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The FDA’s War Against the Truth on Ivermectin

By David R. Henderson and Charles L. Hooper | AIER | October 18, 2021

On July 28, the Wall Street Journal ran our article “Why Is the FDA Attacking a Safe, Effective Drug?” In it, we outlined the potential value of the antiparasitic drug ivermectin for Covid-19, and we questioned the FDA’s vigorous attack on ivermectin. Many people praised us and many criticized us. We had clearly covered a sensitive subject. It didn’t help that one of the studies we referenced was retracted shortly before we submitted our article. Within hours of learning that fact, we sent a mea culpa to the Journal’s editors. They acted quickly, adding a note at the end of the electronic version and publishing our letter. It’s important to address two criticisms of our work. The first is that we exaggerated the FDA’s warning on ivermectin. The second is that Merck’s stance on ivermectin proved that even the company that developed ivermectin thought that it doesn’t work for Covid-19.

First, we didn’t exaggerate the FDA’s warning on ivermectin. Instead, the agency changed its website after our article was published, probably to reflect the points we made. Second, Merck had two incentives to downplay ivermectin’s usefulness against the novel coronavirus. We’ll explain both points more fully.

Ivermectin was developed and marketed by Merck & Co. while one of us (Hooper) worked there years ago. Dr. William C. Campbell and Professor Satoshi Omura were awarded the 2015 Nobel Prize for Physiology or Medicine. They earned it for discovering and developing avermectin. Later Campbell and some associates modified avermectin to create ivermectin. Merck & Co. has donated four billion doses of ivermectin to prevent river blindness and other diseases in areas of the world, such as Africa, where parasites are common. The ten doctors who are in the Front Line Covid-19 Critical Care Alliance call ivermectin “one of the safest, low-cost, and widely available drugs in the history of medicine.” Ivermectin is on the WHO’s List of Essential Medicines and ivermectin has been used safely in pregnant women, children, and infants.

Ivermectin is an antiparasitic, but it has shown, in cell cultures in laboratories, the ability to destroy 21 viruses, including SARS-CoV-2, the cause of Covid-19. Further, ivermectin has demonstrated its potential in clinical trials for the treatment of Covid-19 and in large-scale population studies for the prevention of Covid-19.

Contradicting these positive results, the FDA issued a special statement warning that “you should not use ivermectin to treat or prevent Covid-19.” The FDA’s warning, which included language such as, “serious harm,” “hospitalized,” “dangerous,” “very dangerous,” “seizures,” “coma and even death,” and “highly toxic,” might suggest that the FDA was warning against pills laced with poison. In fact, the FDA had already approved the drug years ago as a safe and effective anti-parasitic. Why would it suddenly become dangerous if used to treat Covid-19? Further, the FDA claimed, with no scientific basis, that ivermectin is not an antiviral, notwithstanding its proven antiviral activity.

Interestingly, at the bottom of the FDA’s strong warning against ivermectin was this statement: “Meanwhile, effective ways to limit the spread of COVID-19 continue to be to wear your mask, stay at least 6 feet from others who don’t live with you, wash hands frequently, and avoid crowds.” Was this based on the kinds of double-blind studies that the FDA requires for drug approvals? No.

After some critics claimed that we overstated or overreacted to the FDA’s special warning, we reviewed the FDA’s website and found that it had been changed, and there was no mention of the changes nor any reason given. Overall, the warnings were watered down and clarified. We noticed the following changes:

  • The false statement that “Ivermectin is not an anti-viral (a drug for treating viruses)” was removed.
  • “Taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too” was changed to the less alarming “Ivermectin has not been shown to be safe or effective for these indications.” (Indications is the official term used in the industry to denote new uses for a drug, such as new diseases or conditions, and/or new patient populations.)
  • The statement, “If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed,” was changed to, “If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.” This more clearly acknowledges that reasonable physicians may prescribe ivermectin for non-FDA-approved uses, such as Covid-19.
  • The ending statement about masks, spacing, hand washing, and avoiding crowds was replaced with one that recommended getting vaccinated and following CDC guidelines.
  • The reasonable statement “Talk to your health care provider about available COVID-19 vaccines and treatment options. Your provider can help determine the best option for you, based on your health history” was added at the end.

The new warning from the FDA is more correct and less alarming than the previous one.

In a statement from February, Merck, the company that originated and still sells ivermectin, agreed with the FDA that ivermectin should not be used for Covid-19. “We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.”[2]

To some, this appeared to be a smoking gun. Merck wants to make money, they reason, and people are interested in using ivermectin for Covid-19, therefore, Merck would warn against such usage only if the scientific evidence were overwhelming. But that’s not how the pharmaceutical industry works.

Here’s how the FDA-regulated pharmaceutical industry really works.

The FDA judges all drugs as guilty until proven, to the FDA’s satisfaction, both safe and efficacious. By what process does this happen? The FDA waits for a deep-pocketed sponsor to present a comprehensive package that justifies the approval of a new drug or a new use of an existing drug. For a drug like ivermectin, long since generic, a sponsor may never show up. The reason is not that the drug is ineffective; rather, the reason is that any expenditures used to secure approval for that new use will help other generic manufacturers that haven’t invested a dime. Due to generic drug substitution rules at pharmacies, Merck could spend millions of dollars to get a Covid-19 indication for ivermectin and then effectively get zero return. What company would ever make that investment?

With no sponsor, there is no new FDA-approved indication and, therefore, no official recognition of ivermectin’s value. Was the FDA’s warning against ivermectin based on science? No. It was based on process. Like a typical bureaucrat, the FDA won’t recommend the use of ivermectin because, while it might help patients, such a recommendation would violate its processes. The FDA needs boxes checked off in the right order. If a sponsor never shows up and the boxes aren’t checked off, the FDA’s standard approach is to tell Americans to stay away from the drug because it might be dangerous or ineffective. Sometimes the FDA is too enthusiastic and these warnings are, frankly, alarming. Guilty until proven innocent.

There are two reasons that Merck would warn against ivermectin usage, essentially throwing its own drug under the bus.

Once they are marketed, doctors can prescribe drugs for uses not specifically approved by the FDA. Such usage is called off-label. Using ivermectin for Covid-19 is considered off-label because that use is not specifically listed on ivermectin’s FDA-approved label.

While off-label prescribing is widespread and completely legal, it is illegal for a pharmaceutical company to promote that use. Doctors can use drugs for off-label uses and drug companies can supply them with product. But heaven forbid that companies encourage, support, or promote off-label prescribing. The fines for doing so are outrageous. During a particularly vigorous two-year period, the Justice Department collected over $6 billion from drug companies for off-label promotion cases. Merck’s lawyers haven’t forgotten that lesson.

Another reason for Merck to discount ivermectin’s efficacy is a result of marketing strategy. Ivermectin is an old, cheap, off-patent drug. Merck will never make much money from ivermectin sales. Drug companies aren’t looking to spruce up last year’s winners; they want new winners with long patent lives. Not coincidentally, Merck recently released the clinical results for its new Covid-19 fighter, molnupiravir, which has shown a 50% reduction in the risk of hospitalization and death among high-risk, unvaccinated adults. Analysts are predicting multi-billion-dollar sales for molnupiravir.[3]

While we can all be happy that Merck has developed a new therapeutic that can keep us safe from the ravages of Covid-19, we should realize that the FDA’s rules give companies an incentive to focus on newer drugs while ignoring older ones. Ivermectin may or may not be a miracle drug for Covid-19. The FDA doesn’t want us to learn the truth.

The FDA spreads lies and alarms Americans while preventing drug companies from providing us with scientific explorations of existing, promising, generic drugs.


David R. Henderson is a Senior Fellow with the American Institute for Economic Research.

He is also a research fellow with the Hoover Institution at Stanford University and emeritus professor of economics with the Naval Postgraduate School, is editor of The Concise Encyclopedia of Economics.

David was previously the senior economist for health policy with President Reagan’s Council of Economic Advisers.

***

Charles L. Hooper is President and co-founder of Objective Insights, Inc. He is also the author of Would the FDA Reject Itself? (Chicago Park Press, 2021), currently available as an ebook on Apple Books and Amazon Kindle. A paper version is forthcoming.

