india

Updated: May 28, 2017 08:37 IST

Tiny room no. 46 on the second floor of the Lok Nayak Jai Prakash Narayan hospital in Delhi is an unlikely site for a medical breakthrough. But, over the years, its walls have welcomed hundreds of men for a clinical trial. They were injected with a sticky gel to immobilise sperm: a contraceptive called RISUG, short for Reversible Inhibition of Sperm Under Guidance.

Today, on a blistering morning in May, it was Fauji’s turn. The 29-year-old security guard from a village in Uttarakhand volunteered for the trial after hearing about it from a neighbour. He has two children; a boy and a girl. He doesn’t want more.

Nearly 28 years after it was first tested on a human being, RISUG is expected to be approved by the Drug Controller General of India. If it passes muster, it could prove revolutionary: no new male contraceptive has hit the market since the first vasectomy in 1899 (although condoms have improved remarkably, the technology itself is centuries-old). And at an estimated cost of Rs 800 this one would also be cheap.

But RISUG’s success hinges on men, who have proved notoriously hard customers for the contraceptives market, largely for cultural reasons. Less than one percent of Indian men undergo vasectomies and just over five percent of them use condoms, according to the government’s latest family health survey. Female sterilisation, a minimally invasive surgery that severs the fallopian tubes, is still the most popular method of birth control in India.

In theory, RISUG would give men an option that is more reliable than condoms and less drastic than a vasectomy. But doctors, health workers and advocates are sceptical because the way they see it, science is up against a familiar and formidable obstacle: patriarchy.

The “better evil”

“Theek laga (it was okay),” says Fauji, after he returned from the operation theatre where he was injected with RISUG. The syringe scared him but there was just “a little bit of pain”. What contraception was he using until now? “Condoms,” he says quickly, his eyes darting around the room. Why not continue using them? “How long can we use them?” he asks, clearly uncomfortable with the conversation.

Doctors at the Lok Nayak Jai Prakash Narayan hospital in Delhi inject 29-year-old Fauji with a male contraceptive as part of an ongoing clinical trial. ( Saumya Khandelwal/ HT Photo )

The only two methods available to men are not popular. Condoms are discomfiting to buy, store or dispose, especially in conservative, rural households; they are also known to fail. Vasectomies, which involve surgically snipping male reproductive ducts, are shunned for fear of emasculation. There is a third method: withdrawal. But for obvious reasons, it’s not ideal.

In the end, women overwhelmingly bear the burden of contraception. Although female sterilisation is prone to infections and worse, so many women opt for it because they are weary of childbirth — over half of Indian women between 15 and 49 years are anaemic because of a poor diet and frequent pregnancies.

Fauji, in fact, opted for RISUG because he didn’t want his wife, weakened by her second pregnancy, to go under the knife. What makes RISUG palatable to men is that, as the name suggests, it’s reversible with a second injection. But it does involve 15 minutes on the operating table and an incision. Still, it sits well with devout couples whose faith prohibits permanent contraception.

“It’s the better evil,” says 45-year-old Babu Khan who got injected in 2001 and keeps returning for regular follow-ups as part of the trial. Even after six children, surgery wasn’t an option for him or his wife, Guddi. But they were unsure of how their extended family would react to RISUG , so it remains a secret.

The battle to block sperm

Black backpack slung over his shoulder, 77-year-old Sujoy Guha bounds up the stairs to the laboratory at the All India Institute of Medical Sciences (AIIMS) in south Delhi. This, a beaming Guha says, is where RISUG was developed.

As soon as he walks through the door, young men spring up, smiling and bending slightly as they say “namaste,” with a mix of deference and fondness. They unlock the door to a small room with a conference table, chairs and an AC with a gaping hole instead of a thermostat. “We did all the studies on the monkey right here,” says Guha. “Those times we didn’t have money. My students and I used to take care of the monkeys, cleaning and everything.”

Why did he want to develop a male contraceptive? “I wanted to be different,” says Guha, a frail, white-haired, sharp-nosed man. When he returned from the US in 1965, he had two degrees in electrical engineering and one in biomedical engineering. After looking in vain for a job that allowed him to use all his degrees, he received some unusual advice from a senior bureaucrat.

