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Morning Briefing

Summaries of health policy coverage from major news organizations

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Wednesday, Dec 6 2023

ϳԹ News Original Stories 6

  • Biden Wants States to Ensure Obamacare Plans Cover Enough Doctors and Hospitals
  • Grassroots College Networks Distribute Emergency Contraceptives on Campus
  • These Programs Put Unused Prescription Drugs in the Hands of Patients in Need
  • Watch and Listen: Opioid Settlement Case Triggers Protests Outside the High Court
  • Listen to the Latest 'ϳԹ News Minute'
  • Readers Slam Hospital Monopolies and Blame the Feds for Understaffed Nursing Homes

After Roe V. Wade 1

  • Tuberville Lifts Most Military Holds Amid Protest Over Abortion Policy

Administration News 1

  • FDA Tells Court It Should Allow Graphic Images As Cigarette Warnings

Coverage And Access 1

  • Consumer Drug Prices Likely Won't Fall, Despite CVS' Simpler-Pricing Plan

Health Industry 2

  • Fla. Health Workers Protest Bounced Pay Checks, Insurance Coverage
  • Joint Commission To Offer Certification Program For Patient Data Privacy

State Watch 1

  • Experts Worry Over Tech Glitches As Florida's Medicaid Portal Launches

Lifestyle and Health 1

  • Doctors Find Indications Of Fetal Fentanyl Exposure Syndrome

Cancer 1

  • Air Force To Review Cancers Among Nuclear Missile Workers

Pharmaceuticals 1

  • Pfizer Says It's Leaving BIO, In Major Blow To Pharmaceutical Trade Group

Prescription Drug Watch 2

  • Health Agency Warns About Possibility Of Unsafe Swine Vaccines; Old Drug Gets The Go-Ahead For STI Prevention
  • Perspectives: What's Causing So Many Drug Shortages?; Smart-Bomb Cancer Drugs Prove Effective

Editorials And Opinions 1

  • Viewpoints: Incarceration Of Mentally Ill Makes Them Worse; Blood Transfusion By Paramedics Saves Lives

From ϳԹ News - Latest Stories:

ϳԹ News Original Stories

Biden Wants States to Ensure Obamacare Plans Cover Enough Doctors and Hospitals

The regulatory proposal was announced Nov. 15 and is likely one of the last major ACA policy efforts of the president’s first term. ( Julie Appleby , 12/6 )

Grassroots College Networks Distribute Emergency Contraceptives on Campus

Peer-to-peer efforts can meet a clear need among students whose colleges may not make sexual health products accessible or affordable. ( Michelle Andrews , 12/6 )

These Programs Put Unused Prescription Drugs in the Hands of Patients in Need

States and counties look to expand programs that accept donations of unused surplus drugs from places like nursing homes and hospitals and redistribute them to low-income and uninsured residents. ( Kate Ruder , 12/6 )

Watch and Listen: Opioid Settlement Case Triggers Protests Outside the High Court

The Supreme Court heard arguments over whether the Sacklers, the family behind Purdue Pharma — which marketed OxyContin — could claim immunity from future lawsuits without claiming bankruptcy. ( Aneri Pattani , 12/5 )

Listen to the Latest 'ϳԹ News Minute'

“Health Minute” brings original health care and health policy reporting from the ϳԹ News newsroom to the airwaves each week. ( 1/2 )

Readers Slam Hospital Monopolies and Blame the Feds for Understaffed Nursing Homes

ϳԹ News gives readers a chance to comment on a recent batch of stories. ( 12/6 )

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Here's today's health policy haiku:

DESPERATE NEED FOR AFFORDABLE HOME HEALTH CARE

Home care costs too much
When will government step in?
Families need help

— C. McCullough

If you have a health policy haiku to share, please Contact Us and let us know if we can include your name. Haikus follow the format of 5-7-5 syllables. We give extra brownie points if you link back to an original story.

Opinions expressed in haikus and cartoons are solely the author's and do not reflect the opinions of ϳԹ News or KFF.

Summaries Of The News:

After Roe V. Wade

Tuberville Lifts Most Military Holds Amid Protest Over Abortion Policy

Sen. Tommy Tuberville, a Republican from Alabama, is ending his months-long blockade on all but 11 military leadership promotions in protest of the Pentagon's abortion policies.

