Pharma Controlled FDA Approves Inadequately Tested Alzheimer’s Drug
By Stephen Lendman | June 9, 2021
According to the Alzheimer’s Association, around 6 million Americans suffer from the degenerative disease.
The number is projected to more than double by 2050.
One in three US seniors dies from Alzheimer’s disease or dementia — more than breast and prostate cancer combined.
In 2021, treating Alzheimer’s and dementia patients cost an estimated $355 billion.
By 2050, the cost is expected to be about $1.1 trillion.
Over 11 million American families have one or more members afflicted by these diseases.
From 2000 – 2019, US deaths from heart disease declined by 7.3% while individuals in the country dying from Alzheimer’s disease rose by 145%.
Professor of Medicine, medical ethics and neurology Dr. Jason Karlawish is board certified to practice geriatric medicine.
Among his extensive credentials, he heads the University of Pennsylvania’s Neurodegenerative Disease Ethics and Policy Program, is associate director of the Clinical Core and co-associate director of the Alzheimer’s Disease Core Center, as well as co-director of the Penn Memory Center.
He’s involved with the Healthy Brain Research Network.
It’s dedicated to surveillance, education, awareness, empowerment and promotion of brain health.
He heads makingsenseofalzheimers.org at the University of Pennsylvania’s Neurodegenerative Disease Ethics and Policy Program.
As part of his research on neuroethics and policy, he investigated issues in dementia drug development, informed consent, quality of life, and treatment decision-making.
On May 30 — days before the FDA’s premature approval of Biogen’s experimental, inadequately tested aducanumab Alzheimer’s drug — Karlawish minced no words saying the following:
If approved, “I won’t prescribe it,” adding:
When asked if any new safe and effective drugs exist to treat Alzheimer’s disease, he unequivocally said, “No.”
He’s been saying the same thing “for the past 18 years,” he explained.
Drugs he prescribes to ease cognitive problems “are only moderately effective.”
No magic bullet otherwise exists.
No drugs slow cognitive impairment to let affected individuals maintain control over their lives.
He and colleagues involved in treating Alzheimer’s patients won’t prescribe aducanumab because “Biogen hasn’t made a convincing case for it,” he explained, adding:
“The consequences of FDA approval are as disturbing as they are vast.”
Millions of “Americans could be prescribed aducanumab, at an estimated cost that ranges from $20,000 to $50,000 per person per year.”
“Biogen claims the benefits of slowing declines in cognition and day-to-day function are worth this price.”
Karlawish disagrees, saying Biogen data are “murky.”
“(T)he drug’s benefits are ambiguous at best and not worth this cost.”
“Putting it on the market will stress Medicare’s resources.”
Dubious benefits will force families of Alzheimer’s patients to decide if the high cost is worth the risks posed by the drug.
One risk “is small bleeds in the brain, a risk that is heightened in those with the APOE4 gene, a gene associated with late-onset Alzheimer’s disease,” Karlawish explained.
“Aducanumab is not the drug to launch a new era of Alzheimer’s treatment.”
“It hasn’t been properly studied…so the FDA has incomplete data to form a judgment.”
What’s going on is “good for business but bad for science and patient care.”
According to investors.com, after aducanumab failed two final-phase studies in March 2019, Biogen’s stock lost a third of its value.
After a phase-three test suggested promise — despite 10 members of an FDA advisory committee recommending against its approval — Biogen’s stock rose over 30%.
According to biotech company Cassava Sciences’ CEO Remi Barbier, the anti-amyloid approach used by Biogen “failed repeatedly…for the past 25 – 30 years, adding:
“Normally, when an approach fails, sometimes you try again.”
“Certainly, three strikes and you’re out.”
“It’s been 20 strikes and they’re still batting.”
Biogen is a troubled company.
According to investors.com, generics are eating into sales of its biggest moneymaker, the multiple sclerosis treatment Tecfidera.”
“In the first quarter, Tecfidera sales plunged 56%.”
In partnership with Ionis Pharmaceuticals, sales of Biogen’s spinal muscular atrophy drug Spinraza fell about 8%.
Is FDA approval of aducanumab more about preventing Biogen’s bankruptcy than treating Alzheimer’s patients safely and effectively?
Before the drug’s approval, macreoaxis rated possible Biogen bankruptcy at 28.56% because of its troubled financial situation.
In Phase 2 clinical trials, the FDA let Biogen “skip a crucial step in drug development…to assure that the final phase of testing (Phase 3) will make a convincing case that the drug should be marketed to providers and patients,” Karlawish explained, adding:
“Biogen’s application for approval divided the FDA.”
Its advisory committee sided with the yeas over the neas even though the latter case was much more convincing.
Company data on aducanumab are “incomplete and contradictory,” said Karlawis.
“Skipping a key phase of research” was a business, not a science-based, decision.
Families with an Alzheimer’s disease member are grasping at whatever may offer hope.
The verdict on aducanumab won’t be known unless “Biogen invests the time and money needed to run well-designed trials and complete them,” Karlawis stressed.
Given premature FDA approval, they’re highly unlikely to be conducted.
Aducanumab users will be playing Russian roulette with their health by volunteering as virtual guinea pigs with an inadequately developed drug that may make a bad situation worse.
Why Is There Such Reluctance to Discuss Natural Immunity?
