To phage or not to phage for superbug infections?

[phdkso]

Hi All: I am a retired microbiologist who has known about phage therapy since the 60's and I have made phage therapy one of 3 remainig professional activities: Phage therapy, bullshit (academic and scholarly approach as illustrated by Harry Frankfurt, 2005, On Bullshit), and finally, The Quest for Safe Food, Celebrating 100 Years of Failure Because Seeing Reality is the First Step to Changing it (this is based on the fact that my literature goes back 100 years and allows me to make the following observation: The food supply has not been safe in the past, is not safe now and probably won't be safe in future - mainly based on microbial foodborne disease). I was disappointed about the meger post on phage therapy my google alert sent me today from this site. I hope this post will correct that:

Choosing to let patients with superbug infections die rather than phage them!!!!

It is my humble opinion that the antibiotic-resistance superbug crisis is the mother of all regulatory-scientific-environmental-medical misadventures; however, the absurdity of the superbug crisis consists of the fact that it can be demonstrated that we had technology, namely bacteriophage therapy, long before we created the antibiotic-resistance superbug crisis through massive abuse of antibiotics and other antimicrobials. Additionally many politicians, bureaucrats, scientists and members of the public health community are or should be well informed about phage therapy which can cure many superbug infections. In spite of a voluminous literature attesting to the scientific validity, safety and medical effectiveness of phage therapy (see http://www.phage.org and find phage therapy references), there are still phage therapy deniers who would resist the careful deployment of these weapons of mass-destruction for specific pathogens in the war with superbugs.
What is Phage Therapy? Prior to the discovery and widespread use of antibiotics, bacterial infections were treated worldwide by the administration of bacteriophages. Bacteriophages or phages are highly specific viruses that invade bacterial cells and, in the case of lytic phages, disrupt bacterial metabolism and cause the bacterium to die. Interestingly it was the French-Canadian microbiologist, Felix d'Herelle, while working at the Institute Pasteur in Paris in 1917 who is credited with discovering and promoting phage therapy. While the use of phage therapy was discontinued in the West soon after the discovery of antibiotics they continued to be utilized in Eastern Europe and today many infections untreatable with antibiotics can be treated in clinics in Georgia (Europe) and Poland. Once one accepts the fact that it requires microscopes to see the world of bacteria and bacteriophages, phage therapy may be compared to any biological control methodology and can conceptually be described as: What a cat is to a mouse the right bacteriophage is to a specific bacterium or superbug. Phage therapy has been going on in nature as a balancing force in the evolution of microbes for a long time. Medical phage therapy is simply the intervention by humans to ensure that the balance is in favour of bacteriophages over susceptible bacterial pathogens! While there is considerable expertise on phage therapy in Canada at the research level, as can be substantiated by googling phage therapy ("pages from Canada" only), medical phage therapy is not currently approved or practised in Canada; however, according to a letter signed by the former federal health minister phage therapy can be made available legally to Canadian patients under the Special Access Program of our Food & Drugs Act! Additionally, there are moral and ethical reasons for making phage therapy available since Canada appears to be a member of The World Medical Association which states: "In the treatment of a patient, where proven prophylactic, diagnostic and
therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life." ( see below for quote source ).
A discussion of phage therapy is currently very timely, not only because too many patients are dying of superbug infections; but also because of the recent release of the Canadian film: Killer Cure: The Amazing Adventures of Bacteriophage and the June 2006 release of the book by Thomas Haeusler entitled, Viruses vs. Superbugs, a solution to the antibiotics crisis? ( see http://www.bacteriophagetherapy.info ) - both are available at Ottawa libraries. Additionally, the record of an excellent questions-and-answers session with Dr. Roger Johnson of the Public Health Agency of Canada can be found at http://meristem.com/topstories/ts06_08.html .
Further, the phage therapy file has dramatically changed during the last few months because the US Food and Drug Administration (FDA) has amended the US food additive regulations to provide for the safe use of a bacteriophage preparation on ready-to-eat meat and poultry products as an antimicrobial agent against Listeria monocytogenes (see http://www.fda.gov/OHRMS/DOCKETS/98fr/02f-0316-nfr0001.pdf ). This excellent submission evaluation changes the scientific validity of phage therapy from Eastern European science, which, sadly, too many of us Westerners dismiss with hubris and bias as not credible, to approved and supported by the all-knowing and all-seeing FDA at least for ready-to-eat meats. An enlightening FDA questions-and-answers document can be found at http://www.cfsan.fda.gov/~dms/opabacqa.html .
Superbugs are everybody’s business because superbugs make everybody their business and every North American should study the above references because sooner or later everybody will be faced with an infection or know a relative or friend who will be suffering or dying with one. Withholding such treatment from patients when antibiotics are failing ought to be a crime; however, those who have the money, knowledge and time to travel when faced with an infection where antibiotics are failing may be able to get phage therapy treatment in Georgia ( http://www.phagetherapycenter.com ) or Poland - http://www.aite.wroclaw.pl/phages/phages.html . A record of a trip to Georgia to get phage therapy treatment by UK citizens can be seen at http://www.relax-well.co.uk/news.html .
What is even more surprising and frustrating is that an American company, Phage International Inc., ( http://www.phageinternational.com ) would probably be willing and able to set up a phage therapy clinic in any country if the right regulatory climate existed. A recent article describing how foreigners from many countries are treated at their Phage Therapy Center in Tbilisi, Georgia can be found at http://www.phagetherapycenter.com/doc/sjbizjournal.pdf .
Since January 1, 2000 as many 87,000 Canadians may have died of superbug bacterial infections and there is not even a memorial for them, although some people are starting to wear blue ribbons in memory of superbug victims. Would it not be nice if the Canadian governments, public health officials and media got together and funded the Felix d'Herelle Center for Phage Therapy to provide the phage therapy treatment option for patients when antibiotics fail and we have nothing left to offer them?
P.S.: WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI PARAGRAPH 32:
"In the treatment of a patient, where proven prophylactic, diagnostic and
therapeutic methods do not exist or have been ineffective, the physician,
with informed consent from the patient, must be free to use unproven or new
prophylactic, diagnostic and therapeutic measures, if in the physician's
judgement it offers hope of saving life, re-establishing health or
alleviating suffering. Where possible, these measures should be made the
object of research, designed to evaluate their safety and efficacy. In all
cases, new information should be recorded and, where appropriate, published.
The other relevant guidelines of this Declaration should be followed."
FROM: The World Medical Association:
http://www.wma.net/e/policy/b3.htm - and
http://www.aite.wroclaw.pl/phages/phages.html

