Toni Dezomits’ advanced ovarian cancer responded well to the first few rounds of chemotherapy, but this spring her doctors told her there was a shortage of key chemotherapy drugs.
Tony Dzomitz
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Tony Dzomitz
Toni Dezomits’ advanced ovarian cancer responded well to the first few rounds of chemotherapy, but this spring her doctors told her there was a shortage of key chemotherapy drugs.
Tony Dzomitz
Toni Dezomits is used to facing death. She fought in the Gulf War, became a police officer, and became North Carolina’s police chief before retiring. She says she doesn’t need to feel sorry for being diagnosed with advanced ovarian cancer.
“I’m probably the strongest person you’ll ever meet,” Dezomits said. Despite her Stage 4 diagnosis, at 55 she still feels mentally strong and physically healthy.
“When we’re done talking, I’m going to go for a 10-mile bike ride,” she says, followed by gardening and then a walk with her three dogs. “I would never sit there and ask ‘how long do people live with this cancer?'”
But even Dezomits was terrified in early April when a drug called carboplatin, which nearly wiped out tumors in previous rounds of treatment, was unavailable. It and a similar drug called cisplatin — both central to the treatment of many different cancers — were in short supply earlier this year.
The shortage is so severe that the U.S. Food and Drug Administration recently said it would allow the import of unapproved cisplatin from China. Manufacturers are scrambling to try and produce more. However, shortages of the two widely used generic drugs may not begin to ease until the end of the year, experts say.
The story of eventual shortages of two key drugs, as well as more than a dozen other cancer drugs, boils down to a faulty system for manufacturing and distributing generic drugs that has begun to lead to growing shortages of various essential medicines.
This latest shortage leaves patients like Dezomits stranded: “Here I am, with two suboptimal treatment plans.”
One option: Substituting a drug with more serious side effects, such as nausea and nerve pain. Another: Continue treatment without it. Dezomits chose not to eat, but she won’t know the health effects of that choice for several weeks, when she will have her next scan to see if the cancer in her abdomen has grown.
Americans rely heavily on generic drugs — they account for more than 90 percent of prescriptions. But over the past 15 years, shortages of these generic drugs have become a more pervasive and acute problem, as everyone from consumers to retail pharmacies and health systems put pressure on manufacturers to sell them at ever lower prices. price production.
“We have a market that’s completely focused on price,” at the expense of safety and ensuring availability, said Dr. Kevin Shulman, a professor of medicine and business at Stanford University.
The way industry contracts work, Schulman said, it’s hard for drugmakers to make money off a drug once a patent expires. The added cost of inflation and the COVID-19 pandemic have made these dynamics worse, causing more factories to shut down. The few companies that remained in the generics industry were forced to take dangerous shortcuts.
That was the case with Intas, the India-based company that—until late last year—made about half of the leading cancer drugs It is used in the U.S. Then, the company halted production of the lead cancer drug last fall, abruptly cutting off supply after FDA inspectors found evidence of major safety and quality violations there. It’s unclear whether other manufacturers of these drugs have the capacity or financial incentive to make up the shortfall.
Schulman said it was a global problem; the pursuit of lower-priced generics came at the expense of safety and ensuring a steady supply. According to the Association for Affordable Drugs, a generic drug industry group, there are currently about 130 generic drug shortages, and the list keeps growing.
“I mean, we save hundreds of billions of dollars a year by using generics instead of branded drugs, but we only save that money when the drugs are available,” Schulman said.
Tony Dzomitz
Tony Dzomitz
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Tony Dzomitz
Denver oncologist Jennifer Rubatt takes a heavy toll when she can’t get a key drug. A few weeks ago, pharmacists at her health system told her that two of the main cancer drugs her patients were relying on were running out, so they recommended alternatives.
“I did cry when I was faced with this drug replacement for a young woman with a young child, because if her cancer came back, I would always question whether it was because I had to give her a replacement,” Rubart said, her voice shaking.
The drugs have since arrived, but Rubatt worries they will run out again, so she researches them carefully for the alternatives least likely to compromise patient care.
Last month, the Society of Gynecologic Oncology issued recommendations to physicians treating gynecological cancers, Advise them on how to manage the use of limited medicines when supplies dwindle. Patients with early-stage, high-risk disease should be a top priority. It also recommends using the smallest dose possible, scraping off drops from multiple vials, and extending the time between treatments to allow it to last.
“There are hundreds of thousands of patients affected by shortages, and missing even a cycle or two of treatment can impact patient outcomes,” said Dr. Amanda Fader, president-elect of the Society for Gynecologic Surgery and vice-chair of the Johns Hopkins University Department of Gynecologic Medicines.
In the longer term, she says the business model itself must change to ensure a high-quality supply: “Of course, it will be critical to reimagine the delivery model to the hospital system, whether it is directly from the manufacturer or through an improved intermediary model .”
Civica offers one such option. The nonprofit was founded five years ago to address shortages of other drugs, starting with injectables that are more complex to manufacture. Civica sources medicines directly from manufacturers to supply the health systems that operate 1,500 hospitals. It conducts its own quality control and prices drugs high enough to keep factories open. It is also building its own domestic manufacturing plant.
Improved margins and predictability in production have other benefits, said Allan Coukell, Civica’s senior vice president of public policy.
“It also allowed us to build a reserve inventory. So we actually had about six months’ worth of drug in the warehouse,” he said.
Civica now offers 80 essential medicines — such as antibiotics or narcotics — and is currently evaluating whether and how to add cancer drugs to its list, Coukell said.
But even if it works, it will take many months — perhaps longer — to benefit patients like retired police chief Tony Dzomitz. However, facing this prospect made her worry about others even more.
“My oncologist was unhinged. I mean, they were struggling because they signed up to help people and they couldn’t do anything,” she said.
Dezomits joined the support group with hundreds of other cancer patients, many of whom lamented how the shortage of medicines had exacerbated their pain. Some turned to Dezomits for support across the country.
As she has done throughout her life, Dezomits welcomes the calls as an opportunity to serve others: “Right now, you’re alive—that’s what I say: ‘I’m alive now,'” she said . “Mentally, if you can keep yourself very positive, it will take you very far in your cancer journey.”
