Biden Admin Replaces 'Mothers' With 'Birthing People' in Maternal Health Guidance: “‘The United States has the highest maternal mortality rate among developed nations, with an unacceptably high mortality rate for Black, American Indian/Alaska Native, and other women of color. To help end this high rate of maternal mortality and race-based disparities in outcomes among birthing people [emphasis added],’ reads the 2022 White House fiscal year budget proposal…
The pro-choice nonprofit NARAL defended use of the term, tweeting, ‘When we talk about birthing people, we're being inclusive. It's that simple. We use gender neutral language when talking about pregnancy, because it's not just cis-gender women that can get pregnant and give birth. Reproductive freedom is for *every* body.’ "
It is a complex issue. Additionally, not all mothers have given birth (e.g., Kamala Harris). But I doubt the reason for the change was linguistic precision. Are there any liberals who will push back on this change?
About pharma
The big health story the news continues to be the approval yesterday of Biogen’s Alzheimer’s drug. The Fierce website has several good articles that summarize the issues around this controversial decision:
Biogen's shockingly broad Aduhelm label—and $56K price—set up a $10B launch, analysts say: “Biogen didn't just win the most closely watched FDA green light of the year. Its newly minted Alzheimer's disease drug, Aduhelm, snared an approval that covers all Alzheimer's patients, not just a select group of them, meaning millions could be eligible.
And it set an aggressive price tag, in the words of one analyst, that's several times higher than market watchers had predicted—roughly $56,000 for the average patient.The upshot? Some $10 billion in peak sales, analysts say. And ‘one of the biggest launches in biopharma history.’”
Ready, set, prescribe? Doctors detail why they'll deploy Biogen's new Alzheimer's drug—or not: “So why would most physicians plow ahead? Because the reality in the neurology, gerontology and even primary care practices where Alzheimer’s patients are treated is that Aduhelm is the now the only drug approved to target the underlying disease process…
Then there's the practical matter of administration: Only about 600 medical centers are able to treat at launch. Those are key considerations in what is expected to be a long runway toward establishing Aduhelm use in practice.
And of course, not all clinicians and researchers agree with the FDA nod for use with any group of patients…
Neither of Biogen’s phase 3 trials completed; the potential benefits are small and come at a high price; and the risks are high, with one-third of patients having developed swelling in the brain.”
FDA's 'intellectually insulting' aducanumab decision opens up a regulatory foothold for leading competitors: “Many analysts and industry watchers spent the hours after the FDA announcement opining about what Biogen's triumph meant for everyone else—and whether the new standard set by the FDA was a good one.
Aducanumab was submitted on data from a pair of conflicting trials that spurred an FDA advisory panel to give the medicine a thumbs-down in November. Patients in one trial saw a modest improvement in dementia symptoms, while the other study showed patients taking aducanumab actually fared worse than those on placebo.
Rather than approve the controversial therapy outright, the FDA opted to give a tentative green light under its accelerated approval pathway, which is for drugs that could provide meaningful benefit over existing treatments for a serious or life-threatening disease. Data to support these approvals can be based on a surrogate endpoint.”
Biogen unveils collaborations with CVS Health, Cigna to boost access to its Alzheimer's drug: “The pharmaceutical company is teaming with CVS Health to launch a new program on brain health, highlighting the importance of screenings and disease education. Screenings will be made available through CVS' Project Health program, which focuses on minority and underserved communities.
The testing will be made available in select markets including Atlanta, Philadelphia, New York City and the District of Columbia beginning in September…
Cigna is the parent company of Express Scripts, the largest pharmacy benefit manager in the U.S. Through the agreement, the insurer and drugmaker will streamline the process of getting patients access to the drug while monitoring the effectiveness against several patient outcome metrics.”
Costly New Alzheimer Disease Medications on the Horizon—Financing Alternatives for Medicare: This article is from last September and is an analysis of projected costs of Aducanumab.
”A simple, informal calculation, which assumes a minimum aducanumab market of 5 million (2 million people with mild AD and 3 million people with MCI, both with amyloid plaque burden), modest uptake of 50%, and a pricing estimate of $40 000 annually, yields direct costs of around $100 billion per year.” The actual price is $57,000. Other costs, such as diagnostics and treatment of complications, can be added to the total. I have not seen a good analysis of savings from using the drug, such as delays in institutional care and complications of Alzheimer’s disease.