By Jon Sanders | AIER | June 4, 2021
If you’re among those of us who aren’t tribally invested in Covid politics but would like good information about when life will resume as normal, chances are you’re interested in herd immunity. You’re likely not interested in having to rely on the Internet Archive for good information on herd immunity. Alas, it’s become a go-to place for retrieving, as it were, previously published information on herd immunity that became inconvenient post-vaccine and then virtually Memory-Holed.
Over the past 15 months, the litany of Experts’ True Facts and Science regarding various aspects of SARS-CoV-2 has changed more often than the starting lineup of a bad minor league ball club. Covid-19 is spread by droplets, especially from asymptomatic people, until one day it was airborne all along and people who weren’t sick in all likelihood weren’t even sick. Stay at home, you’re safer indoors, even stay away from parks and beaches; well, actually, outdoors is the place to be. Masks don’t work against viruses and are actually unhealthy to wear if you’re not sick, then suddenly they did work and without one you might as well be shooting people. Everyone knows and PolitiFact verified that the virus couldn’t have been created in the prominent infectious disease lab doing gain-of-function research on coronaviruses in bats coincidentally at Covid Ground Zero until, one day, PolitiFact had to retract the entire “Pants on Fire!” article. And so forth.
Unfortunately, information about herd immunity has also not been immune to this kind of meddling. Until recent months, people readily understood that active immunity came about either by natural immunity or vaccine-induced immunity. Natural immunity comes from battling and defeating an actual infection, then having your immune system primed for the rest of your life to fight it off if it ever shows up again. This immunity is achieved at a sometimes very high personal price.
Vaccine-induced immunity is to prime your immune system with a weaker, non-threatening form of the invading infection, so that it’s ready to fight off the real thing should you ever encounter it, and without your having first to risk severe illness or death.
Those interested in herd immunity in itself likely don’t have a moral or political preference for one form of immunity to the exclusion of the other. Immunity is immunity, regardless of whether a particular person has it naturally or by a vaccine. All immunity contributes to herd immunity.
Others, however, are much less circumspect. They seem to have forgotten the ultimate goal of the public campaign for people to receive vaccination against Covid-19. It’s not to be vaccinated; it’s to have immunity. People with natural immunity — i.e., people whose immune systems have faced Covid-19 and won — don’t need a vaccine.
They do, however, need to be considered in any good-faith discussion of herd immunity. There are two prongs to herd immunity, as we used to all know, and those with natural immunity are the prong that’s being ignored. It’s not just mere oversight, however. Fostering such ignorance can lead to several bad outcomes:
- People with natural immunity could be kept from employment, education, travel, normal commerce, and who knows what other things if they don’t submit to a vaccine they don’t need in order to fulfill a head count that confuses a means with the end
- The nation could already be at herd immunity while governors and health bureaucrats continue to exert extreme emergency powers, harming people’s liberties and livelihoods
- People already terrified of Covid — including especially those who’ve already had it — would continue to live in fear, avoiding human interaction and worrying beyond all reason
- People could come to distrust even sound advice from experts about important matters, as they witness and grow to expect how what “the experts” counsel diverges from what they know to be wise counsel while it conforms to and amplifies the temporary needs of the political class
Those of us wanting good information certainly don’t want any of those outcomes. But others seem perfectly fine to risk them. They include not only elected officials, members of the media, political talking heads, self-important bureaucrats, and their wide-eyed acolytes harassing shoppers, but strangely also highly prominent health organizations.
For example, late last year Jeffrey Tucker showed that the World Health Organization (WHO) suddenly, and “for reasons unknown,” changed its definition of “herd immunity.” Using screenshots from a cached version on the Internet Archive, Tucker showed how the WHO altered its definition in such a way as to erase completely the role of natural immunity. Before, the WHO rightly said it “happens when a population is immune either through vaccination or immunity developed through previous infection.” The WHO’s change stated that it happens “if a threshold of vaccination is reached.” Not long after Tucker’s piece appeared, the WHO restored natural immunity to its definition.
The Food and Drug Administration (FDA), seemingly apropos of nothing, on May 19 issued a “safety communication” to warn that FDA-authorized SARS-CoV-2 antibody tests “should not be used to evaluate immunity or protection from COVID-19 at any time.” The FDA’s concern appears to be that taking an antibody test too soon after receiving a vaccination may fail to show vaccine-induced antibodies, but why preclude its use for “identifying people with an adaptive immune response to SARS-CoV-2 from a recent or prior infection?” Especially after stating outright that “Antibody tests can play an important role in identifying individuals who may have been exposed to the SARS-CoV-2 virus and may have developed an adaptive immune response.”
Then there is the National Institute of Allergy and Infectious Diseases director, Dr. Anthony Fauci, that ubiquitous font of fatuous guidance. He had told people that herd immunity would be at 60 to 70 percent immunity, and then he started publicly cinching those numbers up: 75 percent, 80 percent, 85 percent, even 90 percent (as if Covid-19 were as infectious as measles). He is quoted in the New York Times admitting to doing so deliberately to affect people’s behavior:
“When polls said only about half of all Americans would take a vaccine, I was saying herd immunity would take 70 to 75 percent,” Dr. Fauci said. “Then, when newer surveys said 60 percent or more would take it, I thought, ‘I can nudge this up a bit,’ so I went to 80, 85.“
Now — or better put, as of this writing — Fauci has taken to arguing herd immunity is a “mystical elusive number,” a distracting “endgame,” and therefore not worth considering. Only vaccinations are worth counting. As he put it recently, “We don’t want to get too hung up on reaching this endgame of herd immunity because every day that you put 2 million to 3 million vaccinations into people [it] makes society be more and more protected.”
