Researchers in Kenya are in the process of developing a male contraceptive pill that will be based on an immunology platform.
A team of scientists from the Institute of Primate Research (IPR) is working on a strategy that involves identifying a unique protein present only in the reproductive system that can elicit a specific immune response that will then induce reversible infertility.
If all goes according to plan, the researchers will then develop a male pill to be taken daily, a patch or gel to be applied on the skin, an injection given every three months, or an implant placed under the skin every 12 months.
By targeting the male of the species, the scientists at IPR have dispensed with the myth that only females can effectively help in birth control. And with Kenya’s population growing by about a million people annually, they have every reason to stem this growth, which is not supported by corresponding economic growth.
The only available means of birth control for men over the years have been prophylactic sheaths and vasectomy, and the latter has seen a slow uptake.
“The (planned) introduction of a male family planning pill is a good idea,” said Dr Thomas Kariuki, the IPR director and senior research scientist at the facility. “But convincing Kenyan men to accept it is likely to be an uphill task, based on preliminary surveys.”
One of the men whom Dr Kariuki and his team will have to convince to use their new product is Mr Julius Odongo, a father-of-seven who comes from one of the most populous regions in the country — Nyanza. “Family planning is a female affair,” says Mr Odongo, “and even then, I wouldn’t advise my wife to start using these things. The primary role of a woman is to give birth, and I fear that encouraging contraceptive use will lead to promiscuity.”
For Mr Odongo, the best way to space children is through what he calls “natural means”, which means birth control without using pills, injectables, patches, or other prophylactics.
But Dr Peter Mwethera, a senior scientist with IPR, says that, despite challenges posed by the likes of Mr Odongo, the team is optimistic that it will come up with a contraceptive that will change the mindset of Kenyan men.
“The global population recently reached seven billion, up from one billion just 1,000 years ago,” says Dr Mwethera. “Closer home, Kenya’s population was just eight million at independence in 1963, today we are inching towards 40 million heads. Surely, something must be done if we are to achieve our development goals.
“A new and wide range of contraceptives is required to address this high growth rate, and the new products must meet the varying cultural, religious, personal, and service needs of all populations, particularly in the developing world.”
But, as researchers burn the midnight oil to address men’s family planning needs, Planned Parenthood, a non-profit organisation providing reproductive health and maternal and child health services, says these are misplaced priorities.
Men are not completely at a loss for contraception, says the organisation. They can choose from other options that include condoms and vasectomy.
Farther afield, researchers at Columbia University Medical Centre are polishing up the development, for the first time, of a non-steroidal, oral contraceptive for men. Tests of low doses of a compound that interferes with retinoic acid receptors (RARs) showed that it caused sterility in male mice.
Researchers also found that low doses of the drug stopped sperm production with no apparent side effects. And crucial for a contraceptive, normal fertility was restored soon after drug administration was stopped.
Earlier research had led the investigators to the discovery that manipulating the retinoid (a vitamin A-related compound that promotes DNA transcription) could interfere with the process of sperm production.
Scientists have known for almost 100 years that depriving an animal of dietary vitamin A causes male sterility. “We were intrigued; one company’s toxin may be another person’s contraceptive,” said Dr Debra J. Wolgemuth of Columbia University.
To investigate whether the compound prevented conception at even lower levels than those cited in the company’s study, Dr Wolgemuth and her team placed the treated male mice with females and found that reversible male sterility occurred with doses as low as 1.0mg/kg of body weight for a four-week dosing period.
Female contraceptives use hormones — estrogens and progestins — to shut off the release of eggs and prevent pregnancy. Male hormonal contraceptives will work pretty much the same way: hormones, such as testosterone and progestins, are used to turn off sperm production.
Male steroid-based options have been plagued with adverse effects, including ethnic variability in efficacy, as well as an increased risk of cardiovascular disease and non-life threatening prostatic enlargement (hyperplasia).
Another side effect of hormonal options for men has been diminished libido. To make the pill a reality, researchers need to show that the compound is safe, effective, and reversible when used for years.
Dr Wolgemuth and Dr Sanny S. W. Chung are now planning longer-term studies to determine how long fertility can be disrupted and still recover after administration of the drug stops. “We hope that in the not-so-distant future, we may finally have more choices for people,” said Dr Chung.
IPR will discuss with the inventor, Dr Debra Wolgemuth, how to conduct pre-clinical trials of the products at local laboratories using well-characterised animal models of reproductive health, the results of which can inform the design and recommendations for clinical trials in humans.
The challenge is now left to reproductive health specialists to conduct civic education among Kenyan men on the idea of taking a pill for family planning.
Currently, only 46 per cent of Kenyan women are on a family planning regimen, with at least 43 per cent of recent births among women aged between 15 to 49 years being unplanned.
The popular contraceptives used by Kenyan women include Depo-provera, the three-month injection used by 22 per cent of married women, pills are used by seven per cent, six per-cent use a traditional method, while female sterilisation and periodic abstinence are each used by 5 per cent of married women.
The women we spoke to said they were glad that scientists were in the process of finally handing over the reins — and burdens — of family planning to the man.
“I have suffered major side effects, including excessive bleeding, constant back pains and nausea when using contraceptives,” said Jane Wairimu. “This has been the most difficult choice I have had to make, which is why I’m happy that the burden may soon be transferred to the man.”
Researchers are, however, optimistic that such side effects will not be transferred to the males because science has given them “the most promising approach to hormonal male contraception”, especially since the planned pill is a combination of testosterone and progestin.
In the US, a daily male birth control pill could be in the market within five to seven years, while the injectable or implantable male version may be available even sooner.