British Study Reveals Alarming Risks of Suicide and Homicide
By Peter A. McCullough, MD, MPH | Courageous Discourse | April 9, 2023
Many of us have been struck by the rapid rise in clinical interest and reported studies on transgender persons. The main clinical indication for gender change medication and or surgery is gender dysphoria. This means that individuals are afflicted with a syndrome in which they are not happy with their natural gender from birth. While changing biological gender the opposite is associated with a modest improvement in gender dysphoria scores, one may wonder if there is a price to pay for such a substantial and and relatively permanent intervention for a psychiatric illness?
Jackson et al, recently reported on the outcomes of total of 1951 British transfeminine (male at birth) (mean [SE] age, 36.90 [0.34] years; 1801 White [92.3%]) and 1364 transmasculine (female at birth) (mean [SE] age, 29.20 [0.36] years. The normal control group was matched to 68,165 cisgender men (59 136 White [86.8%]) and 68,004 cisgender women (57 762 White [84.9%]). Compared with cisgender men, there was an increased risk of overall mortality for transfeminine (MRR, 1.34; 95%CI, 1.06-1.68). Compared with cisgender women, there was an increased risk of overall mortality for transmasculine (MRR, 1.75; 95%CI, 1.08-2.83) adults.
The most notable relative risks for those who changed genders was suicide and homicide as shown in the table. These data suggest that psychiatric and behavioral determinants arising from background gender dysphoria and the transgender process contribute to death at a relatively young age among those who have chosen to change from their original biological gender to the opposite.
The Highwire with Del Bigtree | April 6, 2023
Bombshell vaccine safety surveillance data out of Western Australia shows it was reactions from the Covid vaccine that were overwhelming local hospitals. Data shows Australia’s zero-Covid plan was for nothing, as cases have spiked.
The Highwire with Del Bigtree | April 6, 2023
In March 2022, Florida Surgeon General, Dr. Joseph A. Ladapo, faced significant criticism for advising against the COVID-19 vaccine for children under 17, citing reported risks outweighing the benefits. Now, W.H.O. has rolled back its own recommendation on the vaccine for healthy children and teenagers. Dr. Ladapo joins Del for a nice ‘I told you so’.
The Highwire with Del Bigtree | April 6, 2023
No matter what political affiliation, American’s are now entertaining the idea that someone in their family may have died from a Covid jab. As Robert F. Kennedy, Jr. and others now approach the 2024 elections, vaccine safety and mandated medicine have become a top issue.
BY IAN MACLEOD | THE DAILY SCEPTIC | APRIL 3, 2023
The battle of ideas around Covid has few clashes as hotly contested as Long Covid. Alarmists have hyped the frequency and severity with which infection causes long-term damage. Sceptics see no reason for panic. A new study helps to settle at least part of this debate.
The paper in the Journal of the American Medical Association’s (JAMA) Network Open looked at “post–COVID-19 condition (PCC) in young people after mild acute infection” to find how common it was and to find risk factors. Participants were aged between 12 and 25.
The authors offer this straightforward conclusion: “PCC was not associated with biological markers specific to viral infection.” That is, participants were equally likely to suffer from ‘Long Covid’, whether or not they had suffered from acute COVID-19.
The researchers concluded that Long Covid is predicted by “initial symptom severity” and, intriguingly, “psychosocial factors”.
The full article is available on JAMA Network Open.
The main results from the present study were: (1) the prevalence of PCC six months after acute COVID-19 was approximately 50%, but was equally high in a control group of comparable SARS-CoV-2-negative individuals; (2) acute COVID-19 was not an independent risk factor for PCC; (3) the severity of clinical symptoms at baseline, irrespective of SARS-CoV-2 status, was the main risk factor of persistent symptoms six months later.
Symptom prevalence data are consistent with other controlled studies of young people after acute COVID-19 reporting a high symptom load, with only subtle differences between individuals testing positive and negative for SARS-CoV-2. Correspondingly, a large population-based study found no associations between most persistent symptoms attributed to COVID-19 and serological evidence of SARS-CoV-2 infection. …
These findings suggest that persistent symptoms in this age group are related to factors other than SARS-CoV-2 infection, and therefore question the usefulness of the WHO case definition of PCC.
Worth reading in full.
By Brenda Baletti, Ph.D. | The Defender | April 7, 2023
People who receive Pfizer’s respiratory syncytial virus (RSV) vaccine should be monitored for Guillain-Barré syndrome, according to the authors of a Pfizer-funded study published this week in the New England Journal of Medicine (NEJM).
The paper — one of several published Wednesday reporting interim analyses for Pfizer’s phase 3 clinical trials for the RSV vaccine — concluded the vaccine was effective in preventing RSV in adults age 60 and over “without evident safety concerns.”
But that same article also flagged Guillain-Barré syndrome as a safety concern moving forward with the vaccine.
“If RSVpreF vaccine [Pfizer’s RSV vaccine] is approved and recommended, these adverse events warrant close monitoring in future studies and with real-world data and post-marketing surveillance,” the authors of the NEJM study said.
The U.S. Food and Drug Administration (FDA) is expected to approve Pfizer’s RSV vaccine for older adults in May.
Safe and effective?
Guillain-Barré syndrome is a rare disorder in which the body’s immune system attacks its own nerves. Symptoms can range from brief weakness to paralysis.
The FDA asked Pfizer to include the condition as an “important potential risk” of the vaccine and to develop a safety study to monitor for potential cases if the shot is approved, CNBC reported.
When the FDA vaccine advisory panel met in February to review Pfizer’s data pre-publication, there was substantial disagreement about the data on safety and effectiveness, although the majority of the committee voted to recommend the vaccine for approval.
Four of 12 committee members voted that the safety data was not adequate for approval — and one abstained — because of their concerns with the Guillain-Barré cases.
Four committee members also voted the evidence of vaccine effectiveness was not adequate for approval, while seven said it was and one member abstained.
In the NEJM study, one person developed Guillain-Barré syndrome and another developed Miller Fisher syndrome, a subset of Guillain-Barré. The symptoms appeared six and seven days post-vaccination, respectively.
The person with Miller Fisher syndrome recovered. The person diagnosed with Guillain-Barré continues to suffer from loss of motor function.
CNBC reported:
“In the New England Journal of Medicine article, the scientists said the two cases occurred in patients who were in an age group that has an increased risk of developing Guillain-Barré. Potential factors other than the vaccine also could have caused the individuals to develop the syndrome, they added.
“But the FDA said the agency views the Guillain-Barré cases as possibly related to the vaccine because the patients developed the syndrome shortly after receiving the shot, according to briefing documents published in February.
“Pfizer concluded that the cases were unrelated, and the clinical trial’s data monitoring committee did not identify any safety concerns with the vaccine.”
Dr. Hana El Sahly, the FDA committee chair and professor of molecular virology and microbiology and infectious diseases at the Baylor College of Medicine, said Guillain-Barré has an incidence of about 1 in 100,000 among people ages 60 and older. But in the vaccine trial, the rate was closer to 1 in 9,000, which is significantly higher.
“It’s significant in terms of incidence,” she said. The FDA advisors told Pfizer that safety monitoring for Guillain-Barré after FDA approval “would be crucial,” CNBC reported.
There is currently no vaccine approved to prevent RSV, a lower respiratory disease that is one of the most common causes of childhood cold-like illness and was first discovered in humans in 1956.
The illness is mild for most people.
In children under age 5, RSV causes 58,000 to 80,000 hospitalizations per year and 100 to 300 deaths.
In adults ages 65 and older, RSV causes 6,000 to 10,000 deaths and 60,000 to 160,000 hospitalizations per year, according to the Centers for Disease Control and Prevention.
Research shows the virus originated in monkeys housed in a Maryland facility where they were used to conduct polio vaccine research.
Brian Hooker, Ph.D., P.E., chief scientific officer for Children’s Health Defense (CHD), told The Defender :
“I find it ironic that Pfizer is creating a vaccine for RSV, an illness that was created due to the development of the polio vaccine. It seems like vaccine manufacturers are paid to prevent diseases that they already created.
“The incidence of Guillain-Barré is very troubling and although many patients recover, there is nerve damage associated with it leading to permanent weakness, numbness and fatigue.”
The NEJM study reported that the vaccine was 86% effective at preventing lower respiratory tract illness with three or more symptoms, and 66% effective at preventing the illness with two or more symptoms, among adults over age 60.
The study determined there were not enough cases of severe RSV-associated lower respiratory tract illness — meaning cases needing hospitalization or ventilation or extra oxygen — to determine whether the vaccine was effective for those cases, CNN reported.
RSV vaccines for pregnant women failed to meet major goal in trials
Pfizer is also seeking FDA approval for its vaccine to protect infants from RSV by vaccinating pregnant mothers.
However, in the interim data on clinical trials, also published Wednesday in the NEJM, the vaccine failed to meet one of its two main goals.
Last year, Pfizer reported that its vaccine was highly effective at protecting newborns from RSV. The drugmaker also sought rapid FDA approval for the vaccine for pregnant mothers.
The FDA is expected to decide by August.