While composing an article about natural immunity and herd immunity for my home state of North Carolina, I happened to notice that the Mayo Clinic had removed a compelling factoid about natural immunity. It’s something I had quoted in an earlier discussion of the matter and wanted to revisit it.
Here’s what the Mayo Clinic once wanted people to know in its page on “Herd Immunity and COVID-19” with respect to natural immunity: “[T]hose who survived the 1918 flu (influenza) pandemic were later immune to infection with the H1N1 flu, a subtype of influenza A.” The Mayo Clinic pointed out that H1N1 was during the 2009-10 flu season, which would be 92 years later. That finding attested to just how powerful and long-lived natural immunity could be.
As can be seen from the Internet Archive, however, sometime after April 14 the Mayo Clinic removed that compelling historical aside:
The Mayo Clinic also reoriented its page to feature vaccination over “the natural infection method” (method? ) and added a section on “the outlook for achieving herd immunity in the U.S.” This new section stated that “it’s not clear if or when the U.S. will achieve herd immunity” but encouraged people nonetheless that “the FDA-authorized COVID-19 vaccines are highly effective at protecting against severe illness requiring hospitalization and death … allowing people to better be able to live with the virus.”
Why, from people who know better, is there so much interest in downplaying or erasing natural immunity?
Is it because it’s hard to quantify how many people have natural immunity? Is it out of a mix of good intentions and worry, that discussing natural immunity would somehow discourage (“nudge,” in Fauci’s term) people from getting vaccines who otherwise would? Is it simple oversight, being so focused on vaccinations that they just plain forgot about natural immunity? Or is something else at work?
Whatever the reason, it’s keeping Americans in the dark about how many people have active immunity from Covid-19. It’s keeping people needlessly fearful and suspicious of each other. It’s empowering executive overreach. Worst of all, it’s tempting people to consider government and business restrictions on the unvaccinated, regardless of their actual immunity.
Jon Sanders is an economist and the senior fellow of regulatory studies and research editor at the John Locke Foundation in Raleigh, North Carolina.
Illegitimate rules remove parental consent for Covid vaccines
The Rule of Law is being dismantled and our children are the prey
By Meryl Nass, MD | May 31, 2021
Continuing from the last post: the US had very high rates of Covid compared to many countries, and right now that seems to have been a good thing… since places like Australia and New Zealand seem to want to be able to impose lockdowns for the forseeable future as they pursue the impossible goal of zero Covid. Impossible because you are not going to get everyone on the planet to accept a shot, and then vaccinate the wild animals and pets who are also susceptible. We have basically reached herd immunity with a combination of vaccine and natural immunity. Since only 40% of the US population is fully vaccinated, according to the NYT, there has undoubtedly been a considerable amount of natural immunity that has accrued.
Why aren’t the media celebrating? Apparently the powers that be who have made so many disastrous decisions regarding pandemic management don’t want us to know this. Yet. Thus their huge hurry to vaccinate despite the law, despite the still experimental nature of the vaccine products:
* The colleges demanding vaccinations
* The employers firing the unvaccinated
* The authorization for 12-15 year olds
* The million dollar lotteries for vaccinees, and other excesses to coerce vaccinations
But now the ante has been upped even higher. While many laws have been disregarded during the pandemic emergency, under the rubric of an emergency, two things I learned today are the worst.
Children aged 12-15 are being invited to vaccine clinics without parental permission, in the cities of San Francisco and Philadelphia, and others, based on emergency edicts in local jurisdictions, coupled with a Declaration by Alex Azar in March 2020 broadening the liability waiver umbrella for “covered countermeasures” during a pandemic to virtually anyone who has anything to do with a vaccine program. This could be interpreted as covering anyone who chooses to mandate the vaccine, even while experimental. In other words, even though you are not permitted to mandate an experimental product, Alex Azar said he would not allow you to be punished if you did so.
There do exist real laws, which preceded the pandemic, that protect children as a special class from both being used as experimental subjects (which legally under EUA this is) and protect them by requiring parental consent for procedures, unless they are emancipated minors.
Unless these laws were revoked while I blinked, they still exist and as federal laws should supercede anything imposed by a lesser jurisdiction.
Let’s see what happens. This is “hot” news and I don’t have time to put in the links, but this is true.
Finally, the FDA has announced its vaccine advisory committee will meet on June 10 to advise (aka bless) FDA on authorization and/or licensure for pediatric Covid vaccines. Not to put too fine a point on it, it is possible the FDA will authorize Covid vaccines for younger children, or even license them, starting June 11.
Meanwhile, Israeli media have claimed that one in 3 to 6 thousand vaccinees (I think in the 15-30 age group) develops myocarditis. I am trying to get the official report on this.
It is likely the FDA is trying to forestall any more bad news, which is why it is moving so rapidly. Furthermore, the FDA has warned us that it may not be able to provide any background documents prior to the June 10 meeting. That means the public and the advisors may be entirely in the dark as the advisors vote to provide their approval for whatever the FDA has up its sleeve.
Meanwhile, the Indian Bar Association has served legal notice for suppression of ivermectin against the WHO Chief Scientist, who is a famous Indian who headed up the Indian Council of Medical Research before transferring to the WHO.
