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A Legacy of Corruption in the FDA and Big Pharma

By Liam Cosgrove | Mises Wire | September 11, 2021

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

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

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

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

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

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

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

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

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

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

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

CDC Gives Incoming Refugees Nobel Prize-Winning Ivermectin

By Kelen McBreen | InfoWars | September 3, 2021

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Follow the money and stop paying attention to establishment media.

September 5, 2021 Posted by | Corruption, Deception, Mainstream Media, Warmongering | , , , , | 1 Comment

Why Testing Your Immunity to COVID-19 Is Important

By Dr. Joseph Mercola | September 4, 2021

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

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

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

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

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

SOURCES:

Noorchashm.medium.com August 27, 2021

Epoch Times August 19, 2021

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

You cannot be forced to get the Covid vaccine. Here is the way out.

By Meryl Nass, MD | August 26, 2021

Let me show you how FDA, Pfizer and BioNTech colluded to fool everyone about the EUA status of the vaccine Americans will be offered. But close reading of their document gives you an escape route.

The “Fact Sheet for Recipients, “dated August 23, 2021, is approved by FDA and is on FDA’s website, and is signed by BioNTech and Pfizer.

Direct quotes from this easy to read 8 page document are below, and I suggest you print the document out, as it will help you avoid a vaccine mandate. Pay close attention. I added numbers to the most interesting excerpts.

After stating that you might receive the licensed vaccine or a vaccine under EUA in item 2, item 6 indicates that both the licensed vaccine AND the EUA vaccine are both under EUA. (This may be the way chosen to shield the licensed vaccine from liability.) Item 5 says that while under EUA, it is your choice whether or not to receive the vaccine.

Show this document to your college, your hospital, your boss. They cannot force you to receive either of these vaccines!

—————–

1.  The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.[1]

2. You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.

3. The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

4. WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE?

5. Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.

6. This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

Manufactured by Pfizer Inc., New York, NY 10017

Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany LAB-1451-7.2 Revised: 23 August 2021

August 27, 2021 Posted by | Civil Liberties, Deception | , , , , , | 2 Comments

Regulators knew in 2020 that Covid-19 Vaccines would cause blood clots, heart damage, harm to children, and death

DAILY EXPOSE – AUGUST 22, 2021

Every serious adverse reaction to the Covid-19 vaccines that medicine regulators in both the USA and United Kingdom have been forced to admit is occurring was predicted by the very same medicine regulators to occur before the Covid-19 vaccines were even rolled out.

The following video was released by the US Food and Drug Administration in October 2020 and the person presenting the slides within the video skips past a slide entitled ‘Draft working list of possible adverse event outcomes’ as fast as he possibly can.

Skip to the 2 hour, 33 minute mark and see for yourself…

You’ll have noticed the slide read as follows –

“FDA Safety Surveillance of COVID-19 Vaccines: DRAFT Working list of possible adverse event outcomes ***Subject to change***

-Guillain-Barré syndrome
-Acute disseminated encephalomyelitis
-Transverse myelitis
-Encephalitis /myelitis/encephalomyelitis/meningoencephalitis/meningitis/encephalopathy
-Convulsions/seizures
-Stroke
-Narcolepsy and cataplexy
-Anaphylaxis
-Acute myocardial infarction
-Myocarditis/pericarditis
-Autoimmune disease
-Deaths
-Preganacy and birth outcomes
-Other acute demyelinating diseases
-Non-anaphylactic allergic reactions
-Thrombocytopenia
-Disseminated intervascular coagulation
-Venous thromboembolism
-Arthritis and arthralgia/joint pain
-Kawasaki disease
-Multisymptom Inflammatory Syndrome in Children
-Vaccine enhanced disease”

All of the clotting and coagulation.  All of the heart damage.  All of the female reproductive issues. All of the people suffering heart attacks and strokes and people sadly dying. All of it was predicted by the medicine regulators before the jabs were even rolled out.

Even the multi-symptom inflammatory syndrome in children was predicted and it is a brand new disease where children have symptoms resembling toxic shock syndrome or Kawasaki disease, in which the coronary arteries enlarge or form aneurysms. Also common are heart inflammation with impaired heart function and low blood pressure, rash or red eyes, and gastrointestinal symptoms.

Which is why we can be certain that vaccine enhanced disease also known as antibody-dependent enhancement is occurring and will occur, because the health regulators have predicted it will do so. This is precisely why Public Health England data shows that the double vaccinated have at least a 338% higher chance of death if infected with Covid-19.

The latest PHE report shows that up to the 15th August 2021 the fully vaccinated population had suffered a total of 679 deaths. This equates to 0.9% of all confirmed infections among the fully vaccinated population. Whereas the unvaccinated population had suffered just 390 deaths equating to just 0.2% of all confirmed infections.

The medicine regulators knew precisely what would happen to people once the Covid-19 injections were rolled out yet they allowed it to happen anyway. We wonder if Bill Gates being the primary funder of the UK’s Medicine Regulator the MHRA has anything to do with it? He only has major shares in both Pfizer and BioNTech so perhaps not?

August 26, 2021 Posted by | Deception, Timeless or most popular | , , , | 1 Comment

Vaccine safety evidence

Vaccine Truth | July 20, 2021

We are not “anti-VAXers.” We were vaccinated because we believed we were being told the truth. Now we know better.

Unfortunately, the current gene-based vaccines (all vaccines on the US market today) were rushed to market without proper testing. They are dangerous and appear to have killed over 30,000 previously healthy Americans so far and disabled an equivalent number.

The Phase 3 trials were structured so that the results looked good because they were allowed to exclude unfavorable data (such as Maddie de Garay, a 12-year old girl who participated in the Pfizer trial and who is now permanently paralyzed due to the vaccine). People with a bad first reaction were allowed to drop out which doesn’t reflect the reality of “full vaccination” requirements of workplaces and schools.

