Environmental Science Discussion 2

First, Do No Harm: The US Sexually Transmitted Disease Experiments in Guatemala Beginning in 1946, the United States government immorally and unethically— and, arguably, illegally— engaged in research exper- iments in which more than 5000 uninformed and un- consenting Guatemalan people were intentionally infected with bacteria that cause sexually transmitted diseases. Many have been left untreated to the present day.

Although US President Barack Obama apologized in 2010, and although the US Presidential Commission for the Study of Bioethical Issues found the Guatema- lan experiments morally wrong, little if anything has been done to compensate the victims and their fami- lies.

We explore the backdrop for this unethical medical re- search and violation of hu- man rights and call for steps the United States should take to provide relief and compen- sation to Guatemala and its people. (Am J Public Health.

2013;1 0 3 : 2 1 2 2 – 2 1 2 6 . doi:

10.2105/AJPH.2013.301520) Michael A. Rodriguez, MD, MPH, and Robert García, JD TODAY, GUATEMALA HAS a total population of 14.76 million people; 53.7% live in poverty. 1The average level of education was 4.1 years in 2011, 1and Guatemala is considered a lower-middle-income country. 1In 1946, these demo- graphic characteristics were even more dismal and without the beneﬁt of more than 60 years of national, economic, and cultural development.

In the context of these inequal- ities in 1946, Public Health Ser- vice investigators in a study funded by the National Institutes of Health, with the cooperation of Guatemalan authorities, engaged in a series of immoral and unethical human medical experiments con- ducted without the participants’in- formed consent. The study involved at least 5128 vulnerable people, including children, orphans, child and adult prostitutes, Guatemalan Indians, leprosy patients, mental patients, prisoners, and soldiers.

Between 1946 and 1948, health ofﬁcials intentionally infected at least 1308 of these people with syphilis, gonorrhea, and chancroid and conducted serology tests on others. The study originally began in the United States but was moved to Guatemala when researchers were unable to consistently produce gon- orrhea infections in prisoners at a Terre Haute, Indiana, prison. The public had no knowledge of the experiments for more than half a century, and even today little is known about these violations of medical ethics and human rights. 2 It is important to emphasize the facts surrounding the Guatemala sexually transmitted disease (STD) experiments to properly evaluate themoral, ethical, and legal implications of the experiments. The experiments were not conducted in a sterile clinical setting in which bacteria that causeSTDswereadministeredin the form of a pin prick vaccination or a pill taken orally. The researchers systematically and repeatedly vio- lated profoundly vulnerable individ- uals, some in the saddest and most despairing states, and grievously ag- gravated their suffering. For example: Berta was a female patient in the psychiatric hospital. Her age and the illness that brought her to the hospital are unknown. In Febru- ary 1948, Berta was injected in her left arm with syphilis. A month later, she developed sca- bies (an itchy skin infection caused by a mite). Several weeks later, [lead investigator Dr. John] Cutler noted that she had also de- velopedredbumpswherehehad injected her arm, lesions on her arms and legs, and her skin was beginning to waste away from her body. Berta was not treated for syphilis until three months after her injection. Soon after, on August 23, Dr. Cutler wrote that Berta appeared as if she was going to die, buthedidnotspecifywhy.That same day he put gonorrheal pus from another male subject into both of Berta’seyes,aswellasin her urethra and rectum. He also re-infected her with syphilis. Sev- eral days later, Berta’seyeswere ﬁlled with pus from the gonorrhea, and she was bleeding from her urethra. On August 27, Berta died. 3 In 2010, US President Barack Obama apologized to Guatemalan President Alvaro Colom and the people affected, expressing the United States’commitment to the ethical and legal conduct of contemporary human medical studies. 4The US Presidential Com- mission for the Study of Bioethical Issues (hereafter the Commission)has since issued 2 reports:“Ethically Impossible”STD Research in Guate- mala from 1946---1948 3andMoral Science: Protecting Participants in Human Subjects Research.

