How the Shortage of a $15 Cancer Drug Is Upending Treatment

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

But that outlook has begun to dim in recent weeks after the central California oncology clinic he attends began sporadically running out of critical drugs needed.

Shepard said every treatment session felt like “Russian roulette” after her doctor told her she was short. He knew that if he failed, his vocal cords would be cut off and he would lose his voice.

“I try not to think about it,” said Shepard, 62, a gas station manager in the Central Valley, California town of Madera. “It’s a scary thing to think about, but I know it’s real.”

The country has been facing a months-long shortage of highly potent anticancer drugs, forcing patients and doctors to face an even harsher reality than cancer usually presents. Thousands of patients like Shepard face heartbreaking options, treatment delays, and a potentially bleak future.

Oncologists are concerned that alternatives to two key chemotherapy drugs are far less effective and, in some cases, more toxic in treating certain cancers. The presence or absence of pretreatment presents a particularly alarming prospect for patients with ovarian, testicular, breast, lung, and head and neck cancers, they say.

There are few, if any, signs that the shortage will ease soon. Inventories have been depleted as the factory, which was the main production plant for the more popular drug, closed late last year and has not reopened. The easing of restrictions on drug imports from China this month has provided some relief, but doctors said the influx has yet to have a significant impact. Some companies that sell pharmaceuticals expect the shortage to continue beyond the fall.

So far, neither expert groups organized by the Biden administration nor prominent medical institutions have found a way to circumvent the distribution of critical chemotherapy drugs.

To close this gap, some doctors are extending treatment intervals and scooping up precious milliliters to increase dosages. Some companies are relying on the resumption of supplies to turn to a strategy of surgery first followed by chemotherapy.

The American Society of Clinical Oncology, one of the top cancer treatment organizations in the United States, is now recommending that doctors with low doses of therapeutic drugs give those drugs to patients who are trying to cure them, and to treat recurring or widespread disease. patients are advised to refuse the drug. .

“We are in a situation where patients are being left behind, and we are very concerned that survival will be affected by lack of chemotherapy,” said Gynecologic Oncology President and Gynecologic Oncology Professor. said Dr. Angeles Alvarez Secordo of Duke University School of Medicine.

Two major chemotherapy drugs, cisplatin and carboplatin, are used as frontline drugs in cocktails used to shrink or eliminate tumors. More than a dozen cancer drugs are also officially in short supply. hundreds of other Medications, such as antibiotics and sterile injectable solutions. Still, doctors predict the lack of intensive chemotherapy could do the most damage to patients.

Cisplatin and carboplatin are inexpensive. Prices are $15 and $23 per vial, according to the United States Pharmacopeia, a nonprofit organization dedicated to drug safety and supply. However, drug production requires a reliable supply of the metal used, platinum, as well as a sterile factory and special controls to protect workers from the toxic effects of the drug. As a result, very few companies manufacture them.

A recent shortage of these widely used drugs came when major manufacturer Intus Pharmaceuticals halted production in December after the Food and Drug Administration conducted a surprise inspection at its factory in Ahmedabad, India. Occurred.USA distributor issued a report The report said employees were shredding, tearing and pouring acid over quality control records, pointing to a “chain of failures” at the site.

The company’s Durham, N.C., subsidiary, Accord Healthcare, recently announced it was still making improvements to the plant needed to restart production.

By this spring, the effects of the Intas closure were being felt deeply.a Survey by National Comprehensive Cancer Network A report from academic treatment centers released earlier this month found that 93 percent of the 27 centers that responded had a carboplatin deficiency. As a result, 36% of them reported changing their patient’s treatment, including lowering doses and increasing treatment intervals.

At the cCare Cancer Center in Fresno, Calif., where Shepard is being treated for vocal cord cancer, efforts to expand supply began sporadically. According to oncologist Dr. Ravi Rao, over the past six weeks, platinum vials have been unavailable about half the time.

He said that without drugs, Shepard’s chances of being cured would drop from about 90% to about 45%. Fortunately, Shepard said the drug was available for the first two of his seven treatments.

Dr. Rao said ovarian cancer patients face the worst prospects. This is because of how common the disease is and for decades platinum has been central to tackling the disease. Without these drugs, survival rates for patients with widespread ovarian cancer drop from about 30% to single digits, he said.

