Toni Dezomits’ advanced ovarian cancer has responded well to previous rounds of chemo, but this spring, her doctors told her there was a shortage of a key chemo drug.
Toni Dezomits
hide caption
toggle caption on/off
Toni Dezomits
Toni Dezomits’ advanced ovarian cancer has responded well to previous rounds of chemo, but this spring, her doctors told her there was a shortage of a key chemo drug.
Toni Dezomits
Toni Dezomits is used to facing death. He served in the Gulf War and later as a police officer, rising to police chief in North Carolina before retiring. He says he needs no mercy for his advanced ovarian cancer diagnosis.
« I’m probably the toughest person you’ll ever meet, » says Dezomits. At 55, she still feels mentally strong and physically perfect despite her stage 4 diagnosis.
« When we’re done talking, I’m going to go on a 10-mile bike ride, » she says, followed by gardening and walking her three dogs. « I never sit down and say, ‘How long do people with this cancer live?' »
But Dezomits, too, was spooked in early April when a medicine called carboplatin, which had all but eliminated tumors in its previous courses of treatment, was unavailable. It and a similar drug called cisplatin, both critical for treating many different cancers, fell into short supply earlier this year.
The shortage is so severe that the Food and Drug Administration recently said it would allow the import of unapproved cisplatin from China. Manufacturers are scrambling to try and do more. However, experts say it will be the end of the year before the shortages of these two widely used generics can start to ease.
The story of how two critical drugs, plus more than a dozen other cancer drugs, ended up in shortage boils down to a flawed system for manufacturing and distributing generics that started leading to more and more shortages of various drugs essential.
This latest deficiency puts patients like Dezomits in a difficult situation: « Here I am, faced with two suboptimal treatment plans. »
One choice: Substitute a drug with more serious side effects like nausea and nerve pain. The other: continue treatment without it. Dezomits has opted to go without it, but won’t know the health implications of that choice for weeks, when he receives his next scan to see if the tumors in his abdomen have grown.
Americans rely heavily on generics – they make up for orver 90% of prescriptions. But over the past 15 years, shortages of these off-brand drugs have become a more pervasive and acute problem, as everyone from consumers to retail pharmacies and healthcare systems pressure manufacturers to produce them at ever lower prices.
« We have a market that is totally focused on just price » at the expense of safety and ensuring availability, says Dr. Kevin Schulmanprofessor of medicine and economics at Stanford University.
Schulman says the way industry contracts work, it’s very difficult for drugmakers to turn a profit on the drugs once their patents expire. The added costs of inflation and the COVID-19 pandemic have worsened these dynamics, leading to more factory closures. The few companies that remain in the generic drug industry are being pushed to take dangerous shortcuts.
That was the case for Intas, the India-based company that, up until the end of last year, produced about half of the major cancer drugs used in the U.S. After FDA inspectors found evidence of serious safety and quality violations last fall, the company’s production of key cancer drugs was halted, abruptly halting supply. It’s unclear whether other makers of these drugs have the ability or financial incentive to remediate.
Schulman says this is a global problem; the search for low-priced generics has come at the expense of safety and the guarantee of a constant supply. Currently, about 130 generics lack of medicinesand that list continues to grow, according to the Association for Affordable Medicines, a generic drug industry group.
« I mean, we save hundreds of billions of dollars a year by using generic drugs rather than brand-name drugs, but we only save that money if the drugs are available, » says Schulman.
Toni Dezomits
Toni Dezomits
hide caption
toggle caption on/off
Toni Dezomits
And when crucial drugs aren’t available, the toll is heavy for Denver-based oncologist Jennifer Rubatt. Several weeks ago, pharmacists in her healthcare system told her that both of the main cancer drugs her patients rely on had run out, so they recommended substitutes.
« When I was confronted with this drug substitution for a young woman with young children, I cried, because if her cancer comes back, I’ll always wonder if it was because I had to give her a substitute, » Rubatt says, her voice trembling.
Shipments of drugs have since arrived, but Rubatt fears they will run out again and is dedicated to research, looking for alternatives that are less likely to compromise patient care.
Last month, the Society for Gynecologic Oncology issued recommendations for doctors treatment of gynecological cancers, advising them on how to manage the use of limited drugs if supply decreases. Patients with early-stage and high-risk disease should be given the highest priority. He also recommends using minimal doses, scraping drops from multiple vials, and lengthening the time between treatments to make it last.
“There are hundreds of thousands of patients affected by the deficiency, and even missing a course or two of treatment could affect patient outcomes,” he says Dr. Amanda Fader, society president-elect and vice president of gynecologic surgical operations at Johns Hopkins Medicine.
In the long run, he says the business model itself needs to change to ensure a good quality offering: « Certainly a reinvented model of delivery to hospital systems, either direct from the manufacturers or through an improved intermediate model, is key. »
Civic offers one such alternative. The non-profit organization was formed five years ago to address the shortage of other drugs, starting with injectables, which are more complex to make. Civica purchases medicines directly from manufacturers to supply the health systems that manage 1,500 hospitals. It conducts its own quality control and sets drug prices high enough to ensure factories can stay in business. It is also building its own domestic manufacturing plant.
There are other benefits to making manufacturing more profitable and predictable, says Allan Coukell, senior vice president of public policy at Civica.
« It also allows us to build up a backup inventory. So we actually keep about six months worth of drugs in a warehouse, » he says.
Coukell says Civica now supplies 80 essential medicines — things like antibiotics or anesthesia — and is currently considering whether and how to add cancer drugs to its list.
But even if it does, it will be many months, possibly longer, before it can benefit patients like retired police chief Toni Dezomits. Yet facing that prospect makes her care more for others.
« My oncologist is beside himself. I mean, they’re struggling too, because they signed up to help people and they’re helpless, » she says.
Dezomits has joined support groups with hundreds of other cancer patients, many of whom lament how drug shortages exacerbate their suffering. Some turn to Dezomits for countrywide support.
As he has throughout his life, Dezomits welcomes those callings as an opportunity to serve others: « Right now, you’re living — and that’s what I say: ‘I’m living right now,' » she says. « Mentally, if you can keep yourself in a very positive mindset, it will take you a very long way on a cancer journey. »
