A medical trial for a hormonal birth control shot for men being conducted in several countries including India has shown that injectable male contraceptives are far more effective now than ever before. However, the trial was halted after 20 of 320 men dropped off the trial on the grounds that the side effects were too bad to bear.
The hormonal birth control shot was shown to prevent pregnancies in nearly 96% of cases. Male contraceptive shots suppress the sperm production. But like any hormonal contraceptive, this injection has side effects including mood changes, depression, pain at the injection site, and a shift in libido.
The efficacy is comparable to the female contraceptive pill. The known side effects for the oral contraceptive pill range from minor ones such as headaches, nausea, to increased blood pressure, increased bleeding or spotting, and also other serious health conditions such as breast cancer or thrombosis, which is the formation of blood clots. Just last month, a study by Pyschiatric Central Research Register in Denmark of data collected from 1995 to 2013 of more than 10 lakh women showed that the use of oral contraceptive pills, especially among adolescents, was associated with the first diagnosis of depression.
Many reports have pointed to the hypocrisy of the male contraceptive trial being suspended. As a report in The Guardian points out, the scientists did not attempt to quantify whether the side effects were comparable or worse compared to the known side effects of the female pill. An editorial in Independent went as far as to say that suspending the trial was not justified, unless the researchers produce evidence that the contraceptive increase the risk of death or cancer.
Trials in India
Interestingly, one of the drugs used in the male contraceptive trial is norethisterone enanthate or Net-en, along with a testosterone injection. Net-en was tested as a contraceptive for women in 1970s because a jab of the progesterone-only injection prevents pregnancy for two months.
A Net-en trial conducted by Indian Council for Medical Research showed that 90% of the women in the suffered abnormal bleeding – either too much or just spotting. At the end of one year, most of the women discontinued treatment after using the injection once or twice and only 26% of the women could be recruited. Despite that, the Drug Controller of India had given permission to proceed with Phase IV trials for the contraceptive drug.
The other side effects included headaches, severe abdominal cramps, bone demineralisation, and long-term effects like breast and cervical cancer.
This is not the only drug with considerable side effects, which passed muster with the Indian drug regulators. These drugs are added to the programme on the pretext of increasing the "basket of choices" of contraception for women.
On April 5, Health Minister JP Nadda announced the introduction of another progesterone-only hormonal injectable contraceptive called depot medroxyprogesterone acetate or DMPA. There had been no clinical trial conducted for DMPA under the National Family Planning Programme. The drug has a similar action to Net-en and similar side-effects and can prevent pregnancies for three months after administration.
The US Food and Drug Administration issues a black-box warning for DMPA. Black-box warnings call attention to serious and life-threatening risks. The warning states that the contraceptive should be used only if other methods of birth control are inadequate.
Serious effects or merely irritants
When DMPA was introduced into the National Family Planning Programme in April, it had many supporters. Dr Ravi Anand of ABT Associates in Lucknow that works towards increasing the demand and access to DMPA told Scroll.in at the time, “They may irritate women, like a cold for instance. They require counselling after which the women can handle it. If you can help them tide over that time, then they can deal with it.”
Researchers also seem befuddled when it comes to “intolerance” to irregular bleeding, and consider it a “cultural barrier”. The black box warning issued by the US-FDA was dismissed as yet another case of the US-FDA being abundantly cautious, and not practical.
However, those running the family planning programme in India in India, and other lower and middle-income countries, argue that the risks of family planning measures must be set off against the risk of suffering due to unwanted pregnancy, maternal mortality because of unsafe abortions and declining child health or higher child mortality in families with large numbers of children and lower access to nutrition and resources.
Need for counselling
There should also be more and better counselling for women. Women, more often than not, do not “choose” a contraceptive but given one and almost always are not told about side-effects or about safer alternatives.
Healthcare providers are supposed to counsel women before prescribing a contraceptive but hardly ever do so. Besides, most primary healthcare centres which provide information about contraceptives and administer them are ill-equipped to treat their side effects.
As per the National Family Health Survey 2015-16, nearly half the women interviewed in most states covered by the survey said that they did not receive any counselling related to side-effects of contraceptives. Only women from Puducherry, Andaman and Nicobar Islands, and Meghalaya reported higher numbers of women who were told about side effects of contraceptives.
In India and abroad, we need to make men equally responsible for contraception. Safer options such as use of condoms, vasectomy are not endorsed enough by the government. According to Ministry of Health and Family Welfare data, 39.5 lakh female sterilisation procedures were conducted in in 2014-15 and 52.7 intrauterine devices like copper-T devices administered to women. In contrast, only 78,362 male sterilisation procedures were carried out.
So, the calling off of the male contraceptive trial provides a good opportunity to talk about the side effects of contraception and to as why the India government’s family planning programme still has contraceptives such as DMPA and Net-en? Like in the case of the trial of the male contraceptive injectable, we should extend the same courtesy to women and stop peddling harmful contraceptives to them.