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

The government agency charged with helping Americans obtain treatment for monkeypox may once again allow red tape 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 taken several steps behind a disease that has infected at least 5,000 Americans in the past three months. Now that access to the country’s vaccine stock has finally been eased after months of bureaucratic back-and-forth held back hundreds of thousands of doses abroad, epidemiologists, doctors, elected officials and advocates of LGBTQ communities say bureaucratic red tape is still limiting their ability to actually spread the virus. to deal with.

Tecovirimat — also known as TPOXX — an antiviral drug approved by the Food and Drug Administration for the treatment of smallpox four years ago, has quickly become one of the most important tools in the treatment of monkeypox infections. The disease, which causes deeply painful blisters in addition to flu-like symptoms, is of the same sex as smallpox, prompting doctors to prescribe it as an off-label treatment for severe cases.

But TPOXX was only approved for the treatment of smallpox infections under animal studies rather than human trials, which are impossible to conduct given its global extinction four decades ago. Without human trials for monkeypox, use of TPOXX should only be performed by physicians who are part of a hospital’s internal review committee, each of whom must fill out dozens of pages of paperwork to secure TPOXX for their patients. With some cities seeing dozens of new cases every day, doctors face an increasingly unmanageable backlog of patients.

“Only certain people are allowed to give consent…that limits it to a small number of people,” said Dr. Timothy Brewer, 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 with that authority, and I’m sure other institutions have as well, but that’s clearly the limiting factor.”

The labyrinthine process requires doctors to submit piles 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, schedule multiple exams, collect and send samples to the CDC, and provide pictures of monkeypox — a nearly impossible request for patients with internal lesions.

“The requirements to prescribe this were incredibly tough,” said Dr. Jay Varma, a public health professor and director of Cornell University’s Center for Pandemic Prevention and Response.

A week ago, CDC changed that process, allowing doctors to order the drug from the National Strategic Stock of Medical Supplies and begin treatment before filing the paperwork. The number of forms was also reduced and the required samples and lesion photographs became optional. But the Food and Drug Administration’s continued enforcement of bureaucratic red tape has softened the changes, according to doctors, who fear some providers forego prescribing TPOXX for all but the most severe cases, rather than spend time on them. searching paperwork.

“Some clinicians and hospitals may not choose to use Tecovirimat because of these requirements, as patients do not die,” says Dr. Abraar Karan, an infectious disease researcher at Stanford University. “The antiviral drug could reduce suffering and decrease the duration of viral shedding, both important effects, so making it more accessible would be an important step.”

Now that the World Health Organization—as well as New York City and San Francisco—has declared monkeypox a public health emergency, public health advocates say the Department of Health and Human Services is stepping aside to do the same, which they say. would allow doctors and health authorities to get around some of those hurdles. An emergency use authorization for TPOXX, doctors suggest, would allow clinicians who are not members of an internal review committee to prescribe TPOXX, and would eliminate the requirements for pre-use informed consent and post-prescription reporting by patients and physicians .

“It would allow clinicians to use this drug without the cumbersome barrier of putting together an IRB,” Karan said, calling the requirement “a pretty complicated process.”

“If a patient can gain access, 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 a public health emergency, the federal government must use every available option to cut red tape and make this drug immediately available to clinicians to treat their patients. right and moral thing to do.”

To go the ordinary way for an emergency use authorization, said Dr. David Freedman, professor emeritus of infectious diseases at the University of Alabama and an expert in tropical diseases, would require the manufacturer of TPOXX to “submit stacks of clinical data on real patients.” of efficacy in real people infected with the pathogen.”

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

Doctors have also suggested that doses of TPOXX be shipped preventively from the National Strategic Stockpile to regional stockpiles or local pharmacies in cities with high case counts to speed up treatment.

“If you have to release every time you need a treat and the dosage has to be released from the National Supply, that takes more time and logistical hoops to jump through than if it were available from regional supplies, or, at best case, at pharmacies and local pharmacies,” said Brewer. “Anything that delays getting the drug will affect the effect and treatment.”

The Department of Health and Human Services’ continued opposition to declaring monkeypox a public health emergency is part of a pattern of government inaction against a disease that has almost completely affected gay and bisexual men. community lawyers 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 in a press conference on Wednesday, as well as HHS secretary Xavier Becerra’s lighthearted 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 moment some epidemiologists fear has already passed.

“Again, the FDA and their boss, HHS Secretary Xavier Becerra, seem to be living in la-la land,” said Michael Donnelly, a data scientist and a prominent critic of the public health response to monkeypox. “Listen: we ALREADY have a drug, TPOXX, that is very effective in limiting symptoms and shortening disease duration. We ALREADY have stocks 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 have ALREADY approved it for treating smallpox!”

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

An HHS official, who was asked about plans to potentially follow WHO in declaring monkeypox a public health emergency, or if it is considering issuing an emergency use authorization for TPOXX, noted that for an authorization for emergency use for medicines, the statement of a public health statement is required. emergency.

Some doctors defended the government’s more recent response to the monkeypox outbreak, noting that until recently, no public health agency in the world could have anticipated the virus — which has historically been almost entirely confined to children in Central and West Africa. would become so widespread.

“I understand the frustration, but overall I think the government, public health agencies and the FDA have done a great job 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’d actually say, gosh, we’ve been on it for three months and we already have drugs that you can access, we have two vaccines that we could potentially use.”

But the early missteps in handling the outbreak, public health experts told The Daily Beast, reflect the worst days of the coronavirus pandemic.

“The nation’s use of TPOXX as monkey pox therapy 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 US is now repeating the catalog of missteps we made during COVID-19 regarding access to monkeypox vaccines and therapies.”

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

“In the month of May, there was a very clear, albeit narrow, window 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 epidemiological data that has been funded by the US government over the years.”

“Things have gone much better in the month of July – we should have just seen this level of action in May, not now.”

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