Sitting in the IV center last Wednesday afternoon, Elizabeth Arnold wondered if the anticancer drugs in her veins were enough to make a difference.
Arnold, 63, was recently diagnosed with advanced uterine cancer. Her surgeon said she needed chemotherapy to destroy her tumor before her surgery.
However, due to a shortage of key medicines, I was told that I would receive five bags of the drug carboplatin instead of the usual six. A nurse at her hospital in Anchorage, Alaska, said she will likely be completely short of nurses before her next treatment in three weeks.
“Frankly, it’s very scary,” said Arnold, a professor of journalism at the University of Alaska and a former National Public Radio reporter.
She is embroiled in a terrifying and frustrating nationwide shortage of essential medicines that experts say is putting the lives of more than 100,000 cancer patients, especially women, at risk.
“The last six months have been the worst of my career, including the staffing shortage during the peak of COVID-19. said Julie Kennery Shah, deputy director of pharmacy at the cancer center.
There have been shortages of 14 cancer drugs in recent months, largely due to supply chain problems. Among the most in short supply are cisplatin, a platinum-based drug used to treat gynecologic, breast, testicular, bladder, head and neck, and non-small cell lung cancer; Contains carboplatin.
The American Society of Clinical Oncology (ASCO) is working to fill the shortage, and last week saw the first glimmer of hope with a nationwide supply of carboplatin after a month-long shortage.
“I think it’s very likely that we’ve hit rock bottom and we’re slowly starting to release more drugs,” said Julie Gralow, the association’s chief medical officer and executive vice president.
But it is not yet clear whether the crisis is ending or whether supply will continue to fluctuate.
“None of us know what that means yet. Will it be enough? Are we going to practice every week?” Dr. Nickles Fader says: “Clearly we need a long-term solution.”
Fader’s organization surveyed its members in late April and said only a handful of hospitals, mostly rural and small hospitals, were approaching crisis. By last week, facilities in more than 40 states, including some major medical centers, were reporting shortages of at least one major cancer drug.
“We are at a critical crossroads,” Fader said. “If this crisis gets any worse, every hospital in the United States will be affected.”
Advances in cancer treatment include:Here are three things that could change your life.
alternative approach
If one drug is missing, doctors often give patients another, Feder said. However, cisplatin, which has been restricted since February, is often used as an alternative to carboplatin and vice versa, so the limited availability of both poses a problem.
New ASCO guidelines encourage physicians to adhere to the lowest recommended dose and longest allowed dosing interval.
That’s why Arnold only got 5 sachets of carboplatin instead of 6. That’s within the recommended range based on clinical trials, but Arnold still wanted to get the most out of his cancer.
And while minimal use should suffice for most people, Gralow said, “People are worried about the risks to patients and that some patients are receiving poor care. ‘ said.
On Thursday, Gralow received messages from a cancer treatment center in Florida and another in Tennessee saying they were starting to distribute medical care. She hopes the recently released carboplatin will help her get around that.
Arnold worries that if hospitals are forced to distribute life-saving drugs, he will fall far down the list. Patients most likely to be treated are given drugs first. Arnold’s dangerous tumor type ranked him 18th on a ration list handed to him by a doctor in Seattle.
Michelle Benoit, M.D., a gynecologic oncologist in Washington who has consulted with Arnold about her cancer, said giving too little chemotherapy could leave patients with severe side effects and no benefit. , said that, even worse, tumors could develop drug resistance.
more:New cancer treatments take personalized medicine to a new level
With the health system already incredibly overstretched, it can be difficult for doctors to identify alternative treatment options and get insurance companies to cover them.
Fader’s association is working with insurance companies to ease pre-approval requirements so patients can receive non-standard treatments.
Some alternative therapies are just as effective as the original therapy, but may require different dosing schedules or cause more side effects, Feder said.
Even the fact that some drugs take longer to deliver than others can cause problems, and tightly run infusion centers are said to lack the capacity to keep up with such long schedules. she said.
All these changes will require “a lot of reworking of clinical pathways and workflows to get there,” Fader said.
Why are there current shortages of these anticancer drugs?
Cisplatin and carboplatin are manufactured by five companies, but all rely on a single supplier in India that has been closed for the winter for safety reasons. Although some production has resumed, deliveries are behind schedule and supplies are in short supply.
