Backing the Big Four: Big Pharma and the FDA, WHO, NIH, CDC
By Rebecca Strong | February 16, 2022
I know what you’re thinking. Big pharma is amoral and the FDA’s devastating slips are a dime a dozen — old news. But what about agencies and organizations like the National Institutes of Health (NIH), World Health Organization (WHO), and Centers for Disease Control & Prevention (CDC)? Don’t they have an obligation to provide unbiased guidance to protect citizens? Don’t worry, I’m getting there.
The WHO’s guidance is undeniably influential across the globe. For most of this organization’s history, dating back to 1948, it could not receive donations from pharmaceutical companies — only member states. But that changed in 2005 when the WHO updated its financial policy to permit private money into its system. Since then, the WHO has accepted many financial contributions from big pharma. In fact, it’s only 20% financed by member states today, with a whopping 80% of financing coming from private donors. For instance, The Bill and Melinda Gates Foundation (BMGF) is now one of its main contributors, providing up to 13% of its funds — about $250–300 million a year. Nowadays, the BMGF provides more donations to the WHO than the entire United States.
Dr. Arata Kochi, former head of WHO’s malaria program, expressed concerns to director-general Dr. Margaret Chan in 2007 that taking the BMGF’s money could have “far-reaching, largely unintended consequences” including “stifling a diversity of views among scientists.”
“The big concerns are that the Gates Foundation isn’t fully transparent and accountable,” Lawrence Gostin, director of WHO’s Collaborating Center on National and Global Health Law, told Devex in an interview. “By wielding such influence, it could steer WHO priorities … It would enable a single rich philanthropist to set the global health agenda.”
Take a peek at the WHO’s list of donors and you’ll find a few other familiar names like AstraZeneca, Bayer, Pfizer, Johnson & Johnson, and Merck.
The NIH has the same problem, it seems. Science journalist Paul Thacker, who previously examined financial links between physicians and pharma companies as a lead investigator of the United States Senate Committee, wrote in The Washington Post that this agency “often ignored” very “obvious” conflicts of interest. He also claimed that “its industry ties go back decades.” In 2018, it was discovered that a $100 million alcohol consumption study run by NIH scientists was funded mostly by beer and liquor companies. Emails proved that NIH researchers were in frequent contact with those companies while designing the study — which, here’s a shocker — were aimed at highlighting the benefits and not the risks of moderate drinking. So, the NIH ultimately had to squash the trial.
And then there’s the CDC. It used to be that this agency couldn’t take contributions from pharmaceutical companies, but in 1992 they found a loophole: new legislation passed by Congress allowed them to accept private funding through a nonprofit called the CDC Foundation. From 2014 through 2018 alone, the CDC Foundation received $79.6 million from corporations like Pfizer, Biogen, and Merck.
Of course, if a pharmaceutical company wants to get a drug, vaccine, or other product approved, they really need to cozy up to the FDA. That explains why in 2017, pharma companies paid for a whopping 75% of the FDA’s scientific review budgets, up from 27% in 1993. It wasn’t always like this. But in 1992, an act of Congress changed the FDA’s funding stream, enlisting pharma companies to pay “user fees,” which help the FDA speed up the approval process for their drugs.
A 2018 Science investigation found that 40 out of 107 physician advisors on the FDA’s committees received more than $10,000 from big pharma companies trying to get their drugs approved, with some banking up to $1 million or more. The FDA claims it has a well-functioning system to identify and prevent these possible conflicts of interest. Unfortunately, their system only works for spotting payments before advisory panels meet, and the Science investigation showed many FDA panel members get their payments after the fact. It’s a little like “you scratch my back now, and I’ll scratch your back once I get what I want” — drug companies promise FDA employees a future bonus contingent on whether things go their way.
Here’s why this dynamic proves problematic: a 2000 investigation revealed that when the FDA approved the rotavirus vaccine in 1998, it didn’t exactly do its due diligence. That probably had something to do with the fact that committee members had financial ties to the manufacturer, Merck — many owned tens of thousands of dollars of stock in the company, or even held patents on the vaccine itself. Later, the Adverse Event Reporting System revealed that the vaccine was causing serious bowel obstructions in some children, and it was finally pulled from the U.S. market in October 1999.
Then, in June of 2021, the FDA overruled concerns raised by its very own scientific advisory committee to approve Biogen’s Alzheimer’s drug Aduhelm — a move widely criticized by physicians. The drug not only showed very little efficacy but also potentially serious side effects like brain bleeding and swelling, in clinical trials. Dr. Aaron Kesselheim, a Harvard Medical School professor who was on the FDA’s scientific advisory committee, called it the “worst drug approval” in recent history, and noted that meetings between the FDA and Biogen had a “strange dynamic” suggesting an unusually close relationship. Dr. Michael Carome, director of Public Citizen’s Health Research Group, told CNN that he believes the FDA started working in “inappropriately close collaboration with Biogen” back in 2019. “They were not objective, unbiased regulators,” he added in the CNN interview. “It seems as if the decision was preordained.”
That brings me to perhaps the biggest conflict of interest yet: Dr. Anthony Fauci’s NIAID is just one of many institutes that comprises the NIH — and the NIH owns half the patent for the Moderna vaccine — as well as thousands more pharma patents to boot. The NIAID is poised to earn millions of dollars from Moderna’s vaccine revenue, with individual officials also receiving up to $150,000 annually.
Operation Warp Speed
In December of 2020, Pfizer became the first company to receive an emergency use authorization (EUA) from the FDA for a COVID-19 vaccine. EUAs — which allow the distribution of an unapproved drug or other product during a declared public health emergency — are actually a pretty new thing: the first one was issued in 2005 so military personnel could get an anthrax vaccine. To get a full FDA approval, there needs to be substantial evidence that the product is safe and effective. But for an EUA, the FDA just needs to determine that it may be effective. Since EUAs are granted so quickly, the FDA doesn’t have enough time to gather all the information they’d usually need to approve a drug or vaccine.
Pfizer CEO and chairman Albert Bourla has said his company was “operating at the speed of science” to bring a vaccine to market. However, a 2021 report in The BMJ revealed that this speed might have come at the expense of “data integrity and patient safety.” Brook Jackson, regional director for the Ventavia Research Group, which carried out these trials, told The BMJ that her former company “falsified data, unblinded patients, and employed inadequately trained vaccinators” in Pfizer’s pivotal phase 3 trial. Just some of the other concerning events witnessed included: adverse events not being reported correctly or at all, lack of reporting on protocol deviations, informed consent errors, and mislabeling of lab specimens. An audio recording of Ventavia employees from September 2020 revealed that they were so overwhelmed by issues arising during the study that they became unable to “quantify the types and number of errors” when assessing quality control. One Ventavia employee told The BMJ she’d never once seen a research environment as disorderly as Ventavia’s Pfizer vaccine trial, while another called it a “crazy mess.”
Over the course of her two-decades-long career, Jackson has worked on hundreds of clinical trials, and two of her areas of expertise happen to be immunology and infectious diseases. She told me that from her first day on the Pfizer trial in September of 2020, she discovered “such egregious misconduct” that she recommended they stop enrolling participants into the study to do an internal audit.
“To my complete shock and horror, Ventavia agreed to pause enrollment but then devised a plan to conceal what I found and to keep ICON and Pfizer in the dark,” Jackson said during our interview. “The site was in full clean-up mode. When missing data points were discovered the information was fabricated, including forged signatures on the informed consent forms.”
A screenshot Jackson shared with me shows she was invited to a meeting titled “COVID 1001 Clean up Call” on Sept. 21, 2020. She refused to participate in the call.
Jackson repeatedly warned her superiors about patient safety concerns and data integrity issues.
“I knew that the entire world was counting on clinical researchers to develop a safe and effective vaccine and I did not want to be a part of that failure by not reporting what I saw,” she told me.
When her employer failed to act, Jackson filed a complaint with the FDA on Sept. 25, and Ventavia fired her hours later that same day under the pretense that she was “not a good fit.” After reviewing her concerns over the phone, she claims the FDA never followed up or inspected the Ventavia site. Ten weeks later, the FDA authorized the EUA for the vaccine. Meanwhile, Pfizer hired Ventavia to handle the research for four more vaccine clinical trials, including one involving children and young adults, one for pregnant women, and another for the booster. Not only that, but Ventavia handled the clinical trials for Moderna, Johnson & Johnson, and Novavax. Jackson is currently pursuing a False Claims Act lawsuitagainst Pfizer and Ventavia Research Group.
