Treatment
Phage therapy is the therapeutic use of bacteriophages to treat pathogenic bacterial infections. Those doing this treatment boast of an 80+% success ratio in curing people fully of antibiotic-resistant infections such as the ones my Mom has. Unfortunately, this treatment is only being done in the country of Georgia and there is a trial in Poland. It cannot get FDA approval because of the nature of the treatment. The FDA has a decades long testing process for every new medicine that gets introduced to the market. This treatment involves making a bacteriophage that is catered specifically to the single-individual with the infections. So for the FDA to approve it, every single time someone would need this treatment, they'd have to wait decades for the testing process of the new version of the bacteriophage that is catered to them and their infections. There is no way for this treatment to ever pass that level of barrier, so it will have to be reclassified in some way to ever be sold in the US with FDA approval.
Three providers of this treatment have expressed a willingness to assist my Mom. Phage International was the first to respond to my e-mails seeking assistance. The Eliava Institute later responded. And now the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences has also responded. All have expressed a desire to help, but their help cannot be obtained without having a doctor and facility willing to prescribe and administer the treatment.
There is a path to receiving this treatment under FDA approval. The FDA has programs called single-patient IND and emergency IND where patients who do not qualify for clinical trials or for whom no clinical trials exist can still receive access to experimental medications. I have told this to the hospital, but they are unwilling to do it. I have requested a written response listing their reasons for refusing to provide this treatment here, and am still awaiting that response.
I have asked the hospital if they could at least ship the infection samples to the Eliava Institute for analysis. I have said I would like to find out if anything can even be done for my Mom. Without having these samples analyzed, there is no way of knowing if this treatment would even have any potential for helping her. One of the main doctors at this hospital has twice said "If your Mother didn't have pseudomonas, she'd have been home a long time ago." So I am unwilling to give up on her until this treatment is given. If the samples would be sent, then the labs that provide the treatment could analyze my Mom's infections and tell me if anything can be done or not. If nothing can be done, then I know I've pursued this as far as I can and would have to give up on this treatment at that point. But if something can be done, then I know I have to push that much harder to get this treatment to her somehow.
The hospital said they will not ship this for me. They said all they can do is get me samples of her infections and then I am on my own with shipping them. I contacted FedEx about this and they said I must be certified to ship harmful materials. They said certification requires taking a 3-day class and costs $995.00. There was still some question as to whether or not the materials could even be shipped because they will take 7-10 days to get there. They said there was a certification class in Tampa at the end of January, but her condition is so dire that I do not feel like I can safely leave here for three days (without risking me not being here when she dies), spend $995.00 and then still possibly not even be able to do it. I am trying to find a third party that is already certified that would be able/willing to ship the materials for me.
The infectious disease doctor here has said that her infections are in the process of becoming completely resistant to antibiotics. That means she will be dying of the infection(s) very soon. So I have to act quickly to save her. This hospital has slammed the door in our face regarding this treatment in no uncertain terms. They will not provide this treatment for my Mom and would prefer for her to die of the infections than to get to try this. They regard the treatment as an internet scam. Thus the need for this website. If the only way to receive this treatment lies in flying my Mom via Air Ambulance to Georgia or Poland, then that is what we have to do in a last ditch effort to save her life. If we can achieve full eradication of these infections, there will be an all new patient to work with. She still has other problems that won't allow her to make it home very quickly, but at least she will have a chance.
Below you will find a list of links to many of the resources I could find online that give credibility to phage therapy treatment. This is what I have used in my discussions with the hospital on this subject. But unfortunately it has not been enough to convince them.
Three providers of this treatment have expressed a willingness to assist my Mom. Phage International was the first to respond to my e-mails seeking assistance. The Eliava Institute later responded. And now the Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences has also responded. All have expressed a desire to help, but their help cannot be obtained without having a doctor and facility willing to prescribe and administer the treatment.
There is a path to receiving this treatment under FDA approval. The FDA has programs called single-patient IND and emergency IND where patients who do not qualify for clinical trials or for whom no clinical trials exist can still receive access to experimental medications. I have told this to the hospital, but they are unwilling to do it. I have requested a written response listing their reasons for refusing to provide this treatment here, and am still awaiting that response.
