As of the end of last year, 295 medicines were in short supply, ranging from antibiotics and anesthetics to heart-regulating drugs and chemotherapy drugs, according to the Department of Homeland Security and Government Affairs. report, up 30 percent since 2021. Chemotherapeutic drugs, especially those used to treat childhood cancers, are among the most enduring drug shortages, said Yoram, pediatric hematologist and oncologist and faculty member at Sinai Children’s Hospital. Ungle says. , Berman Institute for Bioethics, Johns Hopkins University.
“These are the backbone of the treatment regime,” he says. “We don’t have a substitute. It’s not like we can substitute another chemotherapeutic for a specific missing chemotherapeutic. , perhaps interchangeable with those of approximately, if not equal, effect.”
Most experts agree that the roots of the drug shortage crisis are linked to low profit margins on generic drugs, overreliance on offshore manufacturing, increased quality risks and supply chain vulnerabilities. “These drugs that are in short supply aren’t blockbuster drugs that drug companies make big bucks,” Angle explains. “They are old generic injectables and companies can’t make big profits.”
As a result, few companies manufacture them, and only enough to meet demand. If one of these companies suddenly decides to withdraw from the market, or encounters production problems, or finds it difficult to procure raw materials, I’ll give you a rough idea. 80 percent One of them is from China and India and will run out of drugs.
Delayed treatment due to shortages can have tragic consequences.one of the recent meta-analysis For more than 40 percent of common cancers such as bladder, breast, colon and lung cancers, they found that delaying treatment for four weeks can lead to increased morbidity and mortality. 2017 report In a study published in the World Journal of Clinical Oncology, based on a survey of more than 190 pediatric hematologist-oncologists, nearly 65 percent of physicians said their care for some patients was affected by shortages There was found.
Recently, Cosuri said, a 40-year-old patient with recurrent testicular cancer will face significant delays in life-saving stem cell transplant surgery due to a shortage of the drug carboplatin, the lead chemotherapy drug used for stem cells. I had to give you the news. Applies to transplantation and many types of cancer. More than 90 percent of people treated for testicular cancer, including cyclist Lance Armstrong, ice skater Scott Hamilton, and NFL player Josh Bidwell, survive the disease. “With this cancer, even if you’re on the brink of death, you have the potential to be cured,” Cosuri said. “But now we have to decide whether to stop treatment or listen to the patient. We may not be able to do this for you because we don’t have drugs.”
Another patient with ovarian germ cell tumor, a 39-year-old woman, also needs a stem cell transplant, but “I probably wouldn’t be able to offer her one either.”
Kosuri said the shortages affect “every patient and disease” including tumors, blood cancers, children and adults. “It has a negative impact on the whole.”
A shortage of the leukemia drug fludarabine has left some patients with no other options for treating cancer, so the debate has started about hospice instead, Kosuri said. “It’s terrible. I have medicine to cure you, but I can’t give it, sorry.” Ungle said one of his new patients faced a similar alarming scenario. . “He’s on the shortlist for two of the drugs this kid needs as part of his treatment plan,” he says. “This is a cancer that can be cured most of the time, but it may not because there are no drugs to treat it now.”
Erin Fox, a pharmacist and Utah Health University professor, says too often a single company produces the majority of the drug supply. She refers to her Accord Healthcare Company, the maker of three of her bedrock cancer drugs: methotrexate, cisplatin, and carboplatin. Accord has a large market share and has “significant quality issues,” but it was first discovered during a 2022 U.S. Food and Drug Administration inspection, leading to a production shutdown at an Indian facility, she said. “Other companies are trying to close the supply gap, but they may not have the capacity to do so,” Fox said.
According to a statement from Accord Healthcare spokeswoman Kellyanne Zuzuro, Accord and its parent company Intus “take the FDA’s findings very seriously and have made the voluntary decision to cease manufacturing and distribution of the product. I did. Both companies are committed to providing safe and effective products for all patients and will move forward cautiously in partnership with the FDA. “
Cosuri and her colleague Mark Latin, an oncologist and professor of medicine at the University of Chicago, recently wrote: Editor He called on the US government to establish a strategic stockpile of life-saving cancer drugs. “Governments need to intervene to protect patients and ensure supplies of cancer-curing drugs when curative therapies become available,” Latin said. “I’m a researcher, so I don’t want to spend any more money on research until I solve the problem of shortages.”
Parliament also Biden administration They turned their attention to the problem of drug shortages in general. To address the chemotherapy shortage of the widely used drug cisplatin, the Food and Drug Administration temporary import The Chinese injectable version will start on Tuesday. FDA monitor for shortages A spokeswoman said the company was working on “temporary imports to meet patient needs in the event of a shortage.” “In cases like this, we evaluate the quality of our overseas products very carefully and work closely with numerous manufacturers and other companies in our supply chain to ensure that U.S. patients are safe. , understand, mitigate, prevent or mitigate the impact of intermittent or reduced supply of certain products. “
A representative of the Pharmaceutical Research Association of America, a trade group for the pharmaceutical industry, said the group could not speak to specific generic drug shortages, but said, “For decades, brand manufacturers have built a strong foundation, powered by complex drugs. We have carefully built a diversified supply chain globally.” We provide manufacturing systems that ensure continuous access to medicines for patients in the United States and around the world. “
In mid-May, the House Energy and Commerce Committee held a hearing to investigate the root causes of drug shortages and identify supply chain vulnerabilities. One of the witnesses at the hearing was Laura Bray, Tampa’s mother and business professor. She started a nonprofit called Angels for Change after her 9-year-old daughter Abby was diagnosed with acute lymphoblastic leukemia (ALL) in 2018. most common childhood cancer. Ninety percent of her childhood ALL patients are cured by following strict chemotherapy, but drug shortages may change that chance. When a drug called Erwinase was no longer available in Abby’s regime, she asked her mother, “Does this mean I’m going to die?”
Erwinase deficiency occurred after Porton BioPharma Limited The company, the sole manufacturer of the drug, was flagged by the FDA for repeated contamination problems, including batches damaged with visible metal particles and cardboard fibers. A drug called PEG-asparaginase, the only alternative to Erwinase, was not an option for Abby. Because she was one in four patients who were allergic to Erwinase.
Luckily for Abby, now a healthy 13-year-old, her mother understood the supply chain issues. “Just because one of her members of the supply chain doesn’t have it doesn’t mean it’s a complete outage,” Laura says. She enlisted her friends and her family to call hospitals across the country until they found the Erwinase Abby needed.
Struggled by the reality that most other parents facing the same situation don’t know what to do, Laura founded the advocacy group Angels for Change in 2019. Since then, the organization has helped hundreds of patients and many hospitals micro-procure medicines from broken supply chains. In 37 medicine shortages. “If you’re a patient doctor, a pharmacist, or a hospital experiencing drug shortages, you can call us,” says Bray. “We navigate the supply chain for them.”
Bray told lawmakers that solving the medicine shortage crisis will require all stakeholders to work towards building more flexible supply chains. “Patients don’t have to hear ‘we don’t have the medicine to treat you’.”
