Patients suffering from severe malaria might have to wait up to 24 hours for treatment because the only government-approved vaccine ran out in April.
Treatment for the mosquito-borne virus is gaining heightened attention from doctors as malaria rates steadily climb around the world, potentially exposing U.S. residents as they travel abroad.
It’s common for malaria cases in the United States to go untreated for several days because it takes time for travelers to return home from the regions from which they contracted the virus. In extreme cases, malaria left untreated can become severe, with symptoms like labored breathing and neurological effects. About 2,000 cases of malaria are observed in the United States each year. Of those, 300 are severe — and about half of them are fatal.
Until recently, the treatment for severe malaria was a compound called quinidine gluconate, an intravenous drug manufactured by Eli Lilly and Co., an Indiana-based pharmaceutical company. Eli Lilly announced in 2017 that it would stop producing the vaccine, leaving hospitals and other treatment centers scrambling for an alternative.
Quinidine was then, and still is today, the only treatment for severe malaria approved by the Food and Drug Administration. In April, the remaining doses expired.
“As I looked into the issue more, it became apparent that this was an alarming situation that could develop,” said Mark Travassos, a pediatric infectious disease physician and assistant professor at the University of Maryland School of Medicine.
The treatment system that has emerged in the absence of quinidine is far from perfect, Travassos said.
In an article published this week in the Annals of Internal Medicine, Travassos and a colleague at Boston Children’s Hospital laid out the challenges posed by the new protocol and the threats it could pose to public health efforts in America.
Under the new system proposed by the Centers for Disease Control and Prevention, patients with severe malaria are treated with injectable artesunate, a drug developed by the U.S. military. It cannot be stored in hospitals because it’s not FDA approved. Instead, doctors who identify cases of severe malaria must call the CDC’s malaria hotline and request delivery of the drug from the agency. A dose is then flown from CDC stockpiles to the closest airport, where it must be picked up and driven to the hospital. The process can take about eight hours on average, Travassos said, though in some cases it can take as long as 24 hours.
In the case of a viral infection like malaria, that can be the difference between life and death. There are a handful of oral medications that the CDC recommends doctors begin treating their patients with, but experts like Travassos insist that these provide little benefit to a patient with severe malaria.
“Any delay in treatment allows the parasite to multiply exponentially in a patient,” Travassos said. “They need that medicine right away. They don’t need that medication eight or 10 hours from their presentation.”
In an email, a representative from Eli Lilly wrote that the decision to stop making quinidine was “because treatment for severe malaria had evolved and a suitable alternative therapy was available that had better efficacy and a more favorable side effect profile.” But Travassos said he believes there was a lack of political influence.
“Patients with severe malaria do not have an advocacy base,” he said. “This is a disease of returning travelers. There’s not an active organization of, you know, severe malaria survivors. They don’t have a clear voice or organization advocating for them, and that’s important, especially when there’s a limited number of patients with a deadly condition.”
In recent years, climate change has had a demonstrable effect on malaria infections in a number of regions. In places like Uganda, which saw a 40% increase in cases in June compared with a year ago, record high temperatures and persistent rain help virus-carrying mosquitoes thrive.
These same shifts in the climate, the CDC has found, have also expanded the footprint of malaria’s stomping grounds, allowing the virus to thrive just beyond the boundaries of its usual habitat. Thanks to air travel, more people are bringing the virus home to the United States. At a certain point, temperatures in colder areas could rise enough to enable temporary or sustained exposure to infectious diseases.
That more people might need treatment just as it’s becoming harder to get is worrying experts. “At present, the prospects for timely, effective treatment of severe malaria in the United States are grim,” the article by Travassos says.
Travassos outlines a number of potential solutions. He said he hopes that advocacy groups will urge the FDA to fast-track approval for artesunate. So far, there has been no attempt to get it approved, he said. Pharmaceutical companies other than Eli Lilly could step in and manufacture quinidine in the meantime, a solution that Travassos conceded is unlikely to happen without financial incentives.
At the hospital level, Travassos said it’s important that care providers know how to get artesunate as fast as possible. That could include instructing patients to get treatment before coming home.
“Depending on the region where you’re traveling, there is a good chance that you will have access to more effective malaria medication in that region than you would in the United States,” said Travassos.