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Tuesday, June 17, 2025

Don't Stop, Israel. Regime Change Now!

 by Roger Simon

(“From a bridge in Tehran, an Iranian woman asks Israel to eliminate Iran’s supreme leader and his son in addition to attacking the IRIB television and radio network.” — Amir Tsarfati)

While some debate whether regime change in Iran is ongoing, it is already happening.

And of course it is necessary. As one of the now deceased Iran nuclear scientists explained just weeks ago, their scientists and nuclear installations can all be destroyed but the information required to construct weapons remains. Everything can be reconstructed. True that.

But that’s just one reason regime change is mandatory. The other is what these sadistic Shiites do to women. The misogyny of the ayatollahs is beyond comprehension. This is regime that got started by scraping makeup from women’s faces with razor blades. It got worse from there, especially regarding females who were incarcerated, almost always falsely..

Here’s just a tinge from Grok since it’s been my observation that most Americans, even supposedly educated ones, don’t know much about this:

“… there is substantial evidence from multiple sources, including human rights organizations, former prisoners, and international reports, indicating that the Iranian regime has engaged in the systematic rape of female prisoners, particularly virgins, before their executions. This practice, rooted in a distorted interpretation of Islamic law, was especially prevalent during the 1980s, notably during the mass executions of political prisoners in 1988. The justification was based on a belief that virgins would go to heaven if executed, and rape was used to prevent this. These acts were often framed as "forced marriages" or "temporary marriages" (sigheh) to prison guards or officials, ensuring the women were no longer virgins before execution.”

While doing research for the screenplay “Keys to Paradise” that is set in Iran, Sheryl and I learned that the parents of the raped women were informed of this “marriage” of their daughters that very night as a final exercise in what one might term paleo-sadism.

At that time we also met several of the former political prisoners whose faces resembled Picasso’s from the artist’s cubist period, their bones beaten into distortion from repeated beatings. Your heart went out to them even as you had difficulty looking directly at them.

To put it mildly, this made me partial to regime change. Horrifying as it is, I could not but approve when I saw this video Jun16 from Iranian TV that is a harbinger of the change that is coming rapidly. (Watch to end)


These evil people could have met their end years ago were in not for Barack Obama. Here’ another excerpt from Grok about what I consider close top the darkest moment of US, when we betrayed freedom to such an extent many of us were sickened:

“The phrase ‘Obama, are you with us or are you with them?’ was reportedly chanted by Iranian demonstrators during the 2009 Green Movement protests, which erupted after the disputed presidential election on June 12, 2009. These protests, sparked by allegations of electoral fraud in favor of incumbent President Mahmoud Ahmadinejad, saw millions of Iranians, particularly supporters of opposition candidate Mir Hossein Mousavi, take to the streets. The specific chant emerged as a plea directed at U.S. President Barack Obama, reflecting some protesters' desire for international support, particularly from the United States, amid the Iranian government's violent crackdown.”

Obama was obviously “with them,” as he elected to “negotiate” (to no end, needless to say) with Ahmadinejad rather than support the demonstrators in any meaningful way.

Many have speculated on why Obama did that, so I won’t do so except to say that those who pretend to the monikers “liberal” and “progressive” are the furthest thing from those.

https://americanrefugees.substack.com/p/dont-stop-israel-regime-change-now

Let Workers Control Their Health Insurance

 The most significant healthcare reform of Donald Trump’s first term may have been letting businesses give their workers pre-tax funds to buy their own health insurance.  But few firms have opted to embrace this option.  A modest regulatory reform could soon change that.

Tax incentives have made employers the main purchaser of health insurance in America.  But employer-sponsored insurance plans poorly fit individual workers’ needs and typically overpay for medical care.  Although a 2019 reform allowed firms to give their workers pre-tax funds to purchase their own health insurance, this new arrangement is being held back by overregulation.