Republican Sen. Tommy Tuberville's blockade on military promotions that stretched over 10 months has come to an end. The Alabama lawmaker, who has been protesting a Pentagon policy on abortion since February, told reporters Tuesday he will be lifting holds on military promotions for nominees three-stars and below. The blockade has prevented more than 400 military jobs from being filled. "It's been a long fight. We fought hard. We did the right thing for the unborn and for our military," he said Tuesday. (Looker, 12/5)

Pentagon leaders have said the holds threatened national security, and Tuberville, a social conservative from Alabama, has not lifted them all. "I've still got a hold on, I think, 11 four-star generals. Everybody else is completely released by me," he told reporters. (12/5)

More abortion news from Texas and Wisconsin —

A Texas woman is asking a judge to allow her to get an emergency abortion after learning that her baby has a rare and typically fatal condition. The first-of-its-kind lawsuit, filed Tuesday, is significant because it comes a week after state lawyers suggested before the Texas Supreme Court that only pregnant women in immediate distress could bring claims against the state’s abortion ban. (Goldenstein, 12/5)

A Dane County judge on Tuesday ruled that a 174-year-old law thought to prohibit abortion in Wisconsin does not, in fact, do so. "The Court declares Wis. Stat. § 940.04 does not prohibit abortions," wrote Dane County Circuit Judge Diane Schlipper. Schlipper ruled that the law in question, a statute written in 1849, does not apply to abortions but to feticide. A consensual abortion is sought out by a pregnant woman who voluntarily determines to end a pregnancy. (Opoien, 12/5)

On birth control and women's health —

Democrats and reproductive rights organizations are putting renewed pressure on the Biden administration to ensure that health insurers fully cover contraception, citing fresh evidence that companies are failing to meet the Affordable Care Act requirement. (Reed, 12/6)

A Minnesota-based startup is hitting the road for abortion rights, but this is not a policy campaign. Just The Pill is an organization that offers reproductive health services to women via telehealth and a mobile clinic that its directors think will be a model for the future of this health care. "We have a lot to build back after Roe," medical director Dr. Julie Amaon told WCCO, referring to the U.S. Supreme Court's decision that rescinded a national right to abortion. (Kaplan, 12/5)

ϳԹ News: Grassroots College Networks Distribute Emergency Contraceptives On Campus 

Limya Harvey and Cydney Mumford set up a folding table a few times a month on the University of Texas-San Antonio campus to give away kits containing emergency contraceptives, condoms, and lube, or menstrual products like tampons and pads. They typically bring 50 of each type of kit, and after just an hour or two everything is gone. The 19-year-old sophomores — Harvey is enrolled at UTSA and Mumford at Northeast Lakeview College — founded the organization Black Book Sex Ed last spring. Their mission is to educate students and others in need about sexual health and connect them with free services and products packaged into kits they distribute on campus, in the community, and through their website. (Andrews, 12/6)

Research on women’s health has been underfunded for decades. That fact was highlighted by First Lady Jill Biden in November as the White House announced the nation’s first initiative for women’s health research. “Every woman I know has a story about leaving her doctor’s office with more questions than answers,” Jill Biden said. “Not because our doctors are withholding information, but because there’s just not enough research yet on how to best manage and treat even common women’s health conditions.” (Woodbury, 12/6)

Administration News

FDA Tells Court It Should Allow Graphic Images As Cigarette Warnings

The Biden administration is pressing a federal appeals court to allow a new regulation requiring graphic cigarette package health warnings to take effect — tobacco companies had challenged the rule. Also, strong lobbying efforts from critics are delaying the ban on menthol cigarettes.

The Biden administration on Tuesday urged a federal appeals court to let a regulation requiring graphic health warnings on cigarette packages and advertisements take effect, a year after it was blocked by a lower court in response to a challenge by tobacco companies. Lindsey Powell, representing the U.S. Food and Drug Administration, told a three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals the images on the proposed labels were necessary because text-only warnings failed to deter teenagers from starting to smoke. The labels would include 11 graphic images, such as diseased feet with amputated toes, to illustrate the risks of smoking. (Pierson, 12/5)

The Biden administration will further delay a long-awaited ban on menthol cigarettes after fierce lobbying from critics who warn that a prohibition could anger some Black smokers who favor the products and could hurt President Biden’s reelection prospects, administration officials said. The administration is expected to announce Wednesday that it plans in March to finalize federal rules that would lead to menthol cigarettes being removed from the market, according to three officials who spoke on the condition of anonymity to discuss forthcoming regulations. The officials acknowledged that the process could be delayed still further because of pressure during an election year. (Diamond and Ovalle, 12/5)

On organ transplants and lead in the water supply —

Evan Dame lives in near-constant fear his body will reject his transplanted kidney. Managing those fears became far more difficult in March, when federal changes regarding how to pay for the screenings meant the at-home tests were no longer available to Dame. Tuesday, a bipartisan group of lawmakers, along with advocates for doctors and patients, planned to call on the Biden administration to reverse the change. (Cuevas, 12/5)

