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Source: https://www.nbcnews.com/health/heal...g-desperate-patients-us-efforts-lag-rcna39444
Clinical trials could get monkeypox drug to desperate patients, but U.S. efforts lag
Patients who have been able to obtain the drug say it's helped improve their symptoms, but getting access was an extremely difficult process.
Luke Brown holds a TPOXX pill. Brown, 29, of New York City, had been suffering severe pain from monkeypox for over a week before he was able to get access to the medication.
July 22, 2022, 12:36 PM EDT
By Benjamin Ryan
On a sultry Tuesday evening in New York City, Luke Brown excitedly opened a newly delivered bottle of black-and-orange pills, popped his first dose in his mouth, and washed it down with root beer.
Having contracted monkeypox this month, the lanky, bespectacled 29-year-old project manager had been suffering from what he called “the most severe pain of my life” for over a week before he finally was able to obtain a course of antivirals — a treatment he hoped would soon clear up his lesions and alleviate his suffering.
For Brown, this was cause for celebration. But it was also a sobering moment for him to reflect on how, to gain access to this medication, he had to leverage high degrees of personal privilege, medical literacy and self-advocacy that he said he was guiltily aware most people at risk for monkeypox probably lack. Because to join the fortunate few who have obtained this prized medication, called TPOXX, he had to navigate what he characterized as the exasperatingly byzantine maze of the medical and public health system.
“Here we are in the epicenter of an outbreak primarily affecting gay men in the city,” Brown said of his hometown, New York, which as of Thursday had 778 confirmed monkeypox cases out of 2,593 nationwide. “The city that of anywhere in the world should have the most impressive and robust infrastructure to respond to the health care needs of gay men. And at every level it has fallen flat on its face.”
Like many of his fellow gay and bisexual men — a demographic that comprises the vast majority monkeypox cases in the global outbreak that has ballooned to 15,848 cases — Brown said he has grown increasingly appalled and infuriated by the nation’s response to a virus spreading so swiftly that many epidemiologists now believe will likely become endemic in the U.S. and around the world.
While the Biden administration has in recent weeks distributed nearly 200,000 doses of the Jynneos vaccine for monkeypox, U.S. prescriptions for the TPOXX antiviral have remained strictly limited.
Supply of the antiviral is not the problem; there are 1.7 million courses in the nation’s Strategic National Stockpile, according to Dennis Hruby, chief scientific officer of the U.S. pharmaceutical company SIGA, TPOXX’s manufacturer. But the drug, also known as tecovirimat, is not approved by the Food and Drug Administration to treat monkeypox as it is by regulators in the United Kingdom and the European Union; the drug is approved only for smallpox in the U.S.
This is bad news for the Americans with monkeypox who like Brown suffer from excruciating physical pain or other severe outcomes from the infection and who are desperate for treatment to speed their healing. They, and the health care providers who care for them, are up against the U.S. regulatory system.
Even as the Centers for Disease Control and Prevention continues to reduce the red tape that impedes TPOXX access, announcing new changes Friday, public health experts pointed to a complementary means of leveraging the drug’s potential power to alleviate suffering: large clinical trials of the antiviral as a monkeypox treatment.
Plans for such trials are already in advanced stages in Canada, the U.K. and the European Union, according to Hruby. The National Institutes of Health is also planning one in the Democratic Republic of the Congo. But the federal agency’s efforts to launch such research in the U.S. are only in the earliest planning stages...
Clinical trials could get monkeypox drug to desperate patients, but U.S. efforts lag
Patients who have been able to obtain the drug say it's helped improve their symptoms, but getting access was an extremely difficult process.
Luke Brown holds a TPOXX pill. Brown, 29, of New York City, had been suffering severe pain from monkeypox for over a week before he was able to get access to the medication.
July 22, 2022, 12:36 PM EDT
By Benjamin Ryan
On a sultry Tuesday evening in New York City, Luke Brown excitedly opened a newly delivered bottle of black-and-orange pills, popped his first dose in his mouth, and washed it down with root beer.
Having contracted monkeypox this month, the lanky, bespectacled 29-year-old project manager had been suffering from what he called “the most severe pain of my life” for over a week before he finally was able to obtain a course of antivirals — a treatment he hoped would soon clear up his lesions and alleviate his suffering.
For Brown, this was cause for celebration. But it was also a sobering moment for him to reflect on how, to gain access to this medication, he had to leverage high degrees of personal privilege, medical literacy and self-advocacy that he said he was guiltily aware most people at risk for monkeypox probably lack. Because to join the fortunate few who have obtained this prized medication, called TPOXX, he had to navigate what he characterized as the exasperatingly byzantine maze of the medical and public health system.
“Here we are in the epicenter of an outbreak primarily affecting gay men in the city,” Brown said of his hometown, New York, which as of Thursday had 778 confirmed monkeypox cases out of 2,593 nationwide. “The city that of anywhere in the world should have the most impressive and robust infrastructure to respond to the health care needs of gay men. And at every level it has fallen flat on its face.”
Like many of his fellow gay and bisexual men — a demographic that comprises the vast majority monkeypox cases in the global outbreak that has ballooned to 15,848 cases — Brown said he has grown increasingly appalled and infuriated by the nation’s response to a virus spreading so swiftly that many epidemiologists now believe will likely become endemic in the U.S. and around the world.
While the Biden administration has in recent weeks distributed nearly 200,000 doses of the Jynneos vaccine for monkeypox, U.S. prescriptions for the TPOXX antiviral have remained strictly limited.
Supply of the antiviral is not the problem; there are 1.7 million courses in the nation’s Strategic National Stockpile, according to Dennis Hruby, chief scientific officer of the U.S. pharmaceutical company SIGA, TPOXX’s manufacturer. But the drug, also known as tecovirimat, is not approved by the Food and Drug Administration to treat monkeypox as it is by regulators in the United Kingdom and the European Union; the drug is approved only for smallpox in the U.S.
This is bad news for the Americans with monkeypox who like Brown suffer from excruciating physical pain or other severe outcomes from the infection and who are desperate for treatment to speed their healing. They, and the health care providers who care for them, are up against the U.S. regulatory system.
Even as the Centers for Disease Control and Prevention continues to reduce the red tape that impedes TPOXX access, announcing new changes Friday, public health experts pointed to a complementary means of leveraging the drug’s potential power to alleviate suffering: large clinical trials of the antiviral as a monkeypox treatment.
Plans for such trials are already in advanced stages in Canada, the U.K. and the European Union, according to Hruby. The National Institutes of Health is also planning one in the Democratic Republic of the Congo. But the federal agency’s efforts to launch such research in the U.S. are only in the earliest planning stages...