Friday, 21 March 2014

Immunotherapy to cure cancer; perhaps a missed opportunity called Coley’s Toxin?

Why Coley's Toxin cure (Mixed Bacterial Vaccine) is not used in mainstream cancer care

As mentioned in one of my previous blog posts, this year 8 million people will die of cancer (see WHO World Cancer Report 2014). What if, approximately 40% of these people could attain a durable remission (no detectable cancer in your body) with a little known immunotherapy that cannot be patented?

Cancer immunotherapy Coley's Toxin mixed bacterial vaccine MBV - how
Cancer immunotherapy: Coley's Toxin therapy diagram showing how 
primary tumor in metastatic cancer is injected with Mixed Bacterial 
Vaccine (MBV) and the percentage chance of durable remission
when a patient suffers from inoperable or end-stage colon cancer
(CRC) or terminal kidney / renal cancer.
The often heard claim "that for various plausible reasons of vested interests, politicians and lawmakers will not allow this treatment (immunotherapy) to be legally available", is treating the absence of this particular therapy superficially. It would be shortsighted to simply lay the blame at the feet of pharmaceutical companies, politicians, or well-intended rules and regulations that govern quality control of pharmaceutical products. 

So why is it not pro-actively pursued by the vast majority of oncologists, clinicians or physicians in mainstream medicine or currently terminally ill cancer patients, even though the American Cancer Society have taken this form of therapy off their quack list? 

There are several reasons:

The only countries where this form of cancer treatment is legally available are Germany, Japan, South Africa, China and Mexico (mainly through private clinics). As such, access to this form of therapy is severely restricted and limited to financially secure people that know about it. (If you represent a clinic that provides proper medical care alongside appropriately managed Coley Toxin therapy then please get in touch if you would like to have your contact details listed on this page). 
Cancer immunotherapy Coley's Toxin mixed bacterial vaccine
Cancer immunotherapy: 5-year survival of 896 Coley Toxin 
treated cancer patients with microscopically confirmed 
cancers - modified fromMonograph 18 by Helen Coley Nauts

Another issue relates to GMP certified manufacturing of this therapy and the import and distribution challenges faced in countries where this form of therapy is not legally allowed. For example, as a scientist with a background in immunology, cancer research and virology, I have the know how and capacity to physically produce large amounts of quality controlled and potent Coley’s Toxin in a standard P2 / P3 molecular biosafety level laboratory. Yet, because of strict laws, rules and regulations in relation to pharmaceutical drug manufacturing, I would not be allowed to supply this to anyone.

Initial estimates suggest that it would cost approximately 5 – 6 million USD or Euros to set up a facility that would be GMP certified and legally allowed to supply this product for use in clinical trials. 

However, a fundraising effort in Canada to set up such a GMP certified production facility failed to generate sufficient public interest. As such, it clearly shows a lack of public support for potentially lifesaving therapies that are not mainstream. Put another way, if every terminally ill cancer patient (that will die this year) donated less than a dollar (0.70 USD), they'd be funding the efforts of a small group of academics (e.g. in Germany) to make this potential cure available. 
Put another way; isn't it terribly shortsighted to solely blame the pharmaceutical industry for lack of treatment options and their unwillingness to invest in unpatentable technology, when patients themselves are unwilling to invest the equivalent of a Mars bar in saving their own skin? Pharmaceutical and / or biotech companies will not invest in Coley’s Toxin vaccine as they have no financial incentive to do so (this technology cannot be patented and as such profits for shareholders are likely to be non-existent). 

Interestingly, there are a growing number of clinicians / investigators (medical doctors that run clinical trials) in Europe and North America that would be eager to conduct a clinical trial with Coley’s Toxin. However, as long as there isn’t a reliable, regular, consistent supply of potent, quality controlled, GMP certified Coley’s Toxin, these clinical trials are unlikely to take place and as such the status quo of limited access to this therapy will be maintained. Hence, if you would like to see this therapy being made available to terminally ill cancer patients (at perhaps a low cost) then my advice would be to donate to those charities or academic institutions that are eager to support clinical trials with, or investigate molecular aspects of this therapy (e.g. a German research group led by Professor Bernd Kreikemeyer, based at the University of Rostock's medical faculty).  

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