We should stop the current gene-based vaccines ASAP. The risk/benefit justification isn’t there for any age group due to the poor safety profile of these vaccines compared with the alternatives.

Based on analysis of VAERS death data for vaccine deaths and CDC death data for COVID deaths, the younger you are, the less sense vaccination makes. If early treatments didn’t work at all, the toxicity of the current vaccines would only make sense for those over 30 (based data to date). However, the vaccines are too toxic and don’t meet the <50 deaths stopping criteria that we’ve used for the past 30 years, so they should never be used because we have better alternatives available today that can achieve the same goals.

We should never be giving vaccines that disable or kill previously healthy people in huge numbers if safer alternatives are available that can achieve all the same objectives.

Why would anyone in America choose to have lipid nanoparticles which deliver a toxic protein into your brain and where the long term effects are unknown, when safer alternatives are available? What parent would choose to experiment on their kids this way when safer and more effective options are available?

It is tragic that schools are requiring students to be vaccinated in order to attend classes. I’ve asked our top universities for the risk-benefit analysis to justify this action and have received nothing. If the vaccines were perfectly safe, no analysis would be needed. But they aren’t.

The rate of severe life-changing side effects appears to be well in excess of 25,000 people (the number reported disabled is comparable to the number dead). The fact that Facebook groups of vaccine victims had 200,000 users suggests that more than 1 in 1,000 are suffering from significant long-term impacts; people with minor temporary reactions have little incentive to seek out and sign up for a vaccine side-effects group.

People who claim “the clinical trials showed no significant side effects so it must be safe” have a tough time explaining how these facebook groups were so large before they were deleted. If you think the vaccines are so safe, show me the severity analysis of the 200,000 people there. These groups don’t appear with the influenza vaccine. You never see neurological effects like this in such high volume with a safe vaccine.

Some have cited the emergence of the Delta variant as changing the math to favor vaccination even if the vaccine is unsafe. But the case fatality rate (CFR) of the Delta variant is only 0.1 percent compared to the CFR of 1.9 percent for the original virus (alpha) according to UK government data. The argument that the lower CFR of delta is due to the higher number of vaccinated people isn’t very credible since the Eta variant has a 2.7 percent CFR.

Early treatments are a more effective and safer option than the current vaccines. We can achieve all of the objectives of the current vaccination program (herd immunity, eradication of the virus, re-opening our economy, ditching of masks) with fewer deaths and near zero serious side effects. In addition, we would have less problem with variants since variants are less likely to be generated if everyone is naturally immune. So why not promote early treatments? Why not give them a try for a month while we hit the pause button on the vaccines? Would that be so bad?

Allowing natural infection will impart broad natural immunity. We should instruct the population how to treat early with early treatment protocols as soon as they believe they are infected. People should have the drugs on-hand so that treatment can be started without delay after speaking with their doctor. This results in superior risk reduction in terms of fewer fatalities and side effects compared to the current vaccines.

There was never a need for masking or social distancing as COVID is very treatable when treated early. Nobody has to die or be hospitalized. We can get to herd immunity quickly this way. The key is to treat the virus early with a proven early treatment cocktail of repurposed drugs, adding novel antivirals if/when available.

Unfortunately, the NIH has unethically suppressed all early treatments in order to push the vaccine narrative. This is clear with the publication of a systematic review of ivermectin, the highest level of evidence possible. Yet the NIH and WHO pretend that it never happened. It isn’t even acknowledged that the systematic review came out. There has never been a peer-reviewed systematic review that was later overturned. This is why they are the top of the evidence pyramid.

Early treatments were never funded. When evidence came in they worked, the NIH ignored it. The corruption at the NIH and FDA should be corrected by Congress. Now.

To prove the point about the unethical suppression of early treatments, I offered $2M to anyone who could show that the NIH got it right. Nobody stepped forward.

Similarly, I offered $1M to anyone who could show that the vaccines are safe. No takers, not even the drug companies.

If a safe sterilizing vaccine can be developed, we should test it adequately for safety before deploying it. We should not cut corners on safety again; with early treatments, there is no need to rush this.

Major medical journals have lost objectivity in publishing papers that go against the “safe” narrative. For example, the NEJM rejected a Letter to the Editor pointing out a flaw in a paper showing vaccines were safe for pregnant women. The Letter showed an alarming statistic. The NEJM refused to reveal their reasoning for the rejection. Three editors quit a journal after a peer-reviewed paper was published that showed that vaccination may cause more harm than good. Those who quit provided no evidence that the paper was in error.

The censorship of legitimate medical information on social networks must end. These networks are the new “public square” and should be regulated so that people are free to express their opinions to anyone who chooses to listen. There should be heavy monetary penalties for suppressing medical information that has the potential to save lives. Social networks should be required to compensate all those people who have been harmed by their actions.

Never again should we deploy a vaccine on the American public without proper testing and without informed consent. Databases such as V-SAFE that track safety data should be made transparent. Am I the only person who thinks that is a problem?

VAERS reporting should be required and the VAERS system should be modernized so that it is easy to use and results in records with consistent field coding. There should be a smaller lag time to get records into the database, all false reports should be 100% enforced as a criminal act, and the safety signal monitoring should be much stronger.

The cost-benefit analysis of the current gene-based vaccines for anyone of any age is at best a wash according to the scientific literature (new paper published June 24, 2021). This peer-reviewed paper looked at the real cost-benefit analysis and concluded that “This lack of clear benefit should cause governments to rethink their vaccination policy.” As far as I know, this is the most optimistic of all the papers looking at actual death rates of COVID vs. the vaccine. All the other ones are even worse for the vaccine.

Independent analysis by a statistician friend shows a similar effect. Like me, Mathew has no axe to grind here, just trying to get at the truth of the risk/benefit for the current vaccines. His conclusion: “More importantly, I also still disagree with the mass vaccination program. In particular, nearly all lives saved are in the high risk group. While vaccinating those in the low risk group might decrease spread into the high risk group, that’s asking young healthy people to act as human shields.

