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Serious adverse events from Pfizer’s mRNA vaccine are not “rare”

Maryanne Demasi, reports | June 27, 2023

Drug regulators and public health agencies have saturated the airways with claims that serious harms following covid vaccination are “rare.”

But there has been very little scrutiny of that claim by the media, and I could not find an instance where international agencies actually quantified what they meant by the term “rare” or provided a scientific source.

The best evidence so far, has been a study published in one of vaccinology’s most prestigious journals, where independent researchers reanalysed the original trial data for the mRNA vaccines.

The authors, Fraiman et al, found that serious adverse events (SAEs) – i.e. adverse events that require hospitalisation – were elevated in the vaccine arm by an alarming rate – 1 additional SAE for every 556 people vaccinated with Pfizer’s mRNA vaccine.

According to a scale used by drug regulators, SAEs occurring at a rate of 1 in 556 is categorised as “uncommon,” but far more common than what the public has been told.

Therefore, I asked eight drug regulators and public health agencies to answer a simple question: what is the official calculated rate of SAEs believed to be caused by Pfizer’s mRNA vaccine, and what is the evidence?

The agencies were FDA, TGA, MHRA, HC, PEI, CDC, ECDC and EMA.

The outcome was startling.

What is the official SAE rate?

Not a single agency could cite the SAE rate of Pfizer’s vaccine. Most directed me to pharmacovigilance data, which they all emphasised does not establish causation.

The Australian TGA, for example, referred me to the spontaneous reporting system but warned, “it is not possible to meaningfully use these data to calculate the true incidence of adverse events due to the limitations of spontaneous reporting systems.”

Both the German regulator (PEI) and European CDC referred me to the European Medicines Agency which, according to its own report, saw no increase at all in SAEs. “SAEs occurred at a low frequency in both vaccinated and the placebo group at 0.6%.”

The UK regulator MHRA went so far as to state it “does not make estimations of a serious adverse event (SAE) rate, or a rate for adverse reactions considered to be causally related for any medicinal product.”

The US FDA, on the other hand, did conceded that SAEs after mRNA vaccination have “indeed been higher than that of influenza vaccines,” but suggested it was justified because “the severity and impact of covid-19 on public health have been significantly higher than those of seasonal influenza.”

Despite analysing at the same dataset as Fraiman, the FDA said it “disagrees with the conclusions” of the Fraiman analysis. The agency did not give specifics on the areas of disagreement, nor did it provide its own rate of SAEs.

Expert response

In response to the criticism, Joe Fraiman, emergency doctor and lead author on the reanalysis said, “To be honest, I’m not that surprised that agencies have not determined the rate of SAEs. Once these agencies approve a drug there’s no incentive for them to monitor harms.”

Fraiman said it’s hypocritical for health agencies to tell people that serious harms of the covid vaccines are rare, when they have not even determined the SAE rate themselves.

“It’s very dangerous not to be honest with the public,” said Fraiman, who recently called for the mRNA vaccines to be suspended.

“These noble lies may get people vaccinated in the short term but you’re creating decades or generations of distrust when it’s revealed that they have been misleading the public,” added Fraiman.

Dick Bijl, a physician and epidemiologist based in the Netherlands, agreed.  “It goes to show how corrupted these agencies are. There is no transparency, especially since regulators are largely funded by the drug industry.”

Bijl said it’s vital to know the rate of SAEs for the vaccines. “You must be able to do a harm:benefit analysis, to allow people to give fully informed consent, especially in young people at low risk of serious covid or those who have natural immunity.”

Bijl said the mainstream media has allowed these agencies to make false claims about the safety of vaccines without interrogating the facts.

“The rise of alternative media is strongly related to the lies being told by the legacy media, which just repeats government narratives and industry marketing. In the Netherlands, there is a lot of discussion about the distrust in public messaging,” said Bijl.

