By Sydney Hoffman
In an increasingly interconnected world where healthcare plays a pivotal role in our well-being, the specter of drug shortages looms ominously over patients, healthcare providers, and policymakers alike. While the pharmaceutical industry has made remarkable strides in developing life-saving medications, the persistent and pervasive issue of drug shortages continues to challenge our healthcare systems. From essential medications for chronic conditions, to critical drugs needed during emergencies, the shortage crisis casts a shadow over our ability to ensure access to safe and effective treatments.
Among several other hundred drugs, the U.S. is presently struggling with unprecedented shortages in cancer medications, including chemotherapy drugs, causing the delay and cancellation of imperative treatment plans. However, the effects of these shortages extend beyond the immediate patient population; experts warn that their repercussions on cancer research could be enduring and far-reaching.
There has been an astounding 33% reduction in the U.S. cancer mortality rate since 1991, equivalent to saving approximately 3.8 million lives. This significant advancement stands as compelling proof of our progress in this field. This achievement was prominently highlighted in a recent report published in CA: A Cancer Journal for Clinicians. However, this crisis jeopardizes this progress and the continuation of critical research. The director of thoracic medical oncology at NYU Langone’s Perlmutter Cancer Center, Vamsi Velcheti, reports the two drugs most scarce and needed for chemotherapy are Cisplatin and Carboplatin. These drugs alone, he says, impact 10% to 20% of cancer patients. Velcheti further amplifies the gravity of this situation by describing them as the cornerstone of care. Gynecological oncologist Amanda Nickles Fader highlights the unfortunate reality, acknowledging that despite remarkable progress in cancer care over the last decade, chemotherapy drugs remain indispensable for extending survival and enhancing the quality of life for cancer patients. Unfortunately, Fadar discloses that the United States currently confronts a shortage of 15 essential chemotherapy drugs, affecting more than 90% of healthcare facilities nationwide. These medications represent a critical lifeline for individuals seeking a chance at recovery. Additionally, drugs used for secondary purposes, such as the frequently prescribed corticosteroid dexamethasone, which helps treat chemotherapy’s side effects, are also in short supply.
CNN gave an account of the following personal story of a man’s life impacted by this drug shortage: Dino Carlone’s journey with bladder cancer took an unsettling turn when he encountered the harsh reality of drug shortages. Initially hopeful, Carlone faced the daunting diagnosis with optimism, believing that the highly effective drug, Bacillus Calmette-Guérin (BCG), would lead him towards recovery. However, his treatment was abruptly cut short due to the unavailability of BCG, leaving him in a precarious situation (CNN). Sadly, Carlone is not alone in his plight. Nationwide, there are estimated to be 8,300 patients annually, who are denied BCG treatments for their bladder cancer. This medication’s shortage is exacerbated by its age and inexpensiveness, further discouraging it from being manufactured at all. A board member of the End Drug Shortage Alliance, Laura Bray, emphasizes the urgency of this issue, stating, “this is a terrible crisis. We should be doing everything we can to give every single one of these patients the best chance of survival.” The shortage of BCG forces medical centers to ration doses and prioritize higher-risk patients despite the drug’s crucial role in combating a disease with a high recurrence rate. As the healthcare system grapples with these challenges, the human toll of drug shortages in the face of aggressive diseases like bladder cancer, remains a stark reminder of the need for comprehensive solutions.
The root causes of these shortages are multifaceted, encompassing manufacturing problems, raw material unavailability, business considerations, and logistical challenges. Manufacturers often face difficult decisions when allocating resources, favoring more profitable products over those with lower profit margins. This tendency is particularly evident in the case of generic and injectable medications, which require stringent quality standards, rendering them less appealing for production. Quality issues further exacerbate the problem, as they are a frequent cause of drug shortages (PHRMA). Quality problems, including microbial contamination, endotoxins, tablet disintegration, and particulate matter in vials, often necessitate recalls after medicines have already entered the market. In the United States, a staggering 67% of drug shortages in 2012, were attributed to quality issues, a trend that persisted in subsequent years (Front. Pharmacol). According to a recent report by the University of Utah Drug Information Service, 2023 witnessed the highest number of active drug shortages in the past decade. We are on the verge of breaking the previous record of 320, according to a report from the American Society of Health-System Pharmacists (ASHP). In order to safeguard the health of patients across the country and maintain a consistent supply of essential medications, it is imperative to adopt a strategy that addresses the complex challenges at hand.
The drug shortages currently plaguing the United States, have brought attention to the intricate interplay between medical needs and market dynamics. In a recent statement released by the Food and Drug Administration (FDA), the agency acknowledged its constraints, emphasizing that it lacks the authority to compel pharmaceutical companies to produce or increase the production of drugs, even in cases where there is a clear medical need. The profit-oriented objectives of pharmaceutical corporations exacerbate the challenges. In a recent statement, Marta Wosińska, a former FDA member, who currently serves as an economist at the esteemed Brookings Institution, emphasized the limited extent to which pharmaceutical companies can be held accountable. Wosińska stated that these companies are bound by a fiduciary duty to their shareholders, which inherently requires them to prioritize market considerations— “so you can only ask them to do so much.”
However, Dr. Yoram Unguru, from the Johns Hopkins Berman Institute of Bioethics, believes that pharmaceutical companies can maintain their profitability, while simultaneously guaranteeing the widespread availability of crucial medications. In a passionate statement, he underscored the crucial significance of the government, firmly stating, “it is imperative that the federal government assumes a more proactive stance, ensuring the availability of vital life-saving drugs and implementing a pricing system for medications, similar to the regulatory bodies that oversee public utilities.”
Addressing the dire consequences of drug shortages, particularly those pertaining to cancer treatments, is an issue that resonates across sectors — from patients to pharmaceutical companies to medical professionals and advocacy groups. The urgency of the situation mandates a collective response and demands immediate action. The medical community, the government, and the private sector must work together to address these challenges, and reduce these shortages so that lives can be improved and saved.