According to the study published Wednesday, the vaccine was 82% effective in preventing severe lower respiratory tract illness — such as very low oxygen levels or need for ventilator support — in infants in the first 90 days of life, but that dropped to 69% efficacy up to 180 days after a baby is born.
But the vaccine failed to meet its second big goal: reducing non-severe RSV-associated lower respiratory illness in infants.
The study enrolled 7,128 women — half received the RSV vaccine and half received the placebo.
Severe illness occurred within three months in six infants whose mothers received the vaccine, compared with 33 infants from the placebo group who contracted serious RSV infections.
The company evaluated 3,570 infants as part of the study, Reuters reported.
Big Pharma’s race for the RSV vaccine
The RSV virus causes annual outbreaks of respiratory illnesses in all age groups, typically during the fall, winter and spring in most regions of the U.S. It has existed for decades and doesn’t usually spark alarm.
But RSV made headlines last fall as part of a “tripledemic” — COVID-19, flu and RSV — scare, just as these new RSV products were preparing to come on the market.
Robert F. Kennedy, Jr., CHD chairman-on-leave, said at the time, “fear sells,” tweeting:
As The Defender reported, pharmaceutical companies have been working on the development of a vaccine for RSV since the 1960s — at times with deadly outcomes.
After a disastrous attempt at producing a vaccine, where 80% of vaccinated children were hospitalized, RSV vaccine development was put on hold.
Over the last several years, “lured by the prospect of a large untapped global RSV vaccine market,” four manufacturers set their sights on RSV vaccine development for infants, pregnant women and the elderly.
Initially, Johnson & Johnson and Bavarian Nordic also were developing RSV vaccines, but the former dropped out of the race last month and Bavarian Nordic’s clinical trials are in progress.
That leaves Pfizer and GlaxoSmithKline (GSK), who have been in a tight race to be the first Big Pharma player to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, Reuters reported last month.
Both companies have RSV vaccines under regulatory review with the FDA.
The FDA advisory committee voted unanimously in favor of GSK’s vaccine’s effectiveness in preventing lower respiratory tract disease caused by RSV in adults aged 60 and above, and voted 10 to 2 for its safety last month, based on interim data presented last October, Reuters reported.
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.
Concerning increase in mortality in New Zealand
By Ian Miller | Unmasked | April 7, 2023
COVID has unfortunately created any number of repetitive stories.
Jurisdiction imposes mask mandates, population complies, masks prove ineffective, media claims masks didn’t work because of lack of compliance.
Another example would be when countries with extraordinary compliance, such as Singapore or South Korea, would see increases ignored entirely, or blamed on the population not wearing masks of a correct level of quality.
Yet as a general rule, the most consistently predictable repetitive storyline has been the media and expert community declaring that a country was a pandemic success, only for their results to dramatically change in a relatively short period of time.
This was the case with the Czech Republic, with Australia, with Taiwan and many other locations.
Even within the United States adjustments showed that states like California – heralded as pandemic winners – actually had significantly worse results than previously realized.
But few places on earth have been as heavily praised as New Zealand.
Their science-following leadership was repeatedly hailed, honored, and praised for their effective communication, endless lockdowns, tyrannical response to protests, and prolific commitment to mandates.
All of the above, combined with their strict border controls, should have meant that New Zealand would avoid the significant increase in negative outcomes seen in other parts of the world.
At least, that’s what the media and activist public health authorities claimed would happen.
The reality is far more complicated.
Throughout 2020 and into 2021, New Zealand saw very little COVID transmission.
Unsurprisingly, the BBC praised the country for their efforts, explaining in detail how the country had become “COVID free.”
Jacinda Arden, now former prime minister, was once so completely committed to maintaining an illusion of infallibility that she claimed that the only source of accurate information available to the public was the government.
Of course, Arden then made the provably inaccurate claim that those who were vaccinated would net get sick and would not die.
The ridiculous over-confidence in the proclamations of public health authorities led to Arden convincing New Zealanders that strict mandates and interventions could stop the spread of the virus.
As winter and new variants arrived in 2021, Arden and local leaders predictably enforced increasingly strict measures. Mask mandates, lockdowns and “red traffic light” policies include vaccine passports.
Surprise. None of it worked.
After several months of completely unchecked spread, even the country’s cumulative metrics, once seemingly so impressive, exploded in dramatic fashion.
Consistently and exceptionally high mask wearing rates were also entirely ineffective.
And yet defenders of New Zealand’s authoritarian policies still believed that the country’s strategy was warranted, for one specific reason.
They had delayed the spread of the virus until the COVID vaccines became widely available.
In theory, that was supposed to prevent a substantial increase in deaths, especially considering their extraordinary rate of uptake.
