Thanks for the information. I'll try to have a written letter to send this
week as this is definitely the solution I am looking forward to the most.
-Leroy
> Hi Jimmy and Leroy,
>
> The press can be a bit like a game of "telephone," with inaccuracies
> getting
> magnified. One story said it was American (instead of Indian)
> researchers,
> one headline said the trial was "successful" rather than being reopened...
>
> For the straight scoop, you can go directly to MCIP's original press
> release
> (which these stories are all based on). The link is
>
> http://www.eurekalert.org/pub_releases/2006-03/mcip-nmc032906.php
>
> The short answer is NO, human trials are not starting in the U.S. right
> now,
> they are reopening in India (and unfortunately, non-local men are not
> eligible, because of the strict follow-up that is necessary if the study
> is to meet
> FDA standards).
>
> Prof. Guha is working to arrange a collaboration with a U.S. group on
> animal
> studies, though, and should be submitting a grant application with them in
> less than a month. We'll be looking for lots of activism at that point--
> letters to let policymakers know how much of a priority it is to get
> things moving
> in the U.S. Right now, the more people who can take a moment to write to
> the
> decisionmaker in India (as described in the newsletter), the better. The
> pressure is really on now to make the RISUG to FDA standards and to train
> the
> clinical trial coordinators in India so that the data management will also
> meet
> all the FDA's requirements. We want to make sure that once preclinical
> (animal) studies are done in the U.S., the Phase III trial won't need to
> be redone!
> That will make development more affordable, and speedier too.
>
> - Elaine Lissner
> Director, MCIP