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Posts Tagged ‘FDA’

Doctors Sue FDA, Allege Crusade Against Ivermectin ‘Unlawfully Interfered’ With Their Ability to Treat Patients

Posted by M. C. on June 8, 2022

In a lawsuit filed June 2, Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik argued the FDA acted outside of its authority by directing the public, including health professionals and patients, to not use ivermectin — even though the drug is fully approved by the FDA for human use.

Children’s Health Defense

Three physicians are suing the U.S. Food and Drug Administration (FDA) for launching what they allege is a “crusade” against ivermectin as a treatment for COVID-19 that “unlawfully interfered” with the doctors’ ability to practice medicine.

In a lawsuit filed June 2, Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik argued the FDA acted outside of its authority by directing the public, including health professionals and patients, to not use ivermectin — even though the drug is fully approved by the FDA for human use.

The suit, filed in the U.S. District Court, Southern District of Texas, Galveston Division, also names the U.S. Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra and Robert Califf, acting FDA commissioner.

According to the complaint:

“The FDA generally cannot ban particular uses of human drugs once they are otherwise approved and admitted to the market, even if such use differs from the labeling — commonly referred to as ‘off-label’ use.

“The FDA also can not advise whether a patient should take an approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient relationship.

“Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is — and always has been — reserved to states.”

The plaintiffs said their lawsuit isn’t about whether ivermectin is an effective treatment for COVID-19. It’s about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.

In their complaint, they site an FDA publication, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” and tweets from the FDA — including one implying that ivermectin is intended only for animals — among examples of the FDA discouraging the use of ivermectin.

The plaintiffs also argued if the FDA is allowed to interfere with the practice of medicine now, using the pandemic as a cover, “this interference will metastasize to other circumstances, destroying the carefully constructed statutory wall between federal and state regulatory powers, and between the FDA and the professional judgment of health professionals.”

“This lawsuit, brought by three eminently qualified physicians, is a welcome development,” said Mary Holland, Children’s Health Defense president and general counsel.

Holland told The Defender:

“These doctors rightfully assert that the FDA, assisted by corporate media, have unlawfully interfered in the doctor-patient relationship and the appropriate treatment for individual patients. Regulating the doctor-patient relationship is an area of well-established state, not federal, law.

“I hope these plaintiffs will enjoin the FDA from continuing to restrict access to ivermectin and from penalizing healthcare practitioners who use this licensed drug for their patients.”

The plaintiffs: well-respected in their field, high success rate treating COVID patients

See the rest here

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Baby Formula: Thank Protectionists and the FDA for the Shortage

Posted by M. C. on May 16, 2022

Within this voucher programs, funds are funneled to select corporations through programs that grant a formula company “the exclusive right to have its formula provided to WIC participants in the State.” In practice, this means the largest companies with the most lobbyists are able to dominate the subsidized portion of the market. Since the subsidized portion of the market is so huge, that usually means those companies dominate the market overall. This makes it harder for newcomers to break into the market and offer any real competition. This means the marketplace becomes reliant on a small number of large firms. 

Protectionism is fundamentally about using violence against Americans who try to bring goods to market in ways that the protectionists don’t like.

https://mises.org/wire/baby-formula-thank-protectionists-and-fda-shortage

Ryan McMaken

For parents who rely on baby formula—whether by choice or due to medical necessity—the nationwide baby formula shortage has become increasingly difficult to ignore. According to the Wall Street Journal, Walgreens, Target, CVS, and Kroger have all begun rationing supplies of formula.

Covid lockdowns, combined with a product recall by formula manufacturer Abbott Nutrition has created a very real shortage in a product that is key for proper nutrition in many children.

With the shortage has come the usual half-baked bromides about “evil corporations” and how baby formula companies are supposedly not regulated enough. Throw in a few references to “late-stage capitalism” and you’ll get a good taste of the usual “blame capitalism” narrative that accompanies every bout of shortages or rising prices.

Formula Is Heavily Regulated and Subsidized

In reality, federal government intervention in the formula market is rampant. Thanks to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), formula companies are heavily subsidized by voucher programs which mean that the US government is “provid[ing] more than half of the formula that is used in the US.

