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Kyle Plank experienced the worst illness of his life when he contracted monkeypox. – I was seven or eight years old [out of 10] It was the worst pain I could ever imagine, and it came and went all day long,” she says, “especially because it was so internal that it was so hard to deal with.”
In early July, a graduate student in infectious diseases in New York had various stages of pustules on her body. He was bedridden for several days. Plank then went on a two-week course of tecovirimat – a TPOXX brand – of antiviral pills. Within two days of taking them, she noticed an improvement: “Some of the pustules actually got smaller and some of them just disappeared back into my skin. They didn’t go through the normal progression that the lesions usually go through,” she said. says.
According to LGBTQ community advocates, Plank is one of the lucky patients to have access to TPOXX. About 215 patients in New York have received TPOXX so far, according to a city health official on July 23.
It is not known how many courses are registered across the country. The government has 1.7 million TPOXX courses in its strategic national stockpile. So far, 10,000 courses have been sent to states and cities on demand, but “No [courses] The number placed is not necessarily the same [courses] A spokesperson for the Department of Health and Human Services wrote in an email to NPR. HHS said the Centers for Disease Control and Prevention monitors administered courses, but the CDC referred the NPR back to HHS, which recommended checking with the NPR. individual jurisdictions.
A drug tested against monkey pox
TPOXX is manufactured by the New York-based pharmaceutical company SIGA. “The drug was developed in cooperation with the US government after September 11. [to address] concerns about [potential] smallpox attack,” says SIGA CEO Phil Gomes. Smallpox, a far deadlier relative of monkeypox, was eradicated as a human disease 40 years ago, but there are samples in laboratories in the US and Russia and it is considered a bioterrorism threat.
“Given how it’s designed, we only sell to governments,” says Gomez, “and it was always the intention to stock it, because if there was [smallpox] epidemic, it is too late to start ordering medicine.
SIGA tested TPOXX’s activity against smallpox-like viruses in two animal models: monkeypox in monkeys and rabbitpox in rabbits. And they proved it safe for humans by giving it to several hundred healthy people in a safety trial and recording their side effects (headaches and nausea were the most common). In 2018, the FDA approved the drug through the agency’s “Animal Rule,” which allows companies to use animal studies “to support FDA approval when effective human trials are impractical or unethical.”
The drug works against smallpox, monkeypox and other smallpox because it blocks a protein these viruses need to multiply. “It greatly reduces virulence in the body, because some cells are infected, but they can’t infect other cells and spread it,” says Rachel Roper, a professor of microbiology and immunology at East Carolina University who has worked with poxviruses for 30 years. a year.
But even though TPOXX worked against monkeypox in monkeys, the FDA approved it only for smallpox in humans. The monkeypox drug is classified as an “investigational new drug” with compassionate use approval, which comes with FDA and CDC requirements. This has created obstacles for doctors and patients in the current epidemic of monkeypox.
There is less paperwork, but some forms are still required
In New York City, Dr. Robert Pitts, an infectious disease specialist at NYU Langone Health, has prescribed TPOXX to dozens of patients. “Every time I send a prescription for TPOXX, I understand what this patient needs,” he says. After taking the drug, patients felt better and did not worry about side effects. Still, the administrative paperwork was cumbersome. In early July, it took three or four hours for each patient to complete the protocol.
On July 22, the CDC updated its TPOXX protocol, streamlining the process to make prescribing the drug easier. Prescribers still request the drug through local health departments or the CDC, but many of the forms are shorter and some of the previously required documentation—including photos of injuries and patient diaries—is now optional. “Actually, it’s gotten a lot better,” he says Dr. Melanie Thompson, an Atlanta physician and HIV researcher who prescribed TPOXX to a patient under the new requirements. “TPOXX took me 15 minutes to do all the paperwork and another 15 minutes to get the patient’s consent.”
The changes came after strong advocacy by clinicians and activists. “There were a lot of health care providers talking directly to the CDC, advocates writing letters and supporting these changes,” Thompson says, “and the CDC realized something had to be done.”
Pitts agrees that the new process is a major breakthrough, but says “it’s still a significant amount of work in addition to treating patients.” He knows the drug hasn’t been used on many people before, and the rules are meant to protect patients. Still, he hears every day from patients struggling to find providers willing to prescribe.
Seeing the lack of opportunity turned patients like Planck into advocates. Isolated, he wrote to his elected officials, asking them to make the drug available. Now that he’s recovered, he’s working with advocacy groups to gain more access. TPOXX can do more than just help people feel better, he says; it can help stop the spread of disease.