I also believe that when the vaccine deaths and adverse events are finally tallied and compared to either a ring vaccination strategy or combination ring vaccination and early treatment strategy, the current plan will look quite foolish and possibly even nefarious.”

Since the focus today is on getting kids vaccinated, I ran the numbers in the VAERS database for 20-24 year olds and 25-29 year olds. In both age ranges, the number of deaths caused by the vaccine outnumber the number of deaths saved. The vaccines caused 1.89 deaths per 100,000 (ages 25-29) and 1.74 deaths per 100,000 (ages 20-24).

This means the vaccines are net killing machines since they kill more people than they save (.3 to 1.0 lives per 100K saved according to the most recent CDC presentation). My calculations are in the body of this document and the calculations show no net benefit for any age group based on real-world data from the US and UK.

The comparison is even more extreme if we tell kids to ignore the current CDC advice and use an early treatment program. In that case, we can reduce the death rate by more than two orders of magnitude from COVID, so that the number of lives saved by the vaccine is fewer than 1 in 10M. This means the vaccines need to be less toxic than the influenza vaccine (which has a death rate of 1 in 10M) in order to be considered. They are not even close to that. Not by a country mile.

For older people, the numbers don’t work out either. We looked at the UK data for <50 and >50 and we found that the absolute death rate is very small for <50 group. There was a high relative risk reduction, but the absolute deaths were small. If the vaccine kills more than 1 in 1 million, it’s game over for the vaccine being useful. For age >50, the UK data shows that even if the vaccines killed nobody, it is not beneficial. So when you factor the death rate of the vaccines and early treatment as the other option, the case is extremely lopsided.

In short, because the current vaccines are so dangerous and early treatment is so effective (relative risk reduction of 100 or more with no permanent side effects), there is no reasonable case that can be made for vaccinating any age group.

Although we just looked at deaths in the analysis above, the same can be true for other side effects as well: the range and intensity of side effects from the vaccine dwarf anything seen in natural COVID. It’s even a more stark contrast when early treatment is added to the mix.

Long term, untreated vax patients and untreated COVID patients are virtually identical in terms of symptoms (thanks to Ram Yogendra for that insight). By vaccinating patients, we are essentially giving a portion of those vaccinated long hauler COVID.

The case numbers in the UK (one of the most heavily vaccinated countries) are now climbing. It suggests we should have listened to the arguments of Geert Vanden Bossche, one of the most famous scientists in the vaccine field, which are further clarified in this excellent video by Chris Martenson which points out that there are really only two ways out of the pandemic: a sterilizing vaccine (using the complete virus as the antigen) or allowing infection and treating with early treatment leading to natural immunity.

The Yellow Card system in the UK showed a similar safety signal. Independent analysis of that data by an expert in medical evidence concluded that the vaccines are unsafe for use in humans. It wasn’t a close call. The death rates from the vaccines are far greater than any absolute risk reduction.

This is taken from a very long article. Read the rest here: docs.google.com

August 11, 2021 Posted by | Corruption, Deception, Full Spectrum Dominance, Science and Pseudo-Science, Timeless or most popular | , , , | 5 Comments

Raising the Alarm on Myocarditis After Covid Vaccination

By Dr Clare Craig and Dr Andrew G. Bostom | Lockdown Sceptics | June 29, 2021

There are now 1160 reports of myocarditis and pericarditis after Covid vaccination in the US Vaccine Adverse Event Reporting System (VAERS). The total could be significantly higher due to latency in reports being processed. Myocarditis is a serious condition associated acutely with fatal arrhythmias, and chronically, because myocytes are irreplaceable, with heart failure and significant associated mortality. The rate of myocarditis/pericarditis reports post-vaccination has historically been low. For the 28 years from 1990 to 2018, during which there were close to three billion vaccinations for influenza alone, there were 708 such events reported in VAERS.1 Using methodology described by Su et al,1 to search the VAERS database,2 the 1160 myocarditis/pericarditis cases occurred in only six months, during which a total of around 150 million people had Covid vaccines, mostly mRNA and excluding lagged reporting.

There are understandable caveats about attributing ‘causality’ to VAERS adverse events associated with vaccination,3 however the numbers of adverse events are likely to be underreported.4 As the aetiology of Covid vaccine-induced myocarditis is new it may be unwise to extrapolate the prognosis from what is known about myocarditis due to other aetiologies. However, it is worth noting that 3-4% of those with acute myocarditis require heart transplantation.5 The overall mortality rate after one year was 20%6 and after five years 44%7 to 56%.6 Of the 1160 reported incidences after Covid vaccination, there have been seven deaths so far with three in under 60 year olds.

Of the myopericarditis cases in under 30 year olds, 496 have an ejection fraction recorded in VAERS. Of these 52 were graded as “decreased” and 36 graded as “normal”. At a minimum, therefore, more than 10% have at least transiently decreased ejection fractions indicating measurable damage to the myocardium. A low ejection fraction has been associated with major adverse cardiac events.8 The transplantation rate is as high as 11% within the first year in those with complications.9 A case report of post-vaccination ‘mild’ myopericarditis in a 16 year-old initially admitted to the intensive care unit, and hospitalised for six days, revealed that he had myocardial fibrosis.10 His troponin levels were high enough to predict a tenfold increased risk of mortality.11

The FDA has expressed concerns around the rate of reported myocarditis within the VAERS reporting system, especially in the young. A presentation by the FDA on June 10th 2021 compared the reported rates of myocarditis with background expected rates, with data up to May 31st 2021.12 However, the expected rates to which observed rates were compared were those expected over a 31-day period. For under-18s, 90% of cases had an onset by day five after vaccination, making comparison with expected rates over 31 days unreasonable. A further meeting on June 23rd 2021 examined the reports in a seven day window with data up to 11 June 2021. A four fold increase above baseline was evident in the seven days after the first dose for under-24 year-olds, rising to over 27-fold for the seven days after the second dose. The rate per million doses given in males 12-17 years old was 17 times higher than in men aged over 50 years seven days after the first dose, rising to 74 times seven days after the second dose. (For females the risk was 50% higher and 13 times higher respectively.)13

