The only drug available to treat monkeypox is so difficult to access that just a fraction of the nearly 7,000 patients in the United States has been given it.
Health officials have designated tecovirimat, also called Tpoxx, an “investigational drug,” which means it cannot be released from the strategic national stockpile without a series of convoluted bureaucratic steps. But most doctors do not have the time or resources to fill out the required 27-page application or to provide detailed patient information.
Experts say it doesn’t have to be this way: There is no law preventing health officials from making tecovirimat more widely available. But for now, the drug remains out of reach for most patients.
Monkeypox is a rare viral disease that is similar to smallpox. It typically causes a fever and rash and can be deadly in some cases. There is no cure for monkeypox, but tecovirimat has been shown to shorten the duration of the illness and reduce the severity of symptoms.
In 2018, there were more than 7,000 monkeypox cases in the United States, according to the Centers for Disease Control and Prevention. Just eight patients were treated with tecovirimat.
The Food and Drug Administration does not yet approve Tecovirimat, but it has been designated as an “investigational new drug” by the agency. That designation allows patients to receive the drug if they meet certain criteria, such as being enrolled in a clinical trial or being part of a compassionate use program.
But most doctors are unfamiliar with the process for accessing tecovirimat, and the FDA has not made it easy to obtain the drug.
To get tecovirimat from the strategic national stockpile, doctors must fill out a 27-page application and provide detailed patient information, including lab results and contact information for the patient’s health care team.
The FDA says it is working on streamlining the process, but for now, the bureaucracy remains a barrier for most doctors.
“The process is onerous, and it’s designed for research settings, not for clinical care,” said Dr William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.
In some cases, patients may get tecovirimat through a compassionate use program, which allows drugs to be used in life-threatening situations before the FDA approves them. But those programs are also difficult to navigate, and most patients will not be eligible for them.
For now, the best hope for monkeypox patients is that the FDA will approve tecovirimat for general use. But that could take years, and in the meantime, patients will continue to suffer.
“It’s a shame because this drug could help many people,” Schaffner said. “But right now, it’s just out of reach.”
How should the U.S. government make tecovirimat more widely available to patients? Should the FDA approve tecovirimat for general use? What are your thoughts on the current process for accessing tecovirimat? Do you think the FDA should streamline the process for accessing tecovirimat? If so, how? Let us know in the comments.
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