More than $2 billion was invested in research and development relevant to the issue of antimicrobial resistance in 2016 alone.
The Society for Healthcare Epidemiology of America defines antibiotic stewardship as “a set of coordinated strategies to improve the use of antimicrobial medications with the goal of enhancing patient health outcomes, reducing resistance to antibiotics, and decreasing unnecessary costs.”
In other words, it’s a decidedly clinician-based effort. However, what if pharmaceutical and biotech companies took on a leadership role?
According to a new report released January 24th by the so-called Antimicrobial Resistance (AMR) Industry Alliance, during the meeting of the World Economic Forum in Davos, Switzerland, at least some of the biggest companies in the sector are doing just that. The report entitled “Tracking Progress to Address AMR” is the first to be released by the alliance of more than 100 life sciences companies since the issue of antimicrobial resistance, and corporate responsibility therein was included in the Davos Declaration of 2016.
“Many Alliance companies are actively engaged in activities to promote appropriate use of antibiotics, including patient and provider education, surveillance to monitor drug resistance, and a review of promotional practices,” the authors of the report note. “However, more can be done.”
According to the analysis, which included responses from 36 of the alliance member companies, more than $2 billion (US) was invested in research and development (R&D) relevant to the issue of AMR in 2016 alone. This includes the development of novel compounds targeting the most resistant bacteria that are the “greatest threats to human health,” as determined by the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC), and compounds with innovative mechanisms of action. In addition, 7 of the responding companies are working on new, non-antibiotic approaches to treat infections, which would, by definition, mitigate the issue of resistance.
“The industry is a major part of efforts to combat antimicrobial resistance,” said Jason C. Gallagher, PharmD, FCCP, FIDSA, BCPS, Contagion® editor-in-chief and clinical professor, infectious diseases director, School of Pharmacy, Temple University. “While it has the obvious role of providing agents to use for resistant infections, many companies have added activities that support appropriate use, such as supporting efforts to expand antimicrobial stewardship. The progress made is notable, but nearly all the drugs in phase 3 studies have tried-and-true mechanisms of action. With few exception, we are still waiting for new mechanisms against resistant bacteria, particularly resistant Gram-negative bacteria.”
Notably, though, more than 90% of the responding companies viewed existing financial incentives to R&D as “promising but far to go” or “insufficient relative to the challenge,” and 30% said they would decrease investment in resistance-related projects “if no new incentives are established and commercial models remain as they currently are.” The authors of the report advocate for so-called “pull incentives” that are “sustainable and sufficient [for]… the full R&D lifecycle, from discovery through development.” According to the CDC, pull incentives guarantee a return on investment in R&D by offering financial rewards to companies that successfully develop novel drug products.
In addition, more than 80% of the companies surveyed say they “are engaged in activities to support appropriate use” of antibiotics, while 90% “are planning to, currently collecting, or supporting the collection of surveillance data.” More than half of the Tracking Progress respondents report that they are engaged in stewardship education, while 70% “have examined, or are intending to examine, their promotional activities to ensure that they are consistent with the goal of advancing stewardship.”
The findings of the report were released the day after the Access to Medicine Foundation released its Antimicrobial Resistance Benchmark, which is designed to assess how the pharmaceutical industry is responding to the threat of drug-resistant infections. It purports to measure the progress of the 30 pharmaceutical companies with the largest R&D divisions and/or market presence on the issue of resistance.
The 2018 Benchmark lists GlaxoSmithKline as having the largest antimicrobial pipeline (with 55 projects), followed closely by Johnson & Johnson, Pfizer, Novartis, and Sanofi. Among manufacturers of generics, Mylan and Cipla lead the way because of their use of equitable pricing approaches, while Fresenius Kabi “performs well for its environmental risk-management strategy.”
“It is intriguing that the Access to Medicine Foundation Antimicrobial Resistance Benchmark report scored companies based on not just drug development, but an assessment of responsible development, including providing access to critical anti-infectives, de-linking sales staff remuneration from antibiotic sale volume, sponsorship of AMR surveillance studies, and the environmental impact of antibiotic wastewater discharge,” Dr. Gallagher said. “This serves as a reminder that industry has both a responsibility and a function beyond providing antibiotics for human use.”
Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous health care-related publications. He is the former editor of Infectious Disease Special Edition.