"Male birth control, without condoms, will be here by 2017," the Daily Beast confidently declared earlier this week. Other outlets picked up on the news. In just a few years, according to the headlines, women will apparently be free from worry about unwanted pregnancy because men will be able to access an amazingly effective, safe, and reversible sperm-blocking procedure for birth control.
If it all sounds too good to be true, there's a reason: it's not actually accurate.
These stories weren't based on published research findings or a Food and Drug Administration approval notice for Vasalgel, a method of birth control that involves injecting a gel into a man's vas deferens — where the sperm flow — so that it stops them from releasing the little swimmers. Vasalgel hasn't even gotten a green light from the FDA for testing in humans, nor does do we have published studies in animals to support its use.
The news came from a press release — and call for donations! — by the foundation behind Vasalgel, highlighting some promising (though again, unpublished, anecdotal findings) from testing on baboons.
Even if this birth control works for male baboons, there's a whole lot that needs to happen before it hits the market for male humans.
What it would take to bring Vasalgel to a bedroom near you
Since Vasalgel doesn't work on people at the chemical level, it would be regulated as a medical device. Animal testing with medical devices is really important since you don't want to implant them in otherwise healthy people to see how they work. If the FDA thinks animal data are sound, they'd approve the device for testing in humans.
At that point, the company would need to find and recruit study participants willing to experiment with Vasalgel. First, they'd test the birth-control method in a small number of people to see if it's safe, and then move to a broader population to test its efficacy and safety again.
With some devices, the process could take only a few months or a year. But a product like Vasalgel is unique: there's no precedent for it, said Alexander Gaffney, a regulatory expert based outside of Washington, DC. And testing in humans to demonstrate that it works would take a long time.
"If they're trying to show people don't get pregnant, you can't run a three-month trial," he said. "They'd have to show two or three years of data for agency to say, 'Yes it prevents pregnancy.' They'd also need to show the procedure is able to be reversed (that men can get women pregnant after Vasalgel), which is one of their claims." This also, of course, takes time, or at least nine months.
There's another potential hurdle for this type of birth control: the FDA might have concerns that men will have more unprotected sex, and that the associated risks outweigh the benefits. "There will be consumer groups who are going to be concerned about negative externalities," explained Gaffney. "There's nothing like this on the market. When you have a product that's never before been tested in humans and there aren't any similar use cases or studies, the FDA has a lot of questions."
Drugs take an average of 12 years to reach the market, and the timeline can be similar for medical devices. "Getting this product to market in three years sounds ambitious," Gaffney concluded.
Is this new contraceptive a real contender for men?
Again, if you read the news about it, you might think so. And according to the Daily Beast, Vasalgel is already en route to reducing unintended pregnancies around the world.
This kind of imagination is good for fiction writing but shouldn't be allowed in health journalism.
When I called a bunch of experts in reproductive and contraceptives research from across the US, they all had either never heard of Vasalgel or said that it was so far away from hitting the market that it wasn't yet a serious contender.
As Mario Ascoli, a reproductive scientist at the University of Iowa, put it, "As usual these companies make it sound as if they have discovered the secret of life because they want to entice investors to give them money."
Michael Skinner, who has studied male contraceptives at Washington State University, said, "Vasalgel is an appropriate scientific approach to investigate. But the clinical results are completely lacking. First we'd need more animal studies, then we'd need need to see them published, and then we can move forward."
Joseph Tash, of the Kansas University Medical Center, said it's important to keep in mind that the safety bar for contraceptives is even higher than it is for other therapies, since you're giving otherwise healthy people a medication. So getting a contraceptive approved can take even longer.
Right now, he added, the leading contender for a male contraceptive is a hormonal pill. But no one has figured out yet how to have a success rate anywhere near similar to the female birth-control pill, which would be the requirement for approval of a male equivalent.
Plus, it's just hard to ward off sperm, Tash added. "When you consider how many sperm are being produced by a male, we're talking millions each day. A female only produces one or two eggs a month. On a pure numbers basis it is a daunting task."
Wishing Vasalgel the best
Vasalgel is based on a procedure called RISUG — which stands for Reversible Inhibition of Sperm Under Guidance — that's been in development in India for years. And again, the idea is that a polymer gel is injected into the vas deferens to block sperm, rather then cutting the vas (a vasteomy).
Vasalgel claims that "if a man wishes to restore the flow of sperm, whether after months or years, the polymer is flushed out of the vas with another injection." This would be great news, since vasectomies aren't always reversible and a man's only other alternative right now is condoms.
But despite the hype about RISUG, when a World Health Organization team went to check it out, they passed on the procedure, saying that it didn't stand up to scientific scrutiny. There were concerns about toxicity and whether the treatment lasted over the long term.
The Parsemus Foundation behind Vasalgel is now trying to pick up where the Indian scientists failed, and maybe they will succeed. I wish them all the best. I really do. It's a great concept in that it's non-hormonal and reversible, and it would finally shift the burden of family planning from women on to men. But unfortunately, right now it seems it's far from reaching a bedroom near you.
Correction: A previous version of this article described the drug development pathway, instead of the device development pathway.