For over-65 year-olds, half of the reported incidences were within eight days of vaccination and 79% occurred in a 31-day window after vaccination. The expected rate for the over-65 year-old age group was 36 to 358 per million over 31 days, whereas the reported rate was 26.12 This gives an indication of the under-reporting of events in the VAERS system which is not capturing even the background expected rates. For both young and old it is not a clinically obvious diagnosis and it is likely that milder cases will have gone undiagnosed. Even for these mild cases, the long term outcome is unknown and the risks to these patients with re-exposure to SARS-CoV-2 is also unknown. Currently, more than half of the reports in VAERS are from patients under the age of 30. It is unclear whether the high excess of reported cases in the younger age groups compared with the old is a reporting issue, as myocarditis may be mistaken for other cardiac pathology in older age groups and not reported, or a genuine finding of increased incidence in the young. Others have found that younger patients have a higher incidence of adverse effects following Covid vaccination which may be a function of more efficient translation of RNA into protein resulting in a higher dosage or a more vigorous immune reaction.14

For an individual the risk of vaccination must be balanced against the benefits. Under the age of 20, the risk of mortality for someone who catches Covid is less than four in a million.15 The risk of catching Covid is far from 100%, with many having naturally acquired immunity and high levels of population immunity. The risk to the individual must be measured as the sum of risks of every adverse effect. With estimates of the incidence of myocarditis alone after Covid vaccination in men 16-24 as high as one in 3-6000, the benefit for young people does not justify this risk.16 Immediately, this summer, controlled one-month longitudinal studies (see “A prospective study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and influenza vaccination”,17for example) of the incidence of myopericarditis should be conducted comparing Covid vaccinated and unvaccinated groups under 30 years of age, undergoing serial echocardiography, electrocardiography, and blood cardiac injury markers (notably, troponin). Pending completion of these studies, and rapid analyses of the data, there should be a moratorium on mass Covid vaccination of healthy, extraordinarily low-Covid-risk persons18 under 30 years old. The FDA’s intention to only continue monitoring is a dereliction of duty.

Dr Clare Craig is a Diagnostic Pathologist in London @clarecraigpath and Dr Andrew G. Bostom, MD, is MS Research Physician at Brown University’s Center For Primary Care and Prevention at Memorial Hospital of Rhode Island @andrewbostom

1  Su JR, McNeil MM, Welsh KJ, et al. “Myopericarditis after vaccination, Vaccine Adverse Event Reporting System (VAERS)”, 1990-2018. Vaccine 2021;39:839–45.

The Vaccine Adverse Event Reporting System (VAERS) Request (accessed June 21st 2021).

3 Shimabukuro TT, Nguyen M, Martin D, et al. “Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)”. Vaccine 2015;33:4398–405.

4 Baker MA, Kaelber DC, Bar-Shain DS, et al. “Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting”. Clin. Infect. Dis. 2015;61:864–70.

5 “UNOS Registry Myocarditis Heart Transplantation Outcome” – ATC Meetings Abstracts. 2020 (accessed June 23rd 2021).

6 Mason JW, O’Connell JB, Herskowitz A, et al. “A Clinical Trial of Immunosuppressive Therapy for Myocarditis”. The Myocarditis Treatment Trial Investigators. N. Engl. J. Med. 1995;333:269–75.

7 Grogan M, Redfield MM, Bailey KR, et al. “Long-term outcome of patients with biopsy-proved myocarditis: comparison with idiopathic dilated cardiomyopathy”. J. Am. Coll. Cardiol. 1995;26:80–4.

8 Wong BTW, Christiansen JP. “Clinical Characteristics and Prognostic Factors of Myocarditis in New Zealand Patients”. Heart Lung Circ. 2020;29:1139–45.

9 Ammirati E, Cipriani M, Moro C, et al. “Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis”: Multicenter Lombardy Registry. Circulation 2018;138:1088–99.

10 Talman V, Ruskoaho H. “Cardiac fibrosis in myocardial infarction-from repair and remodeling to regeneration”. Cell Tissue Res. 2016;365:563–81.

11 Roos A, Bandstein N, Lundbäck M, et al. “Stable High-Sensitivity Cardiac Troponin T Levels and Outcomes in Patients With Chest Pain”. J. Am. Coll. Cardiol. 2017;70:2226–36.

12 FDA. Vaccines and Related Biological Products Advisory Committee June 10th, 2021 Meeting Presentation.

13 COVID-19 Vaccine safety updates Advisory Committee on Immunization Practices (ACIP) June 23, 2021.

14 Menni C, Klaser K, May A, et al. “Vaccine after Effects and Post-Vaccine Infection in a Real World Setting: Results from the COVID Symptom Study App”. 2021. doi:10.2139/SSRN.3795344

15 Ghisolfi S, Almås I, Sandefur JC, et al. “Predicted COVID-19 fatality rates based on age, sex, comorbidities and health system capacity”. BMJ Glob Health 2020;5. doi:10.1136/bmjgh-2020-003094

16 Israel reports link between rare cases of heart inflammation and COVID-19 vaccination in young men. 2021 (accessed June 21st 2021).

17 Engler RJM, Nelson MR, Collins LC Jr, et al. “A prospective study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and influenza vaccination”. PLoS One 2015;10:e0118283.

18 Ioannidis JPA. “Reconciling estimates of global spread and infection fatality rates of COVID-19: An overview of systematic evaluations”. Eur. J. Clin. Invest. 2021;51:e13554.

