�������ýҕ�l

The Food and Drug Administration plans to authorize updated versions of Pfizer-BioNTech’s and Moderna’s Covid boosters around Labor Day, said two people familiar with the discussions. The Biden administration is preparing to distribute the updated booster shots to teenagers and adults as part of its fall booster campaign. (Lovelace Jr., 8/24)

The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites. The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide. (Armour, 8/23)

Dr. Peter Marks, the top vaccine regulator for the Food and Drug Administration, said in an interview on Tuesday that while he could not discuss timing, his team was close to authorizing updated doses that would target the versions of the virus now circulating. Even though those formulations have not been tested in humans, he said, the agency has “extremely good” data showing that the shots are safe and will be effective. “How confident am I?” he said. “I’m extremely confident.” (LaFraniere and Weiland, 8/23)

When it comes to viral infections, past is prologue: The version of a virus to which we’re first exposed can dictate how we respond to later variants and, maybe, how well vaccines work. It’s a phenomenon known by the forbidding name of original antigenic sin, and, in the case of the coronavirus, it prompts a constellation of questions. Are our immune systems stuck still revving up defenses against a version of the virus that has vanished? Will updated booster shots that are designed to thwart variants be much better than the original vaccine? How often will we be reinfected? Is there a better way to broaden immunity? (Johnson, 8/23)

Moderna Inc. has asked U.S. regulators to authorize a new version of its Covid-19 vaccine that targets the latest coronavirus strains. Moderna said on Tuesday that it is ready to ship doses of the new shot in September if it is cleared by the Food and Drug Administration. ... Moderna’s new shot is designed to protect against the original coronavirus strain that emerged in China in late 2019, as well as the Omicron subvariants BA. 4 and BA. 5 that are currently dominant in the U.S. (Walker, 8/23)

Moderna’s vaccine is intended for adults aged 18 and older. Pfizer’s vaccine will be for adults and adolescents aged 12 and older. ... Like Pfizer, Moderna said it does not have clinical trial data for the vaccine. Instead, the request is based on data from a booster targeting an earlier version of omicron, as well as preclinical data from mice. (Weixel, 8/23)

Moderna’s application also includes data on how well the BA.4/BA.5 booster shot performed in animal studies, as studies in humans have yet to be completed. The decision to move forward without complete data from human trials is considered controversial by some scientists, who say it remains unclear whether the new Covid shots will perform any better than the existing vaccines. (Lovelace Jr., 8/23)

Pfizer Inc and BioNTech's vaccine was 73.2% effective in preventing COVID-19 among children aged 6 months through 4 years, new data from the companies showed on Tuesday, two months after the U.S. rollout of the shots began for that age group. The Pfizer-BioNTech (PFE.N), vaccine was authorized for children under 5 years of age in June, based on data that showed the vaccine generated a similar immune response as in older age groups. (8/23)

Unlike Moderna's two-shot vaccine, Pfizer's vaccine is given as three initial doses for in this age group — considered a "primary" series. ... Among children ages 6 through 23 months, the vaccine was 75.8% effective at preventing COVID-19, a median of 1.9 months after the third dose. For children ages 2 through 4 years of age, the vaccine was 71.8% effective at preventing COVID-19, a median of 2.4 months after the third dose. (Mitropoulos and Salzman, 8/23)

The three-dose regimen was compared with placebo injections during the period when omicron’s BA.2 version was spreading widely from March to June, Pfizer and partner BioNTech SE said Tuesday in a statement. There were 13 cases in a group of 794 vaccinated children and 21 cases among 351 children who received the placebo, the statement said. (Lauerman, 8/23)

Vaccinations for babies, toddlers and preschoolers opened in the U.S. in June after months of delay. Only about 6% of youngsters ages 6 months through 4 years had gotten at least one dose of a COVID-19 vaccine by mid-August, according to the American Academy of Pediatrics. (8/23)

Like adults, children who have tested positive for the coronavirus can develop long covid, with 10 percent of youths who were hospitalized with covid-19 experiencing symptoms such as fatigue, weakness, coughing, difficulty breathing and shortness of breath three months later, according to a study published in JAMA Network Open. Based on data from 1,884 children and youths who were treated for covid-19, the study found that long covid was less likely among those under 18 who did not require hospitalization but instead had been treated in an emergency room and discharged. About 5 percent of those youths had post-covid conditions three months later. (Searing, 8/23)

