Thursday, May 30, 2019

Phages don't fit traditional clinical trial format

Antibiotics are failing us and bacteriophages are there waiting to be used.

With decades of proven effectiveness against bacteria, as used in WWI and WWII and now continuing to save lives in a few countries where clinical trials are not required why can't we get clinical trials that allow it? Because phages are personalised medicine, and clinical trial formats do not fit the mould for it. Belgium, USA, Poland and a few other countries now allow it, most under special rules and regulations  It is time we all learn about phages' effectiveness in our fight against antibiotic-resistant bacteria!
More info:…/what-is-bacteriophage-biology-therapy.…

A CSIRO publication, Micro Biology Australia, has dedicated their March 2019 issue to Bacteriophages, this is how important phages are in today's world.

So what is really blocking them from being used? 

Bacteriophages are not currently classified in medicinal legislation since they are neither living nor chemical agents. Therefore, it is complicated to regulate and perform clinical trials and commercialisation. To ensure the efficiency of phage preparations, their effectiveness and host range towards currently circulating pathogenic strains must be monitored. This might explain why the phage preparations approved in the Russian Federation and Georgia are not static but are continuously updated to target newly emerging pathogenic strains. Legislation to allow these updates is necessary to circumvent repeated registration procedures.  
The Belgian Minister of Health has formally acknowledged that it is difficult to define the status of therapeutic phage preparations: should they be considered as industrially-prepared medicinal products (subjected to constraints related to marketing authorisation) or as magistral preparations (prepared in pharmacies’ officina). Magistral preparations (compounded prescription drug products in the US) are made by a pharmacist from the constituent ingredients to meet the specific patient needs. On 26 October 2016, it was formally agreed that natural bacteriophages and their products, which are not fully compliant with the European Directive requirements for medicinal products for human use and for which there is no monograph in an official pharmacopoeia can be processed by a pharmacist as raw materials (active ingredients) in magistral preparations, providing compliance to several logical provisions.

What this means in simpler terms; Clinical trials require ONE preparation to be tested. This is not how phage therapy works. There are millions of bacteriophages and a lab determines which ones are put into the preparation on an individual basis. Even if you had 30 burn infections it is highly unlikely the same phage preparation would be effective for all, and even during treatment the infection needs regular monitoring and phage preparations may need adjusting. Current clinical standards do not allow for any such variations!

Examples of occasions when the same phage cocktail would be effective is in a hospital where a hospital-acquired infection is spreading to patients. The same phage preparation can be given to all suspected patients, or in a nursing home where gastro is doing the rounds, a single phage preparation can clear most cases without causing harm to patients. Keep in mind that each time there is an outbreak typically a new preparation is required. But this is what we want, we want a pharmacy to be able to make the preparations as is now happening in Belgium; Magistral preparations (compounded prescription drug products in the US)!!

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