July 1, 2021 Posted by | Science and Pseudo-Science, Timeless or most popular | , , | Leave a comment

American Medicine, American Malfeasance

By Dr. Gary Null and Richard Gale | Global Research | June 26, 2021

An issue that is rarely discussed or given serious attention is the over-specialization in healthcare. Modern medicine’s approach to identify and treat illnesses and tackle the reduction of infections has in many instances ceased to be multidisciplinary. Medicine has also become increasingly compartmentalized and confined to a rigid materialistic belief system that has now established its own set of standards, criteria and values that are often contrary to gold-standard scientific protocols. The consequence is that its narrow single-mindedness has insulated modern medicine from objective criticism and preserved its internal flaws, errors and fabrications, which have contributed to the unnecessary injury and death of countless patients.

US healthcare spending reached $3.8 trillion in 2019. Due to the Covid pandemic, expenditures for 2020 will be astronomically higher. One might expect that with the world’s most expensive healthcare system, the US would equally have the best evidence-based practices to keep its citizens healthy. By now we should be proficiently expert at preventing and reversing disease, while making minimal errors resulting in injury or death. However, the exact opposite is the case. Instead of minimizing disease-causing factors, American medicine causes more illness through misguided diagnostic testing, overuse of medical and surgical procedures, and over prescribing pharmaceutical drugs. The fundamental reason for this catastrophe is that today’s healthcare establishment, and corporate science in general, over relies on profit-generating motives.

Dr. Peter Gotzsche is arguably recognized as one of the world’s foremost experts in evaluating evidence-based medicine (EBM). As the co-founder of EBM’s preeminent flagship organization – the Cochrane Collaboration — to review and analyze peer-reviewed clinical research, he is intimately knowledgeable about the widespread corruption permeating the pharmaceutical industry and medical journals. In his book Deadly Medicines and Organized Crimehe writes,

“The reason why we take so many drugs is that drug companies do not sell drugs. They sell lies about drugs… The patients do not realize that although their doctors know a lot about diseases, human physiology and psychology, they know very little about the drugs that have been concocted and dressed up by the drug industry.”

After we take a fair and objective look at American medicine during the past five decades, especially at the statistics of iatrogenic fatalities, or deaths caused by prescribed medications and medical error, our healthcare establishment is found to be anything but benign. Despite its many noteworthy discoveries and merits, a substantial amount of recommended medical practice has failed patients. “If the medical system were a bank,” writes Dr. Stephen Persell at Northwestern University’s School of Medicine, “you wouldn’t deposit your money here, because there would be an error every one-in-two to one-in-three times you made a transaction.” Dr. Persell is referring to the rates of preventable medical errors causing patients serious injury and now the third leading cause of death.

There is excellent evidence to support the argument that iatrogenic deaths have passed cancer fatalities and are now challenging heart disease for the number one spot. A 2008 study found as many as half of adverse events reported by patients were not recorded in their hospital charts. As of 2017, investigations continue to find that less than 10% of medical errors are reported. Reported adverse effects vary depending on the specialty and frequently go unnoticed or are improperly evaluated. An additional study found that almost two thirds of cardiologists had refused to report a serious error they had direct personal knowledge of to an authority.

As one example, heart disease is America’s leading cause of fatality, accounting for 665,000 deaths annually. The CDC, which consistently undermines health threats if it means positioning itself in opposition to private commercial interests, estimates that 34 percent of cardiovascular fatalities are premature and preventable. In contrast, the American Heart Association claims 80 percent are preventable. What are the heads of our federal health agencies doing to advocate on the side of prevention? Little to nothing.

There is no realistic and science-based national policy in place to lessen cardiovascular, cancer and diabetic death rates. Since the most viable and effective means to prevent these diseases are natural and within every person’s means, it is not financially lucrative to divert federal funding away from pharmaceutical treatments and surgical procedures. The CDC and FDA are largely dependent upon monetary income received from the drug and medical device industries.

Earlier we reported about the systemic corruption and fraud that has plagued the CDC and FDA for decades. It would be far cheaper to completely empty, dismantle, fumigate and rebuild the agencies anew rather than continue exerting pressure for reforms, which have only perpetuated a killing spree by protecting life-threatening drugs, vaccines and unnecessary medical procedures. Dr. Gotzsche notes, the same is true for private drug companies. Despite the numerous lawsuits drug companies have lost in federal courts, nothing has fundamentally changed in order to deter them from illegal activities to increase profits. In fact, the cost of paying out settlements and settling lawsuits is factored into the expense of doing business.

A decade ago, we teamed up with three board-certified physicians to undertake the task to review the peer-reviewed literature in order to recalculate the statistics from many branches of medicine in order to arrive at a more realistic casualty rate due to medical error. We began with a basic question. Do the current standards of American medical practice and its supporting science prove that the recommended therapies and healthcare protocols – whether drugs, surgery, diagnostic methods, medical devices, etc – are actually effective? And if so, at what cost to the patients’ health and well-being?

Our results and final conclusions were startling and culminated in the release of a widely read and referenced book, Death by Medicine. We made every effort to avoid editorial commentary to our findings. We decided to only report the statistics and facts with our calculations. The fact that our data placed iatrogenic error as the number one cause of death in America was alone sufficient. What was novel in our analysis was that we included preventable deaths, such as certain infections and severe nutrient deficiency, which could have been easily corrected by clinicians and medical personnel if viable prevention programs had been part of our healthcare system. After publication the book was sent to hundreds of journalists, federal officials and non-profit medical organizations. It was completely ignored by the orthodoxy; however, it became increasingly popular among alternative and complementary medical physicians who were already fully aware of the structural dangers to public health within conventional medical care.