Last year, Pfizer banked nearly $37 billion from its COVID vaccine, making it one of the most lucrative products in global history. Its overall revenues doubled in 2021 to reach $81.3 billion, and it’s slated to reach a record-breaking $98-$102 billion this year.
“Corporations like Pfizer should never have been put in charge of a global vaccination rollout, because it was inevitable they would make life-and-death decisions based on what’s in the short-term interest of their shareholders,” writes Nick Dearden, director of Global Justice Now.
As previously mentioned, it’s super common for pharmaceutical companies to fund the research on their own products. Here’s why that’s scary. One 1999 meta-analysis showed that industry-funded research is eight times less likely to achieve unfavorable results compared to independent trials. In other words, if a pharmaceutical company wants to prove that a medication, supplement, vaccine, or device is safe and effective, they’ll find a way.
With that in mind, I recently examined the 2020 study on Pfizer’s COVID vaccine to see if there were any conflicts of interest. Lo and behold, the lengthy attached disclosure form shows that of the 29 authors, 18 are employees of Pfizer and hold stock in the company, one received a research grant from Pfizer during the study, and two reported being paid “personal fees” by Pfizer. In another 2021 study on the Pfizer vaccine, seven of the 15 authors are employees of and hold stock in Pfizer. The other eight authors received financial support from Pfizer during the study.
As of the day I’m writing this, about 64% of Americans are fully vaccinated, and 76% have gotten at least one dose. The FDA has repeatedly promised “full transparency” when it comes to these vaccines. Yet in December of 2021, the FDA asked for permission to wait 75 years before releasing information pertaining to Pfizer’s COVID-19 vaccine, including safety data, effectiveness data, and adverse reaction reports. That means no one would see this information until the year 2096 — conveniently, after many of us have departed this crazy world. To recap: the FDA only needed 10 weeks to review the 329,000 pages worth of data before approving the EUA for the vaccine — but apparently, they need three-quarters of a century to publicize it.
In response to the FDA’s ludicrous request, PHMPT — a group of over 200 medical and public health experts from Harvard, Yale, Brown, UCLA, and other institutions — filed a lawsuit under the Freedom of Information Act demanding that the FDA produce this data sooner. And their efforts paid off: U.S. District Judge Mark T. Pittman issued an order for the FDA to produce 12,000 pages by Jan. 31, and then at least 55,000 pages per month thereafter. In his statement to the FDA, Pittman quoted the late John F. Kennedy: “A nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”
As for why the FDA wanted to keep this data hidden, the first batch of documentation revealed that there were more than 1,200 vaccine-related deaths in just the first 90 days after the Pfizer vaccine was introduced. Of 32 pregnancies with a known outcome, 28 resulted in fetal death. The CDC also recently unveiled data showing a total of 1,088,560 reports of adverse events from COVID vaccines were submitted between Dec. 14, 2020, and Jan. 28, 2022. That data included 23,149 reports of deaths and 183,311 reports of serious injuries. There were 4,993 reported adverse events in pregnant women after getting vaccinated, including 1,597 reports of miscarriage or premature birth. A 2022 study published in JAMA, meanwhile, revealed that there have been more than 1,900 reported cases of myocarditis — or inflammation of the heart muscle — mostly in people 30 and under, within 7 days of getting the vaccine. In those cases, 96% of people were hospitalized.
“It is understandable that the FDA does not want independent scientists to review the documents it relied upon to license Pfizer’s vaccine given that it is not as effective as the FDA originally claimed, does not prevent transmission, does not prevent against certain emerging variants, can cause serious heart inflammation in younger individuals, and has numerous other undisputed safety issues,” writes Aaron Siri, the attorney representing PHMPT in its lawsuit against the FDA.
Siri told me in an email that his office phone has been ringing off the hook in recent months.
“We are overwhelmed by inquiries from individuals calling about an injury from a COVID-19 vaccine,” he said.
By the way — it’s worth noting that adverse effects caused by COVID-19 vaccinations are still not covered by the National Vaccine Injury Compensation Program. Companies like Pfizer, Moderna, and Johnson & Johnson are protected under the Public Readiness and Emergency Preparedness (PREP) Act, which grants them total immunity from liability with their vaccines. And no matter what happens to you, you can’t sue the FDA for authorizing the EUA, or your employer for requiring you to get it, either. Billions of taxpayer dollars went to fund the research and development of these vaccines, and in Moderna’s case, licensing its vaccine was made possible entirely by public funds. But apparently, that still warrants citizens no insurance. Should something go wrong, you’re basically on your own.
To be continued…
By P Gosselin – No Tricks Zone – April 8, 2022
In his book “Herdengesundheit” (Herd Health), German physician and molecular geneticist Dr. Michael Nehls says “Vitamin D would have prevented severe cases of disease and also most Covid-related deaths”.
He is convinced: Vitamin D is the game-changer and suggests the simple act of eliminating the great Vitamin D deficits much of the population now suffers would be far more effective than the current COVID vaccines.
Vitamin D is an important factor in our immune system’s ability to ward off viral infections. To illustrate this Dr. Nehls presents here a chart depicting how much higher mortality is in times of low Vitamin D (November to April):
18 times higher mortality risk
Citing a Belgian study and a Heidelberg study, Nehls reports that in the wintertime, when vitamin D levels are well under 50 nmol/l, you have a four times greater chance of dying from COVID, independent of age or preexisting conditions. And prospects become very dire for persons with a Vitamin D level of less than 20 nmol/l, where the risk of mortality in case of a covid infection is 18 times higher!
Statistically, researchers calculated that with a Vitamin D level of 120 nmol/l, a level that Nehls says is our natural level, a zero mortality rate from respiratory viral infections would be nearly achieved.
Much less infectious
Another interesting feature about Vitamin D levels is that the likelihood of testing positive on a PCR test drops more 50% for a person with a Vitamin D level of over 125 compared to a person with 50 nmol/l. That alone would mean having a healthy Vitamin D level would make you far less infectious. Not even the “vaccines” have been able to achieve that:
Public health gross negligence
In the interview, Dr Nehls says that the government’s failure to make sure the immune system of people stays strong by ensuring healthy Vitamin D levels is “grossly negligent.” Moreover, health authorities are aware that the Vitamin D levels for the general population are far to low, but they choose to do nothing about it.
“A lack of Vitamin D leads to chronic disease” says Nehls. “With chronic disease the most money gets made. I can imagine there’s an interest not to make the recommendation, and that doesn’t apply just to Vitamin D.”
Nehls recommends taking Vitamin K2 along with Vitamin D to avoid possible side effects.
Beware of “cleverly manipulated” studies
Nehls criticizes studies that claim Vitamin D provides no real health benefit, accusing the authors of improperly conducting the studies in order to get a predetermined result. One study, Nehls said, was “very cleverly manipulated in order to encourage people not to bother taking Vitamin D”.
When asked if it would be recommendable to take Vitamin D as a way to treat vaccine injury, Nehls says “absolutely” and that it is urgently advised to have vitamin D levels of 125 nmol/l if you get vaccinated, which he then says wouldn’t be necessary because at that Vitamin D level, the chances of a serious COVID illness are practically zero.
By Rebecca Strong | February 16, 2022
Big Pharma Lawsuits, Scandals, and Cover-Ups
While the OxyContin craze is undoubtedly one of the highest-profile examples of big pharma’s deception, there are dozens of other stories like this. Here are a few standouts:
In the 1980s, Bayer continued selling blood clotting products to third-world countries even though they were fully aware those products had been contaminated with HIV. The reason? The “financial investment in the product was considered too high to destroy the inventory.” Predictably, about 20,000 of the hemophiliacs who were infused with these tainted products then tested positive for HIV and eventually developed AIDS, and many later died of it.
In 2004, Johnson & Johnson was slapped with a series of lawsuits for illegally promoting off-label use of their heartburn drug Propulsid for children despite internal company emails confirming major safety concerns (as in, deaths during the drug trials). Documentation from the lawsuits showed that dozens of studies sponsored by Johnson & Johnson highlighting the risks of this drug were never published.
The FDA estimates that GSK’s Avandia caused 83,000 heart attacks between 1999 and 2007. Internal documents from GSK prove that when they began studying the effects of the drug as early as 1999, they discovered it caused a higher risk of heart attacks than a similar drug it was meant to replace. Rather than publish these findings, they spent a decade illegally concealing them (and meanwhile, banking $3.2 billion annually for this drug by 2006). Finally, a 2007 New England Journal of Medicine study linked Avandia to a 43% increased risk of heart attacks, and a 64% increased risk of death from heart disease. Avandia is still FDA approved and available in the U.S.
