There is only One Drug to Treat Full Tit.  Good Luck Getting It.

There is only One Drug to Treat Full Tit. Good Luck Getting It.

The only drug available to treat monkeys is so difficult to access that only a fraction of the nearly 7,000 patients in the United States have been given it.

Health officials have designated tecovirimat, also known as Tpoxx, an “investigational drug,” which they say means it cannot be released from the national strategic stockpile without a series of convoluted bureaucratic steps. But most doctors don’t have the time or resources to fill out the required 27-page application or provide the detailed patient information.

It doesn’t have to be this way, experts say: There is no law that prevents federal officials from changing those rules and making the drug more widely available.

The Food and Drug Administration approved tecovirimat as a smallpox treatment in 2018, based on safety data in humans and efficacy data in primates—which, for the purposes of the trial, were infected with smallpox. The so-called animal rule allows the agency to approve drugs when testing them in humans would be unethical.

Until the current outbreak, tecovirimat was only rarely administered to monkey patients. As a smallpox treatment, its use against monkeys is considered experimental. But vaccines developed for smallpox are believed to be effective against both diseases. Why not the treatment?

Experts say the FDA’s restrictions are a policy option that can be changed quickly.

“The bureaucracy of accessing Tpoxx is excessive given the smallpox crisis facing the US,” said Larry O. Gostin, an expert in public health law and director of the O’Neill Institute for National Health Law and World at Georgetown University.

“The law gives the agency considerable flexibility to use scientific evaluations to ensure that those in need get the medication that will help them,” he said.

The Department of Health and Human Services announced Thursday that chicken pox is a national health emergency. But Secretary Xavier Becerra did not take an additional step that would allow the FDA to grant emergency use authorizations for vaccines and treatments, as the agency did during the coronavirus pandemic.

In an article published in the New England Journal of Medicine on Wednesday, federal health officials defended their decision to treat tecovirimat as an investigational drug.

Although they acknowledged that animal data were promising and that the drug appeared safe in healthy patients, they wrote that without large clinical trials, “we will not know whether tecovirimat would benefit, harm or have no effect on people with monic disease.”

“At this time, it’s not clear how well this drug works for monkey patients,” said Kristen Nordlund, a spokeswoman for the Centers for Disease Control and Prevention.

Providing Tpoxx only as an investigational drug “ensures that we have data from patients using this drug,” she said. “This will ultimately help us understand who will benefit the most, what the real benefits and potential risks are.”

The restrictions on tecovirimat were even more complicated at the beginning of the outbreak, and – after many complaints from doctors – the CDC loosened some of the rules. But the system is still difficult.

Physicians who want to prescribe the drug must first sign up to be investigators in a clinical trial, sending résumés and informed consent forms signed by monkey patients – a process that is “labor-intensive and almost impossible” for most. of doctors, said Lynda Dee, executive director of AIDS Action Baltimore.

“If this wasn’t a dire emergency, he would make a very good bureaucrat,” Mr Dee said. “Unfortunately, the gay community is being mocked again.”

The rules are so complicated that some patients need to educate their doctors about the process.

Adam Thompson, a 38-year-old chef in Atlanta, developed headaches and body aches on July 17, and two days later had lesions on his face and right side.

The nurse practitioner who saw him had no idea how to treat him, Mr Thompson said. Based on a friend’s experience, he convinced her to prescribe hydrocortisone suppositories and gabapentin, a medication used to treat nerve pain.

They didn’t help. The nurse practitioner had heard about tecovirimat, but told him it would take hours of paperwork to get it.

When Mr Thompson said he wanted her to note in his chart that she was unwilling to prescribe the drug, she told him the doctor would have to make a decision. The doctor finally called him on Sunday, July 31, almost two weeks after first contacting him.

“She was like, ‘I’m in touch with the CDC, I’m in touch with the health department. I’m in touch with multiple doctors in different states, I’m in touch with multiple pharmacists in different states,’” he said.

By then, it didn’t matter. His wounds healed, the pain subsided and he was on the mend.

Dr. Stacy Lane, founder and medical director of a network of seven clinics in Pennsylvania and Ohio that serves the LGBTQ population, said many of his monkey patients were turned away by three or four doctors who could not deal with the federal rules. tortuous regarding. technical virimat.

In early July, Dr. Lane patients with specific eye lesions for shingles infection, which can lead to blindness. She tried to get tecovirimat, but the Pennsylvania health department insisted that the patient get an eye exam first.

It was a Friday afternoon, and Dr. Lane wanted the patient to wait in a crowded emergency room, so she scrambled to find an ophthalmologist rather than wait for the exam to be done “in a very controlled way at an outpatient office. ” the following Monday.

Pennsylvania has since dropped the requirement for a diagnosis, but Ohio has not.

“This does not need to be held back the way it is being held back,” said Dr. Lane about tecovirimat. “It would be great if we could get this Tpoxx treatment at the local pharmacies just like we can get anything else, especially when this thing keeps exploding.”

Dr. Lane and others said they realized there were still questions about the drug’s safety and effectiveness in humans, but noted that it had already been shown to be safe in humans and had been approved by the FDA.

“If a drug is already FDA approved, any doctor can prescribe it off-label because FDA is not allowed to regulate the practice of medicine,” said Dr. Jay Varma, director of the Cornell Center for Pandemic Prevention and Response.

“Releasing or recommending off-label drugs is a CDC policy choice,” he said.

Many patients and doctors, including Dr. Lane, have reported that tecovirimat appears to melt away skin lesions within 24 hours. No serious adverse events were reported.

Given the known and emerging evidence of the drug’s effectiveness in patients and the urgency of the outbreak, experts say there is little rationale for restricting access.

“I understand that there needs to be a lot more surveillance of data collection and post-marketing and everything else,” said Dr. James Lawler, director of the University of Nebraska’s Center for Global Health Security. “But you can do that in a way that doesn’t create barriers.”

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