Does Tpoxx work? We are about to find out.- POLITICIAN

With the help of Ben Leonard.

CONSTRUCTION OF THE PLANE WHILE FLYING — The Biden administration is racing to figure out how monkeypox treatment Tpoxx works, Krista reports, one of many “unanswered questions” about the ongoing outbreak that Anthony Fauci said Thursday the government is trying to address .

Background Story: 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 grant for people with severe illness and those at high risk of serious illness, including children.

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

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

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

WELCOME TO FRIDAY PULSE — Get everything you need to know about the new HIV PrEP decision here on POLITICO’s Snapchat show. Where do you follow health news and policy on Snapchat? Send us your recommendations, along with the usual news and tips, to [email protected] i [email protected].

Want more powder? Listen to the latest episode of our Pulse Check podcast, with Alice Miranda Ollstein on the rise in STD cases and Erin Banco on POLITICO-WELT’s seven-month investigation into the global pandemic response by private nongovernmental organizations elite

ITS ON THE BOOM Preliminary data from the Centers for Disease Control and Prevention show a sharp escalation in sexually transmitted infections that worsened during the Covid-19 pandemic, as local health departments are also dealing with an outbreak of unprecedented smallpox, reports Alice.

CDC data found that total infections in 2021 surpassed the record number of STIs documented in the US in 2020, rising from 2.4 million to 2.5 million.

Syphilis rates rose 26 percent last year, the largest annual increase since the Truman administration. Rates of congenital syphilis (babies who contract the disease in the womb) increased by 24 percent. More than 2,600 babies were born with syphilis in 2021, up from 529 in 2000, when the country appeared to be on the verge of eliminating the disease.

Gonorrhea rose 2.8 percent to nearly 700,000 infections in 2021. Chlamydia, which had declined in 2020, rose 3 percent last year.

FDA USER FEES TALK CONTINUES – Negotiations on legislation to reauthorize the FDA’s user fee programs will drag on into the weekend, POLITICO’s David Lim, Lauren Gardner and Katherine Ellen Foley report.

Senate Republicans are still pushing to attach a five-year net reauthorization to the continuing resolution that Congress must pass to fund the government before the end of the fiscal year on Sept. 30, but there are still a number of ‘political applications, four of the industry. lobbyists told POLITICO.

Rep. Brett Guthrie (R-Ky.), ranking member of the Energy and Commerce Subcommittee on Health, said House Republicans are fighting to include the House-approved provisions in the final package.

But lawmakers are likely to push for bigger policies, including overhauls of how the FDA regulates diagnostics, dietary supplements and cosmetics, in negotiations around a year-end omnibus appropriations package .

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

The devices have often been used for Covid-19 patients. 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 condition.

Advocates have argued that the FDA has moved too slowly to address precisely the problems that research identified years ago. Sens. Elizabeth Warren (D-Mass.) and Cory Booker (DN.J.), among other lawmakers, have pressed the agency to conduct a further market study of the devices.

Current guidance recommends that 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 emphasized ensuring the devices are “safe and accurate enough for all people.”

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

In a letter sent today to the Accreditation Council for Graduate Medical Education, shared exclusively with Pulse, the lawmakers are asking the council to update its requirements “to ensure that physicians-in-training acquire the skills necessary to address the crisis current”.

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

THE AHA SAYS 2022 COULD BE THE WORST YEAR – The American Hospital Association argues that hospitals have serious financial problems at the end of the year, indicating a strategy to push for more support through the final sprints of Congress, reports Daniel.

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

Split screen: Families USA, a health care consumer advocacy group, also released a report Wednesday, arguing the opposite: that hospitals are overcharging and should be reined in by Congress.

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

“Many governments have failed to adhere to the basic norms of institutional rationality and transparency,” the report’s authors wrote. “Too many people, often influenced by misinformation, have disregarded and protested against basic public health precautions, and the world’s major powers have failed to cooperate in controlling the pandemic.”

The key findings: Among the central findings of the report is that World Health Organization acted “too cautiously and too slowly in several important matters”; this coordination between governments was “insufficient in policies to contain the pandemic”; that the spread of the disease was “severely hampered by substantial public opposition to routine public health and social measures”.

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

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

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

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

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