In 2009, Pfizer was forced to pay $2.3 billion, the largest healthcare fraud settlement in history at that time, for paying illegal kickbacks to doctors and promoting off-label uses of its drugs. Specifically, a former employee revealed that Pfizer reps were encouraged and incentivized to sell Bextra and 12 other drugs for conditions they were never FDA approved for, and at doses up to eight times what’s recommended. “I was expected to increase profits at all costs, even when sales meant endangering lives,” the whistleblower said.
When it was discovered that AstraZeneca was promoting the antipsychotic medication Seroquel for uses that were not approved by the FDA as safe and effective, the company was hit with a $520 million fine in 2010. For years, AstraZeneca had been encouraging psychiatrists and other physicians to prescribe Seroquel for a vast range of seemingly unrelated off-label conditions, including Alzheimer’s disease, anger management, ADHD, dementia, post-traumatic stress disorder, and sleeplessness. AstraZeneca also violated the federal Anti-Kickback Statute by paying doctors to spread the word about these unapproved uses of Seroquel via promotional lectures and while traveling to resort locations.
In 2012, GSK paid a $3 billion fine for bribing doctors by flying them and their spouses to five-star resorts, and for illegally promoting drugs for off-label uses. What’s worse — GSK withheld clinical trial results that showed its antidepressant Paxil not only doesn’t work for adolescents and children but more alarmingly, that it can increase the likelihood of suicidal thoughts in this group. A 1998 GSK internal memo revealed that the company intentionally concealed this data to minimize any “potential negative commercial impact.”
In 2021, an ex-AstraZeneca sales rep sued her former employer, claiming they fired her for refusing to promote drugs for uses that weren’t FDA-approved. The employee alleges that on multiple occasions, she expressed concerns to her boss about “misleading” information that didn’t have enough support from medical research, and off-label promotions of certain drugs. Her supervisor reportedly not only ignored these concerns but pressured her to approve statements she didn’t agree with and threatened to remove her from regional and national positions if she didn’t comply. According to the plaintiff, she missed out on a raise and a bonus because she refused to break the law.
At the top of 2022, a panel of the D.C. Court of Appeals reinstated a lawsuit against Pfizer, AstraZeneca, Johnson & Johnson, Roche, and GE Healthcare, which claims they helped finance terrorist attacks against U.S. service members and other Americans in Iraq. The suit alleges that from 2005–2011, these companies regularly offered bribes (including free drugs and medical devices) totaling millions of dollars annually to Iraq’s Ministry of Health in order to secure drug contracts. These corrupt payments then allegedly funded weapons and training for the Mahdi Army, which until 2008, was largely considered one of the most dangerous groups in Iraq.
Another especially worrisome factor is that pharmaceutical companies are conducting an ever-increasing number of clinical trials in third-world countries, where people may be less educated, and there are also far fewer safety regulations. Pfizer’s 1996 experimental trials with Trovan on Nigerian childrenwith meningitis — without informed consent — is just one nauseating example. When a former medical director in Pfizer’s central research division warned the company both before and after the study that their methods in this trial were “improper and unsafe,” he was promptly fired. Families of the Nigerian children who died or were left blind, brain damaged, or paralyzed after the study sued Pfizer, and the company ultimately settled out of court. In 1998, the FDA approved Trovan only for adults. The drug was later banned from European markets due to reports of fatal liver disease and restricted to strictly emergency care in the U.S. Pfizer still denies any wrongdoing.
But all that is just the tip of the iceberg. If you’d like to dive a little further down the rabbit hole — and I’ll warn you, it’s a deep one — a quick Google search for “big pharma lawsuits” will reveal the industry’s dark track record of bribery, dishonesty, and fraud.
In fact, big pharma happens to be the biggest defrauder of the federal government when it comes to the False Claims Act, otherwise known as the “Lincoln Law.” During our interview, Panara told me she has friends still working for big pharma who would be willing to speak out about crooked activity they’ve observed, but are too afraid of being blacklisted by the industry. A newly proposed update to the False Claims Act would help to protect and support whistleblowers in their efforts to hold pharmaceutical companies liable, by helping to prevent that kind of retaliation and making it harder for the companies charged to dismiss these cases. It should come as no surprise that Pfizer, AstraZeneca, Merck, and a flock of other big pharma firms are currently lobbying to block the update. Naturally, they wouldn’t want to make it any easier for ex-employees to expose their wrongdoings, potentially costing them billions more in fines.
Something to keep in mind: these are the same people who produced, marketed, and are profiting from the COVID-19 vaccines. The same people who manipulate research, pay off decision-makers to push their drugs, cover up negative research results to avoid financial losses, and knowingly put innocent citizens in harm’s way. The same people who told America: “Take as much OxyContin as you want around the clock! It’s very safe and not addictive!” (while laughing all the way to the bank).
So, ask yourself this: if a partner, friend, or family member repeatedly lied to you — and not just little white lies, but big ones that put your health and safety at risk — would you continue to trust them?
To be continued…
By Amanuensis | The Daily Sceptic | April 9, 2022
New Zealand is a fascinating country – amazing geography, likeable population, and, unlike its neighbour Australia, most of its wildlife isn’t planning on killing you at the slightest opportunity. It is also fascinating with respect to Covid because its population has a very high vaccination rate across all age groups (well, down to five), but up until recently there has been negligible natural immunity to Covid. Because of these two factors, New Zealand was always going to be of interest as soon as Covid arrived properly, if only to see how its vaccination efforts had protected its population.
For those who missed it, since the end of last year New Zealand has had a succession of Covid waves. These started small, but in the most recent wave, taking place during February and March, infection rates were enormous – if we had these infection rates in the U.K. we’d have peaked at approximately 350,000 cases per day (rather than around 200,000). What’s more, it looks like New Zealand exceeded its testing capacity during that wave, suggesting that peak infections were probably even higher. It is relevant to note that during February and March, New Zealand had over 90% of all the cases it has ever had and most of the rest occurred in January – prior to 2022 New Zealand reported very few Covid infections.
So much for the Covid vaccines protecting against infection – but what do the data look like in detail?
Cases
New Zealand is somewhat helpful in that it does publish daily cases, hospitalisations and deaths by vaccine status; somewhat because it doesn’t allow easy access to anything other than the current day’s report. Thankfully, the Wayback Machine ensures that at least some web pages aren’t forever lost to history. These data were collated for dates since mid February 2022 and smoothed with a seven-day moving average to create a time series of Covid cases by vaccine status.
The first time the above graph popped up on my computer screen I had to go and double check all the data sources – and then I triple checked them. The data shown on the graph are notable for several reasons:
The infections data from New Zealand allow us to estimate the vaccine effectiveness for the Covid vaccines in the absence of natural immunity.
These data are in contrast to recent data from the U.K., which show one and two doses of vaccine to have a VE of minus-50% to minus-100%, and the booster to have a VE of around minus-300%. While this sounds counterintuitive, it is possible that we’re seeing a complex interplay between a waning of the impact of the vaccine and the impact of additional vaccine doses:
In New Zealand, the timescales are very different: those given the booster dose will still be in the two-three month period where short-lived immune responses dominate; those given two doses will be in the proposed period of maximal vaccine negative impact; while those that chose not to accept the offer of a second vaccine dose will be in the period where vaccine effects are waning.
There’s one more point to add for cases in New Zealand, and it relates to the U.K. For months, the UKHSA has been telling us that one possible reason for us seeing far fewer cases in the unvaccinated compared with the vaccinated is because the unvaccinated have natural immunity following high infection rates previously (presumably because the unvaccinated are reckless and didn’t follow lockdown rules – I imagine that they also ride motorcycles too quickly, set off fireworks indoors and play with matches while filling up the car). These data from New Zealand, which at the time had very few individuals previously infected with Covid, show lower case rates in the unvaccinated without any significant levels of natural immunity, contradicting the claim of the UKHSA and eliminating one of its reasons for ignoring the alarming data.
Hospitalisations
Analysis of the hospitalisations data offered by the New Zealand authorities is made complex by there being no stratification of the hospitalisations by age group, and the lack of complete vaccinations data by age. However, U.K. data show that in recent weeks approximately 95% of hospitalisations were in those aged over 60; assuming that this will also hold true for the New Zealand population allows us to offer a indicative analysis of the likely impact for that age group of the vaccines on hospitalisations in the country.
The analysis is also hindered by the data on vaccine coverage for those aged over 60 not differentiating between those that have had only one dose of vaccine and those that are unvaccinated. This might in isolation from other data appear to be ‘sensible’ – after all, the single dosed have the ‘least protection’ as well as ‘the longest time for protection to wane’. However, the data shown in the previous section suggest that the unvaccinated and those having taken a single dose of vaccine are in no way comparable, and that considering them as a single group could lead to misleading conclusions. Nevertheless, that’s the hand that’s been dealt for us.
