COVID-19 is caused by a virus, but in weakening the body, it makes way for severe bacterial infections to take hold. Early research has found that nearly 15 percent of all COVID-19 patients acquire deadly secondary bacterial infections. These bugs can cause or worsen a patient’s pneumonia and lead to septic shock, a life-threatening complication. Furthermore, public health authorities and scientists suggest that of individuals who died from COVID-19, as many as half were afflicted with these secondary infections. Among these opportunistic bacteria are superbugs, microbes that have mutated to resist standard antibiotics. Superbugs are not a unique problem to COVID-19, of course; they already kill 35,000 Americans every year. If bacteria continue evolving to outwit antibiotics, however, the World Health Organization estimates they will become the leading global cause of death by 2050.
Black swan events like viral pandemics are unpredictable. Secondary bacterial infections, in contrast, are commonplace and, with the right medicines, treatable. Yet, while our world’s biotechnology giants are testing over 450 drugs and vaccines to vanquish COVID-19, our hospital wards and pharmaceutical pipelines are severely lacking in novel, powerful antibiotics needed to tackle superbugs as they emerge. As both history and our current conditions attest, infectious diseases can be catastrophically deadly. Why are we leaving ourselves vulnerable to the organisms that may well evolve into the next global pandemic?
It’s not from lack of trying. Promising young antibiotic companies have worked on the problem. But in the last few years, many of them, including Achaogen, Melinta, and Aradigm, filed for bankruptcy. Why? The ability of biotech upstarts to earn revenue clashes with the basics of evolutionary biology. Superbugs develop as bacteria accumulate mutations over time, forming strains that elegantly evade our existing antibiotic arsenal. The more consistently a bug goes up against one of our trusted antibiotics, the more likely it is to evolve to escape it. Accordingly, to prevent the spread of progressively-resistant and dangerous superbugs, as doctors we prescribe the newest, most powerful antibiotics as sparingly as possible, only in situations where no other treatments would work. This antibiotic stewardship is prescient for public health, but devastating for drug sales. There is, essentially, an inverse relationship between an antibiotic drug’s sales volume and its medical value. This makes it difficult, if not quixotic, for biotech companies developing novel treatments to recoup their investment.
Over the last decade, several policy solutions have created financial and regulatory incentives to kickstart commercial development of new antibiotics. The Biomedical Advanced Research and Development Authority, World Health Organization (WHO), and Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator all offer funding for antibiotic research and clinical trials. Passed in 2012, the GAIN Act offered an additional five years of nonpatent exclusivity for antibiotics, as well as eligibility to be fast-tracked through the regulatory process so they can reach patients sooner. This past July, two dozen pharmaceutical firms, in partnership with the WHO and European Investment Bank, launched the Antimicrobial Action Fund, a $1 billion venture fund aiming to acquire or invest in small antibiotic companies.
These initiatives collectively represent a positive first step towards improving our therapeutic arsenal against superbugs. But, as these current solutions all target the early stages of drug development, they haven’t solved the market imbalance between volume and value that sinks many antibiotic companies after their drugs are approved. With these initiatives, we’re begging scientists to develop new antibiotics, and then asking doctors to prescribe—and in turn, have their patients and insurance companies purchase—them as little as possible.
What might really help is a redesign of the antibiotics market altogether. A recent congressional bill, sponsored by Sen. Michael Bennet and Sen. Todd Young, aims to help. Known as the PASTEUR Act–an homage to the father of microbiology, Louis Pasteur–the bill would offer multi-year contracts, paid annually, by the US government to drug developers with new antibiotics. The money would pay for the developer’s antibiotics to be used by anyone who is on a public insurance program, including Medicaid, Medicare, and TRICARE, as needed. This model, which is already in use in the United Kingdom and Sweden, treats access to novel antibiotic medicines like a Netflix subscription: for a fixed price paid out to a biotechnology company each year, the government could use as many antibiotic doses as it needs. If you wind up using Netflix just to watch a new release here and there, the company gets your money all the same. Similarly, if doctors use an antibiotic sparingly, the drug company still profits, and has an incentive to develop new medicines.
Importantly, this model breaks the link between antibiotic sales volume and the total number of patients who receive the drug. This would be a boon for patient care, public health, and pharmaceutical innovation. Patients receive only the antibiotics they need, because drug manufacturers won’t be compelled to oversell drugs to meet revenue targets. The biotechnology industry will benefit from the predictability of financial rewards in exchange for developing much-needed novel treatments. Finally, hospitals and physicians will benefit from a new repertoire of valuable antibiotics to quell emergent superbugs. The global toll of COVID-19 has been a dangerous reminder of how much damage an infectious disease can do and our pressing need for novel antimicrobials. Unless we proactively design a functioning market to attract the talent and investment required to build a new generation of antimicrobial therapies, our next pandemic risks being one of superbugs.
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