Last week, the US Environmental Protection Agency proposed a rule that would require water systems across the country to replace millions of lead service pipes within the next 10 years. The new proposed rule is in line with the Biden administration’s goal of removing all lead pipes, regardless of the lead levels in tap or other drinking water samples, though officials have said that certain “limited circumstances” may be allowed to extend the time to complete system-wide line replacements. This proposal has prompted many questions about the impact of lead on people’s health. (Chakraborty, 12/5)

It’s known that lead in the water supply has severe health effects, including brain damage in children and heart and liver issues in adults. Now the Environmental Protection Agency has released an ambitious and expensive proposal to replace 100% of the lead pipes in water system service lines across the country over the next 10 years. (Merelli, 12/6)

On Obamacare coverage —

ϳԹ News: Biden Wants States To Ensure Obamacare Plans Cover Enough Doctors And Hospitals 

The Biden administration plans to push states to boost oversight of the number of doctors, hospitals, and other health providers insurers cover in Obamacare plans, under rules proposed in November. The annual regulatory proposal, known as the payment parameters rule, also seeks to expand access to adult dental coverage in Affordable Care Act marketplaces and would require states to hold open enrollment periods for Obamacare plans at the same time of year. It’s likely one of the last major ACA policy efforts of President Joe Biden’s first term — and, if he loses reelection, could represent his final touches on the landmark health program created when he was vice president. (Appleby, 12/6)

Coverage And Access

Consumer Drug Prices Likely Won't Fall, Despite CVS' Simpler-Pricing Plan

Drug pricing experts, Stat reports, are dubious that the company's plan to simplify its drug pricing methods will lower consumer costs and instead may merely pad its profits. Axios, though, suggests that the move may point to a bigger industry movement toward more transparent pricing.

CVS Health is promising to simplify how its pharmacies get paid for drugs. At first blush, it sounds like the model popularized by Mark Cuban of Shark Tank fame, whose own drug program claims to save employers up to 60% compared with conventional arrangements. Drug pricing experts, however, say CVS’ CostVantage program appears designed to pad CVS’ own bottom line rather than make drugs cheaper for patients and employers. (Bannow, 12/5)

CVS Health's new plan to make the way it prices prescription drugs more predictable is the latest shift by pharmacy giants to overhaul their business models amid increasing pressure from policymakers and industry upstarts. More transparent pricing that's more closely tied to the base cost of a drug could drive down how much consumers and insurers pay for some medicines. (Reed, 12/6)

More on drug costs, drug shortages, and debt —

Millions of Americans with robust health insurance rely on drug company coupons or discount cards to fill expensive prescriptions for chronic health conditions. But those offerings may soon be limited in the wake of legal challenges and upcoming changes to federal regulations. ... These coupons and discount cards have effectively made prescription meds affordable for consumers with chronic medical conditions, according to patient advocacy groups. (Alltucker, 12/6)

The Pentagon isn't tracking medical debt among troops despite federal recommendations that it should, and now Sen. Elizabeth Warren, D-Mass., the chairwoman of the Senate Armed Services Committee's personnel panel, wants to change that. Warren has been pressing the Pentagon for an update on medical debt and wrote to Defense Secretary Lloyd Austin in March asking about recommendations from the Consumer Financial Protection Bureau, or CFPB, that called for better collection of the data to safeguard service members' financial stability and credit ratings. (Kime, 12/4)

Members of the Senate Finance Committee took their first steps today toward using Medicare payment policy to fix drug shortages. (Wilkerson, 12/5)

ϳԹ News: These Programs Put Unused Prescription Drugs In The Hands Of Patients In Need 

On a recent November evening, Angie Phoenix waited at a pharmacy here in Colorado’s second-largest city to pick up prescription drugs to treat her high blood pressure and arm seizures. But this transaction was different from typical exchanges that occur every day at thousands of pharmacies across the United States. The cost to Phoenix, 50, who lives in the nearby community of Falcon and has no health insurance, was nothing. (Ruder, 12/6)

Health Industry

Fla. Health Workers Protest Bounced Pay Checks, Insurance Coverage

Citing a "pattern of disrespect," health workers at a Plantation, Fla. health system are speaking out about repeated issues with their paychecks bouncing. They also say that insurance payments are withdrawn from their pay, but that their insurance companies tell them their policies have lapsed. A Connecticut long-term care provider is also accused of being months behind on worker pay.