5 The Commission’sﬁrst report condemned the experiments as “impossible”under current ethical standards. The second report ac- knowledged an inability by the United States to conﬁrm that all federally funded research provides optimal protections against avoid- able harms and unethical treatment today 5; the report also recommen- ded reforms, none of which have been implemented as of yet. No mention of reparation or compensation for the victims was made in either report. In addition, little was said about the violations against human rights, which, when considered in conjunction with medical ethics, should provide pro- tection to vulnerable populations. 6 By contrast, the Guatemalan government issued a separate re- port,Consentir el Daño: Experimen- tosMédicosdeEstadosUnidosen Guatemala(To Agree to the Harm:

Medical Experiments by the United States in Guatemala), which went beyond the US reports to state that the experiments were“acrime against humanity”and that racism and discrimination were present throughout the experiments in an explicit and conscious way. 7The Guatemalan report called for repa- ration and compensation for the victims. In addition, 2 independent reports, written by the United Na- tions 8and the Catholic Church 9on human rights violations and geno- cide in Guatemala from the 1950s to the 1990s, bolster the COMMENTARIES 2122|Commentaries|Peer Reviewed|Rodriguez and GarcíaAmerican Journal of Public Health|December 2013, Vol 103, No. 12 Guatemalan commission’sdeclara- tions with respect todiscrimination, reparations, and human rights and highlight weaknesses in the US reports. 7There is little evidence that the US government, the public health community, academic publi- cations, or the media have ac- knowledged the Guatemalan report.

In spring 2012, when the case against the US government was considered by a federal district court as a class action lawsuit brought on behalf of the Guatemalan victims and their survivors, the court dismissed the case on grounds of sovereign immunity.

10Plaintiffs relied on the Ethically Impossiblereport in reciting the facts in the class action complaint.

The US Justice Department did not dispute the facts in moving to dismiss the case, raising only technical argu- ments about sovereign immunity and the plaintiffs’failure to exhaust administrative remedies beforeﬁling suit. The district court is required to assume the veracity of the plaintiff’s allegations when there is a motion to dismiss for failing to state a legally cognizable claim. The case was never heard on its merits and was dis- m i s s e d o n J u n e 12 , 2 012 , e v e n though the court had set a hearing on the matter for July 26, 2012.

The court wrote that the Guatemala Study is a deeply troubling chapter in our Nation’s history. Yet...this Court is pow- erless to provide any redress to the plaintiffs. The pleas are more appropriately directed to the po- litical branches of our govern- ment, who, if they choose, have the ability to grant some modi- cum of relief to those affected by the Guatemala Study. 10 To date, the political branches have provided no relief to the plaintiffs. 11 However, on January 10, 2012, one day after the Justice Depart- ment moved to dismiss the case in Gudiel v Sebelius, 10the Depart- ment of Health and HumanServices announced funding of approximately $1.8 million to im- prove treatment and prevention of HIV and other sexually transmitted infections (STIs) in Guatemala and to further strengthen ethical training on human research protections. 12In addition, the Centers for Disease Control and Prevention was tasked with developing a case study on the unethical research conducted in Guatemala. The study will include learning objectives focused on scien- tiﬁc and ethical issues in designing aﬁeld investigation. Legal training appears to be missing from the De- partment of Health and Human Services directive. 12General fund- ing of global human research pro- tections and STI health initiatives in Guatemalaisnosubstitutefor treatment of and compensation to the victims.

Despite the Department of Health and Human Services’an- nouncement and the Commission’s reports, the lack of publicity re- ceived by the Guatemalan case is startling. The American public is largely unaware of these experi- ments and the outrageous treat- ment of Guatemalans, the reports by the US and Guatemalan com- missions, or the victims’lack of reparations, compensation, and access to justice through the courts.

The media has devoted little atten- tion to the case. Unlike other cases in which human rights were vio- latedinhumansubjectsresearch (e.g., the Tuskegee syphilis experi- ments), few, if any, organizations have taken up the cause for human justice with respect to this vulnera- ble Guatemalan population.

The wrongful actions by US ofﬁcials can be characterized by several facts. First, US ofﬁcials in- tentionally infected victims with bacteria that cause STDs without informed consent. Second, they have failed to provide victims with treatment or compensation.Finally, they covered up and did not publish or disclose the exper- iments, including the intentional infections and their failure to pro- vide treatment.

