Infant Deaths: A Case Study

Authors: Lois Banta, Jeffrey Beetham, Donald Draper, Nolan Hartwig, Marvin Klein, Grace Marquis

You are sitting on a NIH committee that has been charged with the responsibility to evaluate two projects that have been submitted from university-based researchers. Only one project will be funded; monies come from US taxes. You are responsible for deciding which project should be funded.

Project 1: This is a 5-year community-based trial of an oral, yeast-based, genetically engineered, rotavirus vaccine. Preliminary data show that the vaccine is 85% effective; the long-term risks have not been established but the safety of the vaccine has been verified by the FDA. The ethical committees at NIH and the researcher=s university and the Ministry of Health in the target country have given clearance.

The trial will take place in a low-income country in South America where infants 0-12 mo typically have 9 episodes of diarrhea/child-year. Rotavirus causes approximately 10% of all diarrheas and is the cause of 80% of all hospitalizations related to infantile diarrhea. The primary cause of diarrhea-related mortality equaling about 20,000 infant deaths each year (a 10% mortality rate).

The vaccine regimen is given at 3, 6, and 9 months of age. The Ministry of Health already has a vaccine program for other disease in place into which this vaccine can easily be implemented. The full course of treatment costs $50/child. Since we are going to inoculate all 2,000,000 infants in the country, the total cost of the project will be $100,000,000.

Project 2: This is a 5-year subsidy of an on-going influenza vaccine distribution program of DHHS, administered through the local health departments throughout the US. This is a well-established vaccine that has been shown to be effective and risk of side effects is very low. The program provides influenza vaccinations for the elderly and immuno-suppressed individuals who are at increased risk of death from flu. The subsidy will allow the 10,000,000 Americans who could not otherwise afford the influenza vaccine to receive it at a final cost of $100,000,000. This is estimated to save 20,000 lives.

QUESTIONS:
1. Identify the factors that you consider the most important in helping you make this decision.
2. Which of these are factual claims?
3. List the moral considerations that influence your decisions? (See list provided below1)
4. Which grant proposal would you fund?
5. What arguments can be made against your position?
6. Are there any conditions that would lead you to a different decision?

FURTHER DISCUSSION:
B. Go through the same analysis assuming that Project 1 would save 35,000 infants.
C. Go through the same analysis assuming that Project 1 would save 5,000 infants.
D. Imagine a third alternative in which the $100,000,000 is used to develop the infrastructure and transfer the vaccine production technology to the target country so that they are able to produce and distribute the vaccine. This implementation will take eight years.

Values to consider: Health, Personal safety, Security, Human welfare, Emotional well-being, Compassion, Altruism, Empathy, Equality

NB: The discussion leader can also introduce the issue of post-illness quality of life. Many older flu victims, for example, are prone to subsequent illnesses, including stroke, pneumonia.

[Top] [Table of Contents]