Within this voucher programs, funds are funneled to select corporations through programs that grant a formula company “the exclusive right to have its formula provided to WIC participants in the State.” In practice, this means the largest companies with the most lobbyists are able to dominate the subsidized portion of the market. Since the subsidized portion of the market is so huge, that usually means those companies dominate the market overall. This makes it harder for newcomers to break into the market and offer any real competition. This means the marketplace becomes reliant on a small number of large firms. 

[Read More: “Why Are the Feds Subsidizing Baby Formula Companies?” by Ryan McMaken]

The anticompetitive nature of federal WIC policy is just one aspect of how little the formula market has to do with anything we might call “the free market.”

Protectionism Prevents Access to Foreign Formula

See the rest here

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The Necro-Neologism of Lethal Legal Experts

Posted by M. C. on March 31, 2022

As both the drone program and the opioid prescription debacle illustrate, when government agencies such as the Pentagon and the FDA have been captured by industry forces focused above all on maximizing profits, they will simply look the other way as the corpses pile up,

https://libertarianinstitute.org/articles/the-necro-neologism-of-lethal-legal-experts/

by Laurie Calhoun

barack obama 1174489 1280

The power of language is magical to behold. Through the mere pronouncement of words, people can be persuaded to do what they would never have thought to do, left to their own devices. The playbook with the most success in this regard is that of war. When people are “informed” that they and their families are in mortal danger, they can and often will acquiesce to any and all policies which government authorities claim to be necessary in order to protect them.

Young people can be coaxed into killing complete strangers who never did anything personally to them. Citizens can be brainwashed to believe that suitably labeled persons can and indeed must be denied any and all human rights. When the stakes are claimed to be life and death, even apparently intelligent people can be goaded to accept that the mere possession of a divergent opinion is evil, and the expression of dissent a crime. The use of military weapons to execute obviously innocent, entirely innocuous civilians, including children, suddenly becomes permissible, so long as the victims have been labeled collateral damage. All any of this takes is to identify “the enemy” as evil.

In centuries past, “the laws of war” were said to require the humane treatment of enemy soldiers. They were diagnosed as suffering from “invincible ignorance,” misled and mistaken about the dispute said to necessitate recourse to war, but still acknowledged as persons capable of being courageous combatants who found themselves through historical fortuity on the wrong side. An enemy soldier was to be provided with the opportunity to lay down his weapon and surrender in order to save his own life. Disarmed or incapacitated soldiers were not to be executed by their captors, for they had already been neutralized and posed no more danger than unarmed civilians. Prisoners of war were to be treated as human beings, and when they were tortured or summarily executed, this constituted a war crime. Such “laws of war,” which form the basis of international agreements, including the Geneva Conventions, have needless to say often been flouted, but, in theory, they were to be upheld by civilized people.

After the terrorist attacks of September 11, 2001, political leaders and government officials proclaimed that “everything changed.” The Bush administration legal team deployed linguistic innovation to issue in an entirely new era of warfare, wherein the “laws of war” would still be said to obtain, but they would be inapplicable to entire classes of human beings. Jihadist soldiers for radical Islamist causes were labeled unlawful enemy combatants, whose “unlawful” status was said to imply that they were protected by neither international norms such as the Geneva Conventions nor the laws of civil society.

Under this pretext, terrorist suspects were tortured while held captive at prisons in Guantánamo Bay, Abu Ghraib and Baghram, in addition to many black sites around the world. Ever keen to cover their tracks, the CIA (Central Intelligence Agency) also flatly denied that they ever tortured anyone, by redefining as enhanced interrogation techniques the abusive practices inflicted on hundreds, if not thousands, of men in an effort to extract from them actionable intelligence. And just in case any of this “logic” was called into question by pesky human rights advocates, Bush administration officials also derided the Geneva Conventions as “quaint.”

See the rest here

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Moving On

Posted by M. C. on February 12, 2022

What will snap this half of the country out of their frightened narcissistic, anti-human, state worship? Perhaps it will be actually stepping into the abyss with a World War III, prosecuted by a barely sentient Joe Biden and a fiscally and morally bankrupt United States.

