Antibiotic resistance kills as many Americans as car crashes. Someone won an award for stopping a fix.
Antibiotic-resistant infections kill about 35,000 Americans a year, roughly the number who die in car crashes. One in six infections worldwide is resistant to standard antibiotics.
The global toll is over a million deaths a year, mostly in low- and middle-income countries. That’s more than HIV/AIDS and malaria. If it gets worse, the most pessimistic forecasts think antimicrobial resistance could make routine procedures like C-sections and root canals dangerous again.
Doctors and health systems have gotten much better at not overprescribing, which helped. But bacteria keep evolving. Every antibiotic is on a timer, so we need new ones arriving faster than the old ones stop working.
New antibiotics aren’t coming out because they lose money.
Large companies are no longer trying to make antibiotics. Companies that have developed successful antibiotics went bankrupt or sold in fire sales.
New antibiotics aren’t profitable in part because doctors intentionally avoid prescribing these new antibiotics to keep them as a last resort. When they are prescribed, they’re typically only for less than two weeks, unlike diabetes drugs that you stay on for a long time. Small orders also cost more to handle.
We need these drugs ready before people need them. Once resistance to a drug becomes common, it takes 3 to 10 years to get a replacement through development and approval.
A bill in Congress would fix the incentive. Instead of paying per prescription, the government would pay antibiotic makers a guaranteed amount for access to a drug whether or not it sells.
Every person I talked to about this PASTEUR Act told me the same thing: no one’s against it. It’s just stuck because Congress is slow.
Turns out that’s not quite true.
The people against it
PASTEUR got “close to the finish line” before several Democrats were talked out of it. What changed their minds was a group of academics arguing that the program would hand out billions for drugs that had never been shown to make patients better.
Dr. Reshma Ramachandran of Yale and Dr. John Powers of George Washington made that case in an op-ed. Their argument: if PASTEUR doesn’t require proof of better patient outcomes, it becomes a “multi-billion-dollar gift” to industry, and doctors will end up with new antibiotics that they can’t tell are helping.
Ramachandran later received a $25,000 award for social responsibility in medicine. The citation credits her for having “advocated successfully to stop legislation that would have awarded billions to industry.” She is the founder of Doctors for America’s FDA Task Force and co-founded a group at Yale that argues against lowering FDA evidence standards, including the accelerated pathways that let very sick patients try drugs before the full review finishes.
Their core claim is accurate. Trials for new antibiotics are not required to run on people with the most resistant bacteria. Sometimes, trials don’t measure whether patients recovered more or faster, only whether the bacteria responded.
But their arguments aren’t the full story
Making sure new antibiotics exist isn’t predominantly an attempt to improve treatment today. It’s closer to insurance, or to keeping a spare tire in the trunk.
That’s the disagreement underneath all of this.
They want trials based on patient outcomes, not bacterial results: The FDA regularly lets drugs through on biomarkers, like showing a tumor shrank, instead of requiring bigger trials that track the patient’s survival. When the FDA should use data like this is a wider debate. The authors call for the FDA to use patient outcomes because infections respond quickly anyway. The FDA’s current standard for approving new antibiotics doesn’t require patient outcomes because of how difficult gathering participants for trials is. Serious bacterial infections need immediate care, diagnostics can be difficult, and patients often need other simultaneous antibacterial drugs that mess with results.
This is a broader argument about FDA standards, not PASTEUR.
Specifically, they also call for trials in patients who have run out of options. Finding patients with serious bacterial infections that are also resistant is hard. These patients are often scattered across hospitals, often dying of several things at once. The trial mentioned in the op-ed took two and a half years across 95 hospitals in 16 countries across four continents to get 150 people.
Requiring that trial before payment doesn’t produce better antibiotics. It produces no antibiotics.
They object that the FDA approves antibiotics that are no better than existing ones. The FDA allows some drugs to pass on the basis of “not being inferior” to alternatives. There’s a long-running fight over whether the FDA should block an effective drug just because a similar one exists.
For antibiotics, a new drug that is as effective but using a different mechanism is excellent news.
There’s also a practical problem: proving a new drug is superior usually takes many more participants and much more time than proving it’s about as good.
They worry that doctors will face a shelf of drugs without good evidence for their particular patient. Even if the data is noisier and harder to use, those additional drug options could be the difference between life and death for some patients.
Who the argument was written for
The op-ed targeted congressional staff who have limited time and often lack , so likely didn’t see the broader context.
Two things a specialist would have caught in a second:
Their op-ed says that only a couple of companies with approved antibiotics have gone bankrupt, which is offered as evidence that the crisis is exaggerated. But the main problem is that no companies are entering the antibiotics market.
The second is their strongest evidence. They cite an antibiotic that caused more deaths once patient outcomes were studied. They leave out that the difference shrinks once you account for how much sicker those patients were on enrollment. The excess death disappears among patients without one particular bacterium.
Powers now holds a senior NIH post overseeing antibiotic resistance funding. His stated mission is to raise the evidence bar, which makes sense from every individual doctor’s perspective.
But new antibiotics aren’t for the patient in the room. They’re a spare tire. We stock them for the day the current drugs stop working.
This is the wrong place for the fight
The underlying debates are longstanding.
Public health and biosecurity perspectives sometimes clash with medical services perspectives. Rare disease advocates, meta-science researchers, and reform-minded physicians have spent years arguing that the FDA should weigh the cost of a bad approval more heavily. Both sides have compelling reasons.
Making new antibiotics is a public health effort, not a medical services effort.
But this technical argument got translated into a non-technical venue as “billions to industry for the creation of antibiotics of unclear clinical benefit,” the language from Dr. Ramachandran’s $25,000 health equity award.
This wording adds political risk to the Democrats considering the bill.
Higher standards only help if companies are still developing drugs. Almost none are.
“Require proof it works” makes Congress sound irresponsible for passing it. Preparedness spending is often vulnerable this way.
PASTEUR is easy to block for the same reason. The people it saves are not politically organized. They’re anonymous and in the future. Politicians spend political capital and take on risk for very little reward.
Raising the political cost even a little is enough to stop it.
The default outcome is no new antibiotics. We should focus more on the outcome.
Thank you to , Michael Montague (), and an anonymous infectious disease doctor for their time and feedback. All errors my own.