Bayer's billon-dollar Parkinson's disease bets land in the clinic: “The first dose of DA01, which the German Big Pharma refers to as pluripotent stem cell-derived dopaminergic neurons, was given out in a phase 1 test through its biotech subsidiary, BlueRock Therapeutics.
Bayer has also kicked off a gene therapy trial in Parkinson’s disease, this time through Asklepios BioPharmaceutical, an adeno-associated virus (AAV) gene therapy unit also known as AskBio. That trial is a phase 1b.”
After COVID-19 spotlighted supply chain weaknesses, Biden unveils plan to resurrect U.S. drug manufacturing: “Under the plan, the White House is establishing a public-private partnership to select 50 to 100 essential medicines ‘to be the focus of an enhanced onshoring effort,’ the plan says. Further, the government is committing around $60 million to research new technologies to boost domestic API [active pharmaceutical ingredient] production.”
The blueprint follows a February executive order demanding a multi-industry review of key American supply chains. The fact that much of America’s drug production is based overseas isn’t exactly news, but the pandemic put those problems into sharp relief.”
Biosimilars And Follow-On Products In The United States: Adoption, Prices, And Users: “Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the US and worldwide…Using monthly sales data from the period 2005–19 for ten drug classes, we examine how quickly biosimilars/follow-on products gained market share and the subsequent trajectory of prevailing (national average invoice) prices. Our analysis suggests that although uptake has been slower than what is typically seen in generic drug markets, the most recent entrants have captured market share more rapidly than comparable earlier biosimilars/follow-on products. We also document that from biosimilar/follow-on products’ time of entry, their lower prices help offset the overall trend in average annual reference-product price increases.”
About health insurance
Where Does Your Health Care Dollar Go?: The latest breakdown from AHIP of how the premium dollar is spent. The largest single portion is $0.21 for pharmaceuticals. It should be noted that these percentages differ from those for national health expenditures. See: National Health Expenditures, 2019: Steady Spending Growth Despite Increases in Personal Health Care Expenditures in Advance of the Pandemic: Published by the AMA in May. For example, see Exhibit 1 on Page 13.
Medicaid is a hassle for doctors. That’s hurting patients: “A recent study by researchers from the US Bureau of Economic Analysis, the University of Chicago, and the Federal Reserve Bank in San Francisco found providers run into more obstacles when trying to bill Medicaid than they do with other insurers, and that these administrative hurdles explain the access problems experienced by Medicaid patients as much as the program’s payment rates.”
Medicaid pays little and late. Not news. Question is what is being done to correct the problem. Some states’ pay parity initiatives would be a temporary fix until/if federal conditions of participation mandate it.
About Covid-19
Spread of Misinformation About Face Masks and COVID-19 by Automated Software on Facebook: “Scientific journals are easy targets of automated software. Possible approaches to prevent misinformation due to dissemination of articles by automated software include legislation that penalizes those behind automation; greater enforcement of rules by social media companies to prohibit automation; and counter-campaigns by health experts.”
“Nanotraps” Designed to Capture and Clear SARS-CoV-2: “An interdisciplinary team led by University of Chicago researchers is designing biodegradable nanomedicines to capture and clear the novel coronavirus. The ‘nanotraps’ are dotted with angiotensin-converting enzyme 2 (ACE2) receptors or SARS-CoV-2 neutralizing antibodies that bind the virus and prevent it from infecting cells.”
Americans Getting Out More, but Cautiously: From Gallup:
Less than a quarter of Americans now practicing strict social distancing
More than four in 10 still avoiding large crowds; 26% avoiding small gatherings
Visits to grocery stores, restaurants and pharmacies jumped in May
About healthcare professionals
AAPA Responds to National Medical Organizations: This statement was presumably directed at the AMA and AOA, which last week published opposition to changing the name of Physician Assistant to Physician Associate. “We are writing to inform you that AAPA’s House of Delegates recently passed a policy affirming physician associate as the official title for the PA profession. We believe that this title more distinctly articulates the role and responsibilities of PAs in continuing to deliver quality healthcare, while reaffirming our commitment to team-based patient care. We kept “physician” in our title to demonstrate the value we place on our longstanding relationship with our physician colleagues and our historic roots within the physician community.”
About the public’s health
FDA can continue regulating e-cigarettes after Supreme Court declines to hear a case arguing that the agency has too much authority over the vaping industry: “Regulation of e-cigarettes by the U.S. Food and Drug Administration (FDA) can continue after the Supreme Court declined to hear a case on Monday that would have limited the government's authority to oversee the vaping industry.
