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A 2015 article in The Atlantic describes the problem of antibiotic resistance and some of its causes [theatlantic.com]:

The overuse of antibiotics, both in human patients and, importantly, in livestock, has led to an explosion of antibiotic-resistant bacteria, both in the U.S. and around the world. Deaths from resistant infections are currently at about 700,000 per year, and estimated to rise to 10 million per year by 2050. If nothing changes, the World Health Organization predicts the future will look a lot like the past—where people die from minor injuries that become infected.

Though new drugs are an important piece of the puzzle, Laxminarayan worried that there isn’t enough being done to monitor the use of the ones we have. “What I worry about more than the development of new drugs is the lack of money for things like surveillance and stewardship,” he said. “You can have a new drug five years from now, but that could go obsolete if we use it inappropriately.”

Examples of inappropriate use include starting patients on antibiotics before test results come back, putting them on a broad-spectrum antibiotic when it’s unclear what bacteria is causing the infection, or keeping them on the drugs even when tests come back negative.

It can take a few days to get the results from growing a culture to identify the specific bacteria responsible for a serious infection. In those instances, it may be necessary to prescribe a broad spectrum antibiotic while awaiting the results of the culture. Although there are exceptions to these guidelines, antibiotics are overused, and this contributes to the growing problem of antibiotic resistance. Antibiotics also aren't especially profitable for pharmaceutical companies because they're only needed when a person has a bacterial infection. If bacteria quickly develop resistance to new drugs, it might prevent companies from making a return on their investment in new antibiotics. A more recent article in Chemical & Engineering News [acs.org] discusses some of the regulatory and economic barriers to new antibiotics:

Zevtera is one of three antibiotics to gain FDA approval for humans so far [in 2024], and the only systemic one. The other two are for urinary tract infections (UTIs): Utility Therapeutics’ Pivya, for uncomplicated UTIs; and Allecra Therapeutics’ Exblifep, for complicated, or drug-resistant, UTIs.

But outside of 2024, the US has approved few new antibiotics in recent years. Only 17 new systemic antibiotics and one related biologic netted approval between 2010 and May 2021 (Ann. Pharmacother. 2022, DOI: 10.1177/10600280211031390). Experts worry that even that number could represent a peak. These approvals were decades in the making, and a labyrinth of scientific, financial, and regulatory challenges are sending today’s antibiotic developers fleeing.

In biotech, there’s a concept called the valley of death. It marks the stretch of time between when a firm discovers promising science and when that science is de-risked enough, usually with human data, that the firm can raise money to advance it. In antibiotics, there’s a second valley of death that takes place after regulatory approval and before the company can sell enough of the drug to become financially solvent.

There are novel machine learning algorithms to identify possible new antibiotics [mit.edu] including applying the same techniques used in large language models [stanford.edu]. New antibiotics have been proposed to exploit the mechanisms used by bacteria to develop antibiotic resistance [harvard.edu]. Although this research is promising, it is only helpful in solving the antibiotic resistance problem if these antibiotics are eventually used widely to treat infections. That may require changes to existing policies about how antibiotics are used and the regulatory requirements to gain approval before they are brought to market.

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