Revisiting American medicine’s legacy of iatrogenic deaths is now more crucial than ever because the same behaviors that have contributed to the nation’s leading cause of death are being repeated during the Covid-19 pandemic. The government and federal health officials are in reprehensible denial of inexpensive and highly effective drugs, such as Ivermectin and hydroxychloroquine, to treat early and middle stage SARS-2 infections. Cases of Covid infections and deaths have been grossly exaggerated. And now we are realizing that the efficacy and safety profiles of the vaccines are orchestrated scams. As a result, the entire institutional edifice to vaccinate the global population is destined to become the greatest scandal of the 21st century.

Unfortunately, nobody can acquire accurate statistics for Covid-19 vaccine associated injuries and deaths from the CDC’s Vaccine Adverse Events Reporting System (VAERS). Careful weekly monitoring of VAERS’ adverse event updates convince us that the entire system is criminally rigged. CDC officials overseeing the database are undoubtedly fudging numbers after ratio of adverse events, including deaths, per number of doses administered are compared to the more robust and accurate EudraVigilance database in the European Union and the less reliable Yellow Card System in the UK.

As of June 17, VAERS was reporting 329,021 injuries and 5,888 deaths due to the Covid vaccines. The database’s most recent update is reporting an additional 26,541 injuries but 1,972 less deaths. How can this sudden disappearance of almost 2,000 deaths be accounted for? The mysterious loss of fatality entries occurred during the same week as a CDC working group of outside medical professionals was reviewing an association between the mRNA vaccines and the rising number of reported cases of cardiac inflammation or myocarditis. The group concluded that there is indeed “a likely association.” The occasion of deleted deaths in VAERS is also on the heels of the Israeli Shamir Medical Center report that Pfizer’s vaccine is linked with occurrences of thrombotic thrombocytopenic purpura, an autoimmune disorder associated with a rare form of blood clotting. However, despite weekly local news stories around the nation about youth as young as 19 years of age dying of vaccine complications shortly after receipt of an mRNA vaccine, the CDC is claiming that all 1,200 persons, between 16-24 years of age, recovered and no deaths were reported. Does this account for the likely scrubbing of entries in VAERS?

But it is much worse. We only need to look at the European Union’s statistics for adverse Covid-19 vaccine events and compare that with VAERS and the CDC’s recent conclusion to realize there is a massive cover-up in our government’s efforts to sanitize the safety record of Covid vaccines. As of this week the EudraVigilance system is reporting over 1.5 million injuries and 15,472 deaths. Within those figures, 28,583 injuries and 1,862 deaths are from cardiac complications such as myocarditis.

Second, the EU and US have administered approximately the same number of Covid vaccine doses, roughly 409 million and 379 million respectively. Therefore we should expect to find a similar dose-to-injury ratio. Again we discover the CDC gaming the nation’s reporting system to lessen the perception of lethal risks. Based upon the EU ratio we can conservatively estimate that a minimum of 14,300 Americans have been killed by the vaccines so far. If we go back a week before the CDC scrubbed entries in VAERS, it would be over 17,000 Covid vaccine deaths.  The actual number of Americans suffering adverse reactions would be 1.4 million.

In other words the EU is reporting 4 times more vaccine injuries and deaths than American health officials.  In both the US and EU, Pfizer’s mRNA vaccine accounts for the majority of these casualties. Unless the Covid-19 vaccines engineer a personal vendetta against people holding EU passports, these numbers don’t add up.

Before the arrival of the Covid vaccines, Merck’s anti-inflammatory drug Vioxx was widely regarded as the single largest pharmaceutical catastrophe in American medical history. The drug should never have been approved and licensed in the first place; and, Merck knew beforehand that the drug would be lethal and concealed that documentation from FDA regulators. Vioxx was on the market for five years before being withdrawn. At the time of the federal class action lawsuit against Merck, FDA epidemiologist Dr. David Graham estimated the drug had killed 60,000 patients due to heart attacks and strokes.  Since the majority of deaths were among elderly patients, a later report by the American Conservative predicted that upwards to half a million patients may have died from the drug over the course of a longer period. Yet during those years Merck was cashing in $2 billion annually from Vioxx sales, earning over double its eventual $4.8 billion fine after being found guilty.

To put this into a broader perspective, the Covid vaccines have only been distributed for six months and have now contributed to a realistic 17,000 deaths or upwards towards 30,000 this year alone. Since the vaccines’ immunity quickly wanes and it seems certain they provide little protection against new SARS-2 strains, health officials are already recommending regular booster shots.  Similar to a prescription medication, those who buy into the vaccine propaganda hype are in principle relying upon these vaccines for life or until such time the virus resides into just a seasonal nuisance. Consequently iatrogenic vaccine injuries and deaths may likely continue at current rates during forthcoming years.  The Covid-19 vaccines are on track to outpace the conservative number of Vioxx deaths over three-fold and even modern medicine’s most deadly drugCerivastatin, manufactured by Bayer in the late 1990s and responsible for over 100,000 deaths during the four-year period it was on the market.  In short time, Covid vaccines will be the deadliest drug to have emerged from Big Pharma.

A study published in the Journal of Patient Safety estimated that 400,000 unnecessary and preventable deaths occur annually in American hospitals alone. At that rate, it is not surprising that the large majority of deaths ruled as SARS-2 infections happened in hospitals. If our federal health officials had been competent, and less compromised by the demands and influence of drug makers, most of these fatalities likely would never have occurred.

It has been estimated that US taxpayers have paid out $39 billion for Covid-19 vaccine development, funding and towards nationalized response measures. Most of this has been horribly wasted after we consider other options on hand to curb the pandemic but were categorically ignored. “In the case of vaccines in general,” the journal Health Affairs observed,

“the government often plays an outsized role, but in the era of Covid-19 the government’s role was even more central than usual. The government essentially removed the bulk of traditional industry risks related to vaccine development: a) scientific failures, b) failures to demonstrate safety and efficacy, c) manufacturing risks, and d) market risks related to low demand.”

