From Washington, DCm

• The Wall Street Journal reports,
  • “House Democratic leaders said they would block any effort to remove Speaker Mike Johnson (R., La.), moving to protect the Republican leader from retaliation by his hard-right flank following the passage of a sweeping foreign-aid package that included funding for Ukraine.”
• This is a smart move because accord to what the FEHBlog has been reading, the Democrats are likely to retake the House of Representatives in the fall election.

• The Journal also relates,
  • “The Federal Trade Commission is challenging hundreds of pharmaceutical patent listings in an effort to smooth the path to more affordable alternatives to brand-name drugs—including blockbusters such as Ozempic and Victoza.
    • “The crackdown is the latest assault against what the agency regards as drugmakers’ patent ploys intended to stall generic competition.
    • “At issue is what is called the Orange Book, a document published by the Food and Drug Administration that lists patents relevant to brand-name pharmaceuticals. Under a law meant to encourage generics, if a generics maker can successfully challenge listed patents, it can be granted a period of exclusivity before other generics are approved. But a challenge to an Orange Book patent, should a brand-name manufacturer decide to fight in court, also delays a generic’s approval for 30 months.
    • “The FTC says that drugmakers needlessly list oodles of extra patents in the Orange Book, delaying generic alternatives and artificially keeping prices high.”

• HealthLeaders Media adds,
  • “Medicare Part D saved nearly $15 billion over six years with the use of “skinny label” generics, a new report says.
  • “However, the program is imperiled by a lawsuit claiming patent infringement, researchers at Brigham and Women’s Hospital and Harvard Medical School said in a research letter published on Monday in Annals of Internal Medicine.
  • “The researchers are urging Congress to “reinforce the skinny-label pathway by creating a safe harbor that protects manufacturers engaged in skinny labeling from induced patent infringement laws.”
  • “Skinny labels permit the use of generics for conditions that are not specified by brand-name drug makers and allow the cheaper generics to enter the market before the patent of the brand-name drug expires. 

•  The U.S. Preventive Services Task Force finalized a breast cancer screening recommendation today.
  • The Task Force now recommends that all women get screened for breast cancer every other year starting at age 40 [previously age 50 for USPSTF purposes and 40 for Affordable Care Act purposes] and continuing through age 74. This is a B grade. More research is needed about whether and how additional screening might help women with dense breasts stay healthy and on the benefits and harms of screening in women older than 75. These are I statements.
• The New York Times adds,
  • “In 2009, the task force raised the age for starting routine mammograms to 50 from 40, sparking wide controversy. At the time, researchers were concerned that earlier screening would do more harm than good, leading to unnecessary treatment in younger women, including alarming findings that lead to anxiety-producing procedures that are invasive but ultimately unnecessary.
  • “But now breast cancer rates among women in their 40s are on the rise, increasing by 2 percent a year between 2015 and 2019, said Dr. John Wong, vice chair of the task force. The panel continues to recommend screening every two years for women at average risk of breast cancer, though many patients and providers prefer annual screening. * * *
  • “Weighing in again on a hotly debated topic, the task force also said there was not enough evidence to endorse extra scans, such as ultrasounds or magnetic resonance imaging, for women with dense breast tissue.
  • “That means that insurers do not have to provide full coverage of additional screening for these women, whose cancers can be missed by mammograms alone and who are at higher risk for breast cancer to begin with. About half of all women aged 40 and older fall into this category.”
• For Affordable Care Act preventive services coverage purposes, HHS’s Human Resources and Services Administration, not the USPSTF, is the final decision maker regarding the scope of women’s healthcare preventive services.

From the public health and medical research fronts,

• STAT News lets us know today.
  • “Research is still being done to determine if all pasteurization techniques — there are multiple approaches — inactivate the [H5N1] virus. But the findings so far are reassuring. Scientists at St. Jude Children’s Hospital in Memphis, Tenn., have reported that while they could find genetic evidence of the virus in milk bought in stores, they could not grow live viruses from that milk, suggesting pasteurization kills H5N1. * * *
  • “But given the concentration of virus that researchers are seeing in milk from infected cows, they believe that raw milk — milk that has not been pasteurized — is an entirely different story.
  • “If cows that produce milk destined for the raw milk market got infected with H5N1, people who consume that milk could drink a large dose of the virus, scientists say. Thijs Kuiken, a pathologist in the department of viroscience at Erasmus Medical Center in Rotterdam, the Netherlands, said he’s heard of concentrations that would be the equivalent of a billion virus particles per milliliter of milk. He told STAT he thought authorities should ban raw milk sales while the outbreak is underway.”

• The Washington Post reports,
  • “Postpartum depression is a leading cause of maternal death, but its diagnosis and treatment is spotty at best, negligent at worst.
  • “Now San Diego-based start-up Dionysus Digital Health is pitching a blood test to check for the condition, even before symptoms appear. The company says it has pinpointed a gene linking a person’s moods more closely to hormonal changes. The test uses machine learning to compare epigenetics — how genes are expressed — in your blood sample with benchmarks developed during a decade of research into pregnant people who did and didn’t develop postpartum depression.
  • “Researchers at Dionysus’s academic partners, the Royal’s Institute of Mental Health Research and UVA Health, have published peer-reviewedpapers affirming their findings, and the company is partnering with the Department of Defense and the National Institutes of Health for clinical trials, with the eventual goal of making the $250 test widely available and covered by insurance.” 

