Shouldn’t You Be on the Pill?
When it comes to birth-control options, women have all the choices – and men have all the responsibilities. Here’s why...

By Bill Gifford © May 2003 Men’s Health magazine

Jim Pritchard is not ready to be a father. He is so not ready, in fact, that he takes some rather unusual precautions. On a typical evening, he eases into a bathtub full of the hottest water he can stand – close to 116 degrees Fahrenheit – and stays there for as long as 45 minutes. He adds hot water frequently to maintain the proper temperature, which he checks repeatedly with a thermometer. The heat makes him sweat profusely, so he sips lots of cold water to stave off dehydration. Afterward, he cools down with a tepid shower.

The whole process, he admits, “is not very convenient.” But he considers it to be the only reliable form of birth control open to him. A 40-year-old engineer living in the Boston suburbs who describes himself as “single but hopeful,” Pritchard doesn’t trust condoms. Nor is he willing to trust his reproductive destiny to the doe-eyed promises of the fertile, marriage-minded women he dates. “An unplanned pregnancy can destroy a man’s life,” he says solemnly. “Many women plan their ’unplanned’ pregnancies.” So he looked for a contraception method that he could control.

It didn’t take him long to find out what most of us know: There aren’t many good options out there for men. A “male Pill” remains 5 to 10 years away, as it has been for, well, 5 to 10 years. Pritchard investigated, and rejected, various Asian herbal remedies as too uncertain. Then he stumbled across the work of Marthe Voegeli, M.D., a Swiss physician who practiced among the poor of India from the 1930s through the 1950s, and who devised the hot-bath method of male contraception.

Dr. Voegeli knew that excessive testicular heat would shut down spermatogenesis, the production of sperm. (In fact, the scrotum is basically a testicular air conditioner, expanding and contracting to keep the testicles slightly cooler than normal body temperature, for optimal functioning.) In more than a decade of experimentation on hundreds of Indian men, Dr. Voegeli determined that a 3-week cycle of daily hot baths – at least 107 degrees F, and preferably 116 – would cause temporary sterility. The condition would last about 6 months, after which normal fertility would return. It was a cheap, practical way to control India’s booming population – and for Indian men, a way to escape the burden of supporting an endlessly growing family. Of course, with the Indian population now hovering around a billion, you could say that Dr. Voegeli’s tea-bag revolution never really caught on.

Except, that is, with Jim Pritchard, for whom it was a way to control his reproductive destiny. “I said to myself, ‘Hey, I can do this, with no doctors or anything to infringe on my privacy,’ ” he says.

Pritchard has modified Dr. Voegeli’s method a bit. For one thing, he can’t maintain a 116-degree bath for 45 minutes; that would require a special heated tub, which he can’t afford. So he tries to bathe every day, time permitting. To be on the extra-safe side, he also wears snug underwear under his boxer shorts, to hold his testicles closer to the warmth of his body, further suppressing sperm production. Finally, he always uses condoms, which he sees as simple prudence.

Conventional doctors tend to frown on behavior like Pritchard’s, which essentially makes him a human test subject. “A hundred sixteen degrees is really hot,” says Ronald Swerdloff, M.D., of Harbor-UCLA Medical Center, who has researched heat and other methods of male contraception. “It could be dangerous.” Dr. Swerdloff has found that excessive heat caused testicular damage in mice, for example. Pritchard feels he doesn’t have much choice.

“Condoms are unreliable, and vasectomy is dangerous,” he explains, in a carefully worded e-mail. “I concluded that the hot- bath method, inconvenient though it is, is the best male contraceptive available. That shows you how dismal the male- contraception situation is.”

Dismal is one word for it. Another might be “medieval.” If you’re a man in 21st-century America, your contraceptive options aren’t much different from those available to King Henry VIII, who died in 1547: Either pull out before climax, or use a condom and pray. (The king’s third option, killing one’s wife, has fallen out of favor.) Modern men can also have vasectomies, which have their own drawbacks- -and are largely irreversible.

Contrast that with the cornucopia of birth-control methods that are now available to women. Besides the Pill – which itself comes in a dozen varieties – there are caps and shields, sponges and jellies, patches and shots, subdermal implants and little copper widgets, and so on. In other words, when it comes to contraception, women have the whole supermarket, and men have the gumball machine.

Feminists sometimes complain that women bear the “responsibility” for birth control, but the responsibility also brings the power to choose when to have a child. Men are still essential to procreation, but we don’t seem to have much say in the outcome. When she tells us she’s on the Pill, we usually take her at her word. If she turns out not to be telling the truth, we’re still on the hook for child support.

“Every time a man puts his penis into a woman’s body, he puts his life in her hands,” says Warren Farrell, Ph.D., San Diego-based author of Father and Child Reunion.

