Lead Author: Robert Garcia
Organization: The City Project
Country: USA

Abstract 

We request that the UN High Level Panel support our proposed reform of the US “Common Rule” on human medical experiments, and hear our presentation, to remedy policy incoherence, promote public health, safeguard human rights, and implement evidence based reforms. The US government is studying revisions now.
1. The Common Rule must make explicit nonconsensual human medical experiments violate domestic and international laws. Ethical prohibitions are not enough to deter violations.
Nonconsensual human medical experiments violate customary international law because the prohibition is specific, universal and obligatory among nations, according to the court in Abdullahi v Pfizer (2d Cir. 2009).
2. The Common Rule must recognize voluntary consent of the human subject is absolutely essential.
The Nuremberg Code formulation must not be watered down. Under the Common Rule, “informed consent” is virtually meaningless.
3. The Common Rule must address special problems of human medical research in developing countries.
While US researchers engage in unethical behavior in developing nations, the Common Rule is virtually silent on this. The Rule provides special protections for pregnant women, children, and prisoners, and must do so for human subjects in developing nations.
4. The Common Rule must provide for treatment and compensation for research-related injury.
Subjects should not bear costs for research-related injuries, as happened in STD experiments in Guatemala and Tuskegee, and meningitis experiments in Nigeria.
5. The US must waive sovereign immunity and other procedural obstacles in human medical experiments.
The US court dismissed the lawsuit by Guatemalan victims because the US has not agreed to be sued: “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 (D.D.C. 2012). The US must waive procedural obstacles in human medical experiments.

Submission 

This contribution recommends that the UN High Level Panel on Access to Medicines support the proposed reform of US regulations on medical human experiments (“the Common Rule”), and hear this presentation in March 2016. This contribution reflects the proposals of legal, human rights, and civil rights experts, academics, and attorneys.

This contribution remedies policy incoherence, safeguards human rights, promotes public health, and implements evidence based reforms regarding the corrupting influence of financial incentives for medicines, vaccines, diagnostics, and medical devices (‘health technologies’) without proper safeguards.

This contribution:
• reflects, aligns, and demonstrates how it will support attainment of Sustainable Development Goal 3, improving health and wellbeing for all, and Target 7, and the 2030 Agenda for Sustainable Development;
• is evidence-informed and includes references to the principles, literature and models upon which it is based;
• incorporates and demonstrates the link to fundamental human rights and the right to health; and
• indicates the requirements to implement the proposed ideas.

This contribution supports Sustainable Goal 3, improving health and wellbeing for all, and most directly Target 7: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” This Target cannot be achieved on the backs of the victims of human medical experiments without proper safeguards, especially in developing nations. This contribution promotes he 2030 Agenda for Sustainable Development, ensuring that all human beings can fulfill their potential in dignity and equality and in a healthy environment.

In a word, the US Department of Health and Human Services can and should implement these recommendations through its pending study and forthcoming revisions to the Common Rule.

1. The Common Rule must explicitly recognize that nonconsensual human medical experiments violate domestic and international laws.

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. See Abdullahi v Pfizer, 562 F.3d 163 (2d Cir. 2009), cert. denied, 130 S.Ct. 3541 (2010). In Abdullahi, researchers experimented without consent on children with a new antibiotic during an epidemic of bacterial meningitis in Nigeria even though an effective vaccine was available - and left the children without care, causing the deaths of 11 children and leaving many others blind, deaf, paralyzed, or brain damaged. The court relied in part on the Nuremberg Code, which was adopted in 1947 upon the conviction by the US of German doctors for nonconsensual medical experiments. The Common Rule must ensure that the legal as well as the ethical and moral underpinnings of the Rule are made explicit. The responsibilities of individual investigators must be made clear in the Rule. At the present time, institutions at best are generally held responsible.