The purchase of healthcare benefits by employers doesn’t work well.  Just when staff have begun to understand their insurance plans, human resource departments tell them that everything is about to change.  Employers don’t enjoy the experience either.  The cost of covering a family has risen from $9,950 to $25,572 over the past two decades, and Starbucks now spends more on healthcare for its staff than it does on coffee. 

Businesses struggle to get a good deal purchasing health insurance for their employees.  This is because workers resist curbs on access to unnecessary services and higher out-of-pocket costs for visiting costlier providers.  Patients bear the associated inconvenience, but typically believe that the resulting savings accrue to their employers rather than to themselves. 

While individuals care about having their own doctor, local hospital, and a few other key medical providers in their health insurers’ networks of preferred providers, employers must satisfy workers spread across different neighborhoods who use a wide variety of providers.  That makes it very difficult for group health plans to negotiate good rates by threatening to leave costly medical systems out of their networks – encouraging expenses to spiral upwards.

The collective purchase of health insurance by employers also causes benefit packages to be needlessly expansive.  One study estimated that workers would be willing to forego 10% to 40% of the funds their receive from employers, to control of the choice of their health insurance plans.

Nonetheless, employers purchase most private health insurance because it allows them to compensate staff without bearing income or payroll taxes.  To redress this distortion, the first Trump administration from 2019 permitted firms to give staff pre-tax funds to purchase their own insurance from the individual market by establishing Individual Coverage Health Reimbursement Arrangements (ICHRA).  Yet, in 2024, fewer than 1% of workers received health benefits through ICHRA style accounts. 

Until recently, the appeal of ICHRA was inhibited by the woeful state of the individual market’s risk pool.  But this has since been redressed: whereas Gold-tier individual market plans in 2018 cost 19% more than the average employer contribution to similar group insurance, in 2023, Gold-tier individual market premiums averaged 13% less.

As a new Manhattan Institute report notes, this development gives ICHRA benefits potentially widespread appeal – which is now being held back only by a regulatory prohibition on employers giving staff a choice between group health benefits and funds to purchase their own insurance. 

This regulation is designed to stop firms from designing their benefits to selectively dump employees with the costliest medical needs on the individual market.  But this approach prevents businesses from allowing any workers to benefit from a switch, unless they are willing to force all workers off their current plans.  That makes offering ICHRA benefits a big leap for human resource departments, and an unpalatable option for firms.

The Trump administration could maintain this anti-dumping safeguard much less onerously, by reforming ICHRA’s regulations.  It should simply require that ICHRA contributions exceed minimum standards and that associated group plans conform to the same benefit requirements as those which apply to the individual market. 

Doing so would allow firms to give each of their staff the choice to control their own health insurance.  This would allow them to opt for plans which better meet their needs at lower cost – a development which would benefit employers and employees alike.

Chris Pope is a senior fellow at the Manhattan Institute.

https://www.realclearhealth.com/articles/2025/06/16/let_workers_control_their_health_insurance_1116959.html

Top FDA Official Admits She Refused the Covid-19 Vaccine While Pregnant

 One of the most powerful figures at the US Food and Drug Administration (FDA) has admitted she refused the Covid-19 mRNA vaccine while pregnant—even as her agency promoted it as “safe and effective” for all pregnant women.

Dr Sara Brenner’s explosive disclosure, made on 15 May 2025 at the MAHA Institute Round Table in Washington, DC, is as revealing as it is troubling.

A preventive medicine physician, Brenner has worked at the FDA since 2019. As the FDA’s Principal Deputy Commissioner—and briefly its Acting Commissioner—Brenner was at the centre of decision-making.

Dr Sara Brenner with Leland Lehrman on 15 May 2025 at the MAHA Institute Round Table in Washington, DC

Prior to that, she was Chief Medical Officer for diagnostics and was detailed to the White House to support the Biden administration’s Covid-19 response. She didn’t just participate in the pandemic response, she helped shape it from within.

