This year, nearly 10,000 children age 15 and younger in the U.S. are expected to be diagnosed with cancer and more than 1,000 of them are expected to die, according to the American Cancer Society .
As these children struggle with their illnesses, medications they need to fight them are often in short supply.
As of this Saturday , the U.S. Food and Drug Administration listed at least 17 oncology drugs on its drug shortages list that were either discontinued or in shortage. USA Today noted this included a shortage of, methotrexate sodium, a widely used chemotherapeutic often used for acute lymphoblastic leukemia, brain tumors, non-Hodgkin lymphoma and osteosarcoma.
“The older school, cytotoxic chemotherapy drugs that are now primarily generic formulations are in shortage. They remain among the most critical drugs we use. They are part of that chemotherapy backbone that we build upon and add new therapies to,” Dr. Andrea Nickles Fader, a gynecologic oncologist, told Johns Hopkins last year . “Some of them have been around for more than two or three decades but remain some of the most highly effective drugs that we use to treat cancer.”
Over the past decade, eight out of 10 drugs used to treat the most common childhood cancers have been temporarily unavailable, said Angels for Change , an organization dedicated to stopping these shortages. Laura Bray, founder of Angels for Change, learned about drug shortages first hand when her daughter began chemotherapy for leukemia in 2018, USA Today reported this week. Doctors told Bray that the drugs Abby needed were hard to find.
“I had no answers for her when she asked me if she was going to die if she didn’t have her medicine,” said Bray, 47, of Tampa, Fla. “All I could say is that, ‘We’re going to try to find it. Sometimes, extraordinary things happen when you try.’”
Earlier this month, a report from Sardoz – a Swiss company that focuses on generic pharmaceuticals and biosimilars – found that drug shortages for chemotherapy drugs and generic medications were impacting over 90% of hospital systems nationwide in the U.S.
Why are these shortages happening?
“Under current policy, the FDA cannot require a pharmaceutical company to disclose details of why a drug shortage occurs,” explained Angels for Change. However, researchers have been looking into reasons why these drugs become scarce.
Manufacturing issues, supply chain disruptions, and regulatory delays are some of the main reasons, according to Crystal S. Denlinger, CEO of the National Comprehensive Cancer Network (NCCN ), per an article published this July in the American Journal of Managed Care .
“I think that the current cancer drug shortage is actually just an extension of a drug shortage that’s been going on for a while across different generic medications,” she said. “The causes are primarily related to supply chain issues, and a supply chain that has little redundancy or elastic capacity, with poor incentives in the market to make these drugs. So, we have few suppliers. When a supplier goes down, or when there’s an issue with a particular supplier, there's not a lot of other opportunities for other suppliers to step in.”
Experts cited by USA Today said a backlog for pediatric cancer drugs has existed for decades and that advocacy groups have tried to get manufacturers, wholesalers and hospitals to work together on improving the supply chain. In an interview last summer with the Johns Hopkins Bloomberg School of Health , Dr. Mariana Socal , a drug supply chain policy researcher, described how economics plays into the availability of certain drugs.
“If you have four or five different companies that manufacture the same product, they compete for price, and each of them is continuously trying to offer lower prices for their drugs,” she said. “There is no incentive for these companies to invest in improvements in manufacturing practices, like new machinery or renovations for their facilities. As a result, every so often you hear about a facility having [production] problems.”
These drugs, which tend to be sterile injectables, are particularly susceptible to shortages because few companies make them, said USA Today.
Prashant Yadav, a medical supply chain expert and professor of INSEAD, a graduate business school in France, said that generic sterile injectables require strict quality control. However, they also don’t turn much profit, so manufacturers avoid making them.
“It is important to remember that there’s a chain of events happening behind the scenes that ultimately results in the drug being available or not on the pharmacy shelf or in the hospital’s inventory. This drug supply chain typically starts far away from the U.S.” Socal explained. She added that more than 85% of all of the active ingredients needed to produce generic drugs for the U.S. are produced overseas.
“The few remaining companies operate in the U.S. and in China and India, where FDA officials struggle to enforce and maintain the high standards of quality they expect from domestic manufacturers,” said USA Today.
Last December, Bloomberg reported on methotrexate manufactured by Naprod Life Sciences in Mumbai, India. At least four children in Colombia who took the medication died and around a hundred became ill.
“No one had been in charge of the quality department for months,” said Bloomberg. “The methotrexate they were manufacturing was destined for the most vulnerable: leukemia patients, some of them children, in developing countries.”
Yadav said the FDA often detects quality issues with generic sterile injectables. When that happens, the agency shuts production down until the problem is resolved. While these production halts can prevent dangerous complications, they can also result in drug shortages that reverberate across the market, USA Today added.
Once an issue is detected, it can take pharmaceutical companies’ months to resolve it, Yadav said. He called the impact “heartbreaking.”
“All it takes is a glitch at one company for (the drug) to go into a national shortage,” said Dr. Gwen Nichols, executive vice president and chief medical officer of The Leukemia and Lymphoma Society, per the outlet. “It’s terrifying for families and it’s incredibly hard for the doctors who are looking at these families and saying, ‘I can’t find the therapy anywhere.’”
What can be done?
Yadav believes developing a stockpile of medications might help. He also thinks hospitals, wholesalers and drug manufacturers should be working together to solve the problem. Right now, these players are siloed, Yadav said.
USA Today said making these important drugs more profitable without passing on costs to patients might also improve access.
Legislation might be another option. Sardoz said “Congress may need to amend the 340B program to allow sustainable pricing for generics manufacturers and improve oversight to ensure discounted medicines benefit patients directly.” Its report also offered other suggestion in its report for ways to streamline the supply chain.
“In the end, it’s someone’s life,” said Bray.
Local News
Comments / 0