A study published yesterday in JAMA Pediatrics suggests that long COVID is uncommon in children and teens and that risk factors include severe SARS-CoV-2 infection, younger age, and complex underlying chronic diseases. (8/23)

Two Omicron subvariants continued to slowly spread in the United States, almost completely edging out BA.2, which became dominant in the spring, the Centers for Disease Control and Prevention (CDC) said today in its latest update. ... BA.5 now accounts for 88.9% of sequenced samples, up slightly from 88% the previous week. Also, BA.4.6, which first gained traction in the central Midwest, gained more ground and now accounts for 6.3% of sequenced samples, up from 5.3% the week before. (Schnirring, 8/23)

A warning from the Federal Trade Commission said scammers have revived their fake offer for Medicare recipients to get free COVID-19 tests. Con artists are calling people and running websites and television ads to try to convince people to give their Medicare information to get the tests. But if you give them your information, they'll bill fraudulent charges to Medicare. (Roche, 8/23)

Recent studies have just begun to produce answers. They show how the coronavirus pandemic is helping shed new light on the interplay between menstruation and other aspect’s of women’s health. “Menstruation has been so under-studied. Forever,” says Alison Edelman, a professor at Oregon Health & Science University in the department of obstetrics and gynecology. (Kary, 8/23)

Japan said Wednesday it would end a requirement for vaccinated travelers to have a coronavirus test to enter the country, a gradual step toward reviving a hard-hit tourism industry but that comes as other restrictions continue to deter visitors. (Lee and Inuma, 8/24)

The Cayman Islands will lift all coronavirus-related travel restrictions Wednesday, eliminating the requirement to obtain travel declarations and allowing unvaccinated adults to return to the Caribbean vacation destination. Effective Aug. 24, the Cayman Islands will no longer require travelers to present proof of vaccination, quarantine upon arrival or wear a mask. (Hiatt, 8/23)

Democratic efforts to reframe the midterms around the debate over abortion gathered steam, with the party winning a special election for U.S. House in an evenly divided Upstate New York district Tuesday, where their candidate made the issue a centerpiece of his campaign. And in New York and Florida, Democratic primary voters nominated established candidates for governor and Congress. ... Taken together, the results were a welcome sign for Democratic leaders seeking to rally the party base. (Itkowitz and Weigel, 8/24)

A New York special election seen as the last, best test of the electorate’s midterm leanings confirmed what Democrats hoped and Republicans feared: Predictions of a red wave may be overblown. ... Everything we know about the overturning of Roe v. Wade is that it will likely be a major motivator for Democrats in the fall. What abortion does not appear to be — given Nikki Fried’s wipeout in the Florida gubernatorial primary on Tuesday night — is singularly determinative. (Siders, Fineout and Dixon, 8/24)

A majority of registered voters (56%) say the issue of abortion will be very important in their midterm vote, up from 43% in March. Virtually all of the increase has come among Democrats: 71% of Democratic and Democratic-leaning registered voters rate abortion as very important; fewer than half (46%) said this in March. By contrast, views among Republicans and GOP leaners have shown almost no change since then (41% now, 40% then).The two parties are essentially tied on midterm voting intentions: 44% say that if the election were held today, they would vote for the Democratic candidate in their district or lean toward the Democrat, while 42% would vote for the Republican or lean Republican. (8/23)

A New York Democrat who campaigned on abortion rights and the future of U.S. democracy won a special congressional election in a swing district on Tuesday, a victory that Democrats hope could signal a fundamental shift in national voter sentiment ahead of the November midterm elections. Democrat Pat Ryan defeated Republican Marc Molinaro 51.3% to 48.7%, with 99% of the vote counted, Edison Research said, after a hard-fought contest for an open seat in New York's 19th Congressional District, which spans part of the Hudson Valley and Catskill Mountains region and is known as a bellwether. The district voted for Barack Obama in 2012, Donald Trump in 2016 and Joe Biden in 2020. (Beech and Warburton, 8/24)

