Roy Gulick wants to give his monkeypox patients the best possible care. But he and his doctors simply don’t have enough hours in the day to complete dozens of pages of paperwork every time they need to pry medicine out of the Strategic National Stockpile.
“It’s been a very daunting task,” said Gulick, chief of the Division of Infectious Diseases at New York Presbyterian/Weill Cornell Medicine. “There’s a ton of paperwork, there’s a ton of assessments that are required, there’s a tremendous amount that one has to do to be able to administer this drug to someone.”
Physicians’ struggles to prescribe Tpoxx, an antiviral approved to treat smallpox, which is from the same family of viruses as monkeypox, are among a slew of obstacles related to testing, treatment and vaccination that experts say is contributing to a plodding national response that they fear is not keeping up with the virus’s spread. Some worry that the window is closing to prevent the virus from becoming permanently entrenched in this country, with more than 1,400 confirmed infections across 42 states — and hundreds or thousands of additional infections suspected, predominantly in the gay and bisexual community.
“The story that the White House has told us is … frankly insulting to a community that is right now facing an out-of-control outbreak without being able to access the tools they need to protect their health,” said James Krellenstein, co-founder of PrEP4All, a public health advocacy group that has pressed the Biden administration on Tpoxx and other issues.
Nearly two months after the first case of monkeypox was identified in the United States, the pace of the nation’s response continues to echo mistakes made in the early days of the coronavirus outbreak. Physicians still encounter lengthy delays for test results, meaning some undiagnosed patients are unwittingly exposing others to the virus, after federal officials initially relied on several dozen public health laboratories and limited who was eligible to be tested. Experts and White House allies are upset with a vaccine-sharing strategy that they say hasn’t steered enough doses to hot spots such as New York City, where about one-quarter of U.S. cases have been detected but that received only one-tenth of the still-scarce doses.
“New York City is bearing the burden of monkeypox,” Mayor Eric Adams (D) wrote to President Biden on Monday, pleading for more vaccines and criticizing the administration’s “piecemeal approach” to sharing updates about its strategy — an unusually public criticism from a fellow moderate Democrat.
As with coronavirus, doctors, patients, public health experts and even some administration officials are frustrated with decisions by the Centers for Disease Control and Prevention and Food and Drug Administration, saying they have taken too conservative an approach to the rapidly widening outbreak and should have further expedited tests, vaccines and treatments. Many warn that if the United States can’t respond quickly and effectively to an established infectious disease with known treatments and vaccines, it is likely unprepared to combat a new pathogen, or another threat on the scale of coronavirus.
Biden officials publicly insist the U.S. monkeypox outbreak is being appropriately managed and that they are moving quickly to provide more tools to fight it.
“We have tests, we have vaccines, we have therapies, we’re building up our capacity on all of them, and they are going to become more and more readily available to the American people,” White House coronavirus coordinator Ashish Jha said Wednesday on CNN. “We’re going to get our arms around this thing.”
Adams’s complaints were elevated to White House Chief of Staff Ron Klain, who has held monkeypox meetings this past month, pushing officials to reassess the administration’s strategy and move more quickly, said two officials who spoke on the condition of anonymity to detail internal meetings.
CDC Director Rochelle Walensky told reporters Friday that the administration was “evolving” its vaccine strategy to “more heavily” allocate doses to the hardest-hit communities. Biden officials also announced that 131,000 additional doses of vaccine were available to be ordered for arrival as soon as Monday, which would nearly double the 156,000 doses the administration has already distributed.
Administration officials also pointed to the expanding availability of tests from major commercial laboratory companies this month, growing efforts to warn gay and bisexual men that the virus poses an elevated risk to their community. They also stressed their work to expedite treatments, saying that agencies had been responsive to physicians’ complaints about Tpoxx.
“Any provider in any medical setting can access TPOXX expeditiously for their patients,” Department of Health and Human Services spokeswoman Sarah Lovenheim wrote in a statement, adding that requests could go through state health departments or directly to CDC’s emergency operations center. “CDC does not require paperwork on the front end … [and] is working with FDA to streamline post-administration monitoring and data requirements.”
But front-line doctors said Friday they have yet to see changes on Tpoxx prescription requirements, and warned that even if some paperwork is waived on the front-end, it still has to be completed eventually.
‘People … are really suffering’
Experts say the new outbreak is a less significant threat than the coronavirus — with monkeypox yet to be linked to a confirmed U.S. death. But they warn that the virus can still cause severe pain and lead to long-lasting harms, particularly in immunocompromised individuals.
“The reality on the ground is that a lot of people with this infection are really suffering and some actually may be at risk of permanent damage and scarring,” Mary Foote, a New York City health official, said at a Thursday briefing convened by the Infectious Diseases Society of America.
The virus, which can manifest in lesions and fever, is often spread through close contact. Lesions are considered the most significant source of spread, such as skin-to-skin contact with a person with rashes or sharing bedding or clothing exposed to lesions, according to the CDC.
Biden officials Friday said they’re bracing for more infections, after experts warned that virus transmission may have accelerated inside the gay community through parties during June’s Pride month. “We anticipate we may see an increase in cases throughout the month of July and into August,” Walensky said.
Infectious-disease experts say it is only a matter of time before the virus spills further into the general population, in which pregnant people and children would face higher risks. Experts also worry it may gain a permanent foothold in the United States and other countries where monkeypox was not traditionally found.