By Karen Kwiatkowski

I recently received an email from Move-on, a leader in Progressive Democratic advocacy.  They are very concerned about book banning (specifically Maus).  I can’t say it better than they do:

Across the country, book bans have risen dramatically over the past year, led by far-right politicians intent on stopping kids from learning about race, sexual orientation, gender identity, different cultures, or even just an unbiased history of our country.

It is a blatant, despicable attack on our freedoms and an attempt to control the minds of our kids.

We cannot, and will not, let it happen.

Notwithstanding the point here, the very best way to get a kid to read something is to tell them they mustn’t. I mean there are only dozens of websites where you can read this particular graphic novel right now, among a thousand more.

Move-on’s mail listing includes nearly half the country, and it’s the half that enthusiastically endorses the silencing, masking and strait-jacketing of the non-compliant “other.”  They comprise today’s cancel culture, yesterday’s witch hunts, and McCarthyism before McCarthy was vindicated. When they perceive the other half of the country canceling, or even just questioning, something they like, it gets self-righteous, indignant, angry, and ugly real quick.

No doubt, most of this is Democratic fundraising theater.  Still, many of us wonder about what goes on inside the heads of modern leftists.  This short tutorial may help:

Government, if you own it, is good.  Hence Joe Biden is good.  Kamala Harris is good.  The DOJ and FBI and DoD and CDC and FDA, and the Department of Education are all very good.  They were not good in 2019 and 2020, but they are now.

If government is good and the source of good, all must obey, honor and respect it. “Let’s Go Brandon” is code for thinking disrespectful thoughts about the President, therefore it must be eliminated from the cultural language, and those using it and thinking it must be vilified and condemned.

If government is good (and it is when we own it), it does not lie, cheat or steal.

If government does not lie, the CDC at any given moment is telling its best truth to the American people. Those who question the CDC and FDA “truth” and do not follow its “rules of the day” are disobedient.

If government does not cheat, suggesting that government-managed elections have been stolen are lies, not to be tolerated, and insurrectionary.

If government does not steal, suggestions that the vast federal and state administration is not giving us our moneys’ worth in terms of legislation, services, education or justice is disrespectful, disloyal, and ungrateful.

The Move-on message went on to say, “Make no mistake: These are attempts by Republicans to wage a white supremacist culture war and march our country closer toward authoritarianism.

Authoritarianism, rule by a central authority, necessitates threats and punishment to gain compliance, both generally and specifically.  It does not coexist with a decentralized, self-governing, organic authority, of people living their lives as they decide. Some people believe a just and stable balance between the two may be achieved, but the authoritarians know better, and in this they are correct.

Now, Move-on is “opposed” to “authoritarianism.”  The message concludes with this uplifting statement, “As we have done in the past, our grassroots, people-powered movement will fight back, and together we will succeed.”

To understand this conundrum of confusion and hypocrisy, we don’t really have to examine Marx. The animating philosophy for what is dividing the United States is less about marxism and more about narcissism.

There is also a real tension between love of statism, and love for individuals and the natural world. 

See the rest here

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The FDA has Stockholm Syndrome

Posted by M. C. on January 6, 2022

Employees, the lesson for you here is, first seek an exemption.  If your employer denies your exemption request, then consider asking for the specific brand of vaccination they are demanding.  If they say they don’t care, choose Comiranty and wait because the pandemic charade will be over before Pfizer exposes itself to liability by making Comiranty available.  

https://www.williambernardbutler.com/the-fda-has-stockholm-syndrome/

williambernardbutler

Stockholm syndrome is the psychological condition in which a hostage becomes so emotionally and irrationally attached to his or her criminal captor, that the hostage takes the side of the criminal captor as against those trying to thwart the criminal captor.  

It is a sad reflection of the debased state of the U.S. federal government when a $6 billion federal agency actively harms and discredits itself in order to serve the interests of its agency-napper to the detriment of the public it is supposed to serve.  The FDA’s recent actively misleading statements about the FDA-approved status of Pfizer’s Covid shots sadly show that the FDA is playing Patty Hearst to the Pfizer’s SLA.    

