Cancer patients, like those I treat in San Diego and thousands more across the country, are facing an alarming shortage of critical chemotherapy drugs, forcing oncologists to ration cancer treatment doses for patients with curable diseases.
That’s right: If you have cancer right now in the United States, the treatment you need might not be obtainable.
Specifically, oncologists have short supplies of platinum-based generic drugs called cisplatin and carboplatin used to treat lung, breast, bladder, ovarian, endometrial, and head and neck cancers. Alternative, brand-name versions of those drugs are not manufactured anymore and aren’t available. The platinum shortage has been severe for about a month, but it has been brewing for several months. We have been battling one shortage after another on and off for the past few years, and it’s getting worse and worse.
Every week at my practice, my colleagues and I are now forced to compile a list of how much cisplatin and carboplatin we have compared to how much we need. Recently, we had more than a dozen patients we can’t treat in the coming weeks with our current supply. Our physicians and nurse practitioners review this list of patients and our generic drug supply and ask: 1) Are there any other drugs we can reasonably substitute? (In most cases, the answer is no.) 2) Can we delay or reduce the dose without negatively impacting their outcome? If not, we are forced to send them away from our clinic to a hospital infusion center that still currently has these drugs on hand — supplies that won’t last much longer. These are not questions any oncologist in the most highly resourced country in the world should be forced to ask.
Consider my patient with a potentially curable lung cancer that was just slightly too large for upfront surgery. The new treatment paradigm for patients like this is for just three cycles of platinum-based chemo with immunotherapy, then, if there is a good enough response, surgery. 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. 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?”
Cisplatin and carboplatin have been the backbone for lung cancer regimens for decades for a reason: They work better than anything else. And now they are largely unavailable.
Sadly, this isn’t the first time cancer patients have dealt with drug shortages, but now the problem is worse, prevalent, and spreading. There are looming shortages with doxorubicin, a critical component of breast cancer, leukemia, and lymphoma treatment; 5-Flourouracil, a treatment for many gastrointestinal cancers; and generic nab-paclitaxel, a commonly used therapy in pancreatic and metastatic breast cancer.
Yet it doesn’t seem like there’s much sense of urgency to fix the problem.
The economics of manufacturing generic drugs are broken. Most drugs in short supply are older generics that are off-patent and complicated to manufacture. Combine those attributes with extremely thin profit margins, and companies are disincentivized from manufacturing them. The result is that one or two companies are the only manufacturers of certain cancer drugs, with an insufficient ability in their supply chain to accommodate any complication. So, when a facility shuts down, the generic drug supply chain gears seize.
The causes of the current wave of shortages are systemic with no silver-bullet solution to address them. The drug price negotiation provisions included in the Inflation Reduction Act and the outsized negotiating power of insurance company-run middlemen, known as pharmacy benefit managers, are likely to compound drug shortages. So fixing today’s cancer drug short requires a direct response from both the private and public sectors.
As the National Comprehensive Cancer Network, an alliance of 33 academic centers, recently noted, insurance companies need to more flexible with their coverage policies and utilization management policies so clinicians can act in the best interests of their patients when considering alternative treatment options for drugs that are in shortage.
Pharmaceutical companies have a role, too. They have, and need to act on, their moral and ethical obligation to meet the demands of drug shortages.
However, recommendations from the National Comprehensive Cancer Network and private sector solutions won’t adequately address this problem a vacuum of public policy interventions. That’s why policymakers should put everything on the table, including tax incentives for generic drug-makers, temporary drug importation, and other incentives that can boost manufacturer competition and strengthen supply chains.
Furthermore, the Food and Drug Administration needs increased transparency into generic drug quality and manufacturing capacity, alongside increased monitoring capabilities that can be used to predict and prevent shortages, and increased flexibility to fast-track approval of new manufacturing facilities as shortages emerge or modify expiration dates during times of acute shortage to avoid wasting potentially effective medications.
I honestly don’t understand why patients are not rioting in the streets about this. The generic cancer drug shortage can be fixed, but only if the private sector and policymakers each pursue ideas to fix it permanently. Cancer patients’ lives depend on it.
Kristen Rice, M.D., is a medical oncologist treating patients at Medical Oncology Associates of San Diego. MOASD is part of the OneOncology partnership.