58 MOTHER JONES |^ MAY JUNE 2018
THE BEST VIRAL NEWS YOU’LL EVER READhad no idea how to regulate this. It was a
huge uncertainty.”
This was only a few years after the open-
ing of the ussr. Most of the research writ-
ten about phages had never been published
in English and never evaluated by Western
scientists. To make a case for phages in
American medicine, clinical trials such as
the ones that prove antibiotics’ ei cacy
would have to be conducted.
But here was the problem. To be ap-
proved, an antibiotic must at least reliably
kill the common strains and subtypes of
the bacteria that cause a particular infec-
tion; the broadest-spectrum antibiotics,
which doctors usually reach for fi rst, kill
multiple species in several groups. But
phages do not work against entire groups
or even against species. They are weirdly
specifi c and attack bacteria (or not) based
on minute genetic diff erences.
Clinical trials of antibiotics—which prog-
ress through three phases before approval
and in the third phase can include thousands
of patients—are constructed to prove a com-
pound is safe and eff ective and causes a cure,
no matter what minor genetic diff erences
exist from one infection to another. Phages
cannot pass that test, because any one phage
will only work on a subset of patients.
After hitting a roadblock with the fda, Su-
lakvelidze and Intralytix canceled the plan
to try to get phages approved as drugs. But
they had discovered another opportunity:
Food safety is regulated by a diff erent fda di-
vision than drugs are. The company pivoted
to isolating phages that would kill the most
important foodborne-illness organisms—
listeria, salmonella, Shigella, and E. coli. Be-
tween 2012 and 2016, the fda’s food safety
arm granted “generally recognized as safe”
status—a much lower bar than a new drug
approval—to phage cocktails targeting three
of the food safety bugs. Sulakvelidze thinks
the fda’s comfort with phages for food is an
opening. He is on track to begin trials of a
new human product this year.it’s impossible to know whether
Sulakvelidze will be successful, because
the fda says federal law prohibits it from
talking about the process of possibly
licens ing phages for medical purposes.
The agency seems to take the position
that since it might someday be required
to rule on drug licensing for phages, it
can’t give any information now about why DAVID WALTER BANKSPhages brought
Tom Patterson back
from the brink of
death—three times.