On a certain level, it makes sense that women got the Pill first. Men are sperm-making machines, producing them by the hundreds of millions, around the clock. “You’re talking about millions of sperm,” says Richard Anderson, M.D., a leading contraceptive researcher at the University of Edinburgh, “and you’ve got to get it reliably down to zero.” Women pop out just one egg per month, so you can break out the man-to-man defense. And, of course, women are the ones who get pregnant.

Would men even take a birth-control pill? For years, the medicalpharmaceutical establishment assumed we would not. “Until very recently, they were concerned that there wasn’t a market for such a product,” says Dr. Anderson. But they might want to check with guys like NBA star Shawn Kemp, who at last count was supporting seven children by six different women, making him the league leader in paternity suits. Given the opportunity, Kemp would probably be glad to take a Pill (indeed, he should probably be required to do so), and so would his colleagues. Sports Illustrated estimated that the number of illegitimate children fathered by NBA players at least equals the number of players in the league. Other athletes who might be interested in a male Pill include Mark Messier, Oscar de la Hoya, Pete Rose, and Larry Bird, all of whom have paid to support out-of- wedlock children.

It’s not just athletes who’d benefit. Nationwide, more than one million unwanted children are born each year. That’s about two million unhappy parents. A 1997 survey by the Kaiser Family Foundation found that two-thirds of American men would consider taking a birth-control pill; a global survey by Dr. Anderson’s office found similar results in Europe, South Africa, and China.

Only one problem: It doesn’t exist yet.

Or does it? In fact, there already is a potential male birth- control pill. It’s called nifedipine, and it’s sold under brand names like Procardia and Adalat for treatment of high blood pressure. It also seems to cause temporary, reversible infertility in men. Aside from that, it has limited side effects, it’s already been declared safe by the FDA, and it doesn’t mess with testosterone levels or anything else that we men hold dear.

Nifedipine’s sperm-suppressing effect was noticed back in 1992 by Susan Benoff, Ph.D., who worked at a fertility clinic on Long Island. One day, she happened to discover that one of her supposedly infertile male patients was taking Procardia. She asked around and found that many other patients were also on the drug, or similar forms of nifedipine. When the men switched medications, several of them successfully fertilized ova within months.

Benoff immediately took her findings to the major makers of nifedipine. Their responses ranged from silence to outright hostility. “Drug companies didn’t want to hear about our work,” she says. “They wanted to bury it, because of the potential lawsuits involved from people who had been unable to conceive because of this.” (Infertility was not listed among nifedipine’s side effects, essentially because most heart patients tend to be beyond their baby- making years.)

Without funding, the research proceeded slowly, as Benoff and her colleagues sought to understand how nifedipine worked in sperm (it evidently causes sperm cells to produce excess cholesterol, rendering them unable to penetrate the egg). When she finally presented her findings at a 1999 lecture in Toronto, she made headlines. Even Bayer, one of the drug’s manufacturers, reportedly felt the heat, and the company’s director of scientific affairs promised to recommend that Bayer look into Benoff’s discovery.

Of course, nothing happened.

vWe have not pursued that area,” says a Bayer spokeswoman – who then goes on to tout the company’s new erectile-dysfunction drug, a competitor of Viagra.

For more than 30 years now, researchers have believed that a hormonal contraceptive for men was within reach. It needed only one ingredient: money. Unfortunately, the drug companies weren’t interested. Until very recently, the prospects for a male Pill were so bad that Carl Djerassi – who first synthesized the hormones in the female Pill – suggested that Western men should simply store their sperm and have vasectomies, and forget about any kind of Pill.

“Perhaps the single most difficult problem,” says Dr. Swerdloff, who’s worked on male contraception since 1969, “was to get support from the pharmaceutical industry to carry this past the idea stage.” In fairness, most major pharmaceutical companies have abandoned reproductive medicine altogether, in the wake of such liability disasters as the Dalkon Shield of the 1970s and the controversy generated by RU-486, the “abortion pill.” But if female contraception is a low priority, male contraception isn’t even on their radar.

That began to change in the mid-1990s, when a batch of studies showed that men who were given testosterone injections seemed to stop producing sperm. (The extra testosterone fooled the body into shutting down its own production of the hormone.) The studies were financed by the World Health Organization (WHO) and the U.S. Agency for International Development, and they showed that male contraception was at least possible. “That was the landmark,” says Dr. Swerdloff, who conducted one of the studies. The results weren’t perfect – it seemed to work far better in Asian men than in Caucasians, for one thing. And the excess testosterone caused side effects like acne and irritability. More work needed to be done.

It took a few more years, but drug firms recently have shown more interest in developing a male contraceptive. As it turns out, the most promising candidates are simply modified versions of established female contraceptives, like Norplant. The active ingredient in Norplant inhibits the release of gonadotropins, hormones that signal the testes to produce sperm. Two companies, Schering AG and Organon, are financing trials of male “Pills” – which are more likely to be Norplant-style implants or long- lasting injections. An Australian team has been studying a combination of testosterone injections and Depo-Provera, an injectable female contraceptive. And the Population Council has developed a synthetic form of testosterone that also shows promise.

