It's a painful reality we've been telling you about for too long. Kids with cancer are potentially unable to get the drugs they need because of persistent short
It's a painful reality we've been telling you about for too long. Kids with cancer are potentially unable to get the drugs they need because of persistent shortages. It pushes American families into a desperate scramble, while attempts to fix the supply chain hit a wall of regulatory red tape.
Now, a survivor of childhood cancer, who grappled with those life-threatening shortages during her treatment, is telling her story for the first time.
Abby Bray is a childhood cancer survivor, but her story is much bigger than that.
She was diagnosed with leukemia just after her ninth birthday.
As a third-grader, she faced years of treatment, and loss.
"Losing my hair and feeling like I lost my friends were probably the two hardest things for me," she told Spotlight on America.
The drugs Abby needed during her treatment were in short supply multiple times (Photo: The Bray family)Multiple times along the journey, doctors lost her treatment plan because the drugs Abby needed to save her life were in short supply.
Abby's mother, Laura Bray, told us she remembers hearing her 9-year-old ask what would happen if the drugs weren't there.
"Do I die?" she remembered her daughter asking.
"It was almost a dooming feeling," Abby remembered. "Like, what happens if I don't get this?"
Cancer survivor Abby Bray is telling her story for the first time to Spotlight on America (Photo: Nathan Aaron)That was 2019. Today, similar shortages persist.
For years, we've tracked the scary reality: Drug shortages tied to complex supply chains and profit margins affect real people.
Cancer drugs, often inexpensive, generic injectables, are especially vulnerable. Our review of the FDA's shortage list shows seven oncology drugs currently in short supply.
That includes ifosfamide, a critical cancer drug used for bone and soft tissue tumors and lymphoma.
Ifosfamide is a critical treatment for multiple types of cancer (Photo: SBG)Dr. Pinki Prasad, a pediatric oncologist in Louisiana, relies on it, and said the shortage is affecting treatment decisions.
"You're having to make decisions about if, I start somebody on this therapy and in two weeks they're due again, will they be able to get it?" she told us.
Dr. Prasad pointed out that there is no simple substitute to use in its place.
"This is our reality, but it's not fair," she said.
Dr. Pinki Prasad is grappling with the ifosfamide shortage (Photo: SBG)Drug shortages typically don't happen just because of increased demand or lack of ingredients. They happen because of serious quality issues.
This spring, a key maker of ifosfamide in Germany had to temporarily halt production after a scathing warning letter from the FDA, saying its drugs were "adulterated," citing contamination and microbial growth.
The ifosfamide shortage can be traced to a factory in Germany recently issued a warning letter from the FDA (Photo: SBG)The supply chain disruption was serious enough to put ifosfamide into expected shortage until next year.
You might wonder, if foreign manufacturing of critical drugs can't be done right and puts patients at serious risk, why not just make them here?
That question led us to a Dallas parking lot where we met Dr. Alex Oshmyansky, CEO of Cost Plus Drugs, who's made it his mission to fill in the gaps.
"For someone in our country not to be able to get access to a medicine that costs $10, $20 to save their life. It's just absolutely insane," he said.
Cost Plus Drugs is working on shoring up supplies in the US, but told us it faces regulatory hurdles to doing so (Photo: Alex Brauer)Cost Plus is working to make ifosfamide, but is only allowed to do it while the drug is officially in shortage. Once it's off the list, they stop production.
"To prevent the shortage before it's happening and make the drug, that's a much more expensive process," Oshmyansky said.
If Cost Plus wanted to just start making ifosfamide, they'd have to pay nearly $360,000 in FDA filing fees, making it difficult for US manufacturers to operate in the black on inexpensive, yet essential generic drugs.
The FDA could waive those fees.
We asked if it would, and got no response.
To begin making a generic drug in the US, there's an FDA filing fee of hundreds of thousands of dollars (Photo: SBG)We wondered if the President could do it himself through an executive order that would cut through the red tape.
Oshmyansky said yes.
"If that fee could be waived for drugs produced in the United States, we'd get up and running and start making a lot of these products right away," he said.
For now, US drugmakers say they're handcuffed by the financial reality, and in the meantime, the FDA reportedly considered drug makers in India to fill the ifosfamide gap.
The frontrunners were companies we've investigated for serious quality control violations identified by the very agency asking them for help.
The US is reportedly asking Indian manufacturers with histories of quality violations to help fill the gap (Photo: SBG)Ultimately, the FDA approved temporary imports of Ifosfamide for Injection that is currently marketed in China.
Critics say relying on foreign makers over domestic stability comes down to the bottom line.
That's unacceptable for Abby Bray.
"I feel like profit should not be the main driver in anything you do," she said.
Abby is now cancer free.
Abby Bray is now cancer-free, but remembers the "dooming" feeling of finding out her drugs were in shortage (Photo: The Bray Family)She got the drugs she needed because her mom, Laura, was relentless.
That effort turned into the nonprofit Angels for Change, now with mom and daughter together, working to secure drugs for thousands of patients who need them the most.
Nearly seven years later, the organization still has a name for the girl at the beginning of it all.
Patient one.
“Patient one was Abby,” Laura said. “And if I'm not willing to do for patient 800,000 of what I did for patient one, then we're missing the mark.”
Angels for Change has helped countless families ensure their loved ones get the treatments they need (Photo: SBG)"I just want every kid to have what they need to keep going," Abby Bray said.
Abby and her mom are going to be on Capitol Hill early next year, along with other patients who have dealt with this issue firsthand, to speak about their experiences and urge change.
Abby and Laura Bray are now working together to end shortages (Photo: The Bray Family)If you are a patient in need of ifosfamide, Angels for Change can help. You can reach out to them on their website by clicking here.
There, you can also find information about how you can help end drug shortages, or volunteer to speak when Abby and Laura make their case to lawmakers early next year for Hill Day.
You can watch Abby's full story below:
