Does Tpoxx work?  We are about to find out.

Does Tpoxx work? We are about to find out.

With the help of Ben Leonard.

BUILD THE PLANE FLYING – The Biden administration is racing to figure out how well the monkeypox treatment Tpoxx is working, Krista reports, one of many “unanswered questions” about the ongoing outbreak that Anthony Fauci said Thursday the government was trying to address tackle.

Past: The FDA approved tecovirimat, or Tpoxx, for the treatment of smallpox in 2018 based on animal studies. The drug is not approved for monkeypox, but has been available during the unprecedented outbreak through a special allowance for people with severe disease and those at high risk of severe disease, including children.

So far, the federal government has shipped about 38,000 courses across the country, but it’s unclear how many patients actually took the drug. The CDC only received information on 2,643 patients with Tpoxx, and says that’s an undercount.

What happens now: Last week, a clinical trial supported by the National Institute of Allergy and Infectious Diseases began evaluating how Tpoxx – made by New York-based company SIGA Technologies – works in people. Another trial will soon begin in the Democratic Republic of Congo, where monkeypox has been circulating for decades.

The US trial aims to enroll 530 people at more than 60 sites. In the DRC, where a deadlier strain of monkeypox is endemic, NIAID will co-launch a trial with the DRC government on 450 adults and children.

WELCOME TO PULSE FRIDAY – Learn everything you need to know about the new HIV PrEP ruling here on POLITICO’s Snapchat show. Where do you follow health news and politics on Snapchat? Send us your favourites, as well as the usual info and tips, at [email protected] and [email protected].

Want more Pulse? Listen to the latest episode of our Pulse Check podcast, featuring Alice Miranda Ollstein on the rise in STD cases and Erin Banco on the seven-month POLITICO-WELT investigation into the global response to the pandemic from private non-governmental organizations. ‘elite.

STIS ON THE GROWTH Preliminary data from the Centers for Disease Control and Prevention shows a sharp escalation in sexually transmitted infections that worsened during the Covid-19 pandemic, comes as local health departments also grapple with an unprecedented monkeypox outbreak , reports Alice.

CDC data revealed that the total number of infections in 2021 broke the record number of documented STIs in the United States in 2020, rising from 2.4 million to 2.5 million.

Syphilis rates jumped 26% last year, the biggest annual increase since the Truman administration. Rates of congenital syphilis – babies who contract the disease in the womb – have soared by 24%. More than 2,600 babies were born with syphilis in 2021, up from 529 in 2000 when the country seemed on the verge of eliminating the disease.

Gonorrhea increased by 2.8%, reaching almost 700,000 infections in 2021. Chlamydia, which had decreased in 2020, increased by 3% last year.

FDA USER FEES TALKS CONTINUE — Negotiations over legislation to reauthorize the FDA’s user fee programs will stretch into the weekend, POLITICO’s David Lim, Lauren Gardner and Katherine Ellen Foley report.

Senate Republicans are still pushing to attach a new five-year authorization to the ongoing resolution Congress must pass to fund the government before the fiscal year ends Sept. 30, but a number of political factors are still in play. , four industry lobbyists told POLITICO.

Rep. Brett Guthrie (R-Ky.), a ranking member of the health, energy and commerce subcommittee, said House Republicans are fighting to include provisions passed by the House in the package. final.

But lawmakers will likely push bigger policies — including revisions to how the FDA regulates diagnostics, dietary supplements and cosmetics — in negotiations around a set of year-end omnibus credits.

FDA PLANS MEETING ON PULSE OXIMETER The Food and Drug Administration announced yesterday that it will convene a panel of experts on Nov. 1 to discuss pulse oximeter accuracy issues in people of color, Ben reports.

The devices have often been used for patients with Covid-19. Research has shown that they can overestimate blood oxygen levels in people with darker skin, which can cause providers to underestimate the severity of the disease.

Proponents have argued that the FDA moved too slowly to accurately address issues that research identified years ago. Senators Elizabeth Warren (D-Mass.) and Cory Booker (DN.J.), among other lawmakers, have urged the agency to conduct a postmarket study of the devices.

Current guidelines recommend manufacturers study at least 10 people with “at least 2 darkly pigmented subjects,” a level some have pushed the agency to expand.

The agency said it has focused on ensuring the devices are “safe and accurate enough for everyone”.

FIRST IN PULSE – Meaning. Maggie Hassan (D-NH) and Mike Braun (R-IN) are calling for better training of doctors in treating substance use disorders as the country’s overdose crisis has worsened.

In a letter sent today to the Accreditation Council for Higher Medical Education, shared exclusively with Pulse, lawmakers ask the council to update its requirements “to ensure that doctors in training acquire the skills necessary to face to the current crisis.

“The overdose crisis has persisted in part because of a shortage of treatment providers,” they wrote. “Only one in five people with an opioid use disorder receives the treatment they need. In 2019, less than seven percent of all physicians prescribe buprenorphine for an opioid use disorder.

AHA SAYS 2022 COULD BE THE WORST YEAR YET — The American Hospital Association says hospitals are in serious financial trouble heading into the end of the year, pointing to a strategy to lobby for more support through congressional final sprints, Daniel reports.

A new report from the AHA says operating margins have fallen more so far this year than during other periods of the pandemic, adding that labor and supply costs have risen significantly.

Split screen: Families USA, a health consumer advocacy group, also released a report on Wednesday, saying the opposite — that hospitals overcharge and need to be controlled by Congress.

“MASSIVE GLOBAL FAILURE” – The Lancet Commission delivered a scathing review of the global response to the coronavirus pandemic on Thursday, calling the pandemic’s estimated 17.2 million deaths a “profound tragedy and a massive global failure on many levels.”

“Too many governments have failed to meet basic standards of institutional rationality and transparency,” the report’s authors wrote. “Too many people – often swayed by misinformation – have disrespected and protested basic public health precautions, and major world powers have failed to collaborate to control the pandemic.”

The main results: One of the main conclusions of the report is that the World Health Organization acted “too cautiously and too slowly on several important issues”; this coordination between governments was “misfit on policies to contain the pandemic”; that the spread of the disease was “seriously hampered by strong public opposition routine health and social measures.

The report also warned that the world “economic recovery depends on maintaining high rates of immunization coverage and low rates of new clinically significant COVID-19 infections, and on fiscal and monetary policies to mitigate the socio-economic effects of the pandemic and prevent a financial crisis.

POLITICO’s Eugene Daniels profiles Demetre Daskalakis, the White House adviser on monkeypox whose social media has become a right-wing media fixation.

STAT’s Andrew Joseph reports on how Medicare doesn’t deserve older Americans with opioid use disorders.

The New York Times’ Erika Solomon writes about the miraculous recovery of a rising Russian opera singer who was shot in the lungs while on a rescue mission in Ukraine.

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