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Tuesday, December 3, 2024

The Ninth Circuit rules that, yes, the federal government can deport people

 By Andrea Widburg

The Ninth Circuit has long been the left-most federal appellate court in the United States. However, the day after Thanksgiving, the Ninth Circuit issued a decision that must have made President-elect Donald Trump very happy: It concluded that the Supremacy Clause means what it says, namely, that when it comes to the border, local political bodies cannot use regulations governing private parties to override the federal government’s supremacy on immigration matters.

United States v. King County revolved around Boeing Field, an airport in King County, Washington (i.e., the Seattle area). In 1941, King County conveyed the field to the U.S. government for wartime purposes. In 1948, the government reconveyed the field to King County. However, one contingency of the Instrument of Transfer was that the U.S. retained full access to Boeing Field.

Image by AI.

Beginning in 2012, ICE began to use Boeing Field to deport illegal aliens. To this end, ICE leased charter services for planes and personnel. However, in 2018, King County officials took umbrage at this practice. So, in 2019, they issued an executive order mandating that when the airport entered into leases with fixed base operations (FBOs)—that is, private businesses providing essential services such as fueling and stairs—those leases prohibit the FBOs from servicing ICE charter flights.

The County’s explicit purpose was to block the federal government’s ability to deport illegal aliens, and the plan worked. FBOs immediately stopped providing services to ICE because it would have destroyed their businesses had they continued to do so. ICE relocated its flights to Yakima, Washington, which increased their costs—and, of course, increased the federal debt.

The Trump administration sued in 2020 and, much to my surprise, the Biden administration has pursued the case in the ensuing years. Just as surprisingly, the District Court ruled in the government’s favor, and, most surprisingly of all, the Ninth Circuit has just affirmed that decision.

Having dealt with some silly procedural issues that King County raised and addressed questions about whether the U.S. had retained rights in Boeing Field (it had), the Court got to the serious substantive issue. That was whether a local government could indirectly block the federal government’s ability to act within its sphere of power—a sphere that entirely encompasses immigration enforcement. The Ninth Circuit concluded that local governments cannot do that.

These two sentences say it all:

It is of course true that “[p]rivate contractors do not stand on the same footing as the federal government, so states can impose many laws on federal contractors that they could not apply to the federal government itself.” [snip] That said, “any state regulation that purports to override the federal government’s decisions about who will carry out federal functions runs afoul of the Supremacy Clause.”

In other words, just as the federal government cannot use private businesses (such as social media companies) to do indirectly that which the federal government cannot do directly (such as censor speech), local governments cannot use private businesses (such as airport service providers) to do indirectly that which the governments cannot do directly (such as hamstringing the federal government’s completely supremacy on immigration matters).

This should be a warning to Democrat localities all over America. If even the Ninth Circuit doesn’t support your immigration war on the federal government, you have preemptively lost, so don’t even try.

https://www.americanthinker.com/blog/2024/12/the_ninth_circuit_rules_that_yes_the_federal_government_can_deport_people.html

FDA Approves Stelara Biosimilar Yesintek

 The US Food and Drug Administration (FDA) has approved ustekinumab-kfce (Yesintek) as a biosimilar to ustekinumab (Stelara) for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. 

This is the sixth ustekinumab biosimilar approved by the FDA. The biosimilar was developed by Biocon Biologics, a biosimilars company based in Karnataka, India.

Biocon will commercialize ustekinumab-kfce in the United States “no later than on February 22, 2025,” according to a company statement, as part of a settlement and licensing agreement with Johnson & Johnson, the makers of Stelara.

https://www.medscape.com/viewarticle/fda-approves-ustekinumab-biosimilar-yesintek-2024a1000m0s

'BCG Vaccine May Protect Against Long COVID Symptoms'

 Administering the Bacillus Calmette-Guérin (BCG) vaccine during the active phase of COVID-19 may help protect against the development of long COVID.

METHODOLOGY:

  • A phase 3 clinical trial initiated in early 2020 investigated the effect of the BCG vaccine injected during active infection on COVID-19 progression in adults with mild or moderate COVID-19. The current study summarizes the 6- and 12-month follow-up data with a focus on long-COVID symptoms.
  • Patients who tested positive for severe acute respiratory syndrome coronavirus 2 were randomly assigned to receive either 0.1 mL of intradermal BCG (n = 191) or 0.9% saline placebo (n = 202) within 14 days of symptom onset and were followed up at 7, 14, 21, and 45 days and at 6 and 12 months postinjection.
  • Overall, 157 BCG (median age, 40 years; 54.1% women) and 142 placebo (median age, 41 years; 65.5% women) recipients completed the 6-month follow-up, and 97 BCG (median age, 37 years; 49.5% women) and 95 placebo (median age, 40 years; 67.4% women) recipients completed the 12-month follow-up.
  • The researchers primarily assessed the effect of the BCG vaccine on the development of the symptoms of long COVID at 6 and 12 months.

