I knew i was getting into a lot of work when I posted the link to the FDA document.
Crazyguy, you asked for pages where the JWs are mentioned. this following quote(s) come from near the end of the document...I have somehow ended up with more than one copy and the one I took this from is over 600 pages long...so I don't know exactly which page it is from.
This is following many pages of opinion on safety, efficacy, compassionae use, study design, etc...and the opinions are divided - some actively support the WTS supplying the control group and compassionate use subjects. The following speaker gives his rationale for using artifical blood for the JW community ("a control that's not getting anything" means...JWs) - he thinks it would be good to at least know if artifical blood will work:
Mr. Carson:
So you’ve just described the first study. Okay, but the first study is to have a control that’s not getting anything. And if you can’t show it works there, then you wouldn’t go and do another study. So it’s a proof of concept, and it would benefit that small group of people and there are more and more people, you know, who are not from a religious point of view, but have other reasons why they would prefer not to have blood.
So I think, to know that we - - you know, we haven’t - - you know, there’s no trial on red cells that shows that it works, okay, our control group, there’s no trial in red cells against the placebo that shows that it works, and there’s no trial with these drugs that shows that it improves outcome.
I think you know, I don’t know what the regulatory part of this thing is, but it sure would contribute to the field to know that, you know, they actually do what we want them to do and they might save some lives. That - I think has value and whether or not it gets to the point whether it’s widely used or not and approved, that’s not – I think that’s a simple question.
This is responded to by the next speaker:
Mr Emmanuel:
I mean I agree with you, it’s a concept and from that standpoint it would be valuable, but it would only be commercial - - it would only interest the commercial companies in this room if there was a widespread off-label use. There is no market and no one would sink a dime into it if the market were Jehovah’s Witnesses.
Only commercial benefits.
Yes.
And the Watchtower Society was in the thick of it - providing those so valuable research subjects to get Hemopure on the market.