Dr Tom Kerns
North Seattle Community College

 

Jenner On Trial

Tom Kerns

 

 

 

 

Introduction

 

Human experiments to test the efficacy of preventive AIDS vaccines will probably begin before the end of the millennium. The World Health Organization has approved the first such trials to be done within the next year or two, probably in Thailand, and perhaps in other lesser developed nations such as Uganda or Brazil. Efficacy trials will not, in all likelihood, be done in the US for at least another year or two (or perhaps much longer) following that.

The ethical quandaries raised by these HIV vaccine efficacy trials will be at least as complex as, and probably more difficult than, any that have been faced by vaccine researchers in the past.

The Nazi doctors did numerous vaccine trials in Buchenwald and Natzweiler concentration camps in the early 1940s, and the design of these experiments was conceptually simple and straightforward: inject 100 subjects with an experimental typhus vaccine, then wait for some weeks for an immune response to develop. After the weeks have passed, assemble all 100 experimental subjects, as well as an additional 100 control subjects, and then directly challenge (i.e., infect) all 200 of them with virulent typhus. If the experimental vaccine works, then most of those who received it will be protected and will not contract typhus, but the controls will. If the experimental vaccine does not work, then all 200 subjects get typhus, and most of them die.

This method of testing by direct challenge, the method of testing also used by Edward Jenner in his first vaccination experiments, was clearly unethical, or at least it was when the Nazi's did it. The Nuremberg Code, one of the earliest statements of the ethics of medical research involving human subjects, was developed as a result of the doctors' trials at Nuremberg, and has served as a basis for medical-ethical decision-making ever since. The recent WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, published by the World Health Organization in November of 1993, also traces its history back to The Nuremberg Code.

A brief sampling of some of the difficult questions entailed in the planning and design of these HIV vaccine trials would include the following:

How will researchers be able to execute an ethically adequate informed consent procedure when the amount of information necessary for subjects to understand is so great and the nature of it so complicated? How will researchers be able to provide information about the nature of vaccines and immune responses to persons (in developing nations) who may hold conceptions of disease and disease-causality that are quite different from the conceptions of disease held by the researchers? How can research sponsors properly assess whether prospective subjects have understood enough information so that they are able to give adequately informed consent? How can research counselors effectively counsel subjects to not engage in risk behaviors when they themselves, at some level, realize that the research protocol itself requires that subjects do engage in those risk behaviors? What are some of the potential harms that might reasonably be expected to accrue to subjects who participate in these trials, and what are some benefits they might theoretically expect which could counterbalance the risks they could be taking? What is to be done about protecting volunteers' confidentiality, and how can these volunteers be protected against unfair discrimination based on their new serostatus which will (often) result from their participation in the studies?

And underlying all these specific questions is the deeper meta-question: Should the main operative ethical principles in this international vaccine research be different in different countries, varying according to the different mores and different cultural standards in each country, or should there be a set of common, agreed-upon international ethical standards for the protection of research subjects, applicable to all research sponsors regardless of the country in which the research is conducted?

These questions, and numerous others related to them, will not be easy to deal with, nor will the answers to them be simple.

This book does not deal directly with these questions about AIDS vaccines (for that see my recent book, Ethical Issues in HIV Vaccine Trials ), but it will be quite instructive to look instead at some of the first (scientifically designed) medical research ever done on human subjects. This earliest research too was built on the concept of testing the efficacy of a preventive vaccine, an experimental inoculation that would, Edward Jenner hoped, protect people against the most dreaded plague of the age: smallpox.

In many respects the disease of smallpox will turn out to be a fruitful analog for understanding today's AIDS and HIV disease, or at least for understanding some aspects of our battle against them. Smallpox is almost certainly a better model for understanding AIDS than is the (sometimes suggested) Black Death, which was seldom endemic, but rather came in great blows, struck down upon a people by no-one-knew what agency (the word plague being from the Greek plege, meaning a stroke, or blow.) AIDS, by contrast, looks as if it will be more endemic, and probably with us for some years (probably even some generations) to come. If Professor Alan Brandt showed us that the 19th century epidemics of the Great Pox (syphilis) can be intriguing and fruitful as an analog for understanding our attempts to control the spread of AIDS, in this study we will discover that the Small Pox, as an analog, will also be able to provide us with insights into today's research on prevention technologies for AIDS.

 

Jenner homepage and Table of Contents
preface | Introduction | chp 1 | chp 2 | chp 3 | chp 4
cchp 5 | chp 6 | chp 7 | chp 8 | App I | App II
Ethical Issues in HIV Vaccine Trials