Kyle was in the most pain of his life when he was diagnosed with monkeypox. He says it was the worst pain he had ever experienced, and it lasted all day.
He spent a lot of time in the bed. The brand name of the two-week course of pills was TPOimatXX. He noticed an improvement within two days of taking them. He says that they did not go through the normal progression.
Planck is one of the few patients who have access to TPOXX. In New York City, around 215 patients have received the drug.
It is not known how many courses have been prescribed. 1.7 million TPOXX courses are held by the government. The Department of Health and Human Services told NPR that the number of courses deployed does not mean the number of courses administered. The Centers for Disease Control and Prevention keeps track of courses, but the CDC referred NPR back to HHS.
SIGA is based in New York. According to Phil Gomez, the drug was developed in partnership with the U.S. government after 9/11. Smallpox, a much deadlier cousin to monkeypox, was eradicated as a human disease more than 40 years ago, but labs in the US and Russia still have samples.
If there's a smallpox outbreak, it's too late to order the drug, so we only sell it to governments.
The monkeys and rabbits that were tested had monkeypox and rabbitpox, respectively. In order to prove that it was safe in humans, they gave it to a few hundred healthy people and recorded their side effects. The FDA approved the drug through the Animal Rule, which allows companies to use animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.
The drug works because it blocks a proteins that the viruses need to reproduce to survive. Rachel Roper is a professor at East Carolina University who has worked on poxviruses for 30 years.
The FDA only approved TPOXX for use in humans because it worked against monkeypox. The FDA and CDC require certain requirements for compassionate use of the drug for monkeypox. Barriers to access for doctors and patients have been created by that.
The infectious disease specialist at NYU Langone Health in New York has prescribed TPOXX to a number of patients. He says that every time he sends a prescription, he's aware that the patient needs it. The patients felt better after taking the drug. Administrative paperwork was hard to understand. The protocol took up to four hours to complete.
The CDC updated its protocol to make it easier to prescribe the drug. Prescribers still go through their local health departments to request the drug, but many of the forms are shorter, and some of the previously required documentation is no longer required. According to Dr. Melanie Thompson, a physician and HIV researcher in Atlanta, this has been improved. I took about 15 minutes to complete all of the paperwork and another 15 minutes for the patient's consent.
Activists and clinicians advocated for the changes. "There were a lot of health care providers who spoke directly to CDC, advocates wrote letters and lobbied for these changes, and CDC recognized that something had to be done."
It's still a significant amount of additional work to put patients on the treatment even though the new process is a huge improvement. The drug hasn't been used in a lot of people before, and the rules are meant to protect patients. He hears from patients who can't get a provider to prescribe the drug.
Patients like Planck have become advocates because of the lack of access. He pleaded with his elected officials to make the drug more available. He is working with advocacy groups to push for more access. He says that TPOXX could help stop the spread of the disease.
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