One and two doses of the COVID-19 vaccines were linked to an increase in all-cause mortality in a new peer-reviewed study that analyzed data from the Italian National Healthcare System.

Based on their analysis, a team of Italian researchers verified what they called “the real impact of the vaccination campaign” by comparing the risk of all-cause death among vaccinated and unvaccinated residents of the Italian province of Pescara.

In their multivariate analysis, the researchers found the risk of all-cause death to be higher for those vaccinated with one or two doses of the COVID-19 vaccine compared to the unvaccinated.

Those who received three or four doses had roughly the same risk of all-cause death as the unvaccinated, they said, in contrast with prior research done in the same region suggesting those with three or four doses had a lower risk of all-cause death.

“We also found a slight but statistically significant loss of life expectancy for those vaccinated with 2 or 3/4 doses,” they said in the report, which they published June 30 in Microorganisms.

Dr. Peter McCullough told The Defender, “These findings call for an immediate halt of COVID-19 vaccination across the globe and a thorough investigation of what went wrong during the COVID-19 vaccine campaign.”

McCullough wrote on Substack that the paper’s main point is that “COVID-19 vaccination did not ‘save lives’ as so many in Washington have proclaimed without evidence.”

Alberto Donzelli, one of the Italian study’s authors, told The Defender the study is “an important advance” because it looks at all-cause mortality broken down by vaccination status, and accounts for confounding variables that may have affected earlier reports on COVID-19 vaccination and all-cause mortality.

Very few studies in the world have successfully done that, he said.

McCullough also told The Defender the study’s findings are “cohesive” with those of a recent German study — currently available as a preprint — which found COVID-19 vaccination was linked to increased all-cause death in 16 German states.

Researchers undertake study to correct for bias

For their study, Donzelli and his co-authors used the same data analyzed by other researchers in an earlier Italian study on COVID-19 vaccine effectiveness.

The earlier study — which followed up with people two years after the start of the COVID-19 vaccination campaign — found that those who received one or two doses had a significantly higher risk of all-cause death, while those who received three or more vaccine doses had a lower risk of death.

However, these results were likely distorted due to “immortal time bias,” Donzelli and his co-authors said.

Immortal time bias is a common study design flaw that can throw off statistical estimations between an exposure (such as a COVID-19 shot) and an outcome (such as an increased risk of death), according to the University of Oxford’s Catalogue of Bias.

Donzelli said the bias “afflicts most observational studies on mortality from COVID-19.” So he and his co-authors took the necessary steps to correct for the bias and reanalyzed the same data.

They looked at vaccination records from Jan. 1, 2021, through Dec. 31, 2022, for people ages 10 and up.

They also looked at follow-up data collected from Jan. 1, 2021, through Feb. 15, 2023, for these people, as long as they hadn’t tested positive for COVID-19 on the date of the follow-up.

They also looked at other variables, such as pathologies other than COVID-19, that may have affected people’s health.

“The results are startling,” wrote McCullough, after doing calculations using the report’s data. “COVID-19 specific deaths were not reduced with vaccination, however there was a U-shaped trend of note when COVID-19 deaths were adjusted per 1000 population: unvaccinated 1.98/1000, one dose 0.27/1000, two doses 1.08/1000, and 3/4 doses 3.5/1000.”

Additionally, Donzelli and his co-authors in their multivariate analysis found that those who received one dose of the COVID-19 vaccine had a hazard risk ratio — which is a statistical estimate of risk — of 2.4 for all-cause mortality, meaning they were much more likely to die compared to the unvaccinated.

“Those vaccinated with two doses showed an almost double hazard ratio of death: 1.98,” Donzelli pointed out.

These numbers are significantly worse than what was reported in the original study that hadn’t corrected for the immortal time bias, he said. Correcting for that bias changed the results for those who were vaccinated with three or more doses, too.

The original study authors had claimed that being vaccinated three or more times reduced the risk of mortality more than four-fold. Based on his and his co-authors corrected analysis, Donzelli called the claim “implausible.”

He said, “Those vaccinated with three or more doses turned out to die at the same rate as the unvaccinated.”

CDC: COVID shots ‘save lives’

Drug manufacturer Merck misrepresented the efficacy of its mumps vaccine for years, “overfilling” the vaccine with live mumps virus to meet efficacy targets despite the lack of safety testing — and the practice may be continuing today.

Merck appears to have concealed the practice from public health agencies, which have taken no action to stop it.

Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, joined “The Defender In-Depth” this week to discuss the revelations, which stem from a lawsuit two Merck whistleblowers filed in 2010 under the False Claims Act.

The 3rd Circuit U.S. Court of Appeals in Philadelphia heard oral arguments in the case on July 9.

According to Hooker, the Merck measles, mumps rubella vaccine, MMR II — the only mumps vaccine licensed in the U.S. and listed on the childhood vaccine schedule for 12- to 18-month-olds — may contain up to 4 times the approved concentration of live mumps virus.

