For cancer patients in the US right now, a horrifying reality may follow the devastating diagnosis—their malignant disease may go undertreated or even untreated.
The country is in the grips of a dire shortage of cheap, generic platinum-based cancer drugs used to treat various cancers in hundreds of thousands of US patients each year—patients with lung, breast, bladder, ovarian, testicular, endometrial, and head and neck cancers, and others.
Despite being in one of the wealthiest countries in the world, US doctors are being forced to ration the cisplatin and carboplatin drugs. That means prioritizing cancer patients who have a shot at being cured over patients at later stages, in whom the drugs may simply slow progression and buy time. Still, those with curable cancers may not get a full dose; some may only have 80 percent or 60 percent of standard doses available to them. And doctors don't know how these partial doses will affect patient outcomes.
In an opinion piece for Stat News this week, San Diego-based oncologist Kristen Rice described the dilemma faced in caring for just one of her patients, one with a curable lung cancer that is slightly too large to be surgically removed. Normally, the plan would be three cycles of platinum-based drugs, and if the cancer shrinks a bit, they can go in for surgery. But "if we reduce her doses to extend our drug supply, we risk reducing the chance of response, and that could mean missing a chance at potentially curative surgery," Rice wrote. "If her scan after that third cycle isn’t what we hope, the first question she will ask is: 'What if I had received the full dose? Would it have made a difference?'"
Meanwhile, in Fredericksburg, Virginia, oncologist Bonny Moore told KFF Health News that clinicians at her practice had given some uterine cancer patients 60 percent doses of carboplatin last month before shifting to 80 percent doses when a small shipment came in. On June 2, they were glued to their drug distributor's website, hoping for the drug to come back in stock. It did not. Doses stayed at 80 percent.
On Tuesday in Alaska, Melissa Hardesty, a gynecologic oncologist at Alaska Women’s Cancer Care in Anchorage, told Alaska Public Media that her clinic is also rationing drugs. "Right now, as of today, this second, I have no cisplatin in-house," said Hardesty. "So if I have a new cervix cancer patient show up, I’m essentially going to be extrapolating from other things to treat that person." That means, she explained, using other types of cancer-fighting drugs and hoping they work on the cancers her patients have. This may or may not work. And alternative treatments can have more severe side effects.
A plant with problems
The situation is made yet more desperate because the shortage isn't expected to end quickly, and even if the most immediate problems are solved, the long-term foundational cracks in the generic drug industry will likely remain.
The current shortage was triggered late last year when the Food and Drug Administration inspected a drug manufacturing facility owned by Intas Pharmaceuticals in Ahmedabad, India. Inspectors found egregious violations. Afterward, Intas voluntarily shut down the facility, which had supplied around half of the generic cisplatin and carboplatin in the US.
The stunning inspection report, released in January, leaves no doubt as to why the plant was shut down. In addition to various manufacturing violations, including laboratory and quality control problems, inspectors reported finding a truck 150 meters from the facility loaded with plastic bags full of shredded and torn documents. When the inspector dug into the documents, they realized they were quality-control documents and analytical weight slips.