At the end of last year, there were 295 active drug shortages, ranging from antibiotics and anesthetics to cardiac mediations and chemotherapy drugs, according to a National Security and Government Affairs report, a 30 percent increase from 2021. Chemotherapy drugs, particularly those used to treat childhood cancers are among those drugs that experience some of the longest-lasting shortages, says Yoram Unguru, a pediatric hematologist-oncologist at Sinai Children’s Hospital and principal lecturer, Johns Hopkins Berman Institute of Bioethics.
These are the cornerstones of healing regimens, he says. We have no alternatives, it’s not like I can substitute one particular scarce chemotherapy agent for another. This isn’t a strep throat or some other infection where if I don’t have amoxicillin, I can substitute it for something that probably if it’s not as good, almost as good.
The root of the drug shortage crisis, most experts agree, is related to low profit margins on generics, over-reliance on foreign manufacturing, rising quality risks and fragile supply chains. These drugs that are in short supply aren’t the blockbusters that drug companies make big money off, Unguru explains. They are older, generic injectable drugs that companies don’t make huge profits on.
As a result, few companies produce them, and those that do make just enough to meet demand. If one of these companies suddenly decides to go out of business, or there is a production problem, or they have difficulty sourcing raw materials, about 80% of which come from China and India, there will be a drug shortage.
Delays in care caused by shortages can have tragic consequences. A recent meta-analysis found that a four-week delay in treatment may be associated with increased disease or mortality for more than 40% of common cancers, including bladder, breast, colon and lung cancers . A 2017 World Journal of Clinical Oncology report based on a survey of more than 190 pediatric hematologist-oncologists found that nearly 65 percent of physicians said they had patients whose care was affected by deficiencies.
Recently, Kosuri had to break the news to a 40-year-old patient with recurrent testicular cancer that his life-saving stem cell transplant procedures would be significantly delayed due to a shortage of the drug carboplatin, a chemotherapy drug used for stem cells. transplants and for many types of cancer. More than 90 percent of people treated for testicular cancer, including cyclist Lance Armstrong, ice skater Scott Hamilton and NFL gambler Josh Bidwell, survive the disease. With this cancer, you can be at death’s door and still be cured, says Kosuri. But now if we have to make decisions about stopping treatment or tell them to listen, we may not be able to do this procedure for you because we don’t have the medication.
Another patient, a 39-year-old woman with ovarian germ cell cancer, also needs a stem cell transplant, and most likely I won’t be able to offer her a stem cell transplant either.
Kosuri says the shortages are affecting the full spectrum of patients and diseases, including cancers, blood cancers, children and adults. It’s having a negative impact across the board.
A shortage of the leukemia drug fludarabine has left some patients with no other options for treating their cancers, Kosuri says, leading instead to discussions about hospice care. He’s awful. We have medicines that can cure you, but we can’t give them to you, sorry. Unguru says one of his new patients is facing an equally alarming scenario. Two of the drugs this little girl needs as part of her regimen are on the shortage list, she says. This is a cancer that is curable in most cases, and now maybe it won’t be because we don’t have the drugs.
Erin Fox, a pharmacist and professor at the University of Utah Health, says too often a single company is producing the lion’s share of a supply of drugs. You point to Accord Healthcare Inc., maker of three key cancer drugs methotrexate, cisplatin and carboplatin. Accord has a large market share and huge quality issues, she says, which were first identified in a 2022 US Food and Drug Administration inspection, which led to the production shutdown of a plant in India. Other companies are trying to bridge the supply gap, Fox says, but may not have the capacity to do so.
A statement provided by Accord Healthcare Inc. spokesperson Kellyann Zuzulo said Accord and its parent company, Intas, took the FDA’s findings seriously and made the voluntary decision to cease manufacturing and distributing the products. The companies are committed to providing safe and effective products to all patients and will proceed with caution in cooperation with the FDA.
Kosuri and his colleague Mark Ratain, an oncologist and professor of medicine at the University of Chicago, recently wrote an editorial calling for the US government to establish a strategic reserve for lifesaving cancer drugs. The government must step in to protect patients by ensuring there is a supply of drugs to treat their cancers when curative therapies are available, Ratain says. I am a researcher and would not spend another dollar on research before solving the shortage problem.
Both Congress and the Biden administration have turned their attention to the issue of drug shortages in general. In an effort to address the chemotherapy shortage of the widely used drug cisplatin, the Food and Drug Administration has authorized temporary importation of a Chinese injectable version, starting Tuesday. The FDA is monitoring shortages and is working on temporary importation to help meet patient needs during the shortage, a spokesperson said. In these cases, we evaluate the quality of the foreign product very carefully, making sure it is safe for U.S. patients. We work closely with numerous manufacturers and others in the supply chain to understand, mitigate, and prevent or reduce the impact of intermittent availability or reduced by some products.
A representative of Pharmaceutical Research and Manufacturers of America, the pharmaceutical industry trade group, said the group can’t talk about specific generic drug shortages, but that brand-name manufacturers have, over decades, built with care robust globally diverse supply chains underpinned by complex manufacturing systems to help ensure that patients in the United States and around the world have continuous access to medicines.
In mid-May, the House Energy and Commerce Committee held a hearing to examine the root causes of the drug shortage and identify supply chain vulnerabilities. One of the witnesses at the hearing was Tampa mom Laura Bray, an economics professor who launched a nonprofit called Angels for Change after her 9-year-old daughter Abby was diagnosed with acute lymphoblastic leukemia in 2018 ( ALL), the most common childhood cancer disease. Ninety percent of pediatric ALL patients are treated by following a strict regimen of chemotherapy, but a drug shortage can change those odds. When a drug called erwinaze in Abby’s regimen became unavailable, she asked her mother about her, “Does this mean I die?”
The erwinaze shortage came after Porton Biopharma Limited, the drug’s sole maker, was cited by the FDA for repeated contamination issues, including corrupted batches with visible metal particles and cardboard fibers. The only alternative to erwinaze, a drug called PEG-asparaginase, was not an option for Abby because she was one of 4 patients who are allergic to it.
Luckily for Abby, now a healthy 13-year-old, her mother understood supply chain issues. Just because a member of a supply chain doesn’t have it doesn’t mean it’s a complete disruption, says Laura. She enlisted friends and family to call hospitals across the country until they found the erwinaze she needed.
Haunted by the realization that most other parents facing the same circumstances wouldn’t know what to do, Laura launched the Angels for Change advocacy group in 2019. Any patient, pharmacist or hospital doctor in the midst of a drug shortage can call us, Bray says. We navigate the supply chain for them.
Solving the drug shortage crisis will require all stakeholders to work to create more flexible supply chains, Bray told lawmakers. No patient should hear the words, we don’t have the medicine to cure you.
#Cancer #patients #facing #widespread #shortages #chemotherapy #drugs