Congress just made strides toward combating superbugs. Now, let's cross the finish line
A bipartisan group of House and Senate lawmakers just proposed legislation that would address a pressing public health crisis: antimicrobial resistance (AMR). Passing the bill, known as the PASTEUR Act, could help avert millions of AMR-associated deaths in the coming decades.
Humans regularly deal with bacterial and fungal threats, from strep throat and urinary tract infections to tuberculosis and typhoid. The problem is that many of these conditions are becoming impervious to the medicines we use to treat them — part of the global rise in AMR, which could kill as many as 10 million people a year by 2050 if we do nothing.
In 2019, drug-resistant bacterial infections already contributed to nearly 5 million global deaths, according to a report from The Lancet. Then, the pandemic hit. Uncertain of what they were facing and seeking to do everything possible for patients, many doctors prescribed antibiotics early on to treat what we ultimately learned was a virus. Such improper use of antibiotics contributes to greater drug resistance.
At the same time, the number of hospitalizations rose exponentially, increasing the odds of patients acquiring infections. Hospital-acquired drug-resistant infections and deaths increased by at least 15 percent during the first year of the pandemic. Certain types of cases increased even more. For example, cases of carbapenem-resistant acinetobacter, which can cause pneumonia and bloodstream infections, increased by 35 percent overall — and by 78 percent in hospitals.
As our existing arsenal of antimicrobials grows less effective, we need to ensure that companies are developing new ones so physicians and patients have the medicines they need now and in the future.
Unfortunately, with only a few exceptions, most large drug companies have stopped research and development programs for antibiotics. The challenge is that the market for these medicines is broken. Because every exposure to treatment gives the target microbe an opportunity to develop resistance, these drugs must be used appropriately — careful stewardship is critical. And unlike many other drugs — such as those that treat diabetes, heart disease, or cancer — patients only take antibiotics for short periods.
Because of these factors, antibiotics don't offer much of a revenue stream. Yet, like other drugs, each requires years of research and up to billions of dollars to develop when taking into account the cost of failures.
As larger drug companies have left the field, small biotech companies have picked up the mantle and, in fact, are responsible for 95 percent of antibiotics in development today. But they take on this task at their peril.
Consider that almost all of the 13 new antibiotics approved by the FDA since 2012 originated in small companies. But as of now, the companies behind seven of those successful antibiotics have either declared bankruptcy or were sold for pennies on the dollar of their original value.
As a result, the pipeline of new antibiotic candidates has reached critically low levels. The FDA approved 63 new antibiotics between 1980 and 2000 — and just 15 between 2000 and 2018.
Absent a new incentive for companies to engage in this critical area of medicine, the prognosis for the fight against drug-resistant infections looks bleak.
That's where PASTEUR comes in. The recently reintroduced bill would transform the broken market for antimicrobials by establishing an alternative payment model for drug developers through novel contracts with the federal government. The bill has broad support among stakeholders — more than 230 organizations representing health care providers, patient groups, the pharmaceutical and diagnostic industries, and others sent a letter to Congress in support of the bill earlier this year.
Under the PASTEUR model, the government would be guaranteed access to new, effective antibiotics to treat the most threatening resistant microbes, regardless of how many doses were ultimately used. Companies, in turn, could be confident of earning a return that is decoupled from the volume, and, instead, based upon the value the product provides for public health. PASTEUR's model is an innovative way to reimburse developers for novel antimicrobials while reinforcing the pillars of appropriate use, which would also attract investment back into the field.
Each day, drug-resistant infections get stronger, and our current medicines get weaker. We have the tools to reverse the trend. For the sake of patients, lawmakers must leverage the positive momentum from reintroducing PASTEUR to also pass it.
Rachel King is the interim CEO of the Biotechnology Innovation Organization. The co-founder, former CEO and Board member of GlycoMimetics, she also serves on the board of Novavax.