Three reports by the Guatemalan government cited in the resources section below agree that STD experiments by the US beginning in the 1940s violated international human rights and domestic laws. The Guatemalan presidential commission report concludes that the STD experiments were crimes against humanity and domestic crimes, and that racism and discrimination permeated the experiments. The technical report recognizes at page 96: “Given the applicable laws during that period, all directly responsible committed crimes punishable by law, and its cover up suggests knowledge of criminal responsibility.” The archival report concludes at page 165: “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.” The US nevertheless has provided no treatment or compensation to the victims until the present day.
Ethical prohibitions are inadequate to deter crimes against humanity and human rights violations in medical research. The US presidential report acknowledges that the experiments in Guatemala were “ethically impossible” by ethhical standards of the time and today. Yet Dr. John Cutler led the STD experiments in Guatemala, and was later responsible for the Tuskegee experiments that left African American men untreated for syphilis for decades. Cutler nevertheless died a hero at the University of Pittsburgh even after the Tuskegee experiments were exposed. Cutler died without ever disclosing the Guatemala experiments. Sonia Shah has described unethical research in Tuskegee and in developing nations. Prof. Henry Beecher published twenty-two examples of unethical human research.

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

The voluntary consent of the human subject is essential under the Nuremberg Code. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This is the formulation of the Nuremberg Code and it should not be watered down. Research that poses greater risk to subjects should also receive more oversight and deliberation than less risky research. The Common Rule must reflect these requirements.

As it now stands, the term “informed consent” is virtually meaningless under the Common Rule. As explained by Dr. Marcia Angell, former editor of the New England Journal of Medicine:

“[T]he Common Rule itself needs to be revised, because it is almost devoid of ethical content. Instead, it should deal with difficult substantive issues. These include the “therapeutic misconception” (patients’ belief . . . that the researchers are there to provide them with individual care); the higher likelihood of harms than benefits because experimental treatments are usually no better, and often worse, than current treatments; the trade-off between individual benefits and benefits to science and society; whether the scientific merit of the research should be given weight (as called for in the Nuremberg Code); and whether to limit the move to conduct clinical trials in developing countries where there is almost certainly less oversight. . . . As it now stands, the term ‘informed consent’ is virtually meaningless.”

All federal agencies funding or conducting human subjects research must adopt human subjects regulations that are consistent with the legal and ethical requirements and underpinnings of the Common Rule.

Recommendations of the US Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (2011, updated 2012) generally should be implemented. The present contribution reflects recommendations 3, 6, 9, 11, and 13.

3. The Common Rule must be revised to address the special problems of human medical research in developing countries.

The Common Rule says almost nothing about the special problems of human medical research in developing countries. The imbalance between US researches and subjects arises from economic domination by the US of developing nations, discrimination by US researchers against host subjects based on race, color, national origin, gender, religion, income, and other factors; extreme poverty in many regions; cultural differences between researchers and subjects; and the greater likelihood of corruption involving US researchers and agents in the host nation. Poor study design, lack of informed consent, improper handling of adverse outcomes, distortion of findings, outright lying and forgery, blackmail: the meningitis experiments in the notorious case of Abdullahi v Pfizer, discussed above, illustrates a wide variety of ways that US researchers may engage in unethical behavior to pursue profit for big pharma.

The Guatemalan STD experiments are instructive. The Guatemalan presidential report concludes that racism and discrimination permeated the experiments. 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. The archival report concludes the experiments took advantage of the conditions and vulnerability of these people to carry out these practices.
The Common Rule must be revised to provide special protections in developing nations, as the Rule does now for pregnant women, children and prisoners. For example:

• Institutional review boards must include subjects from the host nation who have no interest in the research, or other disinterested international monitors with relevant multicultural fluency.
• The Rule must provide justifications and operational criteria for legal and ethical site selection, whether international or domestic, taking into consideration whether site selection can respond to the needs of the broader community.
• The consent form, nature of the experiment, risks, and right not to take part must be clear to subjects in light of their own language, dialect, and cultural norms. The consent process should be videotaped, as a signature or mark on a written form may mean nothing to a person who does not read or write.
• Community engagement and respect for cultural differences are applicable to medical research both domestically and abroad. The Common Rule must provide a standardized framework for community engagement. The guidelines of the Joint United Nations Program on HIV/AIDS and the AVAC Good Participatory Practice Guidelines, for example, provide such a framework.
• Reports on medical experiments in developing nations must be published in the language of the host nation, not only in English, for the people of the host nation to understand the matter. Such reports must consider the perspective of the host nation. Reports by the host nation must be published in English. For example, the US report “Ethically Impossible” has been published in English and Spanish. In contrast, the US has published its recommendations report Moral Science only in English; the US should publish it in Spanish, too. Both US reports ignore the reports by the Guatemalan government, only one of which is available in English.