The FDA is misleadingly stating that it has approved the Pfizer Covid vaccine, implying that an FDA-approved Pfizer Covid vaccine is currently being offered in the United States.  

The FDA has licensed and approved “a” Pfizer Covid shot.  The distinctive brand-name for the FDA-approved shot is “Comirnaty.”  Do not, however, expect Pfizer to sell, distribute, or make generally available the Comirnaty shot in the U.S.  This is because Pfizer has not obtained legal immunity for the Comirnaty shot.   If Pfizer were to sell, distribute, or make available the Comirnaty shot in the U.S., then Pfizer could be held legally responsible for the adverse health outcomes caused by Comirnaty.  Comirnaty, unlike child vaccines, is subject to normal product liablity laws.  Because of this fact, expect the FDA-approved Comirnaty shot to remain unavailable as long as Pfizer remains exposed to product liability suits brought by anyone injured by Comirnaty shot.  

Pfizer’s other Covid shot, the BioNTech brand shot, enjoys complete legal immunity in the U.S. market but has not obtained FDA approval.  The BioNTech shot is being administered under the Emergency Use Authorization (“EUA”) and enjoys complete legal immunity under the PREP Act.  EUA is a legal end-run around the FDA approval process made possible by the “pandemic.”  

The “show-me-the-incentive-and-I-will-show-you-the-outcome” outcome of the Comirnaty/BioNTech distinction is of course:  (1) Pfizer’s FDA-licensed and approved Comirnaty shot is not available in the United States and won’t be for the foreseeable future; and (2) Pfizer’s unlicensed and unapproved (but legally authorized for emergency use) BioNTech shot is abundantly available and will remain abundantly available.   The reason?  Financial incentives and disincentives.   If Pfizer were to sell or distribute Comirnaty in the U.S., Pfizer would face product liability lawsuits.  Pfizer would be held responsible for the injuries Comirnaty has caused.   Legal responsiblity and liability for injury = powerful economic disincentive to supply = lack of supply.  

Pfizer’s BioNTech shots, however, enjoy complete and total immunity from any and all death, damages and other injuries that they cause.   BioNTech’s immunity means that Pfizer has no risk and no downside for selling it in the U.S.   No legal responsiblity and no liability for injury and death = powerful economic incentive to sell and supply = abundant supply.  

For a loaf of bread a man will transgress.  Pr. 28:21.  

An honest regulator, after going through an arduous expedited approval process, would likely be indignant that its regulatory subject was withholding from the public, in the middle of a “pandemic” mind you, the only licensed and approved anti-pandemic drug.  Not so the FDA.  It falsely implies that the Pfizer vaccine being sold and distributed in the U.S. is FDA approved when it isn’t.  The FDA claims that the two Pfizer shots are the same, although “legally distinct.”  Yes, legally distinct.  If you are killed by the abundantly available BioNTech shot you will have no legal recourse against Pfizer.  If Comirnaty were available and it killed you, you could sue Pfizer and win because Pfizer has determined a known “death rate” for all of its “vaccines.”  In both cases you are dead.  Pfizer has removed the option that allows your family to get compensated for Pfizer’s killing you by removing Comiranty from the market.  The round-heeled FDA will not tell you this.  

Employees, the lesson for you here is, first seek an exemption.  If your employer denies your exemption request, then consider asking for the specific brand of vaccination they are demanding.  If they say they don’t care, choose Comiranty and wait because the pandemic charade will be over before Pfizer exposes itself to liability by making Comiranty available.  If your employer chooses one of the other EUA shots, then remind your employer of his/her Nuremberg Code obligations to provide informed consent before requiring that you submit to an experimental drug test.  If that doesn’t work, you will have to resign.  

Employers, the lesson for you is–grant each and every exemption request, no questions asked.  You are being played.  

Thanks to RFK Jr.’s website for pointing out the Comirnaty/BioNTech distinction.  

