Shortages of cancer drugs are rendering patients defenseless against the disease, doctors in hospitals across the US have warned.
The circumstances are dire for potentially tens of thousands who rely on these medications for conditions such as acute lymphoblastic leukemia in children, metastatic ovarian and bladder cancer, and advanced-stage prostate cancer.
With some shortages expected to carry on for months, healthcare professionals say people will certainly die before manufacturers can ramp up production and remedy supply problems.
Doctors are now scrambling to find alternative treatment routes for their patients, potentially leaving them with substandard care.
The graphs shows at each point the number of active shortages at the end of each quarter going back to 2018. At its peak last year, there were 295 drugs in shortage
Pluvicto, a new medication for advanced prostate cancer, will remain in shortage until June at the earliest due to production delays at Novartis’ facility in Italy
Drug shortages are becoming more common in the US as financial investment in the development of generic medications dries up.
A Senate report published last month found that shortages of even common medications like amoxicillin and Tamiflu and over-the-counter cold and flu medication such as children’s Tylenol have increased 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 bring in less profit.
Dr. Vimala Raghavendran, senior director of the pharmaceutical supply chain center at US Pharmacopeia said last month: ‘Manufacturers only receive pennies per dose for some of these drugs.’
In fact, generic manufacturers now sell many of the most widely prescribed generic drugs in the US for 1 cent to 5 cents per pill.
The injectable methotrexate, which is used to treat cancers such as acute lymphoblastic leukemia in children is in short supply, as is the drug cisplatin for metastatic ovarian and bladder cancer.
Fluorouracil, which is used to treat skin, colon, breast, pancreas, and stomach cancers is also scarce, 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) that the drug is on back order due to manufacturing delays, while Fresenius Kabi, Teva, and Hikma didn’t provide 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.
The shortages may not be alleviated until June in some cases, according to the manufacturers.
Millions of Americans could be affected by the shortages. Methotrexate is very common with more than 5.8 million prescriptions doled out in 2020. Cisplatin is a chemotherapy drug that is given as a treatment for many types of cancers. Meanwhile, roughly 962,000 prescriptions for fluorouracil were written in 2020.
Dr David Margraf, a pharmaceutical research scientist at the the University of Minnesota’s Center for Infectious Disease Research and Policy said: ‘Patients may have already exhausted other treatment options and have few remaining choices. Oncology drug shortages reduce the expected survival times of patients, which leaves them less time to spend with their loved ones. It’s truly a tragedy.’
Cisplatin is a chemotherapy drug that is commonly used for bladder cancer and improves the likelihood that surgery will be successful.
It is the gold standard for treating certain forms of cancer, but shortages have left oncologists wondering if they will be able to continue treating their patients.
Heng Yang, clinical pharmacy specialist at UChicago Medicine said: ‘So far, we are running at a historically low number—that I can say definitely.’
The injectable drug Pluvicto, used to treat advanced prostate cancer, is also in shortage.
Drug behemoth Novartis explained production hiccups at its manufacturing facility in Italy had caused the company to halt further supply to new patients until it can produce more of the drug.
Pluvicto is made in small batches at a manufacturing facility in Italy, with only a 5-day window for each dose to reach its patient and no possibility of stockpiling. The FDA reported the Pluvicto shortage on March 7, saying the drug is expected to be unavailable for four months while it gets approval to open US facilities.
A patient with late-stage prostate cancer that has spread to other parts of their body does not have the luxury of waiting months for their medication to come back in stock. Robert Landfair, a 76-year-old Chicagoan with stage 4 prostate cancer is confronting the shortage head-on.
Mr Landfair’s doctor, 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 waitlist for the medication, which likely won’t become available for at least a couple of months.
Landfair told NBC News: ‘I definitely need that drug. 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 this year of prostate cancer.
Jonathan McConathy, director of the division of molecular imaging and therapeutics at the University of Alabama at Birmingham told the Wall Street Journal: ‘People will die from this shortage, for sure.’
And Andrei Iagaru, a professor of radiology-nuclear medicine at Stanford University said: ‘You’ve got to tell people that they have to wait when you actually know that they don’t have that much time left… Any delay is impactful.’
There were 295 drugs in shortage at the end of 2022, 17 of which have been in shortage for over a decade. Because manufacturers of cheaper generic drugs only make a small profit per dose, there is little financial incentive for multiple manufacturers to make a generic medicine.
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