Researchers say viruses can kill antibiotic-resistant microbes and help treat infections. Regulators have to figure out how to get them on the market.
Assuming that phages can be put through trials the way antibiotics have poses questions the field can’t yet answer. Regulatory structures in the US, UK, and Europe ensure antibiotics’ safety and efficacy by evaluating them with well-established measures.
Even achieving one successful trial won’t provide those answers. Because phages are so specific—narrow-spectrum, to use an antibiotic term—choosing the right one, and deciding how to administer it, will be different for sepsis, for a urinary tract infection, or for a heart valve cloaked in biofilm. And beyond determining formulas, there’s the formidable challenge of scale.
“When you’re dealing with an individual person’s infection, doctors have intimate knowledge of the case, and you can take the time to figure out how to pair these things optimally with antibiotics, and do different artisanal things,” says Paul Bollyky, an infectious disease physician and associate professor who leads a phage-research lab at Stanford University. “The boring, systematic, expensive work of figuring out how to optimally prepare and store and deliver these things hasn’t been done.
The challenges of constructing trials to cover all these issues may mean that compassionate-use cases will dominate phage treatments for now. That doesn’t mean the field is stalled. Trials gather data from participants horizontally, so to speak, by examining the experience of many patients at the same time.
“Phage hunts” require spreadsheet searches, emails, and pleas on Twitter, and sometimes going out in the field to scoop up environmental samples as well. “It’s like having a million locks scattered around the world, and then having to match them to billions of keys,” says Steffanie Strathdee, an epidemiologist and the center’s codirector.
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