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Should the Government Keep People from Harming Themselves? – LewRockwell LewRockwell.com

Posted by M. C. on December 22, 2021

The individual is sovereign, not the state or society.

https://www.lewrockwell.com/2021/12/laurence-m-vance/should-the-government-keep-people-from-harming-themselves/

By Laurence M. Vance

“The only freedom which deserves the name is that of pursuing our own good in our own way, so long as we do not attempt to deprive others of theirs, or impede their efforts to obtain it. Each is the proper guardian of his own health, whether bodily, or mental and spiritual. Mankind are greater gainers by suffering each other to live as seems good to themselves, than by compelling each to live as seems good to the rest.” ~ John Stuart Mill

“Government exists to protect us from each other. Where government has gone beyond its limits is in deciding to protect us from ourselves.” ~ Ronald Reagan

Is keeping people from harming themselves a legitimate function of government? The government certainly thinks so, and many people would agree.

Here are three recent unrelated news stories with different degrees of potential or actual government intervention.

A twenty-year-old college student in Massachusetts died after participating in a hot dog eating contest to raise money for breast cancer research. Although I like hot dogs, I have never been a participant. I have, however, seen events like this on television. Whenever something bad happens at one of these events, and even sometimes when nothing bad happens except an upset stomach and diarrhea, there are always calls for government to ban competitive eating contests. Although earlier this year, China banned competitive eating contests, I have not seen governments in the United States do it—yet.

The U.S. Food and Drug Administration (FDA) has issued voluntary guidance to help Americans reduce their sodium intake. “Excess sodium consumption is a contributory factor in the development of hypertension, which is a leading cause of heart disease and stroke, the first and

fifth leading causes of death in the United States, respectively.” The FDA wants to limit the amount of sodium that restaurants and grocery manufacturers can add to the foods you buy so that you don’t consume more than 3,000 milligrams of sodium per day.

I had never heard of comedian Kate Quigley until I read that she landed in the hospital and three of her friends died from an “accidental” overdose of cocaine and fentanyl at a party in California. Although cocaine and fentanyl are both illegal, the U.S. government and drug warriors are obsessed with the dangers of fentanyl right now. “Fentanyl is killing and wrecking average Americans,” says Kevin Kosar, a senior fellow at the American Enterprise Institute (AEI). Based on data from The Commonwealth Fund, he claims that “more than 50,000 Americans died from it last year alone.”

Although unrelated, these three events have something in common: They all relate in some way to the notion of government keeping people from harming themselves. Should the government keep people from harming themselves? Absolutely not, and for two reasons.

First of all, keeping people from harming themselves is an illegitimate function of government. In the words of men wiser than me:

I would have government defend the life and property of all citizens equally; protect all willing exchange; suppress and penalize all fraud, all misrepresentation, all violence, all predatory practices; invoke a common justice under law; and keep the records incidental to these functions. Even this is a bigger assignment than governments, generally, have proven capable of. Let governments do these things and do them well. Leave all else to men in free and creative effort. ~ Leonard Read

Government is instituted to protect property of every sort; as well that which lies in the various rights of individuals, as that which the term particularly expresses. This being the end of government, that alone is a just government which impartially secures to every man whatever is his own. ~ James Madison

And second, a man’s body belongs to himself—not you, not me, not society, not the state, not some governmental agency, not some puritanical busybody, not some government bureaucrat, and not some nanny statist. And if a man’s body belongs to himself, then he can do what he wants with it.

What these things mean is that no government at any level has any businesses keeping people from consuming any substance or engaging in any activity that may bring them harm. The government should not attempt to prevent people from ingesting or injecting any unsafe, risky, dangerous, harmful, or deadly substance—or punish people for doing so. The government should not attempt to prevent people from overeating, getting obese, starving themselves, eating an unhealthy diet, practicing unsafe sex, getting drunk or stoned, overdosing on liquor or drugs, mutilating themselves, or committing suicide—or punish people for doing so.

Should family, friends, groups, employers, organizations, and other interested parties seek to prevent people from doing these things? Of course they should, but only with reason and persuasion, not with threats, coercion, or violence. Those are the tools of government.