• The National Institutes of Health announced,
  • “Sleep apnea and low oxygen levels while sleeping are associated with epilepsy that first occurs after 60 years of age, known as late-onset epilepsy, according to a new study funded by the National Institutes of Health (NIH) and published in Sleep. The link was independent of other known risk factors for late-onset epilepsy and sleep apnea including hypertension and stroke. The findings may help to better understand the relationship between sleep disorders and late-onset epilepsy, as well as identify potential targets for treatment.
  • “There’s increasing evidence that late-onset epilepsy may be indicative of underlying vascular disease, or neurodegenerative disease, even potentially as a preclinical marker of neurodegenerative disease,” said Rebecca Gottesman, M.D., Ph.D., chief of the Stroke Branch at the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), and an author on the study. “Compared to other age groups, older adults have the highest incidence of new cases of epilepsy – up to half of which have no clear cause. Sleep apnea is common among people with epilepsy, but the association is not well understood.”
• and
  • “Researchers have discovered that the smooth muscle cells that line the arteries of people with atherosclerosis can change into new cell types and develop traits similar to cancer that worsen the disease. Atherosclerosis is characterized by a narrowing of arterial walls and can increase risk of coronary artery disease, stroke, peripheral artery disease, or kidney disorders. The findings, supported by the National Institutes of Health (NIH), could pave the way for the use of anti-cancer drugs to counteract the tumor-like mechanisms driving the buildup of plaque in the arteries, the major cause of cardiovascular disease.
  • “This discovery opens up a whole new dimension for our understanding about therapeutic strategies for the prevention and treatment of atherosclerosis,” said Ahmed Hasan, M.D., Ph.D., program director in the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute, part of NIH. “Previous research has suggested that atherosclerosis and cancer may share some similarities, but this association has not been fully described until now.”

• The Wall Street Journal tells us,
  • “An emerging field of research called chrononutrition indicates that choosing the right foods and meal times may improve our sleep. Some key findings: Eat dinner early. Keep consistent schedules. And, yes, drink milk.
  • You already know that fruits, veggies and lean protein are good for your health. But they can boost your sleep, too. These foods are the basis for the Mediterranean diet, which research shows may improve sleep quality, reduce sleep disturbances and boost sleep efficiency—the amount of time you spend asleep when you are in bed.” 

From the U.S. healthcare business front,

• Healthcare Dive informs us,
  • “Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare.”Walmart is closing its network of health clinics after failing to make them profitable, in a major setback for the retail giant’s push into healthcare.
  • “Walmart Health launched as a one-store pilot in Georgia in 2019, and has since grown to 51 centers in five states, along with a virtual care offering. Yet the network has shown recent signs of trouble: Earlier this month, Walmart decelerated its expansion plans for the centers, which offer inexpensive, fixed-cost medical services like primary and dental care.
  • “Walmart is now closing the clinics entirely due to a challenging reimbursement environment and escalating operating costs resulting in a lack of profitability, according to a Tuesday press release. * * *
  • “In the end of Walmart Health illustrates that size alone is not a recipe for success in providing health services, according to Forrester’s Trzcinski. Walmart is the largest retailer in the U.S., with revenue of $648 billion in its most recent fiscal year.
  • “Despite building out the clinics, Walmart didn’t invest in driving adoption, including through digital health and customer experience, Trzcinski said. That caused it to fall behind other retailers that are surging ahead, such as Amazon and CVS.”

• Per BioPharma Dive,
  • “Eli Lilly raised its revenue forecast for the year by $2 billion as sales of its GLP-1 medicines for diabetes and obesity continue to climb rapidly amid surging demand.
  • “The Indianapolis drugmaker currently can’t make its drugs Mounjaro and Zepbound fast enough, indicating in an earnings statement Tuesday that sales growth will “primarily be a function of the quantity the company can produce and ship.”
  • “Lilly is expanding manufacturing and expects greater capacity in the second half of the year. Revenue from Mounjaro, which is sold for diabetes, totaled $1.8 billion in the first quarter, while Zepbound revenue hit $517 million in its first full quarter on the U.S. market as an obesity treatment.”
• and
  • “Lilly and Novo [Nordisk] aim to maintain their current hold on the market. Both companies are testing several experimental drugs with the goal of launching oral versions or even more effective treatments than their current products.
  • “Novo is already close to completing a Phase 3 trial program testing an oral form of Wegovy. It also has in late-stage development a combination of Wegovy with a compound called cagrilintide that acts on a gut hormone called amylin.
  • “Lilly has two drugs in Phase 3: an oral GLP-1 dubbed orforglipron that is approaching key data readouts next year and an injectable treatment called retatrutide that stimulates GLP-1, GIP and a third hormone known as glucagon. Results in obesity are due in 2026.
  • “Lilly has four experimental drugs in Phase 1 or 2, while Novo has five.
  • “[Lilly and Novo] cover all the bases,” said Clive Meanwell, CEO of Metsera, a newly launched startup that has two obesity drugs in clinical testing. “Our belief is it’s going to be a portfolio play, with mix and match, with different clinical circumstances and different markets.”
  • The article discusses similar projects from other companies.

• Beckers Payer Issues reports,
  • “CMS and the NCQA are extending the quality data submission deadline for health plans by two weeks due to “extraordinary circumstances” caused by the cyberattack on Change Healthcare in late February.
  • “Payers will now have until 5pm Eastern Time on June 28 to report their performance on Healthcare Effectiveness Data and Information Set (HEDIS) measures to the two organizations, according to an April 29 memo from CMS. * * *
  • “The Change Healthcare cyberattack has created unprecedented challenges to healthcare organizations across the country,” Eric Schneider, MD, EVP, Quality Measurement and Research Group at NCQA, said in a statement to Becker’s. “This disruptive incident, falling in the middle of the substantial effort and commitment required for quality reporting efforts, has significantly strained resources. Recognizing these extraordinary circumstances and in alignment with CMS, we are granting a deadline extension for the submission of HEDIS Measurement Year 2023 results.”