A Monash University drug could potentially save the lives of thousands of new mothers.
Every year, over 300,000 women die during childbirth in developing countries from the very common problem of excessive blood loss, known as post-partum haemorrhage (PPH).
The cause? The new mums don’t have access to the injectable medication oxytocin, which can easily help stem bleeding after labour.
The issue, however, is not simply one of supply. Oxytocin injections need to be refrigerated and this can be difficult to achieve in developing countries, particularly in rural areas. Also, healthcare workers attending births in low- and middle-income countries aren’t trained or authorised to safely administer injections of oxytocin.
Yet since 2008, a team at Monash University have been busy developing a new form of oxytocin that doesn’t need to be refrigerated, that aims to cost about the same price as an injection of oxytocin (around 35 cents), and that can be easily breathed in by the patient. While fridge-free inhaled products have been developed in other therapeutic areas to avoid the use of needles (such as insulin for diabetes), this approach is a world first for the maternal health space.
"It’ll be the first orally inhalable form of oxytocin," says the project’s lead, Professor Michelle McIntosh, who’s working with researchers at the Monash Institute of Pharmaceutical Sciences, and the Faculty of Medicine, Nursing and Health Sciences. "Immediately after childbirth, dry powder containing oxytocin is inhaled into the lungs and then absorbed into the blood stream. Once in the blood, the oxytocin works the same way as an injection by ensuring the uterus continues to contract after the baby’s delivered: this helps limit blood loss and prevent PPH."
An independent estimate indicates the product could save 20,000 lives per year. "We hope it’ll be available in three to four years," says Michelle. "Our intention is to work hard with global partners, including the World Health Organisation, Johnson & Johnson and GlaxoSmithKline (GSK), to develop a low cost, commercial scale manufacturing capability and complete the clinical trials."
To help make that happen, members of the Monash team have been to Ethiopia, India, Uganda and Myanmar for research stints of up to six weeks. "Meeting with local partners has added value, to understand local cultural norms and have connections with stakeholders such as the Ministries of Health," says Michelle. "The 19 countries with the highest rates of maternal mortality are all in sub-Saharan Africa, so that region will be a focus for our initial launch."
How the inhaler idea came about is intriguing: it was conceived as a Masters project for a Botswanan student who in 2008 came to Monash on a scholarship to study drug delivery and analytical chemistry. But the revolutionary potential for the product to prevent PPH in potentially millions of resource-poor women only became clear when Michelle and her team began looking for funding to take it into the commercial sphere. Their idea took off in a huge way and Michelle was caught off guard, being "surprised and delighted at the level of interest". In 2010 some of the world’s biggest philanthropists jumped on board, including the Bill & Melinda Gates Foundation and the Saving Lives at Birth Grand Challenges Program, and the project was even singled out in a speech in 2011 by the then US Secretary of State, Hillary Clinton.
Local interest was also forthcoming. Progress on the product to date has been dependent not just from contributions across multiple departments at Monash, but also from other local institutions with world-leading expertise in the field such as the Nossal Institute for Global Health and the Burnet Institute.
Once the product launches, the potential outcome is that every woman, regardless of geography, will have access to oxytocin during childbirth. This will not only save lives but also prevent disabilities that drive women further into poverty. Consider this statistic. For every life saved from PPH, 20 other women are spared from a severe disability caused by PPH such as severe anaemia, infection, post-traumatic stress disorders and hysterectomy. On that last point, loss of fertility can also have cultural consequences in terms of stigma in some communities.
"A published study says that if universal access to oxytocin were achieved, over a 10-year period, 41 million cases of PPH could be prevented, and 1.4 million lives saved," notes Michelle. "But maternal mortality is not reducing as fast as hoped and much more work is needed to address PPH and other drivers of mortality such as poverty, gender inequality and local financial constraints."