Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -394

Accepted - Volume 3

Comment Record
Commentor Mr. John Bisges Date/Time 2002-11-26 10:35:50
Organization Truman State University
Category Individual

Comments for FDA General
Questions
1. General Comments While reading the parental consent form for this study, a couple of major points jumped out at me. The first was under the benefits category, where the major point seems to be that this study is good for humanity, but for the individual children in the study these benefits may not occur and unexpected side effects may develop. Say what? Unexpected side effects? Scrolling down towards the end of the form I came across a second MAJOR point in the lawyer-speak paragraph saying that, if your child is injured because of this research, emergency medical care will be available. The care will NOT necessarily be free of charge. Great. So the researchers are going to inject children with a substance that they know could have some bad side effects, then duck responsibility if something goes wrong and make the parents foot the medical costs? Do they think that the $10 a visit and the gift certificate are going to cover that? After reading this I went over to the CDC web site (www.cdc.gov) to find out just what side effects were possible from this vaccine, and there is some NASTY stuff there. No way I would willingly put any child through some of that stuff even if someone was paying for their medical care. Finally, even if everything went well with the vaccine, anyone who has been around little kids knows that keeping them cooped up for 30 days away from their friends like the experiment requires is near impossible and may even be traumatic for the child. Basically I don't think that this study should be done, and I certainly wouldn't put any child I know in it.




EC -394