What is Tpoxx? Monkey pox is a difficult drug to treat

The only drug available to treat monkeypox was so difficult to obtain that it was given to only a fraction of the approximately 7,000 patients in the United States.

Health officials have labeled the drug, known as Tpoxx, an “investigational drug,” meaning it cannot be removed from the strategic national stockpile without a series of 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 shouldn’t be, experts say: There’s no law preventing federal officials from changing those rules and making the drug more widely available.

The Food and Drug Administration approved the drug in 2018 as a treatment for smallpox based on safety data in humans and efficacy data in primates — which for the purposes of this trial actually had monkeypox. The agency’s so-called animal rule states that it is unethical to test drugs on humans.

Prior to the current outbreak, tecoxiramit was rarely given to people with monkeypox. Its use against monkeypox as a treatment for smallpox is considered experimental. However, vaccines developed against smallpox are believed to be effective against both diseases. Why not treat?

Experts say the FDA’s restrictions are a policy choice that could change quickly.

Larry O. “Given the crisis the U.S. is facing with monkeypox, the bureaucracy involved in getting access to Tpoxx is enormous,” said Gostin, a public health law expert and director of National and Global Health Law at Georgetown University’s O’Neill Institute. .

“The law gives the agency a lot more flexibility to use scientific evaluations to get drugs to help those who need them,” he added.

The Department of Health and Human Services declared monkeypox a national public health emergency on Thursday. But Secretary Xavier Becerra did not take the additional step of authorizing FDA emergency use 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 their decision to treat tekarim as an investigational drug.

Acknowledging that animal data are promising and that the drug appears safe in healthy patients, they wrote that without large clinical trials, “we do not know whether tecovirimate benefits, harms, or has any effect on people with monkeypox.”

“Currently, it is not clear how well this drug will work in patients with monkeypox,” said Kristen Nordlund, a spokeswoman for the Centers for Disease Control and Prevention.

Giving Tpoxx only as an investigational drug “ensures that we have data from patients using this drug,” he said. “This will ultimately help us understand who benefits the most, the real benefits and the potential risks.”

Restrictions on Tecovirimat became more complicated at the beginning of the outbreak, and after much protest from doctors, the CDC relaxed some of the rules. But the system remains cumbersome.

Doctors who want to prescribe the drug must first submit resumes and informed consent forms signed by monkeypox patients and sign up to be investigators in a clinical trial — a process that is “labor-intensive and nearly impossible” for most doctors, said Linda Dee, director of AIDS Action Baltimore. executive director.

“If it wasn’t a dire emergency, it would be a very good bureaucratic joke,” Ms. Dee said. “Unfortunately, the joke is once again on the gay community.”

The rules are so complicated that some patients have to educate their doctors on the process.

Adam Thompson, a 38-year-old chef from Atlanta, first developed headaches and body aches on July 17, and two days later, sores appeared on his face and rectum.

The nurse he sees doesn’t know how to treat him, Mister. Thompson said. Based on her friend’s experiences, she convinced him to prescribe hydrocortisone suppositories and gabapentin, which is used to treat nervous disorders.

They did not help. The nurse practitioner had heard about tekorimat but said it would take hours to get the document.

When mr. Thompson said she wanted him to note on her chart that she didn’t want to prescribe him medication, which he told her would be up to her doctor to decide. The doctor finally called on Sunday, July 31, two weeks after her first visit.

“He said, ‘I contacted the CDC, I contacted the health department. I contacted several doctors in different states, I contacted several pharmacists in different states,” he said.

Before that, it didn’t matter. His wounds were healed, his pain subsided, and he was recovering.

Dr. Stacey Lane, founder and medical director of a seven-clinic chain serving LGBTQ populations in Pennsylvania and Ohio, said many of her monkeypox patients were turned away by three or four doctors who failed to comply with federal medical records regulations.

In early July, Dr. Lane saw a patient with distinctive eye lesions from a monkeypox infection that can cause blindness. He tried to get tekaurimat, but the Pennsylvania Department of Health required the patient to have an eye exam first.

It was a Friday afternoon, and Dr. Lane didn’t want the patient to wait in a crowded emergency room, so instead of waiting to do the exam the following Monday in a “very controlled setting in an outpatient office,” he found an ophthalmologist.

Pennsylvania has since waived the diagnosis requirement, but Ohio has not.

“There’s no need to retreat as if it’s a catch,” said Dr. Lane talked about the tequirimat. “It would be great if we could get this Tpoxx treatment in local pharmacies, just like we can get anything else, especially since this stuff is exploding.”

Dr. Lane and others said they understand there are still questions about the drug’s safety and effectiveness in humans, but noted that it has been shown to be safe in humans and has been approved by the FDA.

“If a drug is already approved by the FDA, any doctor can prescribe it off-label because the FDA is not authorized to regulate the practice of medicine,” said Dr. Jay Varma, director of the Cornell Center for Pandemic Prevention and Response.

“It is CDC policy to avoid prescribing or prescribing off-label medication,” he added.

Many patients and doctors, including Dr. According to Lane, tecociramit appears to dissolve skin lesions within 24 hours. No serious side effects were reported.

Given the established and emerging evidence of the drug’s effectiveness in patients and the urgency of the epidemic, experts say there is no reason to restrict access.

“I understand that there needs to be more data collection and post-marketing surveillance and all that stuff,” said Dr. James Lawler, director of the University of Nebraska Center for Global Health. “But you can do it in a way that’s not disruptive.”

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