A short supply of cancer drugs has doctors and patients worried: 'We're at a critical juncture'

A drug shortage is forcing doctors to reduce doses of chemotherapy. Experts want the U.S. government to protect the drug supply so that over 100,000 cancer patients can get life-saving drugs on time.

Sitting in an infusion center last Wednesday afternoon, Elizabeth Arnold wondered whether the cancer drug dripping into her vein would be enough to make a difference.

Arnold, 63, was recently diagnosed with advanced uterine cancer. Her surgeon said she needed chemotherapy to knock down the tumors before operating.

But with key medications in shortage, she was told she would get five bags of the drug carboplatin, not the usual six. The nurse at her hospital in Anchorage, Alaska, said they would likely run out completely before her next treatment in three weeks.

“I’m terrified, quite frankly,” said Arnold, aFourteen cancer drugs have been in shortage in recent months, mostly because of supply chain issues. Those in the shortest supply include cisplatin and carboplatin, platinum-based drugs used to treat gynecologic, breast, testicular, bladder, head and neck, and non-small cell lung cancers.

The American Society of Clinical Oncology (ASCO) has been working to resolve the shortage and saw the first glimmers of hope last week after a national delivery of carboplatin, which has been in shortage for a month.

Elizabeth Arnold, with her newly shaved head, is keeping active to improve her chances against uterine cancer

“I think we may very well have hit rock bottom and are starting to slowly see more release of drug,” said Julie Gralow, the society’s chief medical officer and executive vice president.

But it’s not yet clear whether the crisis is ending or if supply will continue to ebb and flow. journalism professor at the University of Alaska and former reporter with National Public Radio.

She’s caught up in a frightening and frustrating national shortage of essential drugs that experts say has put the lives of more than 100,000 cancer patients, particularly women, at risk.

“The last six months have been the worst in my career, including some of the shortages we had during the peak of COVID. It’s just been incredibly challenging,” said Julie Kennerly-Shah, associate director of pharmacy at the Ohio State University Comprehensive Cancer Center.

“None of us knows yet what that means. Is it going to be adequate? Are we going to be practicing week to week?” said Dr. Amanda Nickles Fader, a professor of obstetrics and gynecology at Johns Hopkins Hospital and president-elect of the Society of Gynecologic Surgeons. “We obviously need long-term solutions.”

Fader’s organization surveyed its members in late April and only a handful, mostly in rural or smaller hospitals, said they were near a crisis point. By last week, they’d heard from facilities in more than 40 states, including some major medical centers, that they were running short of at least one key cancer medication.

“We’re at a critical juncture,” Fader said. “If this crisis worsens, every hospital in the United States is going to be impacted.”

Cancer treatment advances are underway:Here are 3 that could change lives.

Alternative approaches

Doctors can often give patients a different drug if one is in shortage, Fader said. But cisplatin, which has been limited since February, is often used as a substitute for carboplatin and visa versa ‒ so limited access to both creates problems.

New guidelines from ASCO encourage doctors to stick to the lowest recommended dose and the longest accepted interval between doses.

That’s why Arnold got just five bags of carboplatin instead of six. It’s within the recommended range based on clinical trials, but still, Arnold would have preferred to throw as much as possible at her cancer.

And though using the minimum should be enough for most people, Gralow said, “we’re all worried about the risk to patients and that some patients might be getting inferior care.”

On Thursday, Gralow received messages from a cancer treatment center in Florida and another in Tennessee who said they were about to start rationing care. She hopes the recent release of some carboplatin will enable them to avoid that.

If hospitals are forced to ration life-saving drugs, Arnold is worried she’ll be far down on the list. Medications will go first to patients with the highest likelihood of being cured. Arnold’s dangerous tumor type was down at No. 18 on a rationing list she was given by a Seattle doctor.

Providing too little chemotherapy might leave patients with terrible side effects but no benefit – or even worse, might make their tumor resistant to the drug, said Dr. Michelle Benoit, a gynecologic oncologist in Washington State who has consulted on Arnold’s cancer.

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With the health care system already stretched incredibly thin, it can be challenging for doctors to identify an alternative course of therapy and then get an insurance company to cover it.

Fader’s society is working with insurance companies to relax prior authorization requirements so patients can get nonstandard treatments.

Some substitute therapies are just as effective as original ones but might require a different dosing schedule or carry more side effects, Fader said.

Even the fact that some drugs take longer to deliver than others can cause problems, she said, with tightly run infusion centers lacking capacity to handle these longer schedules.