June 28, 2023 Posted by | Deception, Mainstream Media, Warmongering, Science and Pseudo-Science | , , , , | 1 Comment

Court Orders Merck to Turn Over Gardasil Adverse Event Databases

By Brenda Baletti, Ph.D. | The Defender | April 3, 2023

A North Carolina district court ordered Merck to turn over all of its Gardasil adverse events databases to plaintiffs suing the pharmaceutical giant for injuries allegedly caused by the human papillomavirus (HPV) vaccine.

The databases, which include information from the Merck Adverse Event Reporting and Review System (MARRS) — Merck’s version of the Vaccine Adverse Event Reporting System (VAERS) — should contain all of the reports pertaining to Gardasil adverse events submitted by physicians, patients and publications, plaintiffs’ attorney Michael Baum told The Defender.

In his March 20 order, U.S. District Judge Robert J. Conrad, Jr., said, “Plaintiffs’ and their experts should have the same opportunity as Merck to review and analyze the entirety of the data.”

Merck until now has refused to make the entire MARRS databases available to the plaintiffs’ attorneys.

Gardasil is a widely used vaccine commonly administered to teens and young adults before they are sexually active to protect against HPV infections, which can be sexually transmitted later in life.

HPV infections may lead to the development of cervical cancer. However, most infections are benign and resolve on their own.

The firm Baum Hedlund Aristei & Goldman and Robert F. Kennedy, Jr., Children’s Health Defense chairman-on-leave, have filed more than two dozen lawsuits on behalf of young people injured by Gardasil, alleging Merck knowingly and fraudulently concealed the vaccine’s risks.

The lawsuits are some of the more than 80 pending in the federal court system, and that number is expected to grow. In August 2022, a judicial panel consolidated the lawsuits into a single federal courtroom.

Some of the signature impacts observed following HPV vaccination — which afflict a number of the plaintiffs — include permanently disabling autoimmune and neurological conditions such as postural orthostatic tachycardia syndrome (POTS), fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome, The Defender reported.

There have been thousands of reports of adverse events worldwide, peer-reviewed scientific literature from the U.S., Australia, Denmark, Sweden, France and Japan, and statistics published by public health agencies in each of these countries that demonstrate plausible associations between HPV vaccination and autoimmune conditions.

Merck maintains there is no safety signal in the data for autoimmune conditions. The plaintiffs allege Merck made this argument by discounting reports.

Baum told The Defender access to this full database of adverse event reports should allow experts to better analyze the full extent of post-Gardasil autoimmune symptom clusters, and demonstrate there is a “statistically significant causal connection between Gardasil and autoimmune conditions.”

Gardasil’s long history of autoimmune adverse events

While Merck markets Gardasil as “safe and effective,” safety signals emerged even early, during the vaccine’s clinical trials. However, the U.S. Food and Drug Administration (FDA) granted the vaccine Fast Track approval after only a six-month review process.

In 2006, Gardasil was licensed across the U.S. and Europe. But within a few years, reports of serious adverse events appeared — first in the media and then in academic journals.

In 2013, Gardasil was responsible in the U.S. for three-fifths of all serious vaccine reactions reported in young women under age 30, including 64% of deaths and 81% of cases of permanent disability.

Similarly, disproportionately high rates of adverse events were reported in Australia, Japan, and other European countries at that time.

Yet in 2014, the FDA approved a new version of the vaccine, the nine-valent Gardasil 9. And in 2016 — when GlaxoSmithKline (GSK) withdrew its poorly competing bivalent HPV vaccine Cervarix from the U.S. market — Gardasil 9 became “the only game in town.”

Gardasil 9 is FDA-approved for males and females ages 9 through 45 years.

In 2015, because of the high number of serious adverse events reports in Denmark and around the world, the Danish Health and Medicines Authority asked the European Commission to investigate the relationship between Gardasil and serious adverse events.

Several months later, the European Medicines Agency (EMA) — a European equivalent to the FDA — issued a report concluding there was no link between HPV vaccines and serious neurological adverse events.

But a leaked, confidential EMA document showed substantial disagreement among the agency’s experts.

An article published in The BMJ Evidence-Based Medicine also revealed the EMA made its evaluation based on flawed data and analysis provided by vaccine manufacturers, dismissed compelling evidence from independent researchers and the Uppsala Monitoring Centre, and sought input from experts with financial conflicts of interest, in violation of its own rules.