The result in the closely watched race, which was considered a tossup, will keep the swing-district seat, which was formerly held by Lt. Gov. Antonio Delgado, under Democratic control. Mr. Ryan sought to highlight abortion rights as the predominant issue in his campaign and contrast his support for protecting abortion rights nationwide with the position of his Republican opponent, Marc Molinaro, who believes that the decision ought to rest with states. (Ashford, 8/24)

U.S. Rep. Charlie Crist won the Democratic nomination for governor in Florida on Tuesday, setting him up to challenge Gov. Ron DeSantis this fall in a campaign that the Republican incumbent sees as the first step toward a potential White House run. ... Crist vowed Tuesday night to make abortion rights a priority. “On Day One of my administration, I will sign an executive order protecting a woman’s right to choose,” he said. (Licon, Peoples and Farrington, 8/24)

As DeSantis’ historic $140 million re-election war chest grows by the day, national Democrats have signaled they won’t invest in Florida as heavily as in the past. The state’s growing Hispanic electorate has been shifting rightward since 2018. And, for the first time ever, there are now more registered Florida Republicans than Democrats — a key indicator of voter intensity. (Caputo, 8/23)

Rep. Matt Gaetz (R-Fla.) will face Democratic challenger Rebekah Jones, a fired Florida Health Department data scientist who rose to national prominence early in the pandemic, in the state's 1st Congressional District race in November, per AP. (Falconer, 8/24)

Rep. Markwayne Mullin has won the Republican nomination for Senate in deep-red Oklahoma, defeating former state House speaker T.W. Shannon in a runoff Tuesday. Mullin and Shannon are strong backers of Donald Trump and election deniers who have amplified the former president’s false claim that he won the 2020 election. Mullin and Shannon also favor a national ban on abortion in the aftermath of the Supreme Court striking down Roe v. Wade, which guaranteed abortion rights for nearly 50 years. Mullin favors a total ban on abortion with no exceptions. (8/24)

The Pennsylvania Senate race took a heated -- and personal -- turn on Tuesday as an aide to Dr. Mehmet Oz, the Republican nominee and former cardiothoracic surgeon who for years offered medical advice as a popular TV host, was quoted derisively blaming Democratic opponent John Fetterman for his own stroke. (McDuffie, 8/24)

Colorado state Sen. Kevin Priola was a Republican for 32 years. On Monday, he announced that he couldn’t be one any longer. So he defected to the Democrats. There is “too much at stake right now for Republicans to be in charge,” Priola wrote in a two-page letter explaining his decision, adding: “Simply put, we need Democrats in charge.” ... The change in Priola’s party registration does not affect the balance of power in Colorado’s Senate; Democrats already controlled the chamber. (Edwards, 8/23)

Republicans who control the state Legislature asked a judge Tuesday to dismiss Democratic Attorney General Josh Kaul’s lawsuit challenging Wisconsin’s 173-year-old abortion ban. Kaul filed the lawsuit in June after the U.S. Supreme Court overturned Roe vs. Wade, the landmark decision that essentially legalized abortion across the country. The ruling gave states the authority to regulate abortion on their own, putting Wisconsin’s ban back into play. The ban prohibits abortions in every instance except to save the mother’s life. (8/23)

Reproductive rights groups on Tuesday filed a federal class-action lawsuit to head off possible prosecution from Texas officials for helping Texans gain access to legal abortions in other states. (Harper, 8/23)

North Texas prosecutors are divided over how to apply a new law that criminalizes abortion, setting the stage for a patchwork of enforcement that varies by county. While Dallas County District Attorney John Creuzot vowed not to bring charges under the abortion ban, prosecutors in neighboring Denton and Tarrant Counties said they will handle the cases like any other felony. Collin County did not respond to requests for comment. (Morris, 8/23)

Gov. Eric Holcomb signed legislation on Aug. 5 that earmarks about $75 million for pregnant women and children programs in tandem with the state's new abortion restrictions,but child advocates such as Missler say it's just not enough money to solve a major need in the state. (Fradette, 8/24)

North Carolina’s most powerful state senator said Tuesday he would prefer to have approved restrictions on abortion after roughly the first three months of pregnancy. Senate leader Phil Berger, speaking before convening another round of no-vote General Assembly sessions this week, also said he would support exceptions to any prohibition following the first trimester, such as in situations of rape and incest or when the mother’s life is in danger. (Robertson, 8/23)

