Reflections From a Murky Pond

As with all regulatory agencies when left unchecked, the FDA causes great harm through its hyper-authoritarian stances and rules as well as preventing harm through other rules. It’s why such agencies, operating outside of legislation but having the force of law, need to be regularly checked and forced to defend their actions by properly elected officials.

A perfect case in point is the FDA’s lethal regulations that categorically and absolutely forbid drug manufacturers engaging in any form of speech which can be construed as describing or promoting a use of their drug(s) for any use other than an the FDA approved on-label use, even if the information about this other use is entirely truthful, totally non-misleading, and could help physicians better treat their patients.

As a result of the FDA’s interpretation of the Federal Food, Drug and Cosmetic Act (FDCA), manufacturers of pharmaceuticals may face severe penalties for disseminating truthful and non-misleading information about off-label uses before those uses are approved by the FDA. Indeed, some companies have paid settlements of hundreds of millions or billions of dollars in the face of threatened prosecution or trial in civil false claims cases. Governments and other private actors do not suffer the same burdens on their speech, even though the pharmaceutical manufacturer likely has the most complete, up-to-date, and useful information about the product. Moreover, even when it makes economic sense for a pharmaceutical manufacturer to seek FDA approval for a new use, the FDA can take many months or even years to approve such new uses. Patients — especially those with life-threatening conditions — cannot wait for the agency to act. Even with recent changes in the FDCA, if a new use concerns a rare disease — or the drug is off-patent — it may not be economical for the pharmaceutical manufacturer to seek approval of a new use.

— Regulatory Transparency Project

And, sadly, this is lethal regulatory intransigence and tyranny. It has killed, is killing, and will continue to kill people. And all for no valid purposes other than keeping the manufacturers of pharmaceuticals on their proverbial knees before the Deep State and maintaining the perceived relevance – and budget appropriations – of the FDA.

With the FDA censoring what drug makers can publish – even when it’s true, simply presented, and efficacious – many doctors aren’t able to know that there are alternative, off-label, treatment options available for their patients. Similarly, this censorship makes it functionally and legally impossible for health insurance providers to cover the costs of those prescriptions. That has, can, and will kill people – all for the sake of the powermongers of the FDA.

This seems to be no longer be true, but in my day, if you wanted to try CHANTIX to aid you in stopping smoking, insurance wouldn’t cover it because it was an off-label use of the medication.

And, if we’re to even begin to believe the current, #Woke sorts, this is systemic racism since non-Whites, especially the Blacks, are less likely to be able to afford medications that aren’t covered by health insurance. Hence, they’re “disproportionately impacted” by the FDA’s lethal regulations upon free speech involving medicines’ uses.

Honestly, American or Democrat, everyone should be calling for a end to the FDA’s lethal regulation and censorship and calling upon the organization to account for and defend its regulations – which aren’t laws but carry the weight thereof without Legislative oversight – or be forced to abandon them.

The character, Dale Gribble from King of the Hill was a staunch conspiracy theorist, especially when it came to government conspiracies. It was funny. But… the difference between 1997 and 2022 is that now he’s sounding more sane each week. 🙄

Over the last decade, so many things that have been derided by the Left and their media outlets as misinformation have been found to be true or largely and fundamentally so. And so many things the Left and their media outlets have touted as the unconditional truth have been found to be false or largely and fundamentally so. It’s truly to the point that Gribble sounds pretty damn sane.

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Have A Beautiful Black Friday

Yes, it’s Black Friday, the first and in all likelihood most lethal day of this year’s Christmas Shopping Season. Here’s a thought though – one I’ve put forth many times in the past and will put forth many more times in the future – you and the nation would be better off suborning this phenomenon, turning it sideways, and redefining what Black Friday means. 😛

Believe me; I know of what I speak. You’ll be far happier “shopping” for a Black babe than with any consumer goods you’d be buying. And, going there will set you up for having more to be thankful for next Thanksgiving.

Kuchisabishii. It’s a Japanese term which literally means “lonely mouth,” and is used to describe when you’re not hungry, but you eat anyway because your mouth is lonely. It rather poetically sums up boredom or stress induced eating, i.e., the munchies.

I find this interesting – beyond how cool the word is in and of itself – because most of us in the West tend to think of the Japanese as being very reserved and unemotional – true Stoics even – and yet, their language is filled with words that describe many emotions and emotive actions. That, going by the mainstream thoughts among linguists, indicates quite the opposite.

The amount and nature of Biden’s border commitment can be summed up by Creepy Uncle Joe’s chosen Border Czar, US Customs and Border Protection (CBP) Commissioner, Chris Magnus was very recently forced to resign his position by by US Department of Homeland Security (DHS) Secretary, Alejandro Mayorkas. He was given the choice of resigning – which he did after a short bout of defiance – or being terminated for cause.

So, why would the Cuban-American head of DHS, who has always shown a strong bias against White Americans, fire an openly queer official appointed by Biden to manage the influx of illegals across our southern border and into our cities and towns? Simply put, it’s because Magnus was too laser focused – and too openly so – on diversity for its own sake and most of the agenda of the #DefundThePolice insurrectionists and not at all focused on Border Security or any other real part of his job.

As migrant encounters along the southern border continue to set records, frustration is mounting inside the Biden administration with the head of Customs and Border Protection.

Five current administration officials who work with CBP Commissioner Chris Magnus portrayed him as unengaged in his job, saying he often doesn’t attend White House meetings on the situation on the border, badmouths other agencies to colleagues and superiors, and has not built relationships within CBP and across other agencies to address the influx of migrants at the border. They complain he is unfamiliar with some of the operations of CBP and instead is focused primarily on reforming the culture of the Border Patrol, addressing its long list of allegations of racism and violence.

Some of the officials believe Magnus hasn’t prioritized addressing the high number of migrants attempting to cross the border, but instead has continually tried to shift blame to other agencies. As an example, two of the five current administration officials said Magnus brought his boss, Homeland Security Secretary Alejandro Mayorkas, pages of grievances about Immigration and Customs Enforcement. While CBP is responsible for securing U.S. borders at and between ports of entry, ICE is the agency responsible for arresting and detaining undocumented people within U.S. borders.

— Politico
“Biden’s top border chief comes under internal fire“

This is a simple case of incompetence being finally dealt with. While it’s patently obvious that Magnus was appointed by Biden to do what he’s been doing to make our southern more porous and meaningless – and, of course, being openly queer secured the appointment – Magnus has utterly failed to do so quietly, without drawing attention to his mandate from the White House.