Fed up and frustrated, employees from West Broward Rehabilitation and Healthcare joined members from their union, United Healthcare Workers East, to protest what they say is a pattern of disrespect from their employer. "Every Friday, we got to run to the bank like we're some criminals to cash our checks, and sometimes when we get there, there's no money, we got to wait," said Callette Taylor. ..."They're not fixing the issue. Last week was Thanksgiving, most of us didn't have meals." (McAllister, 12/5)

Athena Health Care Systems, one of the largest providers of long-term care in Connecticut, is six months behind on paying health claims for workers on its health plan, President and CEO Lawrence Santilli said in a memo to employees obtained by The Connecticut Mirror. (Carlesso, 12/5)

Physicians leaving private practice for employment has hurt patient care quality, according to a recent survey of doctors commissioned by the Physicians Advocacy Institute. The survey polled 1,000 physicians employed by insurers, health systems, staffing agencies and private equity firms on how corporate ownership affects their workplace experience and ability to meet patients’ needs. The research was conducted by NORC at the University of Chicago. (Devereaux, 12/5)

Nonprofit hospitals and health systems are recovering financially but more slowly than expected, according to a report Fitch Ratings published Tuesday. Much of the sector has broken even in operations on a month-to-month basis in 2023, but it happened later in the year and to a lesser extent than analysts anticipated, the credit ratings agency reported. Labor costs, although softening, remain the top pressure point. (Hudson, 12/5)

In related news —

Banner Health ceased its hospice operations in Arizona and transitioned 100 staff to a nonprofit hospice organization providing services in the Phoenix and Tucson markets, effective Dec. 1. The Phoenix-based health system will continue to operate its hospice locations in Colorado. (Eastabrook, 12/5)

NorthShore—Edward-Elmhurst Health is now Endeavor Health, the Chicago-area nonprofit system announced Tuesday. Its website, signage, uniforms and other branding will start transitioning to the new name over the coming months. The system's hospitals will keep their names but be associated with the Endeavor brand. Other care sites will change to the Endeavor name. (Hudson, 12/5)

ϳԹ News: Readers Slam Hospital Monopolies And Blame The Feds For Understaffed Nursing Homes 

ϳԹ News gives readers a chance to comment on a recent batch of stories. (12/6)

ϳԹ News: Listen To The Latest 'ϳԹ News Minute' 

This week on the ϳԹ News Minute: The U.S. faces a shortage of physical therapists, and more Americans face the prospect of dying broke because of the rising cost of long-term care. (12/5)

Also —

Expectant parents scrambling to ready the nursery and find affordable childcare, sometimes defer one important decision until late in the game: Choosing where to give birth. For anyone in that group or people planning pregnancies in the new year, this year's ratings of the "Best Hospitals for Maternity Care" by U.S. News & World Report offers a comprehensive cheat sheet. ... Instead of a traditional ranking system, the hospitals in each state were designated as “high performing” and “not high performing.” (Rodriguez, 12/5)

Joint Commission To Offer Certification Program For Patient Data Privacy

The goal is to protect patient privacy and also create standards for secondary use of health care data which has had identifiers stripped from it. Also in the news: the HHS cyberattack that took the department offline in 2020 as covid hit was worse than originally thought.

The Joint Commission will begin offering a new certification program aimed at protecting patient privacy and creating standards for the secondary use of de-identified healthcare data. The program's goal is to provide an objective evaluation of whether best practices are being observed in the use of data and secondary data, the commission said Tuesday. (DeSilva, 12/5)

On March 15, 2020, just days after the US declared a national emergency because of the Covid-19 pandemic, the computer network for the US Department of Health and Human Services briefly vanished from the internet. In public remarks the following day, HHS Secretary Alex Azar attributed the 10-minute outage to a cyberattack but downplayed its severity, telling reporters that “there was no data breach or no degradation in terms of our ability to function and serve our important mission here.” (Robertson and Griffin, 12/6)

On artificial intelligence —

Google wants to make your cell phone a “doctor in your pocket” that relies on the company’s artificial intelligence. But first, the tech giant will need to convince skeptical lawmakers and the Biden administration that its health AI isn’t a risk to patient privacy and safety — or a threat to its smaller competitors. (Reader, 12/4)

In a recent study published in the journal NPJ Digital Medicine, researchers reviewed current guidelines on the ethical implementation of Artificial Intelligence (AI) in military and healthcare applications. Their discussions focus on ‘generative AI,’ a novel technology aimed at efficiently generating information, and attempts to overcome currently prevalent limitations on the ethical use of the technology. They develop and propose a novel system for the ethical application of AI to military and clinical research, named the “GREAT PLEA.” (de Sousa, 12/5)

Also —

Ochsner Health’s digital medicine program hasn't just improved access and outcomes for the New Orleans-based health system’s vulnerable patient population. The organization's leaders say the initiative has also proven a point: If a health system builds a digital medicine program focused on reducing chronic diseases, their patients--including those who have historically faced barriers to accessing services--will use it. (Perna, 12/5)

