Published: 10 November 2016 at 11:00
VIEWPOINT: Anglia Ruskin expert looks at the need to change our understanding of risk
Dr Susan Walker, Anglia Ruskin University
A recent paper, Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men, reported that an otherwise successful trial of a male contraceptive injection was halted early due to the concerns of a safety committee regarding adverse side effects, specifically acne, mood changes and depression.
There have been comments on social media and in the press that female hormonal contraceptive methods often cause adverse side effects but are still considered suitable for use by healthy women. For example, another recent study showed increased rates of depression in women using both kinds of contraceptive pill, and mood changes are a common adverse effect reported by some women using hormonal methods.
As one author in The Conversation asked, would the female contraceptive pill ever be licensed today? One has to wonder – is this apparent double standard of concern about side effects an example of sexism in plain sight?
It is sometimes argued that the apparent lack of concern about female contraceptive side effects is due to a cultural belief that mood swings and depression are simply part and parcel of “femininity”, and of little note. Conversely, when they occur in men, they are viewed as illnesses or side effects, and are considered much less tolerable. There are some deep cultural truths in this view – but there is much more going on, too.
The female contraceptive pill was first available in Britain in 1961 and the trials on it were carried out a few years before the 1964 Declaration of Helsinki, which set the basic ethical benchmark for drug trials. Since then, trial methodology has developed, making adverse effects more visible. Ethical sensitivity has also increased with the well-being of trial participants much more prominent in the research process.
Added to these developments is the perception that end users of drug products are now more likely to sue manufacturers than they were 60 years ago. Everyone is now much more concerned than they were with ensuring the risks of a drug are outweighed considerably by the benefits.
Contraceptive products present particular difficulties when it comes to balancing risks and benefits. Unlike drugs to treat disease, contraceptive methods are used predominantly by healthy people. So any adverse effect might be viewed as tipping the balance towards unacceptable risk.
But of course women use contraception because they wish not to become pregnant. For this reason, taking into account the risks associated with pregnancy, the risk-benefit balance, for a woman, is favourable for any contraceptive method whose risks to health are minor or rare.
This is because the risks of pregnancy to a woman’s health usually greatly outweigh the risks of hormonal contraceptive methods, providing the woman is healthy. But men do not bear the health risks of pregnancy. So in a purely biological sense, almost any risk associated with a male hormonal contraceptive method could be deemed unacceptable.
And therein lies the problem. Many men also wish fervently to avoid unwanted pregnancy. But for them the risk is social, relational, emotional and perhaps financial. While the balance of risks and benefits when applied to treatments for disease can be made on an individualist and biological basis, such reductionism is unhelpful in regards to male contraception. For in this context we are necessarily looking at a couple’s risk, and for men we must assess non-biological risks and benefits as well as clinical ones.
Ethical and risk-benefit calculations have not yet reached this degree of sophistication. There are sound ethical reasons to be wary of balancing risks for one person against benefits for another. After all, I could argue that the risk-benefit balance of you donating one of your kidneys to someone in renal failure is so obviously in favour of donation that it should be commonplace. Perhaps even a moral obligation. But that would be an ethically worrying conclusion.
Nonetheless, in the area of male contraception, where studies have shown both efficacy and acceptability, it is necessary to move beyond an individualised, biological calculation of risk. This requires courage on behalf of researchers, regulators and safety committees. It requires common sense from manufacturers, lawyers and the legal system. But most of all it involves an open public conversation about risk, how it is measured and what the figures mean to an individual user or couple. If this is not undertaken, research into male contraception will remain stopped in its tracks.
The opinions expressed in VIEWPOINT articles are those of the author(s) and do not necessarily reflect the views of Anglia Ruskin University.