I have asked the hospital if they could at least ship the infection samples to the Eliava Institute for analysis. I have said I would like to find out if anything can even be done for my Mom. Without having these samples analyzed, there is no way of knowing if this treatment would even have any potential for helping her. One of the main doctors at this hospital has twice said "If your Mother didn't have pseudomonas, she'd have been home a long time ago." So I am unwilling to give up on her until this treatment is given. If the samples would be sent, then the labs that provide the treatment could analyze my Mom's infections and tell me if anything can be done or not. If nothing can be done, then I know I've pursued this as far as I can and would have to give up on this treatment at that point. But if something can be done, then I know I have to push that much harder to get this treatment to her somehow.
The hospital said they will not ship this for me. They said all they can do is get me samples of her infections and then I am on my own with shipping them. I contacted FedEx about this and they said I must be certified to ship harmful materials. They said certification requires taking a 3-day class and costs $995.00. There was still some question as to whether or not the materials could even be shipped because they will take 7-10 days to get there. They said there was a certification class in Tampa at the end of January, but her condition is so dire that I do not feel like I can safely leave here for three days (without risking me not being here when she dies), spend $995.00 and then still possibly not even be able to do it. I am trying to find a third party that is already certified that would be able/willing to ship the materials for me.
The infectious disease doctor here has said that her infections are in the process of becoming completely resistant to antibiotics. That means she will be dying of the infection(s) very soon. So I have to act quickly to save her. This hospital has slammed the door in our face regarding this treatment in no uncertain terms. They will not provide this treatment for my Mom and would prefer for her to die of the infections than to get to try this. They regard the treatment as an internet scam. Thus the need for this website. If the only way to receive this treatment lies in flying my Mom via Air Ambulance to Georgia or Poland, then that is what we have to do in a last ditch effort to save her life. If we can achieve full eradication of these infections, there will be an all new patient to work with. She still has other problems that won't allow her to make it home very quickly, but at least she will have a chance.
Below you will find a list of links to many of the resources I could find online that give credibility to phage therapy treatment. This is what I have used in my discussions with the hospital on this subject. But unfortunately it has not been enough to convince them.
Treatment Providers
- George Eliava Institute of Bacteriophages, Microbiology and Virology
- Eliava Institute
- Phage Therapy Center - Bacteriophage Therapy for Patients Across the Globe
- Phage International™
- Institute of Immunology and Experimental Therapy Polish Academy of Sciences
- Intralytix, Inc.
- AmpliPhi BioSciences Corporation
- ADVANCED BIOPHAGE TECHNOLOGIES
- Commercial Companies Involved in Phage R&D
Stories, Articles and Studies
- CBS News - 48 Hours - Silent Killers: Fantastic Phages?
- NPR - Scientists Engineer Viruses To Battle Bacteria
- USA Today - U.S. needs to open eyes to 'phage therapy'
- Phage therapy From Wikipedia, the free encyclopedia
- Ampliphi Presents Encouraging Pre-Clinical Data on the Use of Phage-Based Therapies to Treat Bacterial Lung Infections DATA PRESENTED AT THE 26TH ANNUAL NORTH AMERICAN CYSTIC FIBROSIS ASSOCIATION CONFERENCE, OCT 11-13, ORLANDO, FLORIDA
- A controlled clinical trial of a therapeutic bacteriophage preparation in chronic otitis due to antibiotic-resistant Pseudomonas aeruginosa; a preliminary report of efficacy
- Targeted Drug-Carrying Bacteriophages as Antibacterial Nanomedicines
- Bacteriophages: potential treatment for bacterial infections.
- Phage therapy: concept to cure
- The New Phage Biology: From Genomics to Applications
- Stalin’s Forgotten Cure
- Phage Therapy of Pseudomonas aeruginosa Infection in a Mouse Burn Wound Model▿
- Combating bacterial infection
- Targeting Antibacterial Agents by Using Drug-Carrying Filamentous Bacteriophages
- Intralytix Completes Regulatory Clearance for Phage-Based E. coli Food Safety Technology
- Pseudomonas Biofilms, Cystic Fibrosis, and Phage: a Silver Lining?
- Phage Therapy for MRSA - Cheaper Than Antibiotics