Health systems across the country are charging patients for messaging their physicians through patient portals. But Philadelphia-area systems are not joining the new trend. During the COVID-19 pandemic, patients began sending more messages to their physicians, often through portals such as MyChart. Telehealth has remained popular and doctors are finding themselves spending as much as an hour or two a day responding to patient messages — a service that hospitals and physician offices have typically not charged for. (Gutman, 12/6)

State Watch

Experts Worry Over Tech Glitches As Florida's Medicaid Portal Launches

The state is in the middle of its Medicaid unwinding process, which has thrown a spotlight on its decision to revamp the technology running its MyAccess website. Meanwhile, in California, reports say new HIV cases in San Francisco are declining, except among the Latino population.

Florida is flipping the switch Tuesday morning on its new online portal for residents who use Medicaid, SNAP food assistance and child care subsidies. The MyAccess website is retaining its name but shifting the technology that runs it. Meanwhile, Florida is in the middle of its Medicaid unwinding process — the Florida Department of Children & Families is reviewing the eligibility for millions of recipients. The state has made an aggressive push in the redetermination process, terminating 600,000 people in the last six months. The act of switching technologies in the middle of the process is like throwing gasoline on the Medicaid unwinding fire, said Joan Alker, the executive director of the Center for Children and Families at Georgetown University, since big technological shifts in health care are often accompanied by glitches. (Pedersen, 12/5)

New HIV cases in San Francisco declined about 5% in 2022 compared with 2021 — an encouraging trend that was somewhat dampened by a notable and worrisome rise in HIV among the city’s Latino population, particularly Latino men. There were 157 new cases of HIV diagnosed in 2022, down from 166 in 2021, according to an annual HIV epidemiology report released by the San Francisco Department of Public Health on Tuesday morning. (Ho, 12/5)

More than 70 kidney transplants were performed every day in the United States last year. Rachel Watson wanted to be one of the donors, but was told she didn’t qualify — at first. Watson, a 27-year-old digital marketer living in Warrenville, had been moved by a news story about a local politician in need of a kidney. In 2022, she reached out to a Chicagoland hospital about donating one of her kidneys to a stranger. During a phone screening, Watson was told that she weighed too much to be considered as a donor. (Arougheti, 12/5)

The San Francisco City Attorney’s Office has sued three California e-cigarette retailers for allegedly selling flavored vapes online to consumers in San Francisco, which violates a local law banning the sale of such products in the city. ...It is the first lawsuit the city is bringing against online e-cigarette retailers, said a spokeswoman for City Attorney David Chiu. The city has taken previous actions against brick-and-mortar stores. (Ho, 12/5)

A man suspected of killing multiple people in a string of shootings across Austin, Tex., on Tuesday was taken into custody and charged with capital murder and other charges, the police said. Robin Henderson, the Austin Police Department’s interim chief, announced the details of the shooting spree at a news conference early Wednesday morning. She said police had not determined that the incidents were connected until Tuesday night. (Ives, 12/6)

Lifestyle and Health

Doctors Find Indications Of Fetal Fentanyl Exposure Syndrome

At least 10 infants have been found to have distinctive physical birth defects after being born to mothers who said they'd used drugs including fentanyl while pregnant, pointing to a potential new syndrome being identified. A possible monthly overdose prevention treatment is also in the news.

At least 10 babies — possibly more than 12 — have been identified with what doctors believe to be a new syndrome related to exposure to fentanyl in the womb. All of the infants have distinctive physical birth defects, such as cleft palate and unusually small heads. ... All were born to mothers who said they'd used street drugs, particularly fentanyl, while they were pregnant. "This is concerning," said Dr. Elizabeth Cherot, the president of the March of Dimes. "As we see these shared characteristics identified, we may be unroofing a real syndrome." (Edwards, 12/5)

Scientists have developed an antibody treatment that shows promise in blocking the potentially deadly effects of fentanyl for nearly a month, raising hopes for a new tool to combat overdoses. Tests in animals found that the treatment could effectively block the effects of fentanyl, laying the groundwork for assessing whether the medication will prove effective in humans, according to a study published Tuesday in the journal Nature Communications. (Alpert Reyes, 12/5)

ϳԹ News: Watch And Listen: Opioid Settlement Case Triggers Protests Outside The High Court

The Supreme Court heard a case this week about who could claim bankruptcy protection from civil lawsuits. The case stems from the opioid epidemic and lawsuits brought by state and local governments against the companies that made, sold, or distributed prescription painkillers — in this instance, Purdue Pharma, which marketed OxyContin. (Pattani, 12/5)

