FDA Panel Backs IceCure Cryoablation in Early Breast Cancer as Alternative to Surgery

 An FDA panel on Thursday endorsed a cryoablation system as an alternative to surgery for some early breast cancer patients.

By a 9-5 vote, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committeeopens in a new tab or window agreed the benefits of the ProSense cryoablation system in combination with adjuvant endocrine therapy outweigh the risks in early-stage, low-risk breast cancer.

"The benefit-risk profile is acceptable," said Kelly Hunt, MD, of the University of Texas MD Anderson Cancer Center in Houston.

In explaining her vote in support of the minimally invasive device, which destroys tumors by freezing them, Deborah Armstrong, MD, of Johns Hopkins Kimmel Cancer Center in Baltimore, said she came down on the side of "not letting the perfect, or the ideal, be the enemy of the good."

While the panel recognized that patients and their doctors are looking for an effective, less-invasive option to surgery, members still expressed concerns that the supporting evidence lacked certainty regarding recurrence rates and that the proposed indication from sponsor IceCure Medical may be too broad -- specifically, that eligible patients would include those as young as 60 years, whose cancers could be more aggressive.

"I'm not convinced there is sufficient safety data for a 61-year-old who may have a life expectancy of 28 years to consider this procedure as an alternative to a standard lumpectomy," said Harold Burstein, MD, PhD, of the Dana-Farber Cancer Institute and Brigham and Women's Hospital in Boston, who voted against the device, though he also said he might have voted "maybe" if that was an option.

"What we need to do is define low-risk breast cancer because that's where it's just all over the map," said Hunt. "Giving clinicians very specific data on what is low risk, and whether that includes genomic data or not, that to me is an important factor in the overall risk-benefit of this, in lieu of lumpectomy."

Primary support for the cryoablation system came from the ICE3, a single-arm trial involving more than 200 patients with early-stage breast cancer treated with the device instead of lumpectomy.

In data presented by IceCure, the 5-year rate of ipsilateral breast tumor recurrence (IBTR) was 4.3%opens in a new tab or window, and the trial met statistical criteria for positivity. However, FDA analyses including some with patients excluded by the study's data safety monitoring board calculated IBTR rates of 6.2% (95% CI 3.2-11.7) to 8.7% (95% CI 5.2-14.5).

For the indicated population, the FDA's assessed IBTR rate was 2.3% (95% CI 0.6-9.0) based on the 120 patients who also received adjuvant endocrine therapy in ICE3.

"I'm still not sure whether the actuarial risk of recurrence with this procedure is close to 10% at 5 years from the intent-to-treat analysis, or more like 2% to 3%," said Burstein. "We've all sat down at moments with patients and said here are the tradeoffs -- there is an x% risk with this and a y% risk for that, and you can make an informed choice."

Murad Alam, MD, of Northwestern University in Chicago, questioned why the sponsor chose to conduct a small nonrandomized study in a population where the risk of recurrence is so low, and without consultation with FDA. "There's no way to tell -- as far as I can see -- that [ProSense] is comparable to the prevailing standard of care," said Alam. "I think that's what some of us are struggling with in trying to compare this to the historical data."

"If we could go back a decade we would have consulted the FDA -- that would have been a smart thing to do," said ICE3 investigator Richard Fine, MD, of the West Cancer Center and Research Institute in Germantown, Tennessee. "The volume of data that exists on the gold standard in terms of ipsilateral breast tumor recurrence -- that data has tens of thousands of patients and we felt like that would be a good historical comparator."

"We have a lot of information on the control side," agreed panelist Toan Nguyen, MD, of Westchester Medical Center in Valhalla, New York. "There is numerous data out there, and whether [the recurrence rates are] 2%, 4%, or 6%, that's the range and I'm not sure what a control arm would add."

