a hospital emergency room entrance, crowded emergency rooms, emergency room

For drug companies, a shortage of a medication is a business problem. For many patients, however, a drug shortage can be a lethal hazard.

It is especially distressing when the drug in question is long off patent (nearly a hundred years old) and the condition would be easily controlled if the medicine were available. That is the dreadful situation this reader confronts.

Q. I was on a bladder cancer treatment program using BCG, a tuberculosis vaccine, to activate my immune system. But the supply of the BCG has dried up and I had to stop treatment.

Now my cancer has advanced and the doctor is discussing the possible spread of the cancer elsewhere and removal of my bladder. He mentioned another more expensive medicine, but he said my insurance might not pay for it.

A. French scientists Albert Calmette and Camille Guerin were doing bacteriological research at the turn of the 20th century when they came up with the anti-tuberculosis vaccine named after them: Bacillus Calmette-Guérin. Although it is not used much in the U.S. for its original purpose, BCG is an important immunotherapy for cancer, particularly bladder cancer.

It is outrageous that this old drug is now in short supply. Manufacturers had to shut down production due to quality control problems.

There have been many such shortages of critical medicines in recent years. No one, including the FDA, seems able to solve the problem. As a result of this BCG drug shortage, patients like you face life-threatening consequences.

If you have faced a serious health problem due to a drug shortage, share your story below.

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  1. Noel
    Honolulu, HI

    In 2010, I had cancer tumors removed from my bladder. Though the tumors were superficial, the cancer was diagnosed as “high-grade.” After 6 weeks of treatment with BCG, tumors returned, and my oncologist recommended removal of my bladder since BCG did not work. I refused and had a second TUR to remove tumors and, with the recommendation of my urologist, another 6 weeks of chemo treatment using mitomycin. Again, small tumors returned, and again I refused the removal of my bladder, against the strong recommendation of my oncologist to do so. My urologist conferred with the oncologist, removed tumors again, and suggested what the oncologist referred to as a “third-string drug,” Thiotepa, be administered over the next six weeks.

    Well, mid-way through this 3rd chemo treatment, I was informed that the treatment would stop because Thiotepa was no longer available and was no longer manufactured (in U.S.). Fortunately, when I asked a pharmacist I know personally about the matter, she recalled an FDA memo that informed all pharmacies that it approved a Thiotepa equivalent manufactured in Italy.

    After insisting that my treatments continue with Tepadina (European version of Thiotepa), the cancer treatment center reluctantly waded through the bureaucracy of getting health insurance coverage and the protocol for obtaining Tepadina. I am now only 4 months away from my bladder being tumor free for 5 years.

    The point of writing this is to let others know that there are alternatives to BCG….. maybe even foreign equivalents; and what some doctors may consider the “first-string” treatment is not the only treatment. Most importantly, you must be your own advocate, and fortunately, I had an ally in my urologist.

  2. Carey

    Have your doctor talk to your insurance company to get them to cover the alternative!

    • cath

      Do you have the name of the alternative? thanks for sharing that story. My father is suffering from the same cancer.

      • Noel

        Health insurance did finally cover the cost of the alternative but be prepared for some reluctance to do unfamiliar things.

        My urologist suggested the two alternative drugs, Mitomycin and Thiotepa (Tepadina in Europe). I believe there was another alternative (Gemzar?) mentioned so there may be several.

  3. Roger

    I have that cancer, fortunately low grade, BCG in my bladder weekly, for 6 weeks, after removal of polyps & a tumor, is supposed to treat. Will advise outcome later, after a screening. Hopefully all goes well.

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