The Human Use Of Ivermectin

nih.gov |  Ivermectin has continually proved to be astonishingly safe for human use. Indeed, it is such a safe drug, with minimal side effects, that it can be administered by non-medical staff and even illiterate individuals in remote rural communities, provided that they have had some very basic, appropriate training. This fact has helped contribute to the unsurpassed beneficial impact that the drug has had on human health and welfare around the globe, especially with regard to the campaign to fight Onchocerciasis.⁵⁷⁾

Today, ivermectin is being increasingly used worldwide to combat other diseases in humans, such as Strongyloidiasis (which infects some 35 million each year), scabies (which causes 300 million cases annually), Pediculosis, Gnathostomiasis and Myiasis—and new and promising properties and uses for ivermectin and other avermectin derivatives are continuing to be found.⁵⁸⁾ These include activity against another neglected tropical disease, Leishmaniasis.^59,60) Of perhaps even greater significance is the evidence that the use of ivermectin has both direct and indirect beneficial impact on improving community health. Studies of long-term treatment with ivermectin to control Onchocerciasis have shown that use of the drug is additionally associated with significant reduction in the prevalence of infection with any soil-transmitted helminth parasites (including Ascaris, Trichuris and hookworm), most or all of which are deemed to be major causes of the morbidity arising from poor childhood nutrition and growth.⁶¹⁾ It is also known that the prevalence of head lice is markedly reduced in children taking ivermectin tablets⁶²⁾ and that scabies is markedly reduced in populations taking the drug regularly.⁶³⁾ Above all, ivermectin has proved to be a medicine of choice for the world’s rural poor. In many underprivileged communities throughout the tropics, intestinal worms and parasitic skin diseases are extremely common and associated with significant morbidity. They usually co-exist, with many individuals infected with both ecto- and endoparasites.^64,65) Mass treatment of poly-parasitized populations is deemed to be the best means of control and ivermectin is the ideal drug for such interventions. A recent study in Brazil, using locally produced ivermectin, looked at the impact on internal helminthes and parasitic skin diseases. The researchers concluded that “mass treatment with ivermectin was an effective and safe means of reducing the prevalence of most of the parasitic diseases prevalent in a poor community in North-East Brazil. The effects of treatment lasted for a prolonged period of time”. This study also represented the first published report of human medical intervention using ivermectin that had not been produced by the hitherto traditional manufacturer, Merck & Co. Inc., the patent on the drug expiring in 1997.⁶⁶⁾

In reality, the renewed interest in fighting tropical diseases, including the involvement of the pharmaceutical industry, which has become increasingly evident over the past three decades, and which has saved lives and improved the welfare of billions of people, notably the poor and disadvantaged in the topics, can be traced back to the 1987 introduction of ivermectin for use in humans. According to a recent report, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) data show that the global pharmaceutical industry provided over $9.2 billion in health interventions (medicines and equipment) between 2000–2007 alone, benefitting 1.75 billion people worldwide.⁶⁷⁾ The hitherto unprecedented donation of ivermectin in 1987 can rightly be seen to be the origin of this philanthropic outpouring.

Since the inception of the Mectizan Donation Programme, Merck has donated well over 2.5 billion Mectizan^® tablets for Onchocerciasis treatment, with in excess of 700 million treatments authorised. Currently, some 80–90 million people are taking the drug annually through MDA in Africa, Latin America and Yemen. A further 300 million total treatments have been approved for lymphatic filariasis, with around 90 million treatments being administered annually (Fig. ​(Fig.8 ).8 ). At present 33 countries are receiving ivermectin for Onchocerciasis and 15 for Lymphatic filariasis. Consequently, around US$4 billion worth of ivermectin tablets have been donated to date. In 2010, Ecuador became the second country in the Americas to halt River Blindness transmission. It is hoped that transmission of the disease in the Western hemisphere will be stopped by 2012—a goal that will have been achieved thanks to twice-yearly MDA with ivermectin. Lymphatic filariasis is targeted for global elimination by 2020, and, if all goes well, Onchocerciasis may well be eliminated from Africa soon thereafter.

The Story Of Ivermectin

isglobal  |   What do penicillin, aspirin and ivermectin have in common? Apart from the fact that they rhyme, all three belong to a very select group of drugs that can claim to have had the “greatest beneficial impact on the health and well-being of humanity”.

They have at least two other things in common: all three were found in nature and all three led to a Nobel prize. Aspirin is derived from salicin, a compound found in a variety of plants such as willow trees. Its use was first mentioned by Hippocrates in 400 BC, but was isolated only in 1829 as salicylic acid and synthesised some years later as acetylsalicylic acid. The discovery of the mechanisms underlying aspirin’s effects gave Sir John Vane the Nobel prize in 1982. Penicillin was isolated from mold that grew by accident on a Petri dish in Alexander Fleming’s laboratory. Its discovery changed the course of medicine, and earned Fleming the Nobel prize in 1945, which he shared with Howard Florey and Ernst Chain.

And this brings us to ivermectin- not likely a drug you will have in your first-aid kit, like aspirin or penicillin, but definitely a drug that has improved the lives of millions of people since its discovery in 1975.