Prior to forming Objective Insights in 1994, he worked at Merck & Co., Syntex Labs, and NASA.

He is a former visiting fellow at the Hoover Institution at Stanford University.

His experience is in decision analysis, economics, product pricing, forecasting, and modeling.

October 22, 2021 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular | , , | Leave a comment

FDA and CDC Ignore Damning Report that over 90% of a Hospital’s Admissions were Vaccinated for Covid-19

By Aaron Siri | October 17, 2021

A concerned Physician Assistant, Deborah Conrad, convinced her hospital to carefully track the Covid-19 vaccination status of every patient admitted to her hospital. The result is shocking.

As Ms. Conrad has detailed, her hospital serves a community in which less than 50% of the individuals were vaccinated for Covid-19 but yet, during the same time period, approximately 90% of the individuals admitted to her hospital were documented to have received this vaccine.

These patients were admitted for a variety of reasons, including but not limited to COVID-19 infections. Even more troubling is that there were many individuals who were young, many who presented with unusual or unexpected health events, and many who were admitted months after vaccination.

One would think that after an association was identified by a healthcare professional, our health authorities would at least review this finding, right? Sadly, when Ms. Conrad reached out to health authorities herself, she was ignored. My firm then sent a letter to the CDC and FDA on July 19, 2021 on Ms. Conrad’s behalf (see letter below), yet neither agency has responded. Even worse, when doctors came to Ms. Conrad for assistance with filing VAERS report for their patients, the hospital prohibited her from filing these reports.

That the CDC and FDA failed to respond is arguably not surprising – they have been cheerleading this vaccine for months. Admitting almost any harm now would be akin to asking them to turn a gun on themselves.

This again highlights the importance of never permitting government coercion and mandates when it comes to medical procedures.

Full letter to the CDC and FDA:

Letter exchange with the hospital:

In-depth interview with Ms. Conrad on the Highwire:

 

October 21, 2021 Posted by | Science and Pseudo-Science, Timeless or most popular | , , , | Leave a comment

Nebraska AG Says Doctors Can Legally Prescribe Ivermectin, HCQ for COVID, Calls Out FDA, CDC, Fauci, Media for ‘Fueling Confusion and Misinformation’

By Megan Redshaw | The Defender | October 18, 2021

Few subjects have been more controversial than ivermectin and hydroxychloroquine — two long-established, inexpensive medications widely and successfully used in many parts of the world for the prevention and treatment of COVID.

By contrast, the use of both medications against COVID has been largely suppressed in the U.S, where doctors have been threatened and punished for prescribing them.

On Oct. 15, Nebraska Attorney General (AG) Doug Peterson issued a legal opinion that Nebraska healthcare providers can legally prescribe off-label medications like ivermectin and hydroxychloroquine for the treatment of COVID, so long as they obtain informed consent from the patient.

However, if they did neglect to obtain consent, deceive, prescribe excessively high doses or other misconduct, they could be subject to discipline, Peterson wrote.

The AG’s office emphasized it was not recommending any specific treatment for COVID. “That is not our role,” Peterson wrote. “Rather, we address only the off-label early treatment options discussed in this opinion and conclude that the available evidence suggests they might work for some people.”

Peterson said allowing physicians to consider early treatments will free them to evaluate additional tools that could save lives, keep patients out of the hospital and provide relief for our already strained healthcare system.

The opinion, based on an assessment of relevant scientific literature, was rendered in response to a request by Dannette Smith, CEO of the Nebraska Department of Health and Human Services.

Smith asked the AG’s office to look into whether doctors could face discipline or legal action under Nebraska’s Uniform Credential Act (UCA) — meant to protect public health, safety and welfare — if they prescribed ivermectin or hydroxychloroquine.

“After receiving your question and conducting our investigation, we have found significant controversy and suspect information about potential COVID-19 treatments,” Peterson wrote.

For example, a paper published in the Lancet — one of the most prestigious medical journals in the world — denounced hydroxychloroquine as dangerous, yet the statistics were flawed and the authors refused to provide analyzed data.

The paper was retracted, but not before countries stopped using the drug and trials were cancelled or interrupted.

“The Lancet’s own editor-in-chief admitted that the paper was a ‘fabrication,’ a ‘monumental fraud’ and a ‘shocking example of research misconduct’ in the middle of a global health emergency,” Peterson wrote in the opinion.

A recently published paper on COVID recognized that “for reasons that are yet to be clarified,” early treatment has not been emphasized despite numerous U.S. healthcare providers advocating for early treatment and “scores of treating and academic physicians” — who have published papers in well respected journals — urging early interventions.

Peterson cited numerous studies showing ivermectin and hydroxychloroquine reduced mortality by up to 75% or more when used as a preventative or prophylaxis for COVID, suggesting hundreds of thousands of lives could have been saved had the drugs been widely used in America.

“Every citizen — Democrat or Republican — should be grateful for Doug Peterson’s thoughtful and courageous counteroffensive against the efforts of Big Pharma, its captive federal regulators, and its media and social media allies to silence doctors and deny Americans life-saving treatments,” Robert F. Kennedy Jr., chairman of Children’s Health Defense, told The Defender via email.

“We finally have a leader who puts constitutional rights, peer-reviewed science and human health above industry profits. Doug Peterson is uncowed and unbowed — a genuine hero on horseback for all Americans.” Kennedy said.

Children’s Health Defense President Mary Holland agreed. “This Nebraska AG opinion lets doctors get back to being doctors — without being second-guessed by government, pharmacists and others interfering in the crucial doctor-patient relationship,” Holland said.

Although the AG’s office did not rule out the possibility that other off-label drugs might show promise — either now or in the future — as a prophylaxis or treatment against COVID, it confined its opinion to ivermectin and hydroxychloroquine for the sake of brevity.

Nebraska AG highlights science on ivermectin

In his legal opinion, Peterson concluded evidence showed ivermectin demonstrated striking effectiveness in preventing and treating COVID, and any side effects were primarily minor and transient. “Thus, the UCA does not preclude physicians from considering ivermectin for the prevention or treatment of COVID,” Peterson wrote.

In the decade leading up to the COVID pandemic, Peterson found numerous studies showing ivermectin’s antiviral acti­vity against several RNA viruses by blocking the nuclear trafficking of viral proteins, adding to 50 years of research confirming ivermectin’s antiviral effects.

In addition, safety data for ivermectin showed side effects were “vanishingly small.” The latest statistics available through VigiAccess reported only 5,674 adverse drug reac­tions to ivermectin between 1992 and October 13, 2021, an “incredibly low” number given that 3.7 billion doses have been administered since the 1980s, Peterson wrote.

Peterson cited several studies showing ivermectin led to improvement of COVID outcomes when used in early treatment or as a prophylaxis, while noting many studies with negative findings about ivermectin “excluded most available evidence,” cherry picked data within studies, misreported data, made unsupported assertions of adverse reactions to ivermectin and had “conclusions that did follow from evidence.”

Peterson also found that epidemiological evidence for ivermectin’s effectiveness, derived by analyzing COVID-related data from various states, countries or regions is instructive in the context of a global pandemic.

In one instance, a group of scholars analyzed data comparing COVID rates of countries that routinely administer ivermectin as a prophylaxis and countries that did not. The research showed “countries with routine mass drug administration of pro­phylactic … ivermectin have a significantly lower incidence of COVID-19.”

“This ‘highly significant’ correlation manifests itself not only ‘in a worldwide context’ but also when comparing African countries that regularly administer prophylactic ‘ivermectin against parasitic infections’ and African countries that do not,” Peterson wrote. “Based on these results, the researchers surmised that these results may be connected to ivermectin’s ability to inhibit SARS-CoV-2 replication, which likely leads to lower infection rates.”

Nebraska AG calls out FDA, Fauci on hypocrisy on ivermectin

Many U.S. health agencies have now addressed the use of ivermectin for COVID. The National Institutes of Health (NIH) has adopted a neutral position, choosing not to recommend for or against the use of ivermectin — a change from its position in January 2021 where it discouraged use of the drug for treatment of COVID.

