Cancer drug shortages are leaving patients defenseless against the disease, doctors in US hospitals warn.
Conditions are dire for potentially tens of thousands who depend on these drugs for conditions such as childhood acute lymphoblastic leukemia, metastatic ovarian and bladder cancer, and advanced prostate cancer.
As some shortages are expected to persist for months, health professionals say people will surely die before manufacturers can ramp up production and fix supply problems.
Doctors are now struggling to find alternative treatment routes for their patients, potentially providing them with substandard care.
The graph shows the number of active shortages at each point at the end of each quarter, going back to 2018. At the peak last year, there were 295 drug shortages
Pluvicto, a new drug for advanced prostate cancer, will remain in short supply until June at the earliest due to production delays at Novartis’ plant in Italy
Drug shortages are becoming more common in the US as financial investment in generic drug development dries up.
a Senate report published last month, it found that shortages of even common medicines like amoxicillin and Tamiflu and over-the-counter cold and flu medicines like Tylenol for kids have increased by nearly 30 percent between 2021 and 2022.
Generic drugs are versions of more expensive brand-name drugs that are cheaper for companies to make but generate less profit.
Dr. Vimala Raghavendran, senior director of the pharmaceutical supply chain center at US Pharmacopeia said last month: ‘Manufacturers get only pennies per dose for some of these drugs.’
In fact, generic manufacturers now sell many of the most commonly prescribed generics in the US for 1 cent to 5 cents per pill.
The injectable methotrexate, used to treat cancers such as childhood acute lymphoblastic leukemia, is in short supply, as is the drug cisplatin for metastatic ovarian and bladder cancer.
Fluorouracil, which is used to treat skin, colon, breast, pancreatic and stomach cancers, is also in short supply, according to the American Society of Health-System Pharmacists (ASHP).
Methotrexate makers Accord and Pfizer told the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) said the drug is on backorder due to production delays, while Fresenius Kabi, Teva and Hikma have not provided a reason for the shortage.
Cisplatin makers WG Critical Care, Hikma and Teva also gave no reason for the scarcity, while fluorouracil supplier Fresenius Kabi cited increased demand for the drug.
According to the manufacturers, the shortages will not be corrected until June in some cases.
Millions of Americans could be affected by the shortages. Methotrexate is common in over 5.8 million prescriptions handed out in 2020. Cisplatin is a chemotherapy drug given as a treatment for many types of cancer. Meanwhile approx 962,000 prescriptions for fluorouracil are written in 2020.
Dr. David Margraf, a pharmaceutical researcher at the University of Minnesota’s Center for Infectious Disease Research and Policy said“Patients may have already exhausted other treatment options and have few other choices.” Oncology drug shortages are shortening patients’ expected survival times, leaving them less time to spend with their loved ones. It’s really a tragedy.’
Cisplatin is a chemotherapy drug commonly used for bladder cancer and increases the chances of successful surgery.
It is the gold standard for the treatment of certain cancers, but shortages have left oncologists wondering if they can continue to treat their patients.
Heng Yang, clinical pharmacy specialist at UChicago Medicine said: ‘So far we are running at a historically low number – I can say that for sure.’
The injectable drug Pluvicto, which is used to treat advanced prostate cancer, is also in short supply.
Drug giant Novartis explained that production disruptions at its production facility in Italy had caused the company to halt further deliveries to new patients until it could produce more of the drug.
Pluvicto is made in small batches at a production facility in Italy, with just 5 days for each dose to reach the patient and no ability to stockpile. The FDA reported the Pluvicto shortage on March 7, saying the drug is expected to be unavailable for four months while it receives approval to open US facilities.
A patient with late-stage prostate cancer that has spread to other parts of his body does not have the luxury of waiting months for their medication to be back in stock. Robert Landfair, a 76-year-old Chicagoan with stage 4 prostate cancer, is confronting the shortage head-on.
Mr. Landfair’s physician, Alan Tan of Rush University Medical Center in Chicago, started his patient on Pluvicto after several unsuccessful rounds of chemotherapy. Now Landfair is on a waiting list for the medication, which probably won’t be available for a few months.
Country fair told NBC News: “I definitely need that medicine. It’s the only way I see my life.”
An FDA approval of Novartis’ application for a manufacturing facility in New Jersey will come too late for thousands of men who will die from prostate cancer this year.
Jonathan McConathy, director of the division of molecular imaging and therapies at the University of Alabama at Birmingham told the Wall Street Journal: “People are definitely going to die from this shortage.”
And Andrei Iagaru, professor of radiology and nuclear medicine at Stanford University, said, “You have to tell people to wait when you actually know they don’t have that much time left… Any delay has an impact.”
At the end of 2022, 295 medicines were at risk, 17 of which for more than a decade. Because manufacturers of cheaper generic drugs make only a small profit per dose, there is little financial incentive for multiple manufacturers to make a generic drug.