The first male contraceptive method to ever hit the market will almost certainly not be one manufactured in a lab by Bayer or Merck, but by the verdant forests of Indonesia.
The Indonesian plant Justicia gendarussa has long been used homeopathically to reduce stress, but more recently was found to have an alternate side effect: male infertility.
Scientists worked to isolate the active substance, Gandarusa and distill it into pill form. They began testing the substance on animals in the late-1980s and the buzz about this as a promising human contraception has grown in recent years.
Two years ago, a PBS crew traveled to the Indonesian island of Java to document this promising drug in action. In late-2012, a third phase clinical trial with 350 men was completed with even more promising results.
According to yet-unpublished findings, five days after taking the pill researchers found a noted reduction in fertility in trial subjects, and using the pill for 20 days resulted in just one pregnancy among 164 in the treatment group. Although this doesn’t put Gandarusa ahead of any other currently available female method in terms of failure rate, it is still impressive and potentially one more viable method.
That is important in the world of contraception where condom and vasectomy remain the only male methods, yet advocates continue to make the case that contraception is not just a “women’s issue.” In 2008, four in ten pregnancies worldwide were unintended. Women disproportionately bear the physical, mental and financial burden of unintended and unwanted pregnancies, but those pregnancies do not occur on their own.
There are medical reasons why finding a male option is important, but there are social reasons too. “There are contra-indication conditions for women to use particular contraceptive methods. In these conditions, men should take over the responsibility. We are raising gender equality issue,” says Dr. Dyan Pramesti, an Indonesian andrologist who is a co-investigator of the drug along with Dr. Bambang Prajogo.
Gandarusa also offers something no other method does: it is all natural, non-hormonal, reversible, and has almost no side effects. Unlike current female methods, which works at the macro level, either changing the body’s hormonal chemistry in order to suppress ovulation in women and thus fertility or making the uterus inhospitable to pregnancy (as with an intra-uterine device or IUD), Gandarusa functions at the micro level. It essentially de-activates two (of many) types of proteins on the sperm head which are necessary for egg penetration, rendering the sperm incapable of fertilization.
The next step for Gandarusa is a market trial, after which researchers will apply for approval from the Indonesian Food and Drug Administration. Dr. Pramesti says they plan to recruit around 1,000 men from a number of sites across the country, representing a diversity of cultural and socioeconomic backgrounds.
Yet in the homestretch, the project has stalled due to lack of funding. Previous research was funded by the Indonesia National Family Planning Bureau, but a looming presidential election and potentially shifting priorities have made continued such support unlikely.
Running out of money has been a common theme and part of the paradoxical pattern in the arms race for male contraception over the years. The closer the Holy Grail draws, the farther it seems to get. In a nutshell, big pharmaceutical companies are hesitant to fund research on a drug that they aren’t convinced will make a big buck, or whose market might cannibalize an already quite lucrative one (that is, the market for female contraception). Further, scientists are looking at micro-level and fine-tuned methods that have few to no side effects, are reversible, and highly effective. All of this takes lots and lots of time (and money).
There are plenty of promising fits and starts, but only a few that are nearing the finish line. The buzz among researchers and advocates for some time has been that Gandarusa would be the one to finish first. Another promising almost-there option is the “reversible vasectomy,” or RISUG, an injection that renders sperm incapable of fertility and being piloted in India. That method is also likely to appear in the next few years.
The only promising component missing from Gandarusa’s research is the proof that men in Indonesia – or anywhere, for that matter – would actually buy it and use it.
But results from a 2004 survey on men’s attitudes toward male contraception suggest they would. Among more than 9,000 men in nine countries on four continents – including Indonesia – an average of 55.1% expressed willingness to use a hormonal birth control method, and were consistent in their preference for a pill form over other options such as injection, gel or implant. If around half of men surveyed were willing to take a hormonal method, Gandarusa might already have a more promising market given that it is non-hormonal.
Yet of all the countries surveyed on potential use of a male method, men in Indonesia reported the least acceptability. Just 28.5% said they would be willing to use a male method while 34.2% were unwilling. This is compared to 65.4% of men in Mexico who said they would use it and 71.4% of men in Spain.
Uncertainty makes sense, since such market research is based on the potential use of a hypothetical drug. It is an approximation, at best, and an “if you build it they will come” type of attitude may be necessary. Yet if enough funding can be shored up to get even one male method to market, the number of men using it will speak for itself. This evidence may be enough to convince more donors to fund research, thus bringing additional methods to completion.
Perhaps it is how much she has at stake, having devoted much of her career to this quest, but Dr. Pramesti remains optimistic. Even with setbacks, she predicts Gandarusa could hit the market as early as 2015. “It will be the first oral non-hormonal male contraceptive method in the world,” she says, with confidence and excitement. Let us wait and see.