The story of how ivermectin was discovered is quite incredible. In the late 1960s, Satoshi Ōmura, a microbiologist at Tokyo’s Kitasako Institute, was hunting for new antibacterial compounds and started to collect thousands of soil samples from around Japan. He cultured bacteria from the samples, screened the cultures for medicinal potential, and sent them 10,000 km away to Merck Research Labs in New Jersey, where his collaborator, William Campbell, tested their effect against parasitic worms affecting livestock and other animals. One culture, derived from a soil sample collected near a golf course southwest of Tokyo, was remarkably effective against worms. The bacterium in the culture was a new species, and was baptised Streptomyces avermictilis. The active component, named avermectin, was chemically modified to increase its activity and its safety. The new compound, called ivermectin, was commercialised as a product for animal health in 1981 and soon became a top-selling veterinary drug in the world. Remarkably, despite decades of searching, S. avermictilis remains the only source of avermectin ever found.

Questions For The FDA

BritishMedicalJournal |   With the US awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).

And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question.

Approval imminent without data transparency, or even an advisory committee meeting?

Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A “full approval” could remain a high bar.

But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,” but provides no data tables showing the frequency of these, or other, adverse events.)

It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”)

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

Peter Doshi, senior editor, The BMJ.

Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.

Has This Safety Monitoring Been Done? If So, What Were The Results?

FDA  | From Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum  - Page 44

5.2. Pharmacovigilance Activities
Pfizer submitted a Pharmacovigilance Plan (PVP) to monitor safety concerns that could be associated with Pfizer-BioNTech COVID-19 Vaccine. The Sponsor identified vaccine-associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk.

Move Along Now, No Influence, No Conflict Of Interest To See Over Here....,

divergemedia  |  Jim Smith, the Former President and CEO of Thomson Reuters and now the current Chairman of the Thomson Reuters Foundation, the corporate arm of the company, also sits as a board member at Pfizer – except under the name James Smith. Robert Malone, the self proclaimed creator of mRNA vaccines was the first to post Mr. Smith’s LinkedIn profile that showed the connections. The LinkedIn profile that Mr. Malone posted reads that “Jim is a non-executive director of Pfizer Inc.”

regarding the "Trusted News Initiative" and censorship of information regarding COVID vaccine safety, please be aware of the link between Pfizer and Reuters. I would call that a journalistic conflict of interest. What do you think? pic.twitter.com/qQCysxnPX6

— Robert W Malone, MD (@RWMaloneMD) June 28, 2021

Since that tweet, it appears that Mr. Smith has removed his picture off of his LinkedIn profile in an attempt to make the connection harder to make. However, the pictures are the same person and the “James Smith” that sits on the board at Pfizer admits to being the Chairman of Thomson Reuters foundation and the former president – verifying it is in fact the same Mr. Smith. Mr. Smith is also a “member of the International Business Council of the World Economic Forum.”

People all over the world are hungry for unbiased information that they can trust. When the chairman of a media company like Reuters also sits on the board at Pfizer how can we believe that there isn’t any form of bias occurring in their coverage of the vaccine rollout? Are we to really believe that there is no conflict here? Do people really believe someone can sit on the board of a major vaccine manufacturer and still provide unbiased coverage of that same vaccine? I don’t think you can remain unbiased – but that’s just my take.

*We have reached out to the Thomson Reuters Foundation about the connection but did not receive a message back before the release of this article.*

 

It's The Smell..., That 80 Year Old Pelosi Smell....,

thesun  |  The event was hosted in Napa Valley over the weekend and the clip of the dozens of guests sitting side-by-side was shared online by Dem donor and winemaker Kathryn Walt Hall.

Critics were quick to slam Pelosi for attending the event in an area where Covid-19 cases are once again spiking.

"Speaker Pelosi wants to lock you down again while she wines and dines with her political donors," House Minority Leader Kevin McCarthy said.

"It's utter hypocrisy."

Controversial QAnon Congresswomen Marjorie Taylor Greene also took shots at Pelosi's fundraiser, alleging that Democrats only care about "controlling you."

"[Speaker Pelosi] does not care about Covid," she wrote on Twitter. 

"Democrats don’t care about covid. They only care about controlling you.

"Magical covid science: The virus stops spreading the minute you sit down to eat or when you speak in a microphone or if you are one of the elites. Liars."

This is not the first time Speaker Pelosi has been slammed for flouting Covid-19 restrictions while California was dealing with outbreaks.

Last year, she was caught on video inside a hair salon with no mask on while such establishments were supposed to be closed due to the virus.

Pelosi was widely slammed online for ignoring rules that she adamantly supported when speaking publicly.

She later alleged that the owner of the hair salon set her up.

 

Biden Is Under Nearly Unprecented Military-Media Assault For Asserting Civilian Control

NYTimes  |   President Biden used his daily national security briefing on the morning of April 6 to deliver the news that his senior military leaders suspected was coming. He wanted all American troops out of Afghanistan by Sept. 11, the 20th anniversary of the attacks on New York and the Pentagon.

In the Oval Office, Defense Secretary Lloyd J. Austin III and Gen. Mark A. Milley, the chairman of the Joint Chiefs of Staff, wanted to make certain. “I take what you said as a decision, sir,” General Milley said, according to officials with knowledge of the meeting. “Is that correct, Mr. President?”

It was.

I’ve never seen such a coordinated media-military attack on a President for asserting civilian control of the military. https://t.co/BVPXHUTxed

— Matt Stoller (@matthewstoller) August 21, 2021

Over two decades of war that spanned four presidents, the Pentagon had always managed to fend off the political instincts of elected leaders frustrated with the grind of Afghanistan, as commanders repeatedly requested more time and more troops. Even as the number of American forces in Afghanistan steadily decreased to the 2,500 who still remained, Defense Department leaders still cobbled together a military effort that managed to protect the United States from terrorist attacks even as it failed, spectacularly, to defeat the Taliban in a place that has crushed foreign occupiers for 2,000 years.