The FDA cover-up that led to the approval of the Pfizer vaccine
By Jon Rappoport | No More Fake News | May 25, 2021
As I’ve been documenting for the past year, the COVID experts have been contradicting themselves six ways from Sunday. As charlatans, they’re abject failures. They can’t keep their own story straight.
Thanks to an alert reader, I’ve come across a new blockbuster.
BY THEIR OWN STANDARDS, the FDA should never have allowed the Pfizer COVID vaccine to be shot into a single arm. The Agency’s Emergency Use Authorization was a crime—according to their own data.
Here we go.
The document, posted on the FDA website, is titled, “Vaccines and Related Biological Products; Advisory Committee Meeting; FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine.” [1]
It is dated December 10, 2020. The date tells us that all the information in the document is taken from the Pfizer clinical trial, based on which the FDA authorized the vaccine for public use.
A key quote is buried on page 42: “Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group [who received a saltwater shot].”
Those shocking numbers have never seen the light of day in news media.
The comparative numbers reveal that the vaccine was not effective at preventing COVID-19. It was certainly not 50% more effective than no vaccine at all—the standard for FDA Emergency Use Authorization.
To make all this clear, I need to back up and explain the theory of the vaccine clinical trial.
The researchers assumed the SARS-CoV-2 virus was spreading everywhere in the world, and during the clinical trial, it would descend on some volunteers.
The billion-dollar question was: how many people receiving the vaccine would become infected, vs. how many people in the placebo group?
If it turned out that FAR FEWER people getting the vaccine became infected with SARS-CoV-2, the vaccine would be hailed as a success. It protected people against the virus.
But as you can see from the numbers above, that wasn’t the case at all.
So now we come to the vital weasel-phrase in the FDA document I just quoted: “suspected but unconfirmed COVID-19 [cases].”
“Well, you see, we can’t say these were ACTUAL COVID-19 cases. Maybe they were, maybe they weren’t. They’re in limbo. We want to keep them in limbo. Otherwise, our clinical trial is dead in the water, and we’ll never get approval for the vaccine.”
What does “suspected cases” mean? It can only mean these people all displayed symptoms consistent with the definition of COVID-19, but they’re unconfirmed cases because…their PCR tests were negative, not positive.
However, if their tests were negative, why would they be called “suspected cases” instead of “NOT CASES”?
Something is wrong here. The FDA is hedging its bets, muddying the waters, obscuring facts.
By FDA/CDC rules, a case of COVID-19 means: a person has tested positive, period.
That’s the way cases are counted.
These several thousand volunteers in the Pfizer clinical trial were either COVID-19 cases or they weren’t. Which is it?
The official response to that question is obvious: the FDA decided to throw the data from all those suspected cases in the garbage and ignore them. Poof. Gone.
Why do I say that?
Because if the FDA had paid serious attention to the several thousand “suspected cases,” they never would have authorized the vaccine for public use. They would have stopped the clinical trial and undertaken a very deep and extensive investigation.
Which they didn’t.
This is called a crime.
“But…but it’s not that simple. This is a complex situation. It’s a gray area.”
“No. It isn’t. If you were running a clinical trial of a new drug, and a few thousand people in the trial, who were given the drug, nevertheless came down with the disease symptoms the drug was supposed to cure, wouldn’t you cancel the trial and go back to the drawing board?”
“You mean if we were being honest? That’s a joke, right? We’re not honest. Don’t you get it?”
Yes. I get it. You’re criminals. Killers.
But wait. There’s more. The FDA document also states: “Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group.”
That’s explosive. Right after vaccination, 409 people who received the shots became “suspected COVID cases.” This alone should have been enough to stop the clinical trial altogether. But it wasn’t.
In fact, the FDA document tries to excuse those 409 cases with a slippery comment: “It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days post vaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19.”
Translation: You see, a number of clinical symptoms of COVID-19 and adverse effects from the vaccine are the same. Therefore, we have no idea whether the vaccinated people developed COVID or were just reacting to the vaccine. So we’re going to ignore this whole mess and pretend it’s of no importance.
Back in April of 2020, I predicted the vaccine manufacturers would use this strategy to explain away COVID cases occurring in the vaccine groups of their clinical trials.
It’s called cooking the data. It’s a way of writing off and ignoring COVID symptoms in the vaccine group—and instead saying, “The vaccine is safe and effective.”
And the FDA document, as I stated above, just puts an impenetrable cloud over all the volunteers in the Pfizer clinical trial by inventing a category called “suspected but unconfirmed COVID-19 cases,” and throwing those crucial data away, never to be spoken of again.
I’m speaking about them now. Any sensible person, looking at them, would conclude that the vaccine should never have been authorized.
Unless fraud, deception, profits, and destruction of human life via the vaccine were and are the true goals.
Finally: When you have “suspected cases,” and their ultimate status depends on doing a test, you do the test. You do it as many times as you need to, until it registers positive or negative. Then each “suspected case” becomes an actual case or no case at all.
Perhaps these “suspected cases” in the clinical trial were tested, and many of them came up positive, revealing they were actual COVID cases—but the researchers lied and covered up the fact that they were tested.
Or if you really don’t want to know whether “suspected cases” are actual cases, you don’t test them. You leave them in a convenient limbo and park them, never to be seen again.
Either way, the situation is patently absurd. By official standards, the PCR test decides whether a person is a case or not a case. Just do the test. Saying “we don’t know” is nothing more than a con and a hustle.
