Shortly after Aaron Taylor started kindergarten at Lincoln Elementary School in September, he began to experience a variety of seemingly unrelated ailments.
Because no one symptom lasted very long, his parents and his pediatrician believed it had something to do with adjusting to his new routine.
Aaron's parents were stunned when one month later he was diagnosed with acute lymphoblastic leukemia.
"On the morning of October 8, he woke up with a bloody nose," explained Aaron's mom Andrea Taylor. "It wouldn't stop bleeding, so we took him to the ER after conferring with the doctor's office. It took several hours and an ENT specialist to get it to stop. We thought it might be some type of clotting issue, and I told the ER doctors that I would follow up with Aaron's doctor on Monday."
When Aaron's condition worsened over the weekend, Andrea brought her son to the doctor.
"She checked him out, listened again to the symptoms I had been noticing, and told us to go home, get some dinner, and then take him to Morristown ER because she thought he had leukemia," she said. "She felt Morristown had the best resources for handling pediatric leukemia, and had the ability to turn around lab work within an hour so we could get a quick diagnosis. So that's what we did.
"At the ER, we learned that he definitely had leukemia; that the leukemia cells had almost wiped out his red blood cells and platelets, explaining the tiredness, and the unstoppable nose bleed. We also found out that the leukemia cells had invaded his chest cavity, and produced so much fluid that his left lung had partially collapsed from the pressure. He could have died had he not gotten treatment."
More Grim News
The Taylors were told that Aaron would face a three-year course of treatment at the Valerie Clinic in Morristown. Just when Andrea didn't think she could possibly be any more frightened for her child, she said she read an article that indicated there was a nationwide shortage of the very drug she was counting on to cure her son.
Preservative free Methotrexate, a drug commonly used to treat childhood cancers, has been in the news frequently in the past few months as the Food and Drug Administration attempts to stem the largest nationwide drug shortage in nearly a decade.
"The panic that I had when I read that first article, it was terrible, it is unimaginable," she said. "When you've got something set in your head that this is how your child is going to be treated and this is how he's going to be cured and then somebody pulls the rug out from under you and says, 'well, one of the drugs that is absolutely integral to his treatment may not be available' the mother bear comes out."
Aaron is currently undergoing an intensive round of chemotherapy, which includes a 23-hour drip of preservative free Methotrexate every other week. Once a month during this round, he has a lumbar puncture during which preservative free Methotrexate is injected into his spinal fluid.
"The Methotrexate is integral to his treatment," his mother said. "Chemo drugs given by IV or orally do not cross the blood/brain barrier. Methotrexate is given directly into the spinal fluid to kill any leukemia cells that may be in the central nervous system. Methotrexate is the only medication that can be injected in this way, as far as I know. If he could not receive the Methotrexate, any leukemia cells that were to survive in the central nervous system would have nothing to keep them from multiplying, and ultimately killing Aaron."
Dr. Steven Halpern, director of pediatric hematology and oncology at the Valerie Fund Children's Center, said fortunately the shortage has not "been a major issue to date" at the Valerie Clinic. Halpern said skipping or delaying a treatment could have a negative effect but so far treatments haven't been postponed more than a day or two. Halpern also noted that there are multiple advocacy groups, including the American Society of Hemotology, who are working with the FDA to avoid future potential shortages.
Andrea explained that a patient's scheduled treatment may be moved up or back by a day so that as little of the preservative-free Methotrexate is wasted as possible.
"What they had told me was if the shortage continued, what they do is, if for example he's getting a spinal tap, they will stack up as how many kids they do in a particular day because once they open a vile of preservative-free Methotrexate, whatever isn't used gets tossed. So that's why somebody's treatment might be moved from Monday to Tuesday," she said.
Andrea noted preservative-free Methotrexate isn't the only drug that has experienced shortages.
"There are other medications used in the treatment of childhood leukemia that have had shortages in the past year - Cytarabine, and Doxorubicin are two that come to mind," she said. "Each of those shortages occured prior to Aaron's diagnosis, so I was unaware of any potential problems until this recent Methotrexate shortage was publicized. I mentioned Cytarabine and Doxorubicin because Aaron will be needing those medications again in the next few months, and there is no guarantee that they won't experience another shortage. The medication situation as it stands right now almost guarantees that there will be shortages again.
