Most Childhood Cancers Are Curable, but Effective, Low-Cost Drugs Are Often Scarce

When Laura Bray heard the devastating words “leukemia” from her 9-year-old daughter’s doctor, her world came crashing down.

With an early diagnosis of acute lymphoblastic leukemia (ALL)—the most common pediatric cancer—doctors were optimistic about Abby’s chances. They estimated a 90 percent chance of complete remission, wherein all signs of cancer go away, and cancer cells become undetectable.

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.

“Our only ‘plan B’ was a drug, Erwinaze, that was in a national shortage (and had been for years),” Ms. Bray told The Epoch Times. “That’s when I learned the devastating truth: There are life-saving drug shortages right here in the United States.”

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.

About 75 percent of oncologists in the United States couldn’t prescribe the preferred chemotherapy agent because of shortages between December 2019 and July 2020, according to a 2022 review of surveys published in the American Society of Oncology’s JCO Oncology Practice journal. This situation forces doctors to choose less-effective alternatives, delay treatment, or reduce treatment dosages.

“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.

Fortunately, Seattle Children’s can still provide many children with the necessary medications to fight off cancer. Ms. Wright and Dr. Leary attribute this to the hospital’s large size. Smaller hospitals, however, are facing a more challenging battle to obtain scarce medications. Nevertheless, Seattle Children’s remains “at the mercy of the drug manufacturers’ discretion,” Ms. Wright added.

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.

The pharmaceutical industry doesn’t generate its desired profits by creating common drugs, even though they’re in high demand. What produces higher profits are newer drugs, according to the U.S. Food and Drug Administration (FDA).

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.

A March Senate report (pdf) highlighted the issue, emphasizing that neither the industry nor the federal government has complete visibility of the pharmaceutical supply chain. “This lack of transparency limits the federal government’s ability to proactively identify and address drug shortages,” the authors wrote.

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.”

Reposted from: https://www.theepochtimes.com/health/most-childhood-cancers-are-curable-but-effective-low-cost-drugs-are-often-scarce-5408975