Mayo Clinic Study Reveals J&J Vaccine Recipients Four Times More Prone to Blood Clots

The Mayo Clinic released a study on Nov. 1 revealing that Minnesota residents from Olmsted County who received the Johnson & Johnson COVID-19 vaccine are 3.7 times more likely to develop blood clots.  

The Study

Published by the JAMA network, the study analyzed blood clot case numbers that were reported to the CDC Vaccine Adverse Event Reporting System (VAERS) between Feb. 28, 2021 (the date that the vaccine was approved), and May 7, 2021, comparing them to incident case numbers before the pandemic, between Jan. 1, 2001, and Dec. 31, 2015. The study gained approval from the Mayo Clinic institutional review board.

While researching the data from pre-pandemic incident cases, the Mayo Clinic found that 39 Olmsted County residents experienced acute incident cerebral venous sinus thrombosis (CVST), with 28 of those patients having predisposing risk factors such as an infection, birth control use, or active cancer within 92 days before the CVST event.

Evaluating VAERS data from after the J&J vaccine approval date, the Mayo Clinic discovered that 46 potential CVST cases were reported to VAERS within 92 days of receiving the vaccine. Out of the 46 cases, 8 were excluded due to potential duplicate reports or not receiving an objective diagnosis.

“The present study avoided referral bias and included only objectively diagnosed and confirmed cases,” the research letter said. “Only cases with adequate details or imaging findings reported on VAERS were used. Study limitations include possible ascertainment bias by including only objectively diagnosed CVST cases.”

The study showed that females were at an increased likelihood of forming a blood clot after receiving the vaccine, with 71% of VAERS reports being among women.

Risk Factors

“It was surprising that it is predominantly women (especially 30 to 49-year-old women) who are at a higher risk for CVST in the first 15 days after the administration of Johnson & Johnson COVID-19 vaccine.” According to Healio, lead investigator of the Mayo Clinic study, Dr. Aneel Ashrani, reported, “We do not have a good explanation for it but speculate that they may have additional/concomitant CVST risk factors, (e.g., oral contraceptive pill use) or may have a predisposition to autoantibody production that may have led to vaccine-associated thrombocytopenia with thrombosis.”

The average age of those who experienced a CVST after vaccination was 45. The average time to the CVST event was 9 days after receiving the vaccine with 81.6% of cases that occurred 15 days after receiving the vaccine and 94.7% occurred within 30 days.

A Trend?

This isn’t the first time J&J has been met with negative press, as their COVID-19 vaccine rollout came to a screeching halt in April due to six cases of CVST reported after individuals received their vaccine. A few months later, there were 100 reports of individuals who received one J&J dose diagnosed with Guillain-Barre Syndrome, an incurable autoimmune disease that causes a sudden-onset muscle weakness brought to the surface by an individual’s immune system, resulting in damage of the peripheral nervous system.

“In individuals who had thrombotic complications after the administration of an adenovirus vector-based COVID-19 vaccine (e.g., the J&J vaccine), my bias would be to consider one of the mRNA-based vaccines (i.e., one manufactured by Pfizer-BioNTech or Moderna) for their booster shot,” Dr. Ashrani said, according to Healio.

Prominent Group of Researchers

Additional Mayo Clinic professionals that conducted the study alongside Dr. Ashrani include Dr. Daniel J. Crusan, Dr. John Heit, and Statisticians Tanya Petterson and Kent Bailey.

The NIH to Debate Vaccine Mandates

There’s an interesting debate happening over vaccine mandates, and it’s in an unlikely place. The National Institute of Health, the workplace of Dr. Anthony Fauci, who is a mandate advocate. According to a November 7th article in The Wall Street Journal, the NIH will hold a “roundtable session” on December 1st to discuss the “ethics” of the proposed workplace mandate.

Lots of Pushback against the Mandates within NIH

The December discussion is the first of four for the agency, which employs nearly 20,000 people. The pushback against the mandate is coming from several employees, including David Wendler, a senior NIH bioethicist. “There’s a lot of debate within the NIH about whether [a vaccine mandate] is appropriate,” said Wendler, “It’s an important, hot topic.” Wendler has also done a lot of pediatric research.