Across the country Black patients have an abortion rate roughly four times that of their White peers, in part due to lower use of contraception that leads to higher rates of unintended pregnancies. In the states that have moved quickly to enact restrictions, Black women make up a far larger proportion of abortion seekers than in places where abortion remains legal. (Johnson and Butler, 8/23)

JulieAnn Fitzy couldn’t ask her doctor for help. She wasn’t out yet to her family, many of whom went to the same primary care practice as she did. What if they found out? And besides, her physician wouldn’t know where to find someone who offered hormone therapy. (Luthra, 8/22)

Some teens are part of a burgeoning movement of high-schoolers nationwide who, after Roe’s fall, are stepping up to demand more comprehensive lessons on reproduction, contraception and abortion — and who, if the adults refuse, are teaching each other instead. (Natanson, 8/23)

Young people used marijuana and some hallucinogens at record levels last year, according to a new report funded by the National Institutes of Health, as recreational cannabis became legal in more states and as attitudes toward other drugs continue to shift. Nearly 43 percent of young people said they had used marijuana in the past 12 months, up from 29 percent in 2011 and nearly 34 percent in 2016, according to the Monitoring the Future study by the University of Michigan, which surveyed nearly 5,000 young adults between 19 and 30 years old. (Pietsch, 8/24)

The findings, part of the government’s annual survey of drug use among young Americans, also found that nicotine vaping and excessive alcohol consumption continued to climb in 2021 after a brief pause. Another worrying trend among young people, ages 19 to 30: mounting consumption of alcoholic beverages suffused with THC, the psychoactive ingredient in cannabis. But there were some bright spots in the survey. Cigarette smoking and opioid abuse among young adults dropped last year, a continuing trend that has heartened public health experts. (Jacobs, 8/23)

The amount of young adults who said in 2021 that they used marijuana in the past year (43%), the past month (29%) or daily (11%) were at the highest levels ever recorded. Daily use — defined in the study as 20 or more times in 30 days — was up from 8% in 2016. (Archie, 8/24)

A STAT investigation found that vape companies are regularly flouting the FDA’s orders. They’re making, stocking, and selling illicit goods. And the agency is just letting it happen. (Florko and Welle, 8/24)

As the overdose epidemic continues to hit Bristol County and Massachusetts hard, teens and children face unique dangers from drug use, especially vaping, local advocates say. “It’s really become a commonality in all of the schools,” said Marc Dunderdale, a prevention coordinator with SSTAR, a leading substance use treatment provider in the region. (Cooney, 8/22)

Nineteen Illinois counties, including five of six in the Chicago area, are suing some of the nation’s largest pharmacy chains, alleging the companies contributed to the overdose crisis by failing to monitor and restrict improper prescriptions. The lawsuit, filed last week in Cook County, adds to the growing pile of opioid litigation being pursued by state and local governments against drug manufacturers, distributors and retailers. (Keilman, 8/23)

Ohio has launched a campaign to help financial advisors and consumers deal with the ill-effects of opioid abuse. The goal is to help families detect abuse, find treatment options, and prepare financially and also to make sure financial advisors have the tools and know-how to help them access and pay for treatment. (Winokur Muir, 8/23)

Drugmaker Indivior Inc must face a lawsuit by 42 state attorneys general accusing it of using illegal tactics to shield its opioid addiction treatment Suboxone from generic competition, a federal judge has ruled. (Pierson, 8/23)

Kansas Governor Laura Kelly says announced on Tuesday, Aug. 23, that about $3.2 million in grants is available to help rural first responders fight opioid abuse. She said the grants will fund training for carrying and administering approved medication for emergency reversal of opioid overdoses. (Motter, 8/23)

Siga Technologies Inc.’s antiviral Tpoxx, which has mainly been shown to fight monkeypox in animal studies, will undergo human testing by University of Oxford researchers as countries look for ways to tackle a growing outbreak with limited vaccine supply. (Lyu, 8/23)

As countries contend with more and more monkeypox cases, UK and US officials have announced the launch of clinical trials to gauge how effective the antiviral drug tecovirimat, known as Tpoxx, is for treating the disease, and to establish how protective intradermal fractional doses of the Jynneos vaccine are against monkeypox. In addition, Brazil has confirmed 77 cases of the poxvirus in children, and Spain becomes the latest country to initiate fractional vaccine dosing. (Soucheray, 8/23)