Peterson wrote:

“The reason for the change is the NIH recognized several randomized trials and retrospective cohort studies of ivermectin use in patients with COVID-19 have been published in peer-reviewed journals. And some of those studies reported positive outcomes, including shorter time to resolution of disease manifestations that were attributed to COVID-19, greater reduction in inflammatory marker levels, shorter time to viral clearance, [and] lower mortality rates in patients who received ivermectin than in patients who received comparator drugs or placebo.”

Yet, on Aug. 29, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases within the NIH, went on CNN and announced “there is no clinical evidence” that ivermectin works for the prevention or treatment of COVID. Fauci went on to reiterate that “there is no evidence whatsoever” that it works.

“This definitive claim directly contradicts the NIH’s recognition that ‘several randomized trials … published in peer-reviewed journals’ have reported data indicating that ivermectin is effective as a COVI D-19 treatment,” Peterson wrote.

In March 2021, the FDA posted a webpage, “Why You Should Not Use lvermectin to Treat or Prevent COVID-19.”

“Although the FDA’s concern was stories of some people using the animal form of ivermectin or excessive doses of the human form, the title broadly condemned any use of ivermectin in connection with COVID-19,” Peterson wrote. “Yet, there was no basis for its sweeping condemnation.”

Peterson wrote:

“Indeed, the FDA itself acknowledged on that very webpage (and continued to do so until the page changed on September 3, 2021) that the agency had not even ‘reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19.’ But without reviewing the available data, which had long since been available and accumulating, it is unclear what basis the FDA had for denouncing ivermectin as a treatment or prophylaxis for COVID-19.

“On that same webpage, the FDA also declared that ‘[i]vermectin is not an anti-viral (a drug for treating viruses).’ It did so while another one of its webpages simultaneously cited a study in Antiviral Research that identified ivermectin as a medicine ‘previously shown to have broad-spectrum anti-viral activity.’”

“It is telling that the FDA deleted the line about ivermectin not being ‘anti-viral’ when it amended the first webpage on September 3, 2021,” Peterson noted.

Peterson said the FDA’s most controversial statement on ivermectin was made on Aug. 21, when it posted a link on Twitter to its “Why You Should Not Use lvermectin” webpage with this statement: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

“This message is troubling not only because it makes light of a serious matter but also because it inaccurately implies that ivermectin is only for horses or cows,” Peterson wrote.

Peterson said the FDA has assailed ivermectin’s safety while ignoring the fact that physicians routinely prescribe medications for off-label use and that ivermectin is a “particularly well-tolerated medicine with an established safety record.”

Peterson added the FDA is ignoring several randomized controlled trials and at least one meta­analysis suggesting ivermectin is effective against COVID. He pointed out the Centers of Disease Control and Prevention has adopted a similar stance — unsupported by scientific evidence — and the media has fueled confusion and misinformation on the drug.

Peterson questions professional associations’ stance on ivermectin

Professional associations in the U.S. and internationally have adopted conflicting positions on ivermectin and COVID. The American Medical Association (AMA), American Pharmacists Association (APhA) and American Society of Health-System Pharmacists (ASHP) issued a statement in September strongly opposing the ordering, prescribing or dispensing of ivermectin to prevent or treat COVID outside of a clinical trial.

But their statement relied solely on the FDA’s and CDC’s suspect positions.

The AMA, APhA and ASHP also mentioned a statement by Merck — the original patent-holder — opposing the use of ivermectin for COVID because of a “concerning lack of safety data in the majority of studies.”

“But Merck, of all sources, knows that ivermectin is exceedingly safe, so the absence of safety data in recent studies should not be concerning to the company,” Peterson wrote.

Peterson called into question the objectivity of Merck in providing an opinion on ivermectin that U.S. health agencies are relying upon. “Why would ivermectin’s original patent holder go out of its way to question this medicine by creating the impression that it might not be safe?” Peterson asked. “There are at least two plausible reasons.”

Peterson explained:

“First, ivermectin is no longer under patent, so Merck does not profit from it anymore. That likely explains why Merck declined to ‘conduct clinical trials’ on ivermectin and COVID-19 when given the chance.

“Second, Merck has a significant financial interest in the medical profession rejecting ivermectin as an early treatment for COVID-19. [T]he U.S. government has agreed to pay [Merck] about $1.2 billion for 1.7 million courses of its experimental COVID-19 treatment, if it is proven to work in an ongoing large trial and authorized by U.S. regulators.”

Merck’s treatment is known as “molnupiravir,” and aims to stop COVID from progressing when given early in the course of disease. When Merck announced Oct. 1, that preliminary studies indicated molnupiravir reduced hospitalizations and deaths by half, the drug maker’s stock price immediately jumped to 12.3%.

“Thus, if low-cost ivermectin works better than, or even the same as molnupiravir, that could cost Merck billions of dollars,” Peterson wrote.

Peterson takes on science of hydroxychloroquine

Peterson said based on his review of the evidence, his office did not find clear and convin­cing evidence that would warrant disciplining physicians who prescribe hydroxychloroquine for the prevention or early treatment of COVID after first obtaining informed patient consent.

Peterson pointed to similar findings with hydroxychloroquine — a less toxic derivative of a medicine named chloroquine — widely used since it was approved by the FDA in 1955 for treatment of malaria.

Peterson noted that as early as 2004, a lab study revealed chloroquine was “an effective inhibitor of the replication of the severe acute respiratory syndrome coronavirus (SARS-CoV) in vitro” and should “be considered for immediate use in the prevention and treatment of SARS-CoV infections.”

In 2005, another study showed chloroquine had strong antiviral effects on SARS-CoV infection and was effective in preventing the spread of SARS-CoV in cell cultures.

Other studies showed hydroxychloroquine exhibited antiviral properties that can inhibit SARS-CoV-2 virus entry, transmission and replication, and contains anti-inflammatory properties that help regulate pro-inflammatory cytokines.

Peterson wrote, “many large observational studies suggest that hydroxychloroquine significantly reduces the risk of hospitalization and death when administered to ­particularly high-risk outpatients as part of early COVID-19 treatment.”

Peterson said the drug is considered to be so safe it can be prescribed for pregnant women, yet during the pandemic, the FDA raised questions about hydroxychloroquine and adverse cardiac events.

These concerns prompted one group of researchers to conduct a systematic review of the hydroxychloroquine safety literature pre-COVID. Their review indicated people taking hydroxychloroquine in appropriate doses “are at very low risk of experiencing cardiac [adverse events], particularly with short-term administration” of the drug.

Researchers noted COVID itself can cause cardiac problems, and there was no reason “to think the medication itself had changed after 70 years of widespread use,” Peterson wrote.

Peterson said one piece of key flawed data had substantially contributed to safety concerns surrounding the drug — the admittedly fraudulent Lancet study that falsely claimed hydroxychloroquine increased frequency of ventricular arrhythmias when used for treatment of COVID.

The findings were so startling that major drug trials involving hydroxychloroquine “were immediately halted” and the World Health Organization pressured countries like Indonesia that were widely using hydroxychloroquine to ban it. Some countries, including France, Italy and Belgium, stopped using it for COVID altogether.

Peterson wrote:

“The problem, however, is that the study was based on false data from a company named Surgisphere, whose founder and CEO Sapan Desai was a co-author on the published paper.

“The data were so obviously flawed that journalists and outside researchers began raising concerns within days of the paper’s publication. Even the Lancet’s editor in chief, Dr. Richard Horton, admitted that the paper was a fabrication, a monumental fraud and a shocking example of research misconduct in the middle of a global health emergency.”

Despite calls for the Lancet to provide a full expansion of what happened, the publication declined to provide details for the retraction.

As with ivermectin, the FDA and NIH adopted positions against the use of hydroxychloroquine for COVID — making assertions that were unsupported by data. The AMA, APhA and ASHP, which opposed ivermectin, also resisted hydroxychloroquine for the treatment of COVID.

By contrast, the Association of American Physicians and Surgeons, and other physician groups, support the use of both ivermectin and hydroxychloroquine as an early treatment option for COVID. Peterson cited an article co-authored by more than 50 doctors in Reviews in Cardiovascular Medicine who advocated an early treatment protocol that includes hydroxychloroquine as a key component.