Several panel members suggested it would be extremely difficult to conduct a randomized trial involving the ProSense device considering it is already in use. The cryoablation system has received clearance in the U.S. for general minimally invasive cryoablation applications, including kidney, liver, and benign breast tumors, and is offered at several U.S. centers. It is approved for treating malignant breast tumors in Europe, China, and other countries.

"To do a randomized trial when the experimental arm is out there and available is what is the difficulty," said Armstrong, adding that patients are unlikely to participate in such a trial unless they were going to be treated with the ProSense device. "I think that we all agree that the ideal would have been a randomized trial, but I think it's not really feasible because the treatment is available."

While the FDA is not required to follow the advice of its advisory committees, it typically does.

https://www.medpagetoday.com/hematologyoncology/breastcancer/112819

'Paying Docs for Prior Authorizations Among Hot Topics at AMA Meeting'

 Paying physicians and their staff for their time spent on dealing with prior authorization requests and denials was a lively topic of conversation at Saturday's session of the American Medical Association (AMA) House of Delegates

opens in a new tab or window interim meeting in Orlando, Florida.

One of the delegates' reference committees considered a resolution submitted by the delegation from the American Association of Clinical Urologists (AACU) to "initiate prior authorization legislation aimed at Medicare Advantage plans, state Medicaid programs, as well as commercial payers, via model legislation, that allows for fair reimbursement for physician's time and that of their office staff when dealing with prior authorization." The reference committee's preliminary recommendation was to refer the resolution back to the AMA Board of Trustees for a decision.

Should the House of Delegates Weigh In?

Bill Reha, MD, of Woodbridge, Virginia, the delegate from the AACU and the author of the resolution, asked that instead of just letting the Board of Trustees decide what to do, the board should study the issue and report its findings back to the House of Delegates at the delegates' annual meeting next June, "so that the House of Delegates can weigh in on this important matter affecting all physicians before a decision is made."

But Maryanne Bombaugh, MD, speaking for the AMA Council on Legislation, said the council preferred to have the Board of Trustees act. "There are intensive and ongoing efforts at the AMA right now to address prior authorization," she said. "We have serious concerns that this resolution, if adopted, could have a detrimental impact on our prior reform efforts ... A critical component of [the AMA's] prior authorization reform effort has been the development of patient coalitions. The Council on Legislation is concerned with changing course; focusing AMA policy on a model bill that addresses only payment for prior authorization and not the impact on patient access to care could fracture these coalitions and impede our successful prior authorization reforms."

Brian Murray, MD, speaking for the New York State delegation, disagreed. "We understand the issues put forward about ongoing legislation and issues. But the reality is, this has been going on for a number of years. There are at least four or five bills out there regarding this; none of them are comprehensive. Going for a study and report back would not affect ongoing activity, as it is not directly drawing up a new bill or new direction. It's just looking at where we are reporting back to the House." Parag Mehta, MD, a fellow New York delegate, suggested that the resolution "could be seen as a tax on prior authorization, and may actually help as a deterrent to prior authorization, and may even ... push the path toward getting rid of prior authorization completely."

Alex Shteynshlyuger, MD, a New York City urologist who was speaking for himself, said that when it comes to getting rid of prior authorization, "I'd like to be idealistic, but after 20 years, we have to be realistic and practical, and ameliorate our suffering and financial bleeding."

Shteynshlyuger, who has previously floatedopens in a new tab or window the idea of creating a CPT code for time spent on prior authorizations, suggested that physician salary data from the Bureau of Labor Statistics could be used to figure out how to value physician time spent on the process. He noted that the Improving Seniors' Timely Access to Care Actopens in a new tab or window, a bill now in Congress that would more tightly regulate prior authorization, "has not moved anywhere in the past 4 years" and would only affect Medicare Advantage, not Medicaid or commercial insurance plans.

Ted Mazer, MD, a delegate for California who was speaking for himself, urged caution with the resolution. "We don't know what the negative implications would be," he said. "Maybe we get paid for prior authorization work, but it comes off of something else. I think the focus needs to be on eliminating or severely reducing prior authorization and worrying about the negative impacts."

