What We Can Learn From The Cancer Drug Shortages
By Ian Chan, Abpro
Over the last two years, the shortage of cancer drugs has become a national crisis, putting patients at risk of worsened conditions or, in some cases, even death. There are two drugs in particular that are causing doctors to pause, as these are often unavailable — cisplatin and carboplatin — which are both essential for basic cancer treatment and care. Carboplatin is a common injectable chemotherapy drug that is used to treat cancer of the ovaries, head and neck, and breast. Cisplatin is another form of injectable chemotherapy drug that can be used to treat testicular, ovarian, bladder, head, neck, lung, and cervical cancers.
These treatments are essential (cisplatin is prescribed to 10% to 20% of all cancer patients), yet 70% of cancer centers across the United States are experiencing a shortage of this drug, while a staggering 93% of U.S. cancer centers are experiencing a shortage of carboplatin. As a result of these shortages, doctors are rationing the available supply by reducing doses or delaying treatment altogether. Delaying treatment, even if only by a month, can have serious repercussions and increase risks of death by up to 13% according to a recent study. When it comes to life-threatening diseases such as breast cancer, lung cancer, or ovarian cancer, early intervention is critical to increasing the odds of remission.
The FDA has continued working toward a solution to the shortage, yet there has been no resolution found yet. In order to ensure that patients receive the treatments they need, stakeholders in oncology, including drug manufacturers, must advocate for change and take action to reinforce their own supply chains, while continuing to research alternative approaches to treatment to ensure a diverse portfolio of treatments. Approaches and strategies that can be taken are discussed below.
How Did We Get Here?
The initial concern about a shortage began in 2021, during the COVID-19 pandemic, when government restrictions forced large populations to stay inside their homes. These restrictions made it hard for many to seek regular healthcare, or even critical cancer screenings and tests, which resulted in a 40% to 50% decrease in cancer diagnoses during the pandemic in comparison to previous years, according to research from the National Library of Medicine. With restrictions finally easing up, these patients may just now be receiving a diagnosis or seeking care, which may play a key role in the increase in the number of drugs needed and affecting the already short supplies.
Like so many industries, cancer drug-making facilities are experiencing staffing shortages, impacting the supply chain. Quality concerns at manufacturing facilities have also taken a toll on the production of cancer drugs. For example, one of the largest cisplatin and carboplatin manufacturers, Intas Pharmaceuticals, was forced to shut down production after the FDA highlighted a list of manufacturing violations. With this factory making up about 50% of the U.S. supply of these drugs, the shortage emergency only worsened as the news broke, and it remains a major concern as there is still no date to resume manufacturing.
This closure has created a domino effect, leaving doctors scrambling to figure out how to treat patients without access to proper dosages and, more broadly, what this means for the future of cancer treatment. Physicians and healthcare leaders are looking to the government and FDA for help to remedy the supply chain issues.
Alternative Treatment Options
In June, the FDA temporarily allowed imports of unapproved drugs from China to help ease the shortage, but the demand is much higher than what is being brought in. While government officials continue to discuss ways to improve supply chains, clinicians have also begun to investigate alternative medications, such as immunotherapies. Within immunotherapy, there are different treatments that can be utilized, one being monoclonal antibodies, which can help fill the cisplatin and carboplatin gaps.
Unlike chemotherapy, which only works while the drugs are being administered to the patient, immunotherapy will allow the immune system to continue fighting the cancer cells even after leaving the hospital. A primary reason for the limited use is the little amount of knowledge the public has about this form of therapy, signaling the need for more awareness to be generated for this treatment and more funding to complete clinical trials.
Learning From The Drug Shortage Crisis
The drug shortage is exposing critical flaws in our supply chain. It’s clear that there is a need for greater focus on and funds dedicated to supply chains. Supply chains are made up of different levels of the healthcare industry, including vendors and manufacturers — one wrinkle in the supply chain creates a ripple effect, disrupting the entire industry all the way to the patient. In recent years, no biotech company has been immune to supply chain issues.
At Abpro, our team experienced this firsthand during the peak of the pandemic. Many drug manufacturers were either backed up or halted their production entirely due to pandemic restrictions and staffing shortages. Our team left no stone unturned and even sought international manufacturers, but it ultimately felt like we were trying to find a needle in a haystack. After reaching out to our global contacts and continuing to push forward, we were eventually able to find a manufacturer and continue to make strides in our monoclonal antibody development, but the pressure to develop these treatments to meet patient needs was intense.
With Congress playing a vital role in keeping the supply chain operating smoothly, political leaders are beginning to feel the pressure to work toward solutions, including increasing manufacturing and diversifying areas where materials for these manufacturers can be sourced. One bill introduced in July will grant contracts for generic drug manufacturers within the U.S. to increase production, setting the example for what can be done to better enhance the production of specialty drugs as well. Some leaders in healthcare are also putting pressure on lawmakers to provide more clarity and funding throughout the supply chain, but it is not enough.
Specifically, more biotech leaders who are at the frontlines of the supply chain need to be a part of the discussion. These leaders need to share the struggles they are facing while trying to manufacture and distribute drugs, and how this is ultimately harming the patients at the end of the line. I specifically have worked alongside lobbying groups to put similar pressure on Congress to advance COVID-19 treatments, and I found this to be an effective strategy. With applied pressure, lawmakers will have no choice but to address the issue, and we may see changes that could help avoid future situations like the shortage we are currently witnessing.
This also provides industry leaders and policymakers with an opportunity to take a closer look at the historical processes used within supply chains. Through close examination, we can determine what has and has not worked over time and can make necessary adjustments or investigate new solutions. For example, manual projections previously used for supply chains may not be as reliable anymore in a constantly evolving industry, but as technology advances, new predicting and forecasting programs are becoming available to help provide a clearer overview for planning.
This drug shortage crisis also provides an opportunity for health leaders, researchers, and providers across the industry to explore different forms of treatment that may not be the typical or traditional drugs they were introduced to at the beginning of their careers. Technology has continued evolving, and cancer treatment has as well, meaning the realm of possibilities is only beginning to expand. As an industry, we need to become more resilient and forward-thinking. By having alternate and secure plans in place at the governmental level, the healthcare supply chain can be kept up and running, even during a national emergency. Doctors and nurses across the globe also need to be adaptable to change and willing to step outside of their comfort zones to try new forms of treatment. For some patients, immunotherapy may work better at fighting cancer than chemotherapy, but we may never know until it becomes more widely adopted. This challenge should be used as a stepping stone to a better state of healthcare.
About the Author:
Ian Chan is the cofounder and CEO of Abpro, a biotechnology company aimed at improving the lives of mankind facing severe and life-threatening diseases with next-generation antibody therapies. Ian has been with Abpro since its inception in 2007 when he and his brother, Eugene Chan, founded the company. Ian received a B.A. from Brown University and MBA from Harvard University.