Wednesday, August 07, 2024

The recombinant shingles vaccine is associated with lower risk of dementia

From nature.com

Here is the link. Check the charts.

Here is the abstract.

There is emerging evidence that the live herpes zoster (shingles) vaccine might protect against dementia. However, the existing data are limited and refer only to the live vaccine, which is now discontinued in the United States and many other countries in favor of a recombinant vaccine. Whether the recombinant shingles vaccine protects against dementia remains unknown. Here we used a natural experiment opportunity created by the rapid transition from the use of live to the use of recombinant vaccines to compare the risk of dementia between vaccine types. We show that the recombinant vaccine is associated with a significantly lower risk of dementia in the 6 years post-vaccination. Specifically, receiving the recombinant vaccine is associated with a 17% increase in diagnosis-free time, translating into 164 additional days lived without a diagnosis of dementia in those subsequently affected. The recombinant shingles vaccine was also associated with lower risks of dementia than were two other vaccines commonly used in older people: influenza and tetanus–diphtheria–pertussis vaccines. The effect was robust across multiple secondary analyses, and was present in both men and women but was greater in women. These findings should stimulate studies investigating the mechanisms underpinning the protection and could facilitate the design of a large-scale randomized control trial to confirm the possible additional benefit of the recombinant shingles vaccine.

Wednesday, July 31, 2024

Orally Inhaled Flecainide for Conversion of Atrial Fibrillation to Sinus Rhythm

 Here is the Link.

 Here is the abstract.

Background

 INSTANT (INhalation of flecainide to convert recent-onset SympTomatic Atrial fibrillatioN to sinus rhyThm) was a multicenter, open-label, single-arm study of flecainide acetate oral inhalation solution (FlecIH) for acute conversion of recent-onset (≤48 hours) symptomatic atrial fibrillation (AF) to sinus rhythm.

 Objectives

 This study investigated the efficacy and safety in 98 patients receiving a single dose of FlecIH delivered via oral inhalation.


Methods

Patients self-administered FlecIH over 8 minutes in a supervised medical setting using a breath-actuated nebulizer and were continuously monitored for 90 minutes using a 12-lead Holter.

Results

Mean age was 60.5 years, mean body mass index was 27.0 kg/m2, and 34.7% of the patients were women. All patients had ≥1 AF-related symptoms at baseline, and 87.8% had AF symptoms for ≤24 hours. The conversion rate was 42.6% (95% CI: 33.0%-52.6%) with a median time to conversion of 14.6 minutes. The conversion rate was 46.9% (95% CI: 36.4%-57.7%) in a subpopulation that excluded predose flecainide exposure for the current AF episode. Median time to discharge among patients who converted was 2.5 hours, and only 2 patients had experienced AF recurrence by day 5. In the conversion-no group, 44 (81.5%) patients underwent electrical cardioversion by day 5. The most common adverse events were related to oral inhalation of flecainide (eg, cough, oropharyngeal irritation/pain), which were mostly of mild intensity and limited duration.

Conclusions

The risk-benefit of orally inhaled FlecIH for acute cardioversion of recent-onset AF appears favorable. FlecIH could provide a safe, effective, and convenient first-line therapeutic option. (INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm [INSTANT];

Friday, July 26, 2024

Thursday, July 18, 2024

“They Lie and People Die”: Carnegie Mellon Professor Claims Trump Assassination Attempt was “Staged”

From Jonathanturley.org.

There are a lot of Professors that have weird ideas that the rest of us consider wrong or even unhinged – so it’s not surprising how many young people have weird ideas, too.

Smart people can be really stupid.

----------------------------------

Carnegie Mellon University Professor Uju Anya has joined the ranks of academics spreading the conspiracy theory that the assassination attempt on former President Donald Trump was “staged.” As for the killing and wounding of bystanders, Anya explained that “that’s exactly what they do.” We previously discussed other academics who have spread this conspiracy theory. However, few are willing to go as far as Professor Anya in explaining how the other victims were used to make the staging more plausible. Anya declared:

“It was staged. Like a stupid Tubi movie set in the Bronx with palm trees in the background. They lie, and people die. That’s exactly what they do

…That’s the record. Whatever ‘attack’ on him they set up to stoke his followers’ fears and sentiments threat and persecution has now cost lives.

