Coming Soon: Vasalgel

June 29, 2015 by Robert Franklin, Esq, Member, National Board of Directors, National Parents Organization

Here’s a pretty good roundup of the alternatives for male contraception that may be coming down the pike in a few years (Telegraph, 6/18/15). It’s an article by Aaron Hamlin, who’s the Executive Director of the Male Contraceptive Initiative and, as such, well-informed.

As usual, everyday access to an inexpensive and effective male contraceptive is not on the near horizon. If the first one hits the market by 2018, we’ll be lucky. That first major breakthrough will probably be Vasalgel, the U.S. brand name of RISUG that’s been tested in India for over 10 years.

For those unaware of RISUG, it’s an injection of a polymer into the vas deferens that coats the tube’s interior wall and renders sperm cells incapable of fertilizing an egg. In India, the procedure has been found to be 100% effective at rendering a man incapable of fathering children for up to 10 years after the injection. Also, it’s reversible via a second injection. No side-effects have been found beyond the initial slight discomfort of the procedure that dissipates in about two days.

In short, RISUG has much to recommend it for men and women. One downside of course is that, since it’s a procedure done in a doctor’s office by trained personnel, it’s somewhat expensive. That cost though is considerably offset by its long-term effectiveness. Plus, since it’s a one-time thing, there’s no need to remember a daily pill and thus no chance of forgetting.

Vasalgel is a non-hormonal male contraceptive owned by the medical research organisation the Parsemus Foundation. It’s poised as the first FDA (Food and Drug Administration panel) approved male contraceptive since the condom.

What’s more, it’s estimated to hit the US market around 2018-2020 – and could change the way we view contraception for ever.

It’s easy, too. One injection would last for years.

Research tells us that at least half of men would use it.

Vasalgel is essentially a polymer that’s injected under local anesthetic into the man’s sperm-carrying tubes, accessible through the scrotum — not in his penis or testicles as some authors have erred. It works by blocking sperm and is expected to be reversible through a second injection that dissolves the polymer.

Another advantage of Vasalgel is that while it blocks sperm, other fluid can still pass through. This should reduce any risk of pain due to back pressure, an occasional issue with vasectomies. This could make Vasalgel a best-seller, even among men seeking a permanent contraceptive option.

Promising as Vasalgel/RISUG is, there are other possibilities that won’t be available as soon.

Gendarussa, another non-hormonal contraceptive, has gone through phase II human trials in Indonesia. The method is hypothesised to work by preventing the sperm’s ability to fertilise an egg.

Another method, this one from the US, is an anti-Eppin agent that targets sperm’s ability to swim. Both of these non-hormonal methods would involve the man taking a Pill.

These contraceptives are the first in line because they have support from clinical trials. But there are many others, including the ‘Clean Sheets Pill’ – designed to allow orgasm while inhibiting ejaculation.

It’s being developed in London. And because of advances in biotechnology, researchers keep getting new ideas; the bulk of them non-hormonal.

Any of those would be a step up from what men have now — vasectomy, condoms and abstinence. The first is mostly permanent, the second unreliable and the third undesirable. Hamlin reports, for example, that, in actual practice, condoms are ineffective 18% of the time. Needless to say, that’s not nearly good enough.

Important as new contraceptive methods would be to men, they’d be a ray of sunshine to their female partners as well. Women have a wide variety of contraceptives to choose from, but the hormonal ones have a wide range of unpleasant side-effects and the various sponges, rings and other IUDs can be uncomfortable and of course require changing and resetting from time to time.

So for a man to be able to entirely prevent conception for years with a single injection and therefore obviate his partner’s need for any form of contraception would be a great leap forward in our ability to control human fertility. In an ecologically-stressed planet that supports, with declining success, over seven billion people, that’s excellent news.

What’s hard to predict though is the cultural fall-out from the widespread availability of effective and cheap male contraception. What might be the unforeseen consequences of men all of a sudden being the ones to decide whether and when to reproduce?

Up to now (and by that I mean for all of human history), women have usually been the ones to take the lead in family creation. They tend to be the ones to urge their male partner to take the plunge and have children. Not always of course, but that’s the norm. I doubt that would change. And his consent, while a bit more complicated if Vasalgel were involved than it is now, would be easy enough. So in couples in which the man and woman communicate well and seek and get the other’s agreement to anything as important as having a child, I don’t see a male contraceptive changing much.

But of course that’s only a percentage of the potentially child-bearing population. For example, over 40% of children are born out of wedlock. My guess is that the great majority of those are conceived under conditions that are less than crystal clear either to others or the couple. More to the point, about 50% of children conceived in this country are “unintended” pregnancies. That’s according to the Campaign to Prevent Teen and Unplanned Pregnancy.

Now, a high number of those are aborted. Over one million abortions are performed in this country in a year and I suspect a high percentage of those are of unplanned pregnancies. But that still leaves well over one million unplanned pregnancies that are brought to term. Of course the term “unplanned” is, shall we say, a highly flexible one. My guess is that many of those pregnancies fall somewhere in a range between negligently unthought about and intentional. That’s supported by the study of community college women in Washington State that found a whopping 33% of them saying they’d, at some time in the past, already gone off the pill without telling their partner in the hopes of becoming pregnant.

It’s those one million or so “unplanned” pregnancies that may well be erased entirely from the annals of reproduction by the existence and easy availability of effective male contraceptives.

And just what that will mean for women who for decades now have taken for granted their power over that most important and basic of all human decisions — whether to reproduce — is hard to know. That power will be hugely reduced for women and increased for men. How will people respond to that shift in the balance of reproductive power? Who knows? But from some quarters, we already hear cries that their desire to delay marriage means young men want to remain perpetual adolescents. Once men start controlling their own fertility, expect those voices to grow ever louder.

But it will only be voices. The law on access to contraception is clear. There is no way the government can shut down access to contraception or information about it. The 1965 case of Griswold vs. Connecticut leaves no doubt that states may not restrict access to legal contraception.

Vasalgel promises to be on the market by 2020, if not sooner. Then, I suspect, we’ll see some exciting changes to the reproductive landscape and a good bit of weeping, wailing and gnashing of teeth. But whatever happens, it’ll be a new day in the relations between the sexes.

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