1. _____ Vaccine Trials
A Case of Ethics

2. Imagine a disease that strikes children, killing many and crippling others. Parents are afraid. And there’s good reason to be.

3. So far the epidemics are peaking in the summer: “Mommy won’t let us go swimming! She says other kids will get us real sick.”

4. “We think it might be linked to peach fuzz. Seriously
“We think it might be linked to peach fuzz. Seriously. I think there’s something on peaches. It’s all over the papers.” Children aren’t allowed to eat peaches now.

5. Amidst this climate of fear, someone seeks parental approval to try an experimental vaccine in the hope of preventing the disease for more children. “This vaccine will involve injecting a small dose of live _____ virus into your child, ma’am. May we proceed?”

6. If you were a parent, would you give your permission?

7. Randomly chosen school districts are seeking permission now from parents to use their second graders as subjects. Those parents who agree will have to bring their children to a local vaccination site in the spring.

8. “Imagine a long line of kids, inching forward to get a shot
“Imagine a long line of kids, inching forward to get a shot. We stood there, watching and listening as each child in turn reached the front of the line and cried when the vaccine was administered. We waited for our turn to cry.”

9. “About a month later, we made the trip again for the second dose
“About a month later, we made the trip again for the second dose. Another line, another turn to cry.”

10. “After this past _____ season, the figures were checked: it’s clear that the incidence of _____ has been dramatically reduced among those who got the vaccine compared to those who received a placebo injection of a saline solution.”

11. The federal government has now mounted a nationwide program to vaccinate all children. In a few years we hope the disease will be conquered!

12. “Imagine being 7 years old…being told in October that the shots you got last spring were fake, so now you have to go get the real ones.” Some children who got the placebo shot died or were crippled by the disease. The vaccine might have saved them.

13. “In some cases, the vaccine doses were a little too ‘live
“In some cases, the vaccine doses were a little too ‘live.’ They may have actually caused the disease in children whose parents gave permission in hopes of protecting them.” But how could we have known that in advance?

14. This experiment actually has a second design, approved by some schools
This experiment actually has a second design, approved by some schools. In these cases, all the children whose parents approved got vaccinated with the real vaccine. The other non-approved children are used as controls.

15. “We just got the results back from the second design
“We just got the results back from the second design. Surprisingly, the results are less convincing.” Why? Parents with higher levels of education were more likely to give permission, and also likely to raise their children in more hygienic conditions.

16. “These children in hygienic conditions are actually more at risk for polio because their immunity is less developed.” Children raised in less hygienic surroundings have been more likely to contract a mild form of polio early in life, thus developing a natural immunity to the disease when they are older.

17. “This made the control group different from the treatment group at the start of the experiment. The whole point is to have them be the same, not confounding. What a waste.” There is no substitute for double-blinded, placebo-controlled, randomized clinical trials.