The current military leadership hoped it, too, could convince a new president to maintain at least a modest troop presence, trying to talk Mr. Biden into keeping a residual force and setting conditions on any withdrawal. But Mr. Biden refused to be persuaded.

The two Pentagon leaders stood before Mr. Biden near the same Resolute Desk where President George W. Bush reviewed plans in 2001 to send in elite Special Operations troops to hunt for Osama bin Laden only to see him melt over the border into Pakistan. It was the same desk where President Barack Obama decided on a surge of forces in 2009, followed by a rapid drawdown, only to discover that the Afghan military was not able to defend itself despite billions of dollars in training. It was there that President Donald J. Trump declared that all American troops were coming home — but never carried through a plan to do so.

The Root Cause of the Afghanistan Crisis? U.S. Corporate Profit-Seeking...,

diplomaticourier |  With twenty years to prepare for it, there should be plenty of clarity in the post-mortem on “what went wrong in Afghanistan” for American policy. History warned us with everything but flashing red lights that all was not well as the twenty years progressed. History should also tell us that there will be as little clarity as to how America and allies failed in Afghanistan as the lack of clarity that doomed the enterprise.

The comparisons to Vietnam were already numerous. These will only proliferate as photojournalists -- instinctually sensing a fall of Saigon moment -- capture images of the chaotic and poorly planned evacuation of Kabul. Like America’s involvement in Vietnam, this failure did not happen in a vacuum; it happened in a sequence. Policy failures, lacking political will, military issues, and cultural upheaval all contributed to the images of the helicopter leaving the American embassies in both Saigon, with a long line queued up for an escape that was never to come.

That sequence continued after the Vietnam War. In the decades since, that failure has been studied and debated militarily, politically, and policy-wise. The United States military took the lessons of failure and revolutionized itself, moving to an all-volunteer force, integrating National Guard and Reserve components, and focusing on technological superiority and precision. The result was a much smaller overall force that is more capable, lethal, and diverse, while constituting only 1% of the American population.

The government which that military serves, however, failed to carry out a similar soul searching and rebuilding process. Lip service was given, policy papers were written, debates were had, but the power structure largely remained unchanged. The decades of distance meant the personal lessons of Vietnam were operationally lost to the very impersonal machine of American governance. Accountability for decision-making is lacking. The politics of the day has become more about overseeing the system for what could be gained individually and for one’s party than about operating it effectively for the gain of all. The watchdogs of the free press became increasingly reliant on access journalism to the superstars of the political world, and by omission or commission had their investigatory mandate dulled. A vast majority of the American citizenry, most of them lulled into complacency by a level of prosperity unheard of in all of recorded human history, had little interest in changing the systems that weren’t bothering them, even as the number of individuals suffering from it steadily grew.

The answers to "what went wrong in Afghanistan" begin in that grey area of unlearned history lessons from the last failure of American foreign policy leading to desperate evacuations of an embassy in Saigon to the embassy in Kabul. Afghanistan is a political failure, it is a policy failure, it is a military failure, and it is a human failure. Most of all, it is, was, and will forever be known as an avoidable failure as too many of us watched idly while it slowly metastasized into today’s crisis -- a crisis which history and common sense were warning us about.

Any post-mortem on "what went wrong in Afghanistan" that does not include a root cause of dysfunction within the United States government to operate as a competent and accountable governing mechanism is missing the root domestic cause of the foreign policy disaster that the Global War on Terror has become. The failures of the United States government to learn from past mistakes incubated the current dysfunction that inevitably bled through to foreign policy failures like America’s 20 years in Afghanistan. A United States that cannot conduct conflict resolution within its own government can neither project nor maintain a coherent foreign policy to the rest of the world.

Vaccine Resistance In The Military Remains Very Strong

WaPo  | The Pentagon’s effort to mandate coronavirus vaccination for all 1.3 million active-duty service members will continue to face resistance from a segment of the force, troops and observers say, until military leaders devise an effective strategy for countering pervasive doubt about the pandemic’s seriousness and widespread misinformation about the shots designed to bring it under control.

When Defense Secretary Lloyd Austin announced earlier this month that he would seek to require inoculation no later than mid-September, Pentagon data showed that thousands of personnel — about one-third of the force — remained unvaccinated. President Biden quickly endorsed the move.

The looming mandate comes as the virus’s highly transmissible delta variant fuels a new wave of infections globally, and after Biden, in what was widely seen as a signal to state and local governments and the private sector that they should follow suit, directed agencies throughout the federal government to implement proof-of-vaccination requirements or impose restrictions on employees who refuse. For military personnel, administration officials have said, the need is particularly urgent.

“Right now it’s being framed as a readiness issue,” said Katherine Kuzminski, a senior fellow at the Center for a New American Security, pointing to the current security crisis that has unfolded in Afghanistan’s capital, where thousands of U.S. troops were sent with little notice to help evacuate American citizens and U.S. allies following the Taliban’s takeover of the country. “As we see in Afghanistan, there is certainly a need to rapidly deploy people, and they may or may not be going to places that have relatively high rates of vaccinations.”

But, Kuzminski added, “I don’t think we’ve seen a vaccine that was [so] politicized.”

The Defense Department did not respond to a request for comment about its efforts to address vaccine hesitancy within the ranks.

 

Authority Crumbles When The Truth Is Shared

aeromagazine  |  The First Amendment of the US Constitution specifies that Congress “shall make no law … abridging the freedom of speech.” In fairness, Congress has made no such law. The executive branch is simply stating that it will invoke its power to censor by fiat in collaboration with social media companies, on the pretext of a national emergency.