While this may shock and disturb a rational person, Health Affairs – a thoroughly orthodox medical publication – applauds the government’s negligent measures as “money well spent.”

For this reason it is crucial to understand the terrible decisions made during the Covid pandemic in the context of modern medicine’s past crimes and preventable failures. In the coming months Anthony Fauci’s reputation will become further tainted. We might predict he will resign as more evidence of incompetence emerges, and, in our opinion, perhaps criminal negligence in his handling of the pandemic and efforts to whitewash the US’s role in supporting gain of function research leading to the genetic engineering of the SARS-2 virus. Fortunately, unlike past scandals when misguided medical decisions were responsible for thousands of unnecessary disabilities and deaths, numerous doctors and scientists worldwide are raising their voices to condemn the lethal policies of the CDC, NIAID, British Health Ministry and the World Health Organization.

So what can we reasonably surmise at this point? At one time most Americans trusted science, medicine and our healthcare system without question or criticism. However, today we observe systemic corruption and gross conflicts of interest across the same federal health agencies that have also contributed to untold medical errors and deaths prior to SARS-2 arrival. They have weaponized pharmaceutical science and a supplicant braying media supports this perversion of medical facts. Now the drug-happy media is attacking the truth-tellers, the physicians, professors and accomplished journalists who are risking their careers and reputations to bring forth the fallacies in the pandemic narrative. This is one battle that the silent majority can find its voice and courage to step forth and support.

Richard Gale and Gary Null PhD direct Progressive Radio Network.

June 28, 2021 Posted by | Book Review, Corruption, Deception, Science and Pseudo-Science | , , , , , , | Leave a comment

The anti-Covid pill Big Pharma doesn’t want you to have

By John Hollaway | The Conservative Woman | June 22, 2021

From Wikipedia: ‘During the 2020 COVID-19 pandemic, misinformation was widely spread claiming that ivermectin was beneficial for treating and preventing COVID-19. Such claims are not backed by good evidence.’

WHEN encountering an inexplicable anomaly in human behaviour, common rules of thumb can often give an insight. Oddly, though, these differ from country to country. For Americans it is ‘follow the money’. For Italians it is ‘cui bono?’ – who benefits? The nearest French rule is perhaps ‘cherchez la femme’.

Sometimes none of these help. Sometimes a perverse piece of human nature cannot be explained in terms of money, perquisites or feminine influence. The ivermectin mystery is one such.

Ivermectin is a generic prescription drug, discovered in 1975, developed by Merck and released in 1981. It is used to treat many types of parasite infestations in humans and animals. The researchers who created it were awarded the Nobel Prize for medicine in 2015. It is on the World Health Organisation’s List of Essential Medicines and is approved by the Federal Drug Administration (FDA) as an antiparasitic agent.

It can have very rare serious side effects. By 2020 four billion doses had been administered and 16 deaths are believed to have occurred as a consequence, or one in 250million doses. Although the figures are not directly comparable, the annual increased risk of death for a middle-aged man taking a standard (325 mg) aspirin every day to prevent heart disease and stroke is about one in ten thousand. This is about as risky as driving a car. 

Ivermectin is therefore a very safe drug. However, the drug oversight establishment does not think so.

On March 22 this year the European Medicines Agency issued this statement: 

‘EMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials.

‘In the EU, ivermectin tablets are approved for treating some parasitic worm infestations while ivermectin skin preparations are approved for treating skin conditions such as rosacea. Ivermectin is also authorised for veterinary use for a wide range of animal species for internal and external parasites.

‘Ivermectin medicines are not authorised for use in COVID-19 in the EU, and EMA has not received any application for such use.’

On May 3 the US Food and Drug Administration (FDA) issued this warning under the heading ‘Why You Should Not Use Ivermectin to Treat or Prevent COVID-19’:

‘There seems to be a growing interest in a drug called ivermectin to treat humans with COVID-19. Ivermectin is often used in the U.S. to treat or prevent parasites in animals. The FDA has received multiple reports of patients who have required medical support and beenhospitalized after self-medicating with ivermectin intended for horses.

‘FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Ivermectin is not an anti-viral (a drug for treating viruses).

‘The FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19; however, some initial research is underway. Taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too.’

The lack of official support for trials of the efficacy of ivermectin has meant that the typical number of subjects being tested (the ‘cohort’) is fairly small, usually about a hundred. To overcome this a meta-analysis can be undertaken, when the results of many trials are combined and assessed to determine if a trend can be seen. This has been done, most notably by @CovidAnalysis. A paper most recently updated yesterday surveyed 60 properly conducted studies, most with double-blind testing against placebos, with neither the participants nor the researcher knowing who had been given the drug until the trial was over. This report is a preprint, so it has not been peer-reviewed, but the results are conclusive: 93 per cent of the studies show a positive outcome from the administration of ivermectin, with deaths reduced by over 80 per cent.

So why have what might be called ‘Drug Central’ refused to acknowledge this mammoth body of evidence arising from without their bailiwicks? Perhaps because of human nature again. Here they are obeying another rule of thumb commonly seen when institutions encounter new external factors – ‘not invented here’. Perhaps this business school aphorism is also appropriate: ‘Hell hath no fury like a head-office scorned’.

In any event the virucidal properties of ivermectin and its safety have now been established beyond doubt, and we can expect it to be valuable in this role from henceforth. But unfortunately not, perhaps, against Covid-19.

June 22, 2021 Posted by | Deception, Science and Pseudo-Science | , , , | 1 Comment

FDA gives Emergent BioSolutions a consolation prize: it must throw out 60 million vaccine doses but can sell 10 million, which will be labeled as failing GMP standards

By Meryl Nass, MD | June 11, 2021

Now this is a really odd FDA decision. FDA is acknowledging that the 10 million doses it is authorizing is adulterated. But adulterated doses can’t be sold. But EUA products don’t generally get sold, except to the US government. I am scratching my head. I thought all these doses were already bought and paid for, by the taxpayer.