Given the ongoing safety concerns associated with the revelations of the EMA’s flawed study, Rebecca Chandler et al. conducted further research on the link between the HPV vaccine and autoimmune disorders, which was published in Drug Safety in 2017.

Autoimmune disorders can be difficult to identify and take a long time to diagnose because they are typically characterized by combinations of a wide range of symptoms that can be linked to a number of illnesses.

Any one symptom on its own may not provide enough information to alert a physician to the underlying cause.

To identify autoimmune disorders associated with the HPV vaccine, Chandler and her team did a cluster analysis of VigiBase, the World Health Organization (WHO) international database of suspected adverse drug reactions.

They conducted a statistical analysis of reports on HPV adverse events, looking for clusters of symptoms associated with autoimmune conditions like POTS, CRPS and CFS — rather than looking only for cases where an autoimmune disorder was definitively diagnosed — and found statistically significant rates of serious adverse events associated with Gardasil.

It is one of several recent studies linking Gardasil with autoimmune issues.

As part of this now-consolidated lawsuit, the plaintiffs have been seeking access to Merck’s database for several years in order to do a cluster analysis on all of the data Merck has collected.

Suing Big Pharma for vaccine injury difficult — but possible

Vaccine makers can be held liable for injuries caused by a fully licensed vaccine — unless that vaccine is added to the CDC’s childhood vaccination schedule.

The HPV vaccine is listed on that schedule.

People injured by vaccines listed on the childhood schedule can seek compensation through the taxpayer-funded National Vaccine Injury Compensation Program (VICP), a no-fault alternative to the traditional legal system for resolving vaccine injury claims.

But many people are unaware that claimants who are dissatisfied with the outcome of the VICP process can sue the pharmaceutical company directly in civil court as long as that claimant completed the VICP process.

Baum told The Defender that the VICP has paid out more than $70 million to people making claims regarding Gardasil, but that over the last few years, they stopped making payments for autoimmune conditions, without explanation.

The lawsuits against Merck alleging the HPV vaccine caused debilitating autoimmune complications are a result of this process.

Baum also told The Defender that a claimant has only three years from the onset of symptoms to file a complaint, but because autoimmune disorders are challenging to diagnose, many people are not diagnosed until the statute of limitations has expired.

Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

April 3, 2023 Posted by | Deception, Science and Pseudo-Science | , , | Leave a comment

German Mainstream Media: “Serious Flaws In Pfizer BioNTech Vaccine Study”…”Many Irregularities”

By P Gosselin | No Tricks Zone | February 25, 2023

Studies, trials by Pfizer Biontech were “seriously flawed” and fraught with “many irregularities” German journalist finds. It’s all beginning to dawn on the media…

Emergency approval based on sloppy and deceptive  trials and studies?

At Germany’s flagship daily Die Welt, journalist Elke Bodderas recently penned an investigative article: The Many Irregularities In The Pfizer Approval Study

Until recently, Germany’s mainstream media had refused to report on the glaring number of side effects of the COVID 19 mRNA vaccines, dismissing them has disinformation spread by rightwing crackpots. But now there’s no denying something has gone terribly awry, and that the “crackpots” had been right all along.

Cover-up?

In her article, Bodderas concedes that the Biontech/Pfizer’s mRNA vaccine appears to have been “based on incorrect documentation”, that there is “growing doubt about the data from the pivotal Phase 3 trial” and that “Pfizer is dodging the accusations and refusing to be scrutinized.”

The metropolis Buenos Aires was a key area for test phase with almost 6000 of the 43,548 test subjects worldwide, and things there, according to Die Welt’s Bodderas, “did not go as they should have”.

The “significant, consequential irregularities” that arose during the trials “cast the entire study of the efficacy and side effects of the Biontech/Pfizer vaccine in a different light.”

No one believes “safe and effective”, not even the media

In Germany, the days of believing the new mRNA vaccines by Biontech and Pfizer are “safe and effective” are finally disappearing as a reluctant mainstream media begins to report on the glaring adverse effects and the now well-known inadequately conducted trials.