That didn’t work either.
While these rates were generally lower after adjusting for population than many other countries, they still represented an obvious, significant surge compared to previous time periods.
But COVID related deaths only tell a part of the story, often influenced by attribution methodology and testing.
In theory, New Zealand’s exceptional vaccination rate and consistently high mask compliance should have meant that all cause mortality would also remain low.
So did it?
Fortunately, thanks to the New Zealand government’s own data, we now have an answer. And just as the country’s failure to stop omicron, it presents another contradiction to the endless media praise.
Despite the exceptionally high vaccination rate, despite their exceptionally high booster rate, despite vaccine passports, strict lockdowns, “red traffic light” policies and border controls, the pandemic came for New Zealand as well.
The government’s own data shows that all cause deaths in New Zealand jumped significantly in 2022, to the highest level in recorded data.
The country universally praised for their dedication to following The Science™, whose leadership told the public that following her dictates would keep them safe, stop the spread and control outcomes, has seen a record level of all cause mortality.
Exactly the same as other countries who were criticized for their supposedly less effective response.
Even after adjusting for population, the scale of the surge in 2022 is exceptional.
In fact, it represents an over 17% increase from 2020.
Not to mention that the one year increase, over 10%, represented the largest single year increase in New Zealand since the 1918 flu.
So why didn’t their policies prevent this? Why didn’t waiting for widespread vaccination to open up prevent this?
The New Zealand government themselves blame COVID for at least a portion of the increase. So why were so many people dying of COVID given the country’s exceptional vaccination and booster uptake and masking?
After all, ~95% of the population over 12 had been fully vaccinated by the middle of 2022, with over 90% fully vaccinated by early 2022. Similarly, adult booster rates were nearly 80% by early in 2022.
Why didn’t it work?!
Some may try to claim that their results would have been worse had they not had such policies.
But countries like Sweden thoroughly debunk that theory. Sweden had one of the least restrictive responses anywhere on earth, yet their results were among the best in their region.
Even throughout 2022, excess deaths remained low.
So why did New Zealand fail?
Compared to other countries, New Zealand’s cumulative COVID mortality rate still remains low. But the all cause mortality tells a different story.
Their strict policies and delayed opening were supposed to prevent this exact situation from occurring. All because the government put their faith in experts.
The experts mistakenly believed that vaccinations would prevent virtually all deaths, as Jacinda “we are your sole source of truth” Arden explained.
Obviously that was not the case.
It’s not clear what percentage of the excess mortality rate came from vaccinated people. But even more importantly, the majority of the increase was entirely unrelated to COVID.
Nearly 6,000 more people died in 2022 than did in 2020, despite a relatively small population increase. Yet the government says just 2,400 were associated with COVID.
So what caused the other 3,600 unexpected deaths?
In raw numbers, nearly 7,500 more people died in 2022 than in 2016. Accounting for population increases, that meant virtually 100 more people per 100,000 died in 2022 than in 2016.
What happened?
Whatever it was, it’s almost certainly related to New Zealand’s mistaken assumptions. Ancillary lockdown-related causes, missed health screenings, side effects — any or all of it could have contributed to the dramatic increase.
And all of it was because the government mistakenly proclaimed that they could control COVID. Instead, they delayed the inevitable.
Governments have many lessons to learn from the pandemic, but the first should be to never, ever, put blind faith in “experts.”
All too often they’re flying blind themselves.
BY CHRIS MORRISON | THE DAILY SCEPTIC | APRIL 5, 2023
The BBC recently ran a story claiming that the Antarctic ocean currents were heading for collapse, and to drive home the scare there was even a reference to the 2004 climate disaster film, The Day After Tomorrow. Rapidly melting Antarctic ice was reported to be causing a dramatic slowdown in deep ocean currents, “and could have a disastrous effect on the climate”. Like most of these fanciful scare stories, “could” is doing a lot of the heavy lifting work. But alas, missing from this Net Zero-promoting, model-inventing Armageddon tall tale was a note that the Antarctica ice cap appears to be in balance, and is not actually melting.
According to a paper written by NASA satellite ice-mapping scientists in 2021, Antarctica is “close to balance” in the period 2012-16 at -12 +/- 64 Gt a-1. Gt are gigatonnes and the formula is a scientific way of saying that as near as damn it, well within a margin of error, the Antarctica ice sheet loss is, more or less, zero. Back to 1992, the scientists found large total gains for the sheet.