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

Subjects harmed in the course of human research should not individually bear the costs for harms resulting from that research. The Common Rule must provide for compensation and treatment for research-related injuries like those in Tuskegee, Guatemala, and Nigeria in Abdullahi v Pfizer. Surviving family members 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.

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

The US court 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.” Gudiel Garcia v. Sebelius, 867 F.Supp. 2d 125, 144 (D.D.C. 2012), appeal dismissed, 2013 U.S. App. LEXIS 13873 (D.C. Cir. 2013). The US should waive procedural obstacles including but not limited to sovereign immunity and statutes of limitations involving US funded medical experiments abroad. US courts and international tribunals should provide relief to the victims to prevent the US and US funded researchers from acting with impunity. See Michael A. Rodriguez and Robert García, First, Do No Harm: The US Sexually Transmitted Disease Experiments in Guatemala, American Journal of Public Health (Dec. 2013, Vol. 103, No. 12, pp. 2122-2126), available at www.cityprojectca.org/blog/archives/30389.

6. Background on the human horrors of the Guatemala STD experiments

The discussion of legal and ethical reforms of the Common Rule can obscure the horror of what really happens in human terms. The acts described below in the Guatemala STD experiments are violations of customary international law, human rights violations, and crimes against humanity. They also constitute rape, sodomy, battery, assault, conspiracy to do the same, and conspiracy to cover up these wrongs.

The STD infections were not administered with clinical sterility, a pin prick, or a pill. Here is how one woman, identified only as Berta, died at the hands of the lead investigator, John Cutler, MD:

“Berta was a female patient in the psychiatric hospital. Her age and the illness that brought her to the hospital are unknown. In February 1948, Berta was injected in her left arm with syphilis. A month later, she developed scabies (an itchy skin infection caused by a mite). Several weeks later, [lead investigator Dr. John] Cutler noted that she had also developed red bumps where he had 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, but he did not specify why. That same day he put gonorrheal pus from another male subject into both of Berta’s eyes, as well as in her urethra and rectum. He also re-infected her with syphilis. Several days later, Berta’s eyes were filled with pus from the gonorrhea, and she was bleeding from her urethra. On August 27, Berta died.”

Presidential Commission for the Study of Bioethical Issues, “Ethically Impossible:” STD research in Guatemala from 1946-1948 at page 52 (2011).

US funded researchers intentionally infected innocent people with STDs without their knowledge or consent beginning in the 1940s and has left them untreated and uncompensated to the present day. 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. The experiments and cover up continued before, during, and after the convictions and executions of German doctors at Nuremberg. Ethical prohibitions have proven inadequate to deter such violations by US researchers and to hold institutions and individuals responsible and accountable.

The City Project and other civil rights and human rights attorneys represent the Catholic Archdiocese of Guatemala in a petition before the Inter-American Commission on Human Rights against the US and the Republic of Guatemala in the STD experiments. The experiments were covered up until Prof. Susan Reverby exposed them while doing research on the Tuskegee syphilis experiments. President Barack Obama apologized to the people of Guatemala in 2011. An apology is not enough for truth and reconciliation without restorative justice. The government of Guatemala has published three reports documenting that the experiments were crimes against humanity that violated international human rights law and domestic laws, and were motivated by discrimination against vulnerable people in Guatemala. The US published two reports documenting that the experiments were unethical by the standards of the day and by contemporary standards. While the US reports are silent on the legality of the experiments, silence on that point is a tacit admission that the experiments did indeed violate international and domestic laws.

Guatemalan victims have filed lawsuit for damages against Johns Hopkins University, the Rockefeller Foundation, Bristol-Myers Squibb Company, and others in US district court in Maryland, case number 1:15 CV 950 MJG (2015). A criminal complaint reportedly has been filed in Guatemala against the former president, vice-president, and attorney general of Guatemala. These matters are not connected to the human rights petition filed by the Archdiocese of Guatemala.