…And people died behind this farce. Actual people’s lives gone for them to stage this stupid show. People dying doesn’t make the attack any less staged. Someone who thought the attack was real could’ve killed others trying to prevent harm. Also, someone could’ve shot the shooter to hide the plot.”


The faculty bio states that Anya is an Associate Professor of Second Language Acquisition. She describes herself as

“a scholar of language learning and Black experiences in multilingualism. My primary fields of inquiry are critical applied linguistics, critical sociolinguistics and critical discourse studies examining race, gender, sexual and social class identities in new language learning through the multilingual journeys of African American students.”

Likewise, in a now since-deleted Threads posting, Professor of Psychology at San Diego Mesa College Inna Kanevsky also fueled the baseless conspiracy theory. She posted

“‘He took a bullet for his country!’ No he didn’t. He took it, like everything else he took and keeps taking, for himself. For his own personal aggrandizement.”

Professor Anya has long been a controversial figure including her wish that Queen Elizabeth would die a long “excruciating” death. She later doubled down on the hateful statements.

She also tweeted out crude remarks about the 2022 elections: “contrary to all these major media outlets, the red wave coming is my period on Friday.”

So these and other faculty believe that Trump enlisted a kid who was thrown out of his high school shooting club as a bad shot to wing him at 130 yards from a sloped position. The conspiracists also decided to kill or wound some supporters to make the staging look real. In our age of rage, this all makes sense to these professors.

I agree with Professor Anya that such political statements are protected speech. However, her unhinged and hateful commentary exposes the radicalism of many faculty in higher education today.

Tuesday, July 16, 2024

Vagal Nerve Stimulation Shows Promise in Alzheimer Disease

 From practiceupdate.com. Published in Neurology.

 THURSDAY, July 11, 2024 (HealthDay News) -- Auricular transcutaneous vagal nerve stimulation was associated with improved cognition in patients with mild cognitive impairment caused by Alzheimer disease, according to research findings presented at the Congress of the European Academy of Neurology, held from June 29 to July 2 in Helsinki.

“The foundation leading to this study was the results of our many years of research on animals, for the first time confirming the achievement of the hippocampal theta rhythm as an effect of vagus nerve stimulation,” Adam Broncel, M.D., Ph.D., from Neuromedical in Lodz, Poland, told Elsevier’s PracticeUpdate. “As is well known, the hippocampus plays a key role in the process of memory consolidation.

 Broncel and colleagues conducted a randomized, double-blind, placebo-controlled trial of 51 patients with Alzheimer disease. Thirty-five patients were randomly assigned to the treatment arm and 16 patients were randomly assigned to the placebo arm. Patients in the treatment arm underwent a 12-week treatment period with auricular transcutaneous vagal nerve stimulation using the Vguard device. Twenty patients went on to an extension period for an additional 12 weeks. After another 24 weeks, 15 patients underwent a cognitive evaluation.

 The researchers found statistically significant improvement in cognition in the active treatment arm compared with the placebo arm, including on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (P < 0.01). The treatment arm also experienced improvements in the Mini-Mental Status Examination, Color Trial Test, and Verbal Memory Probing. After 24 weeks of no treatment, the cognitive improvement observed in the 15 patients during the treatment phase returned to baseline.

 “The most important finding of this study is the significant improvement in patients’ cognitive status. This result is groundbreaking for several reasons,” Broncel told Elsevier’s PracticeUpdate. “First, none of the previously known therapeutic methods for dementia disorders have shown such a high level of efficacy. Second, improvement was observed after only a few weeks of treatment. Third, the method is safe and does not carry the risk of severe side effects.

 “The method has the potential to fundamentally change the approach to treating cognitive disorders in Alzheimer’s disease, including memory disorders. It represents a groundbreaking shift in the treatment of patients with this diagnosis due to the lack of other effective treatment methods.”

 Broncel noted these results require a series of additional studies. “Future research will help answer several additional questions,” he told Elsevier’s PracticeUpdate, “such as the effect of vagus nerve stimulation in cases of advanced dementia, the optimal duration of therapy, and the use of stimulation in dementia diseases of different etiologies.”

Sunday, July 14, 2024

Ketamine vs Electroconvulsive Therapy for Treatment-Resistant Depression

 From www.practice.com

 IMPORTANCE

 The ELEKT-D: Electroconvulsive Therapy (ECT) vs Ketamine in Patients With Treatment Resistant Depression (TRD) (ELEKT-D) trial demonstrated noninferiority of intravenous ketamine vs ECT for nonpsychotic TRD. Clinical features that can guide selection of ketamine vs ECT may inform shared decision-making for patients with TRD.

 OBJECTIVE

 To evaluate whether selected clinical features were associated with differential improvement with ketamine vs ECT.

 DESIGN, SETTING, AND PARTICIPANTS

 This secondary analysis of an open-label noninferiority randomized clinical trial was a multicenter study conducted at 5 US academic medical centers from April 7, 2017, to November 11, 2022. Analyses for this study, which were not prespecified in the trial protocol, were conducted from May 10 to Oct 31, 2023. The study cohort included patients with TRD, aged 21 to 75 years, who were in a current nonpsychotic depressive episode of at least moderate severity and were referred for ECT by their clinicians.

 EXPOSURES

 Eligible participants were randomized 1:1 to receive either 6 infusions of ketamine or 9 treatments with ECT over 3 weeks.

 MAIN OUTCOMES AND MEASURES

 Association between baseline factors (including 16-item Quick Inventory of Depressive Symptomatology Self-Report [QIDS-SR16], Montgomery-Asberg Depression Rating Scale [MADRS], premorbid intelligence, cognitive function, history of attempted suicide, and inpatient vs outpatient status) and treatment response were assessed with repeated measures mixed-effects model analyses.

 RESULTS

 Among the 365 participants included in this study (mean [SD] age, 46.0 [14.5] years; 191 [52.3%] female), 195 were randomized to the ketamine group and 170 to the ECT group. In repeated measures mixed-effects models using depression levels over 3 weeks and after false discovery rate adjustment, participants with a baseline QIDS-SR16 score of 20 or less (-7.7 vs -5.6 points) and those starting treatment as outpatients (-8.4 vs -6.2 points) reported greater reduction in the QIDS-SR16 with ketamine vs ECT. Conversely, those with a baseline QIDS-SR16 score of more than 20 (ie, very severe depression) and starting treatment as inpatients reported greater reduction in the QIDS-SR16 earlier in course of treatment (-8.4 vs -6.7 points) with ECT, but scores were similar in both groups at the end-of-treatment visit (-9.0 vs -9.9 points). In the ECT group only, participants with higher scores on measures of premorbid intelligence (-14.0 vs -11.2 points) and with a comorbid posttraumatic stress disorder diagnosis (-16.6 vs -12.0 points) reported greater reduction in the MADRS score. Those with impaired memory recall had greater reduction in MADRS during the second week of treatment (-13.4 vs -9.6 points), but the levels of MADRS were similar to those with unimpaired recall at the end-of-treatment visit (-14.3 vs -12.2 points). Other results were not significant after false discovery rate adjustment.

 CONCLUSIONS AND RELEVANCE

 In this secondary analysis of the ELEKT-D randomized clinical trial of ECT vs ketamine, greater improvement in depression was observed with intravenous ketamine among outpatients with nonpsychotic TRD who had moderately severe or severe depression, suggesting that these patients may consider ketamine over ECT for TRD.

Friday, July 12, 2024

Academia and the Media against free speech

From Jonathan Turley.

JT is on target.
---------------------------------------------------

“The First Amendment is Out of Control”: Academic and Media Figures Rally Against Free Speech

Below is my column in Fox.com on renewed attacks on free speech and the apologists for this anti-free speech movement, including most recently comedian Jon Stewart. From moves to amend the First Amendment to mocking those being targeted, the left is pushing back at polls and efforts to restore free speech values.

Here is the column:

“The First Amendment Is Out of Control.” That headline in a recent column in the New York Times warned Americans of a menace lurking around them and threatening their livelihoods and very lives. That menace is free speech and the media and academia are ramping up attacks on a right that once defined us as a people.

In my new book “The Indispensable Right: Free Speech in an Age of Rage,” I discuss how we are living in the most dangerous anti-free speech period in our history. An alliance of the government, corporations, academia, and media have assembled to create an unprecedented system of censorship, blacklisting, and speech regulation. This movement is expanding and accelerating in its effort to curtail the right that Supreme Court Justice Louis Brandeis once called “indispensable” to our constitutional system.

It is, of course, no easy task to convince a free people to give up a core part of identity and liberty. You have to make them afraid. Very afraid.

The current anti-free speech movement in the United States has its origins in higher education, where faculty have long argued that free speech is harmful. Starting in secondary schools, we have raised a generation of speech phobics who believe that opposing views are triggering and dangerous.

Anti-free speech books have been heralded in the media. University of Michigan Law Professor and MSNBC legal analyst Barbara McQuade has written how dangerous free speech is for the nation. Her book, “Attack from Within,” describes how free speech is what she calls the “Achilles Heel” of America, portraying this right not as the value that defines this nation but the threat that lurks within it.

McQuade and many on the left are working to convince people that “disinformation” is a threat to them and that free speech is the vehicle that makes them vulnerable.

It is a clarion’s call that has been pushed by President Joe Biden who claims that companies refusing to censor citizens are “killing people.” The Biden administration has sought to use disinformation to justify an unprecedented system of censorship.

As I have laid out in testimony before Congress, Jen Easterly, who heads the Cybersecurity and Infrastructure Security Agency, extended her agency’s mandate over “critical infrastructure” to include “our cognitive infrastructure.” The resulting censorship efforts included combating “malinformation” – described as information “based on fact, but used out of context to mislead, harm, or manipulate.” So, you can cite true facts but still be censored for misleading others.

The media has been running an unrelenting line of anti-free speech columns. Recently, the New York Times ran a column by former Biden official and Columbia University law professor Tim Wu describing how the First Amendment was “out of control” in protecting too much speech.

Wu insists that the First Amendment is now “beginning to threaten many of the essential jobs of the state, such as protecting national security and the safety and privacy of its citizens.” He bizarrely claims that the First Amendment “now mostly protects corporate interests.”

So free speech not only threatens your life, your job, and your privacy, but serves corporate masters. Ready to sign your rights away?

Wait, there is more.

There is a movement afoot to rewrite the First Amendment through an amendment. George Washington University Law School Professor Mary Anne Franks believes that the First Amendment is “aggressively individualistic” and needs to be rewritten to “redo” the work of the Framers.

Her new amendment suggestion replaces the clear statement in favor of a convoluted, ambiguous statement of free speech that will be “subject to responsibility for abuses.” It then adds that “all conflicts of such rights shall be resolved in accordance with the principle of equality and dignity of all persons.”

Franks has also dismissed objections to the censorship on social media and insisted that “the Internet model of free speech is little more than cacophony, where the loudest, most provocative, or most unlikeable voice dominates . . . If we want to protect free speech, we should not only resist the attempt to remake college campuses in the image of the Internet but consider the benefits of remaking the Internet in the image of the university.”

Franks is certainly correct that those “unlikeable voices” are rarely heard in academia today. As discussed in my book, faculties have largely purged conservative, Republican, libertarian, and dissenting professors. The discussion on most campuses now runs from the left to far left without that pesky “cacophony” of opposing viewpoints.

Experts at leading universities were fired or stripped of positions for questioning COVID claims. Conservative faculty have been hounded from schools and conservative sites have been targeted by government-funded programs. Thousands have been banned from social media.

What is particularly maddening for many in the free speech community is how the left has responded to opposition to censorship and blacklisting. Some are claiming to be victims by those who criticize their work to target individuals and groups as disinformation.

Others, like comedian Jon Stewart mock those who object to the erosion of free speech by noting that conservatives are making these objections on television or online. So, according to Stewart, how can there be a problem if you are able to still object? The suggestion is that there can be no threat to free speech unless people are completely silenced.

Stewart insists that “we are surrounded by and inundated with more speech than has ever existed in the history of communication.” In other words, because people can still speak, the well-documented systems of censorship and blacklisting must not be so bad.

It is not clear what Stewart would accept as sufficient censorship. In universities, polls show both faculty and students afraid to speak openly. The government has funded a host of programs to pressure the source of revenue of conservative sites and to target dissenting voices. Yet, because we are raising objections to these trends, Stewart laughs at the very notion that free speech is under fire. After all, he is doing just fine.

What appears to be a punchline to Stewart is a bit more serious for others who have their livelihoods threatened by the anti-free speech movement.

Stewart has the benefit of being a liberal comedian on a liberal network. Try being a conservative comedian today getting air time on most cable outlets or college campuses. Like so many academics, everything seems just fine to them. With the purging of opposition viewpoints, those who remain have little to complain about.

The effort to assure citizens that “there is nothing to see here” is belied by a massive censorship system described by one federal court as “Orwellian.” Conservatives face cancel campaigns and blacklisting in academic and media forums.

As I discussed in my new book, conservative North Carolina professor Dr. Mike Adams faced calls for termination for years with investigations and cancel campaigns. He repeatedly had to go to court to defend his right to continue to teach. He was then again targeted after an inflammatory tweet. He was done. Under pressure from the university, he agreed to resign with a settlement. Four years ago this month, Adams went home just days before his final day as a professor. He then committed suicide.

Many others have resigned or retired. For them, the anti-speech movement takes away everything that brings meaning to an intellectual life from publications to associations to even employment. It is a chilling message to others not to join the “cacophony of … unlikeable voices.”

Some citizens seem sufficiently afraid or angry to surrender their free speech rights. They have lost faith in free speech. For the rest of us, their crisis of faith cannot be allowed to become a contagion. We must have a reawakening in this country that, despite our many divisions, we remain united by this indispensable human right.

Sunday, July 07, 2024

The Unintended and Anticompetitive Consequences of Laws to Control Health Care Costs

From jamanetwork.com.

A lesson in economics.

Good intentions do not equate to good fixes.

Here is the Link,

Here are some excerpts.

An array of federal and state laws, and accompanying regulations, restrict the supply of health care, driving up costs and making health care less affordable and accessible for many in the US. Too few health policy analysts and commentators have paid attention to these supply-side limitations that play a significant role in limiting the number of clinicians and health care facilities.

Even though some of these policies were well-intentioned and designed to control costs, they have, in practice, undermined competition and ironically led to higher prices in the long run.

Nowhere has this policy challenge been more acute than with respect to the available supply of hospitals across the country. Between 1974 and 2015, the number of hospitals in the US decreased by 22%. This shortage has been particularly severe in rural areas, where a 2017 study estimated that nearly 30 million individuals lived more than 1 hour from a trauma care facility.1 There is also a dearth of new hospital construction and expansions or renovations of older facilities (particularly in states with strict seismic retrofitting requirements, such as California). This shortage of health care facilities, coupled with clinician shortages, contributes to extended wait times for patients.

The health care industry has failed to respond with more facilities because policymakers passed laws that were designed to constrain hospital spending, but counterintuitively have done the opposite. For example, during the 1970s, certificate-of-need (CON) laws were passed in 26 states to constrain costs, but also to ensure access to care in rural or other historically underserved communities. As recently as 2022, CON laws require a state health planning agency or other regulatory agency to approve the expansion or construction of new facilities, or the offering of new service lines at a hospital, based on demonstrated community need and financial viability. This regulatory review process was designed to ensure, for example, that services were not duplicated in a single community. CON laws have generally been applied to hospitals, but are also applied to outpatient and long-term care facilities. In some states, CON review extends to mergers and acquisitions or changes in corporate control at some health care facilities.

In 1974, Congress hastened the adoption of state CON laws by passing the National Health Planning and Resources Development Act that tied federal funding to states passing their own CON laws. The results of this policy were predictable as, within years, nearly all states had adopted these rules that were designed to restrict new spending by ensuring an existing need for new medical facilities. In 1987, Congress repealed the federal inducements for CON laws because the laws proved to be ineffective in meeting their original purpose, and also because Congress itself changed the way in which hospitals were reimbursed under Medicare, rendering the laws largely unnecessary. Although 12 states rapidly eliminated their CON laws, they remain widespread, and as of January 2024, 35 states and the District of Columbia still had laws restricting the supply of new or renovated hospitals and other care facilities.