The data are somewhat surprising. While those given a booster dose of vaccine seem to have lower levels of hospitalisations than found in the group containing the unvaccinated and those given only one dose of vaccine – as might be expected – the double dosed have significantly higher hospitalisation rates.
Also interesting is the trend in the data:
It was not possible to properly disentangle the hospitalisations data for the unvaccinated, but the data suggest that in aggregate those having taken two or three doses of vaccine (when the two groups are put together) have approximately 45% lower risk of hospitalisation than the unvaccinated/single-dosed. It is worth noting that in the U.K. data we see higher hospitalisation rates in the single vaccinated in those aged over 60, compared with the unvaccinated. It is possible that the same pattern is found in New Zealand, only ‘covered up’ by the co-mingling of the data. If this is the case then the apparent protection offered by the vaccine in the two or three dose individuals will be somewhat lower than 45%.
Deaths
The mortality data from New Zealand are also complicated because the health authorities lump together into one group all the unvaccinated and those having taken a single dose of vaccine. Beyond that complication, deaths data can be tricky to analyse, because there are such huge differences in death rates from (or with) Covid by age. Fortunately, the mortality data offered by the New Zealand authorities do include deaths by age group, which allows a finer analysis than was possible with the infections and hospitalisations data.
The above table suggests that while those given three doses of vaccine have a decreased risk of death from (or with) Covid compared with the mortality rate in the strange group called ‘unvaccinated or one dose’, the risk of death is greatest in those given two doses of vaccine.
However, it is possible that New Zealand’s data have a similar pattern to that seen in the U.K. (and elsewhere), where dose effects are complicated by the health of those given each vaccine, namely that those closest to death were spared a dose of vaccine, and thus concentrated deaths into the very small number left in the prior dose group. A comparison of the data for ‘unvaccinated or one dose’ with ‘two or three doses’ suggests that the vaccines do still protect against death, but only to a very low degree in younger age groups.
The data above support the use of vaccination to protect against death from (or with) Covid for those aged over 80. On the other hand, the mortality rate in those aged under 60 is very low, and the estimated vaccine effectiveness in protecting against death for those aged under 80 is only approximately 30% – once again, the real-world vaccine effectiveness estimate is rather low. It is also of note that these rather poor figures for the protection offered by the vaccines against mortality come from a country that started vaccination rather late (summer 2021) and where most of the population were only given their booster doses two to three months ago. These data suggest that the vaccines simply do not offer substantive protection against death for newer Covid variants, rather than it simply being a case of waning vaccine protection.
It is also important to note that the data on the benefits of the vaccine in protecting against death shown above should be treated with caution:
Overall mortality
One other aspect of the data coming from New Zealand that is of interest relating to Covid is excess mortality. These data are of interest because New Zealand managed to keep itself more-or-less clear of Covid until the last few months of 2021, and even then case numbers were very low until 2022, with the result that Covid deaths were negligible prior to 2022. With that in mind, its excess death data between the start of 2020 and the end of 2021 are very interesting.
Many countries around the world had a peak in excess deaths in the first quarter of 2020, followed by a significant reduction in deaths into mid 2020. There has been speculation that this pattern was seen because Covid infections in early 2020 killed the most vulnerable, leaving a period in which there were fewer people left to die. However, New Zealand also has this pattern of excess deaths in the first half of 2020 (black data points in the graph above) without Covid infections, suggesting that the reduction in deaths seen in mid 2020 were a result of lockdown. The reason for the excess deaths in New Zealand in the first quarter of 2020 are not at all clear.
Most countries then saw an increase in deaths towards the end of 2020; this has been explained by a resurgence in Covid cases. However, New Zealand saw a similar pattern without Covid infections (red data points). It is possible that this increase was caused by the impact of the reduced healthcare provision during the extreme lockdown – though there are no data to support this supposition. There are reports that the New Zealand healthcare system experienced its busiest summer (January and February) on record with hospitals across the country reaching ‘crisis point’ and several emergency departments at capacity. The cause of this healthcare pressure is unclear, however.
Perhaps the most interesting data in the graph above are seen in 2021. During the first half of 2021 excess deaths slowly reduced from the high seen at the start of 2021 (green data points), perhaps a result of healthcare provision returning to normal. However, around mid-year the trend reversed and excess deaths started to climb again (purple data points). Again, it must be pointed out that there were very few Covid cases in New Zealand at this time, and negligible deaths. Just about the only unusual things occurring in the country at that time were a lack of international travel, restrictions in day-to-day activities for the population and an enormous mass vaccination campaign using novel, under-tested vaccines.
During 2020-2022, there were approximately 2,000 excess deaths in New Zealand, a significant number in a country with a population of five million. We don’t know the proportion that occurred because of lockdown, vaccines or something else; all that we do know is that they weren’t a result of Covid.
Note on data analysis methods. Infection, hospitalisation and mortality data were obtained from the New Zealand Ministry for Health (using Wayback Machine for historical data). Vaccination data were also obtained from the NZ Ministry for Health. Population data were obtained from Stats.govt.nz. Vaccination data were offset by seven days for the infections analysis to account for the Ministry for Health’s definition of vaccine status at infection. An additional seven days offset was applied for hospitalisation, and 14 days for death, to account for the typical timescales of disease progression.
Amanuensis is an ex-academic and senior Government scientist. He blogs at Bartram’s Folly.
By Vinay Prasad | April 3, 2022
On the one hand, there are many biomedical faculty who are passionately arguing why 2-4 year olds should be forced to wear cloth masks. (NY City is fighting this in the courts). Even though there is no randomized data, even though cloth masks failed in adults (let alone toddlers), even though it contradicts the WHO, even though it fails common sense, we must keep doing this!
On the other hand, doctors post pictures of them attending industry sponsored academic conferences. Getting drinks and partying. Packed in tight rooms. No masks. Praising each other for their work. Drenched in financial conflict of interest and pro-new and pro-costly bias.
How can both these things be true?
We are facing such a health emergency that we have to mask toddlers by force of law AND we can continue to enjoy entirely superfluous medical gatherings that risk viral spread.
Don’t say it’s vaccines.
Because the vaccinated, boosted 50 year old, elevated BMI doc with comorbidities has far higher risk than the healthy, unvax’d 4 year old.
Don’t say it’s about spreading the virus.
Both can spread the virus to others.
Don’t say it’s about the activities, importance.
The adult’s entirely excessive medical conference is less important than the child’s early education.
COVID-19 policy reveals the selfishness of adults, the indifference to kids, and the hypocrisy of medicine. It’s disgusting to witness and history will judge it poorly.
… and they are lying about the reason why
By Alex Berenson | April 7, 2022
Until last week, the British government offered the best source of raw data on the efficacy of the Covid vaccines. Each Thursday, the UK Health Security Agency reported the number of new infections, hospitalizations, and deaths by vaccine status.
Since last fall, and especially since the Omicron variant hit, the reports have presented an increasingly dismal picture of vaccine efficacy. Last week’s report showed that in March, nearly 90 percent of adults hospitalized for Covid were vaccinated. And OVER 90 percent of deaths were in the vaccinated:
The importance of these reports is hard to overstate.
They were the single best source of raw data about how well the Covid vaccines were or were not working anywhere in the world. It was a long-running sequential series with clearly defined rules from a large country with high vaccine coverage.
Plus, because the British have national health insurance, the government could determine with near-certainty who had been vaccinated. As you can see, fewer than 1 percent of the people in the reports are called “unlinked” – meaning their vaccine status was undetermined.
AS OF THIS WEEK’S REPORT THE BRITISH GOVERNMENT IS NO LONGER PROVIDING THESE CHARTS.
The British government is offering the nonsensical excuse that it can no longer provide the figures because it has ended free universal testing for Covid: Such changes in testing policies affect the ability to robustly monitor COVID-19 cases by vaccination status, therefore, from the week 14 report onwards this section of the report will no longer be published.
The British government is lying.
Even if the end of free testing somehow affected its ability to provide “robust” data about infections, it would make no difference to the hospitalization or death figures, which are far more important. Unless Covid patients are going to be hospitalized anonymously, the Health Security Agency will still be able to match their names (and the names on death certificates) against vaccination records.
In fact the British government would be derelict not to continue to collect the data, and it surely will. But the public will no longer see it.
Why?
One reason and one reason only. Ever since I mentioned the existence of these reports to Joe Rogan in October, they have become an embarrassment. They are impossible to spin, and the clearest possible signal of vaccine failure.