I’d love to hear the researchers try to talk their way out of this one. Here is how the conversation might go:
“So you’re saying these several thousand suspected COVID cases couldn’t be adjudicated one way or another?”
“That’s right. Their PCR tests were ‘indeterminate’.”
“That says something devastating about the test itself.”
“Well, sometimes you just can’t tell whether it’s positive or negative.”
“I see. And this ‘indeterminate’ result occurred in SEVERAL THOUSAND suspected cases.”
“I guess so, yes.”
“You know, you could have done something else with these suspected cases. A different test. You could have taken tissue samples and looked for the virus itself in a more direct way.”
“No. That wouldn’t work.”
“Why not?”
“Because…the actual virus…”
“Because no one has been able to come up with a specimen of the actual SARS-CoV-2 virus.”
“Right.”
“So tell me—what does that indicate? I’ll tell you what it indicates. You can’t prove the SARS-CoV-2 virus exists.
“I have to go. I’m late for a meeting.”
“You’re late for more than just a meeting. Is it true a person becomes a virologist by cutting out a coupon from the back of a comic book and mailing it to a PO Box in Maryland?’
“Absolutely not. That’s outrageous.”
“What then?”
“The PO Box is in Virginia.”
SOURCES:
[1] https://www.fda.gov/media/144245/download
Jon Rappoport is the author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX.
America’s Public Health System Is Utterly Corrupt
By Paul Craig Roberts • Institute for Political Economy • May 24, 2021
A sure sign of a country’s collapse is the open corruption of its public and private institutions. When corruption no longer has to be hidden but can be openly flouted, the values and standards that comprised the country’s soul have eroded away.
Try to find an American institution that is not corrupt. Even when presented with the Covid threat the US public health system could not rise above the greed for profit. Effective cures, such as HCQ and Ivermectin were demonized and in many states prohibited. Most Covid deaths are the result of non-treatment.
Throughout the alleged “Covid Pandemic” regulatory agencies, health bureaucracies, medical associations, state governors, media, and Big Pharma have acted to prevent any alternative to a vaccine.
From day one the emphasis was on the profits from a vaccine. To get people to submit to an experimental and untested vaccine required the absence of cures. To keep the road open only for a vaccine even supplements such as NAC, which has shown effectiveness as both preventative and treatment of Covid, has been challenged by the FDA in its use as a supplement. In response, amazon.com, a major online marketer of dietary supplements removed NAC from its offerings.
The generation of fear was essential to stampeeding people to line up to be vaccinated. The fear was supplemented by threats of inability to travel, to attend sports events, to resume working at one’s job.
A Covid test, known as PCR, was intentionally run at high cycles known to result in a very high percentage of false positives. These false positives guaranteed a high infection rate that scared people silly. Economic incentives were used for hospitals to report all deaths as Covid deaths, thus greatly exaggerating Covid’s mortality.
As you might have noticed, last winter had no reporting of flu cases as flu was added to the Covid statistics.
A number of reports have been published that the Covid vaccine does not prevent some vaccinated people from coming down with Covid. Other reports say that vaccinated people become spreaders of Covid. There are also reports of a large number of deaths and injuries from the Covid vaccine.
In order to suppress the facts and keep the Covid vaccine selling, the Center for Disease Control (CDC), which supported running the PCR test at high cycles in order to inflate the number of Covid cases, runs the PCR test at much lower cycles in the case of infected vaccinated people in order to minimize the number of vaccinated people who came down with Covid.
To further create an artificial picture of the vaccine’s effectiveness, asymptomatic and mild infections are excluded from the reporting of vaccinated people who catch Covid. Only vaccinated people who catch Covid who have to be hospitalized or die from Covid are counted among the people who caught Covid despite being vaccinated. However, unvaccinated people with only minor symptoms or false positives from a high cycle PCR test are added to the number of Covid cases.
This is obvious and blatant manipulation of statistics in order to scare people about Covid while reassuring them about the vaccine’s effectiveness. Overstating the number of cases among the unvaccinated while simultaneously understating the number of people who caught Covid despite being vaccinated is shameless and protects the contrived picture of the safety and effectiveness of the vaccine.
The falsification of statistics in order to produce massive public fear and the prevention of treatment with known safe and effective cures in order to maximize death rates produced billions of dollars in profits for Big Pharma and associated industries, with Moderna’s CEO topping the list of nine new billionaires made rich from the rollout of Covid vaccines. These billionaires rode to their riches on the deaths of hundreds of thousands of people who died from an enforced lack of treatment — mandated deaths to protect vaccine profits.
Will anything be done about this extraordinary corruption of the American public health system?
FDA’s last word on the safety of hydroxychloroquine and chloroquine was issued last year/ FDA
By Meryl Nass, MD | May 16, 2021
FDA managed to find 385 adverse event reports for either HCQ or CQ in its FDA adverse event reporting system database, as justification for withdrawing its EUA for the chloroquine drugs.
But there wa something strange about these reports. Only 102 of the 385 reports, or 26%, came from the United States. Why would foreigners be submitting reports of adverse events associated with a chloroquine drug to the FDA, instead of to their own pharmacovigilance system?
According to FDA, “FAERS is a database that contains information on adverse event and medication error reports submitted to FDA.” It is not an international database.
