Bacteriophages are viruses that kill bacteria. Phages are common, found in every nook and cranny of the natural world. There are likely trillions of them. They were first used over a century ago but remain largely unknown. A French microbiologist used them to treat dysentery in children just after World War I. They have been used extensively in Eastern Europe but not in the West.
In many ways, phages look like the solution to problems that beset antibiotics. They each kill only one type of bacteria, so they are less likely to disrupt microbiomes. They penetrate complex matrices that defeat antibiotics—not just the thick mucus caused by cystic fibrosis, but the thin films of organisms that develop on pacemakers and artificial joints. And they are unthinkably abundant…
Phages appear to work well. The biggest problem is finding a facility that has a catalog of phages, knowledge of which phage kills which bacteria and has the one you need. Then there’s the requirement to obtain a compassionate use authorization from the FDA. Having all the above conditions come together when you’re deathly ill is like winning the lottery of life. It’s wonderful when it occurs but very, very rare for most people. Estimates are hard to come by but perhaps more than 100 people have been treated with phages in the United States. Hardly a week goes by but what we hear about a lottery winner with a life-changing award, but for most people it will never happen. The same is true of phages helping sick patients.
Phages are unapproved drugs, not just in the United States, but in the United Kingdom and Western Europe, too. No company makes them for commercial sale in those countries, and hospitals and pharmacies don’t stock them. To administer them, physicians must seek a compassionate-use authorization from a government regulator—in Balasa’s case, the US Food and Drug Administration—showing their patients have no other options.
Phages have been used for more than 100 years. They were commonly used in the old Soviet block countries. The West was made aware of the research on phages after the collapse of the Soviet Union more than 30 years ago. I first heard about phages more than a dozen years ago. Over the years I’ve read numerous anecdotes illustrating how well phages work. Yet, we’re barely closer to having phages commercially available than when I first heard about them. That’s an illustration of how bureaucratic our system of drug discovery is.
That process is inefficient and inherently unfair, since it limits availability to people who are lucky and persistent and whose doctors have strong professional networks. Still, journal articles and accounts by investigators suggest that well over 100 patients in the US have received emergency phage treatments, mostly unpublicized. Researchers are confident that if phages were legally available, more lives could be saved.
The NIH and researchers are moving slowly but moving in the right direction, nonetheless. Billions of dollars are up for grabs to the first companies to catalog and collect phages by the pathogens they stop. Perhaps the goal is harder to achieve since each phage only kills one type of bacteria. Potentially each phage may require new drug application processes like what is required for new antibiotics that attack a broad spectrum of germs.