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

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

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

That outlook began to darken in recent weeks, however, after her oncology practice in Central California began sporadically running out of the vital drug she needed.

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

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

The country’s months-long shortage of highly potent cancer drugs is looming large, forcing patients and their doctors to confront even more grim realities than cancer itself. Thousands of patients like Mr. Shepard face terrifying choices, treatment delays and a potentially bleak future.

Oncologists are concerned that alternatives to two important chemotherapy drugs are much less effective in treating some cancers, and sometimes more toxic. They say backup therapy or the lack thereof poses particularly troubling prospects for patients with ovarian, testicular, breast, lung, and head and neck cancers.

There are few, if any, signs that the deficit will abate anytime soon. A plant that was the main producer of the more popular drug closed late last year and has not reopened, reducing its stock. The easing of restrictions on imported drugs from China this month has brought some respite, but doctors say the influx has still not made much of an impact. Some companies that sell the drug are forecasting that the shortage will last until the autumn or beyond.

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

To bridge the gap, some doctors are increasing the interval of care and spending precious milliliters to increase doses. Others are adopting a strategy of surgery first and chemo later, relying on restoration of supplies.

One of the nation’s top cancer care groups, the American Society of Clinical Oncology, is now advising doctors to give the drug in smaller amounts than to give it to patients with a single shot for treatment — and to give them more frequently or widely. can be denied to patients with communicable diseases. ,

“We are in a situation where patients are being left behind, and we are really concerned that the lack of chemotherapy could impact survival,” says Dr. Ángeles Alvarez Secord, president of the Society of Gynecologic Oncology and Professor he said. Duke University School of Medicine.

The two main chemotherapy drugs, cisplatin and carboplatin, are positioned as frontline drugs in a cocktail used to shrink or eliminate tumors. More than a dozen cancer drugs are also officially in short supply. hundreds of others Medicines including antibiotics and sterile injectable fluids. Still, doctors estimate that the absence of powerful chemotherapy may be hurting patients the most.

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

The most recent shortage of these widely used drugs occurred when a major manufacturer, Intas Pharmaceuticals, halted production in December following a surprise inspection by the Food and Drug Administration at its plant in Ahmedabad, India. american agency issued a report Employees were said to have been breaking, tearing up and pouring acid on quality control records and witnessed “a cascade of failure” at the site.

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

By this spring, the effects of the Intas shutdown were deeply felt. A Survey by the National Comprehensive Cancer Network Academic Treatment Centers, released earlier this month, found that 93 percent of 27 responding centers were facing a shortage of carboplatin. As a result, 36 percent of them reported changing treatments for their patients, resorting to lower doses and longer intervals between treatments.

At SeaCare Cancer Center in Fresno, California, where Mr. Sheppard receives care for his vocal cord cancer, efforts to increase supplies have led to sporadic availability. Oncologist Dr Ravi Rao said, for the past six weeks, the vials of platinum drugs have been unavailable almost half the time.

He said Mr Sheppard’s chances of being cured without the drugs would drop from about 90 per cent to about 45 per cent. Fortunately, Mr. Sheppard said, there are drugs available for the first two of the seven treatments.

Ovarian cancer patients are facing the worst because of how common the disease is and how important platinum drugs have been in combating it over the decades, Dr Rao said. Without those drugs, a patient with extensive ovarian cancer’s chances of survival drop from about 30 percent to single digits, he said.

“People will die because of this shortage,” said Dr. Rao, who is also a board member of the Community Oncology Alliance. “There is no way around it. You can’t take away these life-saving drugs and there will be bad consequences.”

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

“This is significant, with just these two drugs alone, almost half a million Americans could be affected,” Dr. Gralo said.

For Florida Cancer Specialists, which has more than 90 sites, the reduction initially meant saving 10 to 15 percent of patient doses to increase stock, said Dr. Lucio Gordon, president of the practice.

This wasn’t enough, so doctors began prescribing the drugs only to patients who were likely to be cured or who were enrolled in clinical trials. In practice some products were found to be at highly inflated prices – clearly price gouging – but they were bought nonetheless.

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

Arias Pitts, 33, who was diagnosed with aggressive breast cancer in April, was missing it when she arrived to begin treatment on May 16. The carboplatin his doctor had ordered for the first 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. He added, “It’s stressful.”

The FDA has taken steps to reduce the shortage. It oversaw the testing and release of batches of platinum drugs manufactured by Intas in India before the shutdown, but that stock is now exhausted.

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

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

Oncologists and supply chain experts said there was too little data so far to assess the impact of imports. Dr. Gordon said earlier this month about 600 vials of cisplatin from China made their way to Florida cancer specialists. But this was not enough for the practice to resume giving drugs to patients with advanced or recurrent cancer.

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

Studies in the 1980s and ’90s showed that platinum drugs were significantly better than existing treatments, performing best in combination with other drugs and doubling response rates. for ovarian And head and neck cancer. platinum drugs pushed The five-year survival rate for testicular cancer ranges from about 10 percent to 95 percent.

While newer immunotherapy treatments have improved outcomes for patients with certain types of cancer, such as melanoma, oncologists also add them in cocktails with platinum drugs to prolong their lives and increase survival.

“In general, we haven’t seen home remedies in cancer in recent years,” said Dr. Mikel Secares, an oncologist at the University of Miami and former FDA oncology advisor.

Amidst the current shortage, consulting oncologists in the region have urged those treating patients with early stage lung cancer to send them One center that has the drugs said, “There are no equally effective alternatives.”

Researcher Dr. Evan Myers, of Duke University’s Department of Obstetrics and Gynecology, said he was planning to measure the effects of the shortage. One study of the deficiency of a different drug In children and adolescents affected by Hodgkin’s lymphoma, it was found that the substitute drug was “significantly less effective”, and survival rates decreased for youths receiving backup treatment.

Dr. Myers said this year’s shortage At the very least, the quality of life of those receiving treatment is likely to be affected. “They must be waiting for the other shoe to drop,” he said.

Doctors are also struggling with how to communicate such devastating news, said Dr. Prasanthi Ganesh, medical director of the Center for Cancer and Blood Disorders in Fort Worth. His practice is looking at each case individually, but also prioritizing significant doses for patients who could potentially be cured.

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

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

Dr. Knudsen said, “The need for sustainable solutions is increasing by the day,” and added, “Patients are hung up.”

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