This medicine can help with monkey pox. But the FDA makes it harder to get.

The government agency tasked with helping Americans get treatment for monkeypox could once again allow a red tape between doctors and the treatment their patients need.

As a global outbreak of monkeypox continues to surge in Europe and the United States, public health authorities are taking several steps to combat the disease, which has infected at least 5,000 Americans in the past three months. Now, after months of red tape and being held up overseas, the nation’s vaccine supply is finally loosening up, and epidemiologists, doctors, elected officials and LGBTQ advocates say red tape still limits their practical options. virus treatment.

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

But TPOXX was only approved for the treatment of smallpox infection in animal studies rather than human trials, given its global extinction four decades ago. With no monkeypox trials in humans, TPOXX should only be used by doctors who are part of a hospital’s internal review board, each of whom must fill out dozens of pages of paperwork to ensure the safety of TPOXX for their patients. With some cities seeing so many new cases every day, doctors face 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 Field School of Public Health and Medicine. “At UCLA, we’re trying to expand the number of people who have these powers, and I’m sure other institutions are, but that’s a limiting factor.”

The labyrinthine process requires doctors to provide information to the Centers for Disease Control and Prevention, state or local health departments, or sometimes all three. Until recently, the paperwork required clinicians and patients to fill out partial forms as well as schedule multiple tests, collect and send samples to the CDC, and provide monkeypox scans — nearly impossible requests for patients with internal ulcers.

“The requirements for this appointment were incredibly difficult,” said Dr. Jay Varma, professor of public health and director of the Center for Pandemic Prevention and Response at Cornell University.

A week ago, the CDC changed that process, allowing doctors to order drugs from the National Strategic Stockpile of Medical Supplies and begin treatment before submitting the paperwork. The number of forms has also been reduced, and the required samples and photographs have become optional. However, continued red tape by the Food and Drug Administration has stymied the changes, with doctors worried that some providers may refuse to prescribe TPOXX for the most severe cases without spending time reviewing the paperwork.

“Some clinics and hospitals cannot choose to use Tecovirimat because of these requirements because patients are not dying,” said Dr. Abaar Karan, an infectious disease researcher at Stanford University. “Antivirals can reduce suffering and reduce the length of time the virus spreads, two important effects, so making it available would be an important step.”

After the World Health Organization, as well as New York and San Francisco, declared monkeypox a public health emergency, public health officials say the Department of Health and Human Services will allow doctors. and health authorities to remove these barriers. The emergency use authorization for TPOXX would allow clinicians who are not members of TPOXX’s internal review board and would establish consent requirements based on pre- and post-prescription reports from patients and physicians, according to the doctors.

“This will allow clinicians to use this drug without the hassle of setting up an IRB,” said Karan, who called the requirement “a very involved process.”

“TPOXX helps if the patient can access it,” said David S. Harvey, executive director of the National Coalition of STD Directors. “We understand that TPOXX is an investigational drug, but in this public health emergency, the federal government should take every opportunity to cut red tape and make this drug available to clinicians to treat their patients immediately. It is the right and moral thing to do.”

To go the normal route for emergency use approval, said Dr. David Friedman, professor emeritus of infectious diseases at the University of Alabama and an expert on tropical diseases, is demanding that the manufacturer of TPOXX submit “a set of clinical data in real patients of effectiveness in real people infected with the pathogen.”

“The FDA generally has specific guidelines for the use of new drugs,” Friedman said. “These would have to be changed in terms of the documentation required, and I doubt it will be a quick process for a 50-year-old approach.”

Doctors also suggested sending TPOXX doses in advance from the National Strategic Stockpile to regional warehouses or local pharmacies in cities with high numbers of patients to speed up treatment.

“If you always need to get a drug and a dose out of the National Stockpile, it takes more time and logistical hoops than it does with regional warehouses, or in the best case scenario, pharmacies and local pharmacies,” Brewer said. “Anything that delays taking the medicine will affect its effectiveness and treatment.”

The Department of Health and Human Services’ resistance to declaring monkeypox a public health emergency is part of a pattern of government inaction against a disease that affects almost entirely gay and bisexual men, community advocates told The Daily Beast. At a press briefing on Wednesday, White House press secretary Karin Jean-Pierre said she was not familiar with TPOXX, as was HHS Secretary Xavier Becerra. indifferent answer Asked by a reporter Thursday whether the United States still has a chance to prevent the disease from becoming endemic, the moment some epidemiologists fear has passed.

“Once 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 prominent public health critic of the monkeypox response. “Listen: We have a drug called TPOXX that is very effective in limiting symptoms and shortening the duration of the disease. We have stock for over a million doses. The European Medicines Agency has ALREADY approved it for the treatment of monkeypox. Yet the FDA refuses to approve it for treating people in the US with monkeypox, even though it has been approved to treat smallpox!

“Has the FDA already missed a crisis?!” Donnelly gasped.

An HHS official, when asked about WHO’s follow-up plans to declare monkeypox a public health emergency, or whether emergency use authorization for TPOXX is being considered, noted that emergency use authorization for any drug requires a public health declaration. emergency situation.

Some doctors have defended the government’s recent response to the monkeypox outbreak, noting that until recently no public health authority in the world had been able to prevent the spread of the virus, which was confined to children in Central and West Africa. .

“I understand the frustration, but overall, I think the government, the public health authorities and the FDA have done an excellent job of moving things forward,” Brewer said. “These are big bureaucratic systems and it’s hard to move them, but I think given this recognition, I would actually say, hey, we’re three months into this and we already have drugs available. Two vaccines, maybe, we can use.

However, public health experts told The Daily Beast that early lapses in handling the outbreak represent the worst days of the coronavirus pandemic.

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

For the United States, which is best prepared of any nation to handle the monkeypox epidemic, mistakes should have been avoided entirely, Varma said.

“In May, the U.S. government had a very clear, albeit narrow, window to mobilize everything it had against monkeypox — and the U.S. had more than any other country on earth,” Varma said. “It has tests, vaccines, drugs, and good epidemiologic clinical data that the U.S. government has funded for years.”

“Things improved a lot in July – we really should have seen this level of activity in May rather than now.”

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