But hiding the numbers won’t make the vaccines work better. It will just make people less likely to believe anything else public health authorities tell them about Covid and the vaccines – if that’s even possible at this point.
Meryl Nass, MD | April 8, 2022
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They keep telling us to “trust the science.” But who paid for it?
By Rebecca Strong – February 16, 2022
After graduating from Columbia University with a chemical engineering degree, my grandfather went on to work for Pfizer for almost two decades, culminating his career as the company’s Global Director of New Products. I was rather proud of this fact growing up — it felt as if this father figure, who raised me for several years during my childhood, had somehow played a role in saving lives. But in recent years, my perspective on Pfizer — and other companies in its class — has shifted. Blame it on the insidious big pharma corruption laid bare by whistleblowers in recent years. Blame it on the endless string of big pharma lawsuits revealing fraud, deception, and cover-ups. Blame it on the fact that I witnessed some of their most profitable drugs ruin the lives of those I love most. All I know is, that pride I once felt has been overshadowed by a sticky skepticism I just can’t seem to shake.
In 1973, my grandpa and his colleagues celebrated as Pfizer crossed a milestone: the one-billion-dollar sales mark. These days, Pfizer rakes in $81 billion a year, making it the 28th most valuable company in the world. Johnson & Johnson ranks 15th, with $93.77 billion. To put things into perspective, that makes said companies wealthier than most countries in the world. And thanks to those astronomical profit margins, the Pharmaceuticals and Health Products industry is able to spend more on lobbying than any other industry in America.
While big pharma lobbying can take several different forms, these companies tend to target their contributions to senior legislators in Congress — you know, the ones they need to keep in their corner, because they have the power to draft healthcare laws. Pfizer has outspent its peers in six of the last eight election cycles, coughing up almost $9.7 million. During the 2016 election, pharmaceutical companies gave more than $7 million to 97 senators at an average of $75,000 per member. They also contributed $6.3 million to president Joe Biden’s 2020 campaign. The question is: what did big pharma get in return?
ALEC’s Off-the-Record Sway
To truly grasp big pharma’s power, you need to understand how The American Legislative Exchange Council (ALEC) works. ALEC, which was founded in 1973 by conservative activists working on Ronald Reagan’s campaign, is a super secretive pay-to-play operation where corporate lobbyists — including in the pharma sector — hold confidential meetings about “model” bills. A large portionof these bills is eventually approved and become law.
A rundown of ALEC’s greatest hits will tell you everything you need to know about the council’s motives and priorities. In 1995, ALEC promoted a bill that restricts consumers’ rights to sue for damages resulting from taking a particular medication. They also endorsed the Statute of Limitation Reduction Act, which put a time limit on when someone could sue after a medication-induced injury or death. Over the years, ALEC has promoted many other pharma-friendly bills that would: weaken FDA oversight of new drugs and therapies, limit FDA authority over drug advertising, and oppose regulations on financial incentives for doctors to prescribe specific drugs. But what makes these ALEC collaborations feel particularly problematic is that there’s little transparency — all of this happens behind closed doors. Congressional leaders and other committee members involved in ALEC aren’t required to publish any records of their meetings and other communications with pharma lobbyists, and the roster of ALEC members is completely confidential. All we know is that in 2020, more than two-thirds of Congress — 72 senators and 302 House of Representatives members — cashed a campaign check from a pharma company.
Big Pharma Funding Research
The public typically relies on an endorsement from government agencies to help them decide whether or not a new drug, vaccine, or medical device is safe and effective. And those agencies, like the FDA, count on clinical research. As already established, big pharma is notorious for getting its hooks into influential government officials. Here’s another sobering truth: The majority of scientific research is paid for by — wait for it — the pharmaceutical companies.
When the New England Journal of Medicine (NEJM) published 73 studies of new drugs over the course of a single year, they found that a staggering 82% of them had been funded by the pharmaceutical company selling the product, 68% had authors who were employees of that company, and 50% had lead researchers who accepted money from a drug company. According to 2013 research conducted at the University of Arizona College of Law, even when pharma companies aren’t directly funding the research, company stockholders, consultants, directors, and officers are almost always involved in conducting them. A 2017 report by the peer-reviewed journal The BMJ also showed that about half of medical journal editors receive payments from drug companies, with the average payment per editor hovering around $28,000. But these statistics are only accurate if researchers and editors are transparent about payments from pharma. And a 2022 investigative analysis of two of the most influential medical journals found that 81% of study authors failed to disclose millions in payments from drug companies, as they’re required to do.
Unfortunately, this trend shows no sign of slowing down. The number of clinical trials funded by the pharmaceutical industry has been climbing every year since 2006, according to a John Hopkins University report, while independent studies have been harder to find. And there are some serious consequences to these conflicts of interest. Take Avandia, for instance, a diabetes drug produced by GlaxoSmithCline (GSK). Avandia was eventually linked to a dramatically increased risk of heart attacks and heart failure. And a BMJ report revealed that almost 90% of scientists who initially wrote glowing articles about Avandia had financial ties to GSK.
But here’s the unnerving part: if the pharmaceutical industry is successfully biasing the science, then that means the physicians who rely on the science are biased in their prescribing decisions.
Where the lines get really blurry is with “ghostwriting.” Big pharma execs know citizens are way more likely to trust a report written by a board-certified doctor than one of their representatives. That’s why they pay physicians to list their names as authors — even though the MDs had little to no involvement in the research, and the report was actually written by the drug company. This practice started in the ’50s and ’60s when tobacco execs were clamoring to prove that cigarettes didn’t cause cancer (spoiler alert: they do!), so they commissioned doctors to slap their name on papers undermining the risks of smoking.
It’s still a pretty common tactic today: more than one in 10 articles published in the NEJM was co-written by a ghostwriter. While a very small percentage of medical journals have clear policies against ghostwriting, it’s still technically legal —despite the fact that the consequences can be deadly.
Case in point: in the late ’90s and early 2000s, Merck paid for 73 ghostwritten articles to play up the benefits of its arthritis drug Vioxx. It was later revealed that Merck failed to report all of the heart attacks experienced by trial participants. In fact, a study published in the NEJM revealed that an estimated 160,000 Americans experienced heart attacks or strokes from taking Vioxx. That research was conducted by Dr. David Graham, Associate Director of the FDA’s Office of Drug Safety, who understandably concluded the drug was not safe. But the FDA’s Office of New Drugs, which not only was responsible for initially approving Vioxx but also regulating it, tried to sweep his findings under the rug.
“I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference,” he wrote in his 2004 U.S. Senate testimony on Vioxx. “One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.”
Eventually, the FDA issued a public health advisory about Vioxx and Merck withdrew this product. But it was a little late for repercussions — 38,000 of those Vioxx-takers who suffered heart attacks had already died. Graham called this a “profound regulatory failure,” adding that scientific standards the FDA apply to drug safety “guarantee that unsafe and deadly drugs will remain on the U.S. market.”
This should come as no surprise, but research has also repeatedly shown that a paper written by a pharmaceutical company is more likely to emphasize the benefits of a drug, vaccine, or device while downplaying the dangers. (If you want to understand more about this practice, a former ghostwriter outlines all the ethical reasons why she quit this job in a PLOS Medicine report.) While adverse drug effects appear in 95% of clinical research, only 46% of published reports disclose them. Of course, all of this often ends up misleading doctors into thinking a drug is safer than it actually is.
Big Pharma Influence On Doctors
Pharmaceutical companies aren’t just paying medical journal editors and authors to make their products look good, either. There’s a long, sordid history of pharmaceutical companies incentivizing doctors to prescribe their products through financial rewards. For instance, Pfizer and AstraZeneca doled out a combined $100 million to doctors in 2018, with some earning anywhere from $6 million to $29 million in a year. And research has shown this strategy works: when doctors accept these gifts and payments, they’re significantly more likely to prescribe those companies’ drugs. Novartis comes to mind — the company famously spent over $100 million paying for doctors’ extravagant meals, golf outings, and more, all while also providing a generous kickback program that made them richer every time they prescribed certain blood pressure and diabetes meds.
Side note: the Open Payments portal contains a nifty little database where you can find out if any of your own doctors received money from drug companies. Knowing that my mother was put on a laundry list of meds after a near-fatal car accident, I was curious — so I did a quick search for her providers. While her PCP only banked a modest amount from Pfizer and AstraZeneca, her previous psychiatrist — who prescribed a cocktail of contraindicated medications without treating her in person — collected quadruple-digit payments from pharmaceutical companies. And her pain care specialist, who prescribed her jaw-dropping doses of opioid pain medication for more than 20 years (far longer than the 5-day safety guideline), was raking in thousands from Purdue Pharma, AKA the opioid crisis’ kingpin.
