Bob Field was set to kick off his second course of BCG — a potent immunotherapy that treats his fast-growing bladder cancer. Instead, the New York City banking executive got a call from his urologist’s office, canceling that week’s appointment: They were running low on vials of BCG and rationing their dwindling supplies. Field was no longer eligible.

It wasn’t just one doctor’s office. There’s a critical national shortage of BCG, a biologic drug that has been used for decades and that is a remarkably effective medicine. Many smaller clinics have already run out of the lifesaving drug, and larger hospitals — including New York’s Memorial Sloan Kettering Cancer Center, where Field is being treated — have changed their policies on distributing BCG to prioritize newly diagnosed patients with active cancers.

“In a word, I’m horrified. Depressed, annoyed, angry,” said Field, 72, who is now calling hospitals and clinics across New York to see if he can gain access to the drug. “This is a proven, time-tested means of helping people prevent recurrences of bladder cancer — and it’s suddenly unavailable. So there’s some stress.”


Drug shortages are alarmingly common in the U.S., with health care providers often scrambling to make do without sufficient supplies. Those shortages occur for any number of reasons — natural disasters at productions plants or surging demand caused by an outbreak, for instance. But there are also commercial forces at work.

Companies have very little incentive to manufacture a drug like BCG. Although it’s been used to fight cancer since the 1970s, it isn’t easy to produce. And priced at a relatively modest $100-$200 a dose, it’s not a drug that companies are rushing to make, even if it’s no longer patented; right now, Merck is the only manufacturer for the U.S. and European markets.

BCG, in other words, is an example of a medically important drug that gets neglected because it fails to generate a lot of money for its maker.

“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.”

Merck acknowledges supplies are short and has expressed sympathy for cancer patients in need. At the same time, it says it is already working at capacity to produce more of the drug.

The company has every intention of continuing BCG production for “the foreseeable future,” according to Tyrone Brewer, vice president of global oncology marketing at Merck.

“It’s not our intent that we’ll use this drug to increase our margins,” Brewer said. “This is not about the profits, but a mission to save and improve lives.”

BCG, short for Bacillus Calmette-Guérin, is one of the earliest examples of immunotherapy in medicine. The drug was first used as a tuberculosis vaccine in 1921: It’s a live, but weakened, strain of a tuberculosis-causing bacteria called Mycobacterium bovis.

Researchers began to notice that patients with tuberculosis had lower rates of cancer, prompting early study of BCG as an oncologic tool. In the 1970s, it was found that if the live, attenuated BCG bacteria were fed through a catheter directly into a cancer patient’s bladder, they revved up his immune system — stimulating T cells to attack tumors.

Ever since, BCG has been the standard of care for certain forms of bladder cancer. It beats out both surgery and chemotherapy in keeping bladder tumors at bay. It’s substantially cheaper, too.

There are about 80,000 new cases of bladder cancer in the U.S. each year, making it the nation’s sixth most prevalent cancer. About 20 percent of these cancers — specifically, those with high-grade, non-muscle invasive disease — can be treated with BCG. It doesn’t work for everyone, but the response rate is more than 70 percent.

Standard treatment calls for clinicians to continue checking for cancer every three to six months after initial dosing, and administer follow-on doses of BCG to ensure the cancer remains in remission. Those are the kinds of doses that have remained out of reach for Field.

For him and other patients in similar circumstances, the consequences are as emotional as they are physical.

Donna Hoff, a 71-year-old retired bookkeeper, had her bladder tumors surgically removed, then was put on a regimen of BCG combined with interferon, another drug that boosts immune response. So far, the cancer has not come roaring back. But she’s concerned that if her BCG maintenance treatment is abbreviated, it might.

“You’re never really in remission,” Hoff said. “It’s always sitting on your shoulder, waiting to return.”

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.”

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.

As effective as BCG may be, creating a safe strain of a live tuberculosis bacteria is rife with complications. The process, start to finish, takes about three months — beginning with two months of horticulture. BCG is grown on a specific variety of potato, and that alone takes two months to grow. Once harvested, it’s brewed in giant vats over the course of a month. And plenty can go wrong.

Sometimes entire batches of drugs like BCG can get ruined if someone just pushes the wrong switch, or throws one wrong chemical into a big vat of the drug.

“I’ve seen that happen — just a big mistake, somebody puts in the wrong chemical, and several million dollars worth of a drug has to be discarded,” said Dr. Otis Brawley, a physician at Johns Hopkins and until recently the chief medical and scientific officer at the American Cancer Society.