I began with John Stuart Mill and can end with him as well:

The only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others. His own good, either physical or moral is not sufficient warrant. He cannot rightfully be compelled to do or forbear because it will be better for him to do so, because it will make him happier, because, in the opinions of others, to do so would be wise, or even right. These are good reasons for remonstrating with him, or reasoning with him, or persuading him, or entreating him, but not for compelling him, or visiting him with any evil, in case he do otherwise. To justify that, the conduct from which it is desired to deter him must be calculated to produce evil to some one else. The only part of the conduct of any one, for which he is amenable to society, is that which concerns others. In the part which merely concerns himself, his independence is, of right, absolute. Over himself, over his own body and mind, the individual is sovereign.

The individual is sovereign, not the state or society.

Laurence M. Vance [send him mail] writes from central Florida. He is the author of The War on Drugs Is a War on Freedom; War, Christianity, and the State: Essays on the Follies of Christian Militarism; War, Empire, and the Military: Essays on the Follies of War and U.S. Foreign Policy; King James, His Bible, and Its Translators, and many other books. His newest books are Free Trade or Protectionism? and The Free Society.

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FDA Now Wants 75 Years To Release Pfizer Vaccine Documents – LewRockwell LewRockwell.com

Posted by M. C. on December 13, 2021

More secret than the JFK assassination.

“ … it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.”

https://www.lewrockwell.com/2021/12/no_author/fda-now-wants-75-years-to-release-pfizer-vaccine-documents/

By Michael Nevradakis, Ph.D.
Mercola.com

The U.S. Food & Drug Administration (FDA) now says it needs 75 years — up from the 55 years the agency initially requested — to fully release redacted versions of all documents related to the agency’s approval of Pfizer’s Comirnaty COVID-19 vaccine.

In a legal brief filed Dec. 7, the FDA said 59,000 additional pages of documents, not included in the agency’s earlier filings, need to be processed. The agency did not offer an explanation for why those documents initially were overlooked.

The agency said it can release an initial batch of approximately 12,000 pages by the end of January. Past that date, the FDA said it can process and disclose only 500 pages of documents per month.

This would mean the entire cache of documents would not be fully released until 2096. The FDA’s initial timeline would have meant the release of the documents would not be completed until 2076, or 55 years from now.

The FDA did not divulge the criteria it will use to select the initial 12,000 pages of documents, or how the agency will prioritize the release of those pages, or of additional pages going forward.

The documents in question stem from a Freedom of Information Act (FOIA) request filed in August by Public Health and Medical Professionals for Transparency (PHMPT).

In its FOIA request, the group asked the FDA to release “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.

In a filing submitted to a federal judge in November, the U.S. Department of Justice (DOJ), arguing on behalf of the FDA, initially claimed the agency could process some 329,000 pages of documents at a rate of only 500 pages per month, in order to have time to redact legally exempt material.

According to the DOJ, such material includes “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.”

Attorney Aaron Siri, who represents PHMPT, requested the FDA release the documents within 108 days — the amount of time needed by the FDA to license the Comirnaty vaccine.

Remarking on the FDA’s latest request to extend the timeline from 55 to 75 years, Siri stated:

“[I]f you find what you are reading difficult to believe — that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.

“The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure.”

Prior to the FDA’s request for the additional 20 years, U.S. Rep. Ralph Norman (R-S.C.), on Dec. 2, introduced legislation that would require the agency to release all records of information related to Pfizer COVID vaccines within 100 days.

Oral arguments set for Dec. 14

PHMPT, a group comprised of more than 30 medical and public health professionals and scientists from institutions such as Harvard, Yale, and UCLA, initially requested expedited processing of its FOIA submission on the basis there is a “compelling need” for the swift release of the documents in question.

When, in September, the FDA declined the request, Siri’s firm, Siri & Glimstad, filed a lawsuit against the agency on behalf of PHMPT. The lawsuit was filed in U.S. District Court for the Northern District of Texas.

PHMPT argued the release of the documents is a matter of urgency at a time where millions of Americans are facing mandates to get vaccinated or face repercussions.

As stated in PHMPT’s most recent brief demanding timely production of the documents:

“The entire purpose of FOIA is government transparency. In multiple recent cases, in upholding the FOIA’s requirement to ‘make the records promptly available,’ courts have required agencies, including the FDA, to produce 10,000 or more pages per month, and those cases did not involve a request nearly this important — i.e., the data underlying licensure of a liability-free product that the federal government requires nearly all Americans to receive.”