Pediatric Hospital and Unit Closures

Delegates were more in agreement on a resolution offered by the American Academy of Pediatrics (AAP) and the Society of Critical Care Medicine (SCCM) to give support to pediatric hospitals and pediatric units in the wake of many pediatric-related closures. The resolution, which the reference committee recommended for adoption with a few changes, called for the AMA to "recognize the closure of pediatric hospitals and units as a critical threat to children's healthcare access and quality" and to "build a national coalition with the American Hospital Association and other like-minded organizations to increase awareness on the issue of pediatric hospital closures and to develop strategies to preserve access to high-quality pediatric inpatient and critical care."

AAP president-elect Sue Kressly, MD, of Sanibel, Florida, who spoke for the academy delegation, said that "The long-term closure of pediatric care units across the country is hurting children's access. When my hospital closed its peds unit, a 1-month-old with RSV was admitted to a med-surg floor and cared for by nursing staff with limited pediatric experience. The patient's respiratory rate of 22, which is normal for adults, was not recognized as critical, and the child nearly died. This is urgent, and we thank you all for your support."

Katrina Saba, MD, a pediatrician from Oakland, California who spoke on behalf of the PacWest delegation, said that a recent study in JAMA Network Openopens in a new tab or window found that "if every emergency room in the United States were fully prepared to treat children, thousands of lives will be saved, and the cost would be $11.84 or less per child. So although this is about emergency departments, it is a perfect and unfortunate illustration of why this resolution is so important."

Myo Myint, MD, of New Orleans, an alternate delegate from the American Academy of Child and Adolescent Psychiatry, offered an amendment on behalf of his delegation that added the words "including pediatric inpatient psychiatry units and pediatric psychiatry hospitals" to the resolution. "The U.S. pediatric mental health crisis is continuing to mean insufficient access to pediatric mental healthcare services," he said. "Pediatric hospital and inpatient unit closure, including the pediatric psychiatry hospital and inpatient unit closure, reduces access further and delays care, which can [exacerbate] the mental health crisis, and that can result in poor health outcomes."

Combatting Public Health Misinformation

Unlike the AAP and SCCM, whose resolution seemed destined for approval, AMA members from the New England delegation did not have as much luck with an emergency resolution on combatting public health misinformation that they attempted to introduce at the House of Delegates session early Saturday afternoon.

Their resolution sought to empower the AMA Board of Trustees to "appropriately utilize AMA resources to both proactively and reactively combat medical information," to have the AMA "develop a comprehensive strategy to proactively combat public health misinformation through evidence based advocacy, education, and strategic communications," and to have the association "work with federation members and other stakeholders to create rapid response capabilities to address medical misinformation that poses an immediate threat to public health."

Mario Motta, MD, of Salem, Massachusetts, who spoke for the New England delegation, said the emergency resolution was necessary because "never before have we faced possible disinformation from our own government agencies, if certain individuals take over health departments such as HHS [Health and Human Services] and the FDA." Motta appeared to be referring to Robert F. Kennedy Jr., a vaccine skeptic who is expected to play a prominent roleopens in a new tab or window in healthcare decisions in president-elect Donald Trump's administration.

"Our AMA was founded in 1847 specifically to promote science-based medical practice and to stop charlatans of that age," Motta continued. "And yet, here we are basically having to do the same thing ... If certain campaign promises are indeed kept, the past 100 years of progress in public health are in jeopardy. Many worried new parents may be swayed to forgo public health measures such as vaccines if encouraged to do so by our own HHS and the FDA."

Emergency resolutions require approval of 75% of delegates in order to be considered at the current meeting; this resolution fell short, garnering the approval of 382 of the 586 delegates present, or 65%.

https://www.medpagetoday.com/meetingcoverage/ama/112827

Higher Risk of Kidney Cancer Recurrence After Ablative Therapy

 Minimally invasive ablative therapy for early kidney cancer had an increased risk of local and metastatic recurrence, which is associated with increased mortality, Swedish investigators reported.

