Ethically impossible

Soldiers have always had a problem with sexually transmitted diseases. In the 1940s, there was “excitement” about what penicillin could achieve, writes Donald McNeil in The New York Times about the report of Presidential Commission for the Study of Bioethical Issues. Neither of the standard preventive treatments of the day, calomel lotion and squirting silver proteinate up the urethra, were terribly effective nor pleasant.

The excitement led to experiments that began  in a federal prison in Terre Haute, Indiana with consent by and payment for participants. Putting lab-grown gonorrhea on the prisoners’ penises, however, turned out to be impossible to do consistently, McNeil writes.

Penicillin grew to be the effective treatment for syphillis and it was adopted as the U.S. Army’s standard treatment. A fellow with the U.S. Public Health Service, Juan Funes, who had been responsible for a government-run health clinic for prostitutes in Guatemala City, came up with the idea to do venereal disease research in Guatemala. John C. Cutler, the doctor responsible for the work in Indiana, “embraced the idea” and set out to organize it.

There was a “startling array of public health luminaries” involved in the experiments in Guatemala, McNeil reports. Lapses by medical and legal officials led to experiments that were “gross violations of ethics” according to the commission.

In our next post, we will offer a bit more and some excerpts from the report by the White House bioethics panel.

 

 

Medical trials in the regulatory dark

The Economist blog describes the intentional infections with sexually transmitted diseases of more than 1,300 Guatemalans, a “heinous practice,” also as a hindrance to better relations between the U.S. and Latin America.

The class-action suit of the five survivors and their relatives continues. The challenge is that the U.S. does not have in place a way to compensate victims injured in medical studies, which are increasingly done outside of the the U.S., often in the developing world.

As the blog notes, President Obama’s bioethics commission believes this kind of program would be a good idea although it would not probably not please pharmaceutical companies.

A member of the commission, Luis López, told IPS, a news service with a focus on human rights and development news, that medical research oversight in Guatemala was “very weak…” in the 1940s and remains that way to this day. Through its Commission for the Evaluation of Clinical Trials The Health Ministry is responsible for granting or denying permissions for clinical trials.

In the story, Carlos Mejía, who is the president of the Guatemalan medical association and is part of a panel looking into the experiments performed in his country between 1946 to 1948, says that there is not enough staff to monitor health trials and that public health has “not been a priority.”

Going legal

According to an AP story, a group of Guatemalans have filed a class action suit against federal health officials in the hopes of obtaining compensation for the health problems they have had due to the experiments.

The story reports that the Guatemalans had sought to settle out-of-court but had not received a response from the Obama administration.

The case number is 1:11-cv-00527 and the suit was filed on March 14 in U.S. district court of the District of Columbia. There are seven individuals named as well as “Jane and John Does” who are filing it on behalf of themselves and all others who “were subjected to experimental non-consensual human medical testing.”

The lawsuit states that the experiments were performed on “highly vulnerable populations” and that they resulted in harm.

The suit is being brought against officials at the U.S. Public Health Service, the U.S. Department of Health & Human Services, the National Cancer Institute, the Centers for Disease Control and Prevention, and one international organization, the Pan-American Health Organization.

On Natureblogs, Meredith Waldman posts that seven Guatemalans are suing the U.S. government in the District of Columbia district court for “compensatory and punitive damages” because they were repeatedly inoculated with syphilis

Ashby Jones also reports on the lawsuit on Wall Street Journal’s Law Blog

Bloomberg’s Ann Woolner reports in her story, which ran in Business Week, that in these experiments U.S. Public Health Service scientists paid “diseased prostitutes to visit Guatemalan prisoners and infect them with syphilis.”

She writes that when government scientists came up with that idea “someone in the room should have said, ‘You want to do WHAT?’”

Next, after the bioethics meeting

Nature.com’s The Great Beyond reports that the Presidential Commission for the Study of Bioethical Issues has been busily reviewing files about the experiments with Guatemalan citizens. New Scientist has a story on this subject as well.

There have been some reports saying that the country of Guatemala plans to sue the U.S.  That seems a stretch, particularly since the official investigation has just begun. Let’s see if we can find out if this claim is true or not.

According to a press release sent out by the commission, a panel has been set up to report back to the commission. The panel has members from around the world, will meet three times, and then complete a report for the President.

The members will study: the “dominant norms, and competing alternatives, driving the ethics of medical research in different global regions outside of the U.S.,” the “conflicts, if any, between U.S. norms and international standards;” the “challenges facing researchers conducting U.S.-funded research in global settings;” and they will “address how best to address any major differences in regional norms for medical research.”

In an official request from the White House, the commission was tasked with reporting on the effectiveness of current U.S. rules and international standards for the protection of human subjects in scientific studies supported by the federal government and to assure him that “the current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.”

Bioethics meeting in Washington, D.C.

This week is a meeting of the Presidential Commission for the Study of Bioethical Issues. It is chaired by Dr. Amy Gutmann, a political scientist and philosopher who is president of the University of Pennsylvania.