Purdue is now infamous for its wildly aggressive OxyContin campaign in the ’90s. At the time, the company billed it as a non-addictive wonder drug for pain sufferers. Internal emails show Pursue sales representatives were instructed to “sell, sell, sell” OxyContin, and the more they were able to push, the more they were rewarded with promotions and bonuses. With the stakes so high, these reps stopped at nothing to get doctors on board — even going so far as to send boxes of doughnuts spelling out “OxyContin” to unconvinced physicians. Purdue had stumbled upon the perfect system for generating tons of profit — off of other people’s pain.
Documentation later proved that not only was Purdue aware it was highly addictive and that many people were abusing it, but that they also encouraged doctors to continue prescribing increasingly higher doses of it (and sent them on lavish luxury vacations for some motivation). In testimony to Congress, Purdue exec Paul Goldenheim played dumb about OxyContin addiction and overdose rates, but emails that were later exposed showed that he requested his colleagues remove all mentions of addiction from their correspondence about the drug. Even after it was proven in court that Purdue fraudulently marketed OxyContin while concealing its addictive nature, no one from the company spent a single day behind bars. Instead, the company got a slap on the wrist and a $600 million fine for a misdemeanor, the equivalent of a speeding ticket compared to the $9 billion they made off OxyContin up until 2006. Meanwhile, thanks to Purdue’s recklessness, more than 247,000 people died from prescription opioid overdoses between 1999 and 2009. And that’s not even factoring in all the people who died of heroin overdoses once OxyContin was no longer attainable to them. The NIH reports that 80% of people who use heroin started by misusing prescription opioids.
Former sales rep Carol Panara told me in an interview that when she looks back on her time at Purdue, it all feels like a “bad dream.” Panara started working for Purdue in 2008, one year after the company pled guilty to “misbranding” charges for OxyContin. At this point, Purdue was “regrouping and expanding,” says Panara, and to that end, had developed a clever new approach for making money off OxyContin: sales reps were now targeting general practitioners and family doctors, rather than just pain management specialists. On top of that, Purdue soon introduced three new strengths for OxyContin: 15, 30, and 60 milligrams, creating smaller increments Panara believes were aimed at making doctors feel more comfortable increasing their patients’ dosages. According to Panara, there were internal company rankings for sales reps based on the number of prescriptions for each OxyContin dosing strength in their territory.
“They were sneaky about it,” she said. “Their plan was to go in and sell these doctors on the idea of starting with 10 milligrams, which is very low, knowing full well that once they get started down that path — that’s all they need. Because eventually, they’re going to build a tolerance and need a higher dose.”
Occasionally, doctors expressed concerns about a patient becoming addicted, but Purdue had already developed a way around that. Sales reps like Panara were taught to reassure those doctors that someone in pain might experience addiction-like symptoms called “pseudoaddiction,” but that didn’t mean they were truly addicted. There is no scientific evidence whatsoever to support that this concept is legit, of course. But the most disturbing part? Reps were trained to tell doctors that “pseudoaddiction” signaled the patient’s pain wasn’t being managed well enough, and the solution was simply to prescribe a higher dose of OxyContin.
Panara finally quit Purdue in 2013. One of the breaking points was when two pharmacies in her territory were robbed at gunpoint specifically for OxyContin. In 2020, Purdue pled guilty to three criminal charges in an $8.3 billion deal, but the company is now under court protection after filing for bankruptcy. Despite all the damage that’s been done, the FDA’s policies for approving opioids remain essentially unchanged.
Purdue probably wouldn’t have been able to pull this off if it weren’t for an FDA examiner named Curtis Wright, and his assistant Douglas Kramer. While Purdue was pursuing Wright’s stamp of approval on OxyContin, Wright took an outright sketchy approach to their application, instructing the company to mail documents to his home office rather than the FDA, and enlisting Purdue employees to help him review trials about the safety of the drug. The Food, Drug, and Cosmetic Act requires that the FDA have access to at least two randomized controlled trials before deeming a drug as safe and effective, but in the case of OxyContin, it got approved with data from just one measly two-week study — in osteoarthritis patients, no less.
When both Wright and Kramer left the FDA, they went on to work for none other than (drumroll, please) Purdue, with Wright earning three times his FDA salary. By the way — this is just one example of the FDA’s notoriously incestuous relationship with big pharma, often referred to as “the revolving door”. In fact, a 2018 Science report revealed that 11 out of 16 FDA reviewers ended up at the same companies they had been regulating products for.
While doing an independent investigation, “Empire of Pain” author and New Yorker columnist Patrick Radden Keefe tried to gain access to documentation of Wright’s communications with Purdue during the OxyContin approval process.
“The FDA came back and said, ‘Oh, it’s the weirdest thing, but we don’t have anything. It’s all either been lost or destroyed,’” Keefe told Fortune in an interview. “But it’s not just the FDA. It’s Congress, it’s the Department of Justice, it’s big parts of the medical establishment … the sheer amount of money involved, I think, has meant that a lot of the checks that should be in place in society to not just achieve justice, but also to protect us as consumers, were not there because they had been co-opted.”
Big pharma may be to blame for creating the opioids that caused this public health catastrophe, but the FDA deserves just as much scrutiny — because its countless failures also played a part in enabling it. And many of those more recent fails happened under the supervision of Dr. Janet Woodcock. Woodcock was named FDA’s acting commissioner mere hours after Joe Biden was inaugurated as president. She would have been a logical choice, being an FDA vet of 35 years, but then again it’s impossible to forget that she played a starring role in the FDA’s perpetuating the opioid epidemic. She’s also known for overruling her own scientific advisors when they vote against approving a drug. Not only did Woodcock approve OxyContin for children as young as 11 years old, but she also gave the green light to several other highly controversial extended-release opioid pain drugs without sufficient evidence of safety or efficacy. One of those was Zohydro: in 2011, the FDA’s advisory committee voted 11:2 against approving it due to safety concerns about inappropriate use, but Woodcock went ahead and pushed it through, anyway. Under Woodcock’s supervision, the FDA also approved Opana, which is twice as powerful as OxyContin — only to then beg the drug maker to take it off the market 10 years later due to “abuse and manipulation.” And then there was Dsuvia, a potent painkiller 1,000 times stronger than morphine and 10 times more powerful than fentanyl. According to a head of one of the FDA’s advisory committees, the U.S. military had helped to develop this particular drug, and Woodcock said there was “pressure from the Pentagon” to push it through approvals. The FBI, members of congress, public health advocates, and patient safety experts alike called this decision into question, pointing out that with hundreds of opioids already on the market there’s no need for another — particularly one that comes with such high risks.
Most recently, Woodcock served as the therapeutics lead for Operation Warp Speed, overseeing COVID-19 vaccine development.
To be continued…
Rebecca Strong is a Boston-based freelance health and wellness writer currently contributing to Insider, Health magazine, Healthline, Eat This Not That, and more.
By Meryl Nass, MD | April 7, 2022
I don’t write enough about the adverse events from COVID vaccines. The reason is that I like to be accurate, but most of the data on vaccine side effects is hidden from us. So while I have pointed out the many databases that FDA and CDC have available and are supposed to be using to assess vaccine safety, only 1 is publicly available: VAERS. Officially, it is the joint FDA-CDC Vaccine Adverse Event Reporting System. Steve Kirsch and Jessica Rose have done the best job analyzing the VAERS data, so I suggest you go to their substacks and read what they have to say.
Both FDA and CDC each have about ten other databases that taxpayers pay for, but most of them we never hear about. Here are the FDA databases:
Below, then-head of Immunizations at CDC, Dr. Nancy Messonier, told the public about the databases that would be used to assess COVID vaccines’ safety just before the rollout, on December 10, 2020.
Both agencies provided the public with promises of what these vaccine safety databases could provide. The databases FDA rents include more than 100 million Americans, for example. But since the rollout, the federal agencies have been almost silent on what they reveal.
However, yesterday I came across 3 very important items about COVID vaccine safety that I had not seen mentioned until now. Each one is an important, though limited, piece of the COVID vaccine safety puzzle–but together, they give you a very good idea of what we are all dealing with as we traverse this data desert, touching small bits of the elephant like the blind men, but never being able to grasp the picture in its entirety.