Given that the federal government enjoys the cooperation of the vast majority of media outlets, the fact that competing social media narratives are sufficient to prevent them from being able to convince the nation that their message is correct represents a significant problem with the message itself, the effectiveness of its communication or the credibility of their sources.

Of these three factors, credibility seems especially weak. Since the start of the pandemic, health leaders have made definitive statements that have subsequently needed to be reversed. First, early in 2020, they insisted the wearing of masks by the public was unnecessary, as it was not believed that the virus spread via airborne transmission. That was incorrect. The hypothesis that the origin of the virus was a lab leak from the Wuhan Institute of Virology was labelled a conspiracy theory, but has now been deemed as likely as a natural origin. In late March, the current CDC cirector, Rochelle Walensky, announced that vaccinated individuals were unable to carry the virus, even though existing studies confirmed that they could both carry and spread it. The CDC later awkwardly walked these comments back. In May it was announced that vaccinated individuals were free to roam unmasked in most settings because they would not spread or contract the virus except in the rarest of circumstances. This directive has now been reversed again due to the rise of the Delta variant, as data have shown that vaccinated individuals may have the same viral load as the unvaccinated, and may indeed be able to spread it to others. The CDC says that vaccinated individuals should return to masking indoors. Even though some of these reversals were due to changing circumstances, the ongoing back-and-forth leads many to question the credibility of the messengers.

It has also become clear that leaders are disseminating misinformation—or, in some cases, disinformation—on behalf of those who know the truth but are making statements to the contrary.

In a 21 July 2021 CNN Town Hall, President Biden insisted: “You’re not gonna get Covid if you have these vaccinations.” This was a completely inaccurate statement. Vaccinated people have contracted Covid since the vaccinations began, and this trend is increasing now that the Delta variant is the dominant viral strain. Data from the Israeli Ministry of Health reveal that, at five months and six months after the second vaccine dose, individuals are only protected from symptomatic Covid at levels of 44% and 16% respectively. Meanwhile, a new study from Israel indicates that protection from serious disease has fallen to 80%.

It may be that this misinformation was conveyed accidentally as a result of inelegant delivery by the president. But this was a very dangerous statement, as it promoted a false impression that the vaccines are completely protective, and was likely to make many question and potentially resist the new announcement from the CDC that vaccinated people should wear masks indoors.

The CDC director declared that this was a pandemic of the unvaccinated—and was soon echoed by President Biden. A large number of health leaders and media contributors have continued to parrot this phrase. But case data from Israel, the UK and many other countries prove that vaccinated individuals are being significantly impacted. Israel recently announced that 60% of its hospitalised Covid patients were fully vaccinated. The newest Public Health England technical report reveals that 25% of Delta hospitalisations and 54% of Delta deaths have occurred in the fully vaccinated. Iceland has achieved a vaccination rate of almost 90% among adults, but still needed to reinstate public health measures due to a surge in Delta infections. Now that the Delta variant has taken hold in the US, there have been numerous instances of vaccinated individuals being infected, including the notable breakthrough infections in Provincetown, Massachusetts that were a central factor prompting new CDC guidance on indoor masking. It is clear that the Delta variant has produced a much more complicated landscape, in which merely the amount of vaccine that has been administered is a less significant data point. In short, it is false to claim that the pandemic affects only the unvaccinated.

In addition to being inaccurate, the narrative that the pandemic now only affects the unvaccinated has created division and hostility between different groups, which is extremely unhelpful given the many cases of shootings in the US, as well as violent outbursts in public spaces including airlines. I have seen vitriolic statements on social media by vaccinated individuals who are blaming the unvaccinated for the Delta variant, even though it was discovered in autumn of last year, before vaccinations were available to the general public. Even some in the media have engaged in blaming the unvaccinated. CNN host John Berman insisted: “If the unvaccinated aren’t to blame, who is?” We urgently need to promote a climate in which people work together rather than being turned against one another.

Some leaders have suggested that increased vaccination levels will arrest the surge in the Delta variant. After the second dose, it takes 35 days with Pfizer or 42 days with Moderna to achieve fully vaccinated status. It is obvious that new vaccinations, which take more than a month to provide full protection, cannot prevent a viral surge that is presently underway. Additional vaccines may indeed help more people to have better health outcomes if they were to become infected—but that is an entirely different claim.

 

We Don't Need No Stinking Public Discussion Of Our Political Decisions...,

britishmedicaljournal |  Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine.

Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.

“The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 20202 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines,” an FDA spokesperson said.

“The FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license application.”

The spokesperson added, “The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.”

The vaccine has already been rolled out to millions of Americans through an emergency use authorisation. Companies typically apply for full approval after a longer period has elapsed so that more data are available for review.

But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven.

Data scrutiny

Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 said the decision removed an important mechanism for scrutinising the data.

“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”

Petition To The FDA To Refrain From Premature Final Approval Of mRNA Neo-Vaccinoids

britishmedicaljournal |  We are part of a group of clinicians, scientists, and patient advocates who have lodged a formal “Citizen Petition” with the United States Food and Drug Administration (FDA), asking the agency to delay any consideration of a “full approval” of a covid-19 vaccine. The message of our petition is “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.” We believe the existing evidence base—both pre- and post-authorization—is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.

The covid-19 vaccines in widespread use have emergency authorizations (EUA), not actual approvals, a crucial regulatory distinction that reflects major differences in the level of regulatory scrutiny and certainty about the risk-benefit balance.

