With help from Ben Leonard.
Building the plane While flying — The Biden administration is trying to figure out how well the monkeypox treatment Tpoxx works, according to Christa’s Anthony Fauci on Thursday as one of the “unanswered questions” about the ongoing pandemic the government is trying to deal with.
Background: FDA approves Tecovirmat or Tpoxx for Smallpox treatment in 2018 Based on animal studies. The drug is not approved for monkeypox, but during an unprecedented epidemic, it was found in a special allowance for people with serious diseases and those at risk of serious diseases, including children.
Until now The federal government was sent. About 38,000 courses across the country, but it’s unclear how many patients actually took the drug. The CDC has only received information about it. 2,643 Tpoxx patientsAnd this is an underestimation.
What is happening now? Last week, a clinical trial sponsored by the National Institute of Allergy and Infectious Diseases began to evaluate how Tpoxx – by the New York company SIGA Technologies – works in humans. Another trial will soon begin in the Democratic Republic of Congo, where monkeypox has been endemic for decades.
US It is intended to register an experiment. 530 people over 60 sites. In the Democratic Republic of Congo, where a more deadly monkey disease is endemic, NIAID In the Democratic Republic of Congo, the government will begin a trial involving 450 adults and children.
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Want more Pulse? Listen to the latest episode of our Pulse Check podcastAlice Miranda Olstein on the rising cases of sexually transmitted diseases and Erin Banko on POLITICO-WELT’s seven-month investigation into the response of prominent private NGOs to the global pandemic.
Sexually transmitted diseases on the rise – Previous Information from the Centers for Disease Control and Prevention Alice reported that the spike in sexually transmitted infections during the Covid-19 pandemic comes at a time when local health departments are dealing with an unprecedented outbreak of monkeypox.
CDC data from 2015 In 2021, total infections increased from 2.4 to 2.5 million, surpassing the record number of STDs reported in the US in 2020.
Syphilis rates rose 26 percent last year, the largest annual increase since the Truman administration. The rates of congenital syphilis – babies in the womb – have increased by 24 percent. In the year By 2021, more than 2,600 babies will be born with syphilis, up from 529 babies in 2000, as the country prepares to eliminate the condition.
Gonorrhea has increased by 2.8 percent – to nearly 700,000 infections by 2021. Chlamydia, which declined in 2020, increased 3 percent last year.
The FDA user fee continues the conversation — Negotiations on legislation to reauthorize the FDA’s user fee programs will stretch into the weekend, Politico’s David Lim, Lauren Gardner and Kathryn Ellen Foley report.
Senate Republicans are still pushing to attach a clean five-year reauthorization to Congress as a way to continue funding the government before the fiscal year ends on Sept. 30, but several policy drivers are still in play, four industry lobbyists told POLITICO.
Rep. Brett Guthrie (R-Ky), a member of the Energy and Commerce Health Subcommittee, said House Republicans are fighting to include the House-passed provisions in the final package.
But lawmakers are likely to address big policy drivers — including how the FDA regulates testing, dietary supplements and cosmetics — in omnibus budget negotiations at the end of the year.
FDA Schedules PULSE OXIMETER Meeting – The Food and Drug Administration convened a panel of experts yesterday, Nov. 1, to discuss pulse oximeter accuracy issues in people of color, Ben reported.
The devices have been used several times on Covid-19 patients. Studies have shown that dark-skinned people may overestimate blood oxygen levels, which may lead providers to underestimate the severity of the disease.
advocates They argued that the FDA had moved too slowly. To solve the issues that he researched years ago. Sens. Elizabeth Warren (D-Mass.) and Cory Booker (D-N.J.), among other lawmakers; They installed the agency To conduct post-market research of the devices.
Current guidelines recommend that producers study at least 10 people with “at least 2 black subjects,” a standard some have pushed the agency to expand.
The agency said it emphasized making sure the devices are “safe enough and accurate for all people.”
First at PULSE – Sens. Maggie Hassan (D-NH) and Mike Brown (R-IN) have called for better training for medical professionals in treating substance use disorders as the nation’s overdose problem continues to grow.
In a letter shared exclusively with Pulse, the House of Representatives for Graduate Medical Education asked the House to update the standards “so that physicians can acquire the skills needed to address the current crisis in training.”
“The overdose problem is perpetuated in part by a shortage of treatment providers,” they wrote. “Only one in five people with opioid use disorder receive the treatment they need. As of 2019, fewer than seven percent of physicians prescribe buprenorphine for opioid use disorder.”
Ah, 2022 could be the worst year yet. – The American Hospital Association argues that hospitals are in serious financial trouble at the end of the year, indicating a strategy to gain more support in the final races of Congress, Daniel reports.
A new report from the AHA Compared to other pandemic seasons, operating margins are shrinking this year, he said, adding that labor and supply costs have increased significantly.
Split Screen: Families USA, a health consumer advocacy group, also released a report Wednesday arguing the opposite — hospitals are overcharging and should be bought out by Congress.
‘Giant Global Collapse’ – of Lancet Commission He issued a scathing assessment of the global response to the coronavirus pandemic on Thursday, calling the pandemic’s estimated 17.2 million deaths “a grave tragedy and a major global failure on many levels.”
“Too many governments fail to adhere to basic norms of institutional rationality and transparency,” the report’s authors wrote. “Too many people – often under the influence of misinformation – have disrespected and resisted basic public health precautions, and the world’s major powers have failed to cooperate to control the epidemic.
The main findings are: Among the central findings of the report World Health Organization He acted “very cautiously and very slowly on various important matters”; That’s what he said. Coordination between governments It is not enough on policies to contain the epidemic; The spread of the disease”It was seriously hampered by massive public protests. For regular public health and social measures”.
He also warned that the report is global.Economic recovery depends on maintaining high levels of vaccine coverage on low rates of new, clinically significant covid-19 infections and monetary and fiscal policies to reduce the socioeconomic impact of the pandemic and prevent a financial crisis.
Politico’s Eugene Daniels Profiles Demeter DaskalakisSocial media is a fixation on right-wing media, the White House’s monkey disease advisor.
STAT’s Andrew Joseph reports how Medicare is not worth it. Older Americans with opioid use disorders.
Erica Solomon of the New York Times Miraculous recovery A rising Russian opera singer was shot in the lung during a rescue mission in Ukraine.