[Pal]

Thank you so much for sharing your knowledge with us. Hope you would be doing so in the future too.

I find particularly informative following links given by you

US FDA/CFSAN -QandAs on Bacteriophage Prep sprayed on RTE Meat and Poultry Products

Meristem: Top Stories

Phage International, Inc.

IITD PAN - Wroc³aw

[phdkso]

Some years ago I tried to imagine what it would be like to be well informed about phage therapy and end-up with a superbug infection in a hospital where doctors had never heard of phage therapy - here is what I came up with. I hope you all enjoy:

While in Canada people are not usually dying in the streets, a considerable number are currently expiring in hospitals from Clostridium difficile infections resulting in newspaper headlines blaring: ‘Superbug’ kills 100 patients over 18 months, The Ottawa Citizen, August 5, 2004, C17.
Meanwhile, a Canadian expert on Clostridium difficile infections was preparing for the first meeting of the newly minted committee for wasting time by studying what is already known about Clostridium difficile. As he asked himself the question: “What is the answer to this problem?” – fatigue overcame him and he fell asleep. Almost immediately he was dreaming that he was driving to the meeting in his new SUV bought with all the overtime pay he had been earning while working on the Clostridium difficile crisis. Suddenly a voice came from a dark cloud that had formed in the sky – “You have failed in your professional duty towards your patients by not applying all available scientific knowledge towards curing superbug infections!” In the next moment a bolt of lightning came from the cloud and for an instant seemed to hover on the hood of the SUV like a bacteriophage landing on a bacterial cell and then blew the SUV apart the way a bacteriophage would lyse a superbug.