Pointing to a Godrej almirah in his office, the bureaucrat told Guha to buy one and lock up his biomedical degree in it. “Don’t talk about it, you’ll get a faculty position with your BTech and MTech (in electrical engineering), then you do what you want to do,” is how Guha recalls the message. “That’s exactly what I did,” he says, laughing.

So he ended up — at 31— with an offer from IIT and AIIMS to develop a new PhD programme that would address the problem of India’s growing population. “I don’t know what engineering can do,” he remembers telling his supervisor who replied, “that’s your challenge.”

Sujoy Guha, a 77-year-old biomedical engineer, at his lab in Kharagpur. Guha has spent the last 45 years developing a male contraceptive. ( Getty Images )

It was 1972. Condoms and the “s” shaped first-generation loop were still on shaky ground; withdrawal was a common form of birth control. But sterilisation, which required no follow-up and left nothing to chance, was ideal for a young, eager Indian state that believed curbing population was the key to beating poverty. The vasectomy — first offered as a cure for “excessive masturbation” in the US in 1899 — was a quick, simple procedure by now.

But Guha was sympathetic to its pitfalls: “One would not like to have a part of one’s body cut”. When that thought first struck him he wondered if it was possible to block sperm without severing the passage through which it travels to the penis. That question sparked a 45-year-long obsession.

Vasectomies weren’t controversial when Guha started out. This was before Prime Minister Indira Gandhi declared the Emergency in 1975. Post-Emergency, the fallout from the mass forced sterilisations was sweeping: even The Ministry of Health and Family Planning renamed itself (the word welfare replaced planning).

“After that, nobody was willing to touch this (vasectomy) with a barge pole,” says a public health expert working with the Ministry of Health and Family Welfare who spoke on the condition of anonymity.

The problem with the vasectomy, Guha explains, is that it’s permanent. It blocks sperm forcing the body to produce antibodies that destroy the excessive build-up of sperm, which brings down the sperm count. So the longer a vasectomy lasts, the less the chance of reversing its effects.

Instead, Guha and his students invented a molecule that took the form of a gooey, transparent liquid. When injected into each of the two tubes leading to the penis, it takes root like a spider web but firmer. The sperm isn’t blocked because it can pass through the gaps. But while interacting with the gel the sperm loses its efficacy: specifically, the vital membranes that enable it to fertilise the egg. A second reversible injection, which is yet to be tested on humans, will dismantle the molecular web.

RISUG attracted some interest from pharma companies but they retreated — as a one-time, affordable procedure it offers low margins. And in countries like India, where the demand for family planning is huge, the biggest buyer is often the government. Both Pfizer and Bayer told HT male contraceptives are not a priority currently. The last few attempts, including one by Bayer in the early 2000s, made little headway.

But Guha did license the RISUG technology to a US-based non-profit venture, Parsemus Foundation, that is developing the drug for the non-Indian market. Executive director Linda Brent said in an email that the drug, renamed Vasalgel, has a new formulation to suit regulatory standards in the US and Europe. It’s still in the animal testing stage. She believes money, not demand, is a challenge for male contraceptives, which are usually funded by governments or non-profits.

Parsemus’ surveys, she said, show that some men “wish to relieve their partners of the burden of birth control,” while many want a male contraceptive so they “have direct control over whether they become fathers.” Still, the history of birth control has revolved around women the multi-billion dollar female contraceptives market is proof of that.

None of this fully explains why there is no male contraceptive. Some of it is purely biology: it’s hard to block the millions of sperm that are produced every day. Any one of them can fertilise an egg. “It’s easy to mess around with ovulation,” says Ruma Satwik, a reproductive medicine specialist at Delhi’s Gangaram Hospital. “Egg production is a very, very, very, delicate process.” Ten different hormones have to do their job just right to produce an egg. And they get just one chance every month. Stress, diet or any sort of hormonal imbalance can interrupt this — that’s what the birth control pills and intrauterine devices (IUDs) do.

