Hey everybody,
I was just going to start maintenance BCG. I did really well with the 6 week treatments and the dosage was 1/3 of TICE BCG. I wasn\'t nearly as uncomfortable as I had anticipated. It really was very doable. I had the next phase of cystoscopy with biopsy the end of April and it came back clean. Second cystoscopy is tomorrow and if all looks okay I think I will go on the 3 week maintenance program. I took a 12 week yoga program through our local YMCA that was sponsored by Livestrong. Yoga is great to calm anxiety. I highly recommend talk therapy too whether it\'s through a private counselor or just talk with the fine folks on this message board.
Now that I am coming out of my mourning period, I hope that I have taken care of myself enough and the rest of this ordeal will be a breeze.
For now....
xoxoxo
Annie

Update from Len Lavenda of Sanofi-Pasteu:

I just got off the phone with Len. He called me to respond to an E-mail I had sent him. He told me that the reason for the shut down was due to the fact that one of the test that are done to be sure the product is safe to release was failing its own testing process.

This is called the Release Test. All the product was retested and found to be safe and with in specs. But this failure showed that there was chance of a risk to the safety of the product. This risk is why they had to immediately shut down and report the failure to the FDA and Canadian authorities.

They are unable to speak to Merck directly due to legal constraints, so they asked the FDA to do everything they could to warn Merck so they could ramp up production to keep up with the demand.

Then they started to clean and replace all the equipment involved in making the BCG treatment at the facility. A total overhaul of everything from the equipment to the testing procedures is being done.

It takes several months to create the treatment, and it has to be tested by the Canadian and US governments every step of the way. Once each process passes its testing, then the next step can begin until it has to be tested, and so on and so forth until the final product reaches the Release Test.

The sad truth is that this takes a lot of time. Len assured me that they are doing everything as fast as possible, and are working with the Canadian and US Regulator Commissions, along with the FDA and several other governments to speed this process up.

Merck has so far been able to keep up with demand, and should be able to in to the future.

I would like to thank Len Lavenda (Sanofi-Pasteu) for showing great concern pertaining to this situation. And commend him for taking the time to call me and explained the situation more clearly.

He seamed quite sincerer and impressed me with his honestly.

He would also like to send his deepest apologies to all the people waiting for the treatment, and hope they understand that they did not want this to happen, and will do everything thing they can to get things back up and running as soon as possible.

I hope I have conveyed this information accurately, and have calmed some of the fears that you may have. Len will keep in close contact with our own Cynthia, and other cancer agencies and organizations, so as to keep us up to date with how things are progressing along the way.

He sounds like he is a good man. I only can hope he proves this to be true.

Sincerely: Mark Bergquist