The shortage of effective chemotherapy drugs is posing a significant risk to cancer patients and their treatment outcomes. This shortage includes cheap, generic drugs that have been used in cancer medicine for many years.
The number of active medication shortages reached 295 at the end of last year, representing a 30 percent increase since 2021, according to a report by the Homeland Security and Governmental Affairs. Chemotherapy drugs, particularly those used to treat pediatric cancers, are among the medications experiencing the most prolonged shortages.
The primary cause of the drug shortage crisis is the low profit margins on generic drugs, as well as an overreliance on foreign manufacturing, increasing quality risks, and fragile supply chains. Pharmaceutical companies do not generate significant profits from these older, generic injectable drugs, resulting in few companies manufacturing them.
Consequently, if one of these companies decides to leave the market, faces production issues, or struggles to source raw ingredients (80 percent of which come from China and India), a drug shortage occurs.
The delays in treatment caused by these shortages can have devastating consequences. Research has shown that a four-week treatment delay can increase sickness or mortality for over 40 percent of common cancers.
A survey of pediatric hematologists-oncologists revealed that nearly 65 percent of the doctors had patients whose care was affected by shortages. This shortage crisis affects patients of all ages and diseases, including tumors, blood cancers, and both children and adults.
The shortage of vital chemotherapy drugs has led to the postponement or cancellation of lifesaving procedures, leaving patients without effective treatment options. For example, a patient with relapsed testicular cancer may have their stem cell transplant significantly delayed due to a shortage of the chemotherapy drug carboplatin.
Similarly, a 39-year-old woman with ovarian germ cell tumor may not be able to undergo a stem cell transplant. The shortage also affects drugs used in leukemia treatment, such as fludarabine, leaving patients with limited alternatives and potentially compromising their chances of a cure.
The issue of drug shortages extends beyond cancer treatments. For instance, Accord Healthcare Inc., a company responsible for manufacturing three critical cancer drugs—methotrexate, cisplatin, and carboplatin—has faced significant quality issues resulting in a manufacturing shutdown in one of its facilities in India. While other companies are trying to compensate for the supply shortfall, they may not have the capacity to meet the demand.
To address the crisis, experts are calling for the establishment of a strategic reserve for lifesaving cancer drugs, with the government taking the initiative to ensure a stable supply.
Congress and the Biden administration have begun addressing drug shortages in general, with the FDA authorizing the temporary importation of a Chinese injectable version of the widely used drug cisplatin to mitigate the chemotherapy shortage. The FDA closely monitors shortages and explores temporary importation options while prioritizing patient safety and quality assurance.
Pharmaceutical companies' trade group, the Pharmaceutical Research and Manufacturers of America, emphasizes that brand manufacturers have built diverse and complex manufacturing systems to ensure ongoing access to medicines.
However, the current drug shortage crisis highlights the need for greater collaboration and flexibility in supply chains to prevent patients from being deprived of life-saving medications.
Advocacy groups like Angels for Change have emerged to help patients and hospitals navigate the drug shortage crisis by sourcing drugs from alternative supply chains. These organizations work to address supply chain problems and ensure patients receive the medications they need.
Ultimately, addressing the drug shortage crisis requires a collective effort from stakeholders to create more resilient and flexible supply chains. The goal is to ensure that no patient has to hear the devastating words, "we don't have the medicine to treat you."