Might FDA have requested that foreign entities submit reports? Might some of those foreign entities have been sites where the HCQ overdose trials were conducted? The big three multicenter overdose trials were Recovery, Solidarity and REMAP-Covid. Page 8 of the FDA report does indicate that some of those patients, for whom adverse event reports were filed, had received excessive HCQ doses. Of a total of 256 reports for which FDA had dosing data, depending where you place the excessive dose cut-off, between 23 and 95 had received high doses.
FDA did a number of different things to suppress the use of hydroxychloroquine. This just happens to be one thing I had not previously reported on.
What else is interesting is that this report was compiled in May 2020. It is attached to a website dated July 2020, ten months ago.
In the intervening 10 months, well over 100 papers have been published on HCQ’s use in Covid. FDA claims, “The FDA’s job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use…” Yet FDA has ignored this massive amount of accumulating literature on hydroxychloroquine, during which 400,000 Americans died of/with Covid. Why? Willful misconduct?
FDA attempts to stop OTC sales of N-acetyle cysteine, an adjunctive treatment for Covid-19
By Meryl Nass, MD | May 16, 2021
Last July, FDA sent out warning letters to supplement companies, informing them that N-acetyl cysteine (NAC) could no longer be marketed as an ingredient in food supplements, using the justification that it was also a licensed drug.
FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been approved as a new drug under section 505 of the Act [21 U.S.C. § 355], then products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.
But other drugs, such as Coenzyme Q10 and Vitamin D, are licensed as drugs but also permitted to be sold as supplements. And the federal government’s PubChem website lists many virtues of NAC.
In the case of NAC, it has been available as a licensed drug for 57 years in the US. It is widely used and very safe. Unlike many supplements, it has been extensively studied. Clinicaltrials.gov lists 541 studies for the search term ‘N-acetyl cysteine.’ Why did FDA suddenly decide its OTC use should be restricted?
This is especially troubling as a number of doctors have said it is useful in the treatment of Covid-19, especially during the late, cytokine storm stage, since it works as an antioxidant and a substrate for the production of glutathione. In fact, there is a growing body of literature on its benefits for Covid. Here is just one review.
Last week, Amazon stopped selling all products containing NAC. While no absolutely final decision has been made by FDA regarding NAC, it might be the third effective Covid treatment that the FDA has attempted to suppress, after the chloroquine drugs and ivermectin. Stay tuned.
YouTube restrictions on medical information are a public health concern
By PeterYim | TrialSiteNews | May 16, 2021
Recently, the American Journal of Therapeutics reported that there was strong evidence that a treatment for COVID-19 had been found:
“Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance.”
The American Journal of Epidemiology also reported on strong evidence of a different treatment for COVID-19:
“Five studies, including 2 controlled clinical trials (of hydroxychloroquine), have demonstrated significant major outpatient treatment efficacy.”
What these reports have in common is that YouTube explicitly forbids these therapies to be discussed on its platform. It’s policy states:
“Don’t post content on YouTube if it includes ….. Claims that Ivermectin or Hydroxychloroquine are effective treatments for COVID-19”
Furthermore, YouTube characterizes any information that dissents from the view of the “local health authorities” or the World Health Organization as “misinformation”:
“YouTube doesn’t allow content that spreads medical misinformation that contradicts local health authorities’ or the World Health Organization’s (WHO) medical information about COVID-19.”
Under YouTube policy, the peer-review medical literature has lost its place as the source of medical information to governmental and para-governmental organizations. In the US, the relevant organizations are the FDA and the NIH. The FDA currently recommends against the use of Ivermectin and Hydroxychloroquine in COVID-19 except in clinical trials.
The FDA does not, however, offer any evidence to support this recommendation. In fact, the FDA clarifies:
“The FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19 …”
Nor does the FDA claim that any formal procedure was followed. It doesn’t even identify the individual or individuals who developed that recommendation.
The case of the NIH recommendation on Ivermectin is even more troubling. The NIH formally does not recommend for or against the use of Ivermectin but does make it clear that there are “insufficient data” to make that recommendation. The NIH names the medical experts who form the Panel and explains the procedures for developing the COVID-19 recommendations. Then, apparently, the NIH deceptively bypassed both in arriving at its recommendation.
Our reporting on the National Institutes of Health (NIH) COVID-19 Treatment Guidelines has found that the NIH cannot state whether a vote was held to endorse the latest recommendation on Ivermectin. The NIH even decided to fight a complaint in federal court simply to avoid answering that question. This reporting shows that the NIH cannot be trusted.
Aside from the NIH’s deceptive ivermectin recommendation, the American public is generally skeptical of public health authorities. As reported earlier, a survey was recently conducted by the Robert Wood Johnson Foundation and the Harvard T. H. Chan School of Public Health on the public’s views of the US public health authorities. The top line finding was:
“The public lacks the high level of trust in key public health institutions necessary to address today’s and future challenges.”
Why then is YouTube adhering so uncritically to the views of “local health authorities”? In so doing, it is obstructing patients and health care providers from accessing the best medical information.
Memo to medical bloggers living in Mommy’s basement
And to medical reporters living in New York and Georgetown pulling down nice paychecks
By Jon Rappoport | No More Fake News | May 13, 2021
You see, bloggers and reporters, here is the problem (one among many, actually). You have no background.
You don’t understand that every time you write a medical piece, there is a context which should inform your every move:
The modern medical system kills and maims huge numbers of people.