And there seem to be another 100 million doses about which FDA has not made up its mind.

This echoes FDA’s decision last week to license a very expensive but ineffective Alzheimer’s drug, after its advisory committee unanimously voted against it.

We always knew FDA was a political organization. But now, without Biden having appointed anyone to its helm, its decisions are wilder than ever.

From the NY Times today:

WASHINGTON — Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation.

The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices.

The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns, the people said.

The Johnson & Johnson doses administered in the United States so far were manufactured at the firm’s plant in the Netherlands, not by Emergent. For weeks the F.D.A. has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the Baltimore factory.

June 12, 2021 Posted by | Aletho News | , , , , | Leave a comment

THIRD member of FDA advisory body resigns, calls Alzheimer’s drug approval ‘worst in recent US history’

RT | June 10, 2021

Three scientists from a FDA advisory committee have resigned after the US food and drug regulator rammed through the approval of a controversial drug to treat Alzheimer’s disease in the face of near-unanimous opposition.

Ten out of 11 members of the Peripheral and Central Nervous System Advisory Committee voted against approving the drug aducanumab, with one voting “uncertain,” during the hearings in November 2020. On Monday, the FDA granted it accelerated approval anyway.

“This week, the aducanumab decision by FDA administrators was probably the worst drug approval decision in recent US history,” wrote Aaron Kesselheim of Harvard and the Brigham and Women’s Hospital in Boston, Massachusetts – who became the third member of the committee to resign in protest this week.

The agency switched to accelerated approval “at the last minute,” based on the “debatable premise” that the drug’s effect was likely to help patients, but “this pivotal question was not discussed at the Advisory Committee meeting, and its premise was specifically excluded from discussion,” Kesselheim wrote. Furthermore, some of the questions asked of the committee were “worded in a way that seemed slanted to yield responses that would favor the drug’s approval.”

Kesselheim, who has served on the committee since 2015, said it was “clear to me that FDA is not presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”

Two neurologists serving on the committee – David Knopman of the Mayo Clinic in Minnesota and Joel Perlmutter of Washington University in St. Louis, Missouri – resigned on Wednesday.

Developed by the Cambridge, Massachusetts-based Biogen and Japan’s Eisai, aducanumab – also known by the trade name Aduhelm – was touted as the first treatment that directly targets the cause of Alzheimer’s disease, instead of merely helping to ease its symptoms. Biogen’s stock surged at the news that the intravenous treatment – the cost of which is estimated at $56,000 a year – had been greenlit by regulators.

Aduhelm is a monoclonal antibody designed to remove a substance called amyloid from the brain of Alzheimer’s patients. Doctors are not in agreement whether this is the cause or the symptom of the disease that presently afflicts an estimated six million Americans. Clinical trials were halted in 2019 after the drug was not shown to be effective, but Biogen “re-analyzed” the data and told the FDA that some patients who received higher doses had shown a slower rate of decline than others.

The FDA then argued that the drug “is reasonably likely to predict a clinical benefit to patients,” even if it did not show clear clinical benefits in slowing down the progression of Alzheimer’s.

Aduhelm was the final straw for Kesselheim, whose letter also cited an earlier incident with the drug called eteplirsen, approved in 2016 for treatment of Duchenne muscular dystrophy against the advisory recommendations.

“For both eteplirsen and aducanumab, the decisions by FDA administrators to ignore the Advisory Committee’s clear recommendations led to their approval of two highly problematic drugs that offered little evidence that they would meaningfully benefit patients suffering from these devastating conditions,” he wrote, adding that the dual debacles “demonstrate that the agency needs to reassess its decision-making processes.”

June 11, 2021 Posted by | Corruption, Science and Pseudo-Science | | 1 Comment

FDA Approves Non-effective New Alzheimer’s Drug Despite Their Own Doctors Recommending AGAINST It

By Brian Shilhavy | Health Impact News | June 9, 2021

Big Pharma has been trying to create a blockbuster drug for the very lucrative Alzheimer’s Disease for more than a decade.

But they have repeatedly failed, mainly because they start with the wrong presuppositions on the cause of Alzheimer’s, basing it on “genetics” instead of environmental causes.

The over 55 age population has always been a cash cow for Big Pharma, as the most profitable drug of all time was Pfizer’s Lipitor, a statin drug that artificially lowers one’s cholesterol.

Prior to its patent expiring at the end of 2011, no other drug in human history had racked up more sales than this one single drug, as their advertising campaign against cholesterol resulted in doctors placing nearly one out of every four people over the age of 55 on statin drugs to lower their cholesterol.

But 25% of our body’s cholesterol resides in our brains, so there have been honest researchers over the years, such as Dr. Stephanie Seneff at MIT, who have linked low cholesterol to a rise in Alzheimer’s Disease. See:

The Clue to Why Low Fat Diet and Statins may Cause Alzheimer’s

And so it is no surprise that coconut oil, demonized by Big Pharma, the USDA, the FDA and just about every other regulatory agency in the U.S. since the 1970s, can provide dramatic improvement to Alzheimer’s Disease and other forms of dementia, often with dramatic results.

See our body of research provided over the years on coconut oil, along with amazingly dramatic testimonials for curing Alzheimer’s here.

We have covered all the previous failures of Big Pharma to produce a drug to treat Alzheimer’s over the years, but just this week the FDA finally approved a drug for the treatment Alzheimer’s Disease.

But as reporter Andrew Joseph of Stat News writes, the FDA did so in spite of the fact that their own 11 doctor expert panel had 10 of those doctors state that “there was not enough evidence to show it could slow cognitive decline,” and the 11th doctor voted “uncertain.”

And now one of those doctors, Neurologist Joel Perlmutter of Washington University in St. Louis, has resigned. … continue

June 10, 2021 Posted by | Science and Pseudo-Science | , | Leave a comment