TAKEAWAY:

  • Hearing problems were less frequent among BCG recipients at 6 months compared with those who received placebo (odds ratio [OR], 0.26; 95% CI, 0.045-1.0; P = .044).
  • At 12 months, participants who received the BCG vaccine exhibited fewer issues with sleeping (P = .027), concentration (P = .009), memory (P = .009), and vision (P = .022) along with a lower long-COVID score (one-sided Wilcoxon test, P = .002) than those who received placebo.
  • At 6 months, BCG demonstrated a sex-specific paradoxical effect on hair loss, decreasing it in men (P = .031), while causing a slight, though statistically nonsignificant, increase in women.
  • Male sex was the strongest predictive factor for long COVID, cognitive dysfunction, and cardiopulmonary scores at both follow-up assessments.

IN PRACTICE:

"[The study] findings suggest that BCG immunotherapy for an existing ailment may be superior to prophylaxis in healthy individuals," the authors wrote.

SOURCE:

The study was led by Mehrsa Jalalizadeh and Keini Buosi, UroScience, State University of Campinas, Unicamp, São Paulo, Brazil. It was published online on November 19, 2024, in the Journal of Internal Medicine.

LIMITATIONS:

Previous mycobacterial exposure was not tested among the study participants. A notable loss to follow-up, particularly at 12 months, may have introduced bias into the results.

DISCLOSURES:

The study was supported by the Coordination for the Improvement of Higher Education Personnel, Federal Government of Brazil, the General Coordination of the National Immunization Program, Ministry of Health (Brazil), and the National Council for Scientific and Technological Development-Research Productivity. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

https://www.medscape.com/viewarticle/bcg-vaccine-may-protect-against-long-covid-symptoms-2024a1000m14

'Fat in the Belly Correlates With Brain Amyloid'

 Higher levels of visceral fat were correlated with more amyloid plaque in the brains of cognitively normal individuals, according to a study that hints as to why individuals with obesity are more prone to dementia.

Amyloid levels were higher among individuals with obesity compared to those without obesity (P=0.008), and were significantly associated with visceral adipose tissue (P<0.0001), found researchers led by Mahsa Dolatshahi, MD, of Mallinckrodt Institute of Radiology at Washington University School of Medicine in St. Louis.

Higher levels of visceral fat were related to increased amyloid, accounting for 77% of the effect of high body mass index (BMI) on amyloid accumulation, Dolatshahi reported at the annual meeting of the Radiological Society of North Americaopens in a new tab or window. Other types of fat did not explain obesity-related increased Alzheimer's pathology.

"Our study showed that higher visceral fat was associated with higher PET levels of the two hallmark pathologic proteins of Alzheimer's disease -- amyloid and tau," Dolatshahi said. "To our knowledge, our study is the only one to demonstrate these findings at midlife where our participants are decades out from developing the earliest symptoms of the dementia that results from Alzheimer's disease."

The researchers also suggested that higher insulin resistance and lower HDL cholesterol were associated with high amyloid in the brain. The study showed effects of visceral fat on amyloid pathology were partially reduced in people with higher HDL, Dolatshahi said.

"Higher levels of HDL -- good cholesterol -- appears to ameliorate the effects of fat on Alzheimer's-associated pathologies such as amyloid in the brain," said Dolatshahi.

She suggested that modifying lifestyle to reduce fat and increase HDL levels could have a beneficial effect in preventing or delaying progression to Alzheimer's disease.

Study co-author Cyrus Raji, MD, PhD, also of Mallinckrodt, suggested that treatment with new weight-loss drugsopens in a new tab or window "may have brain health benefits in midlife that may prevent Alzheimer's disease later in life."

"A key implication of our work is that managing Alzheimer's risk in obesity will need to involve targeting the related metabolic and lipid issues that often arise with higher body fat," said Raji.

In commenting on the study, Max Wintermark, MD, chair of neuroradiology at the University of Texas MD Anderson Cancer Center in Houston, told MedPage Today, "Physicians should, of course, advise their patients on the very many benefits of weight loss, which are well known. Regarding this study, in particular, it raises some interesting points, but the results need to be considered with caution, given the small number of patients studied."

"Further investigations are needed to confirm the association found by the authors and, most importantly, to determine whether weight loss can reverse some of these changes," Wintermark added.

For the study, the researchers focused on the link between modifiable lifestyle-related factors -- such as obesity, body-fat distribution, and metabolic aspects -- and Alzheimer's disease pathology.

