There’s a lot to this extraordinary story of a humble pharmaceutical dispenser; life, and death. The impact of the ordinary-looking product to millions of new mothers in the developing world could – more than likely, will – be enormous.
It’s been a long, complex journey, but the product is so simple, and the way the clinical trials are going so far, it looks to be incredibly effective. It’s not a surprise that Monash Institute of Pharmaceutical Sciences’ inhaled oxytocin project was quickly corralled into a multimillion-dollar partnership with a major manufacturer, global governments and huge philanthropic foundations.
The project also has strong backing from the Saving Lives at Birth campaign, which is in turn backed by the US Agency for International Development and the World Bank.
It’s also not a surprise it was championed by Hillary Clinton as long ago as 2011, when she was the United States’ secretary of state. The small, plastic inhaler – not unlike those used by asthmatics – could, she said, “save many lives ... no needles, no cold storage, no blood-borne diseases.”
That was then. Now, the project has entered a crucial new phase of clinical trials at Glaxosmithkline in Cambridge. GSK is the company leading the product’s development. Inhaled oxytocin is basically a reinvention of injected oxytocin, which for years has been given to women to prevent potentially fatal haemorrhages during or after delivery of their new babies.
The inhaled version, Monash researchers hope, will be used throughout the developing world, where there is scant refrigeration, lack of trained staff and higher risk of disease from using needles. The new trial in Cambridge compares real patients who have been given either an injection or an inhalation at random. After this there will be two more clinical trials to confirm the safety and feasibility of it. Then, in perhaps three years, the product should be available.
“The world is waiting,” says the project’s leader, Associate Professor Michelle McIntosh. “It needs this product.”
She says the original idea came from Monash Pharmacy’s Dr Richard Prankerd, who said to her one day: ‘I’ve always had the idea in the back of my mind that we could deliver oxytocin via the lungs."
The product is for developing countries almost exclusively. The West has what it needs to be able to use injected oxytocin, but even in major hospitals in cities in Southeast Asia, India and Africa, it isn't an option. Every year more than 300,000 women die during childbirth, and postpartum haemorrhage accounts for half of these.
Monash Institute of Pharmaceutical Sciences’ researchers have had to walk the ground where the new inhaled drug will be used.
“We grasped very early that we needed to understand the use of this product outside of the [lab] bench, in order to better inform what happens on the bench,” says Dr Tri-Hung Nguyen, research operations manager at the Institute.
“We have really probed a lot of those end-use and acceptability issues, and the practicalities of introducing this into a health system.”
Associate Professor McIntosh travelled to India in 2012 and Uganda in 2013, with Dr Nguyen. Researcher Dr Tori Oliver went to Myanmar, Ethiopia and India in 2015 and 2016.
It’s fine to develop a game-changing, life-saving product in the comfort of a sterile laboratory in Parkville, but soon enough Dr Oliver found herself trudging through rice fields in remote Myanmar to visit villages.
Myanmar has community midwives who are employed by the government. They attend homes – most women in developing countries give birth at home. But they're victims of changing legal rules over what they can and can’t do, and they usually work alone and often at night, in the dark.
“The product seems like it would fill a massive gap there; it would be something they would really value,” Dr Oliver says.
Cultural differences between that Parkville lab and the territories in line to benefit most from inhaled oxytocin are also stark. There's a common misconception in many remote – and urban – areas of developing countries that excessive bleeding with childbirth is good, and the more the better.
Monash Pharmacy’s global health, maternal and child health specialist, Abbey Byrne, says even such huge hurdles can easily be overcome. “We can get past these things with careful education and awareness campaigns in the communities with those pre-existing beliefs. We can’t overturn beliefs, but we can educate people and work alongside those beliefs.”
In the end, she says, all communities respond to the single message of inhaled oxytocin: that it will save mothers’ lives.
“There is a massive ripple effect when they lose a mother – it's a very significant burden for these communities. The policymakers are not deaf to it either.”