In August, 1968, three doctors from Boston City Hospital published a paper in the New England Journal of Medicine detailing how more than a dozen patients and a nurse at the facility became infected with methicillin-resistant staphylococcus aureus, more commonly known as MRSA. It was the first documented MRSA outbreak in the United States and the doctors concluded that “it seems reasonable to predict that [MRSA] will become more widespread in the United States and may present some clinical and epidemiological problems in the future.”
It was a prescient warning, but one that dramatically understated the threat.
Today antibiotic-resistant infections, including MRSA, are a leading global killer. Last week the Centers for Disease Control and Prevention announced that US deaths from antibiotic-resistant infections jumped 15 percent in 2020, after years of steady declines. That follows a study published earlier this year in The Lancet that showed 1.27 million people died globally in 2019 from antibiotic-resistant infections, nearly double the number of deaths caused by HIV/AIDS or malaria.
Antibiotics are the original miracle drugs. They treat common infections and make possible modern medical interventions such as chemotherapy, organ transplants, and surgeries. But these life-saving drugs are being taken for granted and many bacteria have become resistant to them. Given enough time, bacterial evolution will render every antibiotic ineffective.
Making matters worse is that few new antibiotics are being developed and investment has dried up because it is not a drug class that generates blockbuster sales. Knowing that bacteria will eventually develop resistance to any antibiotic, physicians try to use new antibiotics only when infections don’t respond to older treatments. This is important for public health, but unsustainable for the small biotechs that develop most of these drugs. For a single new antibiotic to achieve FDA approval, a company invests on average more than $1 billion over 10 to 15 years.
The current economics of these life-saving drugs are so dismal that the companies responsible for almost half of the FDA approvals in the past decade have gone bankrupt or shut down their antibiotic programs. This broken market for new antibiotics starves the field of investment, discourages innovation, and prevents medical systems from keeping up with, let alone getting ahead of, drug resistance.
For decades, Boston has been at the forefront of addressing this crisis, from detecting the first MRSA outbreak to the pioneering work of Tufts University’s Stuart Levy, who showed that giving antibiotics to farm animals fuels resistance and threatens human health. Now the city is leading in another critical way: by serving as the global hub of antibiotic financing.
Our two organizations continue that Boston tradition of leadership. CARB-X, a global nonprofit led by Boston University, and the AMR Action Fund, a public-private partnership based in Kendall Square, will in the coming years inject nearly $1.5 billion into small biotechnology companies that are innovating new antibiotics, vaccines, and diagnostics to address antibiotic resistance. That’s roughly equivalent to all the venture capital invested into antibiotics between 2010 and 2020 — and it is not nearly enough to support the level of research and development needed. While our organizations operate independently of one another, we both recognize the urgent threat that antibiotic resistance poses.
Money alone, however, cannot solve the problem. To maintain this cornerstone of medicine, the federal government needs to fix the broken market, stimulate innovation, and ensure that doctors can prescribe the most effective treatments to patients in need.
One possible solution that’s gaining traction globally is subscription models. Like Netflix, in which customers pay a fixed fee regardless of how many shows they watch, governments pay a pre-determined fee for the successful development of an outstanding new antibiotic, regardless of how often it is prescribed in the first years after approval. By paying for an antibiotic’s value to society instead of its volume of sales, these programs will enable new drugs to be used sparingly while encouraging companies to keep innovating. The United Kingdom launched the world’s first subscription program in April, and lawmakers in Congress are currently considering the bipartisan-sponsored Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act to create a similar model.
Congress is also debating bipartisan legislation to improve how Medicare pays for the use of new antibiotics, and the Biden administration, along with leadership in every other G7 country, has publicly committed to enacting market reforms to address this public health crisis. Given that antibiotic resistance could dwarf the COVID-19 pandemic, it is imperative to maintain momentum.
Massachusetts, with its public-health minded politicians, world-class hospitals and universities, and vibrant biotech industry, should continue to lead on the threat of antibiotic resistance. From doctors to scientists, investors to policymakers, we all have a part to play. Now we must act with the urgency this problem demands.
Antibiotic resistance isn’t a what-if scenario. It’s already killing millions of people, and it’s going to get much worse if we don’t act now.
Kevin Outterson is the founder and executive director of CARB-X and a professor at Boston University School of Law. Henry Skinner is the CEO of the AMR Action Fund.