In summary, the US and Guate- malan commissions have docu- mented many of the facts of the STD experiments and are in agree- ment on many salient points. Each report has determined that the Public Health Service investigators violated contemporaneous medical research ethics standards, and the Guatemalan report determined that the experiments violated human rights law. Given the state of the records, the few judicial precedents, the increasingly unreceptive atti- tude of the US Supreme Court toward class actions, and the com- plicated questions of sovereign im- munity, the plaintiffs’quest for ac- cess to justice through the courts will be long and uncertain. VIOLATION OF CUSTOMARY INTERNATIONAL LAW A signiﬁcant omission of the Commission’s reports is the lack of an explicit discussion of legal responsibility and accountability.

The Guatemalan report asserts that the investigation was immoral and constituted a crime against humanity. 7The report states that it focuses on the moral plane be- causemostoftheresponsibleprin- cipals are surely dead. The report refers to international human rights authorities and ethical principles such as the United Nations Decla- ration of Universal Human Rights (ratiﬁed by both the United States and Guatemala), the Interamerican Declaration on the Rights and Re- sponsibilities of Man, the Rights of Man in the Charter of the Organi- zation of American States, the 1978 Belmont report of the National Commission for the Protection ofHuman Subjects of Biomedical and Behavioral Research, and the Dec- laration of Helsinki. It also refer- ences the Nazi Nuremberg trials and the Tuskegee syphilis experiments. 7 The Obama administration has not conducted a public analysis to determine whether the experiments violated US or international legal standards. There is judicial prece- dent, however, to support the proposition that the Guatemala ex- periments violated international human rights standards. In the 2009 case ofAbdullahi v Pﬁzer, 13 the United States Court of Appeals for the Second Circuit held that nonconsensual medical experimen- tation on human beings violates customary international law be- cause, among other reasons, the prohibition is sufﬁciently speciﬁc andfocusedandisacceptedby nations around the world.

The relevant question with re- spect to the Guatemala STD ex- periments is“At what point in time did customary international law ﬁrst prohibit nonconsensual med- ical experimentation?”The Nur- emberg code, prohibiting human medical research without in- formed consent, was upheld with the conviction of German doctors on August 19, 1947; a case can be made that the intentional STIs in Guatemala violated this code beginning on that date, at a minimum, when US sexually transmitted disease investigators in Guatemala would have known of these developments in human rights law. 3 Whereas US legal standards govern US-led research but do not necessarily protect residents of other nations, international laws protect all citizens of the world and should be closely considered in this case.

For example, according to Article 7 of the International Covenant on Civil and Political Rights, 14“no one shall be subjected without his free COMMENTARIES December 2013, Vol 103, No. 12|American Journal of Public HealthRodriguez and García|Peer Reviewed|Commentaries|2123 consent to medical or scientiﬁcex- perimentation.”This covenant, adopted in 1966 and put in force in 1976, is monitored by the United Nations Human Rights Committee and is part of the International Bill of Rights. Some might argue that the Guatemalan case should be heard by the United Nations governing body to speed up the process of bringing compensation and relief to the victims. Other international human rights authorities and laws, including several articles from the 1948 Universal Decla- ration of Human Rights, also provide international standards for human subjects research, standards that surely were violated in the Guatemalan experiments.

Not only should human rights laws have been applied to the Guatemalan experiments; medical research is also governed by prin- ciples of biomedical ethics 15that call for patient safety, respect, be- neﬁcence, justice, and nonmaleﬁ- cence (“ﬁrst do no harm”). Today’s medical professionals and re- searchers are trained in these bio- medical values and ethics. Most notably, the International Ethical Guidelines for Biomedical Re- search Involving Human Subjects, promulgated by the Council for International Organizations of Medical Sciences, deﬁne how the principles of the Declaration of Helsinki can be applied to devel- oping countries in light of their socioeconomic circumstances.

