As monkeypox cases continue to rise in the United States and around the world, many of those most affected by the virus say they don’t have access to effective treatment.
The current monkeypox outbreak 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 started circulating abroad, so far mainly 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, these are often found on the genitals and anus – and sometimes flu-like symptoms. There have been at least five deaths, according to the World Health Organization.
An antiviral drug called tecovirimat, or TPOXX, is already approved by the US Food and Drug Administration for the treatment of smallpox and can also be used with monkeypox, a related virus. But the only U.S. supply of the drug is in the nation’s strategic national stockpile, and the Centers for Disease Control and Prevention requires healthcare providers to submit an investigational new drug application, or IND, in order to access it. for their patients. Critics say the process of obtaining an IND for TPOXX is cumbersome, however, and the drug – which was originally tested in animals with monkeypox – should be more readily available to treat the disease in humans. ‘man.
“TPOXX’s problems, from a scientific perspective, don’t make sense,” says gay rights activist James Krellenstein, co-founder and managing director of strategy and policy at PrEP4All, an organization that works to increase access to anti-HIV drugs. “TPOXX has been approved on animal data [for monkeypox],” he says. But the CDC’s position is that “you can’t prescribe [the] medicine…for monkeypox because the FDA label says, “Only smallpox.”
Krellenstein and a group of infectious disease experts wrote a letter to the heads of the US Department of Health and Human Services, CDC and FDA describing barriers to accessing TPOXX for the treatment of monkeypox. The letter, dated June 15 and shared with American scientistargued that the IND process was too cumbersome for healthcare providers, who he said had to review a 100-plus-page protocol in order to gain access to the drug and collect detailed information about each patient receiving it , as well as photographs of lesions and other data.
The CDC subsequently clarified its protocol for obtaining TPOXX, allowing forms to be submitted after treatment has begun and making the submission of photographs and samples of lesions optional. “The CDC has released a clarification on the process for obtaining TPOXX after hearing about confusion from clinicians who were having difficulty,” said Kevin Griffis, spokesperson for the agency. “The mail and a subsequent email to clinicians [make] clear that providers can obtain the drug directly from the CDC or through their state health departments and can complete the required forms after treatment begins.
The FDA was also involved in the process. “The FDA has worked closely with the CDC to streamline the protocol to reduce data collection and reporting requirements. The revised protocol is now available for use,” said FDA spokesperson Chanapa Tantibanchachai.
The letter from Krellenstein and others also pointed out that TPOXX was approved by the FDA in 2018 for the treatment of smallpox. There were no data on the effectiveness of TPOXX in humans as it would obviously be unethical to infect humans with smallpox for a trial. Instead, the drug was approved under the FDA’s so-called animal rule, based on data from two related viruses – monkeypox in nonhuman primates and rabbitpox in rabbits. Yet despite this, the CDC still says an IND is needed. to provide TPOXX for monkeypox as it is only FDA approved for smallpox. The letter called it “illogical”.
Krellenstein and his colleagues called for one of two solutions to make TPOXX more readily available to people with monkeypox: In one, the CDC would remove its requirement for an IND to access the drug from the national stockpile. In the other, the FDA would make TPOXX available for monkeypox through an Emergency Use Authorization (EUA) – a process that allows unapproved medical products, or unapproved uses of such products, to diagnose, treat or prevent a serious illness. 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. Emergencies have been declared for COVID-19 and the opioid crisis. But so far, HHS Secretary Xavier Becerra has not declared such a monkeypox emergency.
“The buck stops with him,” Krellenstein says. “He has to do his job now and figure out how to fix this problem. It is no longer up to us to do his job. This [letter] is addressed to Secretary Becerra for a reason, and Secretary Becerra has to do it.
At a press briefing this week, Becerra told reporters he would individually assess an emergency declaration for monkeypox and other public health issues, based on the criteria for such a declaration. “We continue to monitor the nationwide response to monkeypox,” he said. “We have made vaccines, tests and treatments available to all jurisdictions running their public health systems, well beyond the quantities currently needed, and we are willing to work with clinicians to make the three tests , treatments and vaccines available. . And we will weigh any decision to declare a public health emergency based on the response we see across the country. »
During the briefing, Becerra also noted that the government had obtained an additional 786,000 doses of the JYNNEOS monkeypox vaccine on top of the more than 330,000 already distributed to jurisdictions across the country.
“There has been no declaration of a public health emergency at this time,” Bill Hall, an HHS spokesperson, wrote in an email to American Scientist. “If such a statement is made at any time in the future, it will be posted here.”
The United States has also struggled to respond to monkeypox testing and vaccination, and some experts say it may already be too late to prevent the disease from becoming endemic around the world. But Garrett Wilkinson, head of government relations and policy at the nonprofit Partners In Health and signatory to the letter with Krellenstein, thinks the assessment is counterproductive. “I would hate for the message to be ‘It’s too late,'” Wilkinson says.
Krellenstein agrees. “We are at a decision point right now. There are two forks in the road where we can either try to get the situation under control,” he says, “or we can’t.”