Congress is back in Washington for its lame duck session. After a bitterly contested midterm, lawmakers now have a chance to come together on a bipartisan bill that, despite its low-key nature, could be one of the most consequential pieces of legislation in decades.
By passing the PASTEUR Act before the end of the year, lawmakers can help protect all Americans -- and indeed, all of humanity -- from one of the gravest public-health threats of the 21st century: deadly, drug-resistant "superbug" infections. The bill would be a fitting final capstone for a Democrat-led Congress that has worked tirelessly to make our healthcare system more efficient and more equitable.
The PASTEUR Act, short for the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act, is our best chance to stem the rise of superbugs. At present, these infections are involved in nearly five million deaths each year. But if left unchecked, this global health emergency could kill as many as 10 million people annually by 2050.
As a physician by training, I know all-too-well how drug-resistant microbes can threaten the life of even the healthiest patient. In many cases, patients develop an infection after a routine medical procedure, such as a hip replacement or caesarian section. And despite their doctor's best efforts to treat the condition with available antibiotics, the infection persists, growing more ferocious by the day.
It's a scenario every doctor dreads. And the problem is only getting worse. In 2020, as public-health officials struggled with the COVID-19 pandemic, deaths from hospital-onset superbug infections increased by a staggering 15% in the United States. Sadly, we're quickly moving toward a world in which existing antibiotics no longer protect patients against deadly infections.
There is still a chance to avert a cataclysmic health crisis. But doing so will require a global effort to create better, more reliable antibiotics. And, at least so far, that effort has yet to materialize. Consider that, over the last 35 years, just one new direct-acting antibacterial medicine has earned approval from the Food and Drug Administration.
The good news is that researchers are ready and willing to invent a new generation of antibiotics -- if only given the chance. The main barrier they face isn't scientific, but economic. Since advanced antibiotics must be used as infrequently as possible, the companies that invest billions to develop new ones may never sell enough to break even, much less turn a profit.
For years, scientists, public-health experts, and physicians have called on lawmakers to address this market flaw. The PASTEUR Act answers that call. The bill would create a subscription payment model for new antibiotics. Under this system, the federal government would pay for guaranteed access to these medicines -- similar to how customers pay for content on video streaming services like Hulu or Netflix, which allow subscribers to access as much, or as little, of the product as they want. As a result, an antibiotic wouldn't have to be prescribed in huge doses for drug companies to break even on their investment.
It's the kind of urgent reform that ought to have been passed years ago. So it's troubling that the PASTEUR Act faces opposition from a small but vocal group of physicians who insist that any new antibiotic supported by the bill complete a "superiority trial." To pass such a trial, a new drug must be proven superior to existing alternatives.
To laypeople, superiority trials might sound like a good idea -- but they're actually a disastrous way to evaluate new antibiotics for a number of reasons.
First, superiority trials typically require a placebo control. This means that a patient suffering from an aggressive, drug-resistant infection who enrolls in a trial for a new antibiotic might receive a placebo instead of an older antibiotic. (In a non-inferiority trial, by contrast, a candidate treatment is tested against an existing treatment.)
As a physician, the idea of giving a critically ill patient a placebo, and leaving them defenseless against an aggressive infection, is simply outrageous.
Moreover, superiority trials would introduce a winner-takes-all dynamic into the antibiotics market -- which is the opposite of what this moment demands. The medical community desperately needs a diverse array of new antibiotics, not a single new treatment deemed "best" by the superiority trials.
As the party of science, Democrats in Congress have a particular responsibility to lead the charge on this vital issue. Passing the bipartisan PASTEUR Act before the end of the year would prove that, even at a time of immense political division, our leaders can come together for the good of the American people -- and the world.