The only medication available to treat monkeypox is so difficult to use that it is given to only a fraction of the approximately 7,000 patients in the United States.
Health officials have designated tecovirimat, also known as Tipox, a “trial drug,” meaning it cannot be released from the strategic national stockpile without a series of complicated bureaucratic steps. But most doctors don’t have the time or resources to fill out the required 27-page application or provide detailed patient information.
It doesn’t have to be this way, experts say: There’s no law stopping federal officials change those rules and making the drug more widely available.
The Food and Drug Administration approved tecovirimat as a treatment for smallpox in 2018, based on safety data in people and efficacy data in primates—who, for the purposes of the trial, were actually infected with monkeypox. The so-called animal rule allows the agency to approve drugs when testing them in people would be unethical.
Until the current outbreak, tecovirimat was only given to patients with monkeypox. Its use against monkeypox is considered experimental, as a treatment for smallpox. But vaccines developed for smallpox have been shown to be effective against both diseases. Why not cure?
Experts say the FDA’s restrictions are a policy option that could be changed quickly.
Larry O., an expert in public health law and director of the O’Neill Institute for National and Global Health Law at Georgetown University. “Given the crisis America is battling with monkeypox, the bureaucracy to gain access to Tpoxx is excessive,” Gostin said. ,
“The law gives the agency a lot of flexibility to use scientific assessment to make sure they get the drug that can help them,” he said.
The Department of Health and Human Services declared monkeypox a national health emergency on Thursday. But Secretary Javier Becerra didn’t take an extra step that would have allowed the FDA to grant emergency use authorizations for vaccines and treatments, as the agency did during the coronavirus pandemic.
In an article published Wednesday in the New England Journal of Medicine, federal health officials defended his decision As an investigational drug to treat tecovirimat.
Acknowledging that the animal data was promising and that the drug seemed to be safe in healthy patients, they wrote that, without larger clinical trials, “we will not know whether tecovirimat will work on people with monkeypox disease.” There will be no profit, loss or any effect.”
“At this time, it is unclear how well this drug works for patients with monkeypox,” said Kristen Nordlund, a spokeswoman for the Centers for Disease Control and Prevention.
Providing Tpoxx only as an investigational drug “ensures that we have data on patients using this drug,” she said. “This will ultimately help us understand who will benefit the most, what the actual benefits are and what the potential risks might be.”
What’s to know about the monkeypox virus?
What is monkeypox? Monkeypox is a virus similar to smallpox, but the symptoms are less severe. It was discovered in 1958 after an outbreak in monkeys kept for research. The virus was found mainly in parts of Central and West Africa, but in recent weeks it has spread to dozens of countries and infected thousands of people, including more men who have sex with men. Is. On 23 July the World Health Organization declared monkeypox a global health emergency.
Restrictions on tecovirimat were even more complicated at the start of the outbreak, and — after much complaints from doctors — the CDC relaxed some rules, But the system remains cumbersome.
Physicians who want to prescribe the drug must first sign up to be investigators in a clinical trial, sending signed resumes and informed consent forms by monkeypox patients—a process that is “labor intensive and nearly impossible” for most doctors, Linda said. Dee, executive director of AIDS Action Baltimore.
“If it had not been such a dire emergency, it would have become a very good bureaucratic joke,” said Ms. D. “Unfortunately, the joke is on the gay community once again.”
The rules are so complex that some patients need to educate their doctors on the procedure.
Adam Thompson, a 38-year-old cook in Atlanta, first got a headache and body aches on July 17, and two days later he had sores on his face and rectum.
Mr Thompson said the nurse practitioner he saw had no idea how to deal with him. Based on a friend’s experiences, she persuaded him to prescribe hydrocortisone suppositories and gabapentin, a drug used to treat nerve pain.
He didn’t help. The nurse practitioner had heard of TecoVarimat, but she told him it would take hours of paperwork to get it.
When Mr Thompson said he wanted her to note in his chart that he was unwilling to prescribe medication for her, he told her that the doctor would need to make a decision. The doctor finally called her on Sunday, July 31, about two weeks after she first arrived.
“She was like, ‘I’ve contacted the CDC, I’ve contacted the Department of Health. I’ve contacted many doctors in different states, I’ve contacted many pharmacists in different states.'”
Till then it didn’t matter. His wounds were healing, the pain had subsided and he was recovering.
The founder and medical director of a network of seven clinics serving LGBTQ populations in Pennsylvania and Ohio, Dr. Stacey Lane said that many of her monkeypox patients were turned away by three or four doctors who couldn’t deal with the annoying federal regulations in this regard. tecovirimat
In early July, Dr. Lane saw a patient with eye lesions typical of monkeypox infection, which can lead to blindness. She tried to acquire Tecovirimat, but the Pennsylvania Department of Health insisted that patients get an eye exam first.
It was a Friday afternoon, and Dr. Lane didn’t want patients to wait in the overcrowded emergency room, so she called an ophthalmologist instead of waiting to have the exam “in a very controlled way in an outpatient office.” scrambled to find it. “next Monday.
Pennsylvania has since dropped the diagnosis requirement, but Ohio has not.
“It doesn’t need to be put back the way it is being put back,” Dr. Lane said of TecoVarimat. “It would be ideal if we could get this Tpoxx treatment at local pharmacies like we could get anything else, especially as this thing continues to explode.”
Dr. Lane and others said they understood there were still questions about the drug’s safety and effectiveness in people, but noted that it had already been shown to be safe in people and approved by the FDA.
“If a drug is already FDA-approved, any physician may prescribe it as off-label because the FDA is not allowed to regulate the practice of medicine,” said director of the Cornell Center for Pandemic Prevention and Response. Doctor. Jai verma said.
“It’s a CDC policy option to avoid releasing or recommending a drug off-label,” he said.
Many patients and doctors, including Dr. Lane, have reported that tecovirimat clears up skin lesions within 24 hours. No serious adverse events have been reported.
Given the known and emerging evidence of the drug’s effectiveness in patients and the urgency of the outbreak, experts say there is little rationale for restricting access.
“I understand that there is a need for a lot of data-gathering and post-marketing surveillance and everything else,” said Dr. James Lawler, director of the University of Nebraska’s Global Center for Health Security. “But you can do it in a way that doesn’t create obstacles.”