How the shortage of a $15 cancer drug is disrupting treatment

A box of cisplatin injection in the drug warehouse of the Center for Cancer and Blood Disorders in Fort Worth, Texas, June 16, 2023. (Emil Lippe/The New York Times)

A box of cisplatin injection in the drug warehouse of the Center for Cancer and Blood Disorders in Fort Worth, Texas, June 16, 2023. (Emil Lippe/The New York Times)

Tony Shepard learned he had vocal cord cancer this spring, but was encouraged when his doctor said he had an 88 percent chance of being cured with chemotherapy and radiation.

That outlook has begun to fade in recent weeks, however, after the cancer practice he travels to in central California began sporadically running out of critical medications he needs.

Since Shepard’s doctor informed him of the deficiency, every treatment session has felt like Russian roulette, he said, knowing failure would mean the removal of his vocal cords and the disappearance of his voice.

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I try not to even think about it, said Shepard, 62, a gas station manager in Madera, a city in California’s Central Valley. It’s something scary that you don’t really want to think about but you know it’s a reality.

The nation’s shortage of highly potent cancer drugs continues to grind, forcing patients and their doctors to face even grimmer realities than cancer typically presents. Thousands of patients like Shepard have faced heartbreaking options, treatment delays, and potentially grimmer futures.

Oncologists fear that alternatives to two key chemotherapy drugs are much less effective at treating some types of cancer and are sometimes more toxic. Backup therapies or the lack thereof, they say, pose an especially troubling outlook for patients with ovarian, testicular, breast, lung, and head and neck cancers.

There are few, if any, signs that the shortage will ease anytime soon. A plant that was a major producer of the most popular drugs was closed late last year and has not reopened, running out of stock. The easing of restrictions on medicines imported from China this month has provided some relief, but doctors said the influx hasn’t made a dent yet. Some companies that sell the drugs expect the shortage to last until the fall or later.

So far, neither a think tank organized by the Biden administration nor major medical organizations have figured out a way to avoid rationing crucial chemo drugs.

To fill the gaps, some doctors are extending treatment intervals and skimming precious milliliters to lengthen doses. Others are turning to a strategy of surgery before and chemo after, aiming for a resumption of supplies.

One of the nation’s leading cancer treatment groups, the American Society of Clinical Oncology, is now advising physicians on low quantities of the drugs to give them to patients with a chance of cure and to withhold them from patients with recurrent or widely spread disease.

We’re in a situation where patients are being left behind, and we’re really concerned that survival might be impacted by chemotherapy shortages, said Dr. Angeles Alvarez Secord, president of the Society of Gynecologic Oncology and a professor at Duke University School of Medicine.

Two major chemotherapy drugs, cisplatin and carboplatin, are used as first-line drugs in cocktails used to shrink or eliminate tumors. More than a dozen cancer drugs are also officially in short supply, as are hundreds of other drugs, including antibiotics and sterile injectable fluids. However, doctors predict that the absence of powerful chemotherapies could hurt patients more.

Cisplatin and carboplatin are inexpensive: They cost $15 and $23 a vial, according to the US Pharmacopeia, a non-profit organization aimed at drug safety and supply. But manufacturing the drugs requires a reliable supply of platinum, a used metal, as well as a sterile facility and special controls to protect workers from the toxic effects of the drugs. As a result, few companies produce them.

The most recent shortage of these widely used drugs came when a leading manufacturer, Intas Pharmaceuticals, halted production in December after the Food and Drug Administration carried out a surprise inspection at its Ahmadabad, India, plant. The US agency released a report saying employees were shredding, tearing and pouring acid on quality control records and noted a cascade of failures at the site.

The company’s subsidiary, Accord Healthcare, in Durham, North Carolina, said recently that improvements were still being made to the plant to restart production.

This spring, the effects of the closure of Intas were felt. A National Comprehensive Cancer Network survey of academic treatment centers released this month found that 93 percent of the 27 centers that responded suffered from a carboplatin deficiency. As a result, 36% of them reported changing treatments for patients, using lower doses and longer intervals between therapies.

At the cCare Cancer Center in Fresno, California, where Shepard receives treatment for his vocal cord cancer, efforts to increase supply have given way to sporadic availability. Over the past six weeks, vials of platinum-based drugs have been unavailable about half the time, said oncologist Dr. Ravi Rao.

