Supplies of a Critical Bladder Cancer Drug are Dwindling
Bob Field, a 72-year-old New York banking executive, received a call from his urologist’s office canceling his next appointment.
According to a recent article in STATnews, Field was scheduled to receive his second round of BCG, a potent and highly effective immunotherapy for bladder cancer.
His doctor’s office administrator explained that they didn’t have sufficient stocks of BCG and had to ration their supplies. Field was thrown into the category of “no longer eligible”.
He soon discovered that smaller clinics and even larger hospitals no longer have supplies of the drug. That includes Field’s own hospital, Memorial Sloan Kettering, one of the foremost cancer centers in the nation.
BCG is an exceptionally effective biologic therapy that is popularly used to treat cancer patients. Field discovered that many of these hospitals and clinics have changed their policies and are only distributing to recently diagnosed patients that have active disease.
He expressed his feelings as “horrified, depressed, annoyed, and angry” after calling hospitals and clinics throughout New York in an attempt to gain access to the drug.
For Field and others in his situation, the consequences are not only physical but emotional as well.
The standard treatment involves testing for cancer every three to six months after the initial treatment. Follow-up doses are required to maintain remission. Right now this is out of reach for Field.
He declared “This is a proven, time-tested means of helping people prevent recurrences of bladder cancer — and it’s suddenly unavailable. ”
Commercial Forces at Work
Most people may not be aware that drug shortages are common in the U.S. Health care providers are often forced to manage without sufficient supplies. The shortages may be caused by a surging demand due to an epidemic or it may be the result of natural disasters at production plants.
Other shortages are caused by a lack of incentive for manufacturers to produce a drug like BCG, in spite of the fact that it has been effective in treating cancer since the 1970s.
Other causes for drug shortages may include:
- BCG is priced at a low $100 to $200 per dose
- difficulty in production
- Entire batches of any drug can be destroyed through one mistake
Companies are just not interested in manufacturing BCG even though it is no longer patented.
BCG is a good example of a critically important drug that does not generate much profit for its manufacturer and as result gets very little attention from the pharmaceutical community even though it is very effective.
Currently, Merck is the sole manufacturer in the United States and European markets. The company has expressed concern for cancer patients who depend on the drug and it is working at capacity to increase supplies.
Tyrone Brewer, vice president of global oncology marketing at Merck, gave encouragement to cancer patients by saying that Merck intends to continue BCG production. Merck has plans to produce between 600,000 to 870,000 vials of BCG this year and is working on ways to increase production.
Brewer said “It’s not our intent that we’ll use this drug to increase our margins. This is not about the profits, but a mission to save and improve lives.”
The fact that Japan, Canada, and Europe are developing their own strains of BCG is encouraging. If the FDA grants its approval, there is hope for bladder cancer patients.
Dr. Robert Abouassaly, a urologist at the Cleveland Clinic speaking about BCG, said that the shortage is a “huge deal” because there are few alternatives that are as effective for these patients.
Dr. Robert Svatek, Chief of Urologic Oncology at University of Texas San Antonio, commented that chemotherapies such as gemcitabine or mitomycin may be used in lieu of BCG but they are not as effective. He said that this has been proven by multiple trials comparing BCG with chemo drugs.
Donna Hoff, 71 years old and a retired bookkeeper, started BCG therapy after removal of tumors in her bladder. In Huff’s case, BCG was combined with an immune-boosting drug. To date Donna remains in remission.
Now she is very concerned that if she loses BCG therapy she will have a relapse. Donna says that “You’re never really in remission. It’s always sitting on your shoulder, waiting to return.”
About Bacillus Calmette-Guérin (BCG)
Bacillus Calmette-Guérin is a live, weakened strain of Mycobacterium bovis, a tuberculosis-causing bacteria. BCG, one of the earliest examples of immunology, was used as a tuberculosis vaccine in 1921.
Researchers began to study BCG as an oncology tool after observing that the live, weakened BCG bacteria seemed to correlate with tuberculosis patients having a lower rate of cancer.
In the 1970s doctors found that if BCG bacteria were fed directly into a cancer patient’s bladder using a catheter, the bacteria activated the patient’s immune system, thereby stimulating T cells to attack tumors.
BCG became the standard of care for certain forms of bladder cancer. It is more effective than both chemotherapy and surgery plus it is less costly.
BCG’s response rate for bladder cancer patients is about 70%. This pertains especially to cancers with high-grade, nonmuscle invasive disease. Putting this in proper prospective, there are approximately 80,000 new cases of bladder cancer in the U.S. each year. Bladder cancer is the sixth most commonly occurring cancer in the nation.
About BCG’s History of Shortages
Supplies of BCG have always been troublesome. In 2011 the FDA found 58 instances of mold during an inspection of Sanofi’s manufacturing plant as an aftermath of a flood. The FDA closed the plant. This was the first of several BCG shortages.
The issues continued periodically as Sanofi was dealing with various regulations.
In 2016 halted stopped production. This left Merck supplying almost all of the world’s stock of the drug. Unfortunately, at the same time, Merck was having its own manufacturing problems. Then Sanofi attempted to sell its manufacturing assets at a discount but was unsuccessful.
There are always ripple effects each time BCG has a shortage. During BCG’s shortage in 2014, the list price of chemotherapy drugs used in bladder cancers jumped.
Remedies for Expanding Supplies
The Bladder Cancer Advocacy Network and the American Urological Association, together with other physician groups, are suggesting treatment guidelines to help prolong the supply.
These would include dividing dosages and discontinuing maintenance therapy, as is the case with Field. Evidence is mounting that smaller doses may be effective in fighting bladder cancer.