The population-based study showed more than a four-fold increase in the risk of locoregional recurrence and almost a two-fold increased risk of metastatic recurrence when patients opted for local ablation instead of partial nephrectomy. However, the analysis showed a low rate of recurrence overall, whether patients had surgical or nonsurgical treatment.

The analysis also did not include data on treatment-related morbidity, which should figure into discussions with patients, reported Borje Ljungberg, MD, of Umea University, at the International Kidney Cancer Symposiumopens in a new tab or window.

"There is a higher risk for local recurrence and a higher risk for distant metastasis, and we show that in a total population-based study," Ljungberg told MedPage Today, during a poster discussion session. "We have follow-up for when they die. We must inform the patients of the higher risk with ablative therapy."

"We could have made it better if we had comorbidity and everything else," he added. "We will do another study in the coming years where we look at comorbidity together with this, but still, ablation-treated patients have a higher risk of recurrence."

The findings do not make a case for superiority of one treatment strategy over others but instead the need to discuss risks and benefits of the various treatment options with patients to facilitate informed decision making, said Ljungberg.

During almost 5 years of follow-up, the overall recurrence rate was relatively low, about 4%, for locoregional and distant recurrence, said poster discussant Arpita Desai, MD, of the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco. Patients need a complete picture of risks and benefits of treatment options for renal cell carcinoma to make an informed decision about how they want to proceed.

Discussions about surveillance versus treatment for newly diagnosed renal masses are separate from the issue addressed in the study, Desai added. All the patients in the Swedish study had decided they wanted some form of treatment. The decision involved ablation versus surgery.

The analysis involved 2,751 kidney tumors diagnosed from 2005 to 2018 in 2,701 patients in the National Swedish Kidney Cancer Register. All the patients were treated by partial nephrectomy or some form of ablative therapy. The primary outcome was time to local/distant recurrence or death according to the type of treatment.

During a mean follow-up of 4.8 years, 111 local recurrences (4.0%) and 108 distant recurrences (3.9%) were identified. Subsequently, 24 (21.6%) patients with local recurrence died during a mean follow-up of 3.2 years, and 56 (51.9%) of patients with distant metastasis died during a mean follow-up of 2.8 years. That compared with a 7.5% mortality among patients without local or distant recurrence, Ljungberg reported.

Patients who opted for ablative therapy had a hazard ratio of 4.31 versus partial nephrectomy for local recurrence (95% CI 2.79-6.66, P<0.001). Cancer histology (clear cell/chromophobe/other) did not significantly affect mortality risk.

For distant recurrence, ablative therapy was associated with a hazard ratio of 1.91 (95% CI 1.11-3.28, P=0.018) versus partial nephrectomy. However, other factors also influenced the risk:

• Age: HR 1.04 (95% 1.01-1.07, P<0.001)
• Calendar year of treatment: HR 0.87 (95% CI 0.79-094, P<0.001)
• Male sex: HR 1.63 (95% 1.06-2.52, P=0.026)
• Tumor size: HR 1.01 (95% CI 1.00-1.03, P=0.015)
• Stage T1b at diagnosis: HR 1.85 (95% CI 1.11-3.08, P=0.018)
• Stage T2-T4 at diagnosis: HR 2.71 (95% CI 1.25-5.88, P=0.011)
• Papillary/chromophobe histology: HR 0.55 (95% CI 0.34-0.90, P=0.016)

The findings suggest that partial nephrectomy is the preferred treatment for most patients with operable RCC, said Ljungberg. They also imply that ablative therapy may be best for frail patients and those with significant comorbidities, the researchers stated.