Item 1 was posted on the FDA website on July 12, 2021 with no fanfare. It revealed that yes, FDA was using its Medicare beneficiary database to look for potential vaccine adverse reactions, and it found four related to Pfizer’s vaccine, which is the most widely used COVID vaccine. FDA writes:
FDA has routinely been using screening methods to monitor the safety of COVID-19 vaccines and to evaluate potential adverse events of interest (AEI) related to these vaccines. One of these methods, called near real-time surveillance, detected four potential AEIs in the Medicare healthcare claims database of persons aged 65 years and older who had received the Pfizer/BioNTech COVID-19 vaccine. The four potential AEI are pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation. The screening methods have not identified these AEI after vaccination in persons 65 years and older who received the two other authorized COVID-19 vaccines…
These events have not been identified as safety concerns or signals in the CDC Vaccine Safety Datalink (VSD) or the Veterans Administration (VA) Healthcare data systems screening methods. The Vaccine Adverse Event Reporting System (VAERS), another government monitoring system, also has not identified any association between any COVID-19 vaccine and these AEI.
FDA continues to closely monitor the safety of the COVID-19 vaccines and will further investigate these findings by conducting more rigorous epidemiological studies. FDA will share further updates and information with the public as they become available.
If the vaccine caused blood clots and bleeding, as is suspected, these are exactly four diagnoses I would expect to see indicating vaccine injuries. The claim that FDA has not seen them in its other databases, including VAERS, is curious, because people who independently study VAERS have in fact reported higher rates of myocardial infarctions and pulmonary emboli.
Six weeks after FDA posted about these very serious warning signs, FDA issued a full, unrestricted license for Pfizer’s vaccine, the very one they were warning about. The FDA website where the above information is posted has never been updated, and FDA has not revealed what the last 8 months of “more rigorous epidemiological studies” show.
Item 2 is an academic paper published by the CDC in its own, non peer reviewed journal, the Morbidity and Mortality Weekly Report. It was written by CDC scientists with researchers at various sites that participate in a CDC-funded data collection on COVID.
The paper concludes that while myocarditis is known to occur after COVID vaccinations, it is more common after getting the disease COVID. This is an unusual claim, since myocarditis rates as high as 1 in 2000 males aged 18-24 have been reported after the second Covid shot, and no one has claimed that such rates apply after getting the disease.
So what did CDC do? It chose to examine this issue using a database that admittedly misattributed most vaccinations! CDC has access to everyone’s vaccination data and could easily have have used an accurate dataset, but chose not to. Instead, CDC admitted in the paper’s fine print that while 82% of Americans over age 5 have reportedly received at least one COVID vaccine, in the 15 million person dataset it used, only 28% were recorded as vaccinated. The only reasonable interpretation is that a large number of vaccinated individuals were incorrectly assigned to the unvaccinated category. It seems a case could be made that this is scientific fraud.
Item 3 came from the Pfizer documents that were released on April 1. Huge thanks to all the volunteers who have been digging through these documents to piece together the truth about the vaccines. Huge thanks also to the scientists and attorneys who had to file suit and win in court to force FDA to release them.
This information, I think, could be a gamechanger. It turns out that Pfizer had to hire 600 new full-time employees simply to process the adverse event reports that were coming in regarding vaccine injuries and deaths: 600 new hires in the first 2 1/2 months of the vaccine rollout. And Pfizer further said it planned to hire another 1800. Eighteen hundred more! Just to manage the paperwork resulting from its vaccine-caused carnage.
FDA knew. But FDA wanted it buttoned up for 75 years. CDC knew also, since the reports of deaths to VAERS for COVID vaccines exceed all death reports for the past 30 years, for all other vaccines, put together. Both agencies hid what they knew. CDC even played tricks with data to mislead us. Pfizer knew. DHHS must have known.
There is no Public Health without public honesty. Our public health agencies have become public trickery agencies. Why should anyone believe anything they say now? Why would anyone do what they recommend?
By Michael Nevradakis, Ph.D. | The Defender | April 5, 2022
Pfizer hired about 600 additional full-time employees to process adverse event reports during the three months following the Emergency Use Authorization (EUA) of its COVID-19 vaccine, newly released documents reveal.
According to the documents, Pfizer said, “More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.”
The information was contained in a 10,000-page document cache released April 1 by the U.S. Food and Drug Administration (FDA) and made public as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request.
The latest revelations appeared in a document, “Cumulative analysis of post-authorization adverse event reports” of the Pfizer-BioNTech vaccine, highlighting such adverse events identified through Feb. 28, 2021.
The document was previously released in November 2021, but was partially redacted. The redactions included the number of employees Pfizer hired and/or was planning to hire.
According to the unredacted document released April 1:
“Pfizer has also taken a multiple actions [sic] to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.
“To date, Pfizer has onboarded approximately 600 additional full-time employees (FTEs).
“More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.”
The unredacted version also revealed the number of Pfizer-BioNTech vaccine doses shipped worldwide between December 2020 and February 2021:
“It is estimated that approximately 126,212,580 doses of BNT162b2 [the Pfizer EUA vaccine] were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021.”
The number of shipped doses previously was redacted.
Remarking upon this newly revealed information, Brian Hooker, chief scientific officer of Children’s Health Defense, told The Defender :
“The rollout of the Pfizer vaccine has led to an unprecedented number of adverse events reported — 158,000 adverse events in the first two-plus months of the rollout means that the rate of reported AE [adverse events] was approximately 1:1000, with many of the AEs graded as serious. This is based on a denominator of 125,000,000 vaccines distributed.
“It is no wonder that an army of 1,800 individuals was needed to process all of the information.”
Hooker noted the total number (1,205,755) of COVID vaccine adverse events reported to the Vaccine Adverse Event Reporting System between Dec. 14, 2020 and March 25, 2022, now eclipses the total number (930,952) of adverse events reported in the 32-year history of the database.
Dr. Madhava Setty, a board-certified anesthesiologist and senior science editor for The Defender, previously reported on the same Pfizer document, before the unredacted version was released.
“In that piece, I alluded to Pfizer’s admission that they needed more staff to process all of the adverse events being reported to them,” Setty said.
“It seems this document has now been updated. 600 FTEs [full-time employees]! … I wonder how many extra people the CDC [U.S. Centers for Disease Control and Protection] has hired? Given how they are operating, I would say zero.”
Pfizer downplayed adverse reactions in request for full FDA license
The April 1 document release also included “request for priority review” — the documentation Pfizer in May 2021 submitted to the FDA for full licensure of its Comirnaty COVID vaccine.
In this document, Pfizer described its vaccine as fulfilling an “unmet medical need,” claiming:
“Mass immunization with a safe and effective vaccine against COVID-19 can dramatically alter the trajectory of the pandemic.
“According to policy briefing by the Institute for Health Metrics and Evaluation published on 31 March 2021, COVID-19 remains a leading cause of death in the US with up to 100,000 additional deaths projected in the US between March and July 2021, many of which can likely be prevented with COVID-19 vaccination.”
Pfizer expressed “concerns” about lifting COVID-related measures, such as lockdowns, on the basis that the lifting of such restrictions would “counteract the impacts of this vaccination effort.”
The document states:
“Vaccination against COVID-19 began with EUA/conditional approvals in December 2020, in a phased rollout defined by national/regional guidance.
- “However, there continue to be concerning trends that may counteract the impacts of this vaccination effort, including:
- “[L]imitations in access to obtaining a vaccine due to infrastructure challenges (ie, clinic and appointment capacity and systems)
- “[I]ncreasing viral transmission fueled by relaxed compliance with mitigations as the pandemic surpasses the 1-year mark (ie, masks, physical distancing, limiting travel)
- “[I]ncreasing circulation of emerging variants of concern (which are currently driving continued spread of viral infection in Europe despite extensive mitigation mandates).”
Pfizer justified its request for full licensure of its COVID vaccine on the following basis:
“A vaccine program must be implemented expediently and rapidly expanded to have a significant impact on the pandemic course.
“Licensure of BNT162b2 is likely to enhance vaccine uptake by facilitating supply of vaccine from Pfizer/BioNTech directly to pharmacies and healthcare providers/facilities.
“The greatest impact of BNT162b2 licensure may be direct supply to healthcare providers who serve vulnerable populations such as elderly patients and those who live in rural and underserved communities (ie, individuals who might be unable to navigate the challenges of securing vaccine access using the systems in place for EUA).
“Expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control.”
The same document glossed over the adverse effects for which the company previously admitted it hired a significant number of new employees to process, claiming:
“Based on Phase 1 data from the FIH Study BNT162-01, BNT162b1 and BNT162b2 [various vaccines tested during the trial period] were safe and well-tolerated in healthy adults 18 to 55 years of age, with no unanticipated safety findings.
“Phase 2/3 safety data were generally concordant with safety data in Phase 1 of the study, both overall and with regard to younger and older participants.”
