Doctors are about to launch the first new male contraceptive in more than a century. But rather than the launch being from a Big Pharma lab, the breakthrough is indeed coming forward from a university startup in rural India.
Much effort has gone into human trials on the injectable, sperm-zapping product which is now coming to an end and is waiting for regulatory approval. Results so far have indicated that is safe, effective and also easy to make use of—but gaining little traction with drug-makers. It is rather frustrating for its inventor, who says his technique could indeed play a crucial role in condom-averse populations.
A new birth control method for men no doubt has the promising potential to win as much as half the $10 billion market for the female contraceptives worldwide. These cut into the $3.2 billion of annual condom sales, businesses dominated by pharmaceutical giants Bayer AG, Pfizer Inc., and Merck & Co., according to estimates from the last major Drug Company to explore the area.
India’s reversible procedure could indeed cost as little as $10 in poor countries, and may also provide males with years-long fertility control, overcoming compliance problems and also avoiding ongoing costs associated with the condoms and the female birth-control pill, which is usually taken daily.
It could indeed also ease the burden on the 225 million women in developing countries, who the World Health Organization does admit have an unmet need for contraception. But so far only a U.S. non-profit has taken up the required development of the technology abroad.
Sujoy Guha, the 76-year-old biomedical engineer who invented the product, does face the challenge as to how to find a company who wants to sell it—even though male contraception is an area Big Pharma has so far shown little interest in it.
Big companies are run by white, middle-aged males who have the same feeling—that they, in fact, will never be able to do it. Women, on the other hand, react differently. In fact, they have a more positive approach, unlike their men counterpart.
Guha’s technique for impairing male fertility does rely on a polymer gel that does happen to be injected into the sperm-carrying tubes in the scrotum. The gel, which has, in fact, the consistency of melted chocolate, does carry a positive charge that indeed acts as a buffer on a negatively charged sperm, thus damaging their heads and tails, and also rendering male infertility.
The treatment is referred to as reversible inhibition of sperm under guidance, or RISUG, and is actually reversed with a second shot that does break down the gel, thus allowing sperm to reach the penis normally.
The procedure is no doubt 98 percent effective at preventing pregnancy—similar to condoms in case they are used every time. They have no major side effects. About 540 men have indeed received it in India, where it does also continue to prevent pregnancies in their partners 13 years after treatment.
A submission to regulators this year will also seek approval for RISUG as a permanent method of birth control. That will rather be appended with clinical data supporting reversibility. India has more married women with of course an unmet need for family planning than any other country, and social stigma and a lack of privacy in stores has also kept condom use to less than 6 percent.
