The government agency tasked with helping Americans get treatment for monkeypox may once again allow red tape to get between doctors and the treatment their patients need.
As the global monkeypox outbreak continues to grow in Europe and the United States, public health authorities have consistently been several steps behind a disease that has infected at least 5,000 Americans in the past three months. Now, with access to the country’s vaccine supply finally loosened after months of bureaucratic back-and-forth keeping hundreds of thousands of doses stuck overseas, epidemiologists, doctors, elected officials and advocates for LGBTQ communities say the red tape is still restricting their ability to actually treat the virus.
Tecovirimat, also known as TPOXX, an antiviral drug approved by the Food and Drug Administration four years ago for the treatment of smallpox, has quickly become one of the most important tools in the treatment of smallpox infections. The disease, which causes deeply painful blisters in addition to flu-like symptoms, is in the same genus as smallpox, which has led doctors to prescribe it as an off-label treatment for severe cases.
But TPOXX was only approved to treat smallpox infections under animal studies rather than human trials, which are impossible to conduct given its global extinction four decades ago. With no human testing for monkeypox, the use of TPOXX must be carried out only by doctors who serve on a hospital’s internal review board, each of whom must fill out dozens of pages of paperwork in order to secure TPOXX for their patients. With some cities seeing dozens of new cases daily, doctors are facing an increasingly unmanageable backlog of patients.
“Only certain people can give consent … that limits it to a small number of individuals,” said Dr. Timothy Brewer, a professor of epidemiology at UCLA’s Fielding School of Public Health and of Medicine. “At UCLA, we’re trying to expand the number of people who have that authority, and I’m sure other institutions are as well, but that’s clearly the limiting factor.”
The labyrinthine process requires doctors to send reams of information to the Centers for Disease Control and Prevention, state or local health departments, or sometimes all three. Until recently, the paperwork required doctors and patients to fill out a half-dozen forms, as well as schedule multiple exams, collect and send samples to the CDC, and provide photos of monkeypox—an almost impossible request for patients with lesions internal
“The requirements to prescribe this were incredibly onerous,” said Dr. Jay Varma, professor of public health and director of Cornell University’s Center for Pandemic Prevention and Response.
A week ago, the CDC changed that process, allowing doctors to order the drug from the National Strategic Stockpile of Medical Supplies and start treatment before submitting the paperwork. The number of forms and specimens required was also reduced and photographs of injuries became optional. But continued red tape enforcement by the Food and Drug Administration has slowed the changes, according to doctors, who worry that some providers may forgo prescribing TPOXX for all but the more serious, rather than spending time sifting through paperwork.
“Some doctors and hospitals may not choose to use Tecovirimat because of these requirements because patients are not dying,” said Dr. Abraar Karan, an infectious disease researcher at Stanford University. “The antiviral could reduce suffering and it can reduce the duration of viral spread, both important effects, so making it more accessible would be an important step.”
With the World Health Organization, as well as the cities of New York and San Francisco, declaring monkeypox a public health emergency, public health advocates say the Department of Health and Human Services is dragging its feet to do the same, which they say would allow doctors. and health authorities to circumvent some of these obstacles. An emergency use authorization for TPOXX, the doctors propose, would allow physicians who are not members of an internal review board to prescribe TPOXX and eliminate requirements for pre-use informed consent and post-use reporting. prescription by patients and doctors.
“It would allow doctors to use this drug without the cumbersome barrier of creating an IRB,” said Karan, who called the requirement “a fairly complicated process.”
“If a patient can gain access, TPOXX is providing relief,” said David C. Harvey, executive director of the National Coalition of STD Directors. “We understand that TPOXX is an investigational drug, but in a public health emergency, the federal government should use every option at its disposal to cut red tape and make this drug immediately available to doctors to treat their patients . It’s the right and moral thing to do.”
To follow the usual route to obtain an emergency use authorization, said Dr. David Freedman, professor emeritus of infectious diseases at the University of Alabama and an expert on tropical diseases, would require the manufacturer of TPOXX to submit “bundles of clinical data in real patients.” of effectiveness in real people infected with the pathogen.”
“The FDA has specific guidelines for a new investigational drug application in general,” Freedman said. “Those would have to be changed in terms of the paperwork required, and I doubt it’s going to be a quick process for a 50-year-old way of doing things.”
Doctors have also suggested that doses of TPOXX could be preemptively sent from the National Strategic Archive to regional stocks or local pharmacies in cities with a high number of cases in order to expedite treatment.
“If every time you need a treatment and a dose has to be released from the national stock, it will take more time and logistical hoops to jump through than if it was available from regional stockpiles or, at best, from pharmacies and local pharmacies,” Brewer said. “Anything that delays getting the medicine will affect its effect and the treatment.”
The Department of Health and Human Services’ continued resistance to declaring monkeypox a public health emergency is part of a pattern of government inaction on a disease that has almost entirely affected gay and bisexual men, the community advocates at The Daily Beast. They point to White House press secretary Karine Jean-Pierre’s apparent ignorance of TPOXX when asked about the lack of access at a press conference Wednesday, as well as the brazen response from the secretary of HHS Xavier Becerra told a reporter Thursday when asked if there was still a chance. of preventing the disease from becoming endemic in the United States, a moment some epidemiologists fear has passed.
“Once again, the FDA and its boss, HHS Secretary Xavier Becerra, appear to be living on the ground,” said Michael Donnelly, a data scientist and prominent critic of the public health response to the monkey pox “Listen: We ALREADY have a drug, TPOXX, that is very effective at limiting symptoms and shortening the duration of the disease. We ALREADY have supplies for over a million doses. The European Medicines Agency has ALREADY approved it to treat monkey pox.And yet the FDA refuses to approve it to treat people in the US for monkey pox, even though they have ALREADY approved it to treat small pox!
“Isn’t the FDA screwed up enough for a crisis?!” Donnelly disappeared.
An HHS official, asked about plans to follow the WHO in declaring monkeypox a public health emergency, or whether it was considering issuing an emergency use authorization for TPOXX, noted that a emergency use authorization for any medicine would require the declaration of a public health use. emergency
Some doctors defended the government’s most recent response to the monkeypox outbreak, noting that until recently no public health authority in the world could have expected the virus, which has historically been restricted almost entirely to children in Africa central and western, it would have become widespread. .
“I understand the frustration, but overall, I think the government, the public health agencies and the FDA have done an excellent job of trying to move things forward,” Brewer said. “These are big bureaucratic systems and it’s hard to move them, but I think given that recognition, I would actually say, wow, we’re three months into this and we’ve got drugs available that you can access, we’ve got two vaccines, potentially, we could use.”
But early mistakes in addressing the outbreak, public health experts told The Daily Beast, echo the worst days of the coronavirus pandemic.
“The nation’s use of TPOXX as a monkeypox therapy has been chaotic and bureaucratic,” said Lawrence Gostin, director of the Georgetown Law Center’s O’Neill Institute for National and Global Health Law. . “The United States is now repeating the catalog of missteps we made during COVID-19 regarding access to vaccines and therapeutics for monkeypox.”
For the United States, which was perhaps the best prepared of any nation to address a smallpox outbreak, Varma said, the mistakes should have been entirely preventable.
“In the month of May, there was a very clear window, albeit a narrow one, to mobilize everything the US government has available for monkeypox, and the US had more than any other country on Earth.” , Varma said. “It had tests, it had vaccines, it had a drug, and it had pretty good clinical epidemiology data that has been funded by the US government over the years.”
“Things have gone much better in the month of July – we really should have seen this level of action in May, not now.”