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BCG shortage?!

4 years 1 month ago - 4 years 1 month ago #47223 by Cynthia
Merck had a problem in their production of BCG earlier in the year shutting down production until they corrected the problem under The FDA guidelines. As they are the major producers of BCG in the world at this point this has caused problems and major worry for non invasive bladder cancer survivors.

Merck has began production and shipment has resumed. They will be filling back orders and it will take a while for production to return to baseline and the pipeline to be back to normal.

The above is the best answer available at this time and comes from Merck. The truth is that BCG is only one of hundreds of drugs that are in a state of shortage at any given time in the US. This is due to many factors, manufacturing glitches as well as economic reasons.

We have seen shortages in the past this is not the first nor potentially the last. BCG is a biological and because of this the manufacturing of it can be impacted by many factors. Also it is an old drug no longer under patent and demanding the wildly high prices of new drugs on the market. Even without speculating on other factors it answers the questions of why more company's are not manufacturing it and why do we see shortages?

On a personal note I hear the reasons and understand them but can not help thinking that the FDA would be in panicked problem solving mode if the drug in question was Viagra. Can you imagine the press that would get? Call me cynical.

The bottom line is this, if you feel your treatment is being compromised by the BCG shortage it is time to talk to your Urologist about alternatives. If your Urologist is not converse in what is available seek a second opinion from one that specializes in bladder cancer at a major cancer center.

Cynthia Kinsella
T2 g3 CIS 8/04
Clinical Trial
Chemotherapy & Radiation 10/04-12/04
Chemotherapy 3/05-5/05
BCG 9/05-1-06
RC w/umbilical Indiana pouch 5/06
Left Nephrectomy 1/09
President American Bladder Cancer Society

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4 years 1 month ago #47222 by sara.anne
There have been two sources of supply of BCG in the US...Thercys (which is the one I had) is now not on the market. Merck also has one and, according to the FDA Bureau of Biologics web site, it is back on the market. BUT you would need to ask your urologist ....maybe for some reason he doesn't use the Merck version.

But if and when you have questions such as this, do ask your doctor. He can give you the specific reasons for his reply

Sara Anne

Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
Forum Moderator

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4 years 1 month ago #47221 by gina
"Accurate"? You're joking right? Do you not understand my query...Sarah...plz may I have you thoughts reguarding why an oncologist/urologist from one of the country's top hospitals would tell me this...if it werent true?!!

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4 years 1 month ago #47216 by seabreeze
Gina, sorry for your state of confusion. At least now you have accurate information to help calm the worries.. God bless you!!!

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4 years 1 month ago #47213 by gina
I am terribly confused and discouraged...I am not crazy...my urologist/onocologist from the University of Michigan told me what I stated above...days ago...why would he say this if it werent true?.... I asked him further, what does this mean for me and my treatment?...His response, "you and every other bladder cancer patient"....thoughts?

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4 years 1 month ago #47207 by sara.anne
BCG is a live product, and so is regulated in the FDA by the vaccines, blood and biologics division. Here is the link

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351921.htm

According to this listing, Theracys is NOT available, but version supplied by Merck is.

Sara Anne

Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
Forum Moderator

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