If you've gotten vaccinated for monkeypox, you may be familiar with "the lump." Ever since the viral outbreak reached the U.S. this summer, many people have taken to social media to report side effects of the Jynneos vaccine, which can be injected intradermally (into the skin) or through the more traditional subcutaneous method (below the skin). (Ryan, 8/23)

The Houston-area child who had previously tested positive for monkeypox does not have the virus, Harris County Judge Lina Hidalgo said Tuesday at a news conference, during which she also revealed expanded vaccine eligibility. (Gill, 8/23)

Schools and child care centers generally do not need to take extra steps to curb the spread of monkeypox, the Centers for Disease Control and Prevention says. It advises that they can rely on "their everyday operational guidance" to do things like ensure handwashing and clean surfaces, which help reduce the risk of potential cases from the outbreak this fall. (Tin, 8/23)

The stoning and poisoning of wild primates in Brazil is an especially lurid example of how an inaptly named disease can have real-world implications. Just as the so-called Spanish Flu of 1918 wasn’t born on the Iberian Peninsula, the spread of monkeypox has little to do with monkeys. In fact scientists say that rodents are the most likely animal reservoir for the virus, which is a cousin of smallpox that made its first recorded leap to humans decades ago in the Democratic Republic of Congo. But in 1958, when Danish scientists first identified the virus in a colony of lab monkeys, they decided to bestow the naming honor on their captive primates. (Jacobs, 8/23)

Biden administration officials are considering further steps to avoid a steep drop in infant formula access for low-income Americans as shortages linger in pockets across the country. Administration officials in the coming days are likely to again extend federal flexibilities for low-income moms and infants to access formula through the federal WIC nutrition program, with current waivers set to expire Sept. 30, according to two people, including a Biden administration official. (Lee, 8/23)

Experts and advocates are calling on the Biden administration to do more to avoid potential confrontations between police and racial minorities if the Food and Drug Administration finalizes a ban on menthol cigarettes. (Clason, 8/23)

Retired Navy senior chief Leah Stiles caused a stir this summer when she posted a personal account of her 20-year military career on social media. She revealed that she spent much of that time desperately trying to hide an eating disorder that now requires inpatient treatment. (D'Iorio, 8/23)

CNN chief White House correspondent Kaitlan Collins asked Fauci Tuesday how much those threats of investigations played a role in his decision to end his decades-long tenure in government. “None at all, Kaitlan. Really none at all, not even a slight amount,” Fauci said. “I have nothing to hide and I could defend everything I’ve done. So that doesn’t faze me or bother me. My decisions of stepping down go back well over a year.” (Choi, 8/23)

Individuals with a higher number of chronic conditions have a higher chance of encountering financial hardship like medical debt, according to a study published in JAMA Internal Medicine. It further cements the connection between well-being and financial stability. (Reed, 8/23)

Almost 58% of patient bad debt in 2021 came from self-pay accounts after insurance, compared with about 11% in 2018, according to a recent study from professional services firm Crowe. Self-pay accounts after insurance include the deductible and amount due after the insurance payment. (Hudson, 8/23)

KHN: ‘An Arm And A Leg’: How To Negotiate For Lower Medical Bills

Negotiating medical bills is often possible. It sounds hard — and it can be — but what if we got it down to a science? Mapped out all the moves ahead of time? Jared Walker and his team at the nonprofit Dollar For are running a big experiment to see whether they can do just that.  The folks at Dollar For went superviral on TikTok in early 2021 with a 60-second recipe for crushing medical debt by accessing charity care, financial assistance that most U.S. hospitals are legally required to offer. (Weissmann, 8/24)

A secretive deal between a group of hospitals seeking to weaken seismic upgrades at medical centers and an influential union looking to increase the pay of employees collapsed on Tuesday, just days after it was made public. (Gutierrez, 8/23)

KHN: Timely Mental Health Care Is A Key Factor In Strike By Kaiser Permanente Workers 