Supplies of BCG have been erratic for several years, beginning in 2011, when the Food and Drug Administration inspected a Toronto vaccine laboratory where Sanofi was manufacturing the drug and found 58 different instances of mold after a flood. The FDA promptly shuttered the lab, triggering the first of a series of BCG shortages.

The shortages continued, on and off, as Sanofi dealt with regulatory blowback. It stopped BCG production in 2016, leaving Merck to supply the drug for most of the world. But right around the same time Merck began experiencing its own manufacturing issues.

When Sanofi attempted to sell off its BCG-making assets at a discount, there were zero takers.

“Companies like Merck don’t make money off of BCG,” said Dr. Benjamin Davies, a professor of urology at University of Pittsburgh. “So there’s very little incentive, outside of altruism, to make this better.”

When shortages of BCH hit, there are ripple effects.

A 2017 New England Journal of Medicine piece authored by Davies found list prices of chemotherapies used in bladder cancers spiked dramatically during a 2014 BCG shortage: The list price for mitomycin jumped by 99 percent from $436 to $869 for the 40-milligram dose. And between 2012 and 2015 — years of BCG drought — annual Medicare Part B spending on mitomycin increased from $4.3 million to $15.8 million.

Companies don’t have their plants producing batches of the same drug year-round — they tend to tool up a plant to manufacture a drug for a finite amount of time, churning out a massive batch. They’ll typically sell that over the course of a year or two.

This is how Merck doles out its BCG — selling it in bulk to hospitals and other large-scale providers, allocating it proportionally around the world, based on need. The company expects to produce anywhere from 600,000 to 870,000 vials of BCG this year, though isn’t providing a timeline on when the drug will ready. It’s also exploring ways to increase BCG output, Brewer said.

At the same time, companies in Japan, Canada, and Europe are developing their own strains of BCG, however — and if they’re ultimately approved by the FDA, they might be able to allay future shortages of the drug.

For now, however, some patients will struggle to get access, just as other patients do with a host of other treatments in the U.S. health care system, said Erin Fox, senior director of drug information services at University of Utah. Common hospital provisions like IV fluids and morphine are constantly in production limbo.

That doesn’t make the shortages any less frustrating. “We pay the highest prices of any country, so these shortage situations shouldn’t happen like this,” she noted.

If there’s a silver lining to the BCG situation, Fox said, it’s that there’s growing evidence that smaller doses show efficacy in battling bladder cancers.

Indeed, to help prolong the supply of BCG, most urologists wind up dividing the dosage into thirds. There are studies, actually, that suggest that these lower doses are similarly effective in treating bladder cancer.

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, as was the case with Fields.

Dr. Karim Chamie, an associate professor of urology at University of California, Los Angeles, said the BCG shortage hasn’t affected his practice just yet. But although the stockpile of BCG at UCLA is still in good shape, Chamie projects that will soon change.

“Urologists in the community have already hit a shortage, and they’re referring their patients to me,” Chamie said. “So my clinic’s clogging up with patients who need BCG — and they may be using some of the BCG I might have given someone else.”

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  • I was told that Merck had stopped manufacturing bcg about a 10 months ago not sure if Kaiser Permanente were just keeping their supply for non Medicare so patients so now I’m doing 3 month cystoscope last one was clear hope January’s also clear

    • If what you said about Merck is true, I have a provision here and I don’t know if FDA will like it. While I am working to build this facility (American BCG Laboratory) to supply domestically made BCG to people in the U.S./North America, I will invite people to come to my laboratory to grow their own BCG and bring it back, with all proper documentation, to their urologists to help them do the instillation. If their urologists can’t do it due to prescription law, then they can consider doing it themself with the widely available catheters, of course, after proper training and the understanding that under current law, the procedures require prescription and a physician to perform, and may cause harm to people who are sensitive to instillation of BCG. I hope that some lawyers can help answer the questions. Yours, KO

  • So, while my husband fights along with his urologist to not have his in-situ bladder cancer go beyond that, no one cares to produce BCG because it is not profitable! It’s only produced by Merck for altruism! I apologize for this but I call BS! Trying to stack this up against mytomycin, and have BCG the winner, why not just charge the amount of a dose of mytomycin for a dose of BCG? Sanofi can longer be trusted for anything – on of meds for RA, made by Sanofi, has to come from Canada or I don’t get it, period. That is nothing compared to this shortage of BCG. All drug manufacturers know about this shortage, not one is going to step up and carefully manufacture this much needed medication. This is plain and simple pure greed! Oh, just remove the bladder and make a pouch from the intestine! Yeah well, that us a disastrous thing to do and works as well as handles on a football would. SOMEBODY DO SOMETHING ABOUT THIS!