This is despite hard figures regarding adverse reactions provided later in the document:
“Through 28 February 2021 (data lock point aligned with Pharmacovigilance Plan), there were a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Cases were received from 63 countries.
“Consistent with what was seen in Phase 2/3 of Study C4591001, most reported AEs were in System Organ Classes (SOCs) with reactogenicity events: general disorders and administration site conditions (51,335), nervous system disorders (25,957), musculoskeletal and connective tissue disorders (17,283), and gastrointestinal disorders (14,096).
“Post-authorization data have also informed the addition of adverse drug reactions (ADRs) related to the experience of reactogenicity to the product labeling.”
Release of Pfizer vaccine documents still in progress
Many of the documents released as part of the April 1 tranche appear to include more mundane information and data related to the Pfizer COVID vaccine trials.
These documents include:
The next set of documents — an expected 80,000 pages — is scheduled to be released on or before May 1.
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
By Todd Hayen PhD | OffGuardian | April 6, 2022
Stop the party, folks, it’s not over until the fat lady sings, and she is only taking a break.
I’ve written about this premature euphoria several times, warning that we really haven’t won a thing, not even one battle, until some heads roll. And there are no rolling heads to be seen. Not even a cursory fall guy having his career destroyed due to all the blame thrown his way.
I thought at first Fauci was going to get this honour with his mysterious disappearance as a precursor to his public fall from grace. But I was wrong. He is only off somewhere private to lick his wounds, assuming he even considers himself wounded, which I rather doubt.
No, we have won no battle, not even a skirmish. The enemy just backed off a bit. We woke up one morning and they were gone. The hill we were supposedly fighting for was ours.
Really? It doesn’t seem like both sides were fighting for the same hill.
So what happened? I know I am preaching to the choir here. I think most of us have a pretty good idea what happened. The Ukraine/Russia incident makes clear the conditioning that Covid has accomplished over the population of the world.
Suddenly all of the focus shifted, suddenly a new enemy was in sight, much like enemies of old—at least an enemy we could see. It was actually quite astounding how quickly all the profile photos on Facebook changed from “I Got Vaccinated!” to the blue and yellow flag of Ukraine.
As we stand on our deserted Covid hill, waving our own flag, and wanting the enemy to at least acknowledge how clever we were to see through their lies and subterfuge we wonder where everyone has gone. “Yea!!” we shout, “we’ve won!!”
No, we haven’t, and not only have we not won, we have lost—big time. Sorry to break it to you (and like I said, I think most readers of OG know this, maybe you can share this article with all those who don’t even know we were in a fight).
It is beyond the scope of this article to list all of the things they have won, and all of the things we have lost, but I will take a stab at the ones that stand out to me. First of all I think it is important to point out the things many of us think we have won—like the rescinding of mandated mask wearing as the first example.
Most states, provinces, and even whole countries have removed mask wearing in public as a “rule, law, or regulation” or whatever you want to call it. In Canada this is true as well. However, you still must wear a mask on public transit, in medical facilities, and quite a few other places. Why? That’s a “ha ha” question. There never has been a reason why, and there isn’t now. And even as this restriction has been “removed” many people are still wearing masks—everywhere.
I am not sure how it is in other parts of the world, but here in Canada there is quite a large percentage of people still wearing masks, even those walking outdoors, or riding alone in their cars. This is the first example of “what they got”—blind obedience to the cause, even when the cause has officially been announced as being no cause at all.
The fear was created; the high morality of “following the authority for the good of the people” has been established. A superstitious effect follows the fear—wear a mask the same way one wears a talisman to ward off evil spirits (although that is probably more effective). A blind obedient habit follows the bowing down to authority. Soon people won’t even know why they first started wearing them, it is just a thing you do, like shaking hands when you meet someone (which we no longer do).
Of course the normies will say “why not? Why is wearing a mask so difficult to do?” Need I explain why? When it is used as a form of compliance to authority, when wearing one obliterates one of the prime ways humans communicate and socialize, when it is actually medically dangerous to wear one, and when there is absolutely no reason to—then we should get rid of them as soon as we can and should never have worn them to begin with.
The powers that ought not to be have won a very effective form of blind compliance, ready to implement at full force again with a snap of a finger. Not only are people still wearing them, it will take no effort at all to get the majority of the world’s population to don them en masse again.
They have also won, and we have lost, a sense of unsubstantiated fear of our fellow humans.
Social distancing has forced us into an unconscious avoidance of other people. I have not seen much handshaking going on, or even hugging. People now avoid each other, and I doubt if most of these avoidances are even conscious. This has established a deep sense of fear and loss of trust, which again makes us all easily manipulated. It will only take small insertions in the culture through media to basically push us anywhere they want us pushed.
The breakdown of social psychology is clearly part of the agenda, and I believe they can indeed count that as a “win”—a big one. The implications of this sort of thing are unconscionable, and range from a general disconnect from human interaction to massive unrest, impatience, and lack of tolerance—more violence, road rage, disputes, and tribal dissonances, not to mention higher rates of depression, anxiety, drug use, and suicide.
If we think of Orwell’s 1984 as any sort of playbook for this agenda, we can see the foundations laid for many of the more atrocious aspects of Big Brother’s world. The idea of continuous war raging somewhere in the world is certainly in place along with the confusion of which side to be on at any given moment. The propaganda is relentless and leaves us all in a sticky syrupy mess. Hate is an all-powerful stimulator for extreme nationalism and compliance to a singular narrative.
During Covid we were trained to accept nothing but one clearly defined truth, different perspectives were not allowed, as anything with a different view was immediately labeled as “misinformation,” “fake,” and “dangerous.”
There are no “second opinions” anymore, either a source of information is in line with the mainstream, or it is simply degraded as insanity, moronic, or “anti science.” There is no grey—only black and white.
During Covid we learned, through a very conscious manipulation, that there was only one way to see truth, and that polarized thinking can apply to anything the narrative wishes to apply it to. First, “all about Covid and vaccines” now “all about Ukraine and Russia.” Two very different events in nearly every way, yet each with one mainstream view that we all must be in alignment with.
The ease of applying censorship to nearly any situation is a huge win for them. Any contrary opinion has been all but obliterated—if information is labeled “mis” by the mainstream it is blocked. Contrary ideas and opinions on social media are deleted, those who are brave enough to speak out lose their jobs and their reputations are ruined.
Once we start marching to this drum—that anything that challenges the main stream narrative is false, fake, misinformation, dangerous or “anti science”—we are quite literally walking into a totalitarian state. After Covid this sort of censorship will just be that much easier to implement, and it will be that much easier to just go along with it, or worse, advocate it.
In more subtle areas we see the foundation firmly set for other agenda items such as Central Bank Digital Currency and digital ID’s, obviously the way having been paved by the infamous “vaccine passport.” The ground they have acquired through the Covid manipulation is clear, and substantial.
Anything they wish for in the future has been normalized by the events of the past two years, any radical demand made in the future has had its path greased by these events such as travel restrictions, bank closures (as punishment for supporting any sort of protest against the main stream narrative), forced medical intervention with no substantial medical purpose or reason, restrictions on gathering, redefining words in order to fit the agenda, on and on and on.
Depending on how far down the rabbit hole you are willing to go, the “powers that ought not to be” could possibly have accomplished the initial stages of ridding the world of millions of “useless eaters” through the wholesale injection of god knows what into billions of bodies.
We may be seeing only the tiny tip of the iceberg with the thousands of deaths and injuries undoubtedly caused by the “vaccines”—probably effects the makers of the injections see as a minor annoyance when the major event could very well be the deaths of millions spread out over generations (or much less!)
If true, that’s a BIG win for them!—and an equally big loss for us. There is no turning this one around, no stopping it, as it has already been done and all we can do is sit and await the results.
So we have really won nothing, and we have lost an awful lot. In many regards what they have won is really just the beginnings of the foundation of what is yet to come. No one builds a nice foundation to a house without the intention of building the rest of the house that sits upon it. Even though a concrete slab isn’t usually much to look it, it has all the preparations built into it that allow a very complex structure to sit on it. The detail of that structure is yet to be built.
I am afraid it is going to be a very big and complex house and with its eventual erection the beautiful view we used to enjoy will be blocked—a view of freedom and creativity.
These two ingredients have always been necessary to ensure a future that all humans have the right to pursue—a future of life, liberty and happiness, all things surely worth fighting for. Stay on that hill; the battle has only just begun.
Todd Hayen is a registered psychotherapist practicing in Toronto, Ontario, Canada. He holds a PhD in depth psychotherapy and an MA in Consciousness Studies.
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