Our petition doesn’t argue that risks outweigh benefits—or that benefits outweigh risks. Rather, we focus on methods and processes, outlining the many remaining unknowns about safety and effectiveness—and suggest the kinds of studies needed to address the open questions.

If the FDA listens to us, they won’t give serious consideration to approving a covid-19 vaccine until 2022. Our first request is that the FDA require manufacturers to submit data from completed Phase III trials—not interim results. Trials by vaccine manufacturers were designed to follow participants for two years, and should be completed before they are evaluated for full approval, even if they are now unblinded and lack placebo groups. These Phase III trials are not simply efficacy studies; they also are necessary and important safety studies (as the study titles say), and all collected data remain invaluable.

We also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body following vaccination—including studies on their full biodistribution, pharmacokinetics, and tissue-specific toxicities. We ask the FDA to demand manufacturers complete proper biodistribution studies that would be expected of any new drug and request additional studies to better understand the implications of mRNA translation in distant tissues. We call on data demonstrating a thorough investigation of all serious adverse events reported to pharmacovigilance systems, carried out by independent, impartial individuals, and for safety data from individuals receiving more than two vaccine doses, in consideration of plans for future booster shots. We ask the FDA to request necessary studies in specific populations, including those previously infected with SARS-CoV-2, pediatric subjects, and those with immunological or other underlying medical complexities. Given the nature of the novel vaccine platforms, our petition asks for experts in gene therapy to be included among the external committee advising the FDA.

These are several of our major requests. The petition has been signed by a group of 27 clinicians, researchers, and consumer advocates with diverse experiences and thoughts about the pandemic. We all agree that there remain many open, unanswered questions surrounding the efficacy and safety of covid-19 vaccines that must be answered before the FDA gives serious consideration to granting full approval.

Political Tripling-Down To Back mRNA Neo-Vaccinoid Mandates Starts Monday...,

NYTimes  |  The Food and Drug Administration is pushing to approve Pfizer-BioNTech’s two-dose Covid-19 vaccine on Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning.

Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company. The people familiar with the planning, who were not authorized to speak publicly about it, cautioned that the approval might slide beyond Monday if some components of the review need more time.

An F.D.A. spokeswoman declined to comment.

The agency had recently set an unofficial deadline for approval of around Labor Day.

The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting final regulatory action before putting in effect mandates. Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant to take one that was only authorized for emergency use, a phenomenon suggested by recent polling.

 

Anti-Vaccination Isn't What's Roiling Consensus Reality - It's Refusal To OBEY Cooperate

I’ve started wondering about the question of the confidence in, and even the tolerance of, various levels of governance by the people. All government, after all, relies on unspoken intimidation to some extent to stay in power. That being so, determined resistance from 5-10% of the population is usually enough to frustrate government, and can in fact actually bring it down. And here, we might be talking not about a change from Party A to Party B, but a change in the entire political system, with consequences impossible to foresee. This doesn’t have to be (and probably won’t be) violent or even armed resistance, but rather a sullen, passive, mass refusal to cooperate. It’s a question of numbers. If you break the law, you have a problem. If a million people break the law, the government has a problem.

Does this sound alarmist? Well, try for a moment to envision a scenario – one of many possible ones – in 4 months’ time. The virus is still with us, and new strains appear every month, many from abroad brought by travellers. The first signs of long Covid illnesses are now evident. The hospitals are always full, the health services are perpetually over-extended. There are bitter debates about which vaccines, if any, are still effective and how many doses are needed. There are equally bitter debates about the usefulness of prophylactics and treatments.

The government consensus on these issues, such as it is, changes all the time, and differs from county to county. Supply chains continue to be badly affected. Lockdowns are now a regular feature of life. There are multiple, often contradictory, rules about how you can travel and with what medical documents or certificates. Schools and universities remain mostly closed but try to open for a few weeks or a month when they can. Restaurants, theatres and concert halls in many states are progressively closing down. Sports events are only played before empty stadiums. And the key part of this is that the restrictions will already have been in place for a year, with no sign that they will ever be lifted. This is what “living with Covid” means, insofar as it means anything at all. It could be worse than that of course.

What about the political consequences? Three things stand out, I think. First, most of the population of the United States has never known large-scale insecurity, political upheaval, the risk of hunger or, of course, long-lasting pandemics. We have grown up in a narcissistic culture where What I Want is what counts, and politicians who wish to prosper have to accept that.

Second, few political systems are actually geared to dealing with complex, multi-faceted problems. We can see this already with Covid, and it’s going to get worse. The politics of spin and slogan have been around for so long now, that the ability of most governments to deal with, or even properly appreciate, complex problems, has largely disappeared.

Third, it’s almost impossible to pass complex political messages, even when times are calm. In the age of Twitter, it’s impossible. It’s this, rather than mendacity or conspiracy, which explains the constant flailing of government after a single message, and the fact that these messages change frequently.

With Covid I don’t think it’s possible to pass simple messages, and I suspect it will be more and more difficult as time goes on. In the end, the government has already shown that it is overwhelmed by the complexity of the problem, and by its inability to settle on any coherent policy, much less explain it.

Things are about to get very sticky.

The Great Reset Is The Corporate Takeover Of Global Governance

opendemocracy  |  The plan from which the Great Reset originated was called the Global Redesign Initiative. Drafted by the WEF after the 2008 economic crisis, the initiative contains a 600-page report on transforming global governance. In the WEF’s vision, “the government voice would be one among many, without always being the final arbiter.” Governments would be just one stakeholder in a multi-stakeholder model of global governance. Harris Gleckman, senior fellow at the University of Massachusetts, describes the report as “the most comprehensive proposal for re-designing global governance since the formulation of the United Nations during World War II.”

