Just went in for what was supposed to be my 3rd mitomycin treatment - I was to get six of these treatments in place of the remaining two of the six scheduled BCG treatments that were halted after four of them due to the shortage. Good news upon arrival at urology office, they had received four BCG doses that had been on back-order. They allocated 2 of them for me, and I received my 5th dose and will get the final dose (of this round, at least) next week. So, it's been 9 straight weeks of treatment following the 2 TURB's. It has certainly been painful, uncomfortable and stressful. Despite it all, I am very grateful for my care and thankful that this type of therapy is available and has proven so successful in keeping the cancer from returning. I was diagnosed with stage one papillary carcinoma of the bladder this past June. They have scheduled a follow up cystoscopy for mid-December. For now, and a day at a time, I remain cancer-free unless someone tells me differently.
I just check with my uro and they said no BCG shortage problem!! That is here in Florida. I'am coming up on 24 months...all clean so far...thank you God!!!!and thank you God for my uro and staff!!!!and for BCG treatments!! and for this board...
Hi All, If my memory serves me well,(and it often doesn·t) previous shortages arose when the main US supplier had to make modifications to their production plant to reduce or eliminate risks of contamination into the environment, this disrupted production for some time. As patients, we are told to put bleach into the toilet after bcg treatment - this is not only to prevent risk to our families or work colleagues, but also to destroy any organisms that could find their way into sewage systems for example.At the same time as there were shortages in the US, there seemed to be a shortage world wide.At the moment my urologist(private) does not seem to have any problem in obtaining the medication here in Spain.
We all seem to have pieces to the puzzle here we are slowly putting them together. The "shortage" in this country is partially due to the fact that the FDA has only approved Merck and Sanofi Pasteur to supply BCG to the US. There are several other companies that make the agent but have not been approved by the FDA.
I hope for all of our sakes that Sanofi Pasteur comes through with their promise of delivery of BCG early next year. Merck is suppose to supply BCG sometime between October and December. I have also read the FDA is looking into approving more Pharma companies to supply the US to fill the void and prevent future "shortages."
Yes, BCG is a low-profit (not a large market) drug, so there are very few sources producing it. When a glitch happens in the production there is no competing company to pick up the slack.
The problem now, as I understand it, is that there was a problem in the production. BCG is a modified bacterium and is not a chemical produced by laboratory manufacture. If a contaminant appears in the "brewing" mixture, the entire mess has to be thrown away and started over. The FDA Bureau of Biologics is responsible for monitoring the safety and efficacy of the BCG and it will not go back on the market until the problem is resolved. This also happened about a year ago.
This is not a deliberate attempt to close off the market; it is, however, a problem that there is not enough "profit" involved to interest more than the current manufacturer.
For a somewhat accurate summary of the interesting history of BCG, go to the Wikipedia entry! Some of the diseases listed as treated with BCG have long fallen by the wayside.
Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society