UPMC is considering restrictions on its use of a vital chemotherapy drug that is the backbone in the treatment regimens of many cancers, including lung, breast and bladder.
Carboplatin is a generic cancer drug that's been in use since the 1960s and is administered in outpatient settings. The drug slows and can even stop the growth of cancer cells, making tumors easier to remove. Patients taking carboplatin tend to have fewer side effects when compared to those who take other cancer drugs, giving them a better quality of life while they’re in treatment.
In recent months, the supply of this medication and other cancer drugs has been dwindling. The New York Times reports that shortages can be traced to the Food & Drug Administration's temporary shutdown of an overseas manufacturer due to quality control violations.
UPMC, Pennsylvania’s largest medical system, appears to be feeling the most immediate consequences of these supply chain disruptions. However, Allegheny Health Network, West Virginia University Health System and many other cancer centers across the U.S. will likely face difficult choices in the coming weeks and months if the situation does not improve, according to officials at those hospitals.
If shortages continue, medical experts tell WESA that physicians will be forced to decide which patients are treated with this drug. This could further limit the length of a terminal patient’s life; it’s even possible that some people might die — not because their cancer lacks a cure, but because inventory of these medications has run out, medical professionals say.
Who takes priority?
To mitigate the impact of this supply chain crisis, the American Society of Clinical Oncology recommends that patients wait longer between chemotherapy treatments and that providers administer lower doses of the medications.
"If this drug shortage doesn’t turn around quickly … there are curable patients that could potentially die," said Dr. Stanley Marks, an oncologist and chairman of the UPMC Hillman Cancer Center.
Currently, the situation at UPMC is not that dire. On Wednesday afternoon, a UPMC spokesperson said it's slated to receive two shipments of carboplatin, which will sustain oncology operations for the next few weeks.
Still, the ramifications of the carboplatin scarcity are significant for UPMC — the health system provides cancer treatment at nearly 70 outpatient facilities. More than a third of these outpatient centers operate through partnerships with several smaller medical networks throughout Western Pennsylvania, including Washington Health System, St. Clair Health System and Independence Health System, the recently merged Butler Health and Excela Health Systems.
To stretch its inventory, UPMC has switched some terminal cancer patients who were taking carboplatin to alleviate their symptoms to other medications in order to prioritize people with curable cancers, Marks said.
"We do have some drug, but certainly not enough for all of our patients," Marks said. "And so our pharmacy team ... does a daily census of what we're going to need tomorrow and which site, which patients are coming in, what diseases do they have, and honestly, we try to prioritize so that the patients who are getting these chemotherapy drugs with a curative intent would be at the top of the list."
Patients who have a high probability of survival are impacted as well: Those who otherwise would be on carboplatin have been taking chemotherapy drugs with more severe side effects. For example, Marks says some breast cancer patients might have to take adriamycin, which can damage the heart.
"One dose isn't going to matter. But if you got to do it multiple times, there's a great risk of cardiac damage," said Marks, who adds that patients can switch back to carboplatin if the drug becomes more plentiful during the course of their treatment.Bigger than UPMC — and carboplatin
A widely used alternative to carboplatin is cisplatin, another generic medication that's been around for decades.
Cisplatin is not an option for all patients, including those with underlying kidney disease and bladder problems, because the drug can cause renal toxicity. Also, it comes with more side effects, including nausea and temporary hearing loss. But sometimes it's preferred over carboplatin, including for leukemia treatment.
Yet, cisplatin's supply chain is drying up due to the same market forces hindering carboplatin production and distribution. AHN reports that within the next month it may have to start rationing its use of cisplatin by prioritizing it for patients with curable cancers. As at UPMC, some people might be put on alternative regimens or have their care delayed.
Dr. Nathan Bahary, division chief of medical oncology at AHN, acknowledges these realities create ethical dilemmas: "Is the young person with the totally curable germ cancer [growths that form from reproductive cells] more important than the older person with a small-cell lung cancer?"
Medical experts tell WESA this scarcity will likely intensify for at least another couple of months and is unlikely to fully resolve until later this year.
Dr. William Figg, the associate director of cancer research at the National Cancer Institute, says he’s hearing reports of these shortages from all over the country, and he anticipates that there will be patients who are harmed as a result.
Medications due to supply chain issues are not a novel issue even before the COVID-19 pandemic. A contributing factor to the sudden shortfall of carboplatin and cisplatin is that they're generic medications, meaning they cost less and offer less financial incentive to manufacture them. The result is a lack of redundancy: When production stops at one location, its loss is apparent.
"One of the things I think is important is if the FDA does an inspection and they find a problem, they need to immediately notify the other manufacturers to ramp up production," said Figg.
UPMC's Stanley Marks is also frustrated by the FDA's response to this sudden dearth of chemotherapy medications. He said he would like the federal agency to change its regulations in order to allow the drugs to be imported from Canada and Europe, along with new policies to drive up domestic production.
In an email statement, the FDA said it cannot require pharmaceutical companies to make or increase production of a certain drug or change the distribution of that drug. The agency also said it understands that manufacturers expect availability to increase in the near future, but it gave no timeline.
This uncertainty is hard on patients, explained a certified oncology nurse at one of UPMC’s outpatient clinics, who did not have permission from her employer to speak publicly on this topic.
“I can’t tell cancer patients if they’re going to die, I can’t tell them if the medicine is going to work,” said the nurse. “But I should be able to tell them if we have the medicine, and with the medicine I’m going to try my hardest to save their life.”
