Male contraceptive from India on the anvil. Will it hit the shelves any sooner?

 1,21,01,93,422 and 17.64

Wonder what these figures are all about? The first one is the population of India as per 2011 census. The second one is our decadal population growth percentage. More than 65% of our population is below the age of 35. This human resource is a big boost to our growing economy. But with space constraints and the declining resources, the very same population will soon become a liability. Therefore keeping a check on the population growth, by developing birth control measures, especially for those in their 20s and 30s (reproductively the most active period) becomes extremely important.

Birth control techniques include contraception (the prevention of fertilization), contragestion (preventing the implantation of the blastocyst), and abortion (the surgical removal of a fetus or embryo from the uterus). Of these, contraception is the most preferred and is traditionally limited to practice by the female partner only, since male contraception has very limited options. The most prevalent form of birth control practiced by males is the usage of condoms or undergoing vasectomy, which are definitely not 100% effective. The options available to the women include injected contraception, intrauterine devices (IUDs), spermicidal and barrier contraceptions, natural family planning methods, emergency contraception, female sterilization, oral contraception and implant contraception. Although, seemingly numerous, most of these come with a baggage of certain side-effects, sometimes serious ones. Often these may include one or more of the following: nausea, vomiting, dizziness, tiredness, headaches, breast-tenderness, abdominal pain, hormonal imbalances, mood swings, early or late next period with irregular bleeding, weight gain, cancer etc. That is a steep price women pay with respect to their general health for practicing contraception.

In light of the above, scientists have always been on the lookout for an ideal contraceptive solution which would be minimally invasive; interfere very less with the daily life and most importantly be a fail-proof method offering a long-term family planning solution. Now, consider an injection of a harmless chemical in males which remains effective for a period of say 10-15 years, frees couples from looking for any other contraception method resulting in a no-headaches family planning alternative. This is what would happen when the efforts of Dr. Sujoy K. Guha, an Indian scientist at IIT Kharagpur, reach fruition.

Dr. Guha has been working on a MALE CONTRACEPTIVE for about three decades now, which has resulted into Reversible Inhibition of Sperm Under Guidance (RISUG) - a non-hormonal, polymer based, long acting male contraceptive, formerly referred to as the synthetic polymer styrene maleic anhydride (SMA). It has been under a close watch worldwide since Dr. Guha shared the concept.

RISUG works on a very simple mechanism. It is injected into the vas deferens, the tubular part of the male reproductive tract through which the spermatozoa move before ejaculation. The injected material coats the walls of the vas within a short span of time with a clear gel made of the copolymer styrene/maleic anhydride (SMA) dissolved in dimethyl sulfoxide. RISUG’s effect on sperms is not completely understood. Recent reports reveal that it disturbs the negative charge of the sperm membrane on contact. As it is known, the cell membrane of a sperm has the molecular machinery (enzymes) which enables it to interact with and subsequently penetrate the egg. As per Dr. Guha, SMA produces an electrical charge which nullifies the electrical charge on the sperm membrane within an hour . This leads to the bursting of sperm cell membrane, thus preventing it from penetrating and hence fertilizing the ovum.

The injection is administered through the skin of the scrotum without the necessity to make any cuts. The non-scalpel method may also be used, wherein a tiny puncture is made in the skin of the scrotum and a small pair of forceps is used to open up the hole. This hole is used to find the correct place in the vas deferens into which the gel is injected. The procedure usually lasts for fewer than 15 minutes.

This male contraception method is reversible too! RISUG can be reversed using another injection of DMSO. This flushes out the gel inside the vas deferens. Subsequently, vibration, a low electric current and some rectal massage may be required to completely remove the gel. The reversal procedure has only been carried out on primates. That said, each reversal has been successful. A study in 2005 found that sperms return to their normal, healthy state within 150 days of the reversal procedure. RISUG can be reversed within as short a time period say a few months to as long as many years after the procedure has been carried out. Without any reversal, the RISUG can be relied on for birth control upto at least 10 years.

The only side effect of RISUG reported from studies is some slight swelling of the scrotum. However this too has been reported to go down within a span of few weeks. Unlike the vasectomy, which takes two to three months to become fully effective, RISUG is effective almost immediately. As per reports on a women’s health website in UK, “Participants in trials were advised to use condoms for 10 days after the procedure, but even those men who did not do so didn’t get their partners pregnant within that time. Perhaps the most important advantage of RISUG when compared to vasectomy is that the procedure is easily reversible, whereas only 50 % of vasectomy reversals are successful.”

