The cancer nobody cares about: BCG shortage tied to Merck's manufacturing delays

Since 2012 BCG, the gold standard treatment for stage one bladder cancer, has intermittently been unavailable to patients on an international scale.

A BCG shortage stands most of us in my community completely still.

Imagine, if you will, the possibility of having your cancer treated successfully with a drug injected into your bladder over six weeks (or more depending on your situation) or having a radical cystectomy.

Which would you choose?

Many folks continue to work full time while having BCG, some with almost no side effects and others with more serious ones.

Most folks have to stop work for up to six months, but certainly for six weeks, with a radical cystectomy.

It’s likely that only a small number of people will face this particular either/or. But many more will face the anxiety and fear of delayed or interrupted treatment.

I don’t know much about why BCG is facing “manufacturing issues,” as Merck has described it, but I do have to wonder how much the “low status” of our disease contributes to the problem.

Last Thursday, the Bladder Cancer Advocacy Network informed participants in Inspire’s online support group for bladder cancer that Merck, the primary source of BCG, was producing BCG again.

We received word from Merck that as of August 29th, a limited supply of BCG was shipped out for distribution to healthcare providers. The facility issue has been resolved and production of BCG has resumed, though not up to full production levels. There may be some lag in providing the drug through the end of the year while they get back into full production, but are closely monitoring the supply to ensure BCG reaches patients. Merck will also reach out to providers with this production update.

For updated information, go to the BCAN site.

For updated information, go to the BCAN site.

It’s hard to explain to folks outside the bladder cancer community how alarming this drug shortage is, but I’ll try.

First, you should know that bladder cancer is the sixth most common cancer in the U.S. and the fourth most common for men specifically. When diagnosed at stage one, patients have an 88% chance of survival. Put differently, 12% of people diagnosed with stage one cancer die from it.

With treatment. 

If untreated, high grade bladder cancers are aggressive and persistent. They progress relatively quickly. Once the cancer becomes stage two, patients have a 37% chance of dying from it.

Second, you should understand that BCG, which is an “attenuated live bovine tuberculosis bacillus” that has been used as a vaccine for tuberculosis, is used intravesically to treat bladder cancer. It works by creating an immune response in the bladder to kill cancer cells and to prevent their recurrence.

It is the only drug treatment for bladder cancer, and has been for more than 20 years. If the BCG is not successful, then American doctors recommend radical cystectomy, the removal of the bladder and most of the sexual organs. As you can well imagine, the surgery is traumatic and life changing.

Third, research is vastly underfunded for bladder cancer. While incidences of breast cancer outnumber incidences of bladder cancer by about three times (234,000 to 73,000), funding for breast cancer outpaces bladder cancer by 26 times. (All stats are from SEER and the National Cancer Institute.)

Bladder cancer is the neglected middle child of adult cancers despite being the most expensive cancer to treat, partially because of high rates of recurrence. (A little fewer than 40,000 died from breast cancer, and just under 16,000 from bladder cancer.)

Recurrences at stage one, which are very common with bladder cancer, are treated with BCG or, depending on the details of the recurrence, with a radical cystectomy.

At this point, I just hope people in the U.S. and all over the world don’t have the choice of BCG taken from them because of manufacturing problems.

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