RISUG Trials Beginning in the United States

December 2nd, 2011 by Robert Franklin, Esq.
Clinical trials for the male contraceptive RISUG have begun in the United States.  Read about it here (Wired, 4/26/11).

I’ve written about RISUG (Reversible Inhibition of Sperm Under Guidance) before and it continues to seem to be the most promising of all male contraceptives.  For those of you who haven’t read my previous piece, here it is. 

RISUG was first developed and tested in India. 
It involves an injection into both vas deferens.  To do that, two small incisions are made into the scrotum and a substance called styrene maleic anhydride is injected.  SMA is a nontoxic polymer that, when injected, coats the inside of the vas deferens and, when sperm cells travel through it, damages them so they can’t fertilize an egg. 

The procedure requires only a local anesthetic.  Its only side effect is moderate discomfort and possibly slight swelling for about a week after the procedure. 

The upside of RISUG is considerable.  First tested in India in 1993, it seems to be 100% effective at rendering the subject incapable of fertilizing an egg.  It is inexpensive.  It is long-lasting, each injection lasting about 10 years.  It is reversible via a second injection.  In all the human trials conducted in India, SMA has proved nontoxic and no long-term side effects have been recorded.  Toxicology studies have been negative. 

In short, RISUG looks like a dream come true for every sexually active man who wants to control whether or not he fathers a child.  One of its many benefits is that, unlike condoms, RISUG is confidential; only the man need know whether he’s had the injection or not.  

Into the bargain, it could be an enormous benefit for women as well.  Many contraceptives in use today by women are hormonal and as such can produce some very unwanted side effects.  Others can be uncomfortable and/or ineffective.  

So, when RISUG becomes available, sexually active couples will be able to decide which option is best for them.  If the pill isn’t advisable, RISUG might just be the perfect alternative.  Indeed, it might become the first choice of couples who want to avoid pregnancy. 

But.  You knew there was a “but.” 

Even though RISUG has been tested on humans in India for 18 years now, that’s not good enough for the FDA in this country.  As the linked-to article makes clear, those in theUnited Stateswho want to get the procedure on the market have had to go back literally to square one and begin testing.  That means testing it on laboratory animals first. 

Attempts in Canada met with the same response. 

From his home base in Ottawa, Ronald Weiss marvels at the possibilities of RISUG. “If you’re looking for the better mousetrap, this is it,” he says. “I have received emails from men all over the world kind of champing at the bit to get RISUG.” 

Weiss had been trying to bring the process to Canada starting in the late ’90s. But when he presented his notes and [Indian developer Sujoy]Guha’s published studies to the regulators at Health Canada, they shot him down. Guha’s studies did not meet their standards, they said. All of them would need to be redone. “Essentially, we were in a situation where we would have to start from zero,” Weiss says. “We would have to redo every single study to get approval. And I didn’t have millions of dollars at my disposal.” 

In fact, even getting to that point was hard.  For one thing, existing pharmaceutical companies showed no interest in the procedure.  Why?  It’s too good.  It’s too effective and to inexpensive.  After all, what is there to interest Big Pharma in a cheap substance that’s used once every ten years?  Those companies far prefer medications that need to be taken regularly, like once a day. 

[Weiss] looked around for a corporate partner but found no takers. Unlike birth control pills, which must be used daily, sometimes for years, RISUG is a long-lasting, low-cost treatment (the syringe could end up costing more than the material it injects). “Pharmaceutical companies are not interested in one-offs,” Weiss says. “They’re interested in things they can sell repeatedly, like the birth control pill or Viagra.” 

So when Guha tried to interest American companies in RISUG, he was met with a stone wall.  Fast forward a few years, however, and American researcher Elaine Lissner has picked up the gantlet.

She founded a small nonprofit advocacy group called the Male Contraception Information Project to push for better male options. By 2001, she had concluded that RISUG was the most promising new development out there and began tracking its ups and downs closely.

Lissner then created a foundation called Parsemus that would fund the necessary research in the get RISUG to market.

In February 2010, Parsemus bought the international rights to the RISUG technology from Guha and IIT Kharagpur for $100,000. They had worked closely together for years, and she had earned his trust. She also hired Gary Gamerman, a consultant who specializes in shepherding products through the complex FDA approval process. The plan was to get RISUG OK’d in the US, perhaps even before it hit the market inIndia.

Parsemus plans to begin toxicology testing on SMA this year and, if all goes well, as it always has in the past, begin animal testing shortly thereafter.  It’s also changed the name of the contraceptive to Vasalgel.

But to get human clinical trials going will take more funding than the $500,000 that Lissner has budgeted; Gamerman estimates that the whole approval process could cost $4 million to $5 million.

To get that, Lissner plans to ask organizations like Planned Parenthood, the Bill and Melinda Gates Foundation and the Susan Thompson Buffett foundation.  The latter two certainly have the money, and have previously backed population control initiatives. 

How long will it take before men can actually utilize Vasalgel to control their fertility?  That looks like anyone’s guess, but I’d say five years looks like a minimum.  But whatever the case, in the not-too-distant future, men in this country will have the ability to decide for themselves – safely, effectively and privately – whether to father a child.

Thanks to Lenona for the heads-up.

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