According to the story in the BBC, reported faithfully in numerous media, as fresh water from the ice cap melts, sea water becomes less salty and dense and a downwards movement of water towards the sea bottom is interrupted. This in turn can affect world oceanic currents. The activist science blog the Conversation reported that “torrents of Antarctic meltwater are slowing the currents that drive our vital ocean ‘overturning’ – and threaten its collapse”. The BBC noted that a similar collapse in the North Atlantic was depicted in The Day After Tomorrow.
As regular readers will recall, the Daily Sceptic has observed that Antarctica is a difficult neighbourhood for activists to get a good scare story going. Over the last seven decades, there has been little or no warming over large parts of the continent. According to a recent paper, (Singh and Polvani), the Antarctica sea ice has “modestly expanded”, and warming has been “nearly non-existent” over much of the ice sheet. According to NASA figures, the ice loss is 0.0005% per year.
The latest scare arises from a paper published in Nature. It is the product of climate models – the BBC noting that the scientists spent 35 million computer hours over two years collecting their results. However, this story is also of considerable interest since it shows that the BBC and most mainstream media are seemingly incapable of questioning any statement that promotes human-caused climate change and the proposed command-and-control Net Zero political solution. This endemic lack of curiosity means that vast areas of science, including atmospheric physics and chemistry, together with weather, geology and geography, are simply off limits in case any doubt should be cast on the suggestion that humans control the CO2 climate thermostat.
The study lead author, Professor Matthew England from Sydney’s University of New South Wales, is able to state, without any inquiring question or contradiction, that “our modelling shows that if global carbon emissions continue at the current rate, then the Antarctica overturning will slow by more than 40% in the next 30 years”. The BBC repeats emissions continuing at the current rate, but England’s paper states that his model has been loaded with a “high emissions” scenario. The paper is behind a paywall, but the abstract in which this admission occurs is freely available.
These “high emission” scenarios are almost certainly RCP8.5 and SSP5-8.5 that forecast global rises in temperatures of 4-5°C within less than 80 years. As Dr. Judith Curry has recently pointed out, these have been dropped in many science circles on the grounds they are recognised as implausible. Global warming of barely 0.1°C over the last 20 years is almost certainly a factor in this reassessment. Nevertheless, Curry notes that many of the extreme events based on the scenarios are still quoted in IPCC documents. “Rejecting these extreme scenarios has rendered obsolete much of the climate literature and assessments of the last decade,” she states.
Not at the BBC, of course. Settled science – the Science – cannot move on because it suffers from the anti-science proposition that it is somehow settled. Model results suggest deep water circulation in the Antarctic could slow at twice the rate of decline in the North Atlantic, reports the BBC. “It’s stunning to see that happen so quickly,” said climatologist Alan Mix from Oregon State University, a co-author of the latest Intergovernmental Panel on Climate Change (IPCC) assessment. “It appears to be kicking into gear right now. That’s headline news,” he told Reuters. No, Dr. Mix, it’s a model based on assumptions that are regularly contradicted by the data. Some climatologists it appears have trouble distinguishing fact from their own fevered predictions.
Chris Morrison is the Daily Sceptic’s Environment Editor.
By P Gosselin | No Tricks Zone | April 4, 2023
Dark times for political opponents, skeptics of dubious science.
Governments weaponizing the justice authorities to go after political opponents and protest movement leaders seems to have become vogue nowadays in the once democratic western hemisphere.
Victims of the tactic often face dubious charges, some even having to spend months in detention as authorities drag their feet carrying out the “legal” process.
For example, in Germany a number of physicians have been charged and even jailed for allegedly issuing “false mask exemptions” or “false vaccination exemption” certificates to patients who fear the experimental, shoddily launched COVID vaccine. Critics accuse the authorities of using these heavy handed tactics to intimidate legitimate political opponents into silence.
Ballweg released after 9 months of detention
One high profile example in Germany is Michael Ballweg, the founder of the Corona restrictions protest movement dubbed “Querdenken” (unorthodox thinking). Today we know that the “querdenkers” were right about a lot of things, and huge amounts of damage could have been avoided had their warnings been taken seriously.
But instead, the government and media got paranoid and scared of the Ballweg’s protest movement. The media characterized the movement as fringe right wingers who threatened “our democracy”. Last June, Ballweg was arrested and dragged to jail on dubious charges.
Today, after more than 9 months detention, he was finally allowed to leave Stuttgart-Stammheim prison. The Stuttgart Higher Regional Court on Tuesday lifted the arrest warrant in exchange for a condition.
Ballweg had been in pre-trial detention since June 2022 on suspicion of money laundering and fraud. Suspicion is all that’s needed nowadays to arrest unwanted voices.