Although these guidelines were developed after the Guatemalan experiments, they recognize that, even in developing countries, in- formed consent and other basic principles of research ethics clearly apply. Surely, the re- searchers involved in the Guate- malan experiments were not abiding by many of these princi- ples of biomedical research ethics.International human rights standards provide one avenue to address structural injustice and institutional and national re- sponsibility, including discrimi- nation based on gender, race, and class in Guatemala and the complex of political, economic, military, and social relations between Guatemala and the United States. The actions in Guatemala went beyond domes- tic crimes such as rape, battery, assault, and conspiracy and vio- lated international law. 16 UNEQUAL JUSTICE AND DISCRIMINATION The Commission reports 3,5 generally allude to the possibility that discrimination played a role in the Guatemala investigations, but the reports do not address the issue adequately 16or systemati- cally. For example, inEthically Impossible, 3the authors discuss why the investigators selected Guatemala as a setting:“A possible remaining but clearly unaccept- able explanation for choosing Guatemala would reﬂect the no- tion that the Guatemalans were a suitable, if not preferable, ex- perimental population by virtue of poverty, ethnicity, race, re- moteness, national status, or some combination of these fac- tors.” 3TheMoral Sciencereport makes only a passing, ambiguous reference to racism in a footnote, stating simply,“The Commission here focuses on the issues of justice.” 5 By contrast, the Guatemala re- port discusses discrimination in much stronger terms. The report states that racism and discrimina- tion were present throughout the experiments in an explicit and conscious way. The report recom- mends strengthening compliance with the constitutionalrequirements of equality among human beings to combat discrimi- nation and racism.

Ultimately, the nonconsensual human experiments and serol- ogy tests conducted, the process of intentionally infecting people with bacteria that cause STDs, and the failure to provide treat- ment were immoral and unethi- cal and violated both US and international legal standards, re- gardless of the race, color, na- tional origin, or socioeconomic status of the victims here. Dis- crimination in the context of the Guatemalan experiments in- cludes discrimination by US of- ﬁcials against Guatemalan peo- ple and discrimination within Guatemalan society by elites against lower-class indigenous and nonindigenous people.

Discrimination is an aggravating, unacceptable factor that war- rants additional review and dis- cussion.

The US equal protection prin- ciples and laws are relevant when examining evidence of discrimi- nation and the inferences to be drawn from the facts. The laws also provide guidance on how to address discrimination in other human research contexts with re- spect to underrepresented, minor- ity, and vulnerable populations.

The US Supreme Court and other authorities recognize that the fol- lowing factors are relevant in evaluating a claim of intentional discrimination based on race, color, or national origin: the im- pact of the action and whether it bears more heavily on one group than another, a pattern or history of discrimination, depar- tures from substantive norms, departures from procedural norms, and knowledge of the harm discrimination will cause (see, e.g.,Village of Arlington Heights v Metropolitan HousingDev. Corp. 17andGuardians Ass’n v Civil Serv. Comm’n 18).

Under these parameters, evi- dence of discrimination abounds in the Guatemalan experiments.

First, these experiments were lim- ited to the Guatemalan people.

Second, the United States has a history of discrimination and oppression against the people of Guatemala. For example, the Cold War and the war on drugs by the United States devastated Guatemala’s civic society and economy for decades. In 1954, the United States overthrew the country’s democratically elected government.

19Military dictatorships, backed by the United States, assassinated almost 200 000 8people in the next 40 years. The Guatemalan gov- ernment engaged in mass killings of Mayans, obliterating entire villages. 8,9 Bishop Juan Gerardi was bludgeoned to death in 1998 for publishing a report by the Catholic Church documenting the killings. 20 Third, the United States and Guatemala reports document departures from substantive and procedural norms in the Guate- mala investigations. Fourth, the investigators knew of the harms they caused. Finally, civil rights statutes and federal regulations also prohibit unjus- tiﬁed discriminatory actions without requiring a showing of intent or individual racial ani- mus.

