Understanding the BCG Shortage

2 min read

For some time now, there has been a shortage of Bacille Calmette-Guerin (BCG). It is a drug that doctors prescribe to treat bladder cancer in its early stages. People with bladder cancer receive the drug with the help of a catheter passed into the bladder. BCG causes your immune system to hold back cancer cell growth.¹

Understanding the cause of the shortage and how you may be affected can help you better navigate this issue.

Why is BCG in short supply?

Right now, there is a shortage of this critical drug, which experts predict will continue for a while. There are efforts in place to curb ongoing supply issues.

The drug company Merck has unveiled plans to construct a BCG manufacturing plant in Durham, North Carolina. It will likely be up and running by 2026 or 2027. With the new plant in place, the expected output of BCG will triple compared to current manufacturing figures.²

The BCG shortage started in 2011 when the US Food and Drug Administration (FDA) suspended BCG manufacturing at the Sanofi Pasteur plant in Toronto over health and safety issues. An inspection unearthed mold in the production area due to earlier floods. In 2017, Sanofi Pasteur stopped making BCG for good.²

Another reason for the shortage: the process of making BCG is complicated. It is a slow-growing bacteria and must remain sterile. And, since there is no patent on BCG, drug companies do not earn much profit from making and selling it.²

An irregular hospital distribution schedule has only worsened the supply shortage. A hospital that receives BCG one month is not guaranteed to receive it the next.²

What is the impact of the BCG shortage?

BCG is the main immunotherapy for early-stage bladder cancer and works well to stop cancer from coming back. Doctors usually prescribe the drug after surgery to remove cancer.³

BCG works by slowing down the growth of tumors, which lowers your chance of needing your bladder removed (cystectomy) in the future. Research also shows BCG is the most effective therapy for bladder cancer. One study found that 46.7 percent of people with bladder cancer who took BCG stayed cancer-free for nearly 4 years.^3,2

How should doctors prescribe BCG during a shortage?

Until the BCG shortage is resolved, doctors and people living with bladder cancer will have to find ways of adapting. The American Urological Association (AUA) has proposed suggestions for how doctors should prescribe BCG when there are supply issues. The group recommends:¹

When possible, people with high-risk forms of bladder cancer should receive full doses of BCG. If there is a shortage, this group should receive either half- or third- doses.
People with low-risk bladder cancer or those in the maintenance phase of the disease should not use BCG.

What are alternatives to BCG?

While we wait for a larger supply of BCG, the AUA recommends doctors prescribe other drugs as alternatives for treating bladder cancer. They include:¹

Mitosol® (mitomycin)
Valstar® (valrubicin)
Gemzar® (gemcitabine)
Taxotere® (docetaxel)
Ellence® (epirubicin)

Doctors use these drugs to treat bladder and other forms of cancer.

If you take BCG and are concerned about the drug shortage, talk to your doctor. They can offer guidance on adjusting your dosage or finding an alternative treatment.

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sophizzy7 Member
Every time I read an article about the Bacillus Calmette-Guerin (BCG) shortage I get frustrated, irritated, and just outright mad. BCG has been used for decades and is a remarkably effective medicine. The “Gold Standard” for those with NMIBC. We’re told it’s not easy to produce, and with a lapse of the patent and a relatively modest $100-$200 a dose, there’s not much profit in its production. It beats out both surgery and chemotherapy in keeping bladder tumors at bay with a response rate more than 70 percent. It’s substantially cheaper, too. This BCG shortage is a huge deal,” said Dr. Robert Abouassaly, a urologist at Cleveland Clinic. “We don’t have any alternatives that are as effective for these patients.” Certain chemotherapies, such as gemcitabine or mitomycin, can be used in lieu of BCG. But their efficacy pales in comparison, said Dr. Robert Svatek, chief of urologic oncology at University of Texas San Antonio. “There’s no question that BCG is more effective,” Svatek said. “Multiple trials have compared BCG to chemo, and every time it wins. It beats the chemo.” It should also be noted that both gemcitabine and mitomycin costs are 10 times that of BCG. The Bladder Cancer Advocacy Network, a Maryland-based patient advocacy group, along with the American Urological Association and several other physician groups, have come up with treatment guidelines to help navigate the shortage. The suggestions include dividing up doses, and stopping maintenance therapy entirely. Of course, we the patients can also elect a more extreme route: complete bladder removal surgery, or the construction of a bladder-like pouch made out of intestine. The costs of these complex surgeries are in the tens of thousands of dollars, and require years of follow-up treatment. I find this so call advocacy difficult to understand with consideration to the emotional and physical consequences to the patient. Since the (BCG) vaccine appears on the World Health Organization (WHO) list of Essential Medicines; and BCG vaccine is used in many countries to prevent not only TB, but meningitis and military disease - maybe there’s hope that companies in Japan, Canada, and Europe that are developing their own strains of BCG, will ultimately be approved by the FDA. Now with the onset of COVID-19 worldwide pandemic there’s interest in conducting test/trials using the BCG vaccine particularly in the Netherlands and Australia to verify its efficacy against CORVID-19. These trials involve thousands of volunteers. What I found interesting, when questioned about availably or the lack of BCG due to the worldwide shortage, Mr. Paul Hegarty Consultant Urologic Surgeon at Mater Private Hospital Dublin stated “ He did not advocate giving the vaccine to populations until that was completed because of the possibility of side effects as a novel virus was involved, and because not enough vaccine was available – though production could be scaled up quickly.” So why am I frustrated, irritated, and just outright mad. Because (BCG) is a proven effective medicine for NMIBC. Considered the “Gold Standard”, and yet we continue to hear about a shortage since 2012. Its, 2020, by now you would think a solution would have been developed. After all, its been around for a hundred years, and used worldwide. Because (WHO) list it as an Essential Medicine and our FDA needs to address oversea suppliers for approval. Because the so-called Bladder Cancer Advocacy Network cavalier attitude towards patient well-being. Because now that it’s being considered in testing/trials pertaining to CORVID-19, that if necessary, production can be scaled up quickly. I thought part of the shortage problem was due to the amount of time to produce? BCG is working for me; I pray others will have the opportunity to receive this treatment option and continued maintenance as needed.
1. kimpossible Member
 Thank you! Every one of my thoughts and concerns are addressed in your post. I have had success with BCG, and thankfully absolutely no side effects. I very much want to retain my bladder, and I am scheduled for maintenance in July. Unfortunately, due to BCG shortages am being told that my option is GEM/DOCE instillation - Gemcitabine combined with Docetaxel.