Aug 12, 2008

Lifestyle - The long wait for male birth control

Just a few years ago, the new male contraceptive seemed like an inevitable reality. Major pharmaceutical companies like Wyeth, Schering and Organon were pumping millions into hormonal birth-control development programs for men, and researchers were breathlessly promising imminent production.
But in 2008, there's still no birth control for men. What happened? In a word: money. With the cost of new-drug development hovering in the hundreds of millions of dollars, the pharmaceutical industry decided there wasn't enough of a market to make male hormonal contraceptives worthwhile. The German drug giant Schering halted its development program in 2006 (after its high-profile acquisition by Bayer), and other drug companies quickly followed suit, abandoning several projects that were — at least by the researchers' accounts — on the verge of success.
According to Kirsten Thompson, director of the Male Contraception Coalition, if Phase III clinical trials were to begin tomorrow on some of those discarded drugs, men would probably have their pick of contraceptive gels or implants — just like women — within five years. Yet, she says, drug companies still aren't interested. Though industry representatives refused to speak to the marketability question for this article, one spokeswoman for Organon, Monique Mols, told the industry journal Chemistry World in 2007, "Despite 20 years of research, the development of a [hormonal] method acceptable to a wide population of men is unlikely."
That's left some researchers, unsurprisingly, jaded. "You can lead a horse to water, but you can't make it drink," says Dr. David Handelsman, an Australian researcher who has spent two decades studying male contraceptives, including an implant-injection system that delivers testosterone via an implant in the arm, plus a progestin in four yearly injections. "The pharmaceutical industry is completely disconnected from the public and medical perceptions of need."
Indeed, many men say they are open to trying new forms of birth control. In a 2005 global survey conducted by Schering of 9,000 men ages 18 to 50, 55% expressed an interest in a "new male fertility control," and roughly 40% of the American respondents who said they would be interested in new male contraceptives further said they would be willing to use an implant or receive regular injections to control their fertility.
If even a small percentage of sexually active men agreed to try a new method of birth control, that would amount to a colossal number of potential consumers. That's why Thompson doesn't believe the drug industry's hesitance to develop male hormonal birth control is merely about money. "The biggest hurdle that I've encountered in trying to share this information is a sort of knee-jerk reaction that men aren't interested in these kinds of contraceptives and that women won't trust them to take them," she says. "Neither of those assertions are supported by the data."
Ask Durwin Foster, 40, a happily married father of three in North Vancouver who has long been dissatisfied with his lack of birth control options. He says condoms are a hassle and reduce pleasure. For men who want to at some point be fathers, however, the next best alternative — the oft-irreversible vasectomy — is hardly a more appealing option. "My wife has never been that comfortable with the Pill, so it would be nice to have some other options on my end," says Foster. "Something we could take turns with."
The research would suggest several other options are possible. Studies show that the right combinations of testosterone and a progestin can successfully and reversibly suppress sperm production in most men. Though a combination oral birth control pill wouldn't work — the necessary testosterone would get broken down too quickly in the liver — researchers have developed several other delivery methods: monthly injections, creams and twice-a-year synthetic implants into the arm. None of these birth control methods are as convenient or noninvasive as the Pill for women, but they are as safe and as reversible.
The only problem is that they're not always as reliable. In men who respond to them, hormonal contraceptive treatments have been shown to be 100% effective in clinical trials. But studies have also shown that 10% to 15% of men don't respond to hormonal treatments at all — a fairly high nonresponder rate. Researchers don't yet know how to explain those failures. One inherent stumbling block is that a male contraceptive must block millions of sperm, as opposed to a single egg. (The Pill had it easy.) Another is race: according to several proof-of-concept studies, Asian men maintained a suppressed sperm count with greater frequency than Caucasians, but researchers still don't know why.
The lack of definitive results is a major problem, says Dr. John Amory, who has spearheaded much of the male contraceptive research at the University of Washington. He says the science needs to progress before researchers can blame Big Pharma for dragging its heels. Amory's most recent treatment, a daily testosterone gel combined with a quarterly injection, showed a 90% success rate in trials, but, he says, "if we had a compound that was 99% effective, then the drug companies would be on board, the FDA [Food and Drug Administration] would be on board, and consumers would embrace it."
For now, however, male hormonal contraceptives perpetually remain five to 10 years away. And Durwin Foster wasn't willing to wait. He got a vasectomy in January. It was the only option he had left.

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