Satwik’s most vivid memory of her stint running a primary health centre (PHC) in rural Maharashtra is the meetings with the District Health Officer, a short, dark, kindly man in cotton trousers and a shirt. The year was 2000. India’s population had crossed the one billion mark. And the pressure was on: PHCs had to meet their “targets”, recorded in a ruled register, for IUDs, birth control pills, condoms and, most of all, female sterilisation.

Every month, Satwik would assemble along with 50 other doctors from the district and answer the same question: Tum che kithi? (How many?) “If she (a woman) was still menstruating, she was a candidate,” Satwik says. The question was largely about female sterilisation, which has remained the go-to method of family planning for successive Indian governments.

Even though a vasectomy is safer because it’s a minor surgery with no side effects. When women undergo sterilisation, the incision is deeper and the chances of an infection, higher. Oral contraceptives like the birth control pill come with side effects; and inserts such as IUDs are not ideal in large, poor countries where women are more susceptible to vaginal infections and doctors aren’t necessarily qualified to perform the procedure.

So why not push vasectomies more? The firm but unfounded fear that male contraception will somehow hamper masculinity and the pleasure of sexual release. “Fertility and orgasm are delinked in women,” Satwik says. “In men they are inseparable.” That is, many men worry that contraceptives that impede their fertility will also interfere with their orgasm.

Science vs sexism

“Sex power kum ho jaayega (will decrease).” That, health worker Nurjamal Haque says, is a primary concern among men when they are asked to consider a vasectomy. Haque is a community advocate in rural Assam’s Barapeta district — he travels across tiny river islands educating people about the merits of family planning. And he’s relentless. He spent nearly three years persuading a single community elder to allow his 32-year-old wife to undergo sterilisation. Until he agreed, Haque couldn’t convince any of the others in the community.

“Slowly, slowly, change comes but it takes a lot of hard work,” Haque says in a phone interview. Eight years ago, he couldn’t broach the subject in many of these parts; he and his colleagues were routinely harassed for trying. But now staunch community elders have turned “motivators” and some women are coming to the clinic asking for condoms for their husbands. “One day, the way women come on their own, men will also come,” says Haque. “That is my belief.”

The annual reports of advocacy groups such as the Population Foundation, which work with the government on family planning and other health issues, are filled with uplifting stories of persistent efforts that paid off in rural communities; of women who chose their own birth control; of husbands who were eventually convinced; of couples who negotiated and picked what’s best for them.

But there’s also data: of malnourished, anaemic women; of frequent pregnancies; of widening sex ratios. And there are other stories too. “The mothers-in-law are the gatekeepers,” says Mehak Sharma (name changed on request), a quantitative researcher who has spent hundreds of hours speaking or at least trying to speak to women in remote rural villages in Uttar Pradesh, Bihar, Rajasthan and Maharashtra. The government’s Accredited Social Health Activist (ASHA), Sharma says, has to get past the mother-in-law. Even if she does, she’ll often find herself talking under the watchful eye of a sister-in-law.

Sharma’s job is to try and decode the behaviour behind decisions about family planning, among other things. What is the preferred method, for instance, and why. In poor communities, she says, she often finds that women don’t think they have a choice. “The first kid is supposed to come like that,” says Sharma, snapping her fingers. “I’m married, I have to have kids — what’s there to think or talk about? You don’t make decisions for yourself. It’s intimidating.”

The decision, Sharma says, usually comes from the doctor because there is no dialogue between husband and wife. Even educated men are not necessarily involved in the decision. She recalls a woman in Mumbai telling her she got her IUD removed because it made her husband physically uncomfortable. Sharma couldn’t understand what she meant and the woman couldn’t explain either.

The question that concerns doctors and advocates alike is this: if men are so reluctant to use condoms or even discuss contraception, will they consent to being injected with a drug that would disarm their sperm?

Guha seems unperturbed by this. That, he explains, is not his job. “Research and development — that is life,” he says. Next, he says, he wants to start working on a version of RISUG for women: the same gel would enter the fallopian tubes and disintegrate the egg. So far, he has tested it only on a goat.

“There is enough work for me,” he says, chuckling. ” Is he excited that the drug is nearly past clinical trials? Or disheartened that it took this long? After a brief pause, he offers a nugget of wisdom that he inherited from his father: “One should never be happy or sad about anything.”