Next our Clostridium difficile expert finds himself approaching the Pearly Gate. Sitting beside St. Peter is the French Canadian, Felix de’Hérelle, discoverer of bacteriophages and on the Pearly Gate is a message in both Canadian official languages: “THE ANSWER MIGHT HAVE BEEN BACTERIOPHAGE THERAPY.”

Approaching St. Peter our expert complains bitterly that he should not have died yet because he was an important expert on superbug infections and still had so much important research work left to do to save humans from antibiotic-resistant superbug infections. Replied St. Peter: “From our point of view you were redundant. When God gave you natural antibiotics you abused them and created superbugs. Then you fell in love with your new creations and spent all your time studying them. Hubris, false national pride, condescension, russophobia, nih (not invented here) and the Viagra Phenomenon (Canadian penises work differently) prevented you from recognizing that God had given you bacteriophages long before he gave you antibiotics to deal with situations like antibiotic-resistant and superbug infections. You were an obstacle to solving the Clostridium difficile crisis. My problem now is,” said St. Peter, “that I have to decide whether I should let you into heaven or send you to hell for treating so many patients suffering from antibiotic-resistant superbug infections with antibiotics that you knew to be ineffective rather than phage them. I have invited your peer, Dr. Felix de’Hérelle, to help me reach a fair decision.”

Shaking and sweating our expert woke and turned to his computer to google phage therapy. To his amazement there was the answer to the superbug crisis – phage therapy imported from Georgia and Poland. The first paper he read was: Phage Therapy: Bacteriophages as Antibiotics at http://www.evergreen.edu/phage/phagetherapy/phagetherapy.html . Then he discovered http://www.pahgetherapy.org – not only would the Phage Therapy Center in Georgia treat his patients when they failed to respond to antibiotics; but he could communicate directly with the most authoritative experts on phage therapy. Then at amazon.de he discovered the recent book, GESUND DURCH VIREN – EIN AUSWEG AUS DER ANTIBIOTIKA-KRISE by Thomas Häusler (Healthy Through Viruses – a way out of the antibiotic-resistance crisis). He also found that in Germany phage therapy was being used on some apparently hopeless cases with 7 of nine patients cured, http://www.zeit.de/2003/37/P-Phagentherapeut - Meister der Bakterienfresser (Master of the bacteria eaters). At http://www.phage.org he discovered an extensive listing of phage therapy references.

Newly converted our expert felt hubris, false national pride, condescension, russophobia, nih (not invented here) and the Viagra Phenomenon (Canadian penises work differently) melt away and came to appreciate the scientific advances that had been made in Eastern Europe since phage therapy was abandoned in the West after antibiotics became available in the 1940’s. Humbled and appreciative that he had been given a second chance to work on treating superbug infections, he was soon referring patients for treatment, sending applications under the Special Access Program to Health Canada and lobbying regulatory agencies to approve protocols for isolation, purification and characterization of bacteriophages by hospital laboratories for use in treating multi-antibiotic-resistant superbug infections orally and topically.

Then the patient awoke to realize that it was only the dream of the dreamer. He knew that his doctors had nothing to offer to prevent him from dying form his multi-antibiotic resistant infection. His information on phage therapy was viewed with scepticism and total resistance to change. Then he realized that his fellow citizens and colleagues were going to let him die – cruel and unusual punishment went through his mind as he noted that this was nothing personal and apparently not a legal issue; however, not using all available knowledge surely is a moral and ethical issue because they will never be able to claim that all that could have been done was done.

And his epitaph reads:

DEATH BY HUBRIS OR SUPERBUGS?

Why did you choose to let me die

rather than phage me?

You will never be able to claim

that all that could have been done was done!