A two-part deposition by Dr. David Kessler, former head of the U.S. Food and Drug Administration (FDA), also indicates that Merck, rather than informing regulators that it was “overfilling” its MMR vaccine, relied on passive surveillance — reports from parents regarding vaccine reactions in their children — to identify possible safety signals.

‘We do not know how this is going to affect the body’

In this week’s interview, Hooker emphasized that vaccine dosages with a higher concentration of live mumps virus were never tested for safety or efficacy.

“What is in the Merck MMR II vaccine is not what is being reported,” Hooker said. “This is a live virus vaccine, and these viruses are at higher concentrations. and we know, as far as the mumps vaccine, that the concentrations that are in the vials have never been tested for safety.”

Hooker explained that guidelines for the amount of live virus in the MMR II vaccine were last changed in 1999, “as a result of an FDA action that showed that the mumps portion of the vaccine was losing potency over its sort of two-year [shelf life] before the vaccine expired.”

This prompted Merck to “change the mumps concentration of the vaccine,” Hooker said. However, Merck did so without informing health regulators or the public, gaining regulatory approval or performing safety tests.

“The mumps portion of the vaccine lost its potency to an ineffective and an unacceptable endpoint, and the FDA notified Merck of this in 1998,” Hooker said. “In order to compensate for this, Merck merely did something that is called ‘overfill’ to the virus, overfilled the vials to a higher starting level.”

“They started out with …100,000 TCID50,” Hooker said — referring to the measure of the number of viral particles in a vaccine. “They changed that to 160,000 active virus particles in 1999.”

Hooker added:

“What that means from a production standpoint is that the exact middle concentration of virus is 160,000. The vials can deviate as much as four times over that, and they can be as high as 600,000 viral particles, or they can be as low as 100,000 viral particles.”

This poses a public health risk, Hooker said, because concentrations higher than 160,000 viral particles are “far beyond anything that has ever been tested for safety.”

“Safety testing has only been done to that lower limit of 160,000,” Hooker said. “In order to achieve immunity, according to the FDA, you only need 20,000 … virus particles. So, looking at that, Merck is overfilling the vaccine, and it can be as high as 30 times what is required.”

Hooker said:

“More virus particles mean more problems. It means that you can have a cytokine storm. It means that you can have autoimmune reactions, and this has never ever been tested for safety.

“That’s a serious safety problem because we do not know what will happen without a maximum. There is no cap.”

Cytokine storm refers to “life-threatening systemic inflammatory syndromes involving elevated levels of circulating cytokines and immune-cell hyperactivation,” according to The New England Journal of Medicine. Hooker said this can lead to cellular damage and autoimmune disorders.

Hooker noted that higher concentrations of virus do not just mean a higher level of live virus, but also a higher concentration of “dead virus, RNA particles within the vaccine,” which can also lead to adverse reactions.

Referring to Kessler’s deposition, Hooker said it “came to the conclusion that Merck concealed this information [and that] the packet insert was incorrect. It was nebulous and it did not reflect the higher concentration,” Hooker said. “He basically said Merck is deceiving the public.”

Kessler also testified that this practice continued at least until 2018. Hooker said, “Nothing has changed since 2018 that we know of … If Merck has done anything to change the formulation of the vaccine, it has not told the public, it has not told the FDA.”

This means the practice of “overfilling” might still continue today.

“We’re in no-man’s land,” Hooker said. “We do not know how this is going to affect the body because this has never been tested at this concentration. This was a brand experiment that they foisted on the public of the United States.”

Merck ‘defrauded’ the government and the public

Hooker said the revelations stemming from the whistleblower lawsuit show the FDA was initially unaware that Merck was “overfilling” the MMR II vaccine — calling into question the agency’s capability to perform oversight.

“The only way the FDA found out was when these court documents actually surfaced, because the only thing Merck directly told the FDA was the concentration of mumps virus [was] 160,000 virus particles,” Hooker said. “So, FDA had no idea that they’re going even higher.”

The lawsuit was filed under the False Claims Act — under which whistleblowers can be rewarded for disclosing fraud that results in a financial loss to the federal government.

It’s the same law under which a lawsuit alleging safety deficiencies during clinical trials for the Pfizer-BioNTech COVID-19 vaccine was filed.

The two whistleblowers in the Merck case — Stephen Krahling and Joan Wlochowski, virologists who worked for Merck in the early 2000s — have since become the subject of a recently released film, “Protocol 7,” which chronicles their claims.

According to Hooker, the revelations may lead to further legal implications for the company and may call into question the liability shield it enjoys for its MMR II vaccine.

“Merck not only defrauded the government … Merck defrauded the public,” Hooker said. “From my contention, that would be a very, very good legal argument to opt out of the National Vaccine Injury Compensation Program [because] it is a no-fault program, and it assumes that the vaccine manufacturers acted in good faith.”