To put it another way, THE MODERN MEDICAL SYSTEM KILLS AND MAIMS HUGE NUMBERS OF PEOPLE.
Let me help you out.
ONE: “The Epidemic of Sickness and Death from Prescription Drugs.” The author is Donald Light, who teaches at Rowan University, and was the 2013 recipient of ASA’s [American Sociological Association’s] Distinguished Career Award for the Practice of Sociology. Light is a founding fellow of the Center for Bioethics at the University of Pennsylvania. In 2013, he was a fellow at the Edmond J. Safra Center for Ethics at Harvard. He is a Lokey Visiting Professor at Stanford University.
Donald Light: “Epidemiologically, appropriately prescribed, prescription drugs are the fourth leading cause of death, tied with stroke at about 2,460 deaths each week in the United States. About 330,000 patients die each year from prescription drugs in the United States and Europe. They [the drugs] cause an epidemic of about 20 times more hospitalizations [6.6 million annually], as well as falls, road accidents, and [annually] about 80 million medically minor problems such as pains, discomforts, and dysfunctions that hobble productivity or the ability to care for others. Deaths and adverse effects from overmedication, errors, and self-medication would increase these figures.” (ASA publication, “Footnotes,” November 2014)
TWO: Journal of the American Medical Association, April 15, 1998: “Incidence of Adverse Drug Reactions in Hospitalized Patients.”
The authors, led by Jason Lazarou, culled 39 previous studies on patients in hospitals. These patients, who received drugs in hospitals, or were admitted to hospitals because they were suffering from the drugs doctors had given them, met the following fate:
Every year, in the US, between 76,000 and 137,000 hospitalized patients die as a direct result of the drugs.
Beyond that, every year 2.2 million hospitalized patients experience serious adverse reactions to the drugs.
The authors write: “…Our study on ADRs [Adverse Drug Reactions], which excludes medication errors, had a different objective: to show that there are a large number of ADRs even when the drugs are properly prescribed and administered.”
So this study had nothing to do with doctor errors, nurse errors, or improper combining of drugs. And it only counted people killed or maimed who were admitted to hospitals. It didn’t begin to tally all the people taking pharmaceuticals who died as consequence of the drugs, at home.
THREE: July 26, 2000, Journal of the American Medical Association; author, Dr. Barbara Starfield, revered public health expert at the Johns Hopkins School of Public Health; “Is US health really the best in the world?”
Starfield reported that the US medical system kills 225,000 Americans per year. 106,000 as a result of FDA-approved medical drugs, and 119,000 as a result of mistreatment and errors in hospitals. Extrapolate the numbers to a decade: that’s 2.25 million deaths. You might want to read that last number again.
In 2009, I interviewed Dr. Starfield. Here is an excerpt:
What has been the level and tenor of the response to your findings, since 2000?
The American public appears to have been hoodwinked into believing that more interventions lead to better health, and most people that I meet are completely unaware that the US does not have the ‘best health in the world’.
In the medical research community, have your medically-caused mortality statistics been debated, or have these figures been accepted, albeit with some degree of shame?
The findings have been accepted by those who study them. There has been only one detractor, a former medical school dean, who has received a lot of attention for claiming that the US health system is the best there is and we need more of it. He has a vested interest in medical schools and teaching hospitals (they are his constituency).
Have health agencies of the federal government consulted with you on ways to mitigate the [devastating] effects of the US medical system?
NO.
Since the FDA approves every medical drug given to the American people, and certifies it as safe and effective, how can that agency remain calm about the fact that these medicines are causing 106,000 deaths per year?
Even though there will always be adverse events that cannot be anticipated, the fact is that more and more unsafe drugs are being approved for use. Many people attribute that to the fact that the pharmaceutical industry is (for the past ten years or so) required to pay the FDA for reviews [of its new drugs]—which puts the FDA into an untenable position of working for the industry it is regulating. There is a large literature on this.
Aren’t your 2000 findings a severe indictment of the FDA and its standard practices?
They are an indictment of the US health care industry: insurance companies, specialty and disease-oriented medical academia, the pharmaceutical and device manufacturing industries, all of which contribute heavily to re-election campaigns of members of Congress. The problem is that we do not have a government that is free of influence of vested interests. Alas, [it] is a general problem of our society—which clearly unbalances democracy.
Would it be correct to say that, when your JAMA study was published in 2000, it caused a momentary stir and was thereafter ignored by the medical community and by pharmaceutical companies?
Are you sure it was a momentary stir? I still get at least one email a day asking for a reprint—ten years later! The problem is that its message is obscured by those that do not want any change in the US health care system.
Are you aware of any systematic efforts, since your 2000 JAMA study was published, to remedy the main categories of medically caused deaths in the US?
No systematic efforts; however, there have been a lot of studies. Most of them indicate higher rates [of death] than I calculated.
Did your 2000 JAMA study sail through peer review, or was there some opposition to publishing it?
It was rejected by the first journal that I sent it to, on the grounds that ‘it would not be interesting to readers’!
Do the 106,000 deaths from medical drugs only involve drugs prescribed to patients in hospitals, or does this statistic also cover people prescribed drugs who are not in-patients in hospitals?
I tried to include everything in my estimates. Since the commentary was written, many more dangerous drugs have been added to the marketplace.