That concern also reflects rapid global spread — more than 11,000 monkeypox cases have been confirmed worldwide, and the World Health Organization is reconvening experts next week to again consider whether to declare monkeypox a public health emergency of international concern, its highest-level warning.
As doctors race to stop the virus’s spread, they say the federal government’s red tape has further drained health providers who are already exhausted by two years of fighting the coronavirus.
“A lot of the challenges we have here are not just the federal regulatory issues, but the fact that we don’t have enough people on the ground to be able to do this work, to have the capacity to evaluate and treat all of these patients with the amount of time it takes to get access to testing and get access to treatment,” said Amanda Jezek, senior vice president of public policy and government relations at the Infectious Diseases Society of America.
The initial burden has been heaviest in New York City, with about 400 confirmed cases, and where officials say they are again being forced to lead the way against an outbreak — and they want more help from the federal government.
“We learned this lesson during the earliest days of COVID-19: transparency, honesty, and expectation-setting are critical to building and maintaining trust,” Adams wrote in a letter to Biden shared with The Washington Post.
The mayor followed up Tuesday on a call with Health and Human Services Secretary Xavier Becerra and Walensky, reiterating his demand for more doses of Jynneos, the only vaccine the FDA has approved for monkeypox, said two people who spoke on the condition of anonymity because they were not publicly authorized to discuss the conversation.
Under the formula devised by the CDC, Jynneos vaccines have been allocated to jurisdictions based on their confirmed monkeypox cases, as well as on how many HIV-positive gay men live there. CDC officials defend the strategy saying that HIV-positive gay men are at elevated risk, given their more vulnerable immune systems and that monkeypox has primarily spread among men having sex with men. But the result has skewed Jynneos distribution away from some areas with the highest concentrations of monkeypox cases, such as New York, where the city’s vaccine-scheduling website has repeatedly crashed under demand.
Meanwhile, data reporting delays between local health officials and CDC have also contributed to problems — CDC on Thursday afternoon was reporting 159 cases across New York state, even as state officials counted 414 cases — slowing federal officials’ efforts to plan vaccine allocation.
Advocates at PrEP4All and Partners in Health, a public health nonprofit, also argue the FDA has moved too slowly to inspect and ship hundreds of thousands of Jynneos doses that the United States had purchased but which have sat for months in a facility in Denmark. The inspection is finished, and FDA is “aspiring to have [the remaining authorization] process completed by the end of July,” Peter Marks, the FDA official who oversees vaccines, told The Post on Wednesday. About 780,000 doses remain in Denmark, according to HHS officials. But the FDA is allowing doses to be flown to the United States in the meantime.
Advocates note that European officials inspected and certified the facility last year, contending that U.S. officials could have deemed those inspections sufficient, akin to the strategy they used to expedite baby formula shipments. But some Biden officials stressed the importance of the FDA’s own review, pointing to contamination discovered at a Baltimore plant last year as an indicator of the potential risk.
The response has drawn growing scrutiny from Congress and watchdogs, with Sen. Richard Burr (R-N.C.), the top Republican on the Senate health committee, on Thursday faulting the administration’s “egregious failures” on testing and vaccines and demanding a copy of HHS’s “detailed strategy” to fight the virus.
Former FDA commissioner Scott Gottlieb on Friday also called on Congress to “make fundamental changes” to the federal government’s approach to pandemic-planning as a “matter of national security.”
Monkeypox was a slowly expanding crisis; we had plenty of time to prepare. The fact that CDC struggled with so many parts of response should prompt Congress to make fundamental changes to scope and nexus of pandemic planning as matter of national security. https://t.co/mUjZ2HeaOm— Scott Gottlieb, MD (@ScottGottliebMD) July 15, 2022
‘Testing is limited’
Doctors fighting the virus on the front lines have their own litany of concerns, including the continued slow turnaround of tests, which has hampered their ability to identify potential virus clusters, especially given the virus’s lengthy incubation period of as many as 21 days.
While the administration touted June 22 that thousands of commercial laboratories would soon begin to offer monkeypox testing, major facilities such as Massachusetts General Hospital are “still doing all of our testing through the state lab,” said Libby Hohmann, an infectious-disease physician at the hospital. “The testing is limited.”
Gulick, at New York Presbyterian and Weill Cornell Medicine, estimated on Tuesday that it still took “five to seven days” to receive monkeypox test results. But he added that he was optimistic that companies including LabCorp and Quest Diagnostics — which began offering monkeypox testing in the past week — will soon help expedite results.
Infectious-disease physicians and experts also have continued to call for relaxing the barriers that have limited Tpoxx prescriptions, such as collecting multiple kinds of specimens and photographs from each patient, as well as scheduling four visits. The antiviral designed to treat smallpox was tested on animals, narrowly approved by FDA and stored in the national emergency stockpile. CDC officials partly imposed their restrictions on the treatment to ensure they could study the rare cases — until this year — when Tpoxx might be needed.
“Making every physician for every patient go through hours and hours of paperwork and back and forth with the agencies, that’s just not a sustainable approach,” said Jezek of the Infectious Diseases Society. “We know that there are a lot of patients that are missing out entirely on treatment, or getting serious delays in treatment as a result.”