17 ,18 These standards of discrimination provide an analytic framework to evaluate evidence of discrimination in the context of the Guatemalan experiments. Indeed, these are the kinds of evidence that the Guatemala commission re- port cites in concluding that discrimination and racism were present throughout the experiments. 7 COMMENTARIES 2124|Commentaries|Peer Reviewed|Rodriguez and GarcíaAmerican Journal of Public Health|December 2013, Vol 103, No. 12 UNEQUAL JUSTICE:

GUATEMALA AND TUSKEGEE The Tuskegee syphilis experi- ments, involving recompense for past injustice, are directly relevant to the Guatemala injustices. In both the Guatemala and the Tuskegee experiments, directed by the same principal investigator, the US gov- ernment engaged in concededly immoral and unethical actions:

conducting nonconsensual human medical experiments, not treating infected victims, and deceiving vic- tims and the public. In Guatemala, researchers intentionally infected the victims and generally left them with- out treatment or compensation for the remainder of their lives. In Tus- kegee, the nearly 400 victims were already infected but were left without treatment beginning in the 1930s.

The United States eventually provided treatment and compen- sation for victims, families, and heirs in Tuskegee, including fund- ing to locate the victims and pay attorneys’fees. The ethical principle of equal justice strongly suggests that similar relief should be provided for the Guatemalan victims. However, reparation in Tuskegee was made only after organizations championed the cause, made the wrongful acts known to the general public, sought access to justice through the courts, and applied pressure on the govern- ment to take action. 2This has not occurred in the context of the Gua- temalan STD experiments. REPARATIONS AND COMPENSATION Academicians have long noted that, in addition to a duty of justice, an obligation of reparation arises from one’s wrongful acts. 21 Scholars note that such compen- satory action is morally essential not only to“repair”the harm butalso to render victims their due and thereby acknowledge them as agents worthy of respect and entitled to atonement. 22 The au- thors of the Guatemalan report also articulated the principles of compensation and reparations (as didCohenandAdashi 11), which remain valid and extend to the need to address legal issues.

A summary of these principles as they apply to the Guatemalan victims is informative.

First, as a matter of corrective justice, surviving participants or their affected contacts should be compensated in full for injuries sustained. Surviving family mem- bers should also be made whole for harm incurred, whether direct (e.g., disease transmission) or indirect (e.g., emotional distress, loss of a family member at a younger age) in nature. A political solution be- tween the US government and the Guatemalan government can make this happen. Second, a compensa- tion and reparations program would more concretely and per- manently acknowledge the wrong- ful nature of the conduct in question, in keeping with the ex- pressive function of both US and international law. Such a program would also reafﬁrm the legal and ethical standards undergirding hu- man participant research.

Third, compensation and repa- rations would advance healing and reconciliation and constitute an important, tangible, goodwill gesture to the Guatemalan people and nation. Fourth, compensation and reparations could be tailored to enhance the legal and ethical training of current and future in- vestigators, mitigating potential educational shortcomings and preventing future misconduct.

Finally, as a matter of deterrence, compensation and reparations may obviate legal and ethical vio- lations in the future.History has provided a few models of compensation programs that the US response to Guatemala may do well to emulate. For ex- ample, in response to a class-action lawsuit (Allen v United States 23), the US Congress passed the Radi- ation Exposure Compensation Act of 1990. 24 As of October 2011, more than $1.5 billion had been disbursed to more than 23 000 approved claimants ex- posed to ionizing radiation during US-based nuclear experiments. 25 It is this type of compensation that is required to correct the in- justices suffered by the Guatemalan people, not the mere $1.8 million set aside for prevention programs and ethical training on human re- search protections. The Tuskegee payment structure 26,27 ($37 500 for each living participant, $15 000 for each surviving dependent, $16 000 for each living control group participant, $5000 to heirs of de- ceased members of the control group) totaled $10 million in 1974 (approximately $47 million in 2013 currency). A similar payment struc- ture applied to the Guatemalan victims would still be a relatively small amount in comparison with the $1.5 billion already awarded to victims of radiation research. CONCLUSIONS In itsEthically Impossiblereport addressing the Guatemalan ex- periments, the Commission expressed the need to be ever vigilant to ensure that such repre- hensible exploitation of our fellow human beings is never repeated.