A California law that took effect in July requires health plans to offer timely follow-up appointments for mental health and addiction patients. Whether that’s happening is a point of contention in an open-ended strike by Kaiser Permanente clinicians in Northern California who say staffing shortages saddle them with stifling workloads that make providing adequate care impossible. KP says it is making every effort to staff up but has been hampered by a labor shortage. The therapists — and the National Union of Healthcare Workers, which represents them — counter that the managed-care giant has difficulty attracting clinicians because its mental health services have a poor reputation. (Wolfson and Finn, 8/24)

The vision for the growing 684-acre Las Vegas Medical District — which comprises University Medical Center and the soon-to-be completed Kirk Kerkorian School of Medicine at UNLV — was laid out Tuesday at Las Vegas City Hall, in an event that appeared to be aimed at medical professionals and prospective developers. Gov. Steve Sisolak was among those in attendance. (Torres-Cortez, 8/23)

ChristianaCare, a Wilmington, Delaware-based not-for-profit health system, signed a letter of intent in February to purchase Springfield, Pennsylvania-based Crozer Health from Prospect Medical and revert the hospital system to not-for-profit profit status. Prospect Medical, health system based in Orange, California, acquired Crozer Health in 2016 and converted it to for-profit. (Berryman, 8/23)

Carestream Health, the century-old medical imaging company founded by photography pioneer Eastman Kodak Co., filed for bankruptcy with a lender-backed proposal to cut its debt by $470 million. (Church, 8/23)

The Steve and Cindy Rasmussen Institute for Genomic Medicine that focuses on genomics as the root cause of many childhood diseases will be among the areas to benefit from the donation. Since its inception in 2016, the institute has provided more than 59,000 clinical genomics-based tests for more than 16,000 patients with a variety of conditions. (Williams, 8/23)

Every summer, Texas prisoners and officers live and work in temperatures that regularly soar well into triple digits. More than two-thirds of the state’s 100 prisons don’t have air conditioning in most living areas, putting tens of thousands of men and women under the state’s care in increasingly dangerous conditions. Climate change is expected to bring even hotter summers. The heat has killed prisoners and cost millions of taxpayer dollars in wrongful death and civil rights lawsuits, with a recent fatal heat stroke reported in 2018. (McCullough, 8/24)

At the Algoa Correctional Center in Jefferson City, without air conditioning, the best a prisoner can hope for on intensely hot days is some ice. (Moore and Nozicka, 8/24)

High heat combined with high humidity can be a recipe for multiple heat-related health risks. A recent analysis shows that equivalent temperatures, a metric of humid heat, has been increasing since the 1950s, and could contribute to dangerous living conditions now and in the future. (Feito and Ballard, 8/23)

Georgia Gov. Brian Kemp announced Tuesday he would allot $125 million in federal COVID-19 relief money to expand school-based health centers. It’s the latest move by Kemp to spend federal money as he runs for reelection against Democrat Stacey Abrams. (Amy, 8/23)

A Nebraska lawmaker from Omaha is promising to introduce a bill to legalize medical marijuana in the state after similar measures failed to collect enough valid signatures to appear on the November ballot. Sen. Jen Day said in a news release Tuesday that she will introduce legislation in the upcoming legislative session slated to begin Jan. 4. (8/23)

Wastewater treatment plants may have to start testing for presence of PFAS “forever chemicals” in biosolids as early as next year, and those plants may be required to investigate upstream sources of the toxic substances, Colorado regulators say. (Booth, 8/23)

The director of South Carolina’s Department of Mental Health is giving up the post he’s held for two years, officials said. Dr. Kenneth Rogers, a psychiatrist hired to run the agency in April 2020, announced last Thursday at an executive session of a meeting of the Mental health Commission that he would be leaving the department effective Nov. 1, The State reported. (8/23)

University of Michigan researchers are studying how well people with autism spectrum disorder can detect road hazards, and plan to assist the young motorists in sharpening their driving skills. The upcoming effort will be the second phase of a project funded by Ford Motor Co. that teams the Ann Arbor university with a local driving school. (Householder, 8/23)

What would it mean for a health care program to actually pay for the things that help people be healthy, instead of just paying for care once they get sick? That’s what North Carolina’s Medicaid office started trying this past March when the program launched a first-of-its-kind program: the Healthy Opportunities Pilot, or HOP for short. (Donnelly-DeRoven, 8/24)