“Knowing what I knew—not only about nanotechnology, about medicine, about the medical countermeasures—but also having a very strong and firm grounding in bioethics…there were many things that were not right,” she told the audience.

That someone with her seniority and access to internal data privately rejected the vaccine, while her agency promoted it to millions of pregnant women, presents a profound ethical dilemma.

Brenner’s Concerns about mRNA Safety 

Brenner explained that her decision was driven by a lack of safety data, particularly around the biodistribution of the vaccine’s lipid nanoparticles (LNPs)—the tiny fat particles used to deliver the mRNA into cells. 

“It was unknown at the time what the biodistribution patterns of those products were…That was my primary concern, and that exposure I was very concerned about,” said Brenner. 

She had reason to be cautious. 

As a nanomedicine expert who built an MD/PhD program in the field, Brenner had spent years researching the “biodistribution, excretion, metabolism and toxicities associated with engineered nanoparticles.” 

“Materials that don’t exist in nature—there’s a lot of unknowns,” said Brenner. 

She warned that unintended toxic effects—especially in vulnerable populations like pregnant women—could not be ignored. 

“Regardless of the medical product or the intervention, there’s always going to be the need to evaluate both the intended outcomes…and the unintended consequences,” she cautioned.

Warnings Ignored

Brenner’s concerns echoed those raised in 2021 by Canadian immunologist Dr Byram Bridle, who first exposed internal documents from Japan’s regulatory agency showing that LNPs didn’t remain at the injection site, but travelled throughout the body and accumulated in organs including the ovaries, liver, spleen, and bone marrow.

At the time, Bridle’s warnings were aggressively dismissed. His reputation took a hit, and he faced institutional censure from the University of Guelph, where he was a professor, for speaking out against vaccine mandates.

Dr Byram Bridle, Canadian immunologist. Photo credit: Kenneth Armstrong

Now, Brenner’s comments confirm that these concerns were not only valid—they were quietly shared at the highest levels of the FDA.

During the event, Brenner also revealed that her worries extended to breastfeeding and potential exposure to her child after birth.

A 2022 study published in JAMA Pediatrics detected vaccine-derived mRNA in the breast milk of vaccinated mothers for at least 48 hours—the very scenario Brenner had feared. 

Yet the FDA made little effort to publicly investigate or address the findings, dismissing them with the vague reassurance that there was “no evidence of harm.”

No Mandate for Brenner?

It’s unclear how Brenner managed to avoid the vaccine mandate that applied to all federal employees at the time. She didn’t say. Perhaps she received a religious or medical exemption—but she left that part out.

What she did reveal was that she had concerns—deep enough not to take the vaccine during her pregnancy. Yet she said nothing publicly, while her agency told millions of other women it was safe. 

For many, that silence is hard to accept, and it has left many asking why she didn’t warn other women about a product with ‘zero’ clinical safety data in pregnancy.

No one but Brenner knows the full story. But the ethical contradiction is hard to ignore.

Silence Inside the Castle

Brenner acknowledged the immense pressure inside the FDA to stick to the official narrative. 

“They don’t let you get very far out of the castle at FDA with your talking points,” she admitted nervously.

She described the period as a “dark night of the soul” for many civil servants, a time when even “very obvious things” took bravery to say. 

She eventually found support through a group called Feds for Medical Freedom—federal workers advocating for informed consent, bodily autonomy, and pushing back against government overreach.

A Culture Change?

Today, under a new administration, Brenner says the culture inside the FDA is shifting. She praised Commissioner Dr Marty Makary and said transparency is finally becoming a priority.

“We’re moving very quickly to make it such that there will be more transparency…so that people can see and evaluate for themselves what the truths are.”

But Brenner’s remarks won’t undo what has already happened—especially to those who were vaccine-injured or whose pregnancies were affected.

What her comments do offer is a rare glimpse into the internal dynamics of a government institution that issued sweeping public assurances while failing to acknowledge its own uncertainty.