In other parts of the world, it’s been long known that these new experimental vaccines not only did not work like they once had been claimed to do, but that they also never prevented the transmission of the virus and had numerous, dangerous side effects. Only now, months later, are these now well-known facts beginning to dawn on Germany’s mainstream media.

Shoddily conducted trials

Die Welt reports on how Argentine test candidate Augusto Roux, a 36-year old lawyer, felt unwell after having received his second dose in the trials, then “experienced shortness of breath, burning chest pain, nausea, and fever” and that “his urine turned black like cola” before passing out. After having been admitted to a hospital, physician Gisela di Stilio suspected an “adverse reaction to coronavirus vaccine (high probability).” But Roux was simply dropped from the December 2020 study, and never appeared in subsequent evaluations. Instead he was counted as having suffered from COVID-19.

Suppression of unwelcome results?

In total, “In one fell swoop, the test administration [in Buenos Aires] had said goodbye to 53 subjects on August 31, 2020. The test candidates had been ‘unblinded.’” reports Die Welt’s Bodderas.

Die Welt adds: “A total of 302 subjects of the vaccine group were deleted from the study after the second vaccination and thus not included in the evaluation. 200 of them came from Buenos Aires. Have unwelcome results been suppressed here?”

According to Bodderas, “Deaths were concealed, serious side effects were not registered, and the study protocol was violated several times.”

“The case casts a bad light on Pfizer, a company that has often been plagued by scandal in the past, but also on the regulatory agencies EMA and FDA.”

Bodderas also appeared on Bild’s Viertel Nach Acht: “Serious Flaws in Pfizer BioNTech Vaccine Study.”

February 26, 2023 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular | , , , , | Leave a comment

Despite progress in data transparency, the FDA still keeps its data secret

By Maryanne Demasi, PhD | November 10, 2022

History shows that hiding clinical trial data can be deadly.

Vioxx is a well-known example of how the US drug regulator withheld important information about the harms of the drug for over three years, before it was withdrawn from the market and tens of thousands of people died as a consequence.

Numerous initiatives have been launched over the past two decades to improve access to trial data after it became evident that what was reported in peer-reviewed journals was often cherry-picked and misleading.

Eminent scientists have succeeded in gaining access to trial data from the European and Canadian drug regulators, but a recent analysis published in the Journal of Law, Medicine, & Ethics, found that the US FDA still lags behind others when it comes to data transparency.

Europe ahead of the pack

Drug regulators have traditionally been the guardians of a treasure trove of trial data which they kept hidden from the public. But, over a decade ago, the efforts of Danish professor Peter Gøtzsche turned that on its head.

Gøtzsche and his PhD student were studying the effects of an anti-obesity drug and requested the trial data held by the European Medicines Agency (EMA).

“We already had good evidence that the efficacy and harms of drugs were incompletely reported in the medical journals, so by asking for the regulatory data for the anti-obesity pills, we were convinced it would get us closer to the truth”, said Gøtzsche.

At first, EMA denied their request, saying that it needed to protect commercially confidential information, but Gøtzsche was undeterred. He made a formal complaint to the European Ombudsman.

After an arduous 3-year process, the Ombudsman accused EMA of “maladministration” for refusing to share its data – it was a serious and embarrassing charge, so EMA had no choice but to capitulate.

In 2013, EMA announced that it would provide public access to regulatory data – which included study reports, protocols and the raw anonymised patient data in statistical programmes enabling anyone to independently scrutinise the data for all new drugs that it approved.

It was a bitter-sweet moment for Gøtzsche.

“I was satisfied with the outcome, but I also felt a bit betrayed. When EMA praised itself for being transparent, it conveniently omitted telling the public that it was basically forced to make the decision because of my efforts and that of the Ombudsman,” said Gøtzsche.

“I’ve been around a while to know that this is exactly how the drug industry operates. They cover up their failures while praising themselves for what others force them to do,” he added.

Millions of pages containing trial data have since been released. Interestingly though, this remarkable feat has gone largely unrecognised and the response from the research community has been rather tepid.