The study did not examine recurrence rates by different types of ablative therapy, noted Priyanka Chablani, MD, of the University of Pittsburgh Medical Center, co-moderator of the poster session. Recurrence rates might vary by the type of intervention. Limited data exist on recurrence rates for newer types of ablative interventions, such as radiotherapy.

Disclosures

Ljungberg and Desai disclosed relationships with industry.

Chablani disclosed relationships with Astellas, AVEO Oncology Bayer, Exelixis, Seagen, Curio Science, DAVA Oncology, Gilead, and Mashup Media.

Primary Source

International Kidney Cancer Symposium

Source Reference: opens in a new tab or windowLjungberg B, et al "Occurrence of local recurrences and metastases after ablative therapy versus partial nephrectomy of renal cell carcinoma: A competing risk analysis" IKCS 2024; Abstract P1.

https://www.medpagetoday.com/meetingcoverage/ikcs/112828

'AMA Delegates Tackle Protections for LGBTQIA+ Athletes'

 Participation of LGBTQIA+ athletes in sports earned a mixed response during the American Medical Association (AMA) House of Delegates interim meeting in Orlando, Florida on Saturday.

The LGBTQ+ Sectionopens in a new tab or window introduced a policy statement calling for the AMA to support reducing barriers to sports for the LGBTQIA+ community by educating physicians about the "benefits and barriers" to their participation in sports, and by backing legislation and regulations that would ensure this population can participate in sports "inclusive of LGBTQIA+ persons."

Isabel Ball, a medical student and "proud lesbian," who spoke on behalf of the LGBTQ+ Section, highlighted a benefit, explaining that playing sports gave her the confidence and leadership skills to pursue a career in medicine.

She also dealt with the barrier of discrimination: As a high school senior, when she first "came out," she nearly quit soccer after the parents of a teammate suggested that "queer women should not be allowed in locker rooms with their daughter," she explained. Ball said her coach and the teammate quickly "shut down" the disparaging comments.

As a first-year college student, she overheard a teammate use a homophobic slur. Once again, she considered calling it quits, but a supportive coach and her teammates kept her in the game.

Zarah Iqbal, MD, MPH, speaking on behalf of the American Academy of Pediatrics, shared her support for the policy statement, noting that "sports have such an incredible impact on kids, ranging from mental health, obesity prevention, feeling like you're part of the community, and that's what this resolution is about."

"So we really need to think about the benefit to all of the kids, even starting, with 3-year-old sports teams, and all the way up from there... and how we're excluding a group of people from having those benefits," she added.

But what about the "fairness" of biological females playing with biological males, and "the safety of that?," stated Martha McConnell, DO, a psychiatry resident from Indiana University School of Medicine in Indianapolis. McConnell, who spoke for herself, said she agreed with many of the positive comments about the resolution.

Rhonda Sharp, MD, from Indiana, pointed out that there are a lot of sports where anyone can play. "We've had girls on male football teams in Indiana before," said Sharp, who spoke on her own behalf. But she argued that was different from a biological male competing against a biological female in swimming, for example.

"We've got to be fair to everybody," Sharp said.

Kavita Arora, MD, MBE, a delegate for the American College of Obstetricians and Gynecologists, stressed that the resolution isn't centered on "fairness" but on "access and participation" in sports.

"So it's firstly about health. It's about exercise. It's about community. It's about belonging. We should want that for all of our patients," Arora said. She noted that studies have shown that some LGBT people have a higher risk for overweight or obesityopens in a new tab or window.

Vanessa Stan, MD, an alternate delegate for the American Association of Geriatric Psychiatry, spoke as an individual and as the mother of a nonbinary child. She said that in men's professional sports, there are no stated gender-based limits to participation. For instance, the National Basketball Associationopens in a new tab or window (NBA) does not have a rule that explicitly prevents women from playing in the league. Men are not allowed to play in the Women's NBA, although the WNBA has had openly nonbinary players.

It's only in women's sports, where there is controversy, and people worry about "mixing people," she said, although these concerns are not really about safety, she argued, but about "fear-mongering. These are vulnerable folks."

