As cases of monkeypox continue to rise in the United States and the rest of the world, many of those most affected by the virus say they do not have access to effective treatment.
Current an outbreak of monkey pox 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 circulate abroad, so far mostly among men who have sex with men. It spreads through close skin-to-skin contact, including during sex. The virus causes painful, blister-like lesions – in the current outbreak they are often found on the genitals and anus – and sometimes flu-like symptoms. According to the World Health Organization, at least five people died.
An antiviral drug called tecavirmat, or TPOXX, is already approved by the US Food and Drug Administration to treat smallpox and may also be used for monkeypox, a related virus. But the only U.S. supply of the drug is in the country’s Strategic National Stockpile, and the Centers for Disease Control and Prevention requires health care providers to file an investigational new drug application, or IND, to access it for their patients. Critics say the process to get an IND for TPOXX is difficult and that the drug, which was originally tested on animals with monkeypox, should be more readily available to treat the disease in humans.
“TPOXX’s issues do not make scientific sense,” says gay rights activist James Krellenstein, co-founder and managing director of strategy and policy for PrEP4All, an organization that works to expand access to HIV drugs. “TPOXX was approved based on animal data [for monkeypox],” he says. But the CDC’s position is that “you can’t prescribe [the] drug … for monkeypox because the FDA label says, “Pox only.”
Krellenstein and a group of infectious disease scientists wrote a letter to the heads of the US Department of Health and Human Services, the CDC and the FDA description of barriers to access to TPOXX for the treatment of monkey pox. The letter, which was dated June 15 and handed over to Mr Scientific Americanargued that the IND process was too burdensome for healthcare professionals, who it said had to wade through more than 100 pages of protocol to access the drug and gather extensive information about each patient taking it, including photos of lesions and other data.
The CDC later clarified this protocol for obtaining TPOXX, which allows forms to be submitted after treatment has begun and makes submission of photographs and lesion samples optional. “CDC issued a clarification on the process for obtaining TPOXX after hearing about confusion from clinicians who were experiencing problems,” says Kevin Griffis, an agency spokesman. “Message and follow-up email to clinicians [make] it is clear that providers can obtain drugs directly from CDC or through state health departments and can fill out the necessary forms after starting treatment.”
The FDA was also involved in the process. “FDA worked closely with CDC to streamline the protocol to reduce data collection and reporting requirements. The revised protocol is now available for use,” says FDA representative Chanapa Tantibanchachai.
The letter from Krellenstein and others also noted that TPOXX was approved by the FDA in 2018 for the treatment of smallpox. There was no data on the effectiveness of TPOXX in humans because it would obviously be unethical to infect humans with smallpox for testing purposes. Instead, the drug was approved under the FDA’s so-called animal rule, based on data from two related viruses — monkeypox in primates and rabbitpox in rabbits. However, despite this, the CDC still says an IND is necessary to provide TPOXX for monkeypox because it is only FDA approved for smallpox. The letter called it “illogical”.
Krellenstein and his colleagues asked for one of two solutions to make TPOXX more accessible to people with monkeypox: One would be for the CDC to withdraw the IND’s requirement for drug access from the national stockpile. Alternatively, the FDA will make TPOXX available for the treatment of monkeypox through an emergency use authorization (EUA), a process that allows unapproved medical products or unlicensed uses of those products to diagnose, treat, or prevent serious diseases. In order for the FDA to issue an EUA, the Secretary of HHS must first declare an emergency under Section 564 of the Federal Food, Drug, and Cosmetic Act. Emergency situations have been declared in connection with COVID-19 and the opioid crisis. But until now, HHS Secretary Xavier Becerra has not declared such a monkeypox emergency.
“It has to be stopped,” Krellenstein says. “He needs to get down to business now and figure out how to solve this problem. It is no longer up to us to do his work. this [letter] addressed to Minister Becerra for a reason, and Minister Becerra should do it.”
At a press briefing this week, Becerra told reporters that he would weigh whether to declare a monkeypox emergency and other public health concerns on a case-by-case basis, based on the criteria for such a declaration. “We continue to monitor the monkeypox response across the country,” he said. “We have made vaccines, tests and treatments — far more than are currently needed — available to all jurisdictions that operate their public health systems, and we are ready to work with clinicians to make all three — tests, treatments and vaccines are available. . And we will weigh any decision to declare a public health emergency based on the response we’re seeing across the country.”
At the briefing, Becerra also noted that the government has secured another 786,000 doses of the JYNNEOS monkeypox vaccine in addition to the more than 330,000 already distributed to jurisdictions across the country.
“At this time, no public health emergency has been declared,” Bill Hall, a spokesman for HHS, wrote in an email to Scientific American. “If such a statement is made in the future, it will be made public here.”
In the US too struggled in his response to monkeypox testing and vaccination, and some experts say it may already be too late to stop the disease from spreading around the world. But Garrett Wilkinson, a government affairs and policy officer at the nonprofit Partners In Health and a signatory to the Krellenstein letter, thinks that assessment is counterproductive. “I wouldn’t want the message to be ‘Too late,'” says Wilkinson.
Krellenstein agrees. “Now we are at the decision stage. There are two forks in the road where we can either try to get things under control, he says, or fail.