This medicine can help Monkeypox. But the FDA makes it hard to get.

The government agency tasked with helping Americans get treatment for monkeypox may once again allow bureaucracy to come between doctors and the treatment their patients need.

As the global monkeypox epidemic 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 over the past three months. Now that access to the country’s vaccine supply has finally been loosened after months of bureaucratic back-and-forth, hundreds of thousands of doses have been blocked abroad, epidemiologists, doctors, elected officials and LGBTQ community advocates say red tape still restricts their ability to actually deal with 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 infections with monkeypox. The disease, which causes deeply painful blisters in addition to flu-like symptoms, is similar to smallpox, prompting doctors to prescribe it as an off-label treatment for severe cases.

But TPOXX has only been approved to treat smallpox infections in animal studies rather than human trials, which are impossible to conduct, given its global extinction four decades ago. . Without human trials for monkeypox, the use of TPOXX should only be performed by physicians who serve on a hospital’s internal review board, each of whom must complete dozens of pages of paperwork to make TPOXX safe for their patients. As some cities see dozens of new cases daily, doctors are dealing with an increasingly unmanageable backlog of patients.

“Only certain people are allowed to give consent…which limits it to a small number of people,” said Dr. Timothy Brewer, professor of epidemiology at UCLA’s Fielding School of Public Health and Medicine. “At UCLA, we’re trying to increase the number of people who have that authority, and I’m sure other institutions do as well, but that’s clearly the limiting factor.”

The labyrinthine process requires doctors 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 half a dozen forms, as well as schedule multiple exams, collect and send samples to the CDC, and provide pictures of monkeypox — a request almost not possible for patients with internal injuries.

“The requirements to prescribe it 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 begin treatment before submitting paperwork. The number of forms has also been reduced and required samples and photos of lesions have become optional. But the Food and Drug Administration’s continued enforcement of bureaucratic red tape has blunted the changes, doctors say, who fear some providers may forego prescribing TPOXX for all but the most severe cases rather than spend time spending sift through the paperwork.

“Some clinicians and hospitals may not choose to use Tecovimat due to these requirements given that patients do not die,” said Stanford University infectious disease researcher Dr. Abraar Karan. “The antiviral could reduce suffering and reduce the duration of viral shedding, two important effects, so making it more accessible would be an important step.”

As the World Health Organization, along with New York and San Francisco, declare 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 physicians propose, would allow clinicians who are not members of an internal review board to prescribe TPOXX, and eliminate requirements for informed consent before use and post-prescription notification by patients and doctors.

“It would allow clinicians to use this drug without the heavy barrier of building up an IRB,” said Karan, who called the requirement “a fairly complex process.”

“If a patient can access it, TPOXX provides relief,” said David C. Harvey, executive director of the National Coalition of STD Directors. “We understand that TPOXX is an investigational drug, but in the event of a public health emergency, the federal government should use all options available to it to reduce red tape and make this drug immediately available to clinicians to treat their patients. It is the right and moral thing to do.

To go down the ordinary route of an emergency use authorization, said Dr. David Freedman, a professor emeritus of infectious diseases at the University of Alabama and a tropical disease expert, would require the maker of TPOXX to submit “tons of clinical data in real patients”. efficacy in real people infected with the pathogen.

“The FDA has specific guidelines for an investigational new drug application in general,” Freedman said. “These would need to be changed in terms of the documentation required, and I doubt that’s a quick process for a 50-year-old way of doing things.”

The doctors also suggested that doses of TPOXX could be preemptively shipped from the national strategic stockpile to regional stockpiles or local pharmacies in cities with high case numbers to expedite treatment.

“If every time you need a treat and the dosage needs to be released from national stock, it will take more time and logistical hurdles to navigate than if it were available from regional stock or, at best cases, to local pharmacies and pharmacies,” Brewer said. “Anything that delays getting the drug will impact its effect and 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 in the face of a disease that has almost entirely affected gay and bisexual men, community advocates told the Daily Beast. They point to White House press secretary Karine Jean-Pierre’s apparent unfamiliarity with TPOXX when asked about the lack of access during a press briefing on Wednesday, as well as the HHS secretary. Xavier Becerra. flippant response to a reporter on Thursday when asked if there was still a chance to prevent the disease from becoming endemic in the United States, a time some epidemiologists fear has already passed.

“Again, the FDA and its boss, HHS Secretary Xavier Becerra, seem to be living in la-la land,” said Michael Donnelly, a data scientist and prominent critic of the public health response to monkeypox. “Listen: we ALREADY have a drug, TPOXX, which is very effective in 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 for the treatment of monkeypox. And yet the FDA refuses to approve it to treat people in the US for monkeypox, even though they ALREADY approved it for the treatment of smallpox! »

“Hasn’t the FDA screwed up enough for a crisis already?!” Donnelly ventilated.

An HHS official, when asked about plans to potentially follow the WHO in declaring monkeypox a public health emergency, or whether he was considering issuing an emergency use authorization for TPOXX, noted that a Emergency use authorization for any drug would require the declaration of a public health emergency.

Some doctors have defended the government’s most recent response to the monkeypox outbreak, noting that until recently no public health authority around the world could have expected the virus – which has always been almost entirely restricted to children in Central and West Africa – is also becoming widespread. .

“I understand the frustration, but in general I think the government, public health agencies, and the FDA have done a great job of trying to get things done,” Brewer said. “These are big bureaucratic systems and it’s hard to move them around, but I think given that recognition, I would actually say, damn it, we’ve been at it for three months and we already have drugs available that you can have access, we have two vaccines, potentially, we could use.

But the first missteps in the fight against the epidemic, public health experts told the Daily Beast, echo the worst days of the coronavirus pandemic.

“The nation’s use of TPOXX as a treatment for monkeypox has been chaotic and bureaucratic,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at the Georgetown Law Center. “The United States is now repeating the catalog of missteps we made during COVID-19 in terms of access to monkeypox vaccines and treatments.”

For the United States, which was perhaps the best prepared of any country to deal with an outbreak of monkeypox, Varma said, the mistakes should have been entirely preventable.

“In May, there was a very clear, albeit narrow, window to mobilize whatever the US government has available for monkeypox – and the US had more of it than any other country on Earth,” Varma said. “He had tests, he had vaccines, he had medicine and he had pretty good clinical epidemiological data that has been funded by the US government over the years.”

“Things evolved much better in July – we really should have seen this level of action in May, not now.”

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