There Is an Effective Treatment for Monkeypox, but It’s Hard to Get

Many people who have been affected by the disease say they can't get an effective treatment.

More than 4,900 cases of monkeypox have been reported in the U.S., but most of them are men who have sex with men. It can be spread through close skin to skin contact. In the current outbreak, blisters can be found on the genitals and anus. Five deaths have been reported by the World Health Organization.

The US Food and Drug Administration has approved tecovirimat, also known as TPOXX, for use with monkeypox. The only U.S. supply of this drug is in the country's Strategic National Stockpile and the Centers for Disease Control and Prevention requires that health care providers submit an Investigational New Drug application in order to access it. Critics say the process for obtaining an IND for TPOXX is burdensome and that the drug should be more readily available for treating people with monkeypox.

James Krellenstein, co-founder and managing director for strategy and policy at the organization, says that the TPOXX issues are not in line with science. The primate data was approved for monkeypox. According to the CDC, you can't prescribe the drug for monkeypox because of the FDA's labeling.

The letter was written by a group of infectious disease experts to the heads of the U.S. Department of Health and Human Services. The letter was dated June 15 and was shared with Scientific American.

The CDC has made the submission of photographs and samples of lesions optional in order to clarify its procedure for obtaining TPOXX. Kevin Griffis says that the CDC posted a clarification about the process after hearing about confusion from clinicians. The post and subsequent e-mail made it clear that providers can get the medication from the CDC or their state health departments, and complete the required forms after treatment begins.

The FDA played a part in the process. The FDA and CDC worked together to make the protocol easier to use. The revised protocol is now available.

TPOXX was approved by the FDA for the treatment of smallpox, according to the letter. There was no data on TPOXX's effectiveness in humans because it would be unethical to have a trial in which people are exposed to smallpox. The drug was approved under the FDA's Animal Rule, which was based on data for monkeypox and rabbitpox. The CDC states that it is necessary to give TPOXX for monkeypox because it is only FDA approved for smallpox. This was called "illogical" by the letter.

In one solution, the CDC would withdraw its requirement for an instument to access the drug from the national inventory. The FDA would make TPOXX available for monkeypox through an emergency use authorization, a process that allows unauthorized uses of the product to diagnose, treat or prevent a disease. In order for the FDA to issue an EUA, an emergency must be declared by the Secretary of HHS. The Opioid crisis has been declared an emergency. The Secretary of HHS hasn't declared a monkeypox emergency yet.

The buck has to leave him. He needs to figure out a solution to this problem now. We can no longer do his job. Secretary Becerra needs to respond to this letter for a reason.

In a press briefing this week, Becerra told reporters that he would consider an emergency declaration for monkeypox and other public health issues on a case-by-case basis. He said that they continued to monitor the response to the disease. We are willing to work with clinicians to make all three of the tests, treatments and vaccines available, even if they are beyond what is currently needed. We will consider declaring a public health emergency when we see the response in the country.

In addition to the more than 320,000 already distributed, the government has secured 786,000 more doses of the JYNNEOS vaccine.

Bill Hall, a spokesman for the HHS, told Scientific American that there had been no declaration of a public health emergency. It will be posted here if a declaration is made in the future.

It may be too late to stop the illness from becoming endemic worldwide, as the U.S. has struggled in its response to monkeypox testing and vaccine. The government relations and policy officer at the nonprofit Partners In Health believes that the assessment is counter productive. The message to be 'It's too late' would be terrible.

The person agrees. Right now, we are at a decision point. We can either try to get things under control or we can not.