Hi,

RISUG is not ready for clinical trials in the US or Canada-- some of
the older animal tests need to be redone first to satisfy either
regulatory agency. So you are right that Dr. Weiss's proposal from
several years back is not going anywhere.

The priorities right now are to

1) Resolve the manufacturing difficulties and make sure that the RISUG
is made to International Conference on Harmonization Good Manufacturing
Practice (ICH GMP) standards

2) Make sure that the re-opened clincial trial does the extra steps and
record-keeping to meet ICH Good *Clinical* Practice (GCP) standards, so
that the results will be accepted by regulatory agencies all over the
world

and then

3) Get moving on duplicating those animal studies in the U.S. or Canada
or elsewhere, which can be done fairly quickly if there is enough
determination.

RISUG is at a turning point right now. We will have more information
for you in next month's Male Contraception Update.

The way you could make a difference mentioned in the July newsletter
was to test-drive the survey MaleContraceptives.org is preparing. The
results will be compiled quarterly to show policymakers how much demand
there is.

Soon we will provide more RISUG-specific ways you can make a
difference. The subject is quite complicated and delicate, though, so
we want to make sure we are directing you towards activism that will
help rather than hurt.

By the way, anyone on this newsgroup who is not receiving the monthly
update put out by MCIP and MaleContraceptives.org, you may want to sign
up at MaleContraceptives.org. And if you are interested in RISUG, do
be sure you have read the extensive information on its status at
www.mcip.info:

http://www.mcip.info/paper.htm#vas

Regards,

Elaine L.

-----Original Message-----
From: kyudowind@...
To: malecontraceptives@yahoogroups.com
Sent: Wed, 16 Aug 2006 10:57 AM
Subject: [malecontraceptives] Re: Male Contraception Update - July 2006

After months of thinking RISUG was about to vanish down a
bureaucratic
black hole, I was overjoyed to see new activity, but this news item
left me with questions:

... There's hope, though: recognizing the potential importance of a
> long-term contraceptive such as RISUG, a respected NGO which
> specializes in technology advancement has offered to partner with
the
> Indian government in moving the manufacturing forward and planning a
> strategy that will minimize such delays in the future.

What is the name of the NGO?

... If you live outside India and
> would like RISUG to be available sooner rather than later, read on
for
> how you can make a difference.

I "read on" but didn't see how I *could* make a difference. Please
clarify this.

Thanks

PS

I emailed a physician associated with the Canadian RISUG research
about a year ago and he reported no activity, apparently because RISUG
*has* vanished into a bureacratic black hole in Canada. Does anyone
have any new info on Canadian activity?



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