The nation's only drug to treat monkeypox is wrapped up in red tape, The New York Times reported Aug. 6.
There's enough supply of tecovirimat, or Tpoxx, to treat 1.7 million people, according to NPR, but the FDA has only approved it for smallpox, not monkeypox. On Aug. 3, the CDC altered the drug's profile by marking it as an "investigational drug," meaning physicians can prescribe Tpoxx to people infected with monkeypox, but only after enrolling in the clinical trial and a lengthy paperwork process.
Robert Pitts, MD, an infectious disease specialist at New York City-based NYU Langone Health, told NPR filling out each patient's forms for Tpoxx takes about three to four hours.
"If this wasn't such a dire emergency, it would make a very good bureaucratic joke," Lynda Dee, the executive director of AIDS Action Baltimore, told the Times. "Unfortunately, the joke is once again on the gay community."
For months, health experts and LGBTQ leaders have decried the nation's delayed response to the monkeypox outbreak, which is highly concentrated among men who have sex with men but can spread to anyone, as it is transmitted through skin-to-skin contact.
The White House declared monkeypox a national public health emergency Aug. 4, but with a meager demand for tests and not enough monkeypox vaccines to go around, the strained access to Tpoxx is another frustration for physicians, according to the Times.
Tpoxx has only been tested in animals because human testing would be unethical, hence why it's currently stuck with the "investigational drug" tag. In an article published Aug. 3 in The New England Journal of Medicine, federal officials defended the decision.
Because randomized, controlled trials aren't an option, "we will not know whether tecovirimat would benefit, harm or have no effect on people with monkeypox disease," the officials wrote. "Animal studies may be compelling, but efficacy observed in animals does not always translate directly into efficacy observed in humans in subsequent clinical trials."