The Centers for Disease Control and Prevention has identified more than 1,000 cases of monkeypox in the United States, but even though the federal government has ample treatments and vaccinations on hand, physicians say bureaucratic red tape is hindering their ability to respond to and contain the outbreak.
It is "nearly impossible" for physicians and clinics to get patients the monkeypox antiviral TPOXX, even though New York City has enough supply on hand, said Mary Foote, the medical director for emergency preparedness and response in the New York City Department of Health and Mental Hygiene.
She warned that the true number of monkeypox cases in the U.S. is likely much higher than 1,000 because many individuals cannot easily access testing.
"If we learn something from the COVID-19 pandemic, it's that we need to pay attention to these sorts things so they don't get worse," said Lilian Abbo, the associate chief medical officer for Infectious Diseases for the Jackson Health System in Miami. Abbo and Foote spoke to reporters Thursday about treatment concerns during a call organized by the Infectious Diseases Society of America.
The monkeypox treatment, TPOXX, is only available to patients and doctors under a special CDC status because it is usually used to treat smallpox, not monkeypox.
The expanded access status requires physicians to go through more than 100 pages of paperwork each time they prescribe it, and between the forms and administrative requirements, a patient visit to initiate this medication can take between one and three hours.
As a result, many people who need the drug are not receiving the necessary treatment — and the bureaucratic hurdles are hitting uninsured and minority communities particularly hard, Foote said.
"While we understand the need to have clinical data for new medication, everybody knows this is very important. This is an emergency situation that requires us to rapidly adapt. … As we've demonstrated during COVID, it is possible to conduct clinical trials while also extending emergency access for patients," Foote said.
The disease is spreading rapidly: New York City's case count has nearly tripled in the past week.
Roughly 20 to 25 percent of New York City monkeypox patients require TPOXX, Foote said. In Miami, about 10 to 20 percent of patients require TPOXX, Abbo said.
If a patient shows up in an emergency department with monkeypox and requires TPOXX, it is very difficult for a prescriber physician in the ER to coordinate care, Abbo said. Because of TPOXX's special status, a patient needs a prescriber physician who will take charge of the process of sending in the lengthy paperwork for requests and approvals.
"Not everyone has a primary care doctor. So even though [patients] may need the treatment, it is not easy to get it," Abbo said.
Senate Health, Education, Labor and Pensions ranking member Richard M. Burr, R-N.C., also says the administration's response is lacking.
On Wednesday, Burr sent a letter to Health and Human Services Secretary Xavier Becerra demanding clarity on the monkeypox response. He said the testing response is too slow and the absence of a long-term vaccination plan and strategy is "disturbing."
Currently, vaccines are open to certain members of the LGBTQ community who are at high risk of contracting the disease. But the vaccines only became available on a national level on June 28, after some major cities had already begun using the vaccines for the disease.
"Despite the once-in-a-century pandemic caused by a novel coronavirus, the U.S response to an existing threat is falling short, failing to develop and issue a research plan to understand the threat and its characteristics, failing to rapidly engage the private sector to develop tests for the virus and failing to make vaccines quickly available and help states effectively use them," Burr wrote.