The appeal from Big Times Vapes Inc, a Mississippi vape shop, centers around the 2009 Tobacco Control Act (TCA), in which Congress gave the FDA broad authority to regulate tobacco products.”
Rural-Urban Disparity in Mortality in the US From 1999 to 2019: “Rural residents experienced greater mortality and the disparity between rural and large metropolitan areas tripled from 1999 to 2019. Even though there were reductions in AAMRs for all ages, there was a 12.1% increase in the AAMR [age-adjusted mortality rates] rural residents aged 25 to 64 years, which was driven by an increasing AAMR among non-Hispanic White people. However, non-Hispanic Black people had greater AAMRs across all 3 US Census–categorized areas than all other racial/ethnic groups. These trends could be further exacerbated by rural hospital closures and the COVID-19 pandemic.”
General Health Checks in Adult Primary Care: The latest study on the utility of the annual/routine physical exam. “General health checks were not associated with reduced mortality or cardiovascular events, but were associated with increased chronic disease recognition and treatment, risk factor control, preventive service uptake, and improved patient-reported outcomes.”
About healthcare IT
Apple announces new features to share health data with doctors, track trends over time: “At its annual technology showcase known as the Worldwide Developers Conference on Monday, Apple revealed a new feature for users who have opted to share their medical records on their devices. Users can now choose the types of information they would like to share — such as an elevated cholesterol level or their physical activity history — and identify specific people to send it to, such as family members or clinicians.
Apple said the data is privacy-protected and secured during the upload and download process and will not be shared beyond the selected individuals, including Apple itself. The company is also making it possible for doctors using electronic health records made by Cerner, Allscripts, DrChrono, and others to view their patients’ information from Apple devices within the EHR, without having to download or open another app or tab.”
About hospitals and healthcare systems
Trinity Health generates nearly $700M in profit over 9 months thanks to strong investment gains: “Hospital chain Trinity Health generated $694 million in operating income for a nine-month period ranging from July 2020 through March 2021 as the system continues to weather volume declines due to COVID-19….
The improved results were ‘driven by higher operating revenue and strong cost controls on discretionary spending compared to the same period of fiscal 2020,’ Trinity said in its earnings report released Friday. “In addition, strong investment returns drove non-operating gains higher.
But Trinity has also experienced higher expenses handling the pandemic, like other hospital systems across the country. The system reported $14.4 billion in expenses in the nine-month period, an increase of $97.6 million compared to the same period the year before.”
Cleveland Clinic's net income grows to $350M in Q1: “Cleveland Clinic recorded a net income of $350.3 million in the first quarter of 2021, compared to a net loss of $830.6 million in the same period last year, according to recently released financial documents.
The 19-hospital system saw its net revenue reach $2.8 billion in the three-month period ending March 31, up from $2.6 billion recorded in the same period one year prior.
Expenses for the health system also rose to $2.6 billion in the first quarter of this year, an increase of 5.5 percent from the same period last year.”
8 hospital mergers, acquisitions called off: A good summary of the past year’s failed activities.
2021 Impact of Change® Forecast Highlights: From Sg2. Some highlights:
Hospital Outpatient Departments (HOPD) and Ambulatory Surgery Centers (ASCs) will continue to experience rapid patient growth (19% and 25% by 2029, respectively), experiencing a patient volume that is 15 million higher in 2029 than in 2019. This will help drive down the cost of surgical procedures. [Comment- are surgical procedures scalable at these numbers?]
This shift will accelerate as the Centers for Medicare & Medicaid Services (CMS) eliminates all of the procedures listed on their In-Patient Only List (more than 1,700 codes) and expands the number of ASC-covered procedures by 278 by the end of CY 2023. [Comment- there will still be some only-inpatient services, though increased technology has allowed more to be done on an ambulatory basis.]
Physicians Offices and Clinics will see 18% growth by 2029, much of which driven by procedures formerly done in hospitals like cataract surgery and endovascular procedures. [Comment- cataract surgeries have been done for decades in ophthalmologists’ offices/surgicenters. Likewise, many endovascular procedures are being done in the outpatient setting…but in a doctor’s office?]
There will be shift of admissions to the home toward the end of the decade with home-based services increasing by 15% to an estimated volume of 474.9 million.[Comment- this prediction continues a long trend to home care.]
Part of the growth in hospital-at-home will be attributable to a reimagining of senior care that moves patients out of skilled nursing facilities, which will see a 5% reduction in patient volume by 2029, despite an aging population.