KHN: A Needle Exchange Project Modeled On Urban Efforts Aims To Save Lives In Rural Nevada

Richard Cusolito believes he’s saving lives by distributing clean syringes and needles to people who use drugs in this rural area of northeastern Nevada — but he knows some residents disagree. “I’m hated in this town because of it,” said Cusolito, 60. “I’m accused of ‘enabling the junkies,’ pretty much is the standard term. People don’t get the impact of this whole thing.” (Orozco Rodriguez, 8/24)

AstraZeneca ay not stay in the vaccine business in the long run, its CEO told Reuters on Tuesday, showing how quickly fortunes have changed for the drugmaker that produced one of the first COVID-19 shots but has since lost out to rivals. Production delays, probes by regulators following rare cases of severe side effects, and concerns about its relatively short shelf life compared with other shots have stymied adoption of the company's COVID-19 vaccine. (Donnellan and Grover, 8/23)

AstraZeneca's Chief Executive Pascal Soriot warned on Tuesday new U.S. legislation capping drug prices would reduce the ability of companies to recoup their investment on developing new drugs and hurt innovation. In a Reuters Newsmaker interview, he said the British drugmaker's top-selling cancer therapy Tagrisso as well as its potential blockbuster Enhertu would likely be negatively affected by the new law in the coming years. (Donnellan and Grover, 8/23)

The U.S. Preventative Services Task Force reaffirmed guidance that doctors prescribe statins to prevent cardiovascular events like heart attacks and stroke. (Dreher, 8/23)

The United States is far from alone in experiencing shortages of essential drugs. In fact, countries around the world have seen a spate of recent medicine shortages to treat conditions such as HIV and diabetes, which clinicians say could threaten patient health. (Van Beusekom, 8/18)

After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. However, the U.S. subsidiary, Morton Grove Pharmaceuticals, recently decided to discontinue operations at the site, according to court documents. (Silverman, 8/22)

In developments regarding vaccine against mosquito-borne diseases, UNICEF this week announced a contract with GSK worth up to $170 million to produce malaria vaccine, and Valneva announced that it has started the rolling submission process for its candidate vaccine that targets chikungunya. (8/19)

The US Drug Enforcement Agency had planned a public hearing for Monday on its bid to categorize five hallucinogenic compounds as Schedule 1 drugs — an imprimatur reserved for substances with a high potential for abuse and no recognized medical use, such as LSD and heroin. Instead, it withdrew its bid to do so late last month, sending the substances back to the Department of Health and Human Services for review. (Kary, 8/22)

The World Health Organization (WHO) today issued its first guideline for Ebola therapeutics, which has a strong recommendation for using two monoclonal antibodies, mAb114 (Ebanga) and REGN-EB3 (Inmazeb). In a statement, the WHO said clinical trials on the two drugs were conducted during outbreaks in the Democratic Republic of the Congo. It said the medication guidance complements earlier clinical advice on supportive care, which consists of fluid replacement and symptom treatment, and is known to significantly improve survival. (8/19)

Akili Interactive, a Boston startup that made the first prescription video game treatment authorized by the Food and Drug Administration, is going public after merging with a special purpose acquisition company, or SPAC, raising less money than initially anticipated. (Cross, 8/19)

The pharma industry spent just 1% more on all product ads for the first half of this year compared to the same period in 2021, while prescription drug ad spending actually fell. That’s according to new figures out by the Standard Media Index, which found that for the first six months of 2022, the pharma industry spent $5.5 billion on all ads for its products, most of which was on its drug products.  (Adams, 8/22)

Amid pandemic-fueled delays to the FDA’s manufacturing inspection work, staffing issues have emerged as another sticking point for the regulator. While the agency seems to have made good progress on hiring in the past 12 months—even picking up a few lessons courtesy of COVID-19—there’s still much work to be done, especially when it comes to agents overseas. (Kansteiner, 8/22)

A year ago, I introduced the term pharmacoequity in a First Opinion essay for STAT, and later explored it with two colleagues in the Journal of the American Medical Association. This term describes the goal of ensuring that every individual, regardless of race, ethnicity, and socioeconomic status, has access to the highest quality medications needed to manage their health care needs. (Utibe R. Essien, 8/19)

