Health Care — Flu season is coming, and it could be brutal

View Online    Health Care Health Care   Flu season is coming, and it could be brutal   © iStock Tennis is losing another legend this year. Switzerland's Roger Federer announced today he will be retiring, just weeks after Serena Williams played her final game.   In health care news, flu season could be especially difficult this year, the first since most COVID restrictions (notably masks) have been lifted.     Welcome to Overnight Health Care, where we're following the latest moves on policy and news affecting your health. For The Hill, we're Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter? Subscribe here. Nation warned to brace for a difficult flu season   © AP Health experts are warning the nation to brace for what could be an exceptionally severe flu season this fall and winter, as more people who have not built up immunity over the last few years mix and mingle. There are two big reasons why more people could be vulnerable to the flu this year.    The first is that with coronavirus restrictions such as the wearing of masks all but forgotten, people are more likely to come into contact with the flu virus this year than over the last two years.    The second reason is that fewer people are likely to be immune from the flu virus this year because fewer people have been getting the flu over the last two years — as the pandemic locked people down and as people worried more about getting COVID-19.  Richard Webby, a virologist at St. Jude Children's Research Hospital's infectious diseases department, said the past two flu seasons simply have not seen the same levels of exposure to the flu.    "As a population, our immunity to the flu is down a bit," Webby said. "When the virus comes back, it's probably going to have a little bit more room to spread, a little bit more room to potentially cause disease."    Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, said the flu season for the past two years has essentially been "nonexistent" and added that this trend was always bound to end once social distancing became less practiced.    According to Adalja, evidence of the flu picking back up is a sign that people are returning to "some semblance of their life pre-COVID."      Read more here.  Judge temporarily blocks Ohio six-week abortion ban © AP A judge on Wednesday temporarily paused Ohio's six-week abortion ban that went into effect after the Supreme Court overturned Roe v. Wade in June.    Hamilton County Judge Christian Jenkins issued a temporary restraining order that will stop the law's implementation for 14 days, with pro-abortion activists now asking the judge to issue a preliminary injunction that would further block the law for the duration of the case.    Jenkins granted the pause in part because he believes the plaintiffs have a substantially likely chance of winning the case under protections granted by the state's constitution.    The legislation, known as the "Heartbeat Law" and signed by Ohio Gov. Mike DeWine (R) in 2019, bans abortion after a fetal heartbeat is detected, generally at the sixth week of pregnancy. The law was blocked until the Supreme Court struck down federal abortion protections in June.    Meanwhile: In neighboring Indiana, the first abortion ban passed in the post-Roe era takes effect. The legislation includes extremely limited exceptions, but otherwise bans abortion at all stages of pregnancy.     Abortion providers who violate the law are subject to a criminal penalty of up to six years imprisonment and a fine of $10,000.    Read more here. FDA: TPOXX USE SHOULD BE RESTRICTED TO ENSURE EFFICACY   The Food and Drug Administration (FDA) is warning there is potential for the monkeypox virus to change significantly enough that the treatments currently being used to fight the outbreak could be rendered ineffective.    TPOXX, the smallpox antiviral that has been authorized to treat cases of monkeypox, works through the inhibition of the VP37 protein found in orthopoxviruses, the family of viruses that both smallpox and monkeypox belong to.    "However, as noted in the drug label, TPOXX has a low barrier to viral resistance. This means small changes to the VP37 protein could have a large impact on the antiviral activity of TPOXX," the FDA said.    Effectiveness TBD: The efficacy of TPOXX against monkeypox infections is still not known, with little to no human data available. The drug was approved to treat smallpox by the FDA based on data from animal studies and there is currently no safety or efficacy data for monkeypox treatment.    Stingy guidance: The CDC is monitoring for changes to the monkeypox virus that could make it better at evading potential protection from TPOXX. The FDA advised that "the drug be used in a judicious manner," due to the potential of monkeypox becoming resistant.    Read more here.  NEW CLINICAL TRIALS PLANNED FOR BLOOD TESTS TO DETECT CANCERS  President Biden is set to sign an order to boost biotechnology as part of promoting a "Cancer Moonshot." The cancer-focused initiative was launched in 2016 and restarted earlier this year.     On the horizon, the National Cancer Institute (NCI) is planning a large-scale clinical trial for cancer detection tests that can detect multiple types of cancer from blood samples.     If any of these types of screening tests gets approval from the Food and Drug Administration (FDA), cancer diagnosis may become much more accessible for millions of people.     Out-of-reach: There is one multi-cancer early detection test currently available in the U.S. called Galleri, which can be used to detect more than 50 types of cancer. It is not currently FDA approved, so it's not covered by insurance, costing $949 out-of-pocket. It isn't meant to be a stand-alone diagnostic but a supplement to existing cancer screenings like mammograms, low-dose CT scans or colonoscopies.     The upcoming clinical trial spearheaded by the NCI could help bring these tests to a wider number of patients. The agency is planning to enroll 24,000 healthy people ages 45 to 70 in 2024, a total of 225,000 people overall.     Read more here.  White House launches monkeypox research agenda   © The Hill, Peter Afriyie The White House on Thursday announced a round of new research commitments aimed at better understanding how to diagnose, treat and prevent monkeypox, with new clinical trials being done both in the U.S. and in countries where the virus is endemic.    During a press briefing, chief White House medical adviser Anthony Fauci acknowledged there are "a number of unanswered questions" when it comes to the monkeypox response.  There are currently no treatments approved by the Food and Drug Administration (FDA) specifically meant to treat and prevent monkeypox.   The treatments that have been utilized throughout the outbreak — mainly the Jynneos vaccine and the antiviral tecovirimat, or TPOXX — are both approved to treat and prevent smallpox infections.  Funding still unclear: Funding for the responses to the ongoing monkeypox outbreak as well as the COVID-19 pandemic has been stretched thin in recent months, as Congress has yet to approve any more money despite the White House's request for nearly $4 billion for the monkeypox response.    Fauci said the money for the current clinical trials came was pulled from several different sources.    "The money that we're using on the clinical trials is money that we've taken from our poxvirus portfolio as well as others. So we hope that we get supplemental funding to be able to do the things that I'm talking about," he said.    Read more here.  WHAT WE'RE READING Anti-abortion groups are getting more calls for help with unplanned pregnancies (NPR)  These 3 startups are trying to improve diversity in clinical trials, a challenge experts say will take more than just tech (Stat)  'I felt judged': LGBTQ+ Americans report significantly more medical discrimination (The 19th News)  STATE BY STATE "Should this decision be made by Dr. Oz?": Abortion-rights fight is taking center stage in Pennsylvania senate race (Vanity Fair)  Impending hospital closure rattles Atlanta health care landscape and political races (Kaiser Health News)  Louisiana power project stuck in abortion debate gets funded (AP)  That's it for today, thanks for reading. Check out The Hill's Health Care page for the latest news and coverage. See you tomorrow. 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