[FairfieldLife] A possible solution to our growing antibiotic problem

Wed, 31 May 2006 13:18:12 -0700

Eat Me
The Soviet method for attacking infection that we can learn from.
By Daria Vaisman
Posted Tuesday, May 30, 2006, at 12:41 PM ET



Illustration of a bacteriophage

In the 1920s and '30s, with diseases like dysentery and cholera
running rampant, the discovery of bacteriophages was hailed as a
breakthrough. Bacteriophages are viruses found virtually everywhere—
from soil to seawater to your intestines—that kill specific,
infection-causing bacteria. In the United States, the drug company
Eli Lilly marketed phages for abscesses and respiratory infections.
(Sinclair Lewis' Pulitzer-winning Arrowsmith is about a doctor who
uses phages to prevent a diphtheria epidemic.) But by the 1940s,
American scientists stopped working with phages for treatment
because they no longer had reason to. Penicillin, discovered by the
Scottish bacteriologist Alexander Fleming in 1928, had become widely
available thanks to synthetic production and zapped infections
without the expertise needed for finicky phages.

But now the equation has changed. Many kinds of bacteria have become
antibiotic-resistant—prompting a few Western scientists, and
patients, to travel to former Soviet Georgia to give bacteriophages
for treatment a try. Phages have been used in the former Soviet
Union for decades because scientists there had less access to
antibiotics than their American and European counterparts did.
Phages were a cheap alternative, and in Soviet clinical trials, they
repeatedly stopped infections. Now in a bid for medical tourists,
Georgia has opened a center in its capital, Tbilisi, which offers
outpatient phage treatment to foreigners. In connection with the
Eliava phage research institute, which Stalin helped set up in
Tbilisi in 1923, the treatment center offers personalized cures for
a host of infections the United States says it can no longer do
anything about.

In 2000, the Centers for Disease Control, along with other federal
agencies, warned that the world might soon return to a "pre-
antibiotic era." Two million people each year now get hospital-borne
bacterial infections, 1.4 million of them resistant to antibiotics
and 90,000 of them lethal. One example is sepsis, the infection that
killed Joan Didion's daughter, as Didion relates in The Year of
Magical Thinking. New antibiotics are being discovered. But it takes
10 years and at least $800 million to bring an antibiotic to market,
according to the Infectious Diseases Society of America. The big
advantage that phages offer over antibiotics is that bacterial
resistance is less of a problem. Unlike antibiotics, new phage
batches can quickly be whipped up to take the place of phages to
which bacteria become resistant.


The word phage comes from the Greek "to eat." A phage contains
genetic material that gets injected into a virus's host.
Whereas "bad" viruses infect healthy cells, phages target specific
bacteria that then explode. At Eliava, phages are produced as a
liquid that can be drunk or injected intravenously, as pills, or as
phage-containing patches for wounds. Though few published articles
in Western journals report positive clinical trials—most of the
recent long-term research on phages comes out of the Soviet Union—
some Western scientists say that phages are safe and that they
work. "There is no evidence that phage is harmful in any way," says
Nick Mann, a biology professor at the University of Warwick in
England and co-director of phage R&D company Novolytics.

So, why do American patients need to go to all the way to Georgia
for treatment? For starters, in their natural state phages are hard
to patent, the route by which drug companies lock up future profits.
The first company to spend millions of dollars to prove that a
particular phage is safe could allow its competitors to capitalize
on the results. As important is the difficulty of regulation. There
are two ways that phages are currently used in the former Soviet
Union, and both pose problems from the point of view of the Food and
Drug Administration. At the Tbilisi phage center, phages are
personalized: You send your bacterial sample to the lab, and it's
either matched up with an existing phage or a phage is cultured just
for you. In the United States, by contrast, drugs are mass produced,
which makes it easier for the FDA to regulate them.

Phages are also sold over-the-counter in Georgia. People take the
popular mixture piobacteriophage, for example, to fight off common
infections including staph and strep. These phage mixtures are
updated regularly so they can attack newly emerging bacterial
strains. In the United States, the FDA would want the phages in each
new concoction to be gene sequenced, because regulations require
every component of a drug to be identified. To do so would entail
prohibitively expensive and lengthy clinical trials.

In the early years of phage research in the United States, says
former National Institutes of Health scientist Carl Merril,
bacteriophages allegedly killed more people than they cured. Phages
are culled from dirty, wet places—the first was found in the Ganges
River—a recipe for infection unless you know what you're doing. And
some kinds of phages—called lysogenic phages—are potentially
dangerous, because they sometimes carry genes that cause bacteria to
release toxins. So, there is reason for caution.

Despite the caveats, a number of phage biotechnology firms have
recently opened up in the United States and also in countries like
Canada and Israel. Phage biologists point out we know much more
about phage biology now than when the viruses were first discovered.
Methods of using phages for treatment, from distillation to
identification, have improved significantly since then. Clinicians
worldwide also report that patients using phages have had good
recovery rates and minor or fleeting side effects. Evergreen State
College professor Elizabeth Kutter, who collaborates closely with
Eliava researchers in Georgia and heads an international phage
conference each year, is working with others to find ways to
commercialize phages that could sidestep some of the problems with
patenting and regulation. Flu vaccine offers one instructive
possibility. Like over-the-counter phages, the vaccine is updated
regularly with the most recent strain of flu virus—without requiring
FDA approval each time.

There are already multiple uses for phages without FDA approval. A
promising area is American agriculture and livestock, which is
regulated by the less stringent United States Department of
Agriculture. Domestic scientists are looking at ways in which phages
could kill bacteria before they cause infection (rather than fight
an infection after it has begun). Alexander Sulakvelidze, an
assistant medical professor at the University of Maryland and a co-
founder of the phage R&D company Intralytix, awaits federal approval
for a phage-based wash for meat and produce that protects against
food poisoning. Vincent Fischetti, a professor at the Rockefeller
Institute, is designing a phage-based enzyme solution that can be
sprayed into the noses and mouths of hospital and nursing-home
patients. Fischetti and researchers in Tbilisi are also
experimenting with using phages to detect anthrax and cholera in the
case of a terrorist attack.

Using phages to treat infections at home, on the other hand, for the
moment seems unlikely. One company recently tried to open a phage
center in Tijuana but was deterred by the Mexican government. Phages
might be offered someday at clinics on Native American reservations,
as a casinolike quirk of legislative autonomy. But for now, U.S.
patients at a loss for options may decide that Tbilisi is close
enough.


Daria Vaisman is a writer based in Tbilisi, Georgia.

Image of bacteriophage © Varie/Alt/Corbis.





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