In June, the Federal Trade Commission (FTC) announced they will be launching an inquiry into the practices of the “prescription drug middleman” industry. These middlemen, known as Pharmacy Benefit Managers (PBMs), determine if an insurer will pay for a prescription that is prescribed for a patient. Caremark, ExpressScripts and Optum are some of the familiar gatekeepers and suppliers of medications. (Dinah Miller, 8/24)

Giving billions of dollars in government prize money to drug companies might sound like an idea from the pharmaceutical industry. In fact, it was a sweeping 2013 proposal from Sen. Bernie Sanders (I-Vt.) using “innovation prizes” to put the cures of tomorrow and affordability of drugs today on equal footing. (Caleb Watney and Heidi Williams, 8/22)

As a scholar who has published extensively on the politics of health policy, I’m skeptical that giving Medicare the ability to negotiate prices on a handful of drugs will be as transformative as the law’s backers hope. While a good step, it is unlikely to make a significant difference in how much seniors pay overall for medicine. (Simon F. Haeder, 8/21)

Before the Supreme Court overturned Roe v. Wade this summer, polls historically showed that Latinos in the United States were generally opposed to abortion. That opposition might be waning, if findings from a recent comprehensive poll of Latino voters are any indication. In a UnidosUS/Mi Familia Vota survey of 2,750 eligible Latino voters released Aug. 10, 76% of respondents agreed with the following statement: “No matter what my personal beliefs about abortion are, I think it is wrong to make abortion illegal and take that choice away from everyone else.” (Julio Ricardo Varela, 8/23)

Although cigarette smoking has steadily declined over the past several decades, thanks to a more educated and health-conscious society, new and existing combustible and noncombustible tobacco products continue to pose public health challenges. (Michael B. Farber and Anand Shah, 8/24)

The Tennessee General Assembly continues to make our state an unhealthy place to live and a difficult place to practice medicine. The latest legislative attack on the health care community, made possible by the Supreme Court’s abandonment of stare decisis with the recent Dobbs decision, will affect the primary care of Tennesseans –even those who are not women seeking reproductive freedom. (Amy Gordon Bono, 8/23)

The U.S. Dept. of Health and Human Services (DHHS) initiative to Strengthen Primary Health Care, launched in September 2021, aims to establish a federal foundation that supports advancement toward a goal state of the practice of primary health care. (Howard A. Selinger M.D., 8/24)

The devastation caused by malnutrition, HIV, tuberculosis, and malaria in low income countries is well known in the U.S. and other high-income countries, due in part to masterful marketing that has elevated these diseases into the collective consciousness — and convinced many people to open their wallets. But this narrow focus on fundraising and aid limits the public good that comes from investing in child health. (Shiza Abbasi and Carrie B. Dolan, 8/24)

For the first year of the coronavirus pandemic, my family and I were extremely cautious. I gave birth in April 2020, shortly after covid-19 hit. To protect the baby, my husband and I pulled our then-2-year-old son out of preschool. We socialized outdoors only, at a safe distance from others. I limited indoor activities to work and grocery shopping, and I was never without my N95. (Leana S. Wen, 8/23)

Nationally, close to 400 people a day on average succumb to the still-circulating, still-evolving virus, according the COVID tracker maintained by the U.S. Centers for Disease Control and Prevention (CDC). The daily average of new hospital admissions is above 5,000. (8/23)

Like most kids, my daughter doesn't like shots. So getting my 4-year-old her COVID-19 vaccine in August, before school started back up, wasn't what she (or I) would consider fun. (Carli Pierson, 8/23)

Infectious disease outbreaks often come and go, though some persist over the long haul, much like the man who has occupied the campus of the National Institutes of Health in Bethesda, Md., as director of the National Institute of Allergy and Infectious Diseases since 1984: Dr. Anthony Stephen Fauci. (Gregg Gonsalves, 8/23)

For the last three years, this trim, gray-haired doctor with the wire-rimmed glasses has been the vessel into which the country has poured all its fears and frustrations. He is hero and tormentor. Truth-teller and unreliable narrator. He has borne our angst. And through it all, he’s shown the public nothing but patience and decency — and only the occasional flares of angry exasperation mostly reserved for a senator named Rand Paul (R-Ky.) whose preferred response to the pandemic might be summed up as do-as-little-as-possible. (Robin Givhan, 8/23)