The most famous clinical trial of all time was Edward Jenner’s experiment with a smallpox vaccine. He had a hunch that exposure to cowpox would protect humans against smallpox. So he immunised James Phipps, the son of his gardener, and then deliberately infected him with smallpox after six weeks and later on as well, another 20 times. “Poor Phipps” did not die, at least not of smallpox, and his cooperation saved hundreds of millions of lives.
This is a milestone in modern medicine, but Jenner’s experiment would not pass an ethics review nowadays. For one thing, Phipps hardly gave his informed consent. However, unknown to most people, Jenner’s methodology is still used. Healthy people are being infected and observed to see whether they become ill (or die). Nowadays the technique is called a Human Challenge Study (HCS).
An article this week in Science profiled some of the leading figures in HCS in the United States. Volunteers are being deliberately infected with infected with malaria, influenza, shigella, dengue, norovirus, tuberculosis, rhinovirus, Escherichia coli, typhoid, giardia, and campylobacter. Researchers try to make the virus as attenuated as possible to minimise the danger and then treat the illness as quickly and effectively as possible.
In many ways HCS is better than standard clinical trials. It is faster, cheaper and can give useful information about potential side effects of treatments.
Myron “Mike” Levine of the University of Maryland School of Medicine in Baltimore began intentionally giving humans V. cholerae in 1976. He still is.
HCS have been in a bad odour for decades, largely because of how Nazi doctors experimented on prisoners in concentration camps.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.