Carl G. Streed Jr., MD, MPH, a delegate for the LGBTQ+ section, also underscored that the intent of the resolution is access.

"We are acknowledging that there are governing bodies ... that have medical professionals who are providing input on how best to make sure that people are being included at the most elite level appropriately, and therefore we're not countering that," Streed said. "We're really trying to make sure everybody's included, and that we are doing this based on the evidence, the science, and the best thing for our patients."

https://www.medpagetoday.com/meetingcoverage/ama/112830

Was The 2024 Election Too Big To Rig?

 by Edward Ring via American Greatness,

It’s Wednesday, the 6th of November, and America has chosen a new president. But we may not know the results for days or even weeks.

While there is a chance we will see a quick and decisive Trump victory, the media has prepared us for a protracted aftermath to election day. This raises an obvious question: Was there election rigging in 2024? Did the uniparty establishment and the institutions they control, desperate to prevent a Trump victory, break the rules? Did they cheat?

Answering this question in the affirmative doesn’t have to rely on the countless alarming allegations that are dismissed as unfounded conspiracy theories, even though there are so many of them:

The potential for mail-in ballot fraud, hundreds of ballots received at a single address, dozens of ballots received at a single address, questionable last-minute changes in verification procedures by the US Post Office, inaccurate voter rolls and fraudulent voter registrations, voter data leaks to partisan NGOs, vote harvesting, counterfeit ballots, destruction of legitimate ballots, ballot dumps, selectively applied “malfunctions” of voting machines in multiple states, last minute “patches” to fix voting machine software, illegal immigrants voting, and selectively applied closures of polling stations or inadequately staffed polling stations causing voter suppression.

You can claim there is no basis for concern over any one of those alleged cases of calculated, potentially widespread fraud. You can even dismiss the impact of fining and disbarring attorneys who challenged the integrity of the 2020 election and thus have deterred many attorneys from challenging this one.

The election was still rigged.

Anyone who watches David Muir at ABC, Lester Holt at CBS, Norah O’Donnell at NBC, or Amna Nawaz and Geoff Bennett at PBS will know this election was rigged, thanks to a multi-year propaganda campaign of shameless lying by the news anchors and reporters at the most prestigious networks in America. If you make it your business to keep track of what these “trusted news sources” are telling voters, it is obvious how hard they’ve tried to influence the election.

ABC News, for example, pretty much every single night for the last few months, has opened their newscast with 5-10 minutes where they heap slime all over Trump and praise Harris. If you watch the source material, for example, Harris’s CNN Town Hall, then watch the excerpts highlighted on ABC, you get two completely different impressions of her competence and integrity. Precisely the same tactic is used with Trump, but to the opposite effect. Watch one of his news conferences in its entirety, then watch what is grabbed, out of context, and presented on ABC.

Critics of Trump’s often brusque persona and often unvarnished condemnation of the media must ask, if they’re going to be fair, how would anyone react? For nearly ten years, David Muir has told us, with a straight face, that “the walls are closing in on Trump.” Along with fake scandals like the Russian collusion hoax, over and over we hear gross misrepresentations of things Trump has said. He mocked a disabled reporter; no, he didn’t. He told people to inject bleach to treat COVID; no, he didn’t. He called neo-Nazis “fine people;” no, he did not. And on and on it goes.

David Muir earned particular enmity among people who just wanted fair news coverage during the debate between Trump and Harris, when, for example, Muir insisted on “fact-checking” Trump but left Harris alone. For example, Muir contradicted Trump’s assertion that crime rates had risen, and Muir was wrong. The data, as Trump attempted to explain, was missing statistics from California’s major cities. Once that data was added, Trump’s claim was proven accurate.

