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    How Sanofi’s discontinuation of BCG affects patients, clinicians

    Sanofi Pasteur recently announced that it is discontinuing its BCG products TheraCys and ImmuCyst, prompting fears of a shortage of BCG for bladder cancer patients. In this interview, Dr. Benjamin J. Davies, associate professor of urology at the University of Pittsburgh School of Medicine, discusses the implications of the announcement and what’s next for patients and clinicians.      


    Urology Times: What short-term and long-term implications does this announcement have for patients?  

    Dr. Davies: I think in the short term, it’s a challenge to predict. We may well see a decrease in supply in the near term, although it’s a bit of a challenge to know if that’s true or not. I think long term, we’ll actually have a little bit easier time predicting that we’re going to have real supply difficulties with BCG. I think it’s fair to say that barring any change or any new announcement, that’s likely to happen. The reason I say that is because we know that Merck has had challenges in the past in increasing supply of the drug, and that was around 2012 into 2013. That’s probably a product of it being a challenging drug to make. You can imagine that this is not the type of drug where it’s chemical XYZ joins chemical ZYX in a pot and it’s spit out into pills. This is a biologic drug that has to grow under very careful medium conditions, and one mistake in temperature, one contamination into the growth medium, and the whole drug can be spoiled. That can mean up to 5,000 to 10,000 doses can go bad day to day. So it’s a challenging drug to make, and we know that it can be a challenge for one manufacturer to really hold the supply of America in good faith.   

    And I would say in Merck’s defense, it’s not really good for Merck to be the only supplier in America of a drug that’s very challenging to make. You can imagine from a market perspective that that’s not the way we want to be. We want to have multiple people making challenging drugs, biologics in general, because that way we know the drug will be available. If Merck’s one plant in North Carolina goes down, even for reasons of which it really has no ability to control, what do we do? It’s a real big problem. So I say in summary to that question, short term, we don’t know, we may be okay for the next few months, next 6 months. Long term, I think we have a serious problem.

    Next: "I think at this point I would be surprised if we don’t have a severe problem."

    Benjamin P. Saylor
    Saylor is content managing editor for Urology Times.

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    • [email protected]
      Its has been my observation through the years of the misuse of intravesical BCG in patients with high grade TCCA of the bladder, and the inappropriate lack of use for maintenance therapy. Although intravesical BCG has made an significantly positive impact on TCCA of the bladder, cystectomy with diversion or orthotopic diversion is significantly underused, for numerous reasons and sometimes, "excuses" by many urologists. Intravesical BCG is NOT benign therapy, and unfortunately, can delay patients to undergo cystectomy when they have a better shot at real cure of their blabber cancer. As has been said many times at the SUO, and other GU meetings addressing TCCA, high grade T1 and Tcis is a potentially lethal prognosis if handled cavalierly, and now that BCG may not be so readily available, cystectomy should be "front and center" in the treatment paradigm.