Hooker said this “really means that this could be taken to court by … individual petitioners” because Merck was “duplicitous and they have not been forthcoming with the exact concentrations that are in those vials.”

“This is fraud, pure and simple,” Hooker said.

Merck ‘not an entity that we should trust to put things into our bodies’

According to Hooker, the allegations against Merck are indicative of broader corruption among public health agencies and pharmaceutical companies — including a “revolving door” between the two.

Hooker said Merck “is the company that brought us Vioxx, that basically knew that this was going to cause cardiac damage … in individuals that took Vioxx.”

Merck also faces hundreds of lawsuits relating to injuries and deaths connected to Gardasil, its human papillomavirus (HPV) vaccine.

“The first version of Gardasil … that came out in 2007 was then very quickly put on the CDC [Centers for Disease Control and Prevention] schedule,” Hooker said. “And then the CDC director [Dr. Julie Gerberding] … left the CDC in 2008 and started as the president of Merck’s vaccine manufacturing division … in 2009.”

“There’s a revolving door there, and I think that if we really were able to open the coffers in terms of the relationship with Merck and Gerberding while she was at the CDC, we would show that they did quite a few favors,” Hooker added.

“When you look at chief officials at the FDA, in the CDC and in the HHS [U.S. Department of Health and Human Services] … there’s so many conflicts of interest — and the conflicts of interest run not only at the top level, but they get down into the woodwork of the individual workers and scientists,” Hooker said.

Noting that Merck has had an “exclusive license” to distribute MMR vaccines in the U.S. “for many, many years,” Hooker said that this is likely why the company sought to quietly change the concentration of live mumps virus in its vaccine, “even if it meant fudging the books,” to maintain its market exclusivity.

“When you look at Vioxx, when you look at HPV, when you look at the … MMR II vaccine, this is not an entity that we should trust to put things into our bodies,” Hooker said, referring to Merck, adding that agencies like the FDA “are not trustworthy.”

“They are driven very, very much by financial gain directly through incentivization, through the pharmaceutical industry,” Hooker said.

Watch ‘The Defender In-Depth’ here:

https://boxcast.tv/view-embed/new-details-reveal-merck-fraud-tgajtxnhfkwpq939i2o2

Listen to the podcast on Spotify.

‘The Defender In-Depth’ airs on CHD.TV Wednesday at 10 a.m. ET/9 a.m. CT.

The Defender asked the Centers for Disease Control and Prevention (CDC) if it planned to modify its statement that “COVID-19 vaccines save lives” in light of the study’s findings.

A CDC spokesperson told The Defender that the CDC “does not comment on findings or claims by individuals or organizations outside of CDC.” The spokesperson declined to provide studies or data supporting the agency’s claim that the vaccines save lives.

“CDC research has continuously found that COVID-19 vaccines are safe and effective,” the spokesperson said.

Autopsies Link 73.9% of Post-Jab Deaths to the Shot

Analysis by Dr. Joseph Mercola

July 05, 2024

How to Stay Calm Among Chaos

Pros and Cons of Wearing a Weighted Vest During Walks

https://articles.mercola.com/themes/blogs/mercola/VideoPanel.aspx?PostID=1386614&v=20240705&CacheVideo=1

STORY AT-A-GLANCE

A peer-reviewed study in Forensic Science International found that 73.9% of post-COVID-19 vaccination deaths were directly caused by or significantly contributed to by the injections
The study, initially censored by The Lancet, analyzed 325 autopsy cases and found cardiovascular issues were the most common cause of death, followed by blood and respiratory problems
Researchers suggest the spike protein in COVID-19 vaccines may be responsible for side effects, potentially causing inflammation and clotting in various tissues and organs
Another study in South Korea found increased incidences of mild cognitive impairment and Alzheimer’s disease within three months of COVID-19 vaccination, particularly with mRNA vaccines
The article mentions censorship of research critical of COVID-19 vaccines and suggests seeking help from organizations like FLCCC for those experiencing post-vaccination injuries

A bombshell study that The Lancet¹ pulled within 24 hours is finally seeing the light of day. Now published in the peer-reviewed Forensic Science International journal, the systematic review of autopsy findings in deaths after COVID-19 shots revealed 73.9% “were directly due to or significantly contributed to” by the injections.² Canadian oncologist and cancer researcher Dr. William Makis posted on X:³

“This is a victory of SCIENCE over CENSORSHIP!! Incredible perseverance by first author Nicolas Hulscher who didn’t give up after LANCET pulled our paper within 24 hours after 100,000s of downloads for no legitimate reason. Big pharma put the squeeze on @TheLancet but has failed to stop us.

Our paper was delayed by one year, and those actions of CENSORSHIP and CANCELLATION led to many deaths that could have been prevented. This paper could be a game changer.”

