rodriguez and Garcia: The experiments were not conducted in a sterile clinical setting in which bacteria that cause STDs were administered in the form of a pin prick vaccination or a pill taken orally. The researchers systematically and repeatedly violated profoundly vulnerable individuals, some in the saddest and most despairing states of life, and grievously aggravated their suffering.

For example, Cutler infected Bertha, a female patient in a psychiatric hospital, by injecting her with syphilis in her left arm. A few months later Cutler put gonorrheal pus from a male subject into both her eyes, her urethra, and her rectum, and reinfected her with syphilis. Several days later, her eyes were filled with pus, and she was bleeding from the urethra. She died a few days later.

Such actions constitute the crimes of rape, battery, assault, and conspiracy. The actions are also crimes against humanity. The actions violate the principles of the Nuremberg Code that the U.S. established under international law through the trial, conviction, and execution of Nazi doctors in 1947 and 1948 – while the U.S. was conducting the experiments in Guatemala.

Q: Why did the US Government (the NIH) support this method of research?

Rodriguez and Garcia: The STD work began on prisoners in the US but researchers could not consistently cause infections. One stated reason for moving to Guatemala was that prostitution was legal there, as it was in Paris, France.

The Guatemalan government in its published report concludes that the STD experiments were crimes against humanity, and that racism and discrimination permeated the experiments. The US reports do not analyze discrimination, or the legality of the experiments under domestic or international law. There was discrimination by US officials against Guatemalan people, and within Guatemala by elites against lower-class indigenous and non-indigenous people. Discrimination is an aggravating, unacceptable factor for the experiments.

Q: What has been currently done to compensate the victims?

Rodriguez and Garcia: Nothing.

The victims were intentionally infected and have been left without treatment or compensation to the present day. The experiments were covered up until 2010. President Barack Obama then apologized to the president of Guatemala.

By contrast, the victims in Tuskegee were already infected, but were left without treatment or compensation beginning in the 1930s until the 1970s when litigation, organizing, and media attention resulted in compensation. The Tuskegee payment structure should be made available to the Guatemalan victims (with different payments for each living victim, surviving dependent, and heirs of deceased victims).

Human rights attorneys filed suit on behalf of the class of Guatemalan victims and their survivors. The federal district court dismissed the suit on technical grounds of sovereign immunity – in other words, the US did not agree to be sued. The court wrote that the victims could seek redress from Congress and the President. They have done nothing.

Q: What are some further steps that need to be taken by the U.S. Government to help rectify this terrible ordeal and to ensure that this never happens again?

Rodriguez and Garcia: The US government should provide treatment and compensation to the victims. Human rights and health foundations should help provide funding for the victims, as they do in other contexts where government fails.

It is critical to adopt legal and ethical reforms to protect individuals in improper human experiments, waive sovereign immunity for federally funded human research in the United States and abroad, ensure that parallel protections apply to privately funded research, and respect autonomy and equality for all. US training programs should analyze the Guatemala experiments under domestic and international law. Ethical and moral arguments are not enough to deter misconduct. Although two US reports have recommended some reforms in ethical training, the recommendations have yet to be implemented.

The US government should publish the reports by the Guatemala government in English to ensure the voice of the Guatemalan people is heard.

International tribunals should provide relief to the victims so that the US does not act with impunity when it engages in unethical, immoral, or illegal human rights experiments.

Q: Where can we go to learn more about this situation?

Rodriguez and Garcia: To learn more about the Guatemala STD experiments, please visit the City Project website, located at: /blog/archives/14794.

Reference: Michael A. Rodriguez and Robert García.  First, Do No Harm: The US Sexually Transmitted Disease Experiments in Guatemala. American Journal of Public Health: December 2013, Vol. 103, No. 12, pp. 2122-2126. Click here to download the article in English. Click here to download the article in Spanish.  Translation / traducción Border Philanthropy Partnership / Alianza Fronteriza de Filantropía.

 

Medical Research on Humans: Make It Legal. Overhaul the Common Rule.

Latino Coalition for a Healthy California, attorney Henry Dahl, and The City Project have submitted public comments to revise the Federal Policy for the Protection of Human Subjects to modernize, strengthen, and make this “Common Rule” more effective. We draw on lessons from the crimes against humanity and human rights violations under the Nuremberg Code in Guatemala, Tuskegee, and Nigeria.

