The Nazis timed concentration camp inmates as they struggled in the snow to see how long humans could endure the cold.
Not much later, in Macon County, Alabama, black men with syphilis were deprived of penicillin when it became available. The U.S. Public Health Service in collaboration with the Tuskegee Institute wished to keep studying the effect of the disease on their brains and bodies.
In the “The Ethics Police? The Struggle to Make Human Research Safe,” Robert L. Klitzman describes how outrageous ethical violations of the past led to the creation of mysterious committees to oversee medical experiments on humans today.
These Institutional Review Boards (IRBs) are attached to just about every major hospital and research center. They operate in secrecy. Outsiders have no clue they exist.
Klitzman, a medical doctor who directs the Masters of Bioethics Program at Columbia University, is just the right guide into this shadowy world of doctors, clinicians, and administrators confronting moral and medical complexities.
We spoke on the phone.
Hoelterhoff: Nazi doctors severed limbs to reattach them. Was there some intended benefit to the master race?
Klitzman: Yes. The uber-aim was to help Nazi troops wounded on the front. But that was just one of many sickening experiments. The list is long. The Nazis infected prisoners with disease to then try out various possible treatments –- all of which failed. They tried changing the color of eyes.
Hoelterhoff: More blue eyes? A number of German doctors were tried at Nuremberg. They look glum in the photos taken of them standing in the courtroom. Any remorse? Explanations?
Klitzman: Some said that no international law existed to oppose their experiments. Others were just “following orders” or argued that the benefit to Nazi Germany outweighed the risks to the individual subjects.
Hoelterhoff: Those American doctors monitoring the syphilis study, what was their excuse?
Klitzman: They, too, claimed that the social benefit –- improving understanding of disease -- outweighed the harm to the individual subjects.
Hoelterhoff: Today’s review boards are meant to protect us from harm. But that doesn’t always happen.
Klitzman: Dan Markingson was a young man with schizophrenia whose psychiatrist entered him into a drug trial at the University of Minnesota. Dan, psychotic and barred from leaving the hospital, entered the study. He became suicidal and though his mother tried to get him back on standard meds, he ended up killing himself. The University of Minnesota IRB approved the study and has argued that it acted correctly. But several major outside investigations have disagreed.
Hoelterhoff: In reading your book, I’m amazed any drugs get approved by these committees.
Klitzman: Yes. When the regulations were written, studies were far more commonly done by a single doctor, with his or her own patients.
Now, however, to show that a new drug is significantly better than an existing one, researchers need to recruit thousands of patients from dozens of hospitals. So dozens of IRBs may now review the same study, and they often disagree, wanting to change different aspects of the study.
President Obama has proposed centralizing IRB review for all multi-site studies. But other changes are needed.
First, the public needs to become more aware of these issues. These committees generally operate behind closed doors, so no one really knows what they do or how they make decisions. The Federal Office of Human Research Protections (OHRP) oversees these committees, but offers little help as these committees struggle to apply the regulations in particular cases.
Hoelterhoff: The book raises issues of privacy in a very public society.
Klitzman: Pharmaceutical and other companies and university researchers are building large biobanks of people’s genomes and other medical information.
IRBs grapple with what will happen to all this information -– who should see it. Should all genetic information be linked to your medical record? For instance, should law enforcement officials trying to solve a crime have access?
Hoelterhoff: You are already working on your next book, “Designer Babies.” That’s a really creepy growth industry.
Klitzman: The price of eggs appears to increase with the sellers’ SAT scores. Websites have drop-down menus, where you can pick the hair color, eye color, height, education level, etc. In the future, wealthy people will increasingly be able to buy eggs that lack certain mutations. As a result, certain disorders will increasingly become sicknesses of the poor.
This interview was adapted from a longer conversation.