Hi everybody,

There has been a lot of press coverage of RISUG lately, but as with all press
coverage, one has to take it with a grain of salt.

The good news: RISUG is definitely progressing! No, it is not available
yet to the general public, though, and there have been some mistakes in the
various articles in the popular press over the past month. A few
corrections/comments on this particular article you shared with us:

<< By lowering the dose, the period of contraception can be shortened. Also,
the effect of this revolutionary drug, now into its third and final phase of
clinical trials, can be reversed at any time with another injection. >>

Yes, a lower dose results in a shorter period of contraception, but we do not
have systematic data on shorter doses. The initial use would be at the full
dose, which has been most thoroughly tested.

RISUG is in its third phase of clinical trials in India; however, the FDA has
certain ways it requires things be done, so approval in India will not mean
approval in the U.S. or Canada. However, it will be a good sign (and more
than that for men who live in India or are willing to travel there!).

A phase III clinical trial usually requires 500-1000 men. So far there are
140-200 men in the study in India. More will be enrolled when some
genotoxicity work is finished that was not done earlier (the genotocity step
should not
take too long-- a question of months, not years).

There is some talk of a limited, controlled release of RISUG before the phase
III trial is finished. If that happens, the predictions of availability in
India early next year could be realistic. If not, we're talking more like
2007 (again, for India).

I am working on a detailed update of RISUG status which should be available a
few weeks from now. If you don't see it by the end of May, please feel free
to bug me!

<< According to Dr. Sujoy K. Guha, professor of biomedical engineering, IIK,
Karagpur in West Bengal, who led the team that developed the technique, the
contraceptive has no side-effects. It does not affect the user's libido,
performance or sperm count. >>

Prof. Guha tells me this is a misquote. RISUG does have side effects-- it
is well-known that about a third of the men in the studies experienced scrotal
swelling for a week or two, swelling which could be reduced by applying gentle
pressure. And of course RISUG affects sperm counts! (No, it does not
affect libido or performance.) Also, a little thing: It's IIT Kharagpur, not
IIK Karagpur.

<< The wonder injection named 'Risug' has already been patented in India, the
United States and many other countries. >>

I think RISUG is pretty wonderful, but come on, guys, this is not exactly
neutral reporting... With press coverage like this, don't be surprised if you
see a backlash. It would be nice if one could have the pros and cons together
in one article.

<< 'Risug', uses two chemicals - styrene maleic anhydride and dimethyl
sulphoxide - which are injected into each side of the vas deferens, the tube
that
transports semen from the testes to the penis. >>

This is a somewhat confusing description. For a clearer explanation, see
malecontraceptive.org's RISUG page.

<< Marketing the drug is expected to do by mid-November, this year. >>

An ICMR official has been quoted as saying early next year. See comments
above.

As for availability in the U.S., stay tuned to MaleContraceptives.org. A
big update is in the works, with suggestions for targeted activism. Momentum
is building!


- Elaine L.
MCIP



=====================================
From tffas:

This article makes it sound like RISUG is comercially available in
India now.  It seems like something that could be worth a trip to
India, and if Canada approves it soon it would certainly be worth a
trip there.  Anyway know of current status?

http://www.sundayobserver.lk/2005/03/13/new33.html
=======================

In a message dated 4/7/05 7:37:19 PM, aluxeterna writes:

>
> Hmmm...curious article. Has anyone picked up on any other recent RISUG
> developments, particularly the Canadian possibilities?
>
> A Lux
>



[Non-text portions of this message have been removed]