|May 30, 2023|
Cancer drug shortages: 14 medicines now in short supply, according to FDA
Widespread shortages of cancer drugs are forcing doctors to make difficult decisions about how to treat their patients, including rationing doses and turning to other treatment options with potentially more side effects.
As of Wednesday, the Food and Drug Administration listed 14 cancer drugs in shortage.
“The oncology shortage is especially critical,” FDA Commissioner Dr. Robert Califf told NBC News. “I’m a former intensivist doctor and I’m very aware of the consequences if you can’t get needed chemotherapy.”
According to a March report from the Senate Committee on Homeland Security and Governmental Affairs, drug shortages are at record highs. New drug shortages increased by nearly 30% between 2021 and 2022. By the end of 2022, there was a record five-year high of 295 active drug shortages.
“I don’t know of a time that’s worse than this,” said Dr. Julie Gralow, the chief medical officer and executive vice president of the American Society of Clinical Oncology. “What’s different about this shortage is, I think, it’s just the broad applicability of these drugs, how important they are, you know, globally, in the U.S., in the treatment of many diseases.”
Among the drugs in shortage is carboplatin, a chemotherapy agent used as a first-line treatment for a number of cancers.
“Carboplatin is such an important drug for the treatment of many cancers — breast cancer, ovarian, head and neck, lung cancer, among several others,” said Dr. Lucio Gordan, a medical oncologist and president of Florida Cancer Specialists and Research Institute, a network of cancer clinics. Gordan said they were completely out of the drug for nearly two weeks.
“I’ve been doing this for 20-plus years. This is the worst I’ve ever seen,” he said.
Carboplatin isn’t just an effective drug; it’s also less toxic and causes fewer side effects than other available drugs.
“One of the issues though with these alternative medications is often they’re not as good, so it may compromise survival outcomes,” said Dr. Angeles Alvarez Secord, president of the Society of Gynecologic Oncology.
In addition, “when there’s more toxicity, there’s more cost to the treatment because you’re also dealing with the side effects, or giving additional drugs to try to prevent the side effects,” Secord said. “So the alternatives often, even though they’re present, are still not meeting the best standard of care.”
Nationwide, hospitals and cancer centers have been forced to make similar decisions when it comes to cancer care.
According to a May survey conducted by the Society of Gynecologic Oncology, doctors in at least 40 states have at least one chemotherapy drug in shortage.
What led to the shortage and what can fix it?
The current carboplatin shortage was caused in part by quality concerns at one manufacturing facility, Intas Pharmaceuticals, in India, but experts say the real problem is more chronic.
“Unfortunately, the profitability of this industry is very low or nonexistent,” Califf said. “A number of firms are going either out of business, or they’re having quality problems because of difficulty investing in their technology. That’s the core underlying reason for the shortage that we’re seeing.”
Califf said the FDA is working with additional manufacturers to make more carboplatin available.
Long-term solutions, however, are going to require “intervention by Congress and the White House in order to get this industry in the right place,” he said, adding that a White House team has been working on the drug shortage issue.
Teplinksy, the oncologist in New Jersey, said she’s been encouraging her social media followers to reach out to elected officials to advocate for timely production of chemotherapy drugs and long-term policies to ensure this doesn’t happen again.
“Delaying care impacts outcomes,” Teplinsky said. “And so in this case, either we can’t give people what they need, or we have to wait, which we know will lead to negative consequences.” (Source: NBC News)
Story Date: May 26, 2023