Prompt: As a scientist, describe the main experiment you would like to see performed before phage therapy is approved for human use. What are the risks involved with using phage therapy?

As mentioned in The Forgotten Cure, phage therapy has hit many roadblocks in the process of becoming approved for medical use in the United States. Some of the major risks involved with using phage therapy are septic shock, bacterial transduction, as well as the concern of bacteriophage being lysogenic. With septic shock, many bacteria house endotoxins within themselves which can be released into the patient’s body when lysed by the bacteriophage, which can lead to dangerously low blood pressure. In bacterial transduction, the phage has the possibility of exchanging genes with the bacterium and “turning” the bacterial cell into a deadly and pathogenic one. An example is the strains of E. coli 0,157. The main experiment I would like to see performed before phage therapy is approved is decreasing the likelihood that any of these mentioned risks from happening.

In the book, Ramachandran had the idea that if they would be able to block the gene that codes for endolysin, then they could create a phage that kills its prey but never lyse the cell, therefor solving the problem of septic shock in patients. He partnered with Sriram and Bharati Padmanabhan to test his hypothesis using a plasmid to inactivate the endolysin. His hypothesis was successful in that no plaques were formed, but the E. coli bacteria were inactive. This discovery also led Ramachandran to hypothesize that this process could be used to create more effective vaccines. In current vaccinations, the bacteria are killed using intense heat or formaldehyde solution which can denature or destroy many of the antigens on the surfaces of the bacteria. In the study conducted by Bharathi, the vaccinated group all survived, while 80% of the mice not vaccinated died. Such discoveries and research is slowly moving bacteriophage therapy towards medical use, but is not yet a 90-100% success rate.

I believe that bacteriophage research is approaching the threshold of being approved by the FDA for commercial use, but there are still many limitations or “grey areas” in which we have no research to back our hypothesis. Such a grey area is that how will the FDA and general public react to the bacteriophages being left in the patients body after treatment? As of right now, there is no procedure to remove the bacteriophage from the body after administration. Will the FDA approve bacteriophage even though they’re harmless to other “helpful” bacteria found throughout the body and will be degraded after some time? I believe that although there are still many questions that need to be answered, we need to be able to realize that the use of antibiotics have created superbugs that are more deadly than ever and bacteriophage therapy provides a possible solution to these bacterium.