As such, it is critical to adopt legal and ethical reforms to provide treatment and compensation for individuals involved in improperly conducted human experiments, waive sovereign immunity for federally funded human research in the United States and abroad,ensure that parallel protections apply to privately funded re- search, and respect autonomy and equality for all. Greater appli- cation of legal strategies may promote a stronger structural foundation for preventing such unethical acts in the future. j About the AuthorsMichael A. Rodriguez is with the Blum Center on Poverty and Health in Latin America and the Department of Family Medicine, David Geffen School of Medicine, University of California, Los Angeles.

Robert García is with The City Project, Los Angeles.

Correspondence should be sent to Michael A. Rodriguez, MD, MPH, Department of Family Medicine, David Geffen School of Medicine, University of California, Los Angeles, 10880 Wilshire Blvd, Suite 1800, Los Angeles, CA 90024 (e-mail:

[email protected]). Reprints can be ordered at http://www.ajph.org by clicking the“Reprints”link.

This commentary was accepted June 16, 2013.

ContributorsBoth authors contributed substantially to the conceptualization and design of the article and to critical revisions of the article for important intellectual content.

AcknowledgmentsThis work was supported by the Blum Center on Poverty and Health in LatinAmericaandbyagrantfromthe National Institutes of Health (2P20MD000182).

Note.Theﬁndings are those of the authors and do not necessarily represent the views of the funders.

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Accessed July 19, 2013. Crossing the Chasm of Mistrust: Collaborating With Immigrant Populations Through Community Organizations and Academic Partners As a community partner and an academic researcher, we experienced the direct and extended bene ts of a rela- tively small-scale, community- engaged informed consent process that developed in an immigrant occupational health study, Assessing and Control- ling Occupational Health Risks for Immigrant Populations in Somerville, Massachusetts.

The practice of human par- ticipants research played a positive role in the commu- nity, and both community partners and researchers, as well as the larger academic community, reaped unex- pected bene ts during the ve-year project (2005–2010), which continue into the present.

Lessons learned from our experience may be helpful for wider application. (Am J Public Health.2013;103:

2126–2130. doi:10.2105/ AJPH.2013.301517) Alex Pirie, BA, and David M. Gute, PhD, MPH AT A TIME WHEN EXTRAORDI- nary health disparities in the United States are coupled with an increas- ing reluctance on the part of vul- nerable populations to support or participate in health research, it is crucial to engage with these com- munities to ensure the integrity of human participants research. Gaps in trust between vulnerable com- munities and researchers have emerged for a variety of reasons, including historical injury at the community level and the current media coverage of the lack of over- sight on medical devices (e.g., metal- on-metal hip replacement prob- lems 1) and clinical trials. 2The in- tegrity of protection should be en- hanced, 3and at-risk populations need education in the protections that exist and the beneﬁts of engag- ing in health studies through such established research mechanisms asclinical trials research or newer modalities such as community- based participatory research. 4 Community-based participatory research often requires active negoti- ation of the social and cultural differ- ences that separate community or- ganizations from academic partners.

We gained insights into this process from our research experience with immigrant populations living and working in Somerville, Massachusetts.

THE SOMERVILLE PROJECT Assessing and Controlling Occupational Health Risks for Immigrants in Somerville, Massa- chusetts, funded by the National Institute for Occupational Safety and Health (NIOSH), involved a community organization, the Immigrant Service ProvidersGroup/Health (ISPG/H); a pro- vider of health care, Cambridge Health Alliance; and an academic partner, Tufts University. Other community partners were the Haitian Coalition, the Community Action Agency of Somerville, the Brazilian Women’sGroup,and the Massachusetts Coalition for Occupational Safety and Health.

All of these organizations worked collaboratively throughout the project period. The objectives of the project were to enhance the capacity of the community part- ners to address occupational health issues for the populations they serve as well as to gather quantitative and qualitative in- formation regarding immigrant occupational health. 5This work began in 2005 and ended in 2010.

An initial step in the multifac- eted project was to gather COMMENTARIES 2126|Commentaries|Peer Reviewed|Pirie and GuteAmerican Journal of Public Health|December 2013, Vol 103, No. 12