“There was no acknowledgement of what was unknown. There were only statements and assertions that were really more like beliefs,” Brenner said of the FDA’s messaging during the pandemic.

That may be her most important admission.

This is more than a story about one woman’s personal decision. It is a story about institutional culture, regulatory failure, and the consequences of silence.

Those who spoke up were punished. Those who stayed silent kept their jobs and reputations. And those who were forced to comply were often left to deal with the collateral damage.

When asked whether she believed she had made the right decision in refusing the Covid-19 vaccine, Brenner replied simply, “I believe so.”

Now that she has spoken, the question remains—who else knew, and said nothing?

Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

https://brownstone.org/articles/top-fda-official-admits-she-refused-the-covid-19-vaccine-while-pregnant/

General Mills to remove artificial colors from all its US cereals and foods



General Mills (NYSE: GIS) today announced plans to remove certified colors from all its U.S. cereals and all foods served in K-12 schools by summer 2026. Additionally, the company will work to remove certified colors from its full U.S. retail portfolio by the end of 2027.

For nearly 160 years, General Mills has been providing families quality, great-tasting products across its beloved portfolio of brands.

This change impacts only a small portion of General Mills’ K-12 school portfolio, as nearly all its school offerings today are made without certified colors. Similarly, 85 percent of General Mills’ full U.S. retail portfolio is currently made without certified colors.

“Across the long arc of our history, General Mills has moved quickly to meet evolving consumer needs, and reformulating our product portfolio to remove certified colors is yet another example,” said Jeff Harmening, chairman and CEO, General Mills. “Today, the vast majority of our foods are made without certified colors and we’re working to ensure that will soon apply to our full portfolio. Knowing the trust families place in us, we are leading the way on removing certified colors in cereals and all our foods served in K-12 schools by next summer. We’re committed to continuing to make food that tastes great and is accessible to all."

For decades, General Mills has proven its reformulation capabilities and delivered products that delight consumers and meet a changing landscape. General Mills is the leading provider of whole grains to Americans with other notable efforts including industry-leading sugar-reduction work across General Mills’ K-12 school portfolio, doubling vitamin D in General Mills’ cereals in 2023 to help close nutritional gaps, and reducing sodium by 20 percent across key product categories since 2019.

Medicare Rules Finally Ease Access to Simpler Home Ventilation Devices for COPD

 Newly released Medicare national coverage determinations are set to reshape the home ventilation landscape for chronic obstructive pulmonary disease (COPD).

The final determination of coverageopens in a new tab or window released June 9 takes the long-awaited step of simplifying access to bilevel positive airway pressure (BiPAP) respiratory assist devices and restricts the more expensive home mechanical ventilators to only those who need the additional ventilatory modes and features they offer.

"There's definitely celebrating going on," said Lisa Wolfe, MD, of Northwestern University in Chicago and a member of the technical expert panel who worked on the recommendations to the Centers for Medicare and Medicaid Servicesopens in a new tab or window (CMS).

"Because of the way the old guidelines were written, it was really easier to get a full noninvasive ventilator than it was to get a bilevel PAP. And because of that, a lot of COPD patients were getting these larger noninvasive ventilators -- and they are so much more expensive," she told MedPage Today.

The new regulations simplify the burden of proof for both types of devices. They don't have oxygen qualifications or require proof that a patient has tried and failed BiPAP, so "they can go straight to a vent if they need a significant amount of oxygen," Wolfe said.

Conversely, a patient qualifies for a BiPAP machine based on a blood gas test that shows high carbon dioxide (partial pressure of carbon dioxide ≥52 mm Hg by arterial blood gas during awake hours breathing the prescribed fraction of inspired oxygen), without the prior requirement of having to prove the patient had failed 2-L flow of oxygen or a formal sleep study to document that sleep apnea isn't the predominant cause of hypercapnia as long as the treating physician can attest to that.