As pointed out in an article in The Hill, the pushback isn’t coming from “anti-vaxxers”.  In one case, one of the employees opposing the mandate is Dr. Matthew Memoli who supports vaccine use among “high risk” individuals including the elderly and the obese. Memoli has declined to be vaccinated for “religious reasons” and thinks the vaccine mandate is “extremely problematic”.

Blanket Vaccine May have Opposite Impact

Memoli points out that he does vaccine research and has helped develop and create vaccines.  So he’s not against vaccines but “he argues that with existing vaccines, blanket vaccination of people at low risk of severe illness could hamper the development of more-robust immunity gained across a population from infection.”  Memoli has even told Fauci that he believes the way “we are using vaccines is wrong”.

The objections to the proposed mandate are reverberating through the NIH. Christine Grady, who is the head of the Clinical Center of the bioethics department at the National Institute of Health, has agreed to the December 1st discussion.  Grady is married to Dr. Anthony Fauci.  

As pointed out in a recent Wall Street Journal article, Dr. Memoli is now considered an “outlier”, even though he’s done research on vaccines. Epidemiologists and public health officials believe that Memoli can dissuade the general population from being vaccinated. Public health officials believe the only way to defeat the covid pandemic is through mass vaccination.

Dr. Grady signed off on the December discussion with the idea that there is interest throughout the agency. However, David Wendler, who works with Grady points out that the bioethics department doesn’t seek to influence policy because they’re a “consultation service” not “policy people”.

Dr. Memoli simply wants to have the agency discussion. As he says, “if they end up saying I’m wrong, that’s fine. I just want to have the discussion”.

What could be even more interesting is if Grady and Fauci have a discussion before the NIH-led event.

Biden regime shutting off fuel, energy supplies as part of WARTIME EMBARGO against We the People... prepare for famine, collapse and civil unrest

In his latest act of total warfare against the American people, Joe Biden is pushing to shut down the Line 5 pipeline in Michigan that transports over 500,000 barrels of crude oil per day from Canada to Michigan, where it gets processed and distributed throughout the Midwest. Without this pipeline, Midwestern states are going to face critical shortages of fuel this winter, at the same time Biden's handlers are engineering a supply chain collapse, food shortages and unrelenting inflation. As Fox News reports: Jason Hayes, the director of environmental policy at the Mackinac Center for Public Policy, blasted the Biden administration for its energy policies, telling Fox News that their work on Line 5 is "just one more example of being divorced from reality." Hayes presented a dire picture of what shutting Line 5 could mean if people are unable to get natural gas or the electricity it provides as the nation heads into winter. "I hope it doesn't end like this, but where I see it going is unfortunately the same thing that happened in February in Texas: People freezing in their homes," he said.

Pipeline is "essential to the lifeblood of the Midwest"

The deliberate shutting down of this pipeline is an act of war against We the People, as the Biden regime transforms America's heartland into an active theater of war which will soon face widespread food scarcity, energy scarcity and inevitable civil unrest. As the UK Daily Mail explains: The Biden Administration is considering shutting down a Michigan oil pipeline despite warnings from Republican lawmakers who believe the move would result in fuel price shocks throughout the Midwest. The administration is exploring the possibility of terminating the Line 5 pipeline — which links Superior, Wisconsin, with Sarnia, Ontario — and gathering data to determine if shutting down the line will cause a surge in fuel pricing, according to published reports. In a letter dated Thursday, 13 Congress members — led by Ohio Rep. Bob Latta — urged the president to keep the oil line in operation, saying: ‘Line 5 is essential to the lifeblood of the Midwest.’ With alarm bells going off over Biden's deliberate destruction of America's economy, Texas Sen. Ted Cruz is now voicing what millions of Americans are already thinking: At some point, the remaining "free states" have to cut ties with Washington D.C. and form their own new nation, just to survive the planned civilization suicide being pursued by the demon-possessed Democrats. In a recent speech at Texas A&M University, Sen. Cruz stated: If the Democrats end the filibuster, if they fundamentally destroy the country... if they pack the Supreme Court, if they make DC a state, if they federalize elections, if they massively expand voter fraud, there may come a point where it’s hopeless... We’re not there yet, and if there comes a point where it’s hopeless, then I think we take NASA, we take the military, we take the oil. Importantly, Sen. Cruz isn't calling for secession at this point, but he's clarifying that it may be the last remaining option if Democrats continue to wage actual warfare against America in their quest to destroy this nation.