In other health and wellness news —

A surge of mpox in the Democratic Republic of Congo has raised concerns of another global outbreak with more deaths than the one ignited last year, prompting scientists to worry the world will again fail to recognize warnings from Africa. For the first time, scientists have identified sexual transmission of a version of the mpox virus that is linked to more fatalities in a region where mpox is endemic and more typically transmitted through contact with infected animals. (Nirappil and Sun, 12/6)

Could a simple blood test detect Alzheimer’s disease years before symptoms appear? New research from Resonant, a Utah biotech company that develops diagnostic tests for neurodegenerative diseases, suggests it may be possible. Researchers said its new test achieved 100% accuracy in identifying patients with Alzheimer's disease and individuals with mild cognitive impairment (MCI) who went on to develop Alzheimer's disease within five years. (Rudy, 12/5)

Former Vice President Al Gore took aim at social media algorithms on Tuesday, saying sites that are “dominated by algorithms” are the “digital equivalent of AR-15s.”Gore, speaking at the the Bloomberg Green at COP28 event, said that spending too much time scrolling on social media could be dangerous and suggested that algorithms be banned. Numerous lawmakers have raised concerns about the use of social media among children. (Sforza, 12/5)

The Federal Aviation Administration (FAA) announced it will examine its rules on pilot mental health. ... The FAA said Tuesday it would establish a rulemaking committee to "identify and break down any remaining barriers that discourage pilots from reporting and seeking care for mental health issues." The committee will also examine the same issues for air traffic controllers. (Maile, 12/5)

The World Heath Organization called on countries to increase taxes on alcohol and sugary drinks to counter their negative effects on global health. Raising excise taxes on alcohol and sweetened beverages is the most effective way to reduce consumption while generating revenue, the WHO said in a statement Tuesday. (Ganatra, 12/5)

Cancer

Air Force To Review Cancers Among Nuclear Missile Workers

The Air Force is already reviewing whether service members who worked with nuclear missiles have had higher-than-normal rates of cancer, but is now expanding this review. Also in the news: a U.S. Army veteran is suing the government, alleging a VA computer system delayed a cancer diagnosis.

The Air Force is expanding its study of whether service members who worked with nuclear missiles have had unusually high rates of cancer after a preliminary review determined that a deeper examination is needed. The initial study was launched in response to reports that many who served are now ill. The Air Force isn’t making its initial findings of cancer numbers public for a month or so, but released its initial assessment Monday that more review is necessary. (Copp, 12/4)

An Eastern Washington veteran and his wife are suing the federal government and the companies behind a computer system the Department of Veterans Affairs has tested in Spokane, alleging that flaws in the system delayed the diagnosis of cancer that became terminal before it could be treated. Chewelah resident Charlie Bourg and his wife, Deborah Brinson, filed the lawsuit in the U.S. District Court for the Eastern District of Washington on Friday. They are seeking unspecified monetary damages from the government and the companies that have developed the electronic health record system — including Cerner, to which the VA awarded a $10 billion contract in 2018, and Oracle, which acquired Cerner for $28.3 billion in 2022. (Smith, 12/5)

In other cancer news —

Bayer was ordered on Tuesday to pay nearly $3.5 million by a Philadelphia jury that found the company's Roundup weedkiller caused a woman's cancer, the company said, the latest in a string of trial losses for the company as it tries to fend off thousands of similar lawsuits. The verdict in the Philadelphia Court of Common Pleas marks the fifth consecutive loss for Bayer, but it is much smaller than recent verdicts against the company that total more than $2 billion. The German conglomerate has faced pressure from some investors to reach a speedy settlement of the litigation in order to avoid further hefty trial verdicts. (Pierson, 12/5)

Johnson & Johnson's worldwide vice president for litigation said on Tuesday that the company has recently reached settlements with several law firms over their clients' claims that J&J talc products caused cancer. The settlements were reached "with a goal to facilitate our pursuit of a consensual prepackaged bankruptcy resolution," Erik Haas said on an investor call. It was not clear whether the deals have been finalized. (Pierson, 12/5)

Eight months into his tenure, Johnson & Johnson’s R&D chief is putting a big emphasis on medicines for cancer, treatment-resistant depression, and autoimmune disease. To sharpen that focus, R&D chief John Reed told STAT that the company is de-emphasizing two areas that have been mainstays for the drug and medical device giant: infectious disease and vaccines, as well as medicines targeting kidney disease and rare eye conditions. (Herper, 12/5)

About a decade ago, Mike Jensen, a pediatric oncologist at Seattle Children’s hospital, licensed to a startup his designs for a powerful new type of therapy, called CAR-T, that would re-engineer a child’s own immune cells to target cancer. The deal proved be a mixed blessing. The therapy eventually reached market as Breyanzi, one of three CAR-Ts approved for adult leukemia. But it was never approved for childhood cancer. (Mast, 12/5)

Pharmaceuticals

Pfizer Says It's Leaving BIO, In Major Blow To Pharmaceutical Trade Group

Stat says the drugmaker's plan to leave the Biotechnology Innovation Organization is the latest in a growing trend of pharma companies leaving trade groups. Meanwhile, BIO is reported to have selected its new CEO: John Crowley, a longtime biotech executive.