All these changes require “a lot of reworking of clinical pathways and workflows in order to get there,” Fader said.

Why these cancer drugs are in shortage now

Although cisplatin and carboplatin are manufactured by five companies, all rely on a single supplier in India that was shuttered over the winter for safety reasons. Though some production has resumed, deliveries are behind schedule and supplies are low.

Drug shortages have been an issue in the United States for at least a decade, with problems exacerbated during the pandemic, said Bindiya Vakil, CEO of Resilinc, which provides global supply chain mapping and monitoring

And demand, particularly for cancer drugs, keeps rising as patients live longer with their disease.

Globally, spending on cancer drugs reached nearly $200 billion in 2020, according to the IQVIA Institute for Human Data Science, and is expected to reach $375 billion by 2027. 

The irony is that these absolutely essential platinum-based drugs are in shortage in large part because they’re so inexpensive.

Cisplatin costs $15 a vial and carboplatin $25, said Matt Christian, director of supply chain insights at the U.S. Pharmacopeia, a nonprofit that sets standards for the pharmaceutical manufacturing industry.

Latest:A new The platinum-based drugs are also delivered by sterile injection, which makes them trickier to produce than a pill. That’s why sterile injectables are three-times more likely to be in shortage than the average generic drug, he said.

Manufacturers have no incentive to improve their process or product safety.

Plus, with such a small profit margin and because companies don’t want to reveal their competitive advantages, production is a closely guarded secret.

That means the American medical system doesn’t know when a factory is shut down in India or a raw material shortage impacts the drug supply, so hospitals can’t plan ahead or encourage other drug companies to pick up the slack.

How to fix the problem

The Food and Drug Administration is working to address the drug shortage, said spokesperson James McKinney.

“While the agency does not manufacturer drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug, the public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products,” he said via email. “The FDA understands that manufacturers expect availability to continue to increase in the near future.”research effort takes aim at 8 rare diseases. It could revolutionize many more.

Because companies stand to make so little from these medications, they have little incentive to create backup plans in case raw material suppliers or manufacturers run into trouble, Christian said. “It’s hard to incentivize redundancy if the price is $15 a vial.”

But that’s not enough, Gralow said.

Structural changes are needed. Congress should add regulations to require data-sharing, offer incentives to protect the drug supply, manufacture more medications in the U.S. and create a stockpile of essential drugs, she said.

Her organization, American Society of Clinical Oncology, has been lobbying both houses of Congress – and encouraging patients to ask their representatives – to improve the supply of critical medicines.

The U.S. government should use its buying power to encourage multiple manufacturers to make essential drugs, rather than focusing on the cheapest source and a “race to the bottom,” Gralow said. “It’s a vulnerable system that needs to be strengthened."

The U.S. Pharmacopeia has been advocating for what Christian described as a “supply chain control tower.” The goal would be to increase demand information to raw suppliers and manufacturers so they can better plan their production and to hospital pharmacies so they could better predict fluctuations in supply.

“Our goal ultimately is to inform people with insights and help them take mitigative actions,” he said. “The patient impact is why we’re fired up to do this work.”

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Helping people on the ground

Arnold just hopes that changes will come in time to help her live longer.

She was a healthy marathoner before headaches, a high blood pressure reading and a nagging anxiety led her doctor to conduct a pelvic ultrasound.

Diagnosed a month ago with an aggressive form of uterine cancer known as serous, it had already spread to her pelvis, stomach and colon. She was scheduled for a hysterectomy, but the surgeon said she wanted Arnold to get chemotherapy first to knock back the tumors.

Her first round of chemo and the first few days after her second have left her with a lot of abdominal pain, which she hopes is caused by cancer cells dying off. One marker of her disease improved dramatically after that first treatment, suggesting the medication is making a difference.

Elizabeth Arnold after placing second in her age category in a marathon last year.

She’s working out every day – running when she has the energy; walking when she doesn’t – hoping to be among the one-third of people with her tumor type to survive more than five years after diagnosis.

At a time when she wants to be entirely focused on battling cancer, Arnold and her friends on “Team Betsy” have been trying to figure out how to ensure she gets the medication she needs.

She noted that President Biden has been working toward a “Cancer Moonshot,” setting a goal of dramatically reducing cancer deaths. Arnold said she hopes the administration is also focusing “right here on the ground.”

Medications like carboplatin are already proven to work. But only if people can get them, she said.

“They will save lives and prolong lives. Like mine.”

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY 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 input.

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