The rare waterborne infection that killed an Ohio teen who had visited the U.S. National Whitewater Center has been treated successfully in other cases with a drug that was approved by U.S. health officials in 2014 for the treatment of a parasitic disease.
But until recently, the drug, miltefosine, has been available only through the Centers for Disease Control and Prevention and had to be shipped to hospitals in emergencies on a case-by-case basis.
Earlier this month, a Texas hospital became the first to keep the drug stocked, eliminating the wait for shipment and increasing the odds of survival for victims of primary amoebic meningoencephalitis, caused by an amoeba that is prevalent in warm freshwater bodies.
Lauren Seitz, 18, died of the disease on June 19, 11 days after she overturned while rafting at the Whitewater Center.
No one can say whether Seitz could have survived if she’d gotten the treatment, but a Texas couple whose 7-year-old son died of the same disease in 2010 has been fighting ever since to get miltefosine stocked in hospitals.
After their son Kyle’s death, Jeremy and Julie Lewis co-founded the Kyle Cares Amoeba Awareness Foundation in Texas and have worked to prevent similar deaths by advocating to make miltefosine more widely available.
The foundation announced at a news conference June 22 that the drug is now available at Cook Children’s Medical Center in Fort Worth, Texas. It is apparently the first U.S. hospital to have the drug readily available.
Miltefosine, known by the brand name Impavido, was originally created to treat breast cancer and has since been approved by the Food and Drug Administration to treat a tropical parasitic disease.
It was tried experimentally on a 12-year-old girl diagnosed in 2013 with the same disease that killed Seitz. That girl made a full recovery, beating the 99 percent rate of death at the time.
Though the infectious amoeba that causes PAM is common, the disease itself is not. The amoeba can be found in all bodies of warm freshwater, but only 38 infections of PAM have been confirmed in the U.S. in the last 10 years.
It didn’t take long for the Lewis family to hear about the 12-year-old’s survival. They looked into why Impavido wasn’t commonly used to treat PAM. After learning it was only available through the CDC, the Lewises made it their mission to provide hospitals with the drug their son never got.
Taking ‘rare’ out
Jeremy Lewis doesn’t swim in lakes anymore. His wife can’t even bear to look at them. “It’s like looking at the person that killed your loved one,” said Jeremy Lewis, a salesman.
Kyle contracted the infection while swimming and is among the 37 people, excluding Seitz, known to have died from PAM in the U.S. within the last 10 years.
Medically speaking, the disease is rare. But when defined by personal standards, Lewis said his family disagrees – they are all too familiar with the relentlessly debilitating amoeba, Naegleria fowleri, that causes PAM.
“When you read ‘rare,’ what do you think? It’s not going to happen to me, so we’ll go about our daily lives,” Lewis said. “Technically it is rare, but when you look at the devastation behind the cases it affects, you need to take that word ‘rare’ out of there.”
Now, the Lewises, along with their 16-year-old daughter Peyton, work to build awareness on how to prevent PAM through their foundation with events such as baseball tournaments and other activities. They also spread the word on precautions, such as wearing nose plugs or staying above the water.
Prevention is ideal, but after losing his son, Lewis knew a treatment could mean the difference between life and death for future PAM victims. What he didn’t know was that a young survivor in Arkansas would introduce him to a drug – and an idea – that would spur the search for life after infection.
First, Impavido was a drug to treat cancer, then to kill parasites, and then it happened to be tested on Kali Hardig, the 12-year-old from Arkansas. It was shown to have potential killing amoebas in the lab, so her doctors requested it from the CDC.
In addition to administering Impavido and a blend of other medications, doctors cooled Kali’s body to prevent brain damage. Doctors said it was a miracle mix of time and treatment that saved her life, which compelled Jeremy Lewis to figure out how this success could be repeated.
In 2014, the FDA approved the drug. In March of 2016, Profounda, a Florida drug company, announced the drug would now be available in the U.S. Lewis quickly reached out to Todd MacLaughlan, the company’s CEO.
MacLaughlan was unaware of the drug’s potential for treating PAM. “It was the same reaction: shock, disbelief. He had never heard anything like this,” Lewis said.
They began working on a plan to get the drug in hospitals on a consignment basis, meaning the hospital would not pay for the $16,000 drug unless it had to be used.
Lewis then began reaching out to hospitals. His first move was to contact Cook Children’s Medical Center – where Kyle died.
“The story really touched me, because I have grandchildren a little younger than Kyle would have been that all love water,” said Rosanne Thurman, Cook’s pharmacy director. Texas alone has had 34 cases of the disease since 1962, the highest number per state in the country, tied with Florida.
Thurman said the drug appears to kill the amoeba the way an antibiotic would kill certain types of infection. But the drug doesn’t guarantee a complete recovery, Thurman said.
“A lot of it depends on how quick it is identified,” she said. In some last-ditch efforts, it has not worked, she added.
The CDC reports that Impavido, administered orally, is one element of the six-part concoction recommended for treatment.
Though many factors determine whether a victim of PAM will survive, Thurman said that hospitals should consider stocking Impavido because of timing. “In this case, time is brain,” she said.
‘You can’t put your kids in a bubble’
Dallas Children’s Hospital is expected to have the drug by the end of this week. It will soon be available in other states, including South Carolina. It’s not immediately clear when or whether the drug will be stocked in Charlotte-area hospitals.
“We tell people to keep their head above water, though if they’re anything like Kyle, that’s impossible,” Lewis said. “You can’t put your kids in a bubble. If you’re going to go into the water, I would say be careful.
“If you get this drug, it’s not guaranteed you’ll survive or not have brain damage,” he said. “But this has been the only thing that has been shown to kill this.”