Pfizer has decided to leave the Biotechnology Innovation Organization, according to two sources familiar with the planning. The departure is a blow to BIO, which represents members ranging from small biotech startups to massive pharmaceutical companies. It’s the latest instance in a growing trend of pharmaceutical companies re-evaluating their memberships in large trade groups following a historic lobbying loss when Democrats passed a new drug pricing reform law in August 2022. (Cohrs, 12/5)

The Biotechnology Innovation Organization has chosen longtime biotech executive and rare disease advocate John Crowley as its new CEO, the organization announced Tuesday. Crowley came to biotech when his children were diagnosed with a rare genetic neuromuscular disease. (Cohrs, 12/5)

On the weight-loss frenzy —

Forty percent of patients who filled a prescription for Novo Nordisk's (NOVOb.CO) Wegovy to treat obesity in 2021 or 2022 were still taking it a year later, more than three times the rate of adherence with older medicines, according to an analysis of medical records and insurance claims data. Only 13% of patients who started taking Contrave from Orexigen Therapeutics and 10% of those who started on Qsymia from Vivus between 2015 and 2022 were still filling their prescriptions a year later, researchers reported on Wednesday in the journal Obesity. (Lapid, 12/6)

Eli Lilly on Tuesday said its recently approved weight loss treatment Zepbound is now available at pharmacies across the U.S., serving as an alternative to rival obesity drugs such as Wegovy that are facing supply issues. Zepbound is the latest entrant to the budding weight loss drug market, which Wall Street expects to grow to about $100 billion by the end of the decade. (Constantino, 12/5)

Every week, about two dozen patients come to a small room in Frederiksberg Hospital, a maze of old red-brick buildings in central Copenhagen. They are blindfolded and told to insert earphones with music. Then a nurse injects them with what they hope is the blockbuster weight-loss drug Wegovy. (Kresge and Muller, 12/6)

In other pharmaceutical industry news —

Axcella Health, a small biotech created by the venture firm Flagship Pioneering, is closing a year after the Cambridge firm laid off 85 percent of its workforce. Axcella on Monday disclosed in a filing with the Securities and Exchange Commission that shareholders had voted to liquidate and dissolve the 12-year-old company, which was founded by Flagship, the creator of Moderna. (Saltzman, 12/5)

As a teenager, Marie Tornyenu was always having to explain herself. If it wasn’t the chronic absences that had her doing homework from a hospital bed, it was the quilted blanket she carried with her on the days she could attend class. “It was a running joke that I was like 80 years old,” she said. “I would usually just laugh it off because the alternative was too depressing.” Tornyenu was born with sickle cell disease. (Molteni, 12/6)

Startup LambdaVision Inc. has big plans to develop the world’s first protein-based artificial retina for patients with retinitis pigmentosa, a genetic cause of blindness. Manufacturing the retina involves depositing 200 paper-thin layers of a light-sensitive protein in a polymer mesh. The protein layers must be perfectly even for the retina to work properly, a process that’s hard to get right on Earth. (Langreth, 12/5)

Prescription Drug Watch

Health Agency Warns About Possibility Of Unsafe Swine Vaccines; Old Drug Gets The Go-Ahead For STI Prevention

Read recent pharmaceutical developments in ϳԹ News' Prescription Drug Watch roundup.

The World Organisation for Animal Health (WOAH) is warning that more testing of African swine fever vaccines is needed, triggered by Vietnam's plans to export doses in coming months to fight a disease that regularly ravages pig farms worldwide. In a world first, Vietnam authorised in July two attenuated live-virus vaccines against the disease, which is not deadly to humans but is extremely infectious among pigs and has caused repeated disruptions to the global pork market, which data provider Research and Markets said was worth about $250 billion in 2022. (Guarascio, Vu and Flores, 12/6)

Sometime next year, the Centers for Disease Control and Prevention (CDC) will publish guidelines for one of the first new sexually transmitted infection (STI) prevention tools in decades. The tool—the tetracycline antibiotic doxycycline—is not new. In fact, it was first approved by the Food and Drug Administration in 1967 and has since then been used to treat a variety of bacterial infections, from respiratory infections to skin infections and STIs like chlamydia and syphilis. Safe, inexpensive, and widely available, it's the most commonly used tetracycline and is on the World Health Organization's list of essential medicines. (Dall, 12/4)

The U.S. Food and Drug Administration (FDA) said on Friday that Becton Dickinso is recalling its Alaris infusion pumps due to compatibility issues with Cardinal Health's Monoject syringes. The health regulator said Alaris pumps are validated for use with Monoject syringes. However, the dimensions for Monoject syringes have recently changed while rebranding the syringes from Covidien Monoject to Cardinal Health Monoject. (12/4)

Perspectives: What's Causing So Many Drug Shortages?; Smart-Bomb Cancer Drugs Prove Effective

Read recent commentaries about pharmaceutical issues.

