Cancer drug shortages: 14 medicines now in short supply, according to FDA
Category: News & Politics
Via: perrie-halpern • 11 months ago • 28 commentsBy: Marina Kopf and Catie Beck
S E E D E D C O N T E N T
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."
Carrie Cherkinsky, right, was traveling in Australia in March when she started experiencing severe abdominal pain. Doctors discovered a mass on her right ovary that she later learned was cancer.Courtesy Carrie Cherkinsky
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.
Florida Cancer Specialists knew that the shortage was coming and tried to prepare. For the last couple of months, they've been rationing by rounding down doses of carboplatin by 10%, which Gordan said doesn't diminish the drug's efficacy.
"We have been rounding down for a while," he said. "But we just ran out of the drugs, so there's nothing to be rounded."
The empty middle tray on the top shelf of this refrigerator at Florida Cancer Specialists in Gainesville, Florida, is usually stocked with carboplatin.NBC News
Carrie Cherkinsky, 41, of Tallahassee, Florida, learned of the shortage from a Facebook support group for women with ovarian cancer. Even so, she was shocked to learn that she wouldn't be able to get her second round of chemotherapy, scheduled for May 15, at Florida Cancer Specialists. Gordan was not involved with her care.
"Who's going to be held accountable for this?" said Cherkinsky, who was diagnosed with ovarian cancer in March. "For me not getting the lifesaving treatment?"
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.
Dr. Eleonora Teplinsky, a breast and gynecologic medical oncologist at Valley Health System in New Jersey, said the shortages are devastating.
"Cancer is life-changing as it is but you expect as a patient that you're going to walk into an office and be given the very best that exists," Teplinsky said. "And right now we don't have the very best to give in certain cancers."
Drug shortages cause extra stress not only for cancer patients, but for medical providers as well. On top of being in a workforce that's already burned out and exhausted from a pandemic, doctors have to scramble to find lifesaving treatments.
"All the practices in the country, not only in oncology, we have been stressed out much more since Covid," Gordan said. "This is another curveball that impedes us to do the best we can."
Shortages can sometimes catch providers off guard.
Suppliers don't give warning when a drug is about to be in shortage; they'll just stop filling all of their orders, said Andrea Iannucci, the assistant chief pharmacist at UC Davis Health. "So we place an order, and we think it's going to arrive and it doesn't, because the drug was unavailable," Iannucci said.
Keri Carvill, 44, of Sacramento, California, was diagnosed with triple-negative breast cancer in March but wasn't able to get her first dose of carboplatin until May 19. Triple-negative breast cancer is a particularly aggressive form of the disease.
"It's stressful and scary," Carvill said.
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."
In a statement to NBC News, Intas Pharmaceuticals said it is working with the FDA to release existing inventory of carboplatin and other medically necessary products. It is also working with the agency on a plan to resume manufacturing, but added that a date has not yet been confirmed for when that will happen.
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.
Teplinsky, 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.
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This isn't the first time this has happened. During Covid, shortages were delaying treatment, as well.
It seems to me that we need to diversify production. A failure in one plant in India shouldn't result in empty pharmacy shelves worldwide.
Perhaps have the government take over production of certain medications?
I'm not especially crazy about the idea, but it may have to, if the private sector can't get it together.
If a drug isn't a money maker for the drug manufacturer there will not be additional manufacturing facilities built to produce it and although it may not be the best solution the government will have to step in and take over the production of some drugs that are critical to the US.
We saw some of this when the price of insulin went through the roof, low margin drug that the big pharma decided to make big money on.
Florida Cancer Specialists have a center about 10 minutes from our house in Ocala, FL. A first rate facility and oncologists.
We didn't learn that with the baby formula shortage...
When the chip shortage became acute the US government stepped in and, IMO they will have to do this again with a number of life saving drugs.
I was thinking the same thing...
Our trade policies restrict imports of formula from Europe and Canada was also a factor.
Arvo drinker..we had no probs exporting our baby formula to the States to help you mob out at the time...
Probably got kids running around now with an Aussie accent..🐨🐨
I hate to say it but I believe the solution requires tariffs on medical ingredients coming from other countries. We got in this mess for a reason.
just who do you think pays those tariffs?
Sounds like greed. What we should expect from a for profit system I guess.
greed is big pharma's top priority, not health...
What kind of system would you prefer?
Medicare for all....
There should be some sort of government regulation when it comes to life-saving drugs.
Nixon was for that... and it still didn't happen.
I know it really wouldn't help as far as drug manufacturers. I just think it would be a lot easier to give people basic primary care.
I have heard numbers thrown about so I never really trust what anyone says about the cost. I would rather take five or ten more bucks out of a paycheck and not have to worry about insurance.
I like the Australian system. Sort of a combination Medicare and insurance.
Arvo Ender..I have no complaints about our medical system..just damn lucky I live here when I see and hear what goes on elsewhere..
Yes it has its faults but overall it is basically free...I did have private health insurance and what does that get you at my local hospital..a free newspaper...and no private room because those are on a needs only basis..so if a junkie comes in going through with drawl they get it..stuff that..
Down Melbourne to get into a private hospital $400 up front thank you and still no guarantee of a bed.
So far all my treatments etc that I have had over three years for myeloma would probably come in around half a million..has not cost me one cent.. other than for tablets around $20 a month..but at the moment I am not on any medication at all and still in remission..
I just lost my one and only Aunt on Sunday, she had private health insurance and overall it was of no great advantage to her..she was 93 so had a great innings and was a wonderful sister, mum and aunt..
I will miss her forever..
I'm sorry for your loss, shona.
I agree, Shona. All my kids grandkids love the Australian health care.
sorry to hear about your auntie.
I believe that you have one of the best systems in the world with a strong emphasis on disease prevention which lowers overall costs.
My/our condolences on Your and your family’s lives loss.
I do too since it seems sustainable.
So sorry for your loss, too.
Evening.. thank you everyone..
It was my aunt's time and I accept that...has been a long road and she grew very weary at the end..
We were blessed to have her with us for such a long time...she will be dearly missed and always remembered...😊
So sorry for your loss.
my sincerest condolences for your loss. I was in the room when my aunt died of cancer and it was very traumatic for me and my cousin, her daughter.
Since I was a retired paramedic, everybody was looking to me to call 'time of death' on both of my parents at the end of their lives.
With mom all I had to do was look at my watch at her last breath.
I suppose I let heroic measures on dad continue a little too long.