Dr. Anderson’s lab published a study last summer showing that men who were given Organon’s female-targeted Implanon implant, containing a synthetic progestogen, along with implants containing testosterone had almost total suppression of spermatogenesis, with minimal side effects. Interestingly enough, particularly for the Jim Pritchards of the world, the study used existing preparations. “You could make it up and do it yourself,” says Dr. Anderson (who doesn’t recommend doing this). Other clinical trials of Implanon and testosterone are under way at the University of Washington, and Organon hopes to apply for FDA approval in 2005.

Dr. Swerdloff and his UCLA colleague, Christina Wang, M.D., recently published a similar study of Norplant II with various forms of testosterone, seeking a delivery method that would be both convenient and effective – and potentially profitable. (Testosterone injections proved most effective – but also inconvenient and scary.) “There needs to be a way to reimburse the pharmaceutical companies,” says Dr. Swerdloff, by developing “a type of drug that would be patentable.”

Even so, an actual male contraceptive product remains years away- -and it will still have to get past the FDA. “The way the female Pill was developed would not be acceptable now,” says Dr. Anderson. “They went in with a sledgehammer preparation that really worked, and then refined it down from there. Things have to be a lot more careful these days.”

It seems reasonable to ask, at this point, if men would want to sledgehammer their hormones – never mind that women have been doing it for years. Luckily, there are several other innovative treatments on the horizon that bypass the hormones and target the sperm themselves.

A Montreal-based company called Immucon is working on a contraceptive “vaccine” that disrupts a key protein in the acrosome, or head, of the sperm. It’s worked in hamsters so far; monkeys are next, and humans might have access to it in 10 years. In the United States, Rajesh Naz, Ph.D., of the Medical College of Ohio, has targeted sperm-specific antigens that could lead to contraceptive vaccines. Dr. Swerdloff is conducting a study of the effects of simple heat, in order to identify the mechanism by which heat shuts off spermatogenesis – in hopes of developing a drug that does the same thing. There’s also a synthetic compound that seems to “blind” sperm by inhibiting the enzyme that allows them to recognize an egg. And last December, researchers at Oxford University reported that a drug called NB-DNJ caused temporary, reversible infertility in mice- -apparently rendering their sperm unable to swim. The drug is already used in Europe to treat a rare genetic disorder, but more testing will be necessary before it sinks any human swimmers.

All these lag far behind traditional hormonal methods – by decades. They’re science fiction, for now. But there is one method that fits all the criteria: It’s localized, it’s reversible, and it lasts a long time. Best of all, it’s been tested on hundreds of men- -but only in India.

It’s called RISUG – “reversible inhibition of sperm under guidance” – but the unwieldy acronym stands for an elegant, ingenious method of birth control. “It’s probably the most significant advance in contraceptive technology since the birth-control pill for women,” says Ronald Weiss, M.D., a leading Canadian urologist with the University of Ottawa and an advisor to the World Health Organization.

Developed by Sujoy Guha, M.D., a professor of biomedical engineering at the Indian Institute of Technology, RISUG consists of a clear polymer gel that’s injected directly into the vas deferens, through which sperm travel on their way out of the testes. The styrene-based copolymer doesn’t block the vas, but it chemically “confuses” all sperm that flow past it, rendering them unable to fertilize an egg (and in many cases killing them outright).

Dr. Guha hit upon this technique 25 years ago, while looking for a way to kill bacteria in well water. He tested it in rats, rabbits, monkeys – and, beginning around 1990, humans. His original test subjects remain infertile to this day, with few side effects (the major one being a temporary, harmless swelling of the scrotum, he says). Since then, he’s treated hundreds of Indian men, many of whom now besiege him with gifts, out of gratitude. The treatment can be reversed with an injection of sodium bicarbonate, which flushes the polymer away. Phase III clinical studies recently began, and Dr. Guha expects to bring RISUG onto the market in India within a year or two.

RISUG has other advantages: It’s cheap, and it’s relatively easy to administer. “It’s extremely simple and can be easily mastered by any doctor who currently does the no- scalpel vasectomy,” says Dr. Weiss, who became the only Western physician to perform a RISUG injection when he visited Dr. Guha’s lab with a WHO team in February 2002.

“A male method has to be local, reversible, 100 percent effective, and safe, without side effects,” Dr. Weiss says. “The only method that fills all the criteria is RISUG.” Yet those very qualities may also spell its commercial doom. Will pharmaceutical companies invest in a product that costs a couple of bucks and lasts 10 years?

“There is no interest in any kind of semipermanent contraception in the West, unless it’s something that’s done repetitively, like a hormonal treatment,” charges Dr. Weiss. “Pharmaceutical companies want to sell drugs, and they want to sell them over and over again.”

Anybody for a hot bath?