High Likelihood of ‘Causal Link’ Between COVID-19 Shots and Death

Researchers including Makis, cardiologist, internist and epidemiologist Dr. Peter McCullough and Nicolas Hulscher, an epidemiologist with the University of Michigan School of Public Health, searched for all published autopsy and necropsy reports relating to COVID-19 shots through May 18, 2023.

Their systematic review included 44 papers with 325 autopsy cases and one necropsy case, which is an autopsy performed on an animal. The average age of the people in these reports was 70.4 years. Most often, the cardiovascular system was involved in the death, followed by hematological issues, or blood problems, and respiratory issues. In 21 of the cases, three or more organ systems were involved.

The mean time from vaccination to death was 14.3 days, but most deaths occurred within a week of the last shot. Three doctors who are experts in figuring out causes of death and studying diseases looked at each case separately.

They carefully examined all the information available for each person who died and concluded that in 73.9% of the cases, COVID-19 shots either directly caused or played a significant role in the person’s death. Among them, the primary causes of death were:⁴

Sudden cardiac death (35%)	Pulmonary embolism (12.5%)
Myocardial infarction (12%)	Vaccine-induced immune thrombotic thrombocytopenia (VITT) (7.9%)
Myocarditis (7.1%)	Multisystem inflammatory syndrome (4.6%)
Cerebral hemorrhage (3.8%)

“The consistency seen among cases in this review with known COVID-19 vaccine mechanisms of injury and death, coupled with autopsy confirmation by physician adjudication, suggests there is a high likelihood of a causal link between COVID-19 vaccines and death,” the researchers concluded.⁵

What Was The Lancet Trying to Hide? ‘Lots and Lots of Vaccine Deaths’

In the video above from The Jimmy Dore Show, they discuss why The Lancet almost immediately pulled the concerning study.⁶ The journal stated, “This preprint has been removed by Preprints with The Lancet because the study’s conclusions are not supported by the study methodology. Preprints with The Lancet reserves the right to remove a paper that has been posted if we determine that it has violated our screening criteria.”⁷ As noted by The Daily Sceptic on July 6, 2023:⁸

“Without further detail from the Preprints with the Lancet staff who removed the paper it is hard to know what substance the claim that the conclusions are not supported by the methodology really has. A number of the authors of the paper are at the top of their fields so it is hard to imagine that the methodology of their review was really so poor that it warranted removal at initial screening rather than being subject to full critical appraisal.

It smacks instead of raw censorship of a paper that failed to toe the official line. Keep in mind that the CDC has not yet acknowledged a single death being caused by the COVID mRNA vaccines. Autopsy evidence demonstrating otherwise is clearly not what the U.S. public health establishment wants to hear.”

The censored paper has now been peer-reviewed, however, and its findings add further support to those who have been sounding the alarm about COVID-19 shot dangers all along. The researchers explain, “We found by independent adjudication that 73.9% of deaths were attributable to fatal COVID-19 vaccine injury syndromes,” adding:⁹

“These results corroborate known COVID-19 vaccine-induced syndromes and show significant, temporal associations between COVID-19 vaccination and death involving multiple organ systems, with a predominant implication of the cardiovascular and hematological systems.

Criteria of causality from an epidemiological perspective have been met including biological plausibility, temporal association, internal and external validity, coherence, analogy, and reproducibility with each successive case report of death after COVID-19 vaccination combined with population-based studies describing mortality among the vaccinated.

Our findings amplify concerns regarding COVID-19 vaccine adverse events and their mechanisms.”

To answer the question of why The Lancet pulled the paper so quickly, The Vigilant Fox said:¹⁰

“Another COVID ‘conspiracy theory’ becomes reality as a bombshell study CENSORED by The Lancet has now been peer-reviewed. What were they trying to hide, you ask? Lots and lots of vaccine deaths.”

Save This Article for Later – Get the PDF Now

Download PDF

What Makes COVID-19 Shots So Deadly?

Most of the COVID-19 injections are linked to deaths, which suggests they share a common factor causing side effects, most likely the spike protein, the study suggests.¹¹

Spike proteins can circulate in your body after infection or injection, causing damage to cells, tissues and organs. “Spike protein is a deadly protein,” McCullough said.¹² It may cause inflammation and clotting in any tissue in which it accumulates.¹³ In fact, some suggest that spike protein in COVID-19 shots was designed to cause severe disease.

