Years of human trials on the injectable, sperm-zapping product are coming to an end, and researchers are preparing to submit it for regulatory approval. Results so far show it’s safe, effective and easy to use — but gaining little traction with drug makers, which is frustrating its inventor, who says his technique could play a crucial role in condom-averse populations.
A new birth control method for men has the potential to win as much as half the US$10 billion (RM44.2 billion) market for female contraceptives worldwide and cut into the US$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 cost as little as US$10 in poor countries, and may provide males with years-long fertility control, overcoming compliance problems and avoiding ongoing costs associated with condoms and the female birth-control pill, which is usually taken daily.
It could also ease the burden on the 225 million women in developing countries, who the World Health Organisation says have an unmet need for contraception. Yet, so far only a United States non-profit organisation has taken up development of the technology abroad.
For Sujoy Guha, the 76-year-old biomedical engineer who invented the product, the challenge is to now find a company who wants to sell it — even though male contraception is an area Big Pharma has so far shown little interest in.
“The fact that the big companies are run by white, middle-aged males who have the same feeling —that they would never do it — plays a major role,” said Herjan Coelingh Bennink, a gynaecology professor who helped develop the contraceptives Implanon and Cerazette as head of research and development in women’s health for Organon International from 1987 to 2000.
“If those companies were run by women, it would be totally different.”
Sujoy’s technique for impairing male fertility relies on a polymer gel that’s injected into the sperm-carrying tubes in the scrotum. The gel, which has the consistency of melted chocolate, carries a positive charge that acts as a buffer on negatively charged sperm, damaging their heads and tails, and rendering them infertile.
The treatment, known as reversible inhibition of sperm under guidance, or RISUG, is reversed with a second shot that breaks down the gel, allowing sperm to reach the penis normally.
The expected launch of RISUG over the next two years will contribute to the Indian contraceptive market’s 17% growth through 2021, according to a report last year from Pharmaion Consultants, based near New Delhi.
The procedure is 98% effective at preventing pregnancy — about the same as condoms if they are used every time — and has no major side effects, according to RS Sharma, head of reproductive biology and maternal health at the Indian Council of Medical Research. About 540 men have received it in India, where it continues to prevent pregnancies in their partners 13 years after treatment, he said.
A submission to regulators this year will seek approval for RISUG as a permanent method of birth control. That will be appended with clinical data supporting reversibility, Sharma said.
India has more married women with an unmet need for family planning than any other country, and social stigma and a lack of privacy in stores has kept condom use to less than 6%.
Globally, men tend to take a back seat in matters of contraception. Almost 60% of women in spousal relationships used the contraceptive pill or some other form of modern contraception worldwide in 2015, according to a United Nations report. In contrast, 8% relied on their male partner using a condom.
A new option for male birth control could garner as much as half the female contraceptives market, according to research by Organon in the 1990s, when the Dutch drugmaker partnered with Germany’s Schering AG on the last major effort to develop a male birth control pill.
Demand would come from couples in long-term relationships looking to share family-planning responsibilities and single men looking for an alternative to condoms to prevent an unintended pregnancy from casual sex, Coelingh Bennink said.
Still, there were questions at Organon about whether it would be worthwhile financially to develop a new entrant in the low-margin contraceptives market, and the project was eventually shelved, he said.
Efforts on a hormone-based male contraceptive continued in 2008 in a study co-funded by the Bill & Melinda Gates Foundation and UN agencies that was published in October. While the injected regimen’s efficacy was “relatively good” compared to other methods, the study was terminated early after a safety review.
The authors noted a “relatively high” frequency of mild to moderate mood disorders, sparking a media uproar over perceived double standards in the development of contraceptives because the side effects seemed similar to those women experience on the pill.
Bayer, which bought Schering in 2006, stopped all research and development activities around male fertility control about a decade ago, said Astrid Kranz, a company spokeswoman.
Although an earlier clinical trial involving the administration of hormones via injection and an implant was “efficient, with a tolerable side effect profile,” Kranz said, the Leverkusen, Germany-based drugmaker wasn’t convinced this “inconvenient” regimen would find sufficient market acceptance.
Male contraception isn’t an area of active research for Pfizer and Merck either, representatives said. Both companies sell products for female fertility control.
Side-effects aside, it would take about US$100 million and 10 years to bring a hormone-based male birth control pill to market — a low-priority undertaking for pharmaceutical executives, Coelingh Bennink said.
“If those companies were run by women, it would be totally different.”
That’s now the dilemma Indian inventor Sujoy faces.
“In doing anything abroad, quite substantial money is required, and that can only come from the pharmaceutical industry,” Sujoy said, surrounded by dusty stacks of paper, books and prototype inventions that bury every surface in his office at the Indian Institute of Technology in Kharagpur, about 130km west of Kolkata.
In the face of disinterest from the pharmaceutical industry, Sujoy licensed the technology to the Parsemus Foundation, an US-based non-profit, to help establish a market for it outside India, he said.
Parsemus is working on its own version, called Vasalgel, that it plans to manufacture and distribute at near cost — or potentially US$10 to US$20 per person in low- and middle-income countries —and US$400 to US$600 per person in wealthier markets, Elaine Lissner, the foundation’s founder said in an email.
Sujoy, meantime, has registered a startup in India called IcubedG Ideas Pvt Ltd through which he is pushing ahead with introducing the technology in his home country.
He said patents on his invention have long since expired and he won’t see any personal financial gain even if it takes off worldwide.
“Why should the burden be borne by the female only?” he said in his office. “There has to be an equal partnership.”