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How the shortage of a $15 cancer drug continues to be addressed




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

Those prospects began to dim in recent weeks, however, after the oncology practice he attends in Central California began sporadically running out of the critical medicine he needs.

Since Mr. Shepard’s doctor informed him of the deficiency, each treatment session has felt like a game of “Russian roulette,” he said, knowing that failure would mean the removal of his vocal cords and the loss of his voice.

“I try not to even think about it,” said Mr. 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 months-long shortage of highly potent cancer drugs continues, forcing patients and doctors to face even grimmer realities than those forces usually present. Thousands of patients like Mr. Shepard have been confronted with gut-wrenching options, delays in treatment and potentially worse futures.

Oncologists are concerned that alternatives to two key chemotherapy drugs are far less effective in treating certain cancers and are sometimes more toxic. The fallback therapies, or lack thereof, they say, pose a particularly troubling prospect 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 facility that was a major producer of the more popular drugs shut down late last year and has not reopened, depleting its inventory. The easing of restrictions on imported drugs from China this month has brought some relief, but doctors said the influx has yet to do much. Some companies that sell the medicines estimate that the shortage will last until the autumn or later.

So far, neither a group of experts organized by the Biden administration nor prominent medical organizations have found a way to avoid rationing the crucial chemotherapy drugs.

To bridge the gaps, some doctors are extending care intervals and skimming precious milliliters to stretch doses. Others are turning to a strategy of surgery first and chemotherapy later, betting on a resumption of supplies.

One of the country’s top cancer care groups, the American Society of Clinical Oncology, is now advising doctors with low amounts of the drugs to administer them to patients with an attempt at a cure — and deny them to patients with recurrent or widespread disease.

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

Two main 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, as well as hundreds of other drugs, including antibiotics and sterile injectable fluids. Still, doctors predict that the absence of the powerful chemotherapies could harm patients the most.

Cisplatin and carboplatin are inexpensive: They cost $15 and $23 per vial, according to the US Pharmacopeia, a nonprofit organization focused on drug safety and supply. But producing the drugs requires a reliable supply of platinum, a metal used, as well as a sterile facility and special controls to protect workers from the drugs’ toxic effects. As a result, few companies make them.

The latest shortage of these widely used drugs occurred when a leading manufacturer, Intas Pharmaceuticals, shut down production in December after the Food and Drug Administration conducted a surprise inspection at its factory in Ahmedabad, India. The US agency issued a report saying staff shredded, tore and poured acid on quality control records and noted a “cascade of errors” at the site.

The company’s subsidiary, Accord Healthcare, in Durham, North Carolina, said recently that it was still making improvements at the facility needed to restart production.

By spring, the effects of the Intas closure were deeply felt. A National Comprehensive Cancer Network survey of academic treatment centers released earlier this month found that 93 percent of the 27 centers that responded experienced carboplatin shortages. As a result, 36 percent of them reported changing treatments for their patients, resorting to lower doses and longer intervals between treatments.

At cCare Cancer Center in Fresno, Calif., where Mr. Shepard receives care for his vocal cord cancer, efforts to stretch supplies have given way to sporadic availability. For the past six weeks, vials of the platinum drugs have been unavailable about half the time, said an oncologist, Dr. Ravi Rao.

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

Ovarian cancer patients face the worst outlook, Dr. Rao said, because of how common the disease is and how central the platinum drugs have been in tackling it for decades. Without these drugs, a patient with extensive ovarian cancer has chances of survival that drop to the single digits from around 30 percent, he said.

“This shortage will cause people to die,” said Dr. Rao, who is also a board member of the Community Oncology Alliance. “There’s just no way around it. You can’t remove these life-saving drugs and not have bad outcomes.”

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

“This is critical, affecting perhaps as many as half a million Americans with just these two drugs,” Dr. Gralow said.

For Florida Cancer Specialists, with more than 90 locations, the shortage initially meant saving 10 to 15 percent of a patient’s dose to stretch inventory, said Dr. Lucio Gordan, president of the practice.

That wasn’t enough, so doctors began to only give the drugs to patients with a chance of a cure or those enrolled in clinical trials. The practice found some products at enormously high prices – apparently mark-up – but bought them anyway.

Still, by May, the practice was without carboplatin for 12 days and cisplatin for eight days, Dr. Gordan said.

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

“Of course I had questions and concerns,” said Ms. Pitts, an academic advisor at the University of South Florida and a single mother of a 4-year-old. She added: “It’s stressful.”

The FDA has taken steps to ease the shortage. It oversaw the testing and release of batches of platinum drugs manufactured by Intas in India that were made before the closure, but this stock has now been depleted.

It also temporarily allows Qilu Pharmaceuticals, based in China, to ship cisplatin to the United States.

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

Oncologists and supply chain experts said there was little data so far to measure the impact the imports would have. About 600 vials of cisplatin from China arrived at Florida Cancer Specialists earlier this month, Dr. Gordan said. But it was not enough for the practice to resume offering drugs to patients with advanced or recurrent cancer.

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

Studies in the 1980s and 90s showed that the platinum drugs were a huge improvement over existing treatments, they performed best in combination with other drugs and doubled the response rate for ovarian cancer and head and neck cancer. The platinum drugs pushed the five-year survival rate for testicular cancer to 95 percent from about 10 percent.

While newer immunotherapy treatments have improved outcomes for patients with certain types of cancer, such as melanoma, oncologists are also including them in cocktails with the platinum drugs to extend life and increase the potential for survival.

“In general, we haven’t seen these home runs in cancer” in recent years, said Dr. Mikkael Sekeres, an oncologist at the University of Miami and former FDA oncology adviser.

Oncologists advising the field amid the current shortage have urged those treating early-stage lung cancer patients to send them to a center that has the drugs, noting, “there are no equally effective alternatives.”

Dr. Evan Myers, a researcher at Duke University in the department of obstetrics and gynecology, said he plans to measure the effect of the deficiency. A study of another drug shortage affecting children and young people with Hodgkin’s lymphoma found that the replacement drug was “significantly less effective” and reduced the survival rate of the young people who received the back-up treatment.

Dr. Myers said this year’s shortage is at least likely to have an effect on the quality of life of people undergoing treatment. “They’re going to wait for the other shoe to drop,” he said.

Doctors also struggle with how to deliver such devastating news, said Dr. Prasanthi Ganesa, medical director of the Center for Cancer and Blood Disorders in Fort Worth. Her practice looks at each case individually, but also prioritizes crucial doses for patients who can potentially be cured.

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

The situation calls for action, said Dr. Karen Knudsen, executive director of the American Cancer Society. The White House and Congress, which have discussed the problem, have come up with few concrete solutions.

“The need for a durable solution is becoming greater every day,” said Dr. Knudsen, adding, “Patients are left hanging.”



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