In a study published in the journal Science, by researchers with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, it’s revealed that the S-2P spike protein used in several COVID-19 shots binds more strongly to the ACE2 receptors in the heart, lungs, kidneys and endothelial cells of blood vessels in the body compared to the spike protein of the original SARS-CoV-2 virus.¹⁴

“Given the average time (14.3 days) in which cases died after vaccination, a temporal association between COVID-19 vaccination and death among most cases is further supported by the finding that SARS-CoV-2 Spike mRNA vaccine sequences can circulate in the blood for at least 28 days after vaccination,” the featured study notes.¹⁵

Further, it’s been revealed that the spike protein on its own is enough to cause inflammation and damage to the vascular system, even independent of a virus.¹⁶ The spike protein is known to have deleterious effects on the heart, and COVID-19 vaccine-induced myocarditis and heart attack are well-described in peer-reviewed studies.¹⁷ Multisystem Inflammatory Syndrome (MIS) has also been reported after COVID-19 shots in both adults and children.

“A possible mechanism by which MIS occurs after vaccination could be the systemic distribution of the LNPs [lipid nanoparticles] containing mRNA after vaccine administration and the consequent systemic Spike protein expression and circulation resulting in system-wide inflammation,” the researchers explain.¹⁸ Given the study findings, they suggest that anyone who receives a COVID-19 shot should be monitored for at least one year:¹⁹

“The implications of our study apply to cases of unanticipated death without antecedent illness among COVID-19 vaccine recipients. We can infer that in such cases, death may have been caused by COVID-19 vaccination.

Further urgent investigation is required to build upon our results and further elucidate the pathophysiologic mechanisms of death with the goal of risk stratification and avoidance of death for the large numbers of individuals who have taken or will receive one or more COVID-19 vaccines in the future.

Autopsies should be performed on all diseased individuals that have received one or more COVID-19 vaccines. Clinical monitoring of COVID-19 vaccine recipients is indicated for a period of at least one year after vaccination to ensure the absence of serious adverse events that may lead to death.”

Potential Link Between COVID-19 Injections and Alzheimer’s Disease

In addition to deaths related to the cardiovascular system, McCullough and colleagues found COVID-19 shot-related deaths also involved the hematological system, pulmonary embolism and the respiratory system, while adverse events related to the gastrointestinal, immunological and neurological systems have also been reported after COVID-19 shots.²⁰

A separate study investigated the association between COVID-19 shots and the onset of Alzheimer’s Disease and mild cognitive impairment (MCI).²¹ The study involved 558,017 individuals in Seoul, South Korea, who were divided into two groups — those who received a COVID-19 shot and those who did not.

The findings showed an increased incidence of MCI and Alzheimer’s in those who received a COVID-19 injection, particularly in those who received mRNA shots, within three months post-injection. The mRNA vaccine group exhibited a significantly higher incidence of Alzheimer’s compared to the unvaccinated group.

The study suggests a potential link between COVID-19 shots, particularly mRNA injections, and increased incidences of Alzheimer’s disease and MCI. “This underscores the need for further research to elucidate the relationship between vaccine-induced immune responses and neurodegenerative processes, advocating for continuous monitoring and investigation into the vaccines’ long-term neurological impacts,” the researchers stated.

Rampant Censorship Downplays the Truth About COVID-19 Shot Dangers

In another example of the rampant censorship surrounding COVID-19 adverse effects, a now-retracted narrative review published in the journal Cureus called for a global moratorium on mRNA COVID-19 shots.²² The review cited significant increases in serious adverse events among those who received the injections, along with an “unacceptably high harm-to-reward ratio.”²³

When factoring in absolute risk and the “number needed to vaccinate” (NNV), a metric used to quantify how many people need to be vaccinated to prevent one additional case of a specific disease, the review found “for every life saved, there were nearly 14 times more deaths caused by the modified mRNA injections.”²⁴

As for the paper’s retraction, McCullough, one of the paper’s authors, called it a “stunning act of scientific censorship.”²⁵ In addition to calling for a global moratorium on mRNA COVID-19 shots, the authors of the paper said the shots should be immediately removed from the childhood vaccine schedule, while boosters should also be suspended.

“It is unethical and unconscionable to administer an experimental vaccine to a child who has a near-zero risk of dying from COVID-19 but a well-established 2.2% risk of permanent heart damage based on the best prospective data available,” the paper notes.²⁶

The moratorium is warranted based on the shots’ risks of serious adverse events, the mechanisms behind those adverse events, mortality data and issues with inefficacy, vaccine control and processing.²⁷ As with the featured Lancet study, the Cureus study was already incredibly popular, with more than 330,000 views/reads/downloads in one month compared to the average Cureus paper, which gets only 2,700 in an entire year.²⁸

With each unwarranted retraction, more people will begin to ask questions about why this crucial information is continuing to be censored and withheld from the public instead of openly debated and presented to the public.

