Who needs regulations? We do!

Who needs regulations? We do! A few weeks ago most of us were caught unawares when Secretary of State Clinton and Secretary of Human Services Sebelius issued a statement apologizing for reprehensible medical experiments that the U.S. government conducted in Guatemala in the 1940s. They were apologizing for a Syphilis Study. Why did this sound more than vaguely familiar? It turns out that the same Public Health physician who was so instrumental in conducting the infamous Tuskegee Syphilis experiment also conducted an even more unethical experiment in Guatemala on Guatemalan citizens. The announcement was made and then ….nothing, we heard nothing else.

Lately I keep hearing a lot of noise from people about government regulations being overbearing and they toss about the charge we are becoming a “nanny” nation. Then something pops up like say an oil company that practically pollutes the entire Gulf of Mexico by cutting corners and ignoring regulations or a coal mine that considers them unnecessary. Or we discover everything from our drugs to our pet food have been contaminated by unscrupulous manufacturers. Then we scream, “Where were the regulators?” Face it, we need oversight. Humans always have and always will. Medical research is not an exception to that rule either. The Guatemala revelation is just the latest evidence that shows how important a strong Investigational Review Board (IRB) is to our clinical study process.

First, a quick review of a shameful story most people have at least heard about, the Tuskegee Syphilis Experiment. Black men living in the area around Tuskegee, Alabama who were diagnosed with Syphilis were identified and observed, but not told they were infected and were not treated for Syphilis for 40 years. This study was conducted from 1932 -1972 on 399 black men, most of whom were uneducated and living in poverty. These men were never told they had Syphilis. Even after Penicillin became the standard of care for treating Syphilis in 1947, this study did not end until it was leaked to the press in 1972. Many of these men passed Syphilis on to their wives and numerous children were born suffering from congenital Syphilis. The men were told they were being treated for “bad blood” and they were compensated with free medical exams, free meals and free burial insurance. This study is credited for being the catalyst that gave rise to the Institutional Review Boards that oversee all clinical trials today.

As heinous and unethical as the Tuskegee Experiment was, it pales in description to the Guatemala experiment. They didn’t just observe infected people, they intentionally infected people who had never had Syphilis with the Treponema bacterium that causes Syphilis in an attempt to induce the disease. This study was conducted for two years (1946 -1948). It was already well known by then that Syphilis could be cured with Penicillin but the purpose of this study was to see if Penicillin could prevent infection if it given immediately after exposure to Syphilis. As was the case in the Tuskegee study there was no informed consent from these teat subjects. The study population differed in that instead of using poor rural black citizens, the Guatemala study used hundreds of prisoners, men living in army barracks and male patients of mental hospitals. I am assuming they also got the free medical exams and meals since they were all institutionalized in some manner. No mention was made of burial insurance but there was one unusual “study perk”. Most participants appear to have been supplied with a syphilitic prostitute for their participation in the experiment. Still, it seems they were not able to induce a sufficiently high enough infection rate through the prostitution arm of the experiment so they resorted to even less conventional methods. Researcher’s notes reveal that the penises, forearms and faces of the men were abraded when “normal” exposure (i.e. inoculation by prostitution) failed. Next, a solution containing syphilitic bacteria was then poured directly onto the abraded surface. The records examined indicate that the infected patients were treated but the records do not indicate if they were cured or if they were even adequately treated.

Regulation and oversight, who needs them? We do!