The COVID-19 pandemic illustrated the troublesome consequences of CON laws. During the pandemic, states with CON laws restricting the number of beds had 12% higher use rates and hospitals in those states were 27% more likely to have all their beds filled.3

Beyond the CON laws, other policies have undermined the development of new hospitals and raised prices for consumers. States have increasingly passed so-called certificates of public advantage (COPA) laws, which shield hospital mergers from certain federal antitrust laws. In states with COPA laws, hospitals can combine but, in return, regulators exercise additional oversight of postmerger policies and prices. The Federal Trade Commission recently reported that several hospital mergers conducted under COPA laws resulted in higher prices and reduced quality of care.

In 2010, Section 6001 of the Affordable Care Act (ACA) placed restrictions on physician-owned hospitals (POHs) and other health care facilities because of concerns that the ownership structure would lead to performance of unnecessary procedures and higher health care costs. The restrictions extend to the physicians’ immediate family members as well. The ACA included restrictions on the expansion of existing POHs and a requirement that POHs meet certain criteria to maintain eligibility for Medicare payments. The ACA’s restrictions on POHs include an exception for ownership or investment interests in rural facilities.

But the ACA restrictions on POHs have only served to limit market competition by limiting the creation of new facilities and restricting the size of existing POHs. Even though the ACA does not prohibit the existence of POHs, it has had chilling effects because of the primacy of Medicare payments to clinicians and hospitals. Miller and colleagues have noted that the impending imposition of the ACA restrictions several years ago led to the cancellation of 45 hospital expansion projects, and an additional 75 new hospital projects were “prematurely terminated.” These projects represented billions of dollars in lost economic activity—not to mention the loss of competitive pressure that had the potential to expand competition and lower costs for patients.

Together, CON and COPA laws, as well as the ACA restrictions on POHs, have been associated with a host of unintended consequences, such as the aggregation of market power in increasingly larger health care facilities, limited access to care, and higher costs for patients. Indeed, these supply-side restrictions have been critiqued by analysts across the ideological spectrum. Policymakers at both the state and federal level should take note of the unintended effects of these laws and their accompanying regulatory provisions and consider whether their repeal or modification would benefit patients and the communities where they live.

Effectiveness and Safety of Apixaban vs Rivaroxaban in Older Patients With Atrial Fibrillation

From practice update.com.

Here is the Link.

Here are some excerpts.
----------
BACKGROUND

There are no clinical trials with head-to-head comparison between the two most commonly used oral anticoagulants (apixaban and rivaroxaban) in patients with atrial fibrillation (AF). The comparative efficacy and safety between these drugs remain unclear, especially among older patients who are at the highest risk for stroke and bleeding.

OBJECTIVE

To compare the risk of major bleeding and thromboembolic events with apixaban versus rivaroxaban in older patients with AF.

METHODS

We conducted a population-based, retrospective cohort study of all adult patients (66 years or older) with AF in Ontario, Canada who were treated with apixaban or rivaroxaban between April 1, 2011 and March 31, 2020. The primary safety outcome was major bleeding and the primary efficacy outcome was thromboembolic events. Secondary outcomes included any bleeding. Rates and hazard ratios (HRs) were adjusted for baseline comorbidities with inverse probability of treatment weighting (IPTW).

RESULTS

This study included 42,617 patients with AF treated with apixaban and 30,725 patients treated with rivaroxaban. After IPTW using the propensity score, patients in the apixaban and rivaroxaban groups were well balanced for baseline values of demographics, comorbidities and medications; both groups had similar mean age of 77.4 years and 49.9% were female. At one year, the apixaban group had reduced risk for both major bleeding with an absolute risk reduction at one year of 1.1% (2.1% vs 3.2%; HR 0.65 [95% CI, 0.59-0.71]) and any bleeding (8.1% vs 10.9%; HR 0.73 [95% CI, 0.69-0.77]) with no difference in the risk for thromboembolic events (2.2% vs 2.2%; HR 1.02 [95% CI, 0.92-1.13]).

CONCLUSIONS

Among AF patients, 66 years or older, treatment with apixaban was associated with reduced risk for major bleeding with no difference in risk for thromboembolic events compared with rivaroxaban.