"Right now the FDA must be informed of an expected drug shortage by a drug company only if they are the only company that manufactures that drug. In the Methotrexate situation, there are three companies that produce preservative free Methotrexate. Only one had a production issue, and there was no requirement for them to contact the FDA. If there had been better communication, the other companies could have looked to increase their production sooner, possibly averting the crisis.
"It's not until something makes the national news that people start yelling that the FDA says, 'Oops!' looks through their files of what other producers there might be, gets the word out and finds more medication."
Andrea contacted the office of Congressman Leonard Lance (NJ-07) and was told that there is a bill before Congress that could change the way the FDA is notified of potential drug shortages. The bill will be up for a vote in June, Andrea was told. In late February, the FDA approved two new suppliers that should help stave off a shortage in the short term.
"Treatment for acute lymphoblastic leukemia follows a long protocol of a cocktail of drugs over a period of two-and-a-half to three years," Andrea explained. "The goal is to remove all observable leukemia cells within the first month of treatment. The remaining treatment time is to ensure that the leukemia doesn't come back. Take away the drugs, and the chances increase greatly that Aaron will relapse."
A Brave Face
"Aaron has his good days and his bad days in dealing with his illness," Andrea explained. "He knows that he has leukemia, and if he warms up to you, he may even teach you about how the blood cells work, and how leukemia cells make him sick. I don't know how aware he is that the drugs he needs might not be available. We have not had that discussion directly with him, although he has been present when we have discussed it with his doctors."
Andrea said Aaron's feelings about his illness can be best summed up in a conversation she recently had with her son.
"He asked me if Peter Pan ever grows up. I told him no, that Peter Pan never grows up, and he lives in Never Never Land where kids never grow up. Aaron said he wished he could go to Never Never Land, but he wouldn't want to be six forever. He wants to be either five, before he was diagnosed, or 10, when he is done with all his treatments. Then he said he would like to be able to go to a place where he could go to school every day instead of having to go to the hospital."
An Outpouring of Support
Since receiving his diagnosis, Aaron has attended less than 20 days of school, Andrea said, but on the occasions when he has been able to go, the school community has gone out of its way to make it a great experience.
"Lincoln School has been amazing," Andrea said. "The entire staff, the teachers, the administrators, they've made it so stress-free for us. They'd had teachers, when he needs it, come to our home to work with him."
Andrea explained that when she brought Aaron in after he had been out for a while, he was greeted with a huge poster that read "Welcome Back, Aaron!"
"All the kids had signed it," Andrea said. "They made a quilt for him and each child decorated a square, the custodian decorated a square. I could cry just thinking about it."
Lincoln School Principal Audrey Zavetz said the school's annual Walk-A-Thon will benefit the Valerie Clinic this year.
"Our annual Walk-A-Thon is scheduled for June 1 this year with a rain date of June 8," Zavetz said. "Every year we collect money for a cause that is important to Lincoln School. This year we will be collecting for the Valerie Clinic."
In the past, Zavetz explained, the event has benefitted St. Huberts Animal Rescue Center, the American Cancer Society, and a Westfield family who was displaced following a fire.
Andrea said the outpouring of support that the family has received "has been unbelievable."
"Friends of ours and community members have pulled together," she said. "I have a friend who took on organizing dinners for us. Everyone has been just incredible."
Andrea said in addition to realizing how fortunate she and her family are to be surrounded by this caring community, Aaron's diagnosis has also inspired her to raise awareness of the far-reaching effects of drug shortages.
"The preservative free Methotrexate is a huge thing in treating childhood leukemia so you put a little kid face on it and everybody's in an uproar but the reality is every single person who has the cancer has had the potential of having one of their medications that's keeping them healthy taken away," she said. "It's incredibly frightening and it seems like such a simple fix, how is it possible that it's not getting resolved?"
Check back with Patch for more details regarding the Lincoln School Walk-A-Thon to benefit the Valerie Center as the event draws closer.