Dr Edward Jenner (1749 - 1823) was the first medical researcher
to perform controlled experiments on the protective efficacy of
a preventive vaccine. He was, moreover, the first person to use
human beings as research subjects in testing a vaccine. He did
not do any preliminary laboratory research nor any preliminary
animal studies before experimenting with human beings, his subjects
were small children well below the age of consent, and he deliberately
infected them with an extremely virulent, often fatal, disease-causing
agent. (The 200th anniversary of Jenner's first smallpox vaccination
experiment was May 14th, 1996.)
Jenner's experiments were of course performed well before the
formulation of any statements of ethical principles for the protection
of human research subjects, i.e., well before the Nuremberg Trials
which condemned medical experiments on children. These trials
following World War II resulted in the Nuremberg Code for the
protection of research subjects, and later the World Health Organization's
International Ethical Guidelines for Biomedical Research Involving
Human Subjects, (1993).
Nevertheless, Jenner's experiments were
performed in 19th century England, an industrialized, well-educated,
literate society with a tradition of protecting human beings,
particularly vulnerable human beings, from unjust encroachments
upon their persons. Dr Jenner's experiments with children have
not been condemned by history, as were Dr Josef Mengele's experiments
with children in the concentration camps. Would Dr Jenner's experiments
pass ethical review today if they were proposed to one of our
biomedical Ethics Review Committees?
This presentation intends to find out
how a group of thoughtful persons would respond to these proposed
experiments today.
The presentation begins with a brief
description (with photos) of smallpox, one of the greatest disease
scourges in human history - "By the seventeenth century it
had replaced the plague as Europe's most devastating and feared
disease." Also included is a brief summary of what today's
Ethics Review Committees do, and the principles on which they
base their judgments, including a handout of the text of the Nuremberg
Code. (Resemblances to the present AIDS epidemic and the search
for an HIV vaccine will remain implicit, probably until the question
period.)
At this point I take on the persona of Dr Jenner (including some period costuming), and present his smallpox research proposal. Copies of the proposed research protocol are presented to the audience as if they were a contemporary Ethics Review Committee. Dr Jenner then describes the urgency of the present smallpox situation in England where smallpox kills such a large number of persons every year. "The smallpox was always present, filling the churchyard with corpses, tormenting with constant fears all whom it had not yet stricken, leaving on those whose lives it spared the hideous traces of its power, turning the babe into a changeling at which the mother shuddered, and making the eyes and cheeks of a betrothed maiden objects of horror to the lover."
The protocol proposed to the audience will be the exact procedure that Jenner actually used. The first experiment will involve one eight year old boy who will be inoculated with live cowpox, and who will then be challenged some weeks later with actual pus from virulent smallpox sores. Evidence from the milkmaids will be presented, and potential hazards and benefits to the children will be detailed. This experiment and the ones he hopes will follow it are expected to last approximately one to two years. Benefits and risks to the children will be outlined.
Committee members will then be free to
ask questions of Dr Jenner before beginning their deliberations.
Shortly before our time is up, and after
the committee has had time to evaluate Jenner's proposed experiment,
a formal vote will be taken to see whether the committee believes
that his proposed experiment meets ethical guidelines or not.
Engaging this medical-ethical issue in its own historical context may also lead to some realizations about a pressing ethical urgency of our own time: the testing of HIV vaccines on vulnerable human subjects in disadvantaged populations around the world.
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