BLOG POST BY Joan Griffith Tell, PhD, Director of Occupational and Environmental Health Sciences, Corporate Product Stewardship and Science Group of Global Safety and the Environment, MSD, USA
COVID-19 has highlighted our vulnerability to infectious diseases. We’ve experienced first-hand the public health and economic costs associated with not having the diagnostics, treatments, or vaccines we need. The biopharmaceutical industry has quickly responded, and I am optimistic that we will have some of the tools we need to fight this global threat.
But there is an even larger threat, one that is already killing hundreds of thousands of people around the world and complicating the care of many COVID-19 patients. It is the hidden threat from antibiotic resistance, or “superbugs” — bacteria that are not killed by standard antibiotics.
Although antibiotic resistance has not received public attention in the same way that COVID-19 has, antibiotic-resistant bacteria present a growing global menace. In the EU alone, there are 670,000 antibiotic-resistant infections each year and more than 33,000 deaths[1]; although experts fear that the true number is much higher. The superbugs that cause these infections thrive in hospitals and medical facilities, putting all patients — whether they are getting care for a minor illness or major surgery — at risk. In 2019 the WHO included AMR in its list of the top ten global health threats.
For decades the world has struggled with the emergence of superbugs that are highly resistant to the most common and important antibiotics traditionally used to combat them. But COVID-19 has created somewhat of a perfect storm – the perfect opportunity for deadly resistant pathogens to grow and spread among the sickest patients.
AMR can arise in hospitals, but it can also come from inappropriate use of antibiotics in animals or from environmental sources, such as poor sanitation or antibiotic manufacturing. This environmental component has not received as much attention as other potential sources of AMR and more research is needed to fully understand any links between AMR and the environment. While human and animal excretion are currently recognized as the primary sources of antibiotics in the environment[2], processes such as antibiotic manufacturing require study as a potential source of active antibiotic residue which can lead to resistant bacteria.
At MSD, we remain committed to understanding and managing the environmental impacts of our products, including the potential impact from the production of antibiotics. We are working to ensure good practices for antibiotic discharge in both our own and third-party supplier operations. This is a critical part of our commitment to addressing the threat of AMR, in addition to our significant investments in vaccines and antibiotic R&D, collaborations with the farming and healthcare professionals’ communities on appropriate use, and major AMR surveillance programs.
More specifically, we are engaged in the Pharmaceutical Supply Chain Initiative (PSCI), which brings together the pharmaceutical industry in an effort to define, implement, and champion responsible supply chain practices. PSCI supports research and the development of best practices for environmental auditing and reporting, management of waste and emissions, spills and releases prevention, resource efficiency, sustainable sourcing and traceability, and management of the release of pharmaceuticals into the environment.
MSD is also a co-founding member of the AMR Industry Alliance, a coalition of approximately 100 companies working together to curb AMR through four key areas of activity: (1) research and science; (2) appropriate use; (3) access; and (4) manufacturing. Our work in the manufacturing area is guided by the principles enshrined in the Industry Roadmap for Progress in AMR, including the need for good practice in antibiotic discharges in both our own and supplier operations. We have already committed over $100 million to ensure factory discharges do not present a risk to human health and the environment.
In a peer-reviewed, scientific article published in Integrated Environmental Assessment and Management,[3] my colleagues from across the industry and I describe the work of AMR Industry Alliance companies to develop the Common Antibiotic Manufacturing Framework (CAMF); minimum environmental expectations for antibiotic manufacturers, and discharge targets to manage antibiotic discharge based on previously unpublished, company-generated, environmental toxicity data. The Alliance’s first report in 2018 stated that members were indeed two years ahead of schedule in establishing the CAMF. In the Alliance’s second report, published in January 2020, it was revealed that 83% of its members have already assessed their own antibiotics manufacturing sites against this framework. This is great progress, and we continue our efforts.
Meeting the challenges of AMR is a shared responsibility and a common journey. We encourage more companies to adopt the CAMF, including science-driven, risk-based targets for discharges. In our own wastewater treatment plants, we are now working to implement best practices for evaluating potential discharges of residual antibiotics. We believe that these collaborative industry-led actions are delivering sustainable results without the need for regulation that may limit patient access to antibiotics.
While AMR is a global threat, Europe is working to address various aspects of the problem and is proposing solutions that have international implications. The European Commission under its One-Health Action Plan against AMR and the European Parliament are now becoming engaged. EU Member States are also expected to join the discussion on EU’s Pharmaceutical Strategy, beginning with the December 2, 2020 formal meeting of the EU Health Ministers. The Commission has identified AMR as a key priority for this strategy.
As expected, most of the focus in 2021 will continue to be on COVID-19, as we need to maintain our efforts to bring an end to the pandemic. Nonetheless, we cannot take our foot off the gas in our efforts to tackle AMR and reduce potential negative environmental impacts. The industry is willing to play its part.
We know that all stakeholders must work together if we are to safeguard our future from the global threat of AMR. Access to antibiotics to all who need them should not be jeopardized. As we have learned from the COVID-19 pandemic, health and the environment, human and animal health, individual and collective behaviours are all interlinked.
[1] Cassini A. et. al, Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis, 2019, The Lancet Infectious Diseases, Vol: 19, Issue: 1, https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(18)30605-4/fulltext
[2] https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf – p. 31
[3] Tell J, et al., Science‐based Targets for Antibiotics in Receiving Waters from Pharmaceutical Manufacturing Operations, Integrated Environmental Assessment and Management, 2019, 15.