“This shortage will lead to people dying,” says Dr. Rao, who is also on the board of the Community Oncology Alliance. “There’s no way around it. Removing these life-saving drugs doesn’t do any harm.”

Dr. Julie Gralow, ASCO’s chief medical officer, said testicular cancer patients are at greater risk because cisplatin has a known record of curing even advanced cases. in her testimony It was submitted to a House subcommittee earlier this month.

“This is very important and probably affects half a million Americans with these two drugs alone,” Dr. Gralow said.

For Florida oncologists at more than 90 facilities, the shortage initially means storing 10 to 15 percent of a patient’s dose on stretch stock, according to Lucio Gordan, M.D., director of the clinic. It is said that

That wasn’t enough, so doctors began giving drugs only to patients who could be cured or who were in clinical trials. With this practice, some products turned out to be heavily inflated prices (obvious price gouging), but I still bought them.

Still, by May, Dr. Gordan said his practice had been carboplatin-free for 12 days and cisplatin-free for eight days.

Arias Pitts, 33, who was diagnosed with high-grade breast cancer in April, encountered shortages when she arrived to begin treatment on May 16. The carboplatin her doctor ordered for the first of six chemotherapy regimens was not available.

“Of course there were questions and concerns,” said Pitts, an academic adviser at the University of South Florida and a single mother of a four-year-old. “It’s stressful,” she added.

The FDA has taken steps to alleviate the shortage. India’s Intas, which oversaw trials and launches of platinum-based drugs manufactured before the closure, now has depleted stocks.

It will also temporarily allow China-based Qilu Pharmaceuticals to ship cisplatin to the United States.

Jordan Berman, vice president of Toronto-based company Apotex Pharmaceuticals, which imports the Chilu drug, said the company received a shipment of cisplatin on June 6 and will begin shipping via a major U.S. distributor. said to have started.

Oncologists and supply chain experts said so far there is little data to gauge the impact of imports. About 600 vials of cisplatin from China arrived at a Florida oncologist earlier this month, Gordan said. But that alone wasn’t enough to restart drug delivery to patients with advanced or recurrent cancer.

“It’s about six days of treatment for us,” Dr. Gordan said. “We are scrambling.”

Studies in the 1980s and 90s showed that platinum was a significant improvement over existing treatments and was most effective when combined with other agents, doubling response rates. . for ovaries and head and neck cancer.platinum be drugged The five-year survival rate for testicular cancer increases from about 10 percent to 95 percent.

New immunotherapeutic treatments have improved outcomes for patients with certain types of cancer, such as melanoma, but oncologists are using immunotherapy in combination with platinum drugs to extend life and reduce survival. increasing the possibility.

“Generally, we haven’t seen a home run like this in cancer in recent years,” said Dr. Michael Sequeres, an oncologist at the University of Miami and former FDA oncology adviser.

Oncologists advising the field in the current shortage of resources recommend that those treating patients with early-stage lung cancer: please send to “There is no equally effective alternative,” said the center that owns the drug.

Dr. Evan Myers, an obstetrics and gynecology researcher at Duke University, said he plans to measure the effects of the Research on various drug shortages A study of children and adolescents with Hodgkin lymphoma found that alternative drugs were “significantly less effective” and pretreated adolescents had lower survival rates.

Dr. Myers said there was a shortage this year At the very least, it can affect the quality of life of people undergoing treatment. “They will have to wait for the other shoe to fall off,” he says.

Dr. Prasanthi Ganetha, medical director of the Center for Cancer and Blood Disorders in Fort Worth, said doctors are also struggling with how to communicate such shocking news. In her practice, she considers each case individually, but prioritizes critical doses for potentially curable patients.

“I can imagine a patient hearing this and saying, ‘You know, I’m trying to live a long life, and that’s my priority.’ So I need that drug, doctor.” she said. “We feel really helpless.”

The situation requires action, said Dr. Karen Knudsen, chief executive of the American Cancer Society. The White House and Congress, which have debated the issue, have offered few concrete solutions.

“The need for durable solutions is growing by the day,” Dr. Knudsen said, adding that “patients are left hanging.”

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