He said Shepard’s chances of a cure without the drugs would drop from about 90% to about 45%. Fortunately, Shepard said, drugs were available for the first two of the seven treatments.

Ovarian cancer patients are facing the worst prospects, Rao said, because of how common the disease is and how central platinum drugs have been in addressing it for decades. Without those drugs, a patient with extensive ovarian cancer has survival odds dropping to single-digits from about 30%, he said.

This shortage will lead to people dying, said Rao, who is also a board member of the Community Oncology Alliance. There is no way around it. You cannot remove these life-saving drugs and have no adverse outcomes.

Others who face greater threats are testicular cancer patients, because cisplatin has a known record of curing even advanced cases, Dr. Julie Gralow, ASCO’s chief medical officer, said in testimony to a subcommittee on the room this month.

This is critical, impacting perhaps as many as half a million Americans with just these two drugs, Gralow said.

For Florida Cancer Specialists, with more than 90 sites, the shortage initially meant holding 10% to 15% of a patient’s dose to stretch supplies, said Dr. Lucio Gordan, president of the practice.

That wasn’t enough, so doctors started giving drugs only to patients with the possibility of a cure or those enrolled in clinical trials. The practice found some products at greatly inflated prices to appear price gouging, but bought them anyway.

However, in May, the practice was carboplatin-free for 12 days and cisplatin-free for eight days, Gordan said.

Arias Pitts, 33, who was diagnosed with aggressive breast cancer in April, met the shortage when she arrived to start treatment on May 16. The carboplatin her doctor had ordered for the first of six rounds of chemotherapy was not available.

Obviously I had questions and concerns, said Pitts, an academic advisor at the University of South Florida and a single mother of a 4-year-old boy. She added, she’s stressful.

The FDA has taken steps to alleviate the shortage. He oversaw the testing and release of batches of platinum drugs made by Intas in India that were manufactured before the shutdown, but that supply has been depleted.

It is also temporarily allowing China-based Qilu Pharmaceuticals to ship cisplatin to the United States.

Jordan Berman, vice president of Apotex Pharmaceuticals, a Toronto company that imports Qilu drugs, said it received shipments of cisplatin on June 6 and began routing them through major US distributors.

Oncologists and supply chain experts said there was so far little data to assess the effect imports would have. About 600 vials of cisplatin from China arrived at Florida Cancer Specialists this month, Gordan said. But that wasn’t enough for the practice to resume offering the drugs to patients with advanced or recurring cancers.

That’s about six days of treatment for us, Gordan said. We were scrambling.

Studies in the 1980s and 1990s showed that platinum-based drugs were a huge improvement over existing treatments, performing better in combination with other drugs and doubling response rates for head and ovarian cancers and to the neck. Platinum drugs have pushed the five-year survival rate for testicular cancer to 95% from about 10%.

While new immunotherapy treatments have improved outcomes for patients with some cancers, such as melanoma, oncologists are also including them in platinum drug cocktails to extend their lives and improve survival potential.

In general, we haven’t seen these cancer home runs in recent years, said Dr. Mikkael Sekeres, a University of Miami oncologist and former FDA oncology consultant.

Oncologists advising the camp amid shortages have urged those treating patients with early-stage lung cancer to refer them to a center that has the drugs, noting that there are no alternatives as effective.

Dr. Evan Myers, a Duke University researcher in the department of obstetrics and gynecology, said he was planning to measure the effects of the deficiencies. A study of a different drug shortage affecting children and adolescents with Hodgkin’s lymphoma found that the replacement drug was significantly less effective and reduced the survival rate for young people who received the backup treatment.

Myers said this year’s shortages would, at the very least, have an effect on the quality of life of people undergoing treatment. They’ll wait for the other shoe to drop, she said.

Even doctors are struggling to deliver such devastating news, said Dr. Prasanthi Ganesa, medical director of the Center for Cancer and Blood Disorders in Fort Worth. His practice is looking at each case individually, but is also prioritizing doses that are crucial to patients who could potentially be treated.

I can imagine a patient hearing this and saying, You know, I’m trying to live longer, that’s my priority. So I need that drug, doctor, he said. We feel really helpless.

The situation calls for action, said Dr. Karen Knudsen, CEO of the American Cancer Society. The White House and Congress, which have debated the problem, have advanced few concrete solutions.

The need for a durable solution is increasing by the day, Knudsen said, adding: Patients are left hanging.

c.2023 The New York Times Society

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