Oncologists Call for Legislative Action to Address US Drug Shortages
In Partnership With
Amid the ongoing chemotherapy drug shortage in the United States, experts like Nathan Bahary, MD, and Anne LaCasce, MD, MMSc, push for the passing of legislation, yet keep their patients their top priority.
Chemotherapy Treatment © Trsakaoe - stock.adobe.com
The field of oncology continues to wrestle with the concerning shortage of multiple chemotherapy agents. Although the oncology space is short on supply of 11 chemotherapy agents, 2 of the most depleted therapies include carboplatin and cisplatin.1,2
The ongoing scarcity of these drugs has drawn attention from medical professionals across the country, and solutions continue to be needed in order to address the gap in supply.
In response to these shortages, the FDA and the National Comprehensive Cancer Network (NCCN) have started taking action.3,4
The FDA has made the decision to import cisplatin from China to increase its supply amid the ongoing shortage in the United States. A similar plan for importing carboplatin is in the works, however, specifics on the potential supplier for that drug have yet to be announced.
Nathan Bahary, MD, PhD, highlighted the urgency of securing these necessary medications from any available source, noting that the drugs' efficacy has been affirmed by independent labs.
Nathan Bahary, MD, PhD
“Many of these manufacturers have ensured purity. We know that they are pure, and we think they are efficacious. The FDA, maybe because of politics or other reasons, hasn't approved it, because we're trying to keep our own pipelines. But we need the drug from wherever it comes,” Bahary, division chief of medical oncology and director of clinical cancer research at the Allegheny Health Network Cancer Institute, told Targeted OncologyTM, in an interview.
For Bahary, as well as many other clinicians, the priority is placed on the patients' well-being over political considerations. He emphasizes the importance of obtaining these drugs, regardless of where they come from.
The cisplatin shortage has been ongoing in the United States since February, and carboplatin has been in shortage since April. According to the American Society of Health-System Pharmacists5, ongoing and active drug shortages are the highest they have been in a decade.
In May, a survey performed by the NCCN found that 93% of 27 cancer treatment centers surveyed answered that they are experiencing a carboplatin shortage, and 70% have reported a cisplatin shortage, respectively.4
Some of the treatment centers in the survey answered that the cisplatin shortage is not as critical as the carboplatin situation because there are other treatment options that can be used instead. However, the survey noted that only 64% of centers are able to treat all patients who need carboplatin, and 20% of centers said they can treat some patients who need carboplatin, but not all.
“I've got to trust that the FDA has done their basic research and knows that we're not at risk of harming anybody. I have faith in our oversight in our medical system to say that it's equivalent, and it's okay,” added Bahary
Outside of these 2 chemotherapy agents, it is unknown whether the FDA will use this strategy for other cancer medications.
The root causes of these ongoing shortages extend beyond the current crisis. Still, Allegheny Health Network Cancer Institute has managed to alleviate shortages by coordinating with other hospitals within the network and through careful drug distribution, according to Bahary.
Ann LaCasce, MD, MMSc
Similarly, Ann LaCasce, MD, MMSc, notes that her institution, Dana-Farber Cancer Institute, has been fortunate during this crisis as they have an extraordinary lead for their pharmacy who has been proactive in trying to identify sources for these chemotherapy drugs.
“These are life-saving drugs and these are curable diseases for which we don't have standard of care chemotherapy drugs that cost nothing to manufacture. I know it's a big political issue, but it is critical,” LaCasce, associate professor of medicine at Dana-Farber Cancer Institute, director of the Dana Farber/Mass General Brigham Fellowship in Hematology/Oncology, told Targeted OncologyTM, in an interview.
According to Bahary, there has been a shift of generic drug manufacturing overseas where oversight may be less stringent, and notes that this has played a role. He, as well as Ann LaCasce, MD, MMSc, emphasize the need for domestic drug production through the passing of legislation or incentives.6
“One of the things that I'd love to be able to see happen, is some sort of push through Congress through legislation, if necessary, to try to bring some of that back over and into the country, so that it's worthwhile for us to manufacture as well,” said Bahary.
Currently, no regulatory policies are in place to help sustain and subsidize pricing for generic regimens, causing a continued impact on the field of oncology.6
“If our patients don't survive their initial cancer, then developing new drugs is a moot point, right? The patients aren't going to be around to treat, added LaCasce. “We need to lobby our Congress, and there's just got to be better support for these drugs.”
The impact of these shortages extends to clinical trials as well, which often require specific drugs to maintain the integrity of the trial and the accuracy of the data.
Impact on Clinical Trials
According to Bahary, it can be challenging to meet a trial's specific requirements when essential drugs are in short supply. This situation can potentially affect patient accrual, as well as the validity of the findings from the trial.
If a specific drug called for in clinical trial protocol isn’t available, there may be a need to delay enrollment or alter the trial design through use of an alternative treatment.7 However, this substitution can have a significant impact on the study and the results when analyzed.
“If a clinical trial says in order to get on it, you have to have a disease in a certain state, and you can't have any of these issues, you can't change that if you want to actually have data that's helpful. I think these drug shortages have impacted accrual in certain trials,” said Bahary.
“Hopefully, they're short lived, and because many of these trials are nationwide at large, that even if we lost a couple of months, we were able to fulfill the accrual goals, and be able to understand what's going on.”
LaCasce also stressed the importance of communication and collaboration among medical institutions to effectively navigate these challenges, and highlighted the need to ensure patients understand the complexities involved and how medical teams are working to provide the best possible care despite the constraints.
“I think patients also lose trust in their team if they can't get them the drug. It is a complicated discussion, but they don't necessarily understand that our hands are a bit tied. It's just such an important issue.”
The shortage of cisplatin and carboplatin brings up the urgent need for regulation and collaboration in the field of oncology. Medical professionals and regulators continue to seek solutions to bridge this supply gap, but long-term strategies remain a need to prevent the possibility of worse shortages down the line.
REFERENCES:
Current and resolved drug shortages and discontinuations reported to FDA. U.S. Food and Drug Administration. Accessed on August 28, 2023. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
“People will die from this”: 4 cancer drugs are in short supply. Advisory Board. August 29, 2023. Accessed May 5, 2023. https://bit.ly/44jdwE9
To ease cancer drug shortage, FDA will allow imports from China. NBC News. June 5, 2023. Accessed August 28, 2023. https://tinyurl.com/5xjsvj2b
NCCN releases statement addressing ongoing chemotherapy shortages; shares survey results finding more than 90% of cancer centers are impacted. NCCN. June 7, 2023. Accessed August 28, 2023. https://tinyurl.com/yue2vjnd
Drug shortages statistics. American Society of Health-System Pharmacists. Accessed August 29, 2023. https:// bit.ly/3AjrNfZ
Nationwide drug shortage calls for immediate reform on pricing regulation for generic drugs. News release. Florida Cancer Specialists & Research Institute. May 15, 2023. Accessed August 29, 2023. https://tinyurl.com/4r27f2yz
Ventola CL. The drug shortage crisis in the United States: causes, impact, and management strategies. P T. 2011;36(11):740-757.