Just in the last few days we’ve had the big four broadcast news anchors telling us that Trump wanted to put Liz Cheney in front of a firing squad, wants reporters covering his rallies to get shot, “groped” a woman back in the 1990s, expressed “deeply troubling” admiration for Adolf Hitler, held a “Nazi rally,” and intended to use the military against “the enemy within,” along with endless distorted repetition of everything bad they’ve ever said about him. All of this “news” was either truth twisted beyond recognition or outright lies. Meanwhile, their coverage of Harris has been indistinguishable from a paid Harris campaign ad.

There’s no end to the legacy television news media’s war on Trump. It’s not subtle, and despite their dinosaur status, they still exercise decisive influence over millions of voters. For the 2024 season-to-date, ABC Nightly News has averaged 7.7 million viewers, NBC averaged 6.4 million, and CBS averaged 4.7 million. PBS is now a big player as well, with a regular viewership of more than 5 million. That’s nearly 25 million regular viewers, with an average age of 65, nearly all of them high-propensity voters, and very few of them likely to be perusing alternative media. Cable news, for all the visibility and big audiences for the hosted talk shows on their networks, doesn’t compare. Recent estimates for primetime viewers of Fox News have averaged 359,000, versus 175,000 for CNN and 160,000 for MSNBC. Cable news audiences are dwarfed by the audiences for broadcast news content, which is overwhelmingly anti-Trump and pro-Harris. Tens of millions of Americans have been thoroughly brainwashed by these networks. But what about social media and online searches?

Back in 2015, Robert Epstein, a research psychologist with the American Institute for Behavioral Research and Technology, published “The search engine manipulation effect (SEME) and its possible impact on the outcomes of elections.” Continuing his research, in testimony before the U.S. Congress in 2019, Epstein claimed that biased search results on Google “impacted undecided voters in a way that gave at least 2.6 million votes to Hillary Clinton.” Epstein’s studies are compelling reading, and very little has changed. Google still controls 90 percent of the search engine market in the United States. In 2024, Google employee political donations favored Democrats by a ratio of more than 6 to 1. Draw your own conclusions.

As for social media, much is made of Twitter’s transformation into X, with no more censorship. Twitter, or X, has 95 million users in America. That’s a lot. But in the United States, Facebook has 194 million users, Instagram has 166 million users, TikTok reaches 170 million people, LinkedIn connects 200 million, and YouTube’s regular US viewers number 246 million. As a neutral platform, X’s audience reach is exceeded by more than 10 to 1 by the other major online platforms. With the lone exception of X, every one of these platforms employs biased algorithms designed to suppress conservative content. As for print media, intervention by the owners of the Los Angeles Times and the Washington Post to abstain from a presidential endorsement is too little, too late. Every newspaper and magazine with national reach, with the half-hearted exception perhaps of the Wall Street Journal, have been so anti-Trump and pro-Harris it is almost comical.

Social media, search engines, and legacy news media. In every facet of information gathering, the vast majority of Americans have been continuously exposed to anti-Trump, pro-Harris messages. None of this has been happening by accident. Michael Shellenberger, formerly a progressive liberal who was once honored as a Time Magazine “Environmental Hero,” has evolved into an investigative journalist of extraordinary integrity and courage. In recent years, his work has focused on what he has dubbed “the censorship industrial complex.” In a recent substack post, commenting on America’s news media from newspapers to television to online platforms, he had this to say, “It’s not a mirror of reality. It’s not just biased. And it’s not just deferential to the state or the party. It’s a propaganda arm dishonestly representing powerful political, ideological, and financial interests.”

Shellenberger, who alleges government manipulation of information sources available to Americans, is not alone. Mike Benz, a former US State Department official, claims that the U.S. government has become increasingly concerned about the rise of populist movements in the U.S. and around the world and is actively interfering in media freedom. Another window into how this is working is documented by Ben Shapiro in a must-watch video, where he describes the network of state-supported NGOs and quasi-private sector agencies that influence who gets advertising dollars and who gets boycotted, in an ostensibly benign effort to “create a universal framework full of guidelines and ratings designed to enforce approved narratives.”