AUF 1 reports:
Previously, several appeals against Ballweg’s pre-trial detention had come to nothing. As part of the nine-month trial, he can now leave prison. The reason for the revocation of the arrest warrant was proportionality. The expected punishment in case of a conviction was too small to justify a longer pre-trial detention.
Ballweg’s lawyer Dr. Alexander Christ commented on the decision: “I am happy for my client!”
Allegations reduced, allegations dropped
Last week, the allegations were significantly reduced: for example, parts of the money laundering allegations against Ballweg were dropped. Most recently, Ballweg had only been accused of attempted fraud. The prosecution worked with the daring legal construct of an “unsuccessful attempt”. Nobody had ever been harmed by Ballweg.
Lawyer Dr. Alexander Christ from Ballweg’s legal team appeared in an interview with Austria’s AUF1 last week and reported numerous inconsistencies in the 120-page indictment. For example, money laundering allegations that had already been dropped resurfaced in the indictment. “A tale,” summarized Dr. Christ.”
The release of Ballweg is certainly good news. But leading a protest and speaking up against the government still remains dangerously risky today.
Twin Epidemics of Concordant Neuropsychiatric Disease
By Peter A. McCullough, MD, MPH | Courageous Discourse | April 3, 2023
The CDC indicates that 1 in 36 children has been identified with autism spectrum disorder (ASD) according to estimates from CDC’s Autism and Developmental Disabilities Monitoring (ADDM) Network. This represents a sharp increase up from 1 in 10,000 in 1970. There has also been a less well delineated rise in gender dysphoria (GD) which is driving the clinical development of transgender medicine.
A natural question is: could ASD and GD be linked? While the epidemiology of both conditions is not well developed, several papers have reviewed the available evidence and have found a link. Van Der Miesen et al, in a narrative review concluded that about 20% of GD patients indeed have ASD.
When large, well performed epidemiological studies are completed it would not be a surprise if ASD is found to be an independent risk factor for GD. More complex analyses will be needed to understand if both conditions, which co-exist, have common pathophysiological determinants.
So the next time there is a news story on transgender rights, surgical advancement, hormone therapy, and psychological outcomes, keep in mind that autism is likely playing a role in the interpretation of what is portrayed to the public.
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.
Saying “Climate change is mostly natural,” could be a criminal offence, if Swiss politician Valentine Python gets her way.
By P Gosselin | No Tricks Zone | April 2, 2023
Climate change for some has turned into a real doomsday cult, where a small group of people has excessive control over its members and require unwavering devotion. The climate cult members are in fact so brainwashed that they are convinced it’s the Gospel Truth and that disagreement is heresy of dangerous criminals. So it’s not surprising some climate cult members are calling for a Catholic Church model Climate Inquisition to root out and punish the heresy.
Marcel Odermatt of Switzerland’s online WELTWOCHE reports on how one Swiss Green politician wants to make “climate-sceptic statements”, i.e. free speech, a criminal offence.
Green National Councillor Valentine Python, 47, is calling for “climate denial” to be declared a crime.
Ms. Python believes statements casting doubt on man’s dominance over the global climate hinders efforts to educate children on the dangers of climate change, and so obstruct adopting “effective measures”.
28% of youth ignoring climate alarm
Germany’s Pleiteticker elaborates on why Ms. Python is all agitated about people having other opinions and cites a recent French study that found 28 percent of young people consider climate change to be a natural phenomenon against which no special measures are necessary.
Based on such results, Ms. Python claims there’s been a “decline in the scientific understanding of the world” and that the state needs to take action against “climate-skeptical statements”.
“She compares these [statements] to calls for anti-Semitism and racism. Such calls could lead to violence and would violate human rights. The National Councillor believes that the ‘unrestricted dissemination of climate-sceptic views’ could fall under the same law”, reports Pleiteticker. “Python seems to consider herself in possession of an immutable scientific truth. Apparently, Python is not interested in convincing dissenters, but in banning their thoughts and imposing penalties on them.”
Brenda Baletti, Ph.D. | The Defender | March 31, 2023
The National Academies of Science, Engineering, and Medicine (NASEM) met for three days — behind closed doors, except for a two-hour public comment period — to review the epidemiological, clinical and biological evidence on adverse events associated with COVID-19 vaccines.
The committee will generate a report that will be used to add injuries to the federal vaccine injury table, which lists known adverse events associated with existing vaccines.
This list helps the National Vaccine Injury Compensation Program (VICP) and Countermeasures Injury Compensation Program (CICP) — both part of the Health Resources and Services Administration (HRSA) — to decide whether to compensate vaccine injury claims.
Historically, NASEM meetings have been open to the public — but this year’s meetings were closed, except for the two hours of public comment required by federal law.