Drug shortages have been a problem in the United States for at least a decade, and the problem has gotten worse during the pandemic, said Bindiya Bakir, CEO of Resilink, a global supply chain mapping and monitoring company. said.
And demand for cancer drugs, in particular, continues to grow as patients live longer with their disease.
Worldwide spending on cancer drugs reached nearly $200 billion in 2020That amount is expected to reach $375 billion by 2027, according to the IQVIA Institute for Human Data Science.
The irony is that these desperately needed platinum-based medicines are in short supply, largely because they are cheap.
Cisplatin costs $15 per vial and carboplatin costs $25, according to Matt Christian, director of supply chain insights for the United States Pharmacopoeia, a nonprofit organization that sets standards in the pharmaceutical manufacturing industry.
latest:The new research effort is focused on eight rare diseases. More revolutions are possible.
Companies make little profit from these medicines, Christian said, giving them little incentive to have back-up plans in case raw material suppliers or manufacturers run into trouble. “If the price per vial is $15 for him, it’s hard to encourage downsizing.”
Platinum-based drugs are also administered by sterile injection, making them more difficult to manufacture than tablets. That’s why sterile injectables are three times more likely to be in short supply than the average generic drug, he said.
Manufacturers have no incentive to improve process or product safety.
Plus, with margins so small and companies unwilling to reveal their competitive advantage, production is a closely guarded secret.
In other words, the US health system can never know when a factory will close in India or a raw material shortage will affect drug supplies, so hospitals plan ahead and give other drug leeway. cannot be encouraged to do so.
How to solve the problem
The Food and Drug Administration is working to address drug shortages, said spokesman James McKinney.
“The FDA does not manufacture drugs and cannot require drug companies to manufacture drugs, increase drug production, or change the distribution of drugs, but the public believes that the FDA has many manufacturers and other Rest assured that we are working closely with companies and supply chains need to understand, mitigate, and prevent or mitigate the impact of intermittent or reduced supply of certain products,” he said electronically. said in an email. “FDA understands that manufacturers anticipate continued increases in availability in the near future.”
But that alone isn’t enough, says Gralow.
Structural change is required. He said Congress should add regulations mandating data sharing, provide incentives to protect drug supplies, make more drugs in the United States, and create a stockpile of essential drugs.
Her organization, the American Society of Clinical Oncology, has lobbied both houses of Congress to improve supplies of critical medicines, and encourages patients to ask legislators questions.
Instead of focusing on the cheapest sources of supply or a “race to the bottom,” the U.S. government should use its purchasing power to encourage multiple manufacturers to make essential drugs, Grawro said. “This is a fragile system and needs to be strengthened.”
The United States Pharmacopoeia advocates what Christian described as a “supply chain control tower.” The goal is to increase demand information so that raw material suppliers and manufacturers can better plan production, and hospital pharmacies can more accurately predict fluctuations in supply.
“Our ultimate goal is to give people insight and help them take mitigation measures,” he said. “We are passionate about this effort because of the impact it has on patients.”
cancer status1.95 million people could be diagnosed with cancer by 2023
help people on the ground
Arnold just hopes the change will come in time so she can live longer.
She used to be a healthy marathoner, but headaches, high blood pressure readings, and persistent anxiety led her doctors to perform a pelvic ultrasound.
A month earlier she had been diagnosed with advanced uterine cancer, known as serous, which had already metastasized to her pelvis, stomach and colon. She was scheduled for a hysterectomy, but the surgeon wanted Arnold to undergo chemotherapy first to knock the tumor back.
She has had severe stomach pains in the first few days after her first and second chemotherapy treatments, which she hopes are caused by dying cancer cells. . Her one of her disease markers improved dramatically after her initial treatment, suggesting the medication is having an effect.
She works out every day and runs when she has the energy. She walks when she can’t – hoping that her one-third of people with her tumor type will live five years or more after diagnosis.
Now that she wants to focus on fighting cancer, Arnold and her friends in “Team Betsy” are looking for ways to make sure she gets the medicine she needs.
He noted that President Biden is working on a “cancer moonshot” with the goal of dramatically reducing cancer deaths. Arnold said he hoped the administration would also focus “just on the ground.”
Drugs like carboplatin have already proven effective. But only if people can get it, she said.
“They save lives and extend life. Just like mine.”
Please contact Karen Weintraub ([email protected]).
USA TODAY’s coverage of health and patient safety is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare. The Masimo Foundation does not provide editorial opinion.