Governing law allows physicians to prescribe ivermectin and hydroxychloroquine, AG says

Neb. Rev. Stat. § 38-179 generally defines unprofessional conduct as a “departure from or failure to conform to the standards of acceptable and prevailing practice of a profession or the ethics of the profession, regardless of whether a person, consumer or entity is injured, or conduct that is likely to deceive or defraud the public or is detrimental to the public interest.”

The regulation governing physicians states that unprofessional conduct includes:

“[c]onduct or practice outside the normal standard of care in the State of Nebraska which is or might be harmful or dangerous to the health of the patient or the public, not to include a single act of ordinary negligence.”

Peterson said healthcare providers do not violate the standard of care when they choose between two reasonable approaches to medicine.

“Regulations also indicate that physicians may utilize reasonable investigative or unproven therapies that reflect a reasonable approach to medicine so long as physicians obtain written informed patient consent,” Peterson wrote.

“Informed consent concerns a doctor’s duty to inform his or her patient, and it includes telling patients about the nature of the pertinent ailment or condition, the risks of the proposed treatment or procedure and the risks of any alternative methods of treatment, including the risks of failing to undergo any treatment at all.”

Peterson said this applies to prescribing medicine for purposes other than uses approved by the FDA, and that doing so falls within the standard of care repeatedly recognized by the courts.

Peterson said the U.S. Supreme Court has also affirmed that “off-label usage of medical devices” is an “accepted and necessary” practice, and the FDA has held the position for decades that “a physician may prescribe [a drug] for uses or in treatment regimens or patient populations that are not included in approved labeling.”

Peterson said the FDA has stated “healthcare providers generally may prescribe [a] drug for an unapproved use when they judge that it is medically appropriate for their patient, and nothing in the federal Food, Drug and Cosmetic Act (“FDCA”) limit[s] the manner in which a physician may use an approved drug.”

In a statement to KETV NewsWatch 7, Nebraska’s Department of Health and Human Services said:

“The Department of Health and Human Services appreciates the AG’s office delivering an opinion on this matter. The document is posted and available to medical providers as they determine appropriate course of treatment for their patients.”

© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

October 18, 2021 Posted by | Science and Pseudo-Science | , , , , , | Leave a comment

In 20 Years of Practicing Medicine, ‘I’ve Never Witnessed So Many Vaccine-Related Injuries’

The Defender | October 13, 2021

In a letter dated Sept. 28 to officials at the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), an ICU physician detailed her concerns about the adverse reactions, including deaths, she witnessed in people who had received a COVID vaccine.

Dr. Patricia Lee, a licensed physician in California, said her experience with patients harmed by the vaccine “does not comport with claims made by federal health authorities regarding the safety of COVID-19 vaccines.”

In the letter, Lee described observing “entirely healthy individuals suffering serious, often fatal, injuries,” including transverse myelitis, resulting in quadriplegia, pneumocystis pneumonia, multi-system organ failure, cerebral venous sinus thrombosis, postpartum hemorrhagic shock and septic shock.

Lee, a practicing physician for more than 20 years, said she “never witnessed so many vaccine-related injuries until this year.”

Lee told Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Tom Shimabukuro with the CDC’s COVID-19 Vaccine Task Force Vaccine Safety Team, that while “causation is difficult to prove definitively, it is my clinical judgment that each of these injuries were caused by a COVID-19 vaccine, because there was no other plausible explanation for these injuries other than the fact that the patients had recently been vaccinated.”

Lee acknowledged that her report reflects the experience of a single physician. However, she wrote, it appears “statistically improbable” that any one physician should witness this many COVID-19 vaccine injuries if the federal health authority claims regarding the vaccines’ safety were accurate.

“I can no longer silently accept the serious harm being caused by the COVID-19 vaccines,” Lee concluded. “It is my sincere hope that the reaction to this letter will not be to focus on me, but rather to focus on addressing the serious safety issues with these products that, without doubt, you have either missed or are choosing to ignore.”

Since the issuing of the original letter, Lee’s attorneys sent another letter to the CDC and FDA saying that the agencies’ “failure to respond is highly concerning,” adding that they are seeking a response so they can “arrange a discussion and information gathering session between Dr. Lee and the appropriate representatives at the CDC and FDA.”

Read both letters here.

© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

October 14, 2021 Posted by | Science and Pseudo-Science | , , , | 1 Comment

Ex-Pfizer Employee Warns Vaccine Increases COVID By Over 300%

By Lance D Johnson | Humans Are Free | October 1, 2021 

The fraudulence of covid-19 vaccines is on full display, and the evidence is sitting right out in the open. The full FDA approval for Pfizer’s COMIRNATY vaccine contained clinical proof that the inoculation increases COVID infection by over 300 percent!

Varitage.com

A former Pfizer employee named Karen Kingston is blowing the whistle on her former employer. Kingston is currently a pharmaceutical marketing expert and biotech analyst. When she scrutinized the full FDA approval for COMIRNATY, she found blatant fraud in Pfizer’s clinical studies.

FDA Approves Pfizer’s Covid-19 Vaccine, Even Though It Increases Infection By 300 Percent

Kingston brought forth a Briefing Document from the FDA’s advisory committee meeting that took place on September 17, 2021. The title of the document is, “Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA).” The document includes clinical studies conducted by Pfizer. These studies track the durability of immunity offered by the COMIRNATY vaccine and compare it to immunity observed in unvaccinated people.

“If you get the Pfizer vax, you’re more likely to get COVID” said Kingston, “So, when they weren’t injected, their infection rate was 1.3% and when they got injected, it was 4.34%. It went up by over 300%.” How could the FDA have glossed over this evidence and approved blatant fraud?

Since the vaccine was officially approved, the federal government started applying pressure on businesses across the US, threatening them with extortion and fines if they do not impose vaccine mandates on their employees.

The covid-19 vaccines have been injected almost 225 million times into the arms of Americans, causing severe injury and death along the way. Real world observations also support clinical data showing that the vaccines increase one’s susceptibility to covid-19.

In fact, the vaccines increase viral load in the nostrils of the vaccinated. An August 26 article by Dr. Peter McCullough shows that the covid vaccines allow the vaccinated to carry 251 times the viral load of covid-19 in their nostrils, turning them into the asymptomatic super spreaders they once feared.

Pfizer Studies Show That Being Unvaccinated Offers Greater Protection

Medical freedom rights attorney, Thomas Renz, went public with the Pfizer fraud. The Pfizer study involved over 36,000 people. Those who were injected earlier in the study were more likely to come down with covid infections later on, showing a clear trend of waning immunity. Those put in “high priority” groups, who were vaccinated earlier on, have a 36 percent greater chance of infection, compared to the group that vaccinated later on.

The group that vaccinated later on went unvaccinated for 5.1 months longer than the group that got vaccinated early on. This placebo group did not have high rates of infection while they were unvaccinated, even though they went longer without any “protection.”

Because of this, Kingston stated that the vaccinated group “have an even higher chance of being infected with COVID-19 than the 36 percent difference indicated by this portion of the study.”

The study even admitted in its conclusion: “An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2.” Kingston clarified that infection rates “increase over time” when people get two doses of Pfizer mRNA.

Most shocking was the data on the placebo group. In the first four months, the placebo group had “no vaccine protection” and recorded an infection rate of 12.6 cases per 1,000 person-years. The infection rate for the unvaccinated was a meager 1.3 percent.

After their placebo period, the group got “fully vaccinated.” In just a few months, this group became more infectious and showed 43.4 cases per 1,000 person-years. Their infection rate went UP by over 300 percent to a 4.34% infection rate. Mrs. Kingston called this “super alarming.”

“They had less infection when they had no protection. So, that’s a problem,” she said.

References:

LifesiteNews.comFDA.govPapers.SSRN.com

October 12, 2021 Posted by | Science and Pseudo-Science, Timeless or most popular | , , | 5 Comments

Pfizer Says COVID Vaccine ‘Safe’ for Kids — But Pfizer Has Lied About Kids and Drugs Before

In 1996, Pfizer’s drug, Trovan, was still in the clinical stage of development when the drugmaker tested it, without parents’ consent, on about 200 children.