NASEM livestreamed the public comment period, during which each speaker was limited to three minutes of comments.
Brian Hooker, Ph.D., P.E., chief scientific officer for Children’s Health Defense was among those who delivered comments.
Hooker told the committee:
“I have little hope that this National Academies committee of experts will do anything but simply rubber stamp the safety of the COVID-19 vaccines that were recommended and even mandated to the population of the United States.”
The committee is meant to be a neutral external body, but the review is done at the request of the U.S. Department of Health and Human Services (HHS) and partially funded by the Centers for Disease Control and Prevention (CDC).
Hooker said:
“This is the same CDC that discovered as early as February 19, 2021, that mRNA vaccines were causing myocarditis in adolescent and young males, just 10 weeks after the rollout of the first vaccines.
“However, CDC immunization safety officials, including director Dr. Tom Shimabukuro, hid this information until they made the tacit assertion over three months later on May 27, 2021, that there might be a connection between vaccines and myocarditis.
“While CDC officials lied about this adverse event, the U.S. vaccination rate climbed from 8% to over 50% — increasing profit to the vaccine manufacturers who have fully captured this agency.”
Vaccine injury lawyer Aaron Siri told the committee that in his experience helping clients to file claims, past NASEM reports were “incredibly consequential.”
“They are documents that are going to be used by the federal government to fulfill their duty … to fight against any claim of compensation,” Siri said, adding:
“Your task, as I understand it, is to review the medical literature. But understand that pharmaceutical companies don’t have an interest in conducting the studies and neither do our federal health agencies.”
He said the experts he has deposed use the absence of evidence in these reports for any given side effect as evidence the side effect doesn’t exist. They then deny people’s injury claims on that basis.
Siri implored the committee to take seriously the testimonies offered by vaccine-injured people in the public comments when considering what to include in the report.
The committee is led by Kathleen Stratton, Ph.D., who was involved with the 2004 Institute of Medicine report cited as “proof” that vaccines don’t cause autism when there were 5,000 cases pending with the VICP.
Leaked documents showed that Stratton coordinated with the CDC to deny any links between vaccines and autism.
Reed Grimes, M.D., Ph.D., director of the division of injury compensation at the HRSA, and Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, gave presentations at the committee’s first meeting, which was held in January and posted online.
The committee is also reviewing the literature on the administration of vaccines and shoulder injuries. Its findings are expected in March 2024.
Vaccine Injury Compensation Program ‘would be unrecognizable’ to its founders
The more than 30 people who made public comments included vaccine-injured people, physicians, attorneys, researchers working to identify vaccine injuries and treatments, and members of the React19 advocacy group, which has compiled 3,400 peer-reviewed studies listing COVID-19 vaccine adverse events.
Speakers shared extensive personal, scientific and legal evidence of adverse events associated with the COVID-19 vaccines.
Vaccine-injured speakers included Brianne Dressen, who received a dose of AstraZeneca’s vaccine as a volunteer in a clinical trial. Her debilitating side effects, including POTS, tinnitus and other symptoms were not included in the AstraZeneca clinical trial report, even despite the fact they were recognized by the National Institutes of Health (NIH).
Dressen told the committee she remained “perplexed” by the scientific process and said, “I ask for you to please take an honest and unbiased look at the literature that exists. Please do your part and make sure that these people that are suffering are not discarded, that we are not erased and we are not dismissed.”
Dr. Joseph Fraiman, the lead author of a peer-reviewed study on serious mRNA vaccine side effects, spoke to share the results of his research with the committee, emphasizing that there was “no question” that serious adverse events were associated with the mRNA vaccines.
The many speakers drawing attention to severe side effects linked to the vaccines included Dr. Peter McCullough, who drew the committee’s attention to the fact that “Pfizer reported 1,223 deaths that occurred in their 90-day mandatory part post-marketing data.”
He reminded the committee that the U.S. Food and Drug Administration (FDA) attempted to block the release of Pfizer’s clinical trial data, and that research ongoing at multiple U.S. universities indicates hundreds of thousands of deaths are associated with the vaccine.
McCullough said:
“I conclude that the National Academies should join in support for full withdrawal of COVID-19 vaccines from current use in the United States, and they begin a fair evaluation and compensation for the large number of individuals who have suffered vaccine injuries, disabilities, and deaths.”
Dr. Meryl Nass, internist and biological warfare epidemiologist, said the committee must bear in mind the FDA’s Benefit-Risk Assessment and drug regulatory decision-making, which, she said, “states for a drug to be approved for marketing FDA must determine that the drug is effective and that its expected benefits outweigh its potential risks to patients.”