The Biden regime now seen as a terrorist organization targeting the American people

"The Fate of the American Republic Has Been Sealed," declares an article at StateOfTheNation.co, authored by the Armchair Political Philosopher. It warns, "To survive, those conservative states populated with a critical number of Patriots must expeditiously NULLIFY the U.S. Federal Government for good!" The article states: ...[W]herever the New World Order globalists have taken over such as California and New York, there is simply no bringing them back to the American Republic as it was conceived by our Founding Fathers and codified by the U.S. Constitution. They have already taken down the statues of those extraordinarily great men such as Jefferson, Washington, Lincoln, Lee, etc. Therefore, the only way forward, for those states which respect the rule of law and Founding Documents, is to secede from the Union of 50 states. The NWO globalist cabal essentially owns and operates the U.S. Federal Government; and it will never willingly relinquish that raw political and military, financial and economic, social and religious power it wields over the American people. Hence, the Patriot Movement has only one option. Federal power projected from inside the Beltway cannot be effectively fought, but it can be ignored. The red states such as Florida and Texas can cut the umbilical cord to Washington, D.C. which is an unconstitutional and tyrannical city-state that has absolutely no legitimacy in a constitutional republic / representative democracy. Some Americans believe that "white hats" are still somehow in charge and that Trump is secretly still in power, with Joe Biden acting as a puppet president in order to wake up the American people to the sheer terror of Big Government, Big Media, Big Pharma and Big Tech all conspiring to mass murder humanity. The fact the Joe Biden is broadcasting from a fake Oval Office built on a sound stage only adds to the speculation that what we're watching is pure theater. If that's true, and if this is all just theater, what will be the final act? Mass death of vaccine-injected children and mass starvation across the nation? Because that's where Biden and the Democrats are pushing things. If we don't stop them soon, tens of millions of Americans will likely perish from the collapse. If this is theater, it's also a Holocaust-level tragedy in the making. Get full details in today's Situation Update warning: Brighteon.com/a41eefc9-e7cc-48e4-9839-2c53253e7d95Find a new podcast each day -- plus amazing new interviews -- at: https://www.brighteon.com/channels/hrreport

Don’t Vaccinate Kids: Urgent Message From Doctors’ Summit

Leading experts on flawed U.S. COVID policy issued an urgent warning at a summit Saturday: Young children will be harmed in an ill-advised rush to vaccinate a population with very little chance of severe infection from the virus.

“The real risk for healthy kids is about zero — it does appear to be lower than the flu,” said Dr. Robert Malone, inventor of the mRNA technology on which the vaccine is based. Inoculating 28 million children 5 to 11 years old, Malone told attendees of the Florida Summit on Covid, could lead to “a thousand or more excess deaths.”

“That’s a thousand kids,” he told the audience of 800 doctors, nurses and advocates. “It’s a thousand kids too many.”

In addition to other pressing COVID issues, the summit addressed three central questions about childhood vaccination. Do young children need vaccination against COVID? Are the vaccinations safe? Are unvaccinated children a threat to adults? On each, they found the government’s near-universal vaccination policy wanton and unsupported.

“Children don’t get severely ill. Children don’t die from this infection,” said Dr. Paul Alexander, a clinical epidemiologist and former senior advisor on pandemic policy in U.S. Department of Health and Human Services. “We’ve been fed a lot of misleading information.”

Though harshly criticized for keeping schools open, “Sweden had not a single death of a child from COVID,” said Dr. Richard Urso, a Texas ophthalmologist citing published data.

The U.S. Centers for Disease Control counts 576 U.S. children under 18 who succumbed to COVID from Jan. 1, 2020 to Nov. 3, 2021, among 60,811 who died in that period. But the CDC figures offer no perspective on whether another illness or COVID caused the deaths. In a study of 48,000 COVID-infected children under 18, no deaths were reported among those without comorbidities like leukemia or obesity. In other words, healthy kids did not die, suggesting vaccines are not needed for them.

‘Willful blindness’

With the risk of serious illness low, panelists said the potential toll of vaccinating was unacceptably high, pointing to thousands of officially downplayed but real side effects and deaths. The risks to children include – but aren’t limited to – serious inflammation of the heart called myocarditis, which has been reported at three to six times the expected rate in vaccinated adolescents. A CDC study reported 14 vaccine-related deaths and 849 serious reactions in children 12 to 17 years old.

“There will be children lost with the vax — far more than ever happened with COVID,” said Dr. Peter McCullough, a widely published cardiologist and leading voice on a rational pandemic response. Doctors are guilty of “willful blindness” to vaccine hazards, he said, having “bought into this…dream that this vax if both safe and effective. It is shattering their dreams that it is not sufficiently safe.” 

The summit met just after the Pfizer vaccine was recommended by the CDC and as rollout began in pharmacies and clinics.

In Florida, where debate on vaccine mandates is vigorous, summit organizers see child vaccination as a line not to be crossed in a state that could set an example for the nation. They hope to stop the expanded vaccine program with an executive order by Gov. Ron DeSantis or legislation in an upcoming emergency session called to address vaccine mandates.

“We need to pull out all the stops,” Dr. John Littell, an Ocala physician who spearheaded the summit, told me. “We’ve only begun to fight for our children.”

With virtually universal media support, pressure is intense to vaccinate the pint-sized.  On Twitter, the Muppet character Big Bird told of doing his duty for the public good. “I got the COVID-19 vaccine today!” he tweeted on the day of the summit. “My wing is feeling a little sore, but it’ll give my body an extra protective boost that keeps me and others healthy.”

Pfizer video, meantime, widely shared on social media, showed “superhero” boys and girls, in capes, masks and wings, celebrating vaccination. Mouthing words written by a pharmaceutical giant, they praised other kids who took the needle for their “courage,” willingness to “try new things” and “helping the whole entire world.” Another video, of 13-year-old Madeline De Garay injured after vaccination during a trial, tells quite a different story but, sponsors say, was rejected for airing as a television ad.

‘One and done’

The six-hour summit included a premier lineup of COVID doctors who, based on treatment experience and available science, also raised two other urgent concerns:

The effective suppression of physician freedom to treat early COVID with ivermectin, hydroxychloroquine, fluvoxamine and other drugs that could keep patients out of hospitals and save lives.

The protective value of having had COVID, which offers immune benefits that panelists said exceed – and forego the need for — vaccination.

“Natural immunity is robust; it’s complete; it’s durable,” Dr. McCullough told the group. “If it was possible to get it again, it would’ve happened hundreds of millions of times. It’s one and done.” Just 100 or so cases have been reported in the literature, he said, but there is confusion over whether they were actually second infections.

“With COVID, you develop immunity to 50 or so proteins” that spur production of antibodies, Malone said in his talk. “With the vaccine, you develop immunity to one structural protein,” namely the spike protein. “It’s a huge difference.”

“Don’t let them tell you that recovered-from-COVID does not lead to long-lasting immunity,” Dr. Ryan Cole, an Idaho pathologist, told the group, pitting a report on 106 science articles in favor of infection-acquired immunity against a single CDC “pretend paper” saying vaccines offer more protection.

The implications of natural immunity are enormous. The CDC estimates that 120 million Americans – a third of the population — have had COVID. If their immunity was recognized, that would dramatically reduce the lucrative market for vaccines and boosters – what many panelists believe motivates the rush to jab. More than 200 million Americans will have been infected after the Delta wave, McCullough estimates, broadening that population greatly. 

Physicians at the summit left room for some to be vaccinated, including people whose compromised health puts them at risk for severe illness. Malone supports vaccination for high-risk groups, though he told me, “That may change as additional data become available.”

As it stands, however, the vast majority of Americans would be vaccinated under government recommendations that, if mandated by workplaces, schools and municipal governments, leave few exceptions.

‘Unmitigated corruption’

While the urgency of vaccinations took center stage, the failure to treat people at the first sign of COVID – and its immense consequences — was cited as the product of a corrupt, Pharma-controlled system and government.

In a stirring talk, Pierre Kory, president of Frontline Covid-19 Critical Care Alliance and a voice for early treatment, pointed to a litany of methods that science journals, media and government have used to effectively deny care with inexpensive “repurposed” drugs like ivermectin.

Among them: Refusal to publish pro-treatment scientific papers and retraction, under pressure, of others. Insistence on pricey randomized control trials while not funding them. A double standard that has Merck’s expensive molnupiravir poised to become a prime outpatient drug, based on one pharma-sponsored trial, while tossing aside dozens of studies favoring ivermectin, hydroxychloroquine and other potential treatments. Rejection of the clinical experience of hundreds of doctors who have seen early treatment drugs keep people out of hospitals and coffins. 

Having had “a front-row seat on the war on ivermectin,” Kory described in two words the reason for the monumental failure to treat COVID: “Regulatory capture.” In short, the alphabet agencies – NIH, CDC, FDA – aren’t making the decisions.  

“It’s well described that all of those agencies are literally run by Pharma,” he said. “If you want to keep your job, you let the leaders do what they do.” This has led, he said, to unmitigated and repeated acts of corruption, which are hurting public health.”

‘Get sicker’

 While Kory has strongly supported ivermectin – and several doctors in the audience said they had great success with it – he and others said there are other perhaps two dozen compounds that could help early. Nonetheless, public health leaders are silent on recommending any. Among them: aspirin, budesonide, colchicine, curcumin, melatonin, nitazoxanide, quercetin, zinc and vitamins C and D. Even a highly favorable trial on fluvoxamine has failed to earn the government’s endorsement.

“They tell you to go home and get sicker and come back and see us when you’re really sick and your body’s damaged,” Malone said. “Ask yourself, ‘does this make sense?’”

At the same time, speakers dismissed the unsupported contention that unvaccinated children are a threat to adults — who even when vaccinated can themselves get and spread COVID. “Children are not superspreaders,” said Urso. Further, said Malone, “It’s not the kids responsibility to protect the elders.”

It is, however, the responsibility of public health agencies to live up to protecting the public. Instead, said Dr. Bruce Boros, owner of three urgent care centers in the Florida Keys, they thwart doctors at every turn.

“We’re getting the shit kicked out of us, there’s nowhere to go,” he told me.

“The CEOs and administrators of hospitals are threatening us. You’re going to be fired. You must walk in lockstep with our standard of care.”

After recounting harrowing experiences in New York City ICUs early in the pandemic, a critical care physician, Dr. Mollie James, concluded with this: “Doctors must not be blocked from prescribing life-saving medicine in the hospital. Doctors must not be blocked from giving life-saving treatment outpatient.”

***

Mary Beth Pfeiffer is an investigative journalist and author of two books; she has written more than 20 articles on early treatment of COVID since March of 2020. Follow her on Twitter: @marybethpf

Non-Profit Legal Group Launches “Operation Pushback” to Recruit Local Attorneys to Represent Vaccine-Mandate-Related Cases

On October 27, 2021, the Pacific Justice Institute, headquartered in Sacramento, CA, announced an initiative to recruit local attorneys across the US, to become part of a unified legal defense effort against federal vaccine mandates for COVID-19 called “Operation Pushback.” The mission behind this operation is to represent Americans who the organization alleges have had their constitutional rights infringed upon by the recently announced COVID-19 vaccine mandates. 

Founded 1997, the non-profit 501(c)(3), donation-funded organization provides free legal support for clients to defend their cases regarding religious beliefs, parental rights, and other legal matters surrounding civil liberties, such as free speech.

According to their press release, “PJI is the only legal organization leading in the defense of individuals who have sincerely held religious beliefs that prevent them from complying with COVID-19 vaccine mandates.”

These mandates include those coming from the White House imposed on private businesses of 100+ employees, as well as those that are self-imposed by states or other entities to exclude students (who do not get vaccinated) from an in-person education, including charter and private schools. 

California announced that it was the first state to adopt this policy. Governor Gavin Newsom announced his plan in October to require school students of all ages to be vaccinated, even before the vaccine was approved by the FDA for children as young as five. California is among only 6 states that do not allow religious exemption for any required vaccine for students.

“Operation Pushback” is gearing up to support relevant causes, especially those in which religious or medical exemptions are not considered. The operation will focus on defending wrongful termination against unvaccinated employees, and parental rights to decline their children from receiving the newly-developed, experimental vaccine. 

PJI’s press release states that “attorneys who join ‘Operation Pushback’ will have the full support of PJI’s 19 offices throughout the country, and PJI will pay for their litigation expenses and applicable attorney’s fees.” 

PJI has issued a PDF flyer to help guide readers to other free legal resources entailing how they can exercise their rights and protect their own best interests. The flyer also mentions other potential forced vaccination groups such as churches and military personnel. 

President Brad Dacus, an attorney who served as a legislative assistant to the former U.S. Senator Phil Gramm and holds his Doctor of Jurisprudence degree from the University of Texas, explains in an interview with Mike Huckabee, that the government is growing increasingly intolerant of religious people in America. In some instances, PJI has represented plaintiffs who are suing government agencies. However, PJI has also successfully provided legal counsel to city administrators as well. The city representatives of Gig Harbor, WA, were pressured to remove their customary nativity scene displayed among their holiday decorations at the protest of an atheist group, the Freedom from Religion Foundation. 

Looking over the PJI’s website, the main page features a slideshow of several different plaintiff’s testimonials defended by PJI attorneys over time. 

The non-profit also hosts town hall meetings to provide another source of support for those who are struggling with the ramifications of these mandates and other issues of legal concern. 

Call to Action: What are your thoughts? Do COVID-19 vaccine mandates cross the boundary of what is acceptable or is the edict necessary for public health? Mandates regarding new biomedical research raise much controversy. TrialSite monitors the activity.

Lack of Transparency Leads to Suspicions that California Governor Newsom is Ill from “Mix and Match” COVID-19 Booster

Our story starts back on October 27, when the San Francisco Chronicle reported on California Governor Newsom getting his COVID-19 booster shot that day. Newsom made a point to allow media video coverage of him getting the shot while he smiled and flexed his muscles. Although his prior vaccination consisted of the one-shot J&J product, Newsom said, “I’m choosing not to do J&J today — Not because I had any problems with J&J — in fact, it went beautifully — but to make the point about the opportunity to mix and match.” CDC had included Johnson & Johnson recipients in the group who should get a booster. The Chronicle reported that the FDA had then authorized folks to get a booster from any brand, regardless of the initial vaccine product used, the so-called “mix and match” approach, which phrase we heretofore associated with clothing separates or perhaps a lunch menu. Newsom’s videotaped shot was administered by the California Secretary of Health and Human Services Mark Ghaly, who said there are health benefits to mixing and matching: “Let’s mix up the modalities, really challenge the immune system, get that response looking a little different.” The newspaper also noted that Newsom had gotten his flu shot the prior week. Now, the Governor has been missing-in-action due to undisclosed “family obligations” ever since the booster. He was due to travel to Scotland to attend a major climate event. This trip was cancelled.

Flash forward to November 8, and we check in again with the Chronicle who titled that day’s follow up, “Gavin Newsom’s wife, California Democrats bristle at questions about governor’s continued absence.” Newsom had not been seen publicly since “abruptly” cancelling the trip to the Glasgow, Scotland climate conference on October 29, raising suspicions that he might have suffered an adverse vaccine reaction.

Newsom’s office said the trip was cancelled based upon “family obligations,” and gave no further details when pressed by the Chronicle. During the time since, the Governor has had no press conferences, “or public appearances of any kind, which is uncommon for the usually highly visible governor.” In a November 8 comment, Newsom’s press secretary said his boss was working at the Capitol and would be going back to, “resume normal appearances sometime this week.” After building curiosity, “fueled largely by a lack of transparency,”

The Governor has only been seen in a prerecorded video and in a family Halloween picture.

‘Get a Life’

Newsom’s wife Jennifer Siebel Newsom, sent out a tweet: “It’s funny how certain folks can’t handle truth. When someone cancels something, maybe they’re just in the office working; maybe in their free time they’re at home with their family, at their kids’ sports matches, or dining out with their wife. Please stop hating and get a life.” The Tweet went out Sunday night, and was deleted soon after.

Where’s @GavinNewsom?

Unlike the generally liberal Chronicle, The US version of The Sun tends more to the gossip side of things, but their recent piