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Regulators have to figure out how to get them on the market:
Ella Balasa was 26 when she realized the routine medical treatments that sustained her were no longer working. The slender lab assistant had lived since childhood with the side effects of cystic fibrosis, an inherited disease that turns mucus in the lungs and other organs into a thick, sticky goo that gives pathogens a place to grow. To keep infections under control, she followed a regimen of swallowing and inhaling antibiotics—but by the beginning of 2019, an antibiotic-resistant bacterium lodged in her lungs was making her sicker than she had ever been.
Balasa's lung function was down to 18 percent. She was feverish and too feeble to lift her arms over her head. Even weeks of intravenous colistin, a brutal last-resort antibiotic, made no dent. With nothing to lose, she asked a lab at Yale University whether she could volunteer to receive the organisms they were researching: viruses that attack bacteria, known as bacteriophages.
[...] And it worked. The viruses penetrated the goo, attacked the bacteria, and killed a portion of them; the rest of the bacteria weakened enough that antibiotics could knock them out. Balasa's body cleared the life-threatening infection faster than ever before.
[...] There's an asterisk to her success: 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.
A little more than a century after they were first used to cure an infection, it might finally be phages' time.
[...] To be fair, there are places where this would be old news. Phages pervade the natural world: There are possibly trillions of them distributed through every niche of the environment, each tuned by evolution to kill just one type of bacteria. And there are countries where doctors have been using them for decades. After World War I and a decade before the first recognition of antibiotics, a self-taught microbiologist named Félix d'Hérelle harnessed phages' natural killing ability to cure dysentery in several children in Paris. By the 1930s, he had found a research home in what's now the Republic of Georgia. After Stalinism closed the USSR off from Western Europe and the US, phage research quietly flourished there.
It wasn't until the USSR collapsed in 1991 that phage treatments came to the attention of countries with big research budgets, via atmospheric news accounts of funding-starved researchers jury-rigging equipment in the dark. That was good timing, because it was simultaneously becoming clear that antibiotics were losing their power against rising drug resistance. Globally, it's estimated that 1.27 million people per year die from resistant infections. The World Health Organization calls drug resistance a "silent pandemic" that could kill 10 million people per year by 2050.
[...] 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, a refreshing change from an antibiotic pipeline that gets ever more narrow as companies search for novel ways to attack bacteria.
"This is one of the challenges of the phage space right now: There are all these tantalizing little indications that maybe something good can come from this technology," says Robert McBride, cofounder and CEO of Felix Biotechnology, which has been funded by the Cystic Fibrosis Foundation to develop a Pseudomonas phage that was identified at the Yale Center. "And yet we still don't have a rigorous, large, controlled, blinded set of data to support the general case."
(Score: 5, Informative) by Zinho on Monday April 10, @01:46PM (6 children)
IF I recall correctly, a big obstacle to use of phages here in the West is that the best place to find phages that will fight the current batch of nasty bacteria is the sewer system. Sick people poop out some of the bacteria attacking them, and the population of phages adapted to eat those bacteria increases in our cesspools. Researchers in Russia have been harvesting from this source for decades, as mentioned in TFA. It's been shown to be practical, effective, and cheap - even if its source is a bit gross.
These days, now that people are willing to swallow fecal transfer capsules (literally pills filled with healthy people's poo) as a remedy for some autism symptoms and rebuilding a microbiome after antibiotic or radiation therapy, the FDA may be more willing to look past the phages' origins in the sewer and approve their use more generally. Fingers crossed...
"Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
(Score: 3, Informative) by RS3 on Monday April 10, @03:37PM (1 child)
A recent (now ex) co-worker had been an Air Force + Marine field medic, worked for and member of WHO, and generally brilliant including medical expertise. He had worked in Russia- Moscow and St. Petersburg. He not only knew all about phage use in Russia, but needed treatment himself. I forget the infection he contracted, but he marveled at how he felt completely better the next day, whereas with antibiotics he would have been very sick for at least a week, if he survived at all.
(Score: 2) by Reziac on Tuesday April 11, @02:22AM
Yeah, I remember a documentary on phages as used medically in the USSR, in part because antibiotics were not generally available there. That was about 30 years ago. I'm sure their use is presently much more refined.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 4, Informative) by aafcac on Monday April 10, @07:27PM (3 children)
No, you'd isolate them from the bacterial culture as there's usually a few already there, but in insufficient quantity to get the job done. The main issue is regulatory, each strain had to go through the approval process as if it's a new thing.
(Score: 2) by Zinho on Tuesday April 11, @12:03PM (1 child)
(emphasis added)
source: American Society for Microbiology [asm.org]
I won't say that people aren't using the method you suggest, as I don't know what your source for that is. I do have trouble believing that a bacterial culture prepared in a lab as a clean isolate of a specific bacterium will harbor much of anything beyond the single bacterium. "Contaminate" that culture with a tablespoon of garden soil and you'll have a much better chance of finding either a phage that will eat it, a fungus that will fight it, or both. Phages are found in nature, not in sterile labs.
"Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin
(Score: 2) by aafcac on Wednesday April 12, @11:51AM
The source was decades back from a lecture one of the leading authorities on the subject. I was taking classes in a lab down the hall from her.
That may be how they're doing it now. But, it's kind of a weird way of doing it as the best place to look will always be with the sample of bacteria that you've got as that's the most likely place to find any of them. This technology has been used since well before the point where you could conducts such a search and I'm not even sure where you're getting the idea that a bacterial sample is somehow sterile. A bacterial sample is more or less the exact opposite of sterile. It's a lot like looking for raccoons near an open dumpster. Sure, you could look all over the place, but you'd likely start near the thing that attracts them and only look elsewhere if that doesn't work.
(Score: 2) by Zinho on Tuesday April 11, @12:07PM
*sigh* missed this in my knee-jerk post above. No argument here, FDA regs are probably a big roadblock. Congress probably shares some blame, too.
"Space Exploration is not endless circles in low earth orbit." -Buzz Aldrin