—end of interview excerpt—
FOUR: BMJ June 7, 2012 (BMJ 2012:344:e3989). Author, Jeanne Lenzer. Lenzer refers to a report by the Institute for Safe Medication Practices: “It [the Institute] calculated that in 2011 prescription drugs were associated with two to four million people in the US experiencing ‘serious, disabling, or fatal injuries, including 128,000 deaths.’”
The report called this “one of the most significant perils to humans resulting from human activity.”
The report was compiled by outside researchers who went into the FDA’s own database of “serious adverse [medical-drug] events.”
Therefore, to say the FDA isn’t aware of this finding would be absurd. The FDA knows. The FDA knows and it isn’t saying anything about it, because the FDA certifies, as safe and effective, all the medical drugs that are routinely maiming and killing Americans. Every public health agency knows the truth.
FIVE: None of the above reports factor in death or injury by vaccine.
The US system for reporting severe adverse effects of vaccines is broken.
Barbara Loe Fisher, of the private National Vaccine Information Center, has put together a reasonable analysis:
“But how many children have [adverse] vaccine reactions every year? Is it really only one in 110,000 or one in a million who are left permanently disabled after vaccination? Former FDA Commissioner David Kessler observed in 1993 that less than 1 percent of doctors report adverse events following prescription drug use. [See DA Kessler, ‘Introducing MEDWatch,’ JAMA, June 2, 1993: 2765-2768]”
“There have been estimates that perhaps less than 5 or 10 percent of doctors report hospitalizations, injuries, deaths, or other serious health problems following vaccination. The 1986 Vaccine Injury Act contained no legal sanctions for not reporting; doctors can refuse to report and suffer no consequences.”
“Even so, each year about 12,000 reports are made to the Vaccine Adverse Event Reporting System [VAERS]; parents as well as doctors can make those reports. [See RT Chen, B. Hibbs, ‘Vaccine safety,’ Pediatric Annals, July 1998: 445-458]”
“However, if that number represents only 10 percent of what is actually occurring, then the actual number may be 120,000 vaccine-adverse events [per year]. If doctors report vaccine reactions as infrequently as Dr. Kessler said they report prescription-drug reactions, and the number 12,000 is only 1 percent of the actual total, then the real number may be 1.2 million vaccine-adverse events annually.”
SIX: Here is a stunning quote from a doctor who has quite probably read and analyzed as many medical-drug studies as any other doctor in the world:
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.” (Dr. Marcia Angell, NY Review of Books, January 15, 2009, “Drug Companies & Doctors: A Story of Corruption)
Compare that quote with one from “the father of COVID science,” Tony Fauci. In an interview with the National Geographic, Fauci stated: “Anybody can claim to be an expert even when they have no idea what they’re talking about… If something is published in places like New England Journal of Medicine, Science, Nature, Cell, or JAMA—you know, generally that is quite well peer-reviewed because the editors and the editorial staff of those journals really take things very seriously.”
They take things so seriously at the New England Journal, they routinely publish glowing studies of medical drugs which, as evidence shows, are killing people in great numbers.
So… you medical bloggers living in mommy’s basement, and you medical reporters who live in New York and Georgetown and pull down nice paychecks, you now have some background. Every time you write a Mockingbird article (aka puff piece), you can fathom how deep your lies really go, and how much crime you’re really involved with.
It’s never too late to tell the truth. I’m offering you a way out.
FDA Approves Gilead’s Remdesivir To Treat COVID-19 Despite Data Showing Drug Doesn’t Work
By Tyler Durden – Zero Hedge – 10/22/2020
Despite reams of data from an international WHO study raising serious questions about its efficacy, the FDA has finally approved the use of Gilead Science’s remdesivir – a powerful antiviral originally developed to treat ebola – for the treatment of COVID-19, making it the first such drug approved to treat the virus in the US.
The FDA first granted the drug emergency authorization in May, allowing hospitals and doctors to use the drug even though by all accounts it wasn’t that widely used.
President Trump received one course of remdesivir along with several other COVID-19 therapies after contracting the virus. Doctors also gave the president dexamethasone, a steroid that has a much better track record for treating the virus, according to the available data. Trump also received an experimental drug from Regeneron, which, along with Eli Lilly, has filed for emergency use approval for its COVID-19 antibody treatment.
Gilead has been waging a PR campaign against the WHO, which recently publicized the results of its global trial of remdesivir, producing data that was widely hailed as definitive by other scientists.
But Gilead had a lock on approval seemingly from the very beginning, as US officials, including Dr. Anthony Fauci, praised the drug. Dr. Fauci once said the drug would “set a new standard of care” for COVID-19.
Back in August, Gilead said the company planned to produce more than 2 million courses of the drug by the end of the year, with “several million more coming in 2021.”
Initially, Gilead says it will initially focus on meeting “real-time demand” in the US.
Oddly, none of the initial coverage of the FDA’s decision included much discussion of the WHO’s trial data, which pretty clearly branded the drug a flop. Even the evidence that Gilead has managed to marshal in remdesivir’s defense has been pretty unconvincing.
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From the Archives
A short history of British torture
ICC | December 2005
When the House of Commons was debating how much to increase the time limit for detention without trial the question of torture came up. Officially this was limited to the nice considerations of whether it was all right to send people to places where torture is used and whether Britain can use information collected by the use of torture in other countries. This discussion gave an impression of democratic Britain as the home of civilised behaviour where the very idea of torture is repugnant to our legislators – unlike, say, the US with its secret CIA jails… In reality, the British state has a long history of using and developing a whole range of torture techniques. … continue
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