BCG - Understood?

I have mentioned BCG in the past, but when I went for treatment number 10, I was told that due to the shortage I would only get 1/3rd dosage.  Being the inquisitive sort (some, including my wife - think anal retentive is a better term), I decided I would do some more research via the internet to learn more about the shortage.

But first, the long version of BCG.  Bacllus Calmette- Guerin is a form of bovine Tuberculosis that is considered the gold standard for Bladder Cancer treatment (other than an outright bladder removal).  The full dose is 81 mg, mixed with 50 ml of saline solution that is inserted into your bladder via a catheter.  Process normally takes less than 10 minutes.  The 1/3rd dose is 27 mg and is considered the smallest dosage that is still effective.  It needs to be held in the bladder for 2 hours, and you need to make sure that the solution fully coats the inside of the bladder by rolling around.  15 minutes per side minimum...  I won't go into the bio-hazard protocols(and it is a registered bio-hazard) other than to say - lots of bleach, gloves, disinfectants and antibacterial soaps....

But now to the research about the shortage...

Have I said how much I love the internet for more information than you really need on a topic?  This search was entertaining to say the least.  The big trick for me is to sift through the superfluous bullshit and find those nuggets of reality.  The nuts and bolts of the details are that there are only 2 facilities that produce it and they have had quality control problems.

I found 3 main camps of why these facilities are having problems resulting in a shortage of BCG:

Theory number 1 - People that think the facility is staffed by terrorists who are intentionally sabotaging the product to kill us all slowly and eventually.  They are demanding security clearances, background checks and greater oversight of the workers, their beliefs and such.

Theory number 2 - It is all a money making ploy by the big pharma companies.  They want to reduce output in order to develop a demand to which they own the supply and can totally jack up the prices to make more $$.

Theory number 3 - The challenges for producing BCG in an environment where the money that big pharma gets is supposed to go to research, does not help a cancer that doesn't have the publicity of the other cancers that are supported by the rich and famous.  The reality is - nobody rich and famous has Bladder Cancer, so nobody knows that it is 4th most common in men, but ranks 19th for funding dollars.

My version of the reality -

I don't think I have a response to theory #1 without being derogatory - your tinfoil hat is on too tight.. please remove it and go stand under the nearest airplane flight path, if not the chemtrails will be re-directed to you.

BCG is over 25 years old and as such, not protected by a patent.  Big Pharma does get subsidized to produce it.  Many problems in the States results in the fact that Insurance companies will only cover the going rate that is calculated as an average of the years cost.  So, any increased cost would get passed on to the patient - not a business case that any company wants in the media as there is no way that it would come across well.  Bladder Cancer is already considered the most expensive cancer to have.

Even though big Pharma is subsidized, they need to put the money into the causes that get visibility - or they don't get their money.  They are still a business that needs to at least break even, if they can't turn a profit.  With no visible profits in BCG due to the finicky nature of its production and the strict conditions that are required, the limited funding that Bladder Cancer gets (it is number 19 or lower on the funding list) would mostly go to trying to keep the treatment options open, and limited (read probably no) research into alternatives and options.

The facilities that produce this are older, and now having problems.  The Canadian facility has had mold issues that have caused for production to be cancelled while the facility was renovated after 2 separate flooding events in the last couple of years. They hope to be producing product later in 2015 after inspections by the FDA and Health Canada.  The facility in the USA is suffering similar fates of an older facility and has discovered problems in their ventilation, as well as failed monitoring equipment that resulted in unusable product.

BCG sounds like a grown biological culture, not a manufactured chemical compound.  This would make it more technical to produce, and that could be part of the problem.  Any hiccup along the path of production could spoil the batch.  The long, strict process to culture and develop the BCG doesn't allow for an easy increase in production.  The one company currently approved to develop it(in the States), is on track to develop 700,000 doses this year, and at maximum capacity can only produce 850,000 which is their production target, but difficulties have resulted in reduced output.  I haven't found a website that states how many doses are needed, but with an expected 71,000 new patients expected in the USA, their BCG induction treatments would use up almost 60% of it.... leaving only 40% for the rest of us.... hence the 1/3rd dose for maintenance that I now get.

Hopefully this has been somewhat educational, if not confusing - I sure found the websites challenging to navigate as there isn't much information out there.   I did find a blogger who had Bladder Cancer in 2008, and I have been reading his story learning about the USA process, and the challenges that he had learning to live with it.

Other than this, today is Fathers Day, and my 1/3rd dose treatment the other day was pretty easy for me to absorb, and I hope the next 2 go just as easy.  I will start typing more blogs so that I can have more products for the site as video is turning into more effort than I expected  So, I will keep trying to make videos, but put more effort into blogs like this.