There are effective treatments for monkeypox, but they are difficult to obtain.

As monkeypox cases continue to grow in the United States and other countries, many of the most affected by the virus say that effective treatments are not available.

Current Outbreak of monkeypox The virus has caused more than 21,100 confirmed cases worldwide, including more than 4,900 in the United States. The virus has infected people in Central and West Africa for decades, but has recently begun to spread abroad, primarily among men who have sex with men. It spreads through close skin-to-skin contact, including during sexual intercourse. This virus causes painful blister-like lesions. In current outbreaks, these are common in the genitals and anus and sometimes cause flu-like symptoms. At least five people have died, according to the World Health Organization.

An antiviral drug called tecovirimat (TPOXX) has already been approved by the US Food and Drug Administration for the treatment of smallpox and can also be used for the related virus, monkeypox. However, the only supply of this drug in the United States is in the country’s strategic national reserves, and the Center for Disease Control and Prevention submits an application for an investigational new drug, or IND, for healthcare providers to access it for their patients. I’m asking you to. Critics say the process of getting an IND for TPOXX is cumbersome, but the drug, originally tested in monkeypox animals, should be easier to use to treat people’s illnesses.

“The TPOXX issue doesn’t make sense from a scientific point of view,” said Gay, co-founder and managing director of strategy and policy at PrEP4All, an organization working to increase access to HIV drugs. Rights activist James Clerenstein said. “TPOXX approved with animal data [for monkeypox]”He says. However, the CDC’s position is, “It cannot be prescribed. [the] The FDA label says “Smallpox only”, so it’s a drug for monkeypox. “

Clerenstein and a group of infectious disease experts wrote to the heads of the US Department of Health and Human Services, the CDC, and the FDA. Explanation of barriers to access to TPOXX For the treatment of monkeypox. Letter shared on June 15th Scientific Americanargued that the IND process was unduly burdensome for health care providers, who wrote over a 100-page protocol to collect extensive information about each patient who had access to and received the drug. Insisted that it needed to be confirmed. Lesion photographs and other data.

The CDC then revealed that. Protocol for obtaining TPOXXAllows you to submit a form after the start of treatment, and optionally submits a photo and a sample of the lesion. “The CDC posted a description of the process of getting TPOXX after hearing about the confusion from a clinician in question,” said Kebbing Riffis, a spokesman for the agency. “Posting and subsequent email to the clinician [make] Make it clear that healthcare providers can obtain medicines directly from the CDC or through the state health department and can complete the required forms after the start of treatment. “

The FDA was also involved in this process. “FDA has worked closely with the CDC to streamline the protocol and reduce data collection and reporting requirements. The revised protocol is now available,” said FDA spokesman Chanapa Tantibanchachai.

A letter by Clerenstein and colleagues also points out that TPOXX was approved by the FDA in 2018 for the treatment of smallpox. There were no data on the effectiveness of her TPOXX in humans, as it is clearly unethical to infect a person with smallpox for testing. Instead, the drug was approved under the FDA’s so-called animal rules, based on data from two related viruses (non-human primate monkeypox and rabbit rabbitpox). Nevertheless, the CDC still states that he needs IND. Providing TPOXX This is because it is FDA approved only for smallpox. The letter called this “illogical.”

Krellenstein and his colleagues sought one of two solutions to make TPOXX more accessible to people with monkeypox. Meanwhile, the FDA will make TPOXX available to monkeypox through an Emergency Use Authorization (EUA). This is a process that allows unapproved medical products or the unauthorized use of those products to diagnose, treat, or prevent serious illness. In order for the FDA to issue an EUA, the HHS Secretary must first declare an emergency under Section 564 of the Federal Food, Drug, and Cosmetic Act. A COVID-19 and opioid crisis emergency has been declared. But so far, HHS Secretary Xavier Besera has not declared such an emergency to monkeypox.

“Money must be stopped by him,” says Clerenstein. “He now has to do his job and find a way to solve this problem. It’s not up to us anymore to do his job. [letter] It has been addressed to Secretary Besera for some reason, and Secretary Besera must do this. “

At a press conference this week, Mr. Besera told reporters that he would consider individual states of emergency for monkeypox and other public health issues based on the criteria for such declarations. “We continue to monitor the national reaction to monkeypox,” he said. “We have made far more vaccines, tests and treatments available than are currently needed in all jurisdictions that control public health systems, and in collaboration with clinicians. We have made all three available: testing, treatment, and vaccines. And we will consider decisions to declare public health emergencies based on the reactions seen across the country. “

At the briefing, Besera also mentioned more than 330,000 already distributed to jurisdictions nationwide, in addition to the government securing an additional 786,000 doses of the JYNNEOS vaccine for monkeypox.

“At this time, no public health emergency has been declared,” HHS spokesman Bill Hall said in an email: Scientific American.. “If such a declaration is made at some point in the future, it will be posted. here.. “

United States too I had a hard time dealing with it For monkeypox testing and vaccination, and some experts say it may be too late to stop the disease from becoming endemic around the world. However, Garrett Wilkinson, a non-profit Partners In Health government and policy officer and signer of the letter with Krellenstein, believes the assessment is counterproductive. “I don’t want the message to be’too late’,” Wilkinson says.

Clerenstein agrees. “We are now in a decision. There are two turning points on the road, either trying to control things or not controlling them,” he says.