Notwithstanding all the promising features (see box above), Dr. Guha has had a rough ride with the RISUG for the most part. He has by his own admissions spent more than 30 years refining the idea while battling bureaucrats in his own country and skeptics worldwide. Nevertheless, despite all odds he and his team have prevailed, with RISUG proven to work 100 percent of the time! The Indian Council for Medical Research (ICMR) has approved the toxicology data thrice. An American lab, approved RISUG as non-mutagenic in July 2005, after some concerns raised by a WHO team in 2002 in a meeting with Dr. Guha.

RISUG is undergoing advanced clinical trials in India where some of the patients have successfully used it for over 15 years. In an interview to rediff.com, Dr Hemchandra Das (who is in charge of the clinical trials of RISUG at New Delhi's Lok Nayak Jai Prakash Hospital) has said that those who volunteer for trials in the capital are mostly from the villages of Uttar Pradesh, are between 25 and 45 years of age, married, and have two children. “RISUG has been accepted by the poor population, primarily because vasectomy costs about Rs 1,000 while a single dose of RISUG will cost only Rs 200”, opines Dr. Koel Chaudhury, who works with Dr. Guha. 

A lot of interest has been generated in RISUG internationally as well. A small foundation called Parsemus has purchased the rights in the US to begin RISUG trials so as to develop it for the world market by the name of Vasagel. Parsemus has plans to develop RISUG as an alternative to vasectomy.  The clinical trials will start next year and market launch is expected by 2015.

RISUG does not provide protection against the spread of sexually transmitted diseases, although a study has tested its effectiveness as an anti-HIV agent. Styrene maleic acid is believed to reduce pH levels that can potentially destroy HIV in semen. If this aspect is further validated, it will be one more feather in RISUG’s cap.

What is intriguing, however, is the meagre interest that the pharmaceutical companies have shown in RISUG. RISUG being a cheap contraceptive that doesn't require recurring monthly prescriptions is unlikely to be a profit grosser.

Although, the decadal population growth percentage has registered the sharpest decline in India since Independence, India may still surpass China as the world’s most populous nation. Women in the poorest Indian state reportedly bear four children on an average. RISUG could help couples from the lower economic strata of the society to limit their families and thus save them from a vicious circle of poverty,debt, disease and mortality. The advantages are no less for the developed countries. There it would help relieve women of the hazards of long-term birth-control-pill use and give men a more reliable alternative to condoms.

Yet it has been a case of “so-near-yet-so-far” with RISUG’s market launch. The reasons range from scientific skepticism to red-tapism. If the published data from Dr. Guha’s group and clinical trial results are anything to go by, the skepticism stands very well silenced. In the next few years we will know whether a brilliant invention becomes available to the mankind for curbing a very pertinent problem, or will it be relegated as a footnote on the pages of the book called human endeavour. Till then, we will keep the faith.

Select references:-

1.            http://specials.rediff.com/money/2008/apr/01contra2.htm

2.            http://www.womens-health.co.uk/sperm-inhibition.html

3.            http://www.wired.com/magazine/2011/04/ff_vasectomy/

4.            http://en.wikipedia.org/wiki/Reversible_inhibition_of_sperm_under_guidance

5.            Banerjee S, Guha SK (2009). RISUG: a potential candidate for the entry inhibitor group of antiretroviral drugs. Med Hypotheses. 73(2):150-2.

- Puneet Raina  

PR holds a Master's in Zoology and is currently pursuing his PhD on the molecular biology of programmed cell death in Leishmania donovani at Panjab University, Chandigarh. He is a recipient of both Junior and Senior Research Fellowships from CSIR. He was also awarded Science Talent Promotion Scholarship by the Department of Science and Technology, J&K in 1994. His research interests include molecular parasitology, immune response and cell-signaling, programmed cell death, gene knockdown, antisense oligonucleotide design, & systems biology of host-parasite interactions. He has undertaken temporary teaching assignments (undergrad and postgraduate classes) at Panjab University. Apart from research, he likes writing science articles.

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