The government agency charged with helping Americans obtain treatment for monkeypox may once again be allowing red tape to stand between doctors and the treatment their patients need.
As the global monkeypox outbreak continues to grow across Europe and the United States, public health authorities have consistently been several steps behind an illness that has infected at least 5,000 Americans in the past three months.
The labyrinthine process requires physicians to submit reams of information to the Centers for Disease Control and Prevention, state or local health departments, or sometimes all three. Until recently, paperwork required clinicians and patients to fill out a half-dozen forms, as well as to schedule multiple examinations, collect and ship specimens to the CDC and to provide photos of monkeypox—a near-impossible request for patients with internal lesions.
, public health advocates say that the Department of Health and Human Services is dragging its feet on doing the same, which they say would allow doctors and health authorities to sidestep some of those hurdles. An emergency use authorization for TPOXX, physicians propose, would allow clinicians who are not members of an internal review board to prescribe TPOXX, and would eliminate requirements for informed consent prior to use and post-prescription reporting by patients and doctors.
To go the ordinary route for an emergency use authorization, said said Dr. David Freedman, a professor emeritus of infectious diseases at the University of Alabama and an expert in tropical diseases, would require TPOXX’s manufacturer to submit “reams of clinical data in real patients of efficacy in real people infected with the pathogen.”
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