Monday, 10 October 2011

The revolutionary new birth control method for men and India’s lukewarm response

Dr. Devendra Kothari
Population and Development Analyst

Forum for Population Action
Currently men pretty much have three choices when it comes to avoiding pregnancy: Condom (which can break), Vasectomy (which is irreversible), and Withdrawal (not an effective method of contraceptive). But behold thanks to an Indian scientist world could be on the verge of a fourth option.

After a more than 30-year struggle, an unassuming Indian engineer from Indian Institute of Technology, New Delhi named Sujoy K. Giha is on the brink of what could well be the most revolutionary contraceptive technology since the pill – and this time it is for men. The 70 year- old Indian scientist has developed a form of male birth control that is non-hormonal, 100 percent effective and has no side effects. The procedure, called RISUG (reversible inhibition of sperm under guidance), involves injecting a positively charged, non-toxic polymer into the vas deferens that renders passing sperm useless. If the male decides he wants to reproduce, a second injection dissolves the polymer. This post discusses this new development and the Indian government machinery‘s lukewarm response to this revolutionary event.

The device does not inhibit sperm production; instead, it acts, to quote the May issue of Wired[1] , as "a tollbooth on the sperm superhighway”.   Not only is the technique would be an outpatient procedure completed within 15 minutes, does not have to done often, and does not have any side effects. So far all the trials done on Indian men since 1989 have been 100% effective.

If the research pans out, RISUG would represent the biggest advance in male birth control since a clever Polish entrepreneur dipped a phallic mold into liquid rubber and invented the modern condom some four hundred years ago. “It holds tremendous promise,” says Ronald Weiss, a leading Canadian vasectomy surgeon and a member of a World Health Organization team that visited India to look into RISUG. “If we can prove that RISUG is safe and effective and reversible, there is no reason why anybody would have a vasectomy.”

But here’s the thing: RISUG is not the product of some global pharmaceutical company or state-of-the-art government-funded research lab. It’s the brainchild of Prof. Guha, who has spent more than three decades refining the idea while battling bureaucrats in his own country and skeptics worldwide. He has prevailed because, in study after study, RISUG has been proven to work 100% of the time. Among the hundreds of men who have been successfully injected with the compound so far in three clinical trials, there has not been a single failure or serious adverse reaction. In May 2002, it was announced that RISUG was on track for approval in India and would be rolled out on a limited basis within six months. But it did not happen.  However, RISUG has faced a series of bureaucratic barriers.

RISUG has been in Phase III clinical trials in India since 2002. In October 2002, government officials aired concerns about RISUG in India's national press. Their concerns have since been resolved, but the controversy stalled the clinical trial for six months. The next delay was due to concerns about RISUG's initial toxicology tests. The Indian Council for Medical Research (ICMR) has reviewed the toxicology data three times and approved it each time. At around the same time, a World Health Organization team came to visit Guha’s lab in Delhi and examine his data. This it self was a triumph: It meant RISUG was finally on the international radar. In its report, the WHO team agreed that the concept of RISUG was intriguing. But they found fault with the homegrown production methods: Guha and his staff made the concoction themselves in his lab, and the WHO delegation found his facilities wanting by modern pharmaceutical manufacturing standards. Furthermore, they found that Guha’s studies did not meet “international regulatory requirements” for new drug approval. The team stated that the 25-year-old toxicology studies did not meet more recent international standards. RISUG was submitted for a new round of tests at a US lab, and approved in July 2005. In March 2006, the trial was slated to resume at 4 centers around India. Then a manufacturing delay halted progress. The pharmaceutical company making RISUG was finally able to deliver a batch produced to the World Health Organization’s Good Manufacturing Practice (GMP) standards in March 2007.  The trial resumed in earnest in April 2007.  The trial’s data collection, analysis and publication process will take several years to complete.

Guha looked around for a corporate partner for improving the facilities but found no takers. Unlike birth control pills, which must be used daily, sometimes for years, RISUG is a long-lasting, low-cost treatment (the syringe could end up costing more than the material it injects). “Pharmaceutical companies are not interested in one-offs,” Weiss says. “They’re interested in things they can sell repeatedly, like the birth control pill or Viagra.” In other words, “It was not a problem of science,” says A. R. Nanda, an early supporter of RISUG and former secretary of the department of family welfare. “It was a problem of politics and ego.”

In both the East and the West, the need for better contraceptives couldn’t be clearer. India will soon surpass China as the world’s most populous nation; in the poorest Indian state, women bear an average of nearly four children. Cheap to produce and relatively easy to administer, RISUG could help poor couples limit their families—increasing their chances of escaping poverty. The impact could be huge for India, where sterilization is still the most often used method of birth control. The numbers say it all. Today, only 3% of women are on the pill and 5%t of couples use condoms. Meanwhile, some 37% of women undergo the comparatively dangerous tubectomy operation, while only 1% of men get vasectomies.  In the developed countries, RISUG would help relieve women of the risks of long-term birth-control-pill use and give men a more reliable; less annoying option than condoms, and at the same time reduce the number of abortions significantly.

RISUG is garnering interest beyond India.  Thanks to a novel collaboration between Guha and a San Francisco reproductive health activist- Elaine Lissner, RISUG could soon be on the road to FDA approval in the US.  By 2001, she had concluded that RISUG was the most promising new development out there and began tracking its ups and downs closely. By 2009, though, she had grown frustrated with the lack of progress on RISUG in India. Luckily, she was in a position to do something about it. At the beginning of the real estate boom, she’d invested a small amount of money in her father’s construction company, which had become wildly successful building houses around Reno, Nevada. She parked the profits in a small private foundation called Parsemus and set about putting money behind RISUG.

In February 2010, Parsemus bought the international rights to the RISUG technology from Guha and IIT Kharagpur for $100,000. The plan was to get RISUG OK’d in the US, perhaps even before it hit the market in India.  Whether our policy makers are listening?

The next blog discusses what the poverty debate misses in India.  

[1] This post is mainly based on an article:   The Injectable Vasectomy by Bill Gifford appeared in Wired magazine of May 2011, 170-186.

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