Countless Michiganders with cancer face critical shortages of two of the most widely used, life-saving drugs.
Amid the nation’s worst drug shortages in years, several Michigan providers have been forced to scale back doses by 10 percent or more. On Friday, the Barbara Ann Karmanos Cancer Institute ran out of carboplatin, one of the two drugs at issue, one doctor told Bridge.
And Henry Ford Health, oncologists, pharmacists and other staff this week conducted daily7 a.m. meetingsto assess ongoing shortages. About 300 patients could be impacted, according to a health system spokesperson.
The health system has about one week’s worth of drugs left, said Dr. Betty Chu, Henry Ford’s senior vice president of care delivery.
“This is really unconscionable … that something that’s as effective and as well known as carboplatin and cisplatin — and so necessary for cancer patients — could be in shortage for months,” Chu said.
“We are at the point where some places are out of the drug,” said Dr. Emily Mackler, director of the Pharmacists Optimizing Oncology Excellence in Michigan and the Michigan Oncology Quality Consortium — partnerships of oncologists and of pharmacists specializing in oncology care.
At issue are the chemotherapydrugs carboplatin and cisplatin. Both are part of a class of infusiondrugs containing the element platinum, which binds to the DNA of cancer cells and disrupts the cell’s ability to grow. The U.S. Food and Drug Administration alerted providers on Feb. 10 that cisplatin was becoming scarce. On April 28, the administration added carboplatin to its drug shortages list.
The drugs are used to treat multiple cancers, non-small cell lung cancer, head and neck cancer, testicular cancer, thoracic cancer, bladder cancer, and cancer when it’s not clear in what part of the body it started. In children, they are used to treat a type of kidney and a cancer that begins in nerve cells.
They’re especially critical in gynecologic cancers, too.
“They certainly are core drugs for multiple, multiple common cancers,” agreed Dr. William Dahut, chief scientific officer for the American Cancer Society, told Bridge Michigan Thursday.
“The physicians don’t have any ability to get the patient the drugs, and there’s no place for the patients to turn because nobody has them,” said Duhat, who, prior to his role at the American Cancer Society, was scientific director for clinical research at the Center for Cancer Research at the National Cancer Institute.
The shortages force providers to use the lowest doses of the drugs possible for patients, stretch out intervals between doses, and – if worse comes to worst, prioritize patients, doctors told Bridge Michigan.
“It’s really difficult with carboplatin and cisplatin both being short at the same time, because – in a lot of different (patient) scenarios – one is the alternative for the other,” said Mackler with the oncology care improvement groups.
Mackler and others have been tracking the shortages among Michigan cancer treatment providers.
Without “thoughtful” prioritization of dosing and patients, she said, rationing will happen anyway because the drugs will no longer be available for some patients.
It’s already happened at least once.
One Michigan cancer treatment provider reported to Mackler that it had to delay treatment by four days for a patient, said Mackler, declining to name the provider.
It’s a scenario that may be increasingly likely in the coming weeks, and the importance of the drugs can’t be overstated, providers told Bridge.
“This is cancer. This is not like (delaying) my knee surgery three or four weeks,” said Henry Ford’s Chu.
Carboplatin and cisplatin also are the “backbone” of treatment especially in gynecologic cancers — cervical, ovarian and endometrial cancer, said Dr. John Wallbillich, a Karmanos doctor in Detroit.
He also serves on the legislative and regulatory affairs subcommittee for the Society of Gynecologic Oncology, which last month issued guidelines to providers on how to “allocate the limited supply” for patients who would see “the most significant benefit.”
Doctors should stretch out intervals between treatments whenever possible under the guidelines. If a treatment recommendation calls for infusion every three to four weeks, for example, the doctor should default to a four-week cycle. If guidelines offer a dosing range, they are to give the lower dose.
For patients whose cancers appear resistant to carboplatin and cisplatin, the oncologists’ group recommends the drugs be at least minimized, if not altogether abandoned.
On Friday, Karmanos ran out of carboplatin and was running low on cisplatin, Wallbillich said.
Dr. Youssef Hanna, an independent general oncologist in Port Huron, said doctors periodically face drug shortages, but they usually are brief, and there are alternatives.
“We’ve never had to push back patient treatment because we don’t have the drugs,” he said. “We’ve never had to have to do it before – not in 20, 25 years.”
Will inferior cancer drugs fill the gap?
It’s difficult to nail down a single reason for the shortage.
Drug manufacturers have cited an increase in demand. A long-time critic of the drug supply chain, Bloomfield Hills Democrat and U.S. Senator Gary Peters, has cited a lack of manufacturers and overreliance on raw materials from other countries as causes for drug shortages in general.
The American Society of Health-System Pharmacists, which has cited manufacturing delays in the shortage of cancer drugs, specifically, said some of those cancer drugs won’t be available until June or July.
Even if that were sooner, “who wants to promise it until you see that on the shelves?” said Laura Appel, executive vice president of government relations and policy at the Michigan Hospital & Health Association.
The hospital industry group this week called on insurers to suspend “prior authorization” that can delay patient access to alternative drugs, as insurers decide whether to cover those alternative drugs. Additionally, the Michigan State Medical Society asked state lawmakers to pressure federal regulators to address ongoing drug shortages. And Peters, the congressman who released a report on drug shortages in March, told Bridge in an emailed statement that he is “pressing the Food and Drug Administration to take swift action … (and) working on legislation” that would address some of the reasons behind drug shortages.
Meanwhile, the White House has reportedly stepped up focus on drug shortages, too.
For now and for some patients, there may be alternative therapies, albeit likely not as reliable. Some of those chemotherapies were abandoned more than 20 years ago, replaced by carboplatin and cisplatin found to be not only more effective, but also produced fewer side effects, said Karmanos’ Wallbillich.
“It feels like the clock is being set back 25 years,” Wallbillich said.
He and others also told Bridge that it’s not clear what paring back doses or stretching out the times between treatments will mean for long-term survivability.
Unlike a broken bone that may be mended so the patient can return quickly to everyday life, cancer forces “the long game” between and the cancer cells they are designed to kill.
“Will some of these interventions — where you’re reducing the dose, or extending out the timeframe or frequency — lead to drug resistance?” he said.
Ultimately, doctors may have to prioritize patients for whom the drugs may cure the cancer rather than those for whom the drugs may simply extend life, doctors told Bridge.
“I’m thinking that if I can see a 37-year-old with cervical cancer and give her a lifetime — that’s where we would like to spend that cisplatin,” said Dr. Shitanshu Uppal, clinical associate professor of obstetrics and gynecology at the University of Michigan. He also provides cancer care at Trinity Health Ann Arbor Hospital.
It’s a “nightmare – a nightmare for us and for our patients,” said Hanna in Port Huron.
And it’s maddening, said Uppal.
The drug shortage has been an increasing problem for years, and drug shortages are now the highest they’ve been in at least five years. In fact, the FDA lists more than a dozen cancer-treating drugs among its 207 drugs in short supply, as of Friday.
Moreover, the pandemic underscored the lethal implications of short supplies as doctors scrambled at times for masks, ventilators, COVID tests, and lab equipment, he said.
“Three years into the pandemic, and it’s again the supply chain (problem) and we can’t figure this out? I mean, what’s going on?” Uppal said.