Injured by a COVID-19 Shot? Here’s Help

If you’ve had a COVID-19 shot and developed any unusual symptoms, seek out help from an expert. The Front Line COVID-19 Critical Care Alliance (FLCCC) has a treatment protocol for post-jab injuries. It’s called I-RECOVER and can be downloaded from covid19criticalcare.com.²⁹

Dr. Pierre Kory, who cofounded the FLCCC, has transitioned to treating the vaccine injured more or less exclusively. For more information, visit DrPierreKory.com. McCullough is also investigating additional post-jab treatments, which you can find on PeterMcCulloughMD.com. Finally, if you’re suffering from long vax, be sure to review my strategies for boosting mitochondrial health to allow your body to heal.

https://articles.mercola.com/sites/mercola/special-content/dynamic-ending-ad-surplus-sale.aspx?cid_medium=email

– Sources and References

^1, ⁷ Preprints with The Lancet July 5, 2023 (Archived)
^2, ^4, ^5, ^9, ^11, ^15, ^17, ^18, ^19, ²⁰ Forensic Science International June 21, 2024
³ X, William Makis MD, June 21, 2024
⁶ YouTube, The Jimmy Dore Show July 26, 2023
⁸ The Daily Sceptic July 6, 2023
¹⁰ X, The Vigilant Fox June 21, 2024
¹² Rumble, Dr. Peter McCullough, Therapeutic Nihilism and Untested Novel Therapies, October 5, 2021, 6:00
¹³ World Council for Health, Spike Protein Detox Guide
¹⁴ Science. 2020 Mar 13; 367(6483): 1260–1263
¹⁶ Circulation Research March 31, 2021
²¹ QJM: An International Journal of Medicine May 28, 2024
²² Cureus January 24, 2024
²³ Cureus January 24, 2024, Abstract
²⁴ Cureus January 24, 2024, Review
^25, ²⁸ Substack, Courageous Discourse February 24, 2024
²⁶ World Tribune February 5, 2024
²⁷ Children’s Health Defense January 29, 2024
²⁹ Covid19criticalcare.com

“I was even more surprised,” Doshi said, “to learn that the phrase ‘behind-the-scenes assistance’ actually appears in U.S. regulations.”

The U.S. Food and Drug Administration (FDA) informs departing workers that they can still influence the agency’s decision-making after leaving their position to work for the pharmaceutical industry, a new investigation by The BMJ revealed.

According to an internal email obtained by The BMJ, the FDA told departing staffer Doran Fink, M.D., Ph.D. — who had reviewed COVID-19 vaccines while working at the FDA and who had accepted a job at Moderna — that although U.S. law prohibits some forms of lobbying contact between former FDA workers who leave to join the private sector, they “do not prohibit the former employee from other activities, including working ‘behind the scenes.’”

Peter Doshi, Ph.D., who wrote The BMJ’s July 1 report, told The Defender he was surprised to see “just how proactive FDA is at informing departing employees of their ability to work behind the scenes post-FDA.”

Doshi is a senior editor at The BMJ and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy.

He said the FDA’s ethics program staff emailed the information to Fink as he was completing his FDA exit requirements.

“I was even more surprised,” Doshi said, “to learn that the phrase ‘behind-the-scenes assistance’ actually appears in U.S. regulations.”

U.S. law forbids direct lobbying contact between former regulatory staff and federal agencies — but it allows indirect contact. “I’ve yet to hear an argument for how this serves the public interest,” Doshi said.

The fact that the legal ability to work “behind the scenes” is woven into federal regulations highlights a “critical, critical loophole” in U.S. revolving door policy, according to Craig Holman, Ph.D., a government affairs lobbyist for the consumer advocacy nonprofit Public Citizen who was interviewed for The BMJ’s report.

“So, people will leave government service and can immediately start doing influence peddling and lobbying,” Holman said. “They can even run a lobbying campaign, as long as they don’t actually pick up the telephone and make the contact with their former officials — and that’s exactly the advice that’s being given here.”

Holman told The Defender the legally sanctioned revolving door between U.S. regulators and the industries they regulate is “the most pernicious influence-peddling scheme available to wealthy special interests.”

“The prospects of lucrative private employment after public service can influence official actions by regulators,” he explained. “And the inside connections within the regulatory agency by the revolver [the person leaving federal service to work for industry] gives the business community a strong advantage over influencing upcoming regulatory actions.”

FDA repeatedly advises departing staff on ‘behind the scenes’ work

In its report, The BMJ revealed that the FDA’s advice to departing staff on “behind the scenes” work wasn’t limited to one email but appeared repeatedly in emails to Fink and emails to Dr. Jaya Goswami.

Goswami in June 2022 joined Moderna as its director of clinical development in infectious diseases after serving from March 2020 to June 2022 as a medical officer in the FDA’s Center for Biologics Evaluation and Research. She was responsible for evaluating whether the clinical data for Moderna’s COVID-19 vaccine met regulatory standards for approval.

“The FDA’s guidance seems to be part of the standard boilerplate advice sent to employees by FDA staff responsible for ethical compliance,” Doshi wrote.

It’s also on the FDA’s website on post-employment restrictions.

‘This is the key to the revolving door’

Diana Zuckerman, Ph.D., president of the nonprofit National Center for Health Research and a regulatory policy analyst with decades of experience, told The BMJ she was surprised by the FDA’s advice on behind-the-scenes work.