By Chelli Stanley | The Defender | September 30, 2021

Pfizer last week told the public and the U.S. Food and Drug Administration (FDA) its new experimental COVID vaccine is safe for young children.

It’s a familiar story, similar to one the vaccine maker told in the past about another drug it tested on children — a story that had a terrible outcome.

Both stories began with this simple claim: “These drugs are safe for your children.”

In 1996, Pfizer, the transnational multi-billion-dollar pharmaceutical company, was working to bring a new drug — Trovan — to market. The drug was still in the clinical stage of development, when Pfizer made a decision that reportedly cost the lives of many children, and triggered an international firestorm.

Pfizer took its unlicensed Trovan to Kano, Nigeria, during a meningitis outbreak — though Trovan had never been tested in children or against meningitis.

According to Pfizer whistleblower, Dr. Juan Walterspiel, Pfizer sent unskilled doctors to Kano, who were unlicensed to practice medicine in Nigeria, and who had limited experience treating meningitis in children.

Walterspiel also reported the staff were so unskilled they could not place IV lines, and quickly resorted to orally administering the drug to children.

In the short two weeks Pfizer was in Kano, staff worked with 200 children, and gave 99 of the children unlicensed Trovan, despite the children’s desperate state. Pfizer did this even though Doctors Without Borders was operating in the same Kano hospital, treating children for free, with medicine proven to work well against bacterial meningitis.

Doctors Without Borders realized what Pfizer was doing and in a statement said they “were shocked Pfizer continued the so-called scientific work in the middle of hell.” They “communicated their concerns to both Pfizer and the local authorities.”

Pfizer gave the other 101 children ceftriaxone, which is proven effective for meningitis.  However, many children were “low-dosed,” with only one-third of the recommended amount. Because Pfizer didn’t have enough skilled medical personnel to administer ceftriaxone by IV, staff injected it directly into the children’s butts or thighs.

But “the shots were severely painful, leading to ‘great fear and sometimes dangerous struggles with children.’” So Pfizer lowered the dose significantly to ease the severe pain caused by the shots.

Pfizer said available data indicated the dose remained more than sufficient, but the drug’s manufacturer, Hoffmann-La Roche, said the reductions could have sapped the drug’s strength.

“A high dose is essential,” Mark Kunkel, Hoffmann-La Roche’s medical director, told the Washington Post. “Clinical failures … and perhaps deaths of children could have resulted from the low dosing.”

According to a lawsuit against Pfizer, “five of the children who received Trovan and six of the children who were ‘low-dosed’ with ceftriaxone died, and others treated by Pfizer suffered very serious injuries, including paralysis, deafness and blindness.”

Of the 200 children treated by Pfizer, 181 were gravely injured, and 11 died.

The Washington Post investigated Pfizer’s ethics, stating, “Some medical experts questioned why the company did not switch to the proven pills when it was clear the young patients were approaching death.”

“It could be considered murder,” said Evariste Lodi, the leading Doctors Without Borders physician in Kano, after reading a report that Pfizer kept a child solely on Trovan until the child died.

In a statement about the child’s death, a Pfizer spokeswoman said “researchers had no reason to suspect the experimental medicine was not working.” Pfizer also said Trovan was “at least as effective as the gold standard treatment,” despite it having never been used in children, or for meningitis.

Pfizer designed the clinical trial in Kano “in six weeks, though the risks and complications of such a trial would typically require a year to adequately assess,” The Atlantic reported.

The parents in Kano have maintained they were not notified of an experiment, and that Pfizer did not have their consent to use their children in a drug trial in the middle of a health crisis. They organized to sue the drugmaker, while caring for children injured during the experiment.

Pfizer maintains the Nigerian parents gave full consent for their critically ill children to be used in an experiment, though even Pfizer admits no parent ever signed a consent form.

The lawsuits dragged on for years, as Pfizer refused to admit to any wrongdoing. “We are fed up with this case,” said a father who lost his daughter. “Our children are dead and some are maimed.”

Pfizer said “the trial was conducted appropriately, ethically and with the best interests of patients in mind; and it helped save lives.”

However, even the approval letter Pfizer submitted to the FDA about the Kano trial was exposed by a Nigerian doctor, who “said that his office backdated an approval letter and this may have been written a year after the study had taken place.”

The community of Kano has been profoundly affected — “the experiment shaped public perception of Western drugs in the region. Parents told their children about it. Teachers lectured about Pfizer in classrooms. Pundits spoke of Western physicians seeking human guinea pigs.”

Pfizer acknowledged the severe nature of the meningitis outbreak to a Nigerian investigative committee, then said, “Pfizer’s intervention was therefore strictly a humanitarian gesture aimed at saving lives. It was totally devoid of any commercial undertones.” The company called it “the humanitarian trial.”

“If I had the power, I would take away their medical licenses,” said Lodi.

Pfizer’s Trovan history gets worse

In the initial development of Trovan, Walterspiel reported that Pfizer tried another study and:

“ … the study failed and several patients developed severe post-operative infections and one woman had her uterus removed. Pfizer dispatched risk managers and asked affected patients and relatives to fill out checks for whatever amount they felt right against their signature to keep the payments confidential.”

Pfizer made no such offer in Kano. The families of Kano had to sue Pfizer repeatedly, and received no compensation until nearly 15 years after the incident occurred.

Pfizer did not let these mere setbacks of death, maiming and international scandals deter the company. Within a few short years, the drugmaker brought Trovan to market in both the United States and Europe.

Expecting to reap financial windfalls, Pfizer aggressively marketed Trovan — until it discovered the public in both the EU and U.S. was reeling from liver damage, liver failure and death as a result of taking Trovan.

Reports of adverse reactions grew until Europe took Trovan off the market completely, and the FDA severely restricted the public’s access in the U.S.

New York Times article detailed how Trovan’s serious side effects became known only after it was given to the public. “The case showed how a new drug, marketed by an expert like Pfizer, could be swiftly prescribed to thousands of patients before all the side effects were known. Pfizer said its tests of Trovan had not revealed any serious problems.”

In 2000, William C. Steere Jr., then chairman of Pfizer, acknowledged some side effects only become known after a drug is approved, saying, ”You put the drug in the general population, and then everyone is taking it. We just hold our breath and wait to see if there is something unique with the drug.”

‘If I had an enemy, I would not let him take their drugs’

Pfizer was repeatedly sued in Nigeria and the U.S. for its actions in Kano. In 2009, Pfizer agreed to pay $75 million, despite initially being sued for $8.5 billion.

The company got involved in several more scandals that exploded when Wikileaks published several U.S. Embassy cables detailing Pfizer’s communications.

A Pfizer lawyer described in the cables that “Pfizer has worked closely with former Nigerian Head of State Yakubu Gowon. Gowan spoke with Kano State Governor Mallam Ibrahim Shekarau, who directed the Kano AG to reduce the settlement demand from $150 million to $75 million.”

In another cable, a top Pfizer representative in Nigeria said:

“Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. Pfizer’s investigators were passing this information to local media. A series of damaging articles detailing Aondoakaa’s ‘alleged’ corruption ties were published in February and March.”

A cable showed a Pfizer representative commenting that “Doctors Without Borders administered Trovan to other children during the 1996 meningitis epidemic, and the Nigerian government has taken no action.”

The accusation prompted Doctors Without Borders to publish a strongly worded press release stating that they did not give anyone Trovan, and were in fact the first to speak out about Pfizer’s unethical actions.

Finally, the cables showed that “Pfizer was not happy settling the case, but had come to the conclusion that the $75 million figure was reasonable because the suits had been ongoing for many years, costing Pfizer more than $15 million a year in legal and investigative fees.”

The original lawsuit also sought prison terms for Pfizer officials.

Scandals continued even after the case was settled, when Pfizer demanded that anyone collecting the money give a sample of their DNA. Several people refused, distrusting what Pfizer may do with their DNA. They were not allowed to get compensation as a result.

Pfizer said it “always acted in the best interest of the children involved, using the best medical knowledge available.”

Najib Ibrahim of Kano said of Pfizer, “If I had an enemy, I would not let him take their drugs.”  Abdul Murtala said, “Pfizer reminds me of recklessness with human lives.”