In its latest brief, the FDA cited several reasons justifying its proposed disclosure schedule.

The FDA claimed its Center for Biologics Evaluation and Research, which maintains the records in question, has only 10 staff members, two of whom are “new.”

Additionally, the FDA argued an accelerated rate of release for the documents in question will divert “significant resources away from the processing of other FOIA requests that are also in litigation,” as well as other pending FOIA requests submitted prior to that of PHMPT.

According to Siri, response briefs from both sides are due on Dec. 13, and an oral argument will follow in court on Dec. 14.

FDA promised ‘full transparency’ prior to authorizing vaccines

As previously reported by The Defender, a study examining the processing of FOIA requests by the FDA and other federal public health agencies between 2008 and 2017 found the FDA processed 114,938 such requests, fully or partially granting 72.4% of them.

Of these requests, 39.8% were considered “complex.”

By contrast, the FDA now claims a backlog of 400 FOIA requests. It’s unclear how many pending requests are considered complex

Federal law prescribes a 20-day period for processing “complex” FOIA requests, although this timeframe is frequently exceeded.

According to the FDA, “complex requests,” such as “510K, PMA, and De novo records,” require “approximately 18-24 months to process,” a far cry from 55 (or 75) years.

Prior to authorizing or licensing COVID vaccines, the FDA promised full transparency on the process.

The federal government’s FOIA request guidelines outline two conditions under which a FOIA request may be processed on an expedited basis. The first is “if the lack of expedited treatment could reasonably be expected to pose a threat to someone’s life or physical safety.”

The second condition is “if there is an urgency to inform the public about an actual or alleged federal government activity if made by a person who is primarily engaged in disseminating information.”

In its legal brief, the FDA did not explain how the agency was able to review the nearly 400,000 Pfizer documents in order to expedite the approval of Pfizer’s vaccine in just 108 days.

The FDA also did not explain why the agency cannot expand its staffing capacity to better respond to FOIA requests, or why it can’t enlist the help of other federal agencies, such as the DOJ, which is handling the FDA’s legal defense against the PHMPT lawsuit.

Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.

Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.

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Medicare Data Shows 48,465 Deaths Over 80 Within 14 Days Of Shots: Scrubbed As Non Vaccinated: Renz

Posted by M. C. on December 11, 2021

https://celiafarber.substack.com/p/medicare-data-shows-48465-deaths

Celia Farber

This below was submitted as a comment by Edmond Paré. It is of critical importance, as a follow up to the Pfizer smoking gun documents, which Gate funded “fact checkers” are busy denying. [Their essential “Correction” is this: 1. People die, ok? 2. Anyone can file a VAERS report. (Displaying elite contempt for ordinary people.)

At 3:53 of the Thomas Renz video linked below, he reveals raw data from the Medicare servers, “CMS servers.” 18.1% of Americans are on Medicare, or 59.4 million people.

48,465 people over the age of 80 died within 14 days or their first or second dose. “This is raw data,” says Renz. “Raw. There’s no analysis.” He goes on the remind us of the insult-to-injury fact that the system rigged it such that if a person dies within 2 weeks of a a ‘vaccine,’ they are counted as unvaccinated.

Have you ever heard anything like this in your life?

More raw data: Of those patients given Remdesivir, 25.9 % died. More than a quarter. Of those, 46% died within 14 days of treatment. This is what Fauci considers a “life-saving treatment.”
Remdesivir causes kidney failure. This is true of most of the “vir” drugs that emerged from Fauci’s post-AZT, post David Ho “drugs-into bodies” HIV medication boom. More on this another time. Here’s Mr. Paré:

“With regard to these Pfizer documents, Dr Bryan Ardis of Texas uncovered a list of possible serious Covid-19 vaccine-induced adverse outcomes that the FDA has been withholding/hiding from the medical community, from authorized dispensers, and from all potential Covid-19 “vaccine” recipients. The FDA has had this CBER list since at least October 22, 2020, two months prior to the Covid-19 “vaccine” roll-out here in the U.S. At the same meeting, the CDC presented a similar list of possible adverse events they would be tracking. Interestingly, and not surprisingly, the Table 7 adverse events recorded by Pfizer are what were fully expected by the FDA and CDC to start being reported to them once the vaccinations started.

