There is only one drug to treat monkeypox. Good luck getting it.
Doctors wishing to prescribe tecovirimat, or Tpoxx, must navigate a gauntlet of bureaucratic hurdles that experts say could be quickly cleared.
The only drug available to treat monkeypox is so difficult to access that only a fraction of the nearly 7,000 patients in the United States have received it.
Health officials have designated tecovirimat, also known as Tpoxx, an "experimental drug," which they say means it cannot be released from the national strategic stock without a series of complicated bureaucratic steps. But most doctors don't have the time or resources to complete the required 27-page application or provide detailed patient information.
This n It's not mandatory. So, experts say, there is no law preventing federal authorities from changing these rules and making the drug more widely available.
The Food and Drug Administration approved tecovirimat as a treatment for smallpox in 2018, based on safety data in humans and efficacy data in primates – which, for the purposes of the trial, were actually infected with monkeypox . The so-called animal rule allows the agency to approve drugs when testing them on people would be unethical.
Until In the current epidemic, tecovirimat was rarely given to patients with monkeypox. As a treatment for smallpox, its use against monkeypox is considered experimental. But vaccines developed for smallpox were assumed to be effective against both diseases. Why not the treatment?
Experts say F.D.A. are a political choice that can be quickly changed.
"The bureaucracy to access Tpoxx is excessive given the crisis the United States is facing with monkeypox "said Larry O. Gostin, public health law expert and director of the O'Neill Institute for National and Global Health Law at Georgetown University.
"The law gives the agency considerable flexibility to use scientific assessments to ensure those in need get the drugs that can help them," he added.
>The Department of Health and Human Services declared monkeypox a national health emergency on Thursday. But Secretary Xavier Becerra failed to take an extra step that would have allowed the F.D.A. to grant emergency use authorizations for vaccines and treatments, as the agency has done during the coronavirus pandemic.
Doctors wishing to prescribe tecovirimat, or Tpoxx, must navigate a gauntlet of bureaucratic hurdles that experts say could be quickly cleared.
The only drug available to treat monkeypox is so difficult to access that only a fraction of the nearly 7,000 patients in the United States have received it.
Health officials have designated tecovirimat, also known as Tpoxx, an "experimental drug," which they say means it cannot be released from the national strategic stock without a series of complicated bureaucratic steps. But most doctors don't have the time or resources to complete the required 27-page application or provide detailed patient information.
This n It's not mandatory. So, experts say, there is no law preventing federal authorities from changing these rules and making the drug more widely available.
The Food and Drug Administration approved tecovirimat as a treatment for smallpox in 2018, based on safety data in humans and efficacy data in primates – which, for the purposes of the trial, were actually infected with monkeypox . The so-called animal rule allows the agency to approve drugs when testing them on people would be unethical.
Until In the current epidemic, tecovirimat was rarely given to patients with monkeypox. As a treatment for smallpox, its use against monkeypox is considered experimental. But vaccines developed for smallpox were assumed to be effective against both diseases. Why not the treatment?
Experts say F.D.A. are a political choice that can be quickly changed.
"The bureaucracy to access Tpoxx is excessive given the crisis the United States is facing with monkeypox "said Larry O. Gostin, public health law expert and director of the O'Neill Institute for National and Global Health Law at Georgetown University.
"The law gives the agency considerable flexibility to use scientific assessments to ensure those in need get the drugs that can help them," he added.
>The Department of Health and Human Services declared monkeypox a national health emergency on Thursday. But Secretary Xavier Becerra failed to take an extra step that would have allowed the F.D.A. to grant emergency use authorizations for vaccines and treatments, as the agency has done during the coronavirus pandemic.
What's Your Reaction?