The pattern continues, with 12-year-old injured during Pfizer COVID trial

Maddie de Garay was 12 when she voluntarily participated in Pfizer’s COVID-19 vaccine trial for 12- to 15-year-olds in Ohio. After she took the second dose on January 20, 2021, her life changed.

Her mother, Stephanie de Garay, spoke at press conference in June, held by Sen. Ron Johnson (R-Wis.), during which she described the maiming of her child and Pfizer’s disregard towards Maddie and the family — despite Maddie being part of the trial in order to determine whether Pfizer’s covid vaccine is safe for children.

Stephanie said:

“All we want is for Maddie to be seen, heard, and believed, because she hasn’t been.  And we want her to get the care that she desperately needs so that she can go back to normal. She was totally fine before this. They’re not helping her.”

Stephanie said within 24 hours of the second dose, Maddie “developed severe abdominal and chest pain. She had painful electrical shocks down her neck and spine that forced her to walk hunched over. She had extreme pain in her fingers and toes.”

Maddie went to the ER immediately, as instructed by Pfizer’s vaccine trial administrator. After doctors ran few tests, she was sent home with a diagnosis: “Adverse effect of vaccine initial encounter.”

In the first five months after getting her second dose, Maddie would return to the ER eight more times.

According to Stephanie:

“Over the next 2.5 months, her abdominal, muscle and nerve pain became unbearable.  She developed additional symptoms that included gastroparesis, nausea and vomiting, erratic blood pressure and heart rate, memory loss, brain fog, headaches, dizziness, fainting, and then seizures.

“She developed verbal and motor tics, she had loss of feeling from the waist down and muscle weakness, drastic changes in her vision, urinary retention and loss of bladder control, severely irregular and heavy menstrual cycles, and eventually she had to have an NG tube put in to get nutrition. All of these symptoms are still here today. Some days are worse than others.”

Maddie’s doctors began to suggest she had “functional neurological disorder due to anxiety” and even tried to admit her to a mental hospital. Her family fought it.

It took five months for Maddie to get an MRI of her brain and appropriate blood tests, which she got when her family went elsewhere for medical advice after talking to others who were adversely affected by the COVID vaccines.

Stephanie said:

“What I want to ask is: Maddie volunteered for the Pfizer trial. Why aren’t they researching her to figure out why this happened so other people don’t have to go through this? Instead, they’re just saying it’s ‘mental.’”

The de Garay family has joined with emerging grassroots advocacy groups whose members’ lives suddenly changed after they got a COVID vaccine. They are asking the CDC and FDA to recognize their injuries, the medical community to believe and help them, the media to share their stories, for the public to know about these injuries as part of informed consent, and for their injuries to be studied so that solutions can be found.

Since being injured by new vaccines still in phase 3 trials, they have been subjected to stonewalling, cover-ups, bullying, refusal to collect the data and blanket denials.

Pfizer has not commented publicly on Maddie’s case.

At the September FDA advisory meeting on Pfizer COVID boosters in the U.S., Steve Kirsch, executive director of the COVID-19 Early Treatment Fund, said Pfizer did not record Maddie’s extensive injuries in its clinical trial results. Kirsch also noted Pfizer marked the entirety of Maddie’s injuries as “abdominal pain.”

Kirsch reported Pfizer’s fraud to FDA acting Commissioner Dr. Janet Woodcock, but no investigation has been launched into Pfizer for allegedly erasing Maddie’s extensive injuries from its trial data for children.

© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

September 30, 2021 Posted by | Deception | , , , , , , | Leave a comment

Blame Doctors And Hospitals, Not The Virus, For COVID Deaths

By Joel S. Hirschhorn | Principia Scientific | September 28, 2021

Very, very few physicians are courageous enough to stand up against the vaccine-but-not-early treatment with generics tyranny pushing mass COVID vaccination.

Few will prescribe ivermectin. Few acknowledge the many vaccine risks that for most people outweigh the benefits.

Few accept the science that natural immunity is better than vaccine immunity and people with it should not get the jab.

When Americans see the data on COVID deaths of over 600,000 who or what should they blame?  The truth is this: Better than blaming the virus they should blame hospitals and the vast majority of physicians.  Why?

Because the medical establishment has never had the courage to stand up to the medical tyranny engineered by Fauci and implemented by the CDC and FDA.

People still are dying from COVID because their physicians refuse to genuinely follow the science and prescribe cheap, safe and proven generics like ivermectin.

Of course, there have always been a minority of doctors who have since March 2020 been curing their patients of COVID by using a variety of protocols that hospitals and their doctors refuse to use.

Why are so many nurses and physicians refusing to be vaccinated?  Because they have seen on a daily basis large numbers of patients suffering and dying not from the virus but from the COVID vaccines.

Now one of the most respected physicians and medical researchers, Dr. Robert Malone, has spearheaded a movement to combat medical tyranny by organizing physicians from all over the world and creating just days ago a Physicians Declaration.  Here are some key highlights from this historic action.

— There is an unprecedented assault on our ability to care for our patients.

— Public policy [think Fauci] has chosen to ignore fundamental concepts of science, health and wellness, instead embracing a “one size fits all” treatment strategy [think COVID vaccines] that results in too much illness and death when the individualized, personalized approach to health care is safe and equally or more effective.

–Thousands of physicians are being denied the right to provide treatment to their patients [think ivermectin], as a result of barriers put up by pharmacies, hospitals, and public health agencies, rendering the vast majority of healthcare providers helpless to protect their patients in the face of disease.  Physicians are now advising their patients to simply go home (allowing the virus to incubate) and return when their disease worsens, resulting in hundreds of thousands of unnecessary patient deaths, due to failure-to-treat [other than using vaccines].

— Physicians must defend their right to prescribe treatment, observing the tenet FIRST, DO NO HARM.  Physicians shall not be restricted from prescribing safe and effective treatments [other than vaccines].  These restrictions continue to cause unnecessary sickness and death.  The rights of patients, after being fully informed about the risks and benefits of each option [especially vaccines], must be restored to receive those treatments [such as ivermectin].

— We invite patients, who believe in the importance of the physician-patient relationship and the ability to be active participants in their care, to demand access to science-based medical care.

That last point is where you the reader must join this revolt and demand from your physicians and hospitals your right to get access to generic medicines like ivermectin.  Print the Declaration and give it to your doctor.

If this Declaration simply remains words but not profound changes in the practice of medicine in this pandemic, then all hope for saving lives will be lost.

We are rapidly approaching the point where more people will die from COVID vaccines than the virus.

Fauci and his allies will not easily admit their many evil wrong actions.  If you want to examine extensive medical science details on the emerging Vaccine Dystopia, then read this truth-telling article.

September 28, 2021 Posted by | Full Spectrum Dominance, Science and Pseudo-Science | , , , , | Leave a comment

Nutshell version of the boosters, FDA and CDC

By Meryl Nass, MD | September 24, 2021

1. Marion Gruber, the #2 person in CBER, who has been there for decades and her deputy, Phil Krause, announce their resignations in August, just after Biden administration announces its plan to offer 3’d vaccine doses beginning the week of September 20.

2. FDA issues a license for the Pfizer vaccine on Aug 23, for only two doses while permitting a 3d dose only for those who are immunocompromised. FDA fails to hold an advisory committee meeting around this decision.

3. FDA is caught out for a “bait and switch:” licensing Comirnaty when only the EUA vaccine, named Pfizer-BioNTech, is actually available in clinics. The “license” provides legal cover for mandates, while the EUA provides broad liability cover to the manufacturer. I was the first person to publicly identify this fraud.

4. FDA schedules an advisory committee meeting for Sept. 17, the Friday before Biden’s Sept. 20 date to start offering boosters to the public.

5. Gruber and Krause publish an article in the Lancet noting boosters are not necessary.

6. Pfizer presents to the advisory committee a very small and inadequate data collection to justify the requested broad license expansion for boosters, almost as if they don’t want it. Or perhaps they were told it would be a shoe-in.  Israeli data are presented to buttress the argument for boosters. The advisory committee votes against the broad expansion of boosters to the general population, 16-2.  And this is a hand-picked committee, most of whom are temporary members, chosen, it seems, to help usher in the shots with the least difficulty.

