The problem: They cannot prescribe the medication Tecovirimat, also known as Tpoxx, without completing hours of paperwork because the FDA has classified it as an investigational new drug to treat monkeypox.
That bureaucratic hurdle is just one example of why state legislators, physicians and LGBTQ advocates say they remain deeply frustrated by what many call the federal government's "flat-footed" response to the rapidly spreading virus that has infected at least 1,310 people in California, including 501 in San Francisco.
Those frustrations took center stage Tuesday as the state Senate's Select Committee on Monkeypox held its first oversight hearing about the public-health response to the outbreak.
State Sen. Scott Wiener, a San Francisco Democrat who chairs the committee, said lawmakers will push federal officials "very hard" to speed up emergency authorization of Tecovirimat, so it can be readily used to treat monkeypox. Other senators echoed his call to allow for the drug's widespread use.
"It needs to be easier for doctors to provide Tpoxx," Wiener said. "We're so lucky that we actually have this antiviral and supply right now is not a problem, either. We have millions of these treatments. But it is way, way too hard."
Tecovirimat is FDA-approved for treatment of smallpox in adults and children. Researchers believe it's effective in treating monkeypox and other related viruses, but its use for that purpose has not been approved. The FDA, however, recently adopted a protocol that allows the drug to be used to treat monkeypox in some cases, such as with people who are immunocompromised or those with severe infections.
Dr. Vivek Jain, an infectious disease specialist at San Francisco General Hospital and UCSF, told senators that translates into an avalanche of paperwork that doctors have to spend hours filling out in order to prescribe the drug.
Jain said initial data suggests Tecovirimat is very safe to use for monkeypox treatment, and many patients who use it say their symptoms begin to resolve. Monkeypox is not a fatal virus, but he said the infection can be extremely painful for many patients — an ordeal the drug could help mitigate.
"The process of moving through this illness is quite long and can take weeks," Jain said, as he described the severe pain some infected people have when they try to swallow or have bowel movements.
For weeks, LGBTQ advocates have criticized what they've called a sluggish federal response to the virus. Many in the community are furious that federal officials didn't maintain an adequate stockpile of vaccines to prepare for an outbreak.
That anger was palpable during Tuesday's hearing, when some speakers equated the situation to the early days of the AIDS pandemic, when gay and bisexual men died by the tens of thousands as the government largely ignored the spread of the virus. State data shows that gay and bisexual men account for the vast majority of monkeypox infections to date.
Ande Stone, a mobilization manager for the San Francisco AIDS Foundation, told senators that he's outraged by the hurdles to receiving antiviral drugs. He urged them to demand the FDA cut such red tape.
"It is absolutely ridiculous that people are suffering weeks before they're able to access treatment," Stone said.
In addition to venting about hurdles to distributing antiviral drugs and vaccines, health workers and residents urged the committee to ensure there is more support to mitigate the harm caused by the virus, including better testing, protections against medical discrimination and paid sick leave for infected people.
David Watson, a San Francisco resident who recently recovered from monkeypox, said he became infected after he ran into a friend in the street. He said he kissed his friend on the cheek, not realizing the small redish and purple blemish on his cheek was a lesion, not a pimple.
Soon after, Watson became infected and so did his husband; the couple's two dogs also had lesions. Watson said he became exasperated with the constant obstacles to receiving treatment. He said he visited the emergency room three times to seek help because his pain so severe that "opioids could barely touch (it)."
"It didn't matter if I was standing up or lying down, the pain was off the charts," Watson told senators. "We need better access to all forms of treatment. We need to stop the suffering now."
Monkeypox usually causes flu-like symptoms, along with a rash and dense, fluid-filled lesions. The virus is spread by intimate personal contact, including sexual acts and kissing. It can also be spread by sharing bedding or clothes, or potentially, breathing in close proximity.
(c)2022 the San Francisco Chronicle. Distributed by Tribune Content Agency, LLC.
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