Multi-stakeholder partnerships are public-private partnerships on the global stage

Who are these other, non-governmental stakeholders? The WEF, best known for its annual meeting of high-net-worth individuals in Davos, Switzerland, describes itself as an international organization for public-private cooperation. WEF partners include some of the biggest companies in oil (Saudi Aramco, Shell, Chevron, BP), food (Unilever, The Coca-Cola Company, Nestlé), technology (Facebook, Google, Amazon, Microsoft, Apple) and pharmaceuticals (AstraZeneca, Pfizer, Moderna).

Instead of corporations serving many stakeholders, in the multi-stakeholder model of global governance, corporations are promoted to being official stakeholders in global decision-making, while governments are relegated to being one of many stakeholders. In practice, corporations become the main stakeholders, while governments take a backseat role, and civil society is mainly window dressing.

The multi-stakeholder ecosystem

Perhaps the most symbolic example of this shift is the controversial strategic partnership agreement the United Nations (UN) signed with the WEF in 2019. Harris Gleckman describes this as a move to turn the UN into a public-private partnership, creating a special place for corporations inside the UN.

The multi-stakeholder model is already being built. In recent years, an ever-expanding ecosystem of multi-stakeholder groups has spread across all sectors of the global governance system. There are now more than 45 global multi-stakeholder groups that set standards and establish guidelines and rules in a range of areas. According to Gleckman, these groups, which lack any democratic accountability, consist of private stakeholders (big corporations) who “recruit their friends in government, civil society and universities to join them in solving public problems”.

Multi-stakeholderism is the WEF’s update of multilateralism, which is the current system through which countries work together to achieve common goals. The multilateral system’s core institution is the UN. The multilateral system is often rightly accused of being ineffective, too bureaucratic and skewed towards the most powerful nations. But it is at least theoretically democratic because it brings together democratically elected leaders of countries to make decisions in the global arena. Instead of reforming the multilateral system to deepen democracy, the WEF’s vision of multi-stakeholder governance entails further removing democracy by sidelining governments and putting unelected ‘stakeholders’ – mainly corporations – in their place when it comes to global decision-making.

Put bluntly, multi-stakeholder partnerships are public-private partnerships on the global stage. And they have real-world implications for the way our food systems are organized, how big tech is governed and how our vaccines and medicines are distributed.

 

mRNA NeoVaccinoid Prevented Him From Succumbing To SUPERDEATH

RT  | As experts extol the life-preserving qualities of Covid jabs, a news story has claimed that the condition of a man who perished from the virus could have been worse had he not been vaxxed, kindling philosophical debate on Twitter.

The metaphysical social media chatter was triggered by national media coverage of the recent death of Texas native Patricio Elizondo, a diabetic who suffered from heart problems. After Elizondo fell ill in early August, his daughter suspected that he may be suffering from a resurgence of congestive heart failure. The 76-year-old was soon hospitalized after he began having difficulty breathing – a common symptom of heart failure, which can lead to fluid building up in the lungs causing shortness of breath.

But doctors said that a chest X-ray revealed that Elizondo had actually caught Covid. He passed away on August 3 due to lung damage caused by the virus, a cardiologist who treated Elizondo said. 

The Texan’s age and medical history placed him at high risk for contracting a severe case of coronavirus – but the fact that he was fully vaccinated caught the attention of local, then national media. 

Aside from being fully inoculated against Covid, Elizondo “rarely left the house, was always masked up, and even wore gloves,” Yvonne Rodriguez, the daughter of the deceased, told San Antonio news station KSAT. Although she said she couldn’t understand how her father caught the virus, Rodriguez stressed that she felt the vaccine had still been helpful. 

“I saw my dad, how sick as he was,” she said. “I can’t imagine how much more he would have suffered if he had not gotten the vaccine.”

KSAT spoke with a local doctor and infectious disease specialist who suggested that Rodriguez was “right” to think that the vaccine had aided her father.

mRNA Neo-Vaccinoids Damn Near Worthless At Preventing Covid-21 Infection

FT  |  A rise in vaccinated people becoming infected with coronavirus has cast doubt over the lasting efficacy of Covid-19 vaccines, according to new studies, including one that found protection gained from the BioNTech/Pfizer shot declined more rapidly than that from the AstraZeneca jab. An Oxford university study published on Thursday found that the efficacy of the Pfizer vaccine against symptomatic infection almost halved after four months, and that vaccinated people infected with the more infectious Delta variant had as high viral loads as the unvaccinated. Two research papers from the US and Qatar have also fuelled debate over the need for top-up booster shots as they found higher numbers of “breakthrough infections” than anticipated, even though protection against serious cases of the virus appears to hold. Natalie Dean, a biostatistics professor at Emory University, said the spread of the Delta variant had made it “a lot harder” to stop transmission. “The situation has changed with respect to how far we think vaccines can take us,” she said. “We’ve been brought back to a more modest — but still critical — goal: to prevent severe disease, hospitalisations and deaths.” 

