'Are You Using Anything?'

By Cara Gardner, The Inlander. Posted January 6, 2004.

In ancient China, women drank lead and mercury as a form of birth control; during the Middle Ages in Europe, women wore amulets of herbs, animal parts and material soaked in potions to prevent pregnancy. Whether science-based or superstitious, family planning has been practiced since our species understood how babies were conceived.

When the Pill came onto the market in the 1960s, birth control was revolutionized. Since then, a variety of contraceptives -- from patches to pills, from injections to insertions -- are continuously improved and made available to women all over the world.

As contraceptive research continues, more effective forms of birth control -- without the negative side effects -- are being tested. The latest is a simple injection that can make the recipient infertile for six to 15 years, depending on the user's needs. It's non-hormonal, so there's no worry about weight gain, mood swings, losing libido or long-term effects such as cancer, blood clots or high blood pressure. Early testing shows it's reversible, if conception is desired. The most controversial aspect of this birth control? It's for men.

What's more, even though it's considered one of the safest, most effective forms of contraception available, most men will never have access to it -- including American men.

The injection is called Reversible Inhibition of Sperm Under Guidance (RISUG, pronounced RICE-ugh). It was developed by professor Sujoy K. Guha, an Indian researcher of biomedical engineering at the Indian Institute of Technology. Guha has tested RISUG on men for more than 25 years with successful results. His research has drawn praise from the World Health Organization, as well as doctors from around the world. Pharmaceutical companies in India and Egypt are vying to buy RISUG, and, if all continues well with Guha's research, RISUG will be available on the Indian market sometime within the next few years.

"RISUG is the most effective and advanced technology we've had in 40 years," says Ronald Weiss, an assistant professor of medicine at the University of Ottawa, Canada. Weiss focuses his family practice on male health and has traveled to India to see the research on RISUG for himself. RISUG is an injection of two chemicals into the vas deferens, the place where sperm leaves the testicles. The whole procedure is less invasive, causes fewer complications and promises to be easily reversible as compared with vasectomy or rubber plug devices (other currently used methods of male contraception).

The entire procedure is virtually painless and becomes effective within one hour of injection. There are no known side effects, aside from slight swelling immediately after the injection. Guha reports some of his test subjects were sexually active on the same day they received the injection. None of the men who has tested RISUG has gotten a woman pregnant.

"We applied three or four years ago to do a clinical trial [in Canada]," says Weiss. "But it will never be approved. The [RISUG] studies that have been done to date have fallen short -- it's not to say the studies weren't good or aren't useful, but they don't meet the criteria for Western acceptance."

So why can't the studies be completed in Canada or the United States in order to test RISUG by Western standards?

"In order to obtain approval to study RISUG, we need to duplicate a number of the studies and that means you need money," Weiss says. "That either comes from a benevolent rich person, which is hard to come by, or a pharmaceutical company."

Herein lies the problem: RISUG may be too effective. Pharmaceutical companies are pouring millions into research on male contraceptives, particularly the male version of the pill, but none is interested in RISUG.

"What does a hormonal contraceptive [like the Pill] represent to a pharmaceutical company?" Weiss asks. "Recurrent sales. It's like women's birth control. They sell it over and over and over again. They want something they can make an ongoing profit from. Business is business."

RISUG renders a man infertile for six to 15 years; on the Indian market, it'll cost about $500 for the injection. In contrast, the average American woman spends between $3,000 and $4,000 every 10 years for birth control pills. Even though RISUG might be a promising contraceptive, pharmaceutical companies would lose money on it. It takes about 10-15 years and costs anywhere from $20 million to $70 million to bring a contraceptive method through research, development and final approval for marketing by the Food and Drug Administration.

"To be fair, pharmaceutical companies are in the business of making money and answering to their shareholders," Weiss says. "It's physicians who are looking for what's best for their patients. I don't blame big business. Hormones -- that's where all the research and money is."

Though men in most Western countries won't have the option of RISUG, men in parts of the developing world may be able to use it. Some say cultural and religious beliefs, in addition to fear and suspicion over science-based fertility control, might hold men back from getting the injection. Still, RISUG is a sign of hope in a world where 125 million couples cannot access current methods of birth control.

In the Western world, men will soon have the option of controlling their fertility with hormones. Weiss says he guesses the male pill will be on the market in five to 10 years.

"The only people who should be excited about the male pill are pharmaceutical companies," Weiss said in an interview with Grist Magazine. Pharmaceutical companies will have plenty of opportunity to make a profit on the male pill. But will men go for it?

The Pill for Men?

Soon, men will have the option of never having to hear the words "I'm pregnant" when they least wanted to be a father. Nor will they find themselves protesting, "but she said she was on birth control!" Male birth control pills are on their way to a pharmacy near you. This could be a very good thing. Half of the pregnancies that occur each year in the United States are unintended -- that's almost 3 million unintended pregnancies. Of those unplanned pregnancies, 47 percent are the result of no birth control at all. Of course, many men are already doing what they can by using condoms. But according to the FDA, the condom has a failure rate of 14 percent.

Even though the average American spends about 30 years of his or her life avoiding pregnancy, some doctors say men would rather risk it than take a pill.

"I really think that men will have a huge resistance to taking the pill," Weiss says. "They see the results of studies done on hormone replacement on women. And we're just not sure what effects the pill is having. They see their partner's libido is reduced."

Weiss believes that women have more to lose, and therefore are willing to take more proactive steps to avoid pregnancy than men are. "There's more motivation to take the pill for a woman than a man," Weiss says.

Bill Heaton, an urologist at Rockwood Clinic in Spokane, agrees. "The childbearing population [of women] is seeing their gynecologists already and birth control is part of that," Heaton reasons. "Men, on the other hand, don't go to see doctors. Men may not support [male pills] because it's not practical."

But one in six married American men have had vasectomies, a procedure that definitely involves seeing a doctor -- and is clearly more invasive than having a pill prescribed. Besides, wouldn't the introduction of a male contraceptive encourage more men to see their doctors?

"I think what we already got works pretty good," Heaton says. "We have a longer track record studying women's [birth control]."

Medical technology, however, doesn't subscribe to the "if it ain't broke don't fix it" philosophy. There are currently more than 100 experimental contraceptive methods being studied around the world. More men may be interested in having some control over their fertility than many doctors assume. A study completed by the Kaiser Family Foundation, a national health research and education organization, shows that two-thirds of respondents (both men and women) think men should have more to do with choosing and using contraception. Of the 71 percent of American men who said they'd be willing to try at least one form of male contraceptive, 66 percent said they'd try the pill.

"From a man's perspective, taking a shot or a pill once in a while is worth it," says John Amory, a doctor at the University of Washington. Amory researches hormonal methods of male birth control.

"Men count for a third of all contraceptive use with only two options: vasectomies and condoms. So, with just those two options, men count for 30 percent," Amory says. "I say men are interested... if [men] could take a pill or a shot, 75 percent would be interested."

But, as Weiss cautions, the male pill comes with side effects, just as do birth control pills for women. And as Heaton, the urologist in Spokane, explains, women's birth control pills have undergone decades of testing and improvements, while the male pill is still new.

For couples in monogamous relationships, the male pill may be a method worth trying -- that is, unless the guy wants to fly to India for a RISUG treatment.

Amory, with the UW, says it's up to consumers to convince pharmaceutical companies that male contraceptives are important. "The more male contraceptives are out there and are successful, the more the pharmaceutical companies are going to want to be involved."

Cara Gardner is a staff writer for the Inlander, a weekly newspaper in Spokane, Washington.

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