Conclusion

The Common Rule must be revised so that nonconsensual human medical experiments never happen again. With all due respect, the UN High Level Panel on Access to Medicines should support reforms proposed above, and hear the presentation in support in March 2016. The US government can and must implement these recommendations through its pending study and forthcoming revisions to the Common Rule.

Bibliography and References 

Abdullahi v Pfizer, 562 F.3d 163 (2009), cert. denied, 130 S.Ct. 3541 (2010). Available at caselaw.findlaw.com/us-2nd-circuit/1442878.html.

US Department of Health and Human Services, Notice of Proposed Rulemaking for Revisions to the Common Rule to Improve Rules Protecting Human Research Subjects. Changes proposed to ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight. www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html

Marcia Angell, Medical Research on Humans: Making It Ethical, N.Y. Review of Books (Dec. 3, 2015). Available at www.nybooks.com/articles/2015/12/03/medical-research-humans-making-it-ethical/.

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 rule is available at www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

Nuremberg Code, paragraph 1, available at www.hhs.gov/ohrp/archive/nurcode.html#; "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182, U.S. Government Printing Office (1949).

George J. Annas and Michael A. Grodin, The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation (1992).

Sonia Shah, The Body Hunters: Testing New Drugs on the World’s Poorest Patients (2006).

Henry K. Beecher, Ethics and Clinical Research, New England Journal of Medicine, Vol. 274, No. 24 (June 16, 1966).

Guatemala STD experiments

Petition by the Human Rights Office of the Archdiocese of Guatemala (ODHAG) against the U.S. and Guatemala for Human Rights Violations and Crimes Against Humanity before the International Commission on Human Rights (2015). Click here for the complete Appendix (17 MB on Dropbox).

Guatemala Presidential Commission Report, Consenting to the Damage: Presidential Commission Report for Elucidation of the Experiments Carried Out on Humans in Guatemala, 1946-48 (2011). The US Department of State provided the English translation to The City Project under the Freedom of Information Act. Síga este enlace para leer el reporte en español, Consentir el Daño: Experimentos Médicos de Estados Unidos en Guatemala, 1946-48 (2011).

US Presidential Commission report, “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948 in English. Síga este enlace para leer “Éticamente Imposible”: Investigación sobre las STD en Guatemala desde 1946 hasta 1948 en español.

US Presidential Commission report, Moral Science: Protecting Participants in Human Subjects Research in English.

Article by UCLA Medical School Prof. Michael Rodriguez, and civil rights and human rights attorney Robert García, in the American Journal of Public Health – First, Do No Harm: US Sexually Transmitted Disease Experiments in Guatemala. Síga este enlace para leer el articulo en español.

Two additional reports explicitly describe the violations of domestic and international law and provide background for the report by the Guatemalan Presidential Commission “Consenting to the Damage” These two reports are published in Spanish and are not available in English, except for the translated excerpts below.

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 excerpts that discuss domestic and international laws in the technical report in English.

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 excerpts that discuss domestic and international laws in the archival report in English.

Gudiel Garcia v. Sebelius, 867 F.Supp. 2d 125, 144 (D.D.C. 2012), appeal dismissed, 2013 U.S. App. LEXIS 13873. Available at casetext.com/case/garcia-v-sebelius-2.

Estate of Arturo Giron Alvarez, et al., v. Johns Hopkins University, Case: 1:15-cv-00950-MJG, 1:15-cv-1100 MJG (D.C. MD 2015) (second amended complaint). Available at static1.squarespace.com/static/55033401e4b015246a9aeda8/t/565dd1a3e4b00481fade3761/1448991713704/Guatemala+Complaint.pdf.

Tuskegee, Alabama, syphilis experiments

Susan M. Reverby, Examining Tuskegee: The Infamous Syphilis Study and Its Legacy (2013 ed.).

Fred D. Gray, The Tuskegee Syphilis Study (1998).

James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (1993 ed.).

Nigeria meningitis experiments

Abdullahi v Pfizer, 562 F.3d 163 (2d Cir. 2009), cert. denied, 130 S.Ct. 3541 (2010).