The Oxford scientists showed vaccine efficacy falling since the Delta strain became dominant in the UK in May. While the Pfizer shot was more effective at first, by four to five months after the second dose its efficacy was roughly the same as AstraZeneca’s jab, as the protection offered by the latter has barely budged. The paper’s authors were not involved in the creation of the AstraZeneca vaccine, which originated at Oxford university. Tomas Hanke, professor of vaccine immunology at Oxford’s Jenner Institute, speculated that the AstraZeneca shot generates longer-lasting immunity because its spike protein sticks around for more time, promoting a bigger immune response. “When you deliver RNA, like the Pfizer vaccine, you deliver a finite number of mRNA molecules which are eventually cleared from the system,” he said. “But when you deliver the adenovirus, as AstraZeneca does, you deliver a template which then keeps producing these mRNAs that then produce the spike protein, so there’s no ceiling.” A preprint based on evidence collected at the Mayo Clinic hospital chain in the US state of Minnesota showed protection against infection fell from 91 per cent to 76 per cent between February and July for the vaccine made by Moderna, and from 89 per cent to 42 per cent for the Pfizer jab. 

mRNA NeoVaccinoids HIGHLY EFFECTIVE At Disrupting Women's Menstrual Cycles

thegrayzone  | Amid rising reports of vaccine-related menstrual disruptions, the CDC and FDA are dismissing women’s concerns and denying them information while corporate media pathologizes them in sexist fashion.

This August 11, the US Center for Disease Control (CDC) overhauled its COVID-19 vaccine guidance for pregnant women, now “urging” them to accept their shots.

Just 23% of pregnant women in the US have received one dose of a COVID-19 vaccine. Only something like 11.1% have been fully vaccinated. 

The CDC is seeking to drive these numbers up, but it is not doing the one thing that would, perhaps more than anything else, assuage the “hesitations” of these so-called “anti-vaxxers”: investigate and explain widespread reports of menstrual disruption post-Covid 19 vaccine – and, if necessary, add a warning about it.

Why?

I have five female friends who, after receiving Covid-19 vaccines, experienced disruption to their menstrual cycles. Their symptoms have included hemorrhagic bleeding lasting more than a month; heavy intermittent bleeding for four months; passing golf-ball size clots of blood; and extreme cramping, serious enough to land one friend in the ER.

Most of these women are in their 20s and 30s, and at least one of them thinks she might want to have children. She now worries that her symptoms might be the harbinger of long-term fertility problems. At least two of my friends have symptoms that have not resolved. All are feminists and have throughout the years been consistent Democratic Party voters.

Other women of childbearing age have reported becoming temporarily “postmenopausal” after their second mRNA shot; conversely, women in menopause are reporting suddenly beginning to bleed again; trans men on hormone therapy have also reported sudden bleeding. Apparently, the number of vaccinated women around the world reporting alarmingly disrupted menstruation is, to be conservative, in the tens of thousands. 

The US Food and Drug Administration (FDA), however, does not warn women who get the shots that they may experience a disrupted menstrual cycle. 

Why is this? In part because even though menstruation is sometimes called the sixth vital sign and directly implicates fertility, and the fact that women on average suffer higher rates of adverse reaction to vaccines of all sorts and medication in general, the effects of Covid vaccines on women’s health specifically, including the menstrual cycle, were not studied as part of the Emergency Use Authorization process.

Can You Even Imagine The Press Kwestioning Biden Like This?!?!?!

thesaker |   The first Taliban press conference after this weekend’s Saigon moment geopolitical earthquake, conducted by spokesman Zabihullah Mujahid, was in itself a game-changer.

The contrast could not be starker with those rambling pressers at the Taliban embassy in Islamabad after 9/11 and before the start of the American bombing – proving this is an entirely new political animal.

Yet some things never change. English translations remain atrocious.

Here is a good summary of the key Taliban statements, and

here (in Russian) is a very detailed roundup.

These are the key takeaways.

– No problem for women to get education all the way to college, and to continue to work. They just need to wear the hijab (like in Qatar or Iran). No need to wear a burqa. The Taliban insists, “all women’s rights will be guaranteed within the limits of Islamic law.”

– The Islamic Emirate “does not threaten anyone” and will not treat anyone as enemies. Crucially, revenge – an essential plank of the Pashtunwali code – will be abandoned, and that’s unprecedented. There will be a general amnesty – including people who worked for the former NATO-aligned system. Translators, for instance, won’t be harassed, and don’t need to leave the country.

– Security of foreign embassies and international organizations “is a priority.” Taliban special security forces will protect both those leaving Afghanistan and those who remain.

– A strong inclusive Islamic government will be formed. “Inclusive” is code for the participation of women and Shi’ites.

– Foreign media will continue to work undisturbed. The Taliban government will allow public criticism and debate. But “freedom of speech in Afghanistan must be in line with Islamic values.”

– The Islamic Emirate of Taliban wants recognition from the “international community” – code for NATO. The overwhelming majority of Eurasia and the Global South will recognize it anyway. It’s essential to note, for example, the closer integration of the expanding SCO – Iran is about to become a full member, Afghanistan is an observer – with ASEAN: the absolute majority of Asia will not shun the Taliban.

For the record, they also stated that the Taliban took all of Afghanistan in only 11 days: that’s pretty accurate. They stressed “very good relations with Pakistan, Russia and China.” Yet the Taliban don’t have formal allies and are not part of any military-political bloc. They definitely “won’t allow Afghanistan to become a safe haven for international terrorists”. That’s code for ISIS/Daesh.

On the key issue of opium/heroin: the Taliban will ban their production. So, for all practical purposes, the CIA heroin rat line is dead.

As eyebrow raising as these statements may be, the Taliban did not even get into detail on economic/infrastructure development deals – as they will need a lot of new industries, new jobs and improved Eurasian-wide trade relations. That will be announced later.