It ought to be obvious to anyone who finds both sides of the story by using alternative media that in a fair election, America’s print, video, and online media, and search engine results, could have easily delivered just as much negative coverage about Harris as they have inflicted on Trump, and they could have delivered just as much positive coverage about Trump as they’ve lavished on Harris. Maybe the only rules that were broken were supposed norms of journalistic integrity. But by an order of magnitude, America’s sources of “news” and information were massively tilted in favor of Harris and against Trump.

If for no other reason but media bias, this election was rigged. As a result, regardless of the outcome, half of all Americans have lost faith in fair elections. Even if every allegation of actual, fraudulent, widespread rigging is false, nobody who thinks so will change their minds. For them, the media sources that might help debunk any of it have no credibility. That is a crime perpetrated by the elite who control these institutions that transcends even this moment.

https://www.zerohedge.com/political/was-2024-election-too-big-rig

'Fed's Kashkari says central bank may not cut rates as much if economy remains strong'

 Minneapolis Federal Reserve President Neel Kashkari on Saturday said that the central bank would probably deliver fewer interest rate cuts than expected if the U.S. economy continued to show strength.

Kashkari, who is not a voting member of the Fed's monetary policy committee, is the first central bank official to deliver public remarks after the Fed's 25 basis point rate cut on Thursday.

"One of the pleasant surprises that we've had is that productivity seems to be higher in the U.S. economy over the last few years. If that is sustained, and we're in a structurally more productive economy going forward, then that tells me we probably wouldn't end up cutting (rates) quite as far," Kashkari said in a Fox News interview.

"Productivity is notoriously difficult to forecast, so we'll have to see how the economy evolves. I've been surprised over the last year or so how resilient the economy has been. I hope that continues, and then that'll factor into our rate cut decisions," the Minneapolis Fed President added.

The Fed's 25 basis point rate cut was widely expected, following which chair Jerome Powell at the post-decision press conference said both the labor market and inflation was normalizing. 

Kashkari's remarks on Saturday about the strength of the economy echoed Fed chair Powell's at the conference. 

"It's actually remarkable how well the U.S. economy has been performing with, you know, strong growth, a strong labor market, inflation coming down. We're, you know, really performing better than any of our global peers," Powell had said. 

Kashkari also commented on the recent run up in U.S. Treasury yields in the Fox News interview. Between the September Fed meeting and Thursday's, the benchmark U.S. 10-year yield (US10Y) surged 71 basis points while the shorter-end, more rate-sensitive 2-year yield (US2Y) jumped 62 basis points. The bond sell-off was partly attributed to a reaction to Donald Trump's election victory.   

"As we've been cutting rates over the past couple of months, a lot of people have focused on the fact that long-term Treasury yields have gone up and what's causing those yields to go up," Kashkari said. "Some people have speculated it is expectations about what a new administration might do, we'll see what the new administration does or what Congress does."

"Another possible explanation is that we're just in a higher productivity, higher growth environment. And in a higher productivity, higher growth environment, all else equal, I would expect higher interest rates to go along with that," Kashkari added.   

Fed chair Powell at Thursday's press conference did not appear to be too concerned about the run up in U.S. Treasury yields. He said rising yields reflected higher expectations for growth, not inflation.  

For Wall Street, the Fed event was largely overshadowed by the culmination of the U.S. election. 

https://www.msn.com/en-us/money/markets/fed-s-kashkari-says-central-bank-may-not-cut-rates-as-much-if-economy-remains-strong/ar-AA1tNVZM

McKesson, Oracle, Thoma Bravo among finalists to acquire Veradigm: report

 McKesson and Oracle are among the finalists vying to acquire electronic medical records company Veradigm.

https://seekingalpha.com/news/4271782-mckesson-oracle-thoma-bravo-among-finalists-to-acquire-veradigm-report