“I had this vision that they actually had meaningful restrictions on what people could do for at least a year” after serving at a federal agency, she said.

Zuckerman voiced concern about how proactive the FDA was in providing behind-the-scenes work information to workers as they leave federal service. “I just think that this is the key to the revolving door.”

“It’s one thing to know it happens,” she said “and it’s another thing to know that the [FDA] ethics folks are saying, ‘Don’t worry, you can do this.’”

Zuckerman told The Defender it’s an “outrageous situation for the FDA’s so-called ethics office to be telling employees they can do behind-the-scenes work and, to some extent, encouraging it.”

Behind-the-scenes lobbying can be just as powerful as direct lobbying, she said. The FDA’s practice of proactively telling employees they can do behind-the-scenes work “undermines the integrity of the FDA and is unfair to patients,” Zuckerman added.

The FDA told The BMJ it wasn’t concerned that proactively informing employees about their ability to work behind the scenes could be interpreted as encouraging former FDA staff indirectly to lobby the agency.

“Working behind the scenes does not necessarily equate to direct or indirect lobbying activities,” the FDA spokesperson said. “Lobbying activities are governed by the Lobbying Disclosure Act. Former employees would need to adhere to these requirements, just like any other individual or organization.”

Legislators need to close the loophole

Meanwhile, some are pushing to close the legal loophole that allows those who leave federal agencies like the FDA to influence the agency after they take industry jobs.

Federal lawmakers on May 1 introduced legislation to amend the law regulating restrictions on departing employees. “It seems it’s time for this loophole to be fixed,” Doshi said.

Dubbed the Fixing Administrations Unethical Corrupt Influence (FAUCI) Act, the bill would prohibit “former employees of covered health agencies” from serving on the boards of manufacturers of drugs, biological products, or devices after public service.

Versions of the FAUCI Act were introduced in both the Senate and the House of Representatives.

In June 2023, Sen. Elizabeth Warren (D-Mass.) introduced legislation to curtail behind-the-scenes lobbying activity.

So far, none of the bills have passed.

Additionally, Holman in 2021 helped draft legislation that would have prohibited anyone in the FDA responsible for issuing a contract to a company from taking a job with that company for two years.

The legislation was “largely ignored” and did not receive a hearing, Holman told The Defender. “It may take future scandals to get Congress to address the problem.”

The Defender reached out to the FDA for comment on The BMJ’s report but did not receive a response by deadline.

Florida Woman Says COVID Shots Made Her Sick, but Federal Law Protects Vaccine Makers

The Daytona Beach News-Journal reported:

A Port Orange woman and eight others say they were harmed by COVID-19 vaccinations and have filed a federal lawsuit against the U.S. Department of Health and Human Services, seeking to break the immunity granted to vaccine makers.

Moms for America, an Ohio-based nonprofit, was joined by Michelle Utter of Port Orange and eight other individuals in suing the government in a case filed last week in the Middle District of Florida in Tampa. They argue a provision of a federal law protecting vaccine manufacturers from damage claims is unconstitutional and should be struck down.

After receiving the first shot of the two-part vaccination on Dec. 22, 2020, Utter became ill for two weeks, with inflammation throughout her body, restless leg syndrome and flu-like symptoms, the suit states. She was hesitant, but took the second dose three weeks later, which the lawsuit described as “a tragic mistake.

She was ultimately diagnosed with CIDP, a neurological disorder caused by damage to the myelin sheath, the protective covering that surrounds nerve fibers, due to an autoimmune response, the suit states.

She has had other complications, as well, and has been regularly receiving intravenous immunoglobulin (IVIG), which manages immunodeficiency and other conditions including micro-clotting in her blood. “Tests show that her body still produces the COVID-19 spike protein, a vaccine artifact,” the suit states.

CDC Looks to Expand Capacity to Test for H5N1 Bird Flu in People

STAT News reported:

As the H5N1 bird flu outbreak in dairy cows enters its fourth month, the Centers for Disease Control and Prevention is taking steps to ramp up the nation’s capacity to test for the virus in people.

In a call with reporters Tuesday, Nirav Shah, the CDC’s principal deputy director, emphasized that the risk to the general public remains low at this time. But given that the virus is showing no signs of slowing its push deeper into the U.S. cattle population — threatening to create lasting risks to dairy workers and giving it more chances to evolve in ways that make it better at spreading to and among humans — the agency is looking to increase the number and types of tests that can effectively detect H5N1 infections in people.

Currently, the CDC’s bird flu test is the only one the Food and Drug Administration has authorized for use. Shah said the agency has distributed 750,000 of these tests to local public health labs and is expecting 1.2 million more to come online in the next two to three months.