Gøtzsche suspects it’s because analysing regulatory documents is complex and requires experience to decipher regulatory data – skills that few researchers have.

“It is a huge job to do systematic reviews of clinical study reports held by drug regulators, but it is the difference between producing reliable reviews or merely “garbage-in, garbage-out” reviews,” said Gøtzsche.

Since then, Gøtzsche’s group showed this was the case for reviews of antidepressant drug trials.

When they compared data from medical journals to that from regulatory documents, they found major discrepancies such as underreporting of harms, including suicide attempts and aggressive behaviour.

Canadian regulator in the cross hairs

Following the landmark policy change in Europe, researchers believed it would help unlock regulatory documents elsewhere that were historically kept hidden from the public.

In 2016, Peter Doshi, professor at the University of Maryland and senior editor of The BMJ requested the release of unpublished clinical trial data relating to antivirals for the treatment of influenza (Tamiflu, Relenza) and three human papillomavirus vaccines from the Canadian drug regulator, Health Canada.

After some resistance, Health Canada agreed to allow Doshi access to the documents but imposed a confidentiality agreement that would prevent him from making his findings public.

When Doshi refused to sign the confidentially agreement, his request for access to the trial data was denied, so he filed a lawsuit in a federal court seeking a judicial review of the regulator’s decision.

Remarkably, in 2018, in the case of Peter Doshi v. Attorney General of Canada, a federal court judge ruled in favour of Doshi and in the public’s interest, ordering Health Canada to hand over the trial data for independent scrutiny.

It was hailed a “major victory” for transparency and after the win, Doshi told The BMJ, “For me this case has always been about something larger than my specific request. It is about the principle of transparency. If my case sets a precedent and Health Canada begins making clinical trial data available to others—promptly, and without imposing confidentiality agreements—that will be the real victory.”

Notably, the Canadian drug regulator has gone one step further than EMA by proactively releasing data for not only approved drug submissions, but also “unapproved, and withdrawn drug and biologic submissions… Class III and IV medical device applications.”

What about the US FDA?

The US FDA houses the largest known repository of clinical trial data in the world, but it doesn’t proactively share it.

In 2018, the FDA launched a new pilot program to proactively publish clinical study reports from the pivotal studies of nine recently approved drugs – but the agency put an end to that program in March 2020.

“It is just so typical of the FDA, which is very beholden to industry, and which some have dubbed the Foot Dragging Agency when it comes to the public interest,” said Gøtzsche.

Now, the only mechanism to ascertain regulatory data for FDA-approved drugs is to submit Freedom of Information Act (FOIA) requests, a lengthy process which often results in heavily redacted documents of limited value.

A study by US researchers, analysed the FDA’s willingness to release data, compared to other regulators, EMA and Health Canada.

They found that between 2016 and April 2021, EMA released data for 123 unique medical products, while Health Canada released data for 73 unique medical products between 2019 and April 2021.

In stark contrast, the FDA only proactively disclosed data supporting one single drug that was approved in 2018, clearly demonstrating that the agency has failed to keep pace with the European and Canadian regulatory bodies.

The problem of data secrecy within the FDA has been especially evident during the pandemic. Recently, I reported in The BMJ that the agency had failed to disclose covid-19 vaccine ‘safety signals’ derived from post-marketing data.

Also, the non-profit group, Public Health and Medical Professionals for Transparency had to sue the FDA for access to trial documents used as the basis for licensing Pfizer’s covid-19 mRNA vaccine. Initially, the agency wanted 75 years to release all the data but a Federal Court Judge rejected its request, ordering the release of the documents at a rate of 55,000 pages per month, taking approximately 8 months.

Given the widespread use of this important public health intervention, and the billions of dollars in public funds used to conduct vaccine research and development, these data should have been made publicly available immediately.

Data secrecy has undermined the health care system by subverting the allocation of scare resources and eroding public trust. The damage done to people’s confidence in vaccines, and medicines more broadly, will be felt for generations and likely to harm public health.

November 13, 2022 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular | , , | 1 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