The first day of the meeting is about genetics and neuroimaging testing and the second day is about human subjects protection.

The webcast is here and starts February 28 at 9 a.m.

Here is the draft agenda.

A panel with Guatemalan participation

Continuing to be a bit back-logged, but let’s add this item because it is helpful to know.

In November of last year, President Obama asked the Presidential Commission for the Study of Bioethical Issues to perform a “thorough review of human subjects protection” and specifically look into the syphilis study in Guatemala, the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study.

He wrote he wanted to “be assured that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.”

He asks the commissions to seek insights and perspective from experts, including participants from Guatemala. He expects the report to be completed in nine months.

President Obama also wrote: “While I believe the research community has made tremendous progress in the area of human subjects protection, what took place in Guatemala is a sobering reminder of past abuses. It is especially important for the Commission to use its vast expertise spanning the fields of science, policy, ethics, and religious values to carry out this mission. We owe it to the people of Guatemala and future generations of volunteers who participate in medical research.”

Here is the full text of his memo.

 

About this site

We are a group of historians, journalists, writers, and students who want to document cases of bad medicine. Our first focus: the unethical medical experiments performed by American scientists between 1946 to 1948 in Guatemala. We are collecting and presenting information in Spanish and English about these events and the people who were involved.

Were you or someone in your family a victim of these experiments? Please do not be silent about these events. Telling the world will help bring justice to you and your family. Post your comments. Help us by contributing to this blog.

Some official responses

Sorry, we are a plenty late with this post. But perhaps it is still useful to have, even if late.

U.S. President Barack Obama, U.S. Secretary of State Hillary Clinton, and Health and Human Services Secretary Kathleen Sebelius have apologized to the government of Guatemala.

In their apology U.S. Secretary of State Hillary Rodham Clinton and Secretary of Health and Human Services Kathleen Sebelius say that the

“sexually transmitted disease inoculation study conducted from 1946-1948 in Guatemala was clearly unethical” and that they are “outraged that such reprehensible research could have occurred under the guise of public health.” …

“We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices.”

La secretaria de Estado Hillary Rodham Clinton y la secretaria de Salud y Servicios Sociales Kathleen Sebelius:

“El estudio de inoculación de enfermedades de transmisión sexual que se llevó a cabo de 1946 a 1948 en Guatemala claramente fue antiético. Aunque estos sucesos ocurrieron hace más de 64 años, estamos indignados de que tal investigación reprochable haya ocurrido bajo el pretexto de la salud pública.”

“Lamentamos profundamente que esto haya sucedido y ofrecemos nuestras disculpas a todas las personas que resultaron afectadas por esas abominables prácticas de investigación.”

Here is the full text of that statement.

According to a White House statement, President Barack Obama called President Alvaro Colom to “extend an apology to all those affected” by the research.

Información sobre la conversación de Presidente Barack Obama con Presidente Colom de Guatemala

Greetings

Hi there, thanks for stopping by.

We are documenting cases of bad medicine. Our first focus: the unethical medical experiments performed by American scientists between 1946 to 1948 in Guatemala. We are collecting and presenting information in Spanish and English about these events and the people who were involved.

Were you or someone in your family a victim of these experiments? Please do not be silent about these events. Telling the world will help bring justice to you and your family. Post your comments. Help us by contributing to this blog.

Dr. Susan Reverby, professor of the history of ideas and professor of women’s and gender studies at Wellesley College has made these facts public. A copy of her paper is available on her web site.

Her study, “Normal Exposure’ and Inoculation Syphilis: A PHS ‘Tuskegee’ Doctor in Guatemala, 1946-48,” will be published in the Journal of Policy History.

The experiments were supposed to help researchers understand how to treat the sexually transmitted disease syphilis after someone was exposed to it and to see what dosages of penicillin cured infection. It sounds like the project was about better understanding the disease, but what happened “was anything but benign,” Dr. Reverby writes in an essay in The Hastings Center Report.

The researchers experimented on prisoners in a national penitentiary, inmates in a mental hospital, children in the country’s national orphanage, and soldiers who lived in the barracks in the capital.

The people in this experiment were vulnerable, they did not give consent, and the scientists were deceptive about how they conducted the experiments.

Dr. Reverby writes:
“Anyone infected was given penicillin and presumed to be cured, although there appears to have been no real follow up to determine this.” She found descriptions of the experiments and correspondence like this:

As you can imagine we are holding our breaths, and we are explaining to the patients and others concerned with but a few key exceptions, that the treatment is a new one utilizing serum followed by penicillin. This double talk keeps me hopping at time,” John C. Cutler, the physician in charge of the project in Guatemala, wrote in 1947 to a colleague, R.C Arnold, who was a penicillin researcher and a PHS physician.

Here is some of the reporting on these experiments and Dr. Reverby’s study:
The New York Times, The Washington Post, Noticias de Guatemala , La Prensa, La Tribuna, and 24h, Noticiero Guatevision.

There are many more, and we will continue to post what we find.