7. A new question is quickly created and put to the advisory committee, asking whether they will approve boosters for those over 65 and those at high risk of severe disease.  They give a unanimous vote yes.

8. FDA leadership has the right to make decisions that go against the advisory committees, but there is a political and prestige cost when this is done. On Wednesday evening 9/22/21, just before the CDC’s advisory committee, the ACIP was to vote on which demographics would get a recommendation for a booster dose the FDA announced its decision to go against its advisory committee and, with weasel words I explained yesterday, opened the booster dose to a broad swathe of Americans. However, they did not license the vaccine for this; instead, they expanded the EUA.

6. ON 9/23/21 the ACIP committee met, were briefed, and were posed 4 questions to vote on. They assented to 3, but, like the FDA advisory committee, refused to approve a recommendation for a broad expansion of the third dose. (It should be noted that all members of the advisory committee work at medical schools, where a third dose would probably become mandatory in the near future.)

7. Unlike the FDA, which issues the rules for drugs and vaccines, the CDC claims to allow its advisory committee to make the decisions about how vaccines should be used. I could not recall a time that the CDC Director had tried to overrule its advisory committee. Helen Branswell of Stat says it happened only once before, in 2003 over the smallpox vaccine.  But on 9/24/21 CDC Director Walensky overruled the advisory committee to broaden the recommendation for a third dose to practically all Americans aged 18 and over. The smallpox vaccine decision was totally political, designed to scare Americans into going to war against Iraq, where no smallpox was ever found.

How will CDC be able to hide behind ACIP’s skirts, claiming that ACIP makes the vaccine decisions, when this time ACIP didn’t?

8. The Biden administration eventually got what it said it wanted, but at the cost of revealing it didn’t give a damn about the Science. Both the FDA and CDC leadership were forced to publicly ignore the evidence as well as their own advisers.

9. A usual suspect was trotted out to applaud the tyrants:

“American Medical Association President Gerald E. Harmon, M.D., applauded Walensky’s leadership and said that his organization believes the recommendation “is a critical step to preserve our nation’s health care capacity and prevent illness among those who have continued to put their own health and safety at risk to care for patients.”‘

As I noted a few days ago, Harmon, a 2-bit family practitioner from South Carolina, rode to fame and fortune as a flight surgeon by exposing and punishing anthrax vaccine refusers with an iron hand, eventually making Major General. This is a ‘leader’ who knows on which side his bread is buttered.

10. Lots of boosters are coming, since the US Government and other governments have already purchased them. New vaccines are a super conduit for graft and corruption.They are sold for several times more than what they cost to make; the profits are incalculable; and so there is an awful lot of money available to pay for “lobbying,” i.e., lobbing cash at politicians.

September 24, 2021 Posted by | Deception, Science and Pseudo-Science | , , , | Leave a comment

Here’s the skinny on what happened yesterday and today regarding the booster dose

By Meryl Nass, MD | September 23, 2021

Last Friday, FDA’s advisory committee (VRBPAC) voted 16 to 2 against giving a license to a third Pfizer booster shot for everyone age 16 and up.

Although a second vote at Friday’s meeting had not been planned, another question was hastily developed. That question asked whether the vaccine could be licensed for a third booster dose for high risk people under the age of 65. That vote got a unanimous yes.

The panels decisions are not final. The FDA is obliged to take the panels advice into consideration, but it is not required to adopt it. So yesterday, the FDA issued a license for the Pfizer vaccine for the booster dose.

But in doing so, FDA added an additional category of people for the booster dose, a category that had not been included in the Advisory Committee’s vote:

  • “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

This is what I call weasel wording. This statement does not make sense. People whose occupation puts them at high risk of exposure to COVID are no more likely to be at high risk of serious complications or severe COVID-19 than anyone else. They are at higher risk of developing COVID, but not at higher risk of serious COVID.

What FDA did (and you know who did this:  Peter Marks, head of CBER and Janet Woodcock, acting Commissioner, are the only people with the authority to come up with this BS) was to take the VRBPAC approval for people with underlying conditions that put them at high risk for severe COVID, and twist it into an approval for all health care workers, staff at schools and colleges, grocery store workers, big box employees, etc.

Why? Because a license is necessary to impose a mandate, that’s why.

It looked like the weasels had won again. However, there was a small hoop left to jump through before any mandates came down.

While FDA determines how a drug or vaccine should be licensed or authorized for use, the CDC’s ACIP committee is the group responsible for creating the recommendations for use of the vaccine in different demographic groups.

And so ACIP did what it never does. It rejected the CDC’s proposal to widen the license for the third dose to all with potential occupational exposures. the ACIP limited their approval to what the FDA advisory committee had voted for last Friday. As CNBC noted,

The panel struggled over a controversial proposal to give boosters to a wide swath of the U.S. population, rejecting the plan by a vote of 9-6.

… Dr. Leana Wen [member of the Council on Foreign Relations and the World Economic Forum], an emergency physician and former Baltimore health commissioner, on Twitter called the CDC panel’s vote to reject boosters more widely a “mistake.”

“Really, we are not allowing healthcare workers, many of whom got vaccinated in back in December, to get a booster? What about teachers in cramped classrooms where masks aren’t required?” she tweeted, adding CDC Director Dr. Rochelle Walensky should overrule the recommendation.

… In a paper published days before an FDA advisory meeting last week, a leading group of scientists said available data showed vaccine protection against severe disease persists, even as the effectiveness against mild disease wanes over time. The authors, including two high-ranking FDA officials and multiple scientists from the World Health Organization, contended in the medical journal The Lancet that widely distributing booster shots to the general public is not appropriate at this time.

I think 2 things happened. The propaganda that the vaccines still prevent serious disease while perhaps not preventing mild disease stood in the way of approving boosters to prevent mild disease. Why give a potentially dangerous booster to prevent a cold? It doesn’t make sense.

Second, everyone on those committees knew that if the vaccine’s third dose did get approved for a huge swath of the general public, it would be mandated for themselves in no time. A third dose would have been required for every member of both FDA’s and CDC’s advisory committees. I don’t think they were ready for that.  And maybe they weren’t ready for the resistance from those who took the 2 shots thinking they were done… and now, it seems they could get into a situation where they could be fired for not having a third dose. What about more and more doses?

Or maybe the large demonstrations in Australia and Europe were influencing those advisory committee members…

September 23, 2021 Posted by | Aletho News | , , , , | Leave a comment

A Legacy of Corruption in the FDA and Big Pharma

By Liam Cosgrove | Mises Wire | September 11, 2021

Our healthcare system is broken, a fact nobody would have disputed in precovid days. Regulatory capture is a reality, and the pharmaceutical industry is fraught with examples. Yet we trusted private-public partnerships to find an optimal solution to a global pandemic, assuming a crisis would bring out the best in historically corrupt institutions.

Here is a brief list of less-than-savory behavior demonstrated by our titans of healthcare:

  • Pfizer and Johnson & Johnson plead guilty to “misbranding with the intent to defraud or mislead” and paying “kickbacks to health care providers to induce them to prescribe [their] drugs,” resulting in fines of $2.3 billion in 2009 and $2.2 billion in 2013, respectively.
  • Pfizer settled another lawsuit for “manipulating studies” and “suppressing negative findings” just a few years later.
  • Moderna has never developed an approved drug, yet one of their board members was placed in charge of Operation Warp Speed. This certainly is unrelated to the fact that they received the most federal vaccine research and development funding and have received over $6 billion from our government since the start of the pandemic.
  • Gilead Sciences paid $97 million in fines, because it “illegally used a non-profit foundation as a conduit to pay the Medicare co-pays for its own drug.”
  • In 2005, AstraZeneca’s drug Crestor was shown to be linked to a life-threatening muscle disease while the company withheld evidence of this and two dozen other effects from the public.
  • In 2012, GlaxoSmithKline paid $3 billion in fines, as it “failed to include certain safety data” relating to their drug, since labeled as connected to heart failure and attacks.

Thankfully, our public health guardians are in place to protect us from the greed and deceit of the private sector, right? Wrong. Enjoy another brief list:

  • The Food and Drug Administration (FDA) worked behind the scenes with company Biogen to alter previously conducted trials of their $56,000 per year Alzheimer’s treatment, and “by removing the subset of people for whom the drug didn’t work, they found a slight statistical effect in favor of the drug.” Even after doing this, an advisory committee voted 10–0 against approving the drug. The FDA approved the drug anyway, causing three committee members to resign.
  • In that case, the third-party advisors did the right thing. This is not always the case: a study by Science Magazine tracking 107 FDA advisors for four years found that 62 percent received money from related drug makers, with 25 percent receiving over $100,000 and 6 percent receiving over $1 million. It only takes a few corrupt advisors to fix a panel and feign medical consensus.
  • In 2017, it was revealed that the acting Centers for Disease Control and Prevention (CDC) director for heart disease and stroke prevention had been secretly communicating with Coca-Cola, providing guidance on how “to influence world health authorities on sugar and beverage policy matters.”

The American healthcare system remains mired in good old-fashioned crony capitalism, fascism, corporatism, mercantilism, protectionism … fancy words for when private companies work with governments to subvert the forces of competition. The suppression of research into off-patent drugs is a nasty symptom of this problem.

While there are countless drugs to which this applies, we will discuss ivermectin. First, addressing the drug’s dismissal by its own manufacturer, Merck, let it be known that ivermectin is no longer under patent. Merck no longer owns exclusive rights to the drug’s production. The forces of competition have been bestowed upon the drug, thus making it far cheaper. Meanwhile, Merck is also currently rolling out an oral covid treatment, which the US government is providing $1.2 billion in funding to research. This would be under patent and may explain the company’s opposition to using ivermectin.

The usefulness of ivermectin remains debatable. However, it’s important to note that in early April 2020,  a study at the University of Monash in Australia suggested it can be effective. Moreover, the drug is FDA approved, has existed for forty years, won a Nobel Prize, and is extremely safe when used at recommended levels. Given the crisis and ivermectin’s safety—safe even if not conferring big benefits for covid sufferers—the rush to condemn use of the drug appears suspect. Indeed, a week after the Australian study was published, the FDA advised against using ivermectin for COVID-19 treatment, forcing desperate people to the black market and to self-prescribe versions of the drug intended for animals.

The FDA noted subsequently that “additional testing is needed.” Yet, to date, there has not been a single completed government-funded study on the effectiveness of ivermectin against covid-19. Meanwhile, they have funneled billions toward research into vaccines and patented treatments. The National Institutes of Health (NIH) funded trials for remdesivir, still under patent with Gilead, despite it being less effective and having more severe side effects than ivermectin. The FDA approved remdesivir under emergency use authorization (EUA) despite published trials, later stating “remdesivir was not associated with statistically significant clinical benefits.”

One would think that if “additional testing” is so important, the US government might be interested in funding research to examine the potential benefits of cheap, safe, and proven drugs that have shown some promise in treating covid. But that’s clearly not what going on. Funding is geared toward helping huge pharmaceutical companies develop new patented drugs. As long Big Pharma wants it, and if there’s a profit to be made, apparently our government will be there to provide funding.

September 13, 2021 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , , | Leave a comment

CDC Gives Incoming Refugees Nobel Prize-Winning Ivermectin

By Kelen McBreen | InfoWars | September 3, 2021

All Middle Eastern, Asian, North African, Latin American, and Caribbean refugees entering the U.S. since 2019 have been prescribed ivermectin.

The CDC recommendation advises doctors working for the International Organization for Migration (IOM), who screen refugees in their home countries, and American doctors who treat them when they arrive to prescribe both ivermectin and albendazole.

Since the CDC guidance was released pre-Covid, naysayers will point out the ivermectin was prescribed for parasites and not for Covid-19, and presume the drug probably doesn’t work against viral infections.

Ivermectin’s creators won a Nobel Prize in Medicine in 2015 for the drug’s ability to battle infections caused by roundworm parasites.

As Tokyo, Japan’s top health official Dr. Haruo Ozaki recently explained, “In Africa, if we compare countries distributing ivermectin once a year with countries which do not give ivermectin… I mean, they don’t give ivermectin to prevent Covid, but to prevent parasitic diseases… but anyway, if we look at Covid numbers in countries that give ivermectin, the number of cases is 134.4 per 100,000, and the number of death is 2.2 in 100,000.”

He continued, “Now, African countries which do not distribute ivermectin: 950.6 cases per 100,000 and 29.3 deaths per 100,000. I believe the difference is clear.”

Several studies show ivermectin actually is effective at treating Covid-19, but what this information truly exposes is the current media and government demonization campaign against it.

Despite media cries of “people eating horse paste” and several stories about an increase in poison control calls from people misusing the drug, the CDC has been giving it to refugees for at least two years.

By the way, a Fox 9 Minnesota story lists possible symptoms of an ivermectin “overdose” as “nausea, vomiting, diarrhea, decreased consciousness, hallucinations, seizures, coma, and death.”

However, not a single person in the United States has died from a Covid-related ivermectin overdose.

Plus, the majority of people resorting to the horse version of ivermectin are doing so because the attacks on the drug have convinced many doctors and pharmacies not to prescribe or carry it.

The establishment is even upset that celebrities like top podcast host Joe Rogan and “Cheers” star Kirstie Alley have touted the drug as helping them defeat Covid.

The CDC is obviously aware that the drug is safe for people to use as its physicians prescribe it to refugees just as tens of thousands of doctors across the U.S. are now giving it to patients for Covid.

So, why is mainstream media and a government agency like the FDA scaring Americans out of a treatment that could help them with the virus?

The FDA’s website explains, “Certain animal formulations of ivermectin such as pour-on, injectable, paste, and ‘drench,’ are approved in the U.S. to treat or prevent parasites in animals. For humans, ivermectin tablets are approved at very specific doses to treat some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea.”

Well, no doctors are prescribing ivermectin animal formulations to their patients, and the government and media both know this.

Perhaps it’s because the FDA, which is “virtually controlled by Pfizer” according to President Trump, is currently developing their own Covid drug to be taken twice a day alongside their vaccine.

Merck, the company that produces ivermectin, is also developing a drug to treat Covid which will make them much more money than the cheap antiviral ivermectin.

On June 9, Merck revealed that the U.S. government is paying the company $1.2 billion to supply 1.7 million courses of the new drug to federal government agencies.

Or, it could be that the Covid vaccines still being used under Emergency Use Authorization would no longer have that emergency approval if a legitimate low-risk treatment were available.

Follow the money and stop paying attention to establishment media.

September 5, 2021 Posted by | Corruption, Deception, Mainstream Media, Warmongering | , , , , | 2 Comments

Why Testing Your Immunity to COVID-19 Is Important

By Dr. Joseph Mercola | September 4, 2021

Antibody testing is the gold standard for determining immunity, says immunologist and physician Dr. Hooman Noorchashm. Yet, the CDC and FDA are actively deterring people from testing their immunity. Why?

In May 2021 the FDA issued an advisory discouraging Americans from testing the status of their antibody immunity to COVID-19, Noorchashm wrote in an editorial on his blog. “Those who are adequately immune to COVID-19 are rarely, if ever, getting reinfected — regardless of whether this immunity comes from vaccination or from a natural infection,” Noorchashm said.

Meanwhile, “those who are NOT immune to SARS-CoV-2 are susceptible to being infected,” he said. He surmises that to end the pandemic upward of 90% of the population need to become immune.

As far as testing for immunity, according to Noorchashm, the FDA advisory prevents people from obtaining critical information necessary to protect themselves during the pandemic. “ … by not encouraging liberal COVID-19 antibody testing, especially in fully vaccinated Americans, the FDA and CDC are preventing vaccinated, but inadequately immune, persons from finding out that they remain susceptible to infection,” he wrote.

Citing his own experience as a physician, he said “patients who hesitate to undergo vaccination are far more likely to do so when they are confronted with a negative antibody test demonstrating they are susceptible.”

SOURCES:

Noorchashm.medium.com August 27, 2021

Epoch Times August 19, 2021

September 4, 2021 Posted by | Science and Pseudo-Science, War Crimes | , , | Leave a comment