After five years of enduring chronic infections and a trip to the Republic of Georgia, Shalini Zachariah Mendelsohn from Chicago is cured, no thanks to antibiotics or the U.S. Food and Drug Administration (FDA).
Following sinus surgery in December 2015, Mendelsohn, 43, was diagnosed with staph A MRSA, a bacterial infection resistant to most antibiotics. Although a senior account executive in the pharmaceutical industry, at the time she was diagnosed she was unfamiliar with the treatment that would cure her: bacteriophage therapy.
“A doctor in Chicago finally explained the serious nature of the infection and that no drugs were effective which were available to me,” Mendelsohn told Health Care News. “The phage therapy was effective from the first dose, and after three days I could truly feel my body was healing.”
Care Flight to Europe
Mendelsohn was feeling her body heal in the Republic of Georgia.
Unable to access bacteriophage, commonly called “phage,” therapy in the United States, Mendelsohn contacted Phage International, the San Francisco-based holding company for two bacteriophage treatment clinics in Tbilisi, Georgia’s capital: Phage Therapy Center and the NovoMed Integrative Medicine Center.
Mendelsohn received treatment at Phage Therapy, which specializes in providing an “effective treatment solution for patients who have bacterial infections that do not respond to conventional antibiotic therapy,” according to the clinic’s website.
“Years of sinus drainage in my face which had traveled to my chest, ears, and stomach were loosening and beginning to heal,” Mendelsohn said.
Despite phage treatment’s almost total absence in the United States, bacteriophage science is not new.
Phage’s therapeutic potential was observed as long ago as the 1920s at the Eliava Institute. Eliava was founded in 1923 in Tbilisi, in what was then the Union of Soviet Socialist Republics, and directly funded by the Kremlin until the collapse of the Soviet Union in 1991, according to a briefing on phage therapy from the U.S. National Center for Biotechnology Information.
A bacteriophage is a virus that destroys a bacterium by self-reproducing within the bacterial cells. Phages have been proven to combat dangerous bacterial infections such as salmonella and staphylococcus, or “staph” infections. Phage therapy has successfully treated infections of skin and soft tissue, as well as gastrointestinal, respiratory, and orthopedic infections.
‘Losing the Race’
Doctors widely abandoned phage treatment when penicillin and other antibiotics were proven to be effective treatments for bacterial infections in the 1940s, The Wall Street Journal reported in a January 2016 article describing a French burn victim’s successful treatment when phages were applied to her “potentially deadly bacterial infection.”
Tom Frieden, director of the U.S. Centers for Disease Control and Prevention, says bacterial resistance to antibiotics has reached a state of potential crisis.
“We are at risk of losing the race here,” Frieden told the Journal. “This has the potential to undermine much of modern medicine.”
Western No Fly List
Chris Smith, CEO of Phage International, says phage therapy is a restricted market in the Western world.
“Some countries in Western Europe refuse import of any phage products,” Smith said. “These include France, Holland, and Germany.”
In the United States, FDA blocks bacteriophage medical treatments, Smith says.
“The FDA terminated human use in the early 1990s because there had been no random double-blind studies,” Smith said. “We follow FDA’s guidelines for import for our patients’ [drugs].”
For now, phage treatment for U.S. patients is largely reserved to those who seek it out, Smith says.
“Our current patients are a bit above average regarding their curiosity and desire to get themselves well,” Smith said. “I think that most people do not care what antibiotic or antibacterial they receive as long as they get well.”
“Having worked in the pharmaceutical industry for 10 years, I am not surprised that phage therapy is not available in the United States,” Mendelsohn said. “It is extremely frustrating to see patients who are chronically ill and ultimately dying of diseases that can be treated.”
Calls for FDA Changes
FDA’s testing process stands between patients with treatable bacterial infections and bacteriophage therapy, Smith says.
“What needs to be done in order to make this highly effective antibacterial available is the FDA needs to change their testing model when performing clinical studies,” Smith said. “Currently, they want to test phages like antibiotics, a very long and expensive process. Humans and bacteriophages, which are ubiquitous in the environment, have coexisted since humans arrived on the Earth, and thus they are very safe. The FDA knows this, and I believe they are already considering a different model.”
Smith says the flu vaccine provides a well-established model for the kind of FDA approval phage treatment requires.
“As is the case with the flu vaccine, there needs to be an approval process that allows manufacturers to add new phages every year, or even more often, in order to address newly emerging drug-resistant and/or phage-resistant strains of bacteria,” Smith said.
Phages for Food … and Dogs
FDA has approved phages to be recognized as a “generally recognized as safe” food additive, in compliance with the 1938 Federal Food, Drug, and Cosmetic Act.
Smith says the only form of bacteriophage production for humans in the United States is probiotics made from dried phages by just a few companies, including Probiotic America. A veterinary antibacterial made from phages by Delmont Laboratories is used to treat canines diagnosed with staphylococcus aureus, Smith says.
Michael McGrady ([email protected]) writes from Colorado Springs, Colorado.
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