Reverby recalls discovery, Hadler puts Guatemala case in context

Earlier this week we posted lots of links to headlines about Susan Reverby’s discovery of U.S. medical experiments on nonconsenting Guatemalans in the 1940s. Today, she wrote in more detail about the discovery of this horrific medical history over at the Hastings Center’s Bioethics Forum:

What might have been buried in an historical journal, however, took another step. To make sure I had the medicine right, and because we had briefly discussed it, I sent a copy [of my paper] off to Dr. David Sencer, the former director of the Centers for Disease Control and Prevention whom I had interviewed about his role in the responses to the study in Tuskegee. Duly disturbed by what I had written, Sencer asked if he could send it to current CDC officials before it came out. I agreed.

This is when my discovery took on another life. CDC officials were concerned enough to ask me for more notes and then to send their leading syphilis expert to [the archives in] Pittsburgh. His report confirmed my findings and by examining the medical records more carefully determined that not enough penicillin was given to everyone. After that my paper and the story went up the chain of command. It took some convincing along the way to explain to officials outside the CDC how important this was. By early September, this realization had clearly permeated various sectors of the government as far as Department of Health and Human Services and even the White House.

By October 1, I agreed to post my pre-copyedited article, and the official apologies by Secretaries Hillary Clinton and Kathleen Sebelius were arranged, the Guatemalan government was alerted, NIH and the State Department held a joint press conference, and President Obama called President Colom in Guatemala. The administration has asked for an Institute of Medicine report and the Presidential Commission for the Study of Bioethical Issues is set to examine how we protect individuals now, especially in studies done by Americans outside our borders.

Read Reverby’s full post, After the Media Frenzy, Preventing Another ‘Guatemala’.

In our conversations about this news with others in the UNC Press community, we learned more from Dr. Nortin Hadler (author of Worried Sick and Stabbed in the Back) that puts a wider scope on Reverby’s discovery about 1940s tests in Guatemala. What might we be doing now that, when discovered and made public years from now, might horrify us? In an email, Hadler writes:

Susan Reverby is doing us all a great service by rubbing the collective noses in the persistent tendency to rationalize, even excuse outrageous behavior under the banner of “science.” Experiments on prisoners are another classic example.

There is an enormous literature on the ethical demands for informed consent whenever a fellow human being submits to an experimental therapy, or a “common practice” or licensed intervention for that matter. Most of this literature takes the resource-advantaged world for its context.

Someone needs to look at the fact that increasingly, pharmaceuticals are tested in the resource-disadvantaged world. The CROs are crawling all over S and SE Asia. Quintiles just opened a branch in sub-Saharan Africa. There is much angst over the “quality of the data” but only whispers over the ethics of “informed consent” in such a setting. The exception was the brouhaha over AIDS trials in pregnant South African women.

We’ll keep our eyes and ears following Reverby’s story as well as other stories of current medical trials around the world. As Hadler points out, and as Reverby indicates the Obama administration seeks to confirm, we must ensure that there is not a next Tuskegee, or a next Guatemala, or a next or a next.