But should the virus begin to spread easily among humans, testing needs may quickly outpace existing public health laboratory capacity. Which is why the CDC is also working with commercial labs to build additional tests. So far, the agency has given eight companies licenses for its tests, Shah said. Three additional licenses are pending and another four companies are in the process of applying for licenses.

NIH Announces Launch of Clinical Trial for Nasal COVID Vaccine

CIDRAP reported:

The National Institutes of Health (NIH) yesterday announced the launch of a phase 1 trial of a nasal vaccine against COVID-19, which also marks the first National Institute for Allergy and Infectious Diseases (NIAID) trial conducted as part of the government’s Project NextGen — an effort designed to advance the development of next-generation vaccines against the disease.

The investigational vaccine, called MPV/S-2P, uses a murine pneumonia vector (MPV) to deliver a version of the SARS-CoV-2 spike protein. The NIH said MPV has an affinity for epithelial cells that line the respiratory tract and may be useful for delivering the vaccine to body sites where natural coronavirus infection begins. In preclinical nonhuman primate studies, the vaccine prompted a robust systemic immune response as well as mucosal immunity, which plays a greater role in controlling respiratory virus replication.

Researchers will enroll 60 adults ages 18 to 64 who have received at least three doses of mRNA COVID vaccine, who will be divided into three groups receiving progressively higher doses of the nasal vaccine. They will be followed up for about 1 year as investigators track participants’ immune responses in the blood and nose. Study sites are Baylor College of Medicine in Houston; Hope Clinic at Emory University in Decatur, Georgia; and New York University, Long Island.

GSK Buys COVID, Influenza Vaccines From Retrenching CureVac

Reuters reported:

British drugmaker GSK (GSK.L) on Wednesday bought partner CureVac out of their alliance on influenza and COVID-19 vaccine development, boosting its messenger RNA credentials and extending the German biotech company’s financial lifeline.

GSK, one of the world’s largest vaccine manufacturers, will take control of CureVac’s leading experimental vaccines to fight infections, including seasonal flu and bird flu.

It will pay CureVac 400 million euros ($430 million) upfront and up to 1.05 billion euros contingent on achievements. CureVac shares surged on the news, trading 24% higher to reach a three-week high at 0739 GMT.

Under the partnership that began in 2020 during the COVID-19 pandemic, the companies have worked together to develop mRNA vaccines for infectious diseases.

Israeli Scientists Get Funding to Help Eradicate Polio

Israel21c reported:

Ben-Gurion University of the Negev has received a $1.3 million grant from the Bill & Melinda Gates Foundation to develop and validate a novel and safe approach for measuring immune responses to polioviruses.

This research is being led by Prof. Tomer Hertz of the Department of Microbiology, Immunology and Genetics and the National Institute for Biotechnology in the Negev.

Since 2018, Hertz has been developing antigen arrays capable of predicting immune responses of patients vaccinated against polioviruses, influenza viruses or viruses from the flavivirus family (including, among others, Zika and the viruses that cause dengue and yellow fever).

FDA Approves New Drug to Treat Alzheimer’s

U.S. News & World Report reported:

A new drug to treat Alzheimer’s disease was approved by the U.S. Food and Drug Administration on Tuesday.

In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early stages of the memory-robbing disease. But it also carried significant safety risks, including swelling and bleeding in the brain.

Prescription Drug Prices Have Surged Almost 40% Over the Past Decade

FOXBusiness reported:

The cost of prescription drugs in the U.S. has surged nearly 40% over the past decade, easily outstripping the pace of inflation, according to a new study.

Findings published by GoodRx, a drug savings company, show that the list price for prescription drugs has climbed about 37% since 2014. Although price increases have slowed this year, costs continue to pose a “significant burden” to many consumers.

Biden Joins Sanders’ Campaign Targeting Novo Nordisk, Eli Lilly’s Diabetes and Obesity Drug Prices

Fierce Pharma reported:

In recent months, frequent pharma critic Sen. Bernie Sanders has been ratcheting up a campaign against Novo Nordisk over the price of its popular diabetes and weight loss medicines. Now, the senator has big-time backup in his fight.

In a new USA Today op-ed piece, President Joe Biden and Sen. Sanders blasted Novo Nordisk for “charging the American people unconscionably high prices” for its popular GLP-1 medicines Ozempic and Wegovy. They noted that the drugs cost several times more in the U.S. than in many other developed nations, a point Sanders has raised repeatedly during his recent crusade against Novo Nordisk.

“Each country has its own healthcare system and making isolated and limited comparisons ignores this fundamental concern,” Novo’s spokesperson added. “What remains constant is the indisputable value and cost savings Novo Nordisk medicines bring to patients, healthcare systems and society.”

Besides Novo, the two politicians said Eli Lilly is charging “unconscionably high prices for Mounjaro, a drug with similar health effects as Ozempic.” Lilly’s drug costs about $1,100 monthly in the U.S., according to the op-ed.