This column was originally published on Roger Waldron’s blog at The Coalition for Government Procurement and was republished here with permission from the author.
The COVID-19 pandemic brought many unforeseen challenges to the forefront of our nation, but it also provided key reminders and lessons that are critical to national security and our response to health and safety threats. The spread of the virus shed light on the importance of biosecurity, those efforts to assess and manage risks from biological threats, and the development of biomedicine. Although many COVID patients suffered secondary bacterial infections associated with the virus, the danger of antibiotic resistant infections loomed prior to the arrival of COVID-19.
Through changes in genetics, over time, bacteria develop resistance to antibiotics. The continued use of antibiotics against resistant bacteria increases resistant mutations, leading to further complications for patients. According to the Center for Disease Control’s 2019 Antibiotic Resistance Threats Report, more than 2.8 million antibiotic resistant infections occur in the United States each year, resulting in over 35,000 deaths. The World Health Organization stated that by 2050, the worldwide death toll from antibiotic resistance could climb to 10 million per year. Thus, to save lives, the development of new and innovative antibiotics is imperative.
To improve biosecurity and advance medicine, investment into research and development opportunities is key. To this end, the government should support the efforts of industry partners who make up the bioeconomy, which is defined by the National Academies of Sciences, Engineering and Medicine as “economic activity that is driven by research and innovation in the life sciences and biotechnology, and that is enabled by technological advances in engineering and in computing and information sciences.” The bioeconomy is able to help the government respond to bio-related threats, such as the COVID-19 pandemic and antibiotic resistance.
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Unfortunately, gaps in the economic model for antibiotic research and development are causing many large pharmaceutical companies to leave the market. An estimated $300 million in annual sales revenue is required to justify the estimated $1.5 billion development cost for an antibiotic. Under current circumstances, however, these drugs generate only a small fraction of that annual sales revenue. Thus, little incentive exists for large companies to remain in the antibiotic market when the option for greater revenue generation exists elsewhere.
Over the past 20 years, we have seen this reality play out. Large pharmaceutical companies have exited the antibiotic space, leaving a market almost exclusively made up of small biotech firms. Given the aforementioned economics of the antibiotic market, many of these small firms have found themselves struggling for survival, left without proper funding or the prospect of becoming strategic partners with larger companies. Indeed, within the last few years, a handful have been forced to shut down, drastically reducing the availability of multiple Food and Drug Administration approved antibiotics.
Fearing that the use of new medicine will prompt further resistance challenges, hospitals continue to use established antibiotics, leaving the newly developed drugs sitting on the shelves. For example, in 2018, three new antibiotics were only used in 35% of the cases for which their use was appropriate. Such an approach risks negative consequences for suitable patients, but developers face increased challenges, as well. Government agencies already are reluctant to accept paying a premium for the new drugs. Now, with the use of new drugs delayed to forestall bacterial resistance, companies cannot sell their product at a pace to make their efforts economically sustainable.
Recognizing that bacteria are not going away, the development of tools to address them is necessary to sustain not only public health, but also our national security, as the health of our warfighters is critical to our defense. Government and industry need to identify investment and development incentives to reinvigorate the antibiotics market. In addition to regulatory and legislative-based incentives for antibiotic developers, government can provide “push” incentives to fund early-stage research and development, along with “pull” incentives that reward successful, approved drugs.
The COVID-19 pandemic showed just how rapidly illnesses can spread, and the devastating impact they can have on our daily lives. The pandemic also underscores the need for our nation to be prepared for future emergencies, which may come in the form of bacterial illnesses. Although our national stockpile must include cutting-edge antibiotics to help protect us from biothreats, without improving the market and creating the research and development incentives to address antibiotic resistance, the risk to our public health and national security will continue to grow. Policymakers and stakeholders alike must recognize that, as the threat of resistance continues to evolve, our nation’s preparedness for the next biothreat must evolve to address it.