The only drugs available to treat monkeypox are very difficult to obtain and are given to only a fraction of the approximately 7,000 patients in the United States.
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. However, most physicians do not have the time or resources to complete the required 27-page application form and provide detailed patient information.
It doesn’t have to be, experts say: change those rules And make the drug more widely available.
In 2018, the Food and Drug Administration approved tecovirimat for the treatment of smallpox based on safety data in humans and efficacy data in primates. 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 say the FDA’s restrictions are policy choices that can change quickly.
“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 said Larry O. Gostin, Institute Director. .
“The law gives institutions considerable flexibility to use scientific assessments to ensure that those in need get drugs that can help them,” he added.
The Department of Health and Human Services on Thursday declared monkeypox a national health emergency. But Secretary Xavier Becerra did not take additional steps to allow the FDA to grant emergency use authorizations for vaccines and treatments, as it did during the coronavirus pandemic.
In an article published in the New England Journal of Medicine on Wednesday, federal health officials said: defended their decision Tecovirimat will be treated 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.
What you need to know about the monkeypox virus
What is monkeypox? Monkeypox is a virus similar to smallpox, but less severe. It was discovered in 1958 after an outbreak in monkeys kept for research. The virus was primarily found in parts of Central and West Africa, but has spread to dozens of countries in recent weeks, infecting tens of thousands of people. On July 23, the World Health Organization declared monkeypox a global health emergency.
“At this time, we do not know if or how well this drug works for monkeypox patients,” said Kristen Nordland, a spokeswoman 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 more complicated early in the outbreak, and after numerous complaints from doctors, the CDC loosened some of the rulesBut the system remains unwieldy.
Physicians wishing to prescribe this drug must first sign up to become a clinical trial investigator and provide a resume and informed consent form signed by a monkeypox patient. The process is “labor-intensive and virtually impossible” for most doctors, says Lynda Dee. Executive Director of AIDS Action Baltimore.
“If this weren’t such a dire emergency, it would be a very good bureaucratic joke,” Dee said. “Unfortunately, jokes are circulating in his gay community again.”
The rules are so complicated that some patients have had to educate their doctors about 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.
Thompson said the nurse practitioner he met had no idea how to treat him. Based on her friend’s experience, he convinced her to prescribe hydrocortisone suppositories and gabapentin, a drug used to treat neuralgia.
They were no help. The nurse practitioner had heard of tecovirimat, but told him it would take hours of paperwork to get it.
When Mr. Thompson asked the chart to write down that she was unwilling to prescribe medication for him, she told him the doctor would have to decide. Doctors finally called him on Sunday, July 31, nearly two weeks after they first contacted him.
“She was like, ‘I’ve contacted the CDC, I’ve contacted the health department. I got
Until then, it didn’t matter. His lesions had healed, his pain subsided, and he was recovering.
Stacey Lane, Ph.D., founder and medical director of a network of seven clinics serving LGBTQ people in Pennsylvania and Ohio, says many of her monkeypox cases are three or four. He said he was rejected by a doctor. Tecobilimat.
In early July, Dr. 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 insisted that the patient get an eye exam first.
It was a Friday afternoon, and Dr. Laing didn’t want to keep his patients waiting in a crowded emergency room, so instead of waiting for the tests to be performed “in an outpatient and highly controlled manner,” he rushed to see an ophthalmologist. I found. ” next Monday.
Pennsylvania has since lifted the diagnostic requirement, but Ohio has not.
“This doesn’t have to be suppressed the way it is suppressed,” Dr. Lane said of tecovirimato. “It would be ideal if this Tpoxx treatment of his was available at my local pharmacy like any other, especially as this treatment continues to explode.”
Dr. Lane and others 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.
Dr. Jay Varma, Director of Cornell University’s Center for Pandemic Prevention and Response, said:
“Avoiding off-label drug launches or endorsements is the CDC’s policy choice,” he added.
Many patients and doctors, including Dr. Lane, report that tecovirimat appears to dissolve skin lesions within 24 hours. No serious adverse events were reported.
Given the known and emerging evidence about the efficacy of the drug for patients and the urgency of the outbreak, experts say there is little reason to limit access.
Dr. James Lawler, Director of the University of Nebraska’s Global Center for Health Security, said: “But we can do it in ways that don’t create barriers.”
