Eight-year-old Madison "Maddie" Major was cancer-free for eight months, but she and her family learned that her leukemia had returned on Monday – hours before the federal government shutdown.
Maddie's mother, Robyn Major, feared the worst: that the shutdown would somehow hamper her daughter's ability to get into a clinical trial, which was a necessity for Maddie because her cancer stopped responding to chemotherapy and she needed new treatment options.
"We're kind of stuck," Major said, adding that she brought Maddie to Capitol Hill two weeks ago to lobby Congress to fully fund federal health agencies – before they knew about the relapse. "We're stuck because people are acting like children."
She said she imagined the paperwork for the trial was "sitting on someone's desk at the FDA, awaiting approval," but had been abandoned because of the shutdown.
In reality, the paperwork for the drug trial Maddie hoped to participate in was set to be submitted to the Food and Drug Administration next week, so it wasn't sitting on an abandoned FDA desk.
What's more, the FDA is continuing to review and approve clinical trials during the shutdown, said FDA spokesman Steven Immergut.
But Maddie's doctors at the Children's Hospital of Philadelphia said the added level of fear from the shutdown is palpable on the pediatric cancer ward.
"I think that from the patient and parent perspective, this just adds uncertainty to the situation where there's already a lot of uncertainty," said Dr. John Maris, who directs the Center for Childhood Cancer at the Children's Hospital of Philadelphia. "I'm in clinic right now, and it's more just waiting to see what happens and some added fear."
Maris said he was able to get an experimental drug approved by the FDA for emergency use in one of his patients this week. But he said he submitted the paperwork for that approval last week, before the shutdown, which makes him wonder whether submitting the emergency paperwork this week would work if he had to do it for another patient, he said.
"The Food and Drug Administration, from what I can tell, is operating and is working, but again, it's how long that can sustain themselves that I don't know," Maris said.
Most patients probably won't be affected by the shutdown in the short term, said Dr. Kara Kelly, a professor of pediatrics at Columbia University Medical Center who works primarily with children who have Non-Hodgkin's lymphoma. But they may pay in the long run when trials and research becomes delayed, she said.
Kelly, who has two ongoing trials through the National Institutes of Health, said NIH trials won't be able to move onto their next phases, because furloughed NIH employees need to review previous phases before they can approve new ones. As a result, she feared drug companies would stop supplying drugs to these trials if they think the trials are frozen, she said.
The NIH said Tuesday that 200 patients will be blocked from starting clinical trials each week of the shutdown – including 10 children with cancer and 20 children with other ailments. It's since received permission to bring employees back from furloughs to re-open clinical trial enrollment.
Even so, what most people don't know, Maris said, is that the federal government plays a key role in childhood cancer care and research. The National Cancer Institute, which is part of the NIH, runs a large proportion of clinical trials, which he fears may suffer during a prolonged shutdown.
"It's not going to have an impact today or tomorrow, but it's going to have major impacts down the road," Maris said, adding that he already knows of people who aren't able to submit grants for research until the shutdown ends. "It's an especially acute problem for children who have relapsed or refractory disease because they really need access to more innovative treatment."
Dr. Alan Wayne, who worked as the clinical director of pediatric oncology at the NIH until July, said NIH lab research has been halted as well.
"We've been told not to submit proposals for new work from here," Wayne said from Children's Hospital Los Angeles, where he is now the director if its cancer center. "If trials are slower to come on board and progress is made more slowly, that's going to have an impact down the line."
He said his lab research at the NIH, which involves studying cell samples from cancer patients to understand why they aren't responding to certain treatments, has been put on hold. His partners have been furloughed and the experiment has been abandoned until the shutdown is over, he said. If the shutdown lasts long enough, those cells could die, forcing him to start the experiments over.
Wayne said it's clear that the shutdown's delays will become substantial the longer it lasts, and it will hurt patients in the long run.
"It's not a hypothetical. These are very real individuals," Wayne said. "Each one of them deserves our maximum effort and speed to develop therapies to help them."