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Monkeypox treatments are difficult to get despite the nation's large stockpile

ARI SHAPIRO, HOST:

There are more than 1,900 confirmed cases of monkeypox in the U.S. The virus causes painful sores that can last for weeks. There are anti-viral pills that can help people recover faster, but patients and their advocates say the treatments are too hard to get. NPR's Pien Huang explains why.

PIEN HUANG, BYLINE: The treatment is called TPOXX, and it's a two-week course of pills. Kyle Planck is on Day 7.

KYLE PLANCK: You have to eat a fatty meal beforehand. So I eat, like, a bagel with cream cheese or a McGriddle or something like that. And then I take three of these pills with a full glass of water.

HUANG: Planck tested positive for monkeypox this month.

PLANCK: Monkeypox is the worst pain I've had in my life. And especially because it was, like, an internal sort of pain, it was very - really hard to deal with.

HUANG: Planck is a grad student in New York City studying infectious diseases, and he believes the TPOXX helped him get better faster. Within two days of starting it...

PLANCK: I noticed that some of the pustules were actually shrinking in size, and some of them just kind of, like, disappeared back into my skin. So they didn't go through the normal progression that the lesions usually do.

HUANG: According to advocates in the queer community, Planck is one of the lucky few to access TPOXX. The federal government controls the supply, but officials with the CDC and the Department of Health and Human Services declined to tell NPR how much they've given out. TPOXX is made by SIGA, a drugmaker that's worked closely with the U.S. government for years. Phil Gomez is the company's CEO.

PHIL GOMEZ: Given the nature of how it was developed, we only sell to governments currently. So the intent has always been for this to be stockpiled because if there's an outbreak, it's too late for people to order the drug.

HUANG: It was made to protect against smallpox, a much deadlier cousin to monkeypox. Smallpox was eradicated from the world 40 years ago, but some labs have samples, and it's considered a bioterror threat. Gomez from SIGA says they developed TPOXX by testing it on animals.

GOMEZ: So two animal models were used - monkeypox in monkeys and rabbitpox in rabbits.

HUANG: In 2018, the FDA approved the drug through something called the animal rule. TPOXX was effective at stopping smallpox-like viruses in rabbits and monkeys. And it was shown to be safe in a few hundred healthy people who took it in a trial. Rachel Roper, a virologist at East Carolina University, says the drug works across smallpox, monkeypox and other related pox viruses because it blocks a protein they need to reproduce.

RACHEL ROPER: And so it decreases virulence in the body tremendously because even though some cells get infected, they can't infect the next cells and spread it.

HUANG: But even though the drug worked against monkeypox in monkeys, the FDA only approved its use for smallpox in humans. And that has created dense ribbons of red tape for doctors and patients in the current monkeypox outbreak. There's enough TPOXX in the strategic national stockpile for 1.7 million people. Dr. Robert Pitts, an infectious disease specialist at NYU Langone Health, has prescribed it to seven. Each time it takes three to four hours of paperwork.

ROBERT PITTS: Like, every time I send a TPOXX prescription, I'm very cognizant of, like, this is what the patient needs. But the work that I'm going to put into this is, like, more time that I have.

HUANG: The FDA and CDC consider TPOXX an investigational new drug for monkeypox, so it comes with a lot of requirements. Prescribers like Pitts have to go through local health departments or the CDC to get the drug. They get consent forms from patients and submit progress reports. Patients themselves keep diaries of their treatments. Pitts says he knows the drug hasn't been used in a lot of people before and that the rules are meant to protect patients. Still, they make it hard to get TPOXX to people suffering now.

PITTS: People have a very hard time, you know, accessing providers who are comfortable with this, so it's not scalable in any means.

HUANG: A CDC spokesperson told NPR that the agency is working with FDA to simplify the process and dramatically reduce the paperwork for patients and providers using TPOXX. In the meantime, lack of access has turned patients like Kyle Planck into advocates.

PLANCK: So now that I'm feeling a lot better, I'm feeling very, like, energized and restless because I'm still stuck inside, and I'm like, what can I do to make this better?

HUANG: Planck has been writing to his elected officials, pleading with them to make this drug more available for monkeypox. It does more than just help people feel better, he says; it could help stop the spread of the disease.

Pien Huang, NPR News. Transcript provided by NPR, Copyright NPR.

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Pien Huang is a health reporter on the Science desk. She was NPR's first Reflect America Fellow, working with shows, desks and podcasts to bring more diverse voices to air and online.