They recruited 80 cognitively normal individuals in midlife (mean age 49.4). Men made up 62.5% of the sample. The cohort's mean BMI was 32.3, and 57.5% of the group was diagnosed as being obese. The participants underwent PET, body MRI, and metabolic assessment as well as lipid panel blood testing. MRI scans of the abdomen were performed to measure the volume of the subcutaneous fat and visceral fat.

Thigh muscle scans were used to measure volume of muscle and fat. Alzheimer's disease pathology was measured using PET scans with tracers that bind to amyloid plaques and tau tangles that accumulate in the brains of people with Alzheimer's disease.

Disclosures

Dolatshahi and Raji disclosed no relevant relationships with industry.

Wintermark disclosed no relevant relationships with industry.

Primary Source

Radiological Society of North America

Source Reference: opens in a new tab or windowDolatshahi M, et al "The association between body fat localization, insulin resistance, and amyloid burden in midlife" RSNA 2024.


https://www.medpagetoday.com/meetingcoverage/rsna/113176

Compounded GLP 1 and Dual GIP/GLP 1: Statement from the American Diabetes Association

 The use of glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA (GIP/GLP-1 RA) classes has increased substantially over the past several years for treating type 2 diabetes and obesity. Increased demand for these pharmacotherapies has resulted in temporary product shortages for both GLP-1 RA and dual GIP/GLP-1 RA medications. These shortages, in part, have led to entities producing and marketing compounded formulations that bypass regulatory measures, raising safety, quality, and efficacy concerns. Even as shortages resolve, compounded GLP-1 RA and GIP/GLP-1 RA products continue to be heavily marketed to people with diabetes and obesity. The purpose of this statement by the American Diabetes Association is to guide health care professionals and people with diabetes and/or obesity in these circumstances of medication unavailability to promote optimal care and medication use safety.

This American Diabetes Association (ADA) statement was reviewed and approved by the ADA Professional Practice Committee in October 2024.

An ADA statement is an official ADA point of view or position that does not contain clinical practice recommendations and may be issued on advocacy, policy, economic, or medical issues related to diabetes. ADA statements undergo a formal review process, including external peer review and review by the appropriate ADA national committee, ADA clinical leadership, ADA scientific team, and, as warranted, the ADA Board of Directors.

https://diabetesjournals.org/care/article/doi/10.2337/dci24-0091/157478/Compounded-GLP-1-and-Dual-GIP-GLP-1-Receptor

'Most Top Medical Journals Prohibit Use of AI During Peer Review Process'

 Most of the top 100 medical journals provide guidance on the use of artificial intelligence (AI) during the peer review process, with many explicitly prohibiting its use, a study showed.

Of the 78 top journals that provide this guidance, 59% prohibit its use in peer review, while the rest allow its use if confidentiality is maintained and authorship rights are respected, reported Jian-Ping Liu, PhD, of Beijing University of Chinese Medicine, and co-authors.

In addition, 91% of the journals prohibited the uploading of content related to manuscripts to AI, and 32% allowed for restricted use of AI that mandated reviewers disclose in review reports, they noted in their research letter in JAMA Network Openopens in a new tab or window.

In their introduction, Liu and colleagues pointed out that "the rapid growth of medical research publishing and preprint servers appears to be straining the peer review process, potentially causing a shortage of qualified reviewers and slower reviews."

"Innovative solutions are urgently needed," they added. "Recent advancements in artificial intelligence, particularly generative AI (GenAI), offer potential for enhancing peer review, but its integration into this workflow varies by journal policy."

Co-author Zhi-Qiang Li, MPH, PhD, also of Beijing University of Chinese Medicine, told MedPage Today that "it was striking to discover that, despite AI's potential to augment the efficiency of peer review, a substantial 91% of journals have prohibited the submission of manuscript-related content to AI. This underscores a heightened awareness for safeguarding the confidentiality and integrity of manuscripts."

He noted that there was considerable divergence among different journals' AI policies, with many identifying a few primary reasons for choosing to limit the use of AI, including the desire to protect manuscript confidentiality; concerns about the introduction of incorrect, incomplete, or biased information by AI; and the potential for violating data privacy rights.

"This study indicates that the impact of AI on the scientific publishing process and medical research is a double-edged sword," Li said. "On one hand, AI has the potential to enhance the efficiency of peer review, but on the other hand, it raises concerns about biases and confidentiality breaches."

"The varying stances of journals towards AI use may significantly influence the decisions of researchers when drafting and submitting their papers," he added.

For this study, the authors used data from Scimago.org for the top 100 medical journals to determine the existence and nature of their AI guidance during peer review. They searched the journals' websites for AI-related policies on June 30 and August 10. If a journal did not have its own AI guidance but linked to its publisher's guidance, the authors used that guidance for the analysis.