There’s been a bombardment of bad news for drug supplies. The American Society of Health-System Pharmacists found this summer that nearly all of the members it surveyed were experiencing drug shortages, which generally affect half a million Americans. (Emily Tucker, 12/6)

Cancer drugs that work like heat-seeking missiles to deliver chemicals directly to tumors are having a bit of a moment. Pharmaceutical companies, in need of assets to counter flagging sales, are making these so-called antibody-drug conjugates the technology of choice in oncology dealmaking, as illustrated by last week’s $10.1 billion acquisition of ImmunoGen Inc. by AbbVie Inc. (Lisa Jarvis, 12/5)

Ozempic and other weight loss drugs are a new vista for the treatment of obesity. However, there is still much to learn. (Cory Franklin and Robert Weinstein, 12/3)

I keep reading horrifying stories of tragedy and loss at the hands of fentanyl. It happened again. “CSI Miami” actor Evan Ellingson died of an accidental overdose in early November. It’s the second time his family had to bury a child after an opioid tragedy. I’m left to think that overdose-reversing nasal spray Narcan is the new CPR — giving America the power to save lives. (Sterling Elliott, 12/6)

On Monday, the Supreme Court heard arguments in the complex bankruptcy case of Purdue Pharma, whose owners, the Sackler family, have become synonymous with the carnage wreaked on American families by the profligate and dishonest marketing and distribution of OxyContin and other opioids. (Robin Abcarian, 12/6)

Editorials And Opinions

Viewpoints: Incarceration Of Mentally Ill Makes Them Worse; Blood Transfusion By Paramedics Saves Lives

Editorial writers tackle mental illness, EMS, weight loss drugs, and more.

I sit on the Advisory Board for the Connecticut Department of Mental Health and Addiction Services and am co-president of NAMI Shoreline but I’m speaking here today as a mother whose son was arrested four years ago while still in his senior of high school. My son Ellis is known as being bright, funny and well-liked. His natural disposition is extremely easygoing. To give a little context, for senior superlative, he was voted Most Likely to Sleep Through an Earthquake. He was a strong student, thrived in high school, and received a Presidential Scholarship to attend the college of his choice. And then one day he went missing. He was experiencing a psychotic break. Initially, we had no idea. (Denise Paley, 12/6)

Preventable blood loss kills about 85 injured Americans every day, according to Caruba’s reporting. About 31,000 Americans bleed to death from survivable injuries each year. Traumatic injuries, like those sustained in car wrecks, construction accidents, or gunshots, for instance, are the leading cause of death for children and adults under age 45 in the nation. In 2021, Texas led the country in deaths from motor vehicle crashes and guns. First responders have all too many stories of patients bleeding out before they make it to a hospital to receive life-saving transfusions. (12/6)

The news about anti-obesity drugs keeps getting better. In November, data presented at the American Heart Association meeting added cardiovascular benefit to value in combating obesity and diabetes. This comes on the heels of news that Novo Nordisk halted a clinical trial to test Wegovy’s impact on renal function early because the results they were seeing were so strong. Yet beneath the hype lies a real fear. Unless we reverse the rising tide of metabolic syndrome, Medicare will be crushed, with tens of millions of Americans having shorter, harder lives. The new drugs offer the first real chance to deploy at scale treatments to halt a seemingly unstoppable trend. (Jeremy L. Shane, 12/6)

Former President Donald Trump is increasingly focusing on an unachieved objective from his days in the White House: repealing Obamacare, also known as the Affordable Care Act (ACA). Trump raised the issue of getting rid of Obamacare in a social media post over the Thanksgiving weekend. He followed it up last week with another post about Obamacare, this time vowing to “replace it” with something “much better.” (Dean Obeidallah, 12/4)

When asked about her lifelong commitment to improving mental health services and support for caregivers, former first lady Rosalynn Carter would share her experience on the campaign trail: Exhausted caregivers urgently reaching to grab her hand. Families pleading for resources. Americans bravely sharing their stories of hurdles and heartache. (Mitual Desai, 12/6)

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