the only medicine that can cure monkeypox Only a small percentage of the approximately 7,000 patients in the United States have received it because it is so difficult to obtain.
Health officials have granted tecovirimato, also known as Tpoxx, “Investigational Drug” designation. This means they cannot be released from strategic national stockpiles without a complex series of bureaucratic measures. But most doctors don’t have the time or resources to complete the required 27-page application and provide detailed information. Patient information.
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That doesn’t necessarily have to be the case, experts say: There’s no law preventing federal officials from changing these rules and making the drug more widely available.
The Food and Drug Administration approved tecovirimato for the treatment of smallpox in 2018 based on safety data in humans and efficacy data in primates. infected with monkeypox. The so-called animal rule allows the FDA to approve drugs when it would be unethical to test them on humans.
Until the current outbreak, tecovirimat was rarely given to monkeypox patients. As a treatment for smallpox, its use against monkeypox is considered experimental. However, vaccines developed for smallpox have been assumed to be effective against both diseases. why not treat?
Experts FDARestrictions are policy choices that can be changed on the fly.
“Given the crisis the United States is facing with monkeypox, the bureaucracy to gain access to Tpoxx is overkill,” said O’Neill, a public health law expert and Georgetown University National and International Health Law Institute Director Larry Gostin said.
“The law gives institutions considerable flexibility to use scientific assessments to ensure that information is available to those who need it. dosage It can help them,” he added.
The Department of Health and Human Services on Thursday declared monkeypox a national health emergency. But Commissioner Xavier Becerra did not take additional steps to allow the FDA to grant emergency use authorization for vaccines and treatments. coronavirus pandemic.
In an article published Wednesday in the New England Journal of Medicine, federal health officials defended their decision to treat tecovirimato as an investigational drug.
While acknowledging that the animal data are promising and that the drug appears to be safe in healthy patients, without large clinical trials, it remains to be seen whether tecovirimato will benefit or harm monkeypox patients. , or ineffective,” they wrote.
“At this time, we do not know if or how well this drug works for monkeypox patients,” said Kristen Nordland, a spokesperson for the Centers for Disease Control and Prevention.
By offering Tpoxx only as an investigational drug, “we can ensure that we get data from patients using this drug,” she said. “This ultimately helps us understand who benefits most, what the real benefits are, and the potential risks.”
Restrictions on tecovirimato were even more complicated early in the outbreak, after many complaints from doctors. CDC Relax some rules. But the system remains unwieldy.
A doctor who wants to prescribe a drug must first sign up to become an investigator. clinical trialsSubmitting signed resumes and informed consent forms for monkeypox patients is “labor-intensive and virtually impossible” for most doctors, said Lynda Dee, executive director. AIDS Action Baltimore.
“If this weren’t such a dire emergency, it would be a very good bureaucratic joke,” said Dee. “Unfortunately, the joke is circulating in the gay community again.”
The rules are so complicated that some patients have had to educate their doctor on the process.
Adam Thompson, a 38-year-old cook in Atlanta, first developed headaches and body aches on July 17, followed two days later by lesions on his face and rectum.
of nurse practitioner He didn’t know how to treat him, Thompson said. Based on a friend’s experience, he convinced her to prescribe hydrocortisone suppositories and gabapentin, a drug used to treat nerve pain.
They were no help. The nurse practitioner had heard of tecovirimat, but told him it would take hours of paperwork to get it.
When Thompson asked Karte to write down that she didn’t want to prescribe medication for him, she told him the doctor would have to decide. I finally called him on July 31st, almost two weeks after taking it.
“She said, ‘I contacted the CDC. I contacted the health department. I contacted multiple doctors in different states. I contacted multiple pharmacists in different states,'” he said.
Until then, it didn’t matter.his disease Healingthe pain subsided and he felt fine.
Dr. Stacy Lane, founder and medical director of a network of seven clinics in Pennsylvania and Ohio, said: LGBTQ Many of her monkeypox patients were turned down by three or four doctors who could not cope with the complicated federal regulations regarding tecovirimato.
In early July, Lane saw a patient with eye lesions typical of monkeypox infection that could lead to blindness.She tried to get tecovirimato, but the Pennsylvania Department of Health told patients eye examination first time.
It was a Friday afternoon and Lane didn’t want patients waiting in a crowded emergency room. Ophthalmologist Instead of waiting next Monday for testing to be done “in an outpatient and highly controlled manner”.
Pennsylvania has since lifted the diagnostic requirement, but Ohio has not.
“This doesn’t have to be suppressed in a controlled way,” Lane said of tecovirimat. “It would be ideal if I could get this Tpoxx treatment locally. pharmacy Especially since this one keeps blowing up, just like you can get other things.
Lane et al. said they understand that there are still questions about the drug’s safety and effectiveness in humans, but it has already been proven safe in humans and has been approved by the FDA. pointed out that
Dr. Jay Varma, Director of Cornell University’s Center for Pandemic Prevention and Response, said: “It is a CDC policy choice to avoid launching or recommending off-label drugs.”
Many patients and doctors, including Lane, report that tecovirimato appears to dissolve skin lesions within 24 hours. No serious adverse events were reported.
Given the known and emerging evidence for medicineGiven the impact on patients and the urgency of the outbreak, experts say there is little reason to limit access.
Dr. James Lawler, Director of the Global Center for Health Security at the University of Nebraska, said: “But we can do it in ways that don’t create barriers.”
This article was originally published in The New York Times.
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