After watching/listening to several hospital healthcare personnel whistleblowers stating that it is primarily vaccinated individuals presenting to hospital, not with Covid-19 symptoms, but with what appear to be Covid-19 vaccine-induced injuries; and, then encountering vaccine-injury attorney Aaron Siri’s substack, I wrote the following article to assist in disseminating this info. At one point, GlobalResearch changed the URL, deleting all of the stats to that point, but that’s another story.

The FDA’s “Intentional Malfeasance”: Vaccine Injuries include “Deadly Strokes, Bizarre Rashes, Cardiac Arrest, Blood Clots, Neurological Symptoms

https://www.globalresearch.ca/do-you-truly-want-end-mandates-then-everyone-must-call-out-fda-withholding-serious-covid-19-vaccine-adverse-event-outcome-information-medical-community-authorized-dispensers-vaccine-recipients/5760435

The reason I’m posting this here is that, in addition to these FDA lists, the ten hospital whistleblower interviews and the eleven physician declarations of vaccine-injury to themselves and/or to their patients, I believe commenters here will be particularly interested in watching/listening to international trial attorney Reiner Fuellmich’s interview of Dr Bryan Ardis, where the first half of the interview explains how Ardis uncovered Herr Fauci’s genocidal dictate that all hospitals employ the deadly remdesivir as the primary drug in their Covid-19 treatment protocol; and the second half of the interview which “…deals with the CBER FDA C-19VAE list of possible serious adverse event outcomes (of Document 2 above); and briefly discusses the tens of thousands of apparently vaccine-related deaths reported to the VAERS and to the CMS (Medicare/Medicaid) reporting systems.”

In this regard, in the following recent bitchute video, attorney Thomas Renz of Renz-Law.com presents CMS (Medicare/Medicaid) data from New York State which undeniably proves that, contrary to statements by the FDA and CDC, the serious Covid-19 vaccine-induced adverse event outcomes from these lists, including “deaths” are occurring in large numbers of partially vaccinated and fully vaccinated individuals.

ATTORNEY THOMAS RENZ We Got Them! Fact Check This! ALL NEW WHISTLEBLOWER INFO

https://www.bitchute.com/video/2pmlxhO374X2

If you’re pressed for time, skip forward to time = 12:46; but, I would encourage you to listen to the entire presentation.

And, finally, to truly understand the seriousness of the issues at hand, watch, on bitchute, the following interview of Karen Kingston, who was introduced in the above Thomas Renz presentation as the ex-Pfizer employee whistleblower. Karen Kingston has a superb grasp of these deadly vaccines and will surprise you with the depth and extent of her knowledge.

Covid-19 “Vaccines” Are Poison: Greg Hunter Interviews Pharmaceutical Analyst Karen Kingston

And, get the word out on Plandemic III, coming soon (-:

Plandemic 3 Teaser”

—Edmond Paré, submitted as comment

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FDA Wants 55 YEARS to Release Vaccine Approval Documents

Posted by M. C. on December 6, 2021

The lawsuit says that the FDA refused expedited processing of the scientists’ Freedom of Information Act request on the grounds that they did not demonstrate an urgent need. The FDA proposed releasing the documents on a rolling basis of 500 pages per month. That means it would be just under 55 YEARS before the FDA released all 329,000 pages of documents it used to approve the Pfizer COVID vaccine.

50 years of cherry picked data.

Be seeing you

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‘Team Pfizer’? Possible Conflict Of Interest On FDA’s ‘Jabs For Kids’ Panel

Posted by M. C. on October 28, 2021

Why do so many members of the FDA Panel that just approved the covid shot for young children seem to have ongoing ties to Pfizer? Is the panel’s objectivity compromised? Also today: Danish authorities threaten more lockdowns, Ireland’s most-jabbed are also most new cases, and Biden threatens vax refusers with “re-education.”

If this surprises, you haven’t been paying attention.

Be seeing you

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