1. The Common Rule must make explicit that nonconsensual human medical experiments violate domestic and international laws. Ethical considerations are not enough to deter violations.

The United States Court of Appeals for the Second Circuit held that nonconsensual medical experimentation on human beings violates customary international law and is actionable under the Alien Tort Statute because the prohibition is specific, universal, and obligatory among nations around the world. The court relied in part on the Nuremberg Code. See Abdullahi v Pfizer, 562 F.3d 163 (2009), cert. denied, 130 S.Ct. 3541 (2010). The responsibility of individual researchers must be made explicit too, not only institutions.

2. The content of the Common Rule must be strengthened to recognize that voluntary consent of the human subject is absolutely essential.

This is the formulation of the Nuremberg Code and it should not be watered down. As it now stands, the term “informed consent” is virtually meaningless under the Common Rule.

3. The Common Rule must be revised to address the special problems of human medical research in developing countries, as it does for pregnant women, children, and prisoners.

Discrimination, poor study design, lack of informed consent, improper handling of adverse outcomes, distortion of findings, outright lying and forgery, blackmail: there are a wide variety of ways that US researchers may engage in unethical behavior to pursue government grants, foundation support, corporate profit, or tenure and advancement.

4. The Common Rule must provide for treatment and compensation for research-related injury.

Subjects should not individually bear the costs of care required to treat research-related injuries like those in Guatemala, Tuskegee, and Nigeria.

5. The US should waive sovereign immunity and other procedural obstacles involving federally funded medical experiments abroad.

The federal US District Court for the District of Columbia threw out the lawsuit by Guatemala STD victims against the US on the grounds that the US has not consented to be sued. The court concluded that “the Guatemala Study is a deeply troubling chapter in our Nation’s history. Yet . . . this Court is powerless to provide any redress to the plaintiffs.” Garcia Gudiel v Sebelius, 867 F.Supp. 2d 125, 144 (D.D.C. 2012), appeal dismissed, 2013 U.S. App. LEXIS 13873.

* * *

The US imprisoned or executed German doctors after trial at Nuremberg for gruesome nonconsensual medical experiments. The US and Guatemala infected innocent Guatemalan people with STDs without their consent beginning in the 1940s and has left them untreated and uncompensated to the present day. In Tuskegee, African American men already infected with syphilis were left untreated from the 1930s until 1972 without consent. In Nigeria, researchers experimented on children during an epidemic of bacterial meningitis without consent, causing the death of 11 children and leaving many others blind, deaf, paralyzed, or brain damaged.

Ethical considerations did not stop these researchers. Criminal and civil liability is required.

The Common Rule must be revised so that nonconsensual human medical experiments never happen again.

Researchers infected a 16 year old girl with syphilis in Guatemala. “Records indicate that the patient was “uncooperative.”
Source: victim profiles from the US Presidential Commission on Bioethics report “Ethically Impossible,” page 60.

Latino Coalition for a Healthy California serves as the leading voice for Latino health in California by initiating and advancing policies to build healthy communities. Henry Dahl is an attorney with experience in international law and human rights. The City Project represents the Catholic Archdiocese of Guatemala in the petition before the Inter-American Commission on Human Rights against the US and Guatemala for crimes against humanity and human rights violations in the STD experiments.

 

 

US STDs in Guatemala Crimes against Humanity Overhaul the System NY Review of Books

The Archdiocese of Guatemala has filed an international human rights petition against the US and Guatemala for intentionally infecting Guatemalan people with STDs and leaving them untreated and uncompensated from the 1940s to the present day. The US has failed even to carry out the reforms governing human rights experiments recommended by its own presidential commission in 2011. Dr. Marcia Angell, the former editor of the New England Journal of Medicine, concludes: “[T]he Common Rule says almost nothing about the special problems of research in developing countries . . . . [A]n overhaul of the system . . . is what is needed.”

Rigoberta Menchu, Robert Garcia and Judy Baca 2002

[T]here have been many real experiments over the years involving . . . extreme choices in which researchers sacrificed the welfare of human subjects . . . .

The most horrifying and grotesque of these were the medical experiments carried out by Nazi Germany during World War II on inmates in concentration camps.[3] . . .

At the end of the war, a series of war crimes trials were held by the victorious Allies in Nuremberg, Germany. One of them, presided over by American judges in a US military tribunal, was known as the Doctors’ Trial. In that trial, which began in December 1946, the twenty-three surviving researchers (twenty of them physicians) responsible for the medical experiments in the concentration camps were accused of war crimes and crimes against humanity. . . . The Nazi Doctors’ Trial resulted in the conviction in August 1947 of sixteen of the twenty-three defendants, seven of whom were hanged and nine imprisoned. As part of the judgment, the court issued the celebrated Nuremberg Code in 1947—the first, shortest, and in many ways most uncompromising of the major ethical codes and regulations for the conduct of medical research on humans. . . .

Was the issuance of the Nuremberg Code the end of unethical medical research? Not at all. [Editor’s note: The NYRB ignores the STD experiments against Guatemalan people.] In fact, over about thirty years, from 1944 to 1974, the US government conducted multiple experiments in which people were deliberately exposed to radiation without their knowledge or consent. The aim was to study the effects of testing nuclear weapons. To cite only two examples, the testicles of state prisoners in Oregon and Washington were irradiated to study the effects on sperm production, and terminally ill patients in a Cincinnati hospital underwent irradiation of their entire bodies to learn about its dangers to military personnel.4 Note the irony that these experiments were taking place during the Nuremberg trials, and involved a similar justification—namely, that extreme circumstances, in this case the cold war, demand extreme actions.

From 1956 to 1972, a study was conducted at the Willowbrook State School for the Retarded in New York, in which the children there were deliberately infected with hepatitis to study the natural course of the disease and its treatment. The justification was that the sanitation in the facility was so poor that nearly all of these children would have contracted the illness anyway. [5] Note the similarity to the Nazi doctors’ excuse that many of the inmates in the concentration camps were condemned to death anyway.

Still, with the promulgation of the Nuremberg Code, there were now some broadly accepted principles, despite such egregious violations. Nevertheless, for all its strengths, it was felt that the Nuremberg Code needed change . . . .

In 1964, the World Medical Association (WMA), which consists of a group of national medical societies, including the American Medical Association (AMA), issued the first Declaration of Helsinki. It has undergone seven revisions since then, most recently in 2013. . . .

But the debate did not stop. Instead, two years later, under pressure from the AMA, footnotes were added to the relevant sections that modified them to the extent that the document became internally inconsistent. The NIH and the FDA no longer refer to the Declaration of Helsinki (the FDA instead refers to the International Conference on Harmonisation’s less specific Good Clinical Practice guidelines), but it remains a touchstone in many other countries, despite its inconsistencies, and it is of great historical importance.

*  *  *

In the first part of this review, I discussed principles and codes of ethics concerning human experimentation, including the Nuremberg Code and the Declaration of Helsinki. But principles and codes are not the same as laws and regulations, even though they might inspire them. The first US statute dealing with the ethics of medical research on human subjects was enacted in 1962, as a reaction to the thalidomide tragedy of the late 1950s, in which pregnant women given thalidomide to alleviate morning sickness gave birth to infants with deformed or missing limbs. . .

[After the Tuskegee experiments were discovered and halted] Congress passed the National Research Act of 1974, and regulations were issued that mandated the establishment of ethics committees, now called institutional review boards (IRBs), to review federally funded human research. The law also established a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop overarching principles. Its report—called the Belmont Report, named for the conference center where the commission began its deliberations—was issued in 1978. As of 2014, fifteen federal departments and agencies have adopted a common set of regulations based on the Belmont Report to govern research on human subjects. Known as the Common Rule (it appears as Subpart A of Title 45, Part 46 of the Code of Federal Regulations), it applies to virtually all federally funded research on human subjects, and most institutions follow it even for privately funded research. . . .

[T]he Common Rule says almost nothing about the special problems of research in developing countries, including whether it is ethical to use placebos in control groups instead of a known effective treatment, and whether consent can be truly voluntary in regions with autocratic governments that benefit from the money and prestige that come from hosting research sponsored by developed countries. One IRB member, speaking about the use of placebos in control groups, told Klitzman, “The solution is to do things elsewhere that wouldn’t be considered ethical in this country. The FDA has no problem accepting those data from abroad.” He went on to say, “The favorite place to do these now is either South America or Eastern Europe.”

“[A]n overhaul of the system . . . is what is needed.”

Read part one here of this article and part two here.

Texts reviewed

The Nuremberg Code issued by the Nuremberg tribunal in 1947 

The Declaration of Helsinki issued by the World Medical Association in 1964 and revised most recently in 2013

The Common Rule (Title 45, Part 46, Subpart A, Code of Federal Regulations), issued by the US Department of Health and Human Services in 1991

The Ethics Police? The Struggle to Make Human Research Safe by Robert L. Klitzman, Oxford University Press, 422 pp., $35.00 2015

* * *

3 See The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation, edited by George J. Annas and Michael A. Grodin (Oxford University Press, 1992). This is an excellent history and analysis, which includes the Nuremberg Code and the Declaration of Helsinki up through the 1975 revision.

5 In 1966, Henry Beecher, professor of research anesthesia at Harvard Medical School, published twenty-two examples of unethical human research. Example number sixteen was the Willowbrook study. Beecher’s paper was widely reported, and contributed to the impetus for the 1974 National Research Act. See Henry K. Beecher, “Ethics and Clinical Research,” The New England Journal of Medicine, Vol. 274, No. 24 (June 16, 1966).

Photo: UCLA Prof. Judy Baca, Nobel Peace Laureate Rigoberta Menchú from Guatemala, The City Project’s Robert García. Photo by Nic García.

 

Guatemala US STD Human Rights Victims Sue Johns Hopkins Guardian

Lawsuit seeks damages for individuals, spouses and children of people infected with STDs through US government program in 1940s and 1950s

Johns Hopkins University is among the defendants in a lawsuit over its role in a series of medical experiments in Guatemala in the 1940s and 1950s.

Associated Press in Baltimore

More than 750 plaintiffs are suing the Johns Hopkins Hospital System Corp over its role in a series of medical experiments in Guatemala in the 1940s and 1950s during which subjects were deliberately infected with venereal diseases without their consent.

The lawsuit in Baltimore seeks $1bn in damages for individuals, spouses and children of people infected with syphilis, gonorrhea and other sexually transmitted diseases through a US government program from 1945-56. . . .

The suit, which includes 774 plaintiffs, says the experiments were conducted abroad in order to give “researchers the opportunity to test additional methods of infecting humans with venereal disease easily hidden from public scrutiny”.

According to the US department of health and human services, researchers initially infected Guatemalan sex workers with gonorrhea or syphilis, then allowed them to have sex with soldiers and prison inmates with the aim of spreading the disease.

The suit says that orphans, children and mental patients were also deliberately infected without their consent, and that treatment was withheld from some subjects.

Revelations of these experiments came to light in 2010. Barack Obama apologized for the research, as did then-secretary of state Hillary Clinton and then-secretary of health and human services Kathleen Sebelius. . . .

In a written statement, Hopkins called the experiments “deplorable”.

But Robert Mathias, the lead counsel for Johns Hopkins in the case, said the lawsuit “baseless”. . .

In a written statement, the Rockefeller Foundation called the research “morally repugnant”, and said it agrees that the US government owes reparations to victims and their families. However, it says the foundation “did not design, fund, or manage any of these experiments, and had absolutely no knowledge of them”, and will oppose the lawsuit.

Pharmaceutical company Bristol-Myers Squibb is also a defendant in the case.

A spokeswoman for Bristol-Myers Squibb declined to comment on Wednesday. . . .

A federal judge in 2012 dismissed a lawsuit against the US government involving the same study after determining that the US government can’t be held liable for actions outside the United States.

Read the entire story in the Guardian . . .

Read the interview and article by UCLA Medical School Prof. Michael Rodriguez and civil rights attorney Robert García in English in the American Journal of Public Health – First, Do No Harm: US Sexually Transmitted Disease Experiments in Guatemala.

Lea la entrevista con UCLA Prof. Michael Rodriguez y el abogado Robert García en Español. Con Nuestra América: Lo primero es no hacer daño: Los experimentos con enfermedades de transmisión sexual realizados por los EE.UU. en Guatemala.

 

Jon Stewart Guatemala Syph Happens “Sorry we secretly gave you syphilis”

Click on the image to view the Jon Stewart video. 

Click here for Justice for Guatemalan People: The U.S. STD Atrocities.