Kyle Planck, who was recovering from a painful case of monkeypox, joined advocacy groups and begged elected officials to make the antiviral drug TPOXX more available.
Yuki Iwamura / AFP via Getty Images
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Yuki Iwamura / AFP via Getty Images
Kyle Planck, who was recovering from a painful case of monkeypox, joined advocacy groups and begged elected officials to make the antiviral drug TPOXX more available.
Yuki Iwamura / AFP via Getty Images
When Kyle Planck suffering from monkeypox, he was in the worst pain of his life. “I was seven or eight years old [out of 10] about the worst pain I can imagine, it comes and goes all day long,” he said, “especially because it’s a kind of inner pain – so hard to deal with. ”
In early July, the infectious disease fellow in New York City developed pustules at various stages of the body. He was bedridden for many days. Then Planck got access to tecovirimat – brand name TPOXX – a two-week antiretroviral drug. Within two days of taking them, he noticed an improvement: “Some of the pustules had really shrunk in size and some of them just disappeared back into my skin. They didn’t progress. as normal as injuries do,” he said.
According to LGBTQ advocates, Planck is one of the lucky few to have access to TPOXX. Hitherto, about 215 patients received TPOXX in New York City, according to a city health official on July 23.
It is not clear how many courses have been regulated nationally. The government’s strategic national stockpile holds 1.7 million courses TPOXX. To date, 10,000 courses have been sent to states and cities on request – but the “quantity [courses] implemented is not necessarily equivalent to the number of [courses] administered,” a Department of Health and Human Services spokesperson wrote in an email to NPR. HHS said the Centers for Disease Control and Prevention tracks administered courses, but the CDC has moved NPR back back to HHS, which recommends that NPR check with individual jurisdictions.
A drug for smallpox, tested against smallpox in monkeys
TPOXX is manufactured by the New York-based pharmaceutical company SIGA. “The drug was developed in cooperation with the US government after 9/11, [to address] concern about a [potential] SIGA CEO Phil Gomez said. Smallpox, a cousin of monkeypox, has been eradicated as a human disease more than 40 years agobut labs in the US and Russia have samples and it’s considered a bioterrorism threat.
“Given the nature of the way it’s developed, we’re only selling to governments,” says Gomez, “The aim has always been for this to be hoarded because if there were [smallpox] outbreak, it’s too late to start prescribing. “
SIGA demonstrated that TPOXX was active against smallpox-like viruses by testing it on two animal models: smallpox in monkeys, and smallpox in rabbits. And they proved it’s safe in humans by giving it to a few hundred healthy people in a safety test and documenting their side effects (headaches and nausea being the most common). In 2018, FDA drug approval passed the agency’s “Animal Rule,” which allows companies to use animal studies “to support FDA approval when it is not feasible to conduct efficacy trials in humans, or unethical.”
The drug works for smallpox, monkeypox and other related legumes because it blocks a protein these viruses need to reproduce. “It reduces the virulence in the body a lot, because even if some cells are infected, they can’t infect the next cell and spread it,” Rachel Ropera professor of microbiology and immunology at East Carolina University who has studied poxvirus disease for 30 years.
But although TPOXX is effective against smallpox in monkeys, the FDA has only approved its use for smallpox in humans. For monkeypox, the drug is classified as “new drug investigation” allowed to use compassion, which comes with requirements from the FDA and CDC. That has created a barrier to access for doctors and patients during the current monkeypox outbreak.
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 very well that this is what the patient needs,” he says. The patient feels better after taking the drug and is not too concerned about the side effects. However, administrative procedures are still difficult. In early July, the procedure took up to three or four hours per patient to complete.
On July 22, CDC updated its TPOXX protocol, streamlining the process to make prescribing much easier. Prescribers still go to their local health department or CDC to request medication, but many shorter forms and some of the previously requested documents – including photographs of lesions and patient logs – are now available. option. “Really, this has improved dramatically,” says Dr. Melanie Thompson, a physician and HIV researcher in Atlanta, who prescribed TPOXX to a patient on a new request. “It took me about 15 minutes to do all the TPOXX paperwork, and another 15 minutes to give consent to the patient.”
The changes came after intense lobbying from doctors and activists. “There were many health care providers who spoke directly to CDC, advocates who wrote letters and campaigned for these changes, and CDC realized that something needed to be done,” Thompson said. “.
Pitts agrees that the new procedure is a major improvement, but says that “there is still a huge amount of additional work to get patients into treatment.” He knows that the drug has not been used on many people before and that the rules are intended to protect patients. Yet every day he still hears from patients who are having a hard time finding providers willing to prescribe them.
Witnessing the lack of accessibility has turned patients like Planck into advocates. From his isolation, he wrote to his elected officials, begging them to provide more of the drug. Now that he’s healed, he’s working with advocacy groups to promote wider access. TPOXX has the potential to do more than just help people feel better, he says; It can help prevent the spread of disease.
