This medicine can help monkeypox. But the Food and Drug Administration makes it difficult to obtain.

The government agency tasked with helping Americans get treatment for monkeypox may once again allow it to stand among doctors and the treatment their patients need.

As monkeypox continues to spread across Europe and the United States, public health authorities have consistently been taking several steps behind the disease that has infected at least 5,000 Americans in the past three months. Now, with the country’s vaccine supplies finally accessing after months of bureaucratic redundancy that kept hundreds of thousands of doses trapped abroad, epidemiologists, doctors, elected officials and advocates for LGBTQ communities say red tape still restricts 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 to treat smallpox, is fast becoming one of the most important tools in treating monkeypox infections. The disease, which causes extremely painful blisters in addition to flu-like symptoms, is the same genus as smallpox, leading doctors to prescribe it as an unofficial treatment for severe cases.

But TPOXX is only approved to treat smallpox infection under animal studies rather than human trials, which are impossible to do, given its global extinction four decades ago. Without human trials of monkeypox, TPOXX should only be used by physicians who are part of a hospital’s internal review board, each of whom are required to fill out dozens of pages of paperwork in order to secure TPOXX to their patients. With dozens of new cases in some cities on a daily basis, doctors are faced with a growing backlog of patients that cannot be managed.

“Only certain individuals are allowed to consent … and that is limited to a small number of individuals,” 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 power, and I’m sure other institutions do as well, but that’s clearly the limiting factor.”

Operation Maze requires clinicians to submit packets of information to the Centers for Disease Control and Prevention, state or local health departments, or sometimes all three. Until recently, paperwork required doctors and patients to fill out six forms, as well as schedule multiple examinations, collect and ship samples to the Centers for Disease Control and Prevention, and submit pictures of monkeypox—a nearly impossible request for patients with internal lesions.

“The requirements to describe this were very onerous,” said Dr. Jay Varma, professor of public health and director of the Cornell University Center for Epidemic Prevention and Response.

A week ago, the Centers for Disease Control and Prevention changed that process, allowing doctors to order the drug from the National Strategic Stockpile of Medical Supplies and begin treatment before paperwork is submitted. The number of forms has also been reduced, and required samples and photos of pests are now optional. But continued enforcement of bureaucratic red tape by the Food and Drug Administration has weakened the changes, according to doctors, who are concerned that some providers may waive prescribing TPOXX for all but the most serious cases rather than spend time sifting through the papers.

“Some clinicians and hospitals may not choose to use tecovermat because of these requirements because patients don’t die,” said Dr. Abrar Karan, an infectious disease researcher at Stanford University. “Antivirals can reduce suffering and may reduce the duration of virus shedding, both of which are important effects, so making it more accessible would be an important step.”

With the World Health Organization — as well as New York City and San Francisco — declaring monkeypox a public health emergency, public health advocates say the Department of Health and Human Services is failing to do the same, which they say will allow doctors and health authorities to dodge some of those hurdles. Physicians suggest that an emergency use authorization for TPOXX would allow physicians who are not members of the Internal Review Board to prescribe TPOXX, and would eliminate requirements for informed consent prior to use and post-prescription reporting by patients and physicians.

“It would allow clinicians to use this drug without the cumbersome barrier of IRB synthesis,” said Karan, who described the requirement as a “totally involved process.”

“If a patient has access, TPOXX provides relief,” said David C. Harvey, executive director of the National Alliance of STD Managers. “We understand that TPOXX is an experimental 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 clinicians to treat their patients. It is the right and ethical thing to do.”

Going the usual route to obtaining an emergency use authorization, Dr. David Friedman, professor emeritus of infectious diseases at the University of Alabama and expert in tropical diseases, said that it would require the manufacturer of TPOXX to provide “packets of clinical data in real patients” of efficacy in real people. infected with pathogens”.

“The FDA has specific guidelines for an experimental new drug application in general,” Friedman said. “These have to be changed in terms of the documentation required, and I doubt this will be a quick process for a 50-year-old way of doing things.”

Doctors also suggested that TPOXX doses could be proactively shipped from the National Strategic Stockpile to regional stockpiles or local pharmacies in cities with high case numbers in order to expedite treatment.

“If you needed every time you needed a treatment and a dose had to be released from the national stockpile, it would take longer and logistical hoops to jump than if it were available in regional stockpiles, or, in the best case scenario, at local drugstores and pharmacies,” Breuer said. Delaying getting the drug will affect its effect and treatment.”

Community advocates told the Daily Beast that the Department of Health and Human Services’ ongoing resistance to declaring monkeypox a public health emergency is part of a pattern of government failure to address a disease that has almost entirely affected gay and bisexual men. They point to White House Press Secretary Karen Jean-Pierre apparently unaware of TPOXX when asked about the inaccessibility at a press conference on Wednesday, as well as HHS Secretary Xavier Becerra. fluctuating response to a reporter on Thursday when asked if there was still a chance of preventing the disease from becoming a pandemic in the United States, a moment that some epidemiologists fear is already over.

“Once again, the FDA and its chief, HHS Secretary Xavier Becerra, appear to be living on la-la land,” said Michael Donnelly, a data scientist and prominent critic of the public health response to monkeypox. “Listen: We already have TPOXX, which is very effective in reducing symptoms and shortening the duration of the disease. We already have a supply of over a million doses. The European Medicines Agency has already approved this for monkeypox. However, the FDA is refusing to approve the drug. Treating people in the United States for monkeypox, even though they have already agreed to do so to treat smallpox!”

“Hasn’t the FDA already failed enough for one crisis?!” Donnelly vent.

Asked about potential WHO plans to follow in declaring monkeypox a public health emergency, or whether it would consider issuing an emergency use authorization for TPOXX, a HHS official indicated that an emergency use authorization for any drug would require a 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 body in the world could have predicted that the virus – which has historically been almost entirely restricted to children in Central and West Africa – would spread on a large scale. . .

“I understand the frustration, but overall, I think the government, public health agencies and the Food and Drug Administration have done an excellent job of trying to get things moving,” Brewer said. “These are big bureaucratic systems and it’s hard to move them, but I think, given that recognition, I would say actually, we’ve spent three months on it and we already have medicines that you have access to, we have two vaccines that, perhaps, we can use.”

But public health experts told the Daily Beast that missteps early in tackling the outbreak reflected the worst days of the coronavirus pandemic.

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

For the United States, perhaps better prepared than any country to tackle an outbreak of monkeypox, Varma said, mistakes should have been avoided altogether.

“In May, there was a very clear, albeit narrow, window to mobilize everything available to the US government to fight monkeypox — and the United States had more than any other country on Earth,” Varma said. “She’s had tests and vaccines, she’s had medication, she’s had good clinical epidemiology data that has been funded by the US government over the years.”

“Things moved a lot better in July – we really should have seen that level of action in May, not now.”

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