The determination will expand the role of sleep labs in making decisions and titrating people on BiPAP beyond diagnoses of obstructive sleep apnea or central sleep apnea to now include COPD. "But the problem is it will significantly cut down access to respiratory therapy in the home," which has been tied to home mechanical ventilator rentals, Wolfe acknowledged.

"This has been a rather controversial area for a long time," said Nicholas Hill, MD, of Tufts University in Boston and a co-chair with Wolfe on the recommendations to CMS.

"As recently as 2013, [a Cochrane review] said that the evidence wasn't sufficiently clear to justify use more than on an investigational basis," he noted.

Key turning points were the publication of two trials proving benefit. A randomized trialopens in a new tab or window from Germany and Austria among 195 stable GOLD stage IV COPD patients showed that use of a standard BiPAP-type machine substantially boosted survival. One-year mortality was 12% with the noninvasive PAP compared with 33% in the control group, a 76% relative reduction in risk (P=0.0004). The BiPAP group also gained an advantage in multiple measures of blood oxygenation and lung function, as well as health-related quality of life.

"Results for 6-min walk distance did not reach the predefined significance level, but the suggested minimal clinically important increase in 6-min walk distance of 54 m was reached by 45 (44%) patients in the intervention group versus 23 (25%) control patients," the authors wrote.

A subsequent study from the U.K.opens in a new tab or window that randomized 116 COPD patients with persistent hypercapnia after recent resolution of respiratory acidemia to either home oxygen alone or with BiPAP-type home ventilation showed a longer median time to readmission or death (4.3 vs 1.4 months, adjusted HR 0.49, P=0.002) and a 17% absolute lower 12-month risk of readmission or death (63.4% vs 80.4%) with the added BiPAP. The difference was driven by a reduction in hospitalizations without a difference in mortality, "but they allowed crossovers, which generally is going to make it hard to show positive outcomes," Hill acknowledged.

Guidelines have shifted to recommend noninvasive home ventilation, and now the CMS regulations are in line with the science, Hill suggested.

"Both these positive studies used simple BiPAP-type devices, not these more expensive ones. And there really isn't any justification for CMS rules to encourage use of these more expensive ones as a first option," he told MedPage Today.

A big change was the creation of a pathway for hospitalized patients to go home with a BiPAP machine, although there are documentation requirements, Wolfe said. "In order to make that work, when a patient is in the hospital, the physicians will need to get an arterial blood gas, not a venous one, because the venous won't count. It has to be arterial. And they have to document that the patient is using the BiPAP machine and what the full settings of the machine are and that they are benefiting from that machine up to and including the last 24 hours that they're admitted to the hospital."

Patients who need more than 4 L of oxygen or who use their PAP machine more than 8 hours a day will still qualify for the "Cadillac" version, Wolfe added. "But other than that, they've made it so easy to get a standard BiPAP machine that you're not going to get the higher-end machine unless you have those significant problems."

The new national coverage determination goes into effect by September, and while it only covers COPD, not any other respiratory conditions for which patients might need respiratory assist devices, Wolfe noted that this additional national coverage determination is anticipated to be forthcoming.

A more intractable problem is getting patients on and using the devices.

"I don't think there's any question that people who would stand to benefit from this are not getting it," Hill said. Even in his own hospital, COPD patients on general medical services often don't get pulmonary consultations and thus typically are not offered noninvasive home ventilation. And of those who do get it, "many of them don't continue when they leave the hospital and not infrequently that's because they don't want to," he explained.

This older population often has comorbidities and socioeconomic and cognitive challenges that make them not good candidates or lead them to decline, Hill noted. Then, "a lot of people who are prescribed and even get to the point of receiving them at home are not going to use them as prescribed. You know, they end up in the closet."

After the first 6 months, continued coverage requires that the patient be using the device at least 4 hours per a 24-hour period on at least 70% of days and achieve some clinical benefit.

Disclosures

Wolfe disclosed no relevant relationships with industry.

Hill disclosed a research grant to his institution from Telesair.


https://www.medpagetoday.com/spotlight/copd/116105