There is only one drug to treat smallpox in monkeys. Good luck getting it.

The only drug currently available to treat monkeypox is so difficult to access that only a fraction of the nearly 7,000 patients in the United States have received it.

Health officials have designated tecovirimat, also known as Tpoxx, an “investigative drug,” which they say means it cannot be released from the strategic national stockpile without a series of steps. complex bureaucracy. But most doctors don’t have the time or resources to fill out the required 27-page application or provide detailed patient information.

Experts say it doesn’t have to be this way: There’s no law stopping federal officials change those rules and make the drug more widely available.

The Food and Drug Administration approved tecovirimat as a treatment for smallpox in 2018, based on safety data in humans and efficacy data in primates – for the purposes of this study. test, was actually infected with smallpox in monkeys. The so-called animal rule that allows an agency to approve drugs when testing them in humans would be unethical.

Until the current outbreak, tecovirimat was rarely given to patients with monkeypox. As a treatment for smallpox, its use in monkeypox is considered experimental. But the vaccine developed for smallpox has been found to be effective against both diseases. Why not the treatment?

Experts say the FDA’s restrictions are a policy option that could quickly be changed.

Larry O. Gostin, an expert in public health law and director of the O’Neill Institute for National and Global Health Law at Georgetown University, said: “The bureaucracy in accessing Tpoxx is excessive in the context of the crisis that the United States is facing with monkeypox. .

“The law gives the agency considerable flexibility in using scientific assessments to ensure people in need receive drugs that can help them,” he added.

Department of Health and Human Services on Thursday monkeypox declaration a national health emergency. But Secretary Xavier Becerra failed to take an extra step that would allow the FDA to authorize 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 defend their decision for the treatment of tecovirimat as an investigational drug.

While acknowledging that animal data are promising and that the drug appears to be safe in healthy patients, they write that, without large clinical trials, “we would not know if tecovirimat would beneficial, harmful or ineffective in people with monkeypox.”

Kristen Nordlund, a spokeswoman for the Centers for Disease Control and Prevention, said: “At this point, it’s unclear how well this drug works for monkeypox patients.

Offering Tpoxx only as an investigational drug “ensures we have data from patients who take this drug,” she said. “This will ultimately help us understand who will benefit the most, what the real benefits are, and what potential risks there may be.”

Restrictions on tecovirimat were even more complicated at the start of the outbreak, and – after many complaints from doctors – the CDC loosen some rules. But the system is still cumbersome.

Physicians who wish to prescribe a drug must first register to become an investigator in a clinical trial, submitting a resume and informed consent forms by monkeypox patients – a process that is “expensive” laborious and virtually impossible” for most doctors, says Lynda Dee. executive director of the Baltimore AIDS Action.

“If this wasn’t such a serious emergency, it would have been a very nice official joke,” Ms Dee said. “Unfortunately, the joke is once again appearing in the gay community.”

The rules are so complicated that some patients need to instruct their doctors about the procedure.

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

A nurse practitioner he met didn’t know how to treat him, Mr. 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 didn’t help. The nurse practitioner had heard of tecovirimat, but she told him it would take hours of paperwork to get.

When Mr. Thompson said he wanted her to put on his chart that she didn’t want to prescribe him, she told him the doctor would need to decide. Finally, the doctor called him on Sunday, July 31, almost two weeks after he made his first contact.

“She was like, ‘I’ve contacted the CDC, I’ve contacted the health department. I contacted many doctors in different states, I contacted many pharmacists in different states,” he said.

Until then, it doesn’t matter. His wounds have healed, the pain has subsided and he is healing.

Stacy Lane, founder and medical director of a network of seven clinics in Pennsylvania and Ohio serving the LGBTQ community, said many of her monkeypox patients were turned away by three or four doctors. , who can’t deal with the tortuous federal rules regarding tecovirimat.

At the beginning of July, Dr. Lane saw a patient with eye damage, especially monkeypox, which can lead to blindness. She tried to buy tecovirimat, but the Pennsylvania health department required her patients to get an eye exam first.

It was a Friday afternoon, and Dr. Lane didn’t want her patients to wait in a crowded emergency room, so she tried to find an ophthalmologist instead of waiting “in a very nice way.” control in the outpatient clinic. “Next Monday.

Pennsylvania dropped the diagnostic requirement, but Ohio did not.

Dr. Lane said of tecovirimat: “This doesn’t need to be withheld the way it is being held. “It would be ideal if we could buy this Tpoxx therapy at our local pharmacies like we can buy anything else, especially as this thing continues to boom.”

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

“If a drug has been approved by the FDA, any doctor can prescribe it as a label,” said Dr. Jay Varma, director of the Cornell Centers for Pandemic Prevention and Response. FDA is not authorized to regulate drug practice.”

It was a policy choice by the CDC to avoid releasing or introducing an off-label drug.

Many patients and physicians, including Dr. Lane, have reported that tecovirimat seems to dissolve skin lesions within 24 hours. No serious side effects have been reported.

Given the known and emerging evidence about the drug’s effectiveness 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 Center for Global Health Security, said: “I understand that there is a need for more data collection and post-marketing surveillance and everything else. “But you can do it in a way that doesn’t create barriers.”