She sat up front at the Presidential Commission for the Study of Bioethical Issues meeting in New York City, listening closely and feeling extremely curious as to how the Commission would proceed in its in-depth look at human subjects research in clinical trials.
But Susan M. Reverby, a professor of women’s studies at Wellesley College in Wellesley, Massachusetts, was more than an interested bystander. She was the reason these hearings are happening. Her research uncovered documentation that showed U.S.-funded scientists deliberately infected Guatemalan commercial sex workers, prisoners, and people in mental asylums with sexually transmitted diseases. For some of the patients, the researchers withheld treatment, all in the name of science, which in this case meant the study of the painful progression of syphilis and gonorrhea on unsuspecting people.
Her research prompted an outcry around the world, an apology from senior U.S. government officials, and President Obama’s charge that the Commission fully investigate the Guatemala episode as well as making sure that current federal regulations provide adequate safeguards for people participating in clinical trials today. In addition, the government of Guatemala started its own investigation, which is expected to be released in the next month.
Commission Chair Dr. Amy Gutmann, the president of the University of Pennsylvania, recognized Reverby at the beginning of the meeting on Monday, saying she was honored that Reverby could be present. Afterward, in an interview, Reverby said she was “amazed” by the firestorm that followed her findings.
“I was an historian going to an archive and writing what I thought was an outtake of my work,” she said. “I had no idea. The important person in this is David Sencer.”
Sencer, who died earlier this month, was a giant in public health, and one of his contributions was as the former director of the Centers for Disease Control and Prevention. Reverby asked him to fact check her paper on the Guatemala medical trials. After Sencer read it, he called her.
“He said the facts are not the problem, and the CDC needs to know about this before it breaks,” she said. “I said, ‘It’s going in a small journal. No one will read it.’ He said, ‘Oh yes, they will.’ Sencer contacted senior CDC officials, who sent a senior investigator to unearth what Reverby had found earlier to double-check Reverby’s source material. The material was solid. The CDC’s action helped form the basis of the US government apology, which was released right after the journal article was published, and also the current investigations.
Reverby said she hopes that her findings strengthen oversight of human subject trials, but also that it doesn’t scare off people from participating in well-run trials.
“It woud pain me to think that because of this expose that people would be afraid to be involved in medical research,” she said. “And I say this as someone who got pneumonia when I was 14, and thank God for penicillin, or I would be dead. Thank God for that research.”
She said she agreed with Gutmann’s characterization the Commission must walk a “tightrope” in its future recommendations that would find the right balance between protecting human subjects and not imposing regulations so burdensome that it stifles research.
Reverby said the reality of today’s research is that researchers face many pressures that could lead to unethical behavior.
“There’s pressure to get the material out and cut corners – there’s financial incentives and institutional incentives for researchers to move as quickly as possible. We also need to have more hard thinking about what does community participation really mean.”
In the end, she said the starting point in medical research had to be that people who participate in trials are protected.
“We have to be sure anyone who gets involved is as protected as possible,” she said. “It is good to be rethinking what we are doing and to change the climate of our discussion.”