Of the 78 journals, 41% linked to their publisher's website that had preferences for AI use. Wiley and Springer Nature favored limited use of AI, while Elsevier and Cell Press prohibited any AI use during peer review.

Notably, 22% of journals also provided links to statements from the International Committee of Medical Journal Editors or the World Association of Medical Editors, which allowed for limited use of AI. However, the authors noted that five of those journals had specific guidance that contradicted the statements of those organizations.

Liu and colleagues said that they only considered the policies of the top 100 medical journals, which could have missed other trends or attitudes in lower-ranked journals' policies. They also noted that relying on shared publisher guidance as a proxy for all journals could have overestimated the number with specific guidance on AI.

Disclosures

The study was funded by grants from the National Administration of Traditional Chinese Medicine.

The authors reported no conflicts of interest.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowLi ZQ, et al "Use of artificial intelligence in peer review among top 100 medical journals" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2024.48609.


https://www.medpagetoday.com/practicemanagement/informationtechnology/113200

House education chair demands Biden admin nix ‘blatantly illegal’ latest student loan scheme

 House Education Committee Chairwoman Virginia Foxx is ripping the outgoing Biden administration’s latest proposed student loan forgiveness scheme as “blatantly illegal” and demanding the federal Department of Education nix it.

Just before last month’s election, the Department of Education announced it was launching yet another attempt to get through President Biden’s hotly controversial plan despite numerous court slap-downs in the past.

The latest machination would again offer to broadly wipe out student loans based on hardship, including those thought to have an “80% chance of being in default within the next two years.”

“This fourth scheme is just as legally dubious as the prior Biden-Harris administration attempts to
‘cancel’ student loan borrowers’ debts, but have the American taxpayer pick up the tab,” Foxx wrote to DOE Secretary Miguel Cardona in a Monday letter exclusively obtained by The Post.

Rep. Virginia Foxx (R-NC) has ripped the Education Department’s latest student loan forgiveness plan as “illegal.”AP

Throughout his administration, Biden has pushed hard to use executive action to cancel student loans en masse. The first effort involved the Higher Education Relief Opportunities for Students (HEROES) Act, which was scuttled by the US Supreme Court.

Since then, the administration has made various other attempts, including through its SAVE Plan, which was predicated on income-driven repayment and also has been stymied in the courts.

Under the most recent proposal, the administration would wipe out loans for individuals it believes have an 80% chance of defaulting by using a “predictive assessment using existing borrower data.”

“Congress has not written any enabling legislation to provide the Department the power to use artificial intelligence or a subjective application process to hear borrower stories of hardship and determine whose loans to cancel,” Foxx wrote in her letter to Cardona.

President Biden’s administration has looked for legal avenues to forgive student loans en masse.Aaron Schwartz/POOL/EPA-EFE/Shutterstock

The Biden administration estimated that, if finalized, the latest proposal “would authorize loan forgiveness for approximately 8 million borrowers experiencing hardship.”

Foxx, 81, said that while the Education Department estimates the proposal’s price tag is just over $100 billion, other estimates “show the true amount could be eight times higher.”

Her letter comes as the public notice and comment period on the plan wraps up. The Department of Education previously indicated it would work to finalize the regulations behind the latest plan next year.

Foxx contended the Education Department is trying to be the arbiter of “subjective life circumstances” and insinuated that the rationale behind that proposal could lead to broader forgiveness.

“It would effectively give the Secretary direct control over the $1.7 trillion student loan portfolio and the ability to forgive any and all of the loans in it,” she bemoaned.

Foxx stressed that about 87% of Americans either never attended college or paid off their loans and would be on the hook for the forgiveness plan as taxpayers.

“This latest scheme is merely a Band-Aid that forces taxpayers to shoulder the responsibility of paying off someone else’s debt,” she wrote.

“Taken together, the Department has attempted to spend more on loan ‘forgiveness’ than the federal government will spend helping families afford college through the Pell Grant over the next decade.”

Federal Education Secretary Miguel Cardona has championed efforts to wipe out student loans.AP

Instead of student loan forgiveness, she argued that the department should be focused more on trying to lower college costs and its revamp of the Free Application for Federal Student Aid, which was bogged by delays and other issues.

Biden, 82, seemingly pushed for student loan forgiveness in a bid to woo younger voters and excite progressives while running for re-election.

President-elect Donald Trump has opposed the sweeping student loan plans pushed by his successor and soon-to-be predecessor and has called for eliminating the Department of Education altogether.

The DOE did not respond to a Post request for comment.

https://nypost.com/2024/12/03/us-news/rep-virginia-foxx-demands-biden-admin-nix-blatantly-illegal-latest-student-loan-scheme/