    • Hi Polly: Sorry to hear your story. I am working on a solution through the establishment of the American BCG Laboratory (a nonprofit organization: with the goal to provide domestic supply of BCG for people in need. I am still waiting for the approval of the state attorney office to be eligible to receive donation from the public. I was told that it would take 8-12 weeks. I am also waiting for the opening of the laboratory where the research will be conducted and maybe some clinical-grade BCG will be produced (small amount but still will be regulated by FDA). Please don’t lose hope and please help spread the news about the BCG laboratory. Feel free to go to the website (under construction, still) and leave a message. Yours, KO

  • Trying to find out if there’s a list to get on for the medicine. I’m a bladder patient in Austin, Tx. My doctors says there’s a shortage, what can I do to help?


    • Luanne, I don’t live in Austin, but I would call other doctors to see if they have BCG available. I don’t know if Merck has a waiting list; they probably don’t dispense it that way. But if you are the only manufacturer of a lifesaving, necessary medication, you have a responsibility to produce what is needed. This situation has gone on too long! There is no excuse for this.

    • Call Merck directly and insist they send your urologist the BCG. Unbelievable my doctor recieved the BCG and a letter from Merke saying that he should give me my normal doses and voila…my doctor called me to let me go know my BCG treatments would not be changed. I had a treatment today.
      Contact your Congress representatives and tell. My letter from Tammy Duckworth was a waste of time. Basically her assistant answered my letter by telling me Merke couldn’t produce any faster. No kidding, I was patronized and decided to join any organization willing to take on the FDA and Merke.
      Very disappointing.

  • Dear All:

    American BCG Laboratory has been grated the 501(c)(3) status. I have to get everything in order so that I can start fund-raising and get the facility going and start the application for license from FDA to produce and market BCG in North America (US and Canada). Berkshire Innovation Center (Pittsfield, MA) in which the American BCG Laboratory is housed will be operational in January, 2020.

    As I have said before, how likely is it for you (the patients) to come to my facility to grow your own BCG, titer it and bring it back to your urologist for your own treatment? I will provide all necessary materials for you to make your own BCG. No FDA involved and you use it at your own risk but I will help you test it to ensure that it is what it is (genome sequencing and titering and free of contamination). I need someone who know regulation and law to answer the following questions:

    Will I get into trouble?

    Will your urologist do the intravesical instillation for you? The hospital?

    Will you (the patients) sign waiver forms to not sue us, in case you don’t like the treatment outcome?




  • Claiming Merck does not make a profit on BCG is like the auto dealer telling you the car is being sold at cost….no one is in business not to make money. If Merck is in fact not making a profit then that is the reason the supply is being cut back, and will totally stop at some point. With the need growing, one wonders why another company has not entered the marketplace. How we can discuss healthcare for all and without paying for it (oh, the very rich will get taxed) can ever be a promise when we can’t provide the drugs to keep those alive who currently need it and are paying for it. There is more to this story than meets the eye.

    • I agree there is something rotten in Denmark. From all the reading I have done, not only is there a shortage of BCG, but some facilities have all kinds while others have none. Somebody needs to get involved and do something before people die or are forced to have surgery that BCG may have kept them from.

  • My husbands bladder cancer recurred because he wasn’t able to get his BCG dosing. This is outrageous in this country.

    • You’re right; this shouldn’t be happening! I changed doctors for this reason! They were out of BCG, and were giving mitomycin instead. They didn’t tell me it was not as effective; I knew that on my own. There needs to be some regulation of these companies that are so cavalier about drug shortages. People’s lives depend on them!

  • As a healthcare professional this is very upsetting to me that my brother a newly diagnosed with bladder cancer patient is only able to receive 2 doses of treatment before being aware of the shortage. I’m wondering if there is an abundance of the alternative more expensive less effective chemotherapy? Things that make you go hmmm.

  • I’m entering the maintaince treatment part of the bladder cancer Meaning 1/3 dose bcg every six months. My dr says I need to do this so this cancer doesn’t return. If it’s not needed They would not be treating me Right ?

    • You’re right; this shouldn’t be happening! I changed doctors for this reason! They were out of BCG, and were giving mitomycin instead. They didn’t tell me it was not as effective; I knew that on my own. There needs to be some regulation of these companies that are so cavalier about drug shortages. People’s lives depend on them!

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