For that reason, among others, says FDA spokesperson Karen Riley, phage therapy used to treat or cure humans must be regulated as a biological product. That means that if the viruses show serious signs of mutating or changing during clinical trials, even if those changes pose no risk to patients, the trials could be scrapped. Which explains why Big Pharma isn't eager to conduct them. "I understand where the FDA is coming from, because each phage poses a certain risk," Sullam says. "When viruses have the ability to exchange genetic material, it makes people nervous on a visceral level."
Wolcott calls Eliava the "mother ship of phage research," a worldwide Mecca for people suffering from antibiotic-resistant infections. Only it doesn't look like the sort of place you'd want to go with a health problem. When Wolcott visited to hunt down alternatives for his patients, the four-story facility bore a closer resemblance to a neglected sanatorium. The walls were unpainted, the rooms were dark, and the equipment looked like museum pieces. "The conditions were abysmal," he says. "Yet the science is amazing."single page
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