She presented data — noting the committee did not allow any commenters to share slides they had prepared for the committee — showing how quickly efficacy wanes for any of the vaccines.
Albert Benavides, who runs the Vaersaware.com website told the committee that miscoding or undercoding and delayed publication in the Vaccine Adverse Event Reporting System (VAERS) has hidden thousands of serious adverse events.
Several speakers commented on the way these reports are misused by the VICP and the CICP.
Professor Renee Gentry, director of the Vaccine Injury Litigation Clinic at The George Washington University Law School, told the committee that over the last ten years, she witnessed, “the aggressive delegitimization of all non-table vaccine injuries by HHS.”
She said the HHS has aggressively fought against any claims regarding injuries not on the list, despite the fact that vaccine people are legally permitted to make claims for injuries whether they are on the list or not.
She said:
“The hard line drawn by HHS in contesting these cases, I believe, contravenes congressional intent as well as the intent of this committee and pushed the vaccine court further into the protracted litigation of the civil arena that Congress hopes to avoid.”
She explained that the stakeholders that created the VICP — vaccine manufacturers, lawyers and parents — set it up to be petitioner-friendly, informal, generous and non-adversarial, adding:
“The congressional record at the time recorded Congress’ admonition that it was better to compensate someone who was not injured by the vaccine than to fail to compensate someone who was …
“I believe the VICP as it exists today would be unrecognizable to those original stakeholders. In some circumstances, HHS’ unrelenting opposition to vaccine injuries using epidemiology discussed by this committee has resulted in the elimination of entire categories of injuries …
“In order to guarantee a strong and successful universal immunization program, you must have a vibrant safety net for those rare individuals who are injured. A compensation program must be a reasonable and meaningful alternative to civil litigation or it has failed.”
How does vaccine injury compensation work?
The PREP Act protects vaccine makers from liability for injuries or deaths associated with Emergency Use Authorization vaccines, but 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 COVID-19 vaccine was added to the schedule earlier this year.
People injured by vaccines listed on the childhood schedule can seek compensation through the taxpayer-funded VICP, a no-fault alternative to the traditional legal system for resolving vaccine injury claims.
However, the revisions voted on by the ACIP committee last year explicitly state (slide 24) that the COVID-19 vaccines are not covered under the VICP.
Instead, the COVID-19 vaccines added to the childhood schedule will remain covered by the CICP.
As of Jan. 1, 2023, since the CICP was established in 2010, 11,596 claims have been filed (95% COVID-19-related).
Only 19 claims related to COVID-19 filed with the CICP have been found eligible for compensation, though no compensation has yet been paid.
10,604 claims are still under review.
During the first NASEM meeting, Dr. Chandy John, professor of pediatrics at Indiana University School of Medicine, asked HRSA’s Grimes when the COVID-19 vaccines that are fully approved by the FDA would move from coverage under CICP to VICP, saying many concerned parents were asking this question of their infectious disease group.
Grimes gave no timeline. Instead, he simply listed the steps in the process.
He said to move to CICP coverage, a vaccine needs to be recommended for routine administration for children and pregnant women, it needs to have an excise tax imposed upon it through the legislature, and there needs to be a notice of coverage published in the federal record.
“So once those things all happen that is when the CICP would cover the COVID-19 vaccines, if those three things were all to happen.”
Brenda Baletti Ph.D. is a reporter for . 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.
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By Mahdi Darius NAZEMROAYA | Strategic Culture Foundation | 30.03.2015
The United States and the Kingdom of Saudi Arabia became very uneasy when the Yemenese or Yemenite movement of the Houthi or Ansarallah (meaning the supporters of God in Arabic) gained control of Yemen’s capital, Sanaa/Sana, in September 2014. The US-supported Yemenite President Abd-Rabbuh Manṣour Al-Hadi was humiliatingly forced to share power with the Houthis and the coalition of northern Yemenese tribes that had helped them enter Sana. Al-Hadi declared that negotiations for a Yemeni national unity government would take place and his allies the US and Saudi Arabia tried to use a new national dialogue and mediated talks to co-opt and pacify the Houthis.
The truth has been turned on its head about the war in Yemen. The war and ousting of President Abd-Rabbuh Manṣour Al-Hadi in Yemen are not the results of «Houthi coup» in Yemen. It is the opposite. Al-Hadi was ousted, because with Saudi and US support he tried to backtrack on the power sharing agreements he had made and return Yemen to authoritarian rule. The ousting of President Al-Hadi by the Houthis and their political allies was an unexpected reaction to the takeover Al-Hadi was planning with Washington and the House of Saudi. … continue
Aletho News If Americans Knew No Tricks Zone
Aletho News 