The go-to Russian guy

Sharp US observers are remarking, half in jest, that the Taliban in only one sitting answered more real questions from US media than POTUS since January.

What this first press conference reveals is how the Taliban are fast absorbing essential P.R. and media lessons from Moscow and Beijing, emphasizing ethnic harmony, the role of women, the role of diplomacy, and deftly defusing in a single move all the hysteria raging across NATOstan.

The next bombshell step in the P.R. wars will be to cut off the lethal, evidence-free Taliban-9/11 connection; afterwards the “terrorist organization” label will disappear, and the Taliban as a political movement will be fully legitimized.

Moscow and Beijing are meticulously stage-managing the Taliban reinsertion in regional and global geopolitics. This means that ultimately the SCO is stage-managing the whole process, applying a consensus reached after a series of ministerial and leaders meetings, leading to a very important summit next month in Dushanbe.

It's Like Cornpop Let Jen Psaki Run The Operation, And Not Just Her Mouth....,

tandfonline | It is an old cliché that the Pashtun highlands of Afghanistan and Pakistan are highly resistant to state authority, and old masters of ‘the art of not being governed’ (to use James Scott’s phrase).¹ Like so many clichés, this has a real basis in historical fact. The old name ‘Yaghistan’ (the land of lawlessness, rebellion or dissent)² was given to them by the people of the region, not by Western observers. This name, and what it indicates, also corresponds very closely to patterns in other Muslim tribal regions, first systematically analysed by Ibn Khaldun in the fourteenth century ce in the Maghreb.

As an index of the Afghan state’s failure to make its society ‘legible’ (in another phrase of Scott’s), it may be noted that in the whole of modern Afghan history there has never been a census that could be regarded as remotely reliable. As for Max Weber’s classic definition of a state as ‘a human community that (successfully) claims the monopoly of the legitimate use of physical force within a given territory’,³ that has never been true of Afghanistan. Even when the Afghan state was at its strongest, local communities insisted, usually successfully, on keeping rifles, on conducting limited armed disputes with other kinship groups, and on executing their own members who violated traditional community norms.

Only in the late 1940s, as a result of the import of modern tanks and aircraft, did the Afghan state army become strong enough to defeat a general tribal uprising – and that superiority lasted a bare 30 years. It collapsed with the anti-communist revolts and army mutinies of the late 1970s, and since then, no Afghan state – not even the Taliban, which came closest – has successfully possessed a monopoly of organised armed force across the whole of Afghanistan.⁴

This basic truth obscures an important nuance, however. The Pashtun tribes have not been categorically hostile to state authority as such; after all, Pashtun tribes created the kingdom of Afghanistan in the first place, and most rural Pashtuns accepted Taliban rule in the 1990s willingly enough. Rather, they have been hostile to three kinds of government: those lacking traditional or religious legitimacy; those which force them to pay too many taxes; and those which try rapidly to change their lives, their society and their traditions. In the traditional Pashtun tribal view, the legitimate role of the state, though essential, is also highly limited. Apart from leading the people against invaders, it is to judge tribal disputes, and thereby prevent these disputes from creating a state of permanent warfare.⁵ Given the traditional omnipresence of weapons in Pashtun society, and the cultural obsession with honour and prestige, journalist Anand Gopal has observed that ‘the role of dispute resolution in Pashtun society cannot be emphasised enough … In post-2001 Kandahar, the Taliban’s judicial services became one of the key advantages that the movement had over the state.’⁶

The Pashtun tragedy lies in the fact that in practice, this rejection of state interference has usually amounted to a rejection of the modernising state as such, since modernising states need to raise taxes to pay for development, find it very hard to base themselves on tradition, and by definition have to set out to change society.

Scott, as an anarchist, sympathises unconditionally with the hill peoples of Southeast Asia in their flight from and resistance to local states. The melancholy history of Afghanistan, by contrast, would suggest that the only thing worse than having a state is not having a state; and indeed, this tragic dilemma is summed up in a very old Pashtun proverb: ‘feuding ate up the mountains, and taxes ate up the plains’.⁷

The great value of Scott’s approach is that it reminds us of something that Western societies have long forgotten, and that the vast majority of the Western ‘experts’ who tried (or pretended) to develop Afghanistan after 2001 simply could not comprehend (as was probably true also of their Soviet equivalents 20 years earlier): the intense nastiness of most states in history, especially in their formative stages. As a famous nineteenth-century British-Indian policeman wrote of the history of South Asia in general:

There has seldom been any idea of reciprocity, of duties and rights, between the governor and the governed … For in India, the difference between the army of a prince and the gang of a robber was, in the general estimation of the people, only in degree – they were both driving an ‘imperial trade’, a padshahi kam.⁸

In other words, if Pashtuns have often revolted against the Afghan state (whether foreign-backed or purely indigenous), they have often had good reasons to.

There is, however, a reciprocal relationship between state nastiness and tribal resistance. It takes a great deal of nastiness (or at least the threat of it) to persuade tribes to pay taxes, but without taxes, what is the state? Either an impotent shadow, or a dependency of some foreign state and its subsidies. Both of these fates have befallen Afghanistan repeatedly over the past 200 years.

Key to the West’s failure successfully to build a new order in Afghanistan after 2001 was not just an inability to understand the historic alienation of ordinary Afghans in general, and Pashtuns in particular, from ‘their’ state, but also a refusal to recognise that, given the miserable history and eventual collapse of Afghan states, the Taliban may have been the best state-building option left, at least as far as rural Pashtuns were concerned. Not by any means a good option – just better than all the others.