When Laura Bray heard the devastating words “leukemia” from her 9-year-old daughter’s doctor, her world came crashing down.
The treatment protocol for ALL involved the drug pegaspargase because it is usually successful for a patient like Abby. However, during her first round of chemotherapy, Abby had an anaphylactic reaction to it.
Drug Shortages Undermine Progress in Pediatric Oncology
Treating childhood cancer was once challenged by inadequate technology. But today, what scares oncologists is the shortage of highly effective medications.“Most people don’t realize that over 80 percent of pediatric cancers are curable,” Dr. Sarah Leary, an attending physician and medical director of the Pediatric Brain Tumor Program at Seattle Children’s Hospital, told The Epoch Times. Central to curing pediatric cancers are older, well-known drugs—and they aren’t being manufactured to meet demand, she added. “If we don’t have access to these drugs, kids won’t get cured.”
Every day, Seattle Children’s, one of the nation’s largest pediatric cancer centers, grapples with the pressure of the drug shortage. Oncologists and pharmacists there are often forced to batch treatments together so that “not a drop of the drug goes to waste,” Dr. Leary said.
The hospital pharmacists place drug orders weekly, uncertain if manufacturers will meet the hospital’s needs. “It’s a rollercoaster, not knowing whether we’ll get the drugs we need to treat the patients,” said Tara Wright, who holds a doctorate in pharmacy and is a clinical pharmacist at Seattle Children’s Hospital.
What’s Causing the Shortage of Much-Needed Drugs?
Essential pediatric oncology medicines, often older sterile injectables with limited or no substitutes, have a 90 percent higher risk of being in shortage than other common drugs, according to the U.S. Pharmacopeia (USP), a nonprofit organization dedicated to tracking shortages and streamlining drug access.The primary reasons for the shortage are manufacturing complexity, geographic challenges, and quality control issues. However, the most prevailing factor is the high demand for older, inexpensive drugs. “There is a well-documented correlation between low-price medicines and shortages,” Vimala Raghavendran, vice president of informatics product development at USP, told The Epoch Times.
“This means manufacturers have little incentive to invest in process upgrades, expanded capacity, or redundancy in production facilities,” Dr. William Dahut, chief scientific officer for the American Cancer Society, told The Epoch Times. “Companies make business decisions to discontinue manufacturing certain drugs, particularly generic drugs, based on profitability or other business considerations without always ensuring the continued manufacture of the drug elsewhere,” he added.
Can the Government Do Anything?
In February, Akorn Pharmaceuticals, a company dedicated to producing generic drugs, filed for bankruptcy and had to close all its U.S. operating sites. In response to news of Akorn’s closure, the FDA wrote on Twitter that pharmaceutical companies operate independently, and the FDA does not have the authority to mandate drug production, increased manufacturing, or distribution changes.Finding a solution to drug shortages is complex due to the contentious nature of agency authority, including that of the FDA, among lawmakers.
Mother’s Determination Leads to Change
When doctors told Ms. Bray that her daughter couldn’t get the necessary medication, she tirelessly pursued a solution as any parent would. “After thousands of calls to hospitals, pharmacies, lawmakers, pharmaceutical companies, and many miracles along the way, we found Erwinaze in 10 days,” Ms. Bray said.Today, Abby is cancer-free.
Though Ms. Bray successfully obtained medicine for Abby, the journey was tumultuous, prompting her to reflect on the broader issue.
“What about every other parent and child?” she said. “How could this be the standard of care? Why were the necessary amounts of these drugs not being made? Who could fix this?”
In response to her experience, Ms. Bray founded Angels for Change, a nonprofit that aims to provide families with necessary medicines and ultimately end drug shortages.
The problem has drawn attention from both the legislative and executive branches of the federal government, but their response has yet to extend beyond the congressional hearings on Capitol Hill.
Despite the issue’s complexity, Dr. Leary and Ms. Wright said they believe pharmaceutical companies should be held accountable.
“We’re talking about life and death scenarios with kids,“ Dr. Leary said. ”It doesn’t get any more important than this.”