There is only one drug to cure monkeypox. Good luck getting it.

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

Health officials have designated tecovirimat, also called Tpoxx, an “experimental drug,” which, according to them, means it cannot be released from national strategic stocks without a series of convoluted bureaucratic steps. But most doctors don’t have the time or resources to fill out the 27-page request or to provide detailed patient information.

It doesn’t have to 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 tecovirimat as a treatment for smallpox in 2018, based on human safety data and efficacy data in primates – which, 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 on people would be unethical.

Until the current outbreak, tecovirimat was only rarely given to patients with monkeypox. As a treatment for smallpox, its use against monkeypox is considered experimental. But vaccines developed for smallpox are assumed to be effective against both diseases. Why not the treatment?

Experts say FDA restrictions are a policy option that can be changed quickly.

“The bureaucracy to gain access to Tpoxx is excessive given the crisis the US is facing with monkeypox,” said Larry O. Gostin, public health law expert and director of the O’Neill Institute for National and Global Health Law from Georgetown University.

“The law gives the agency considerable flexibility to use scientific assessments to ensure that those in need receive the 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 a further 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 their decision to treat tecovirimat as an investigational drug.

While acknowledging that the animal data were promising and that the drug appeared safe in healthy patients, they wrote that, without large clinical trials, “we will not know whether tecovirimat could benefit, harm or have no effect on people with monkeypox. “.

“At the moment, it is unclear whether or how well this drug works for monkeypox patients,” said Kristen Nordlund, a spokesperson for the Centers for Disease Control and Prevention.

Providing Tpoxx as an investigational drug only “ensures that we have data from patients using this drug,” he 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 loosened some rules. But the system remains cumbersome.

Doctors who want to prescribe the drug must first sign up to become investigators in a clinical trial by submitting resumes and informed consent forms signed by monkeypox patients, a process that is “tiring and virtually impossible” for most doctors. said Lynda Dee, the executive director of AIDS Action Baltimore.

“If this weren’t such a serious emergency, it would be a great bureaucratic joke,” said Ms. Dee. “Unfortunately, the joke is once again on the gay community.”

The rules are so complex that some patients have had to educate their doctors about the process.

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

The nurse he saw had no idea how to treat him, Mr. Thompson said. Based on a friend’s experiences, she convinced her to prescribe suppositories of hydrocortisone and gabapentin, a drug used to treat nerve pain.

They didn’t help. The professional nurse had heard of tecovirimat, but she told him it would take hours of paperwork to get it.

When Mr. Thompson said he wanted her to note in her medical record that she was unwilling to prescribe the drug, he told him that the doctor would have to decide. The doctor finally called him on Sunday, July 31, almost two weeks after he first contacted.

“He told me, ‘I contacted the CDC, I contacted the health department. I have contacted multiple doctors in different states, I have contacted multiple pharmacists in different states, ‘”she said.

At that point, it didn’t matter. Her injuries were healing, the pain had subsided and she was on the mend.

Dr Stacy Lane, founder and medical director of a network of seven clinics in Pennsylvania and Ohio serving the LGBTQ population, said many of her monkeypox patients were turned away by three or four doctors who couldn’t face the torturous rules. federal regulations relating to tecovirimat.

In early July, Dr. Lane saw a patient with eye lesions characteristic of monkeypox infection, which can lead to blindness. She tried to acquire tecovirimat, but the Pennsylvania Health Department insisted that the patient get an eye exam first.

It was a Friday afternoon and Dr. Lane did not want the patient to wait in a crowded ER, so she rushed to find an eye doctor instead of waiting for the exam to be done “in a very controlled way in a doctor’s office” the following Monday.

Pennsylvania has since dropped the requirement for a diagnosis, but Ohio has not.

“This does not need to be restrained the way it is restrained,” said Dr. Lane said of tecovirimat. “It would be ideal if we could get this Tpoxx treatment in local pharmacies just like we can get anything else, especially since this thing keeps exploding.”

Dr Lane and others said they understood that there were still doubts about the drug’s safety and efficacy in people, but noted that it had already been shown to be safe in people and had 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 the medicine,” said Dr. Jay Varma, director of the Cornell Center for Pandemic Prevention and Response.

“It is a political choice of the CDC to avoid releasing or recommending an off-label drug,” he added.

Many patients and doctors, including Dr. Lane, have reported that tecovirimat appears to dissolve skin lesions within 24 hours. No serious adverse events were reported.

Given the known and emerging evidence of the drug’s efficacy in patients and the urgency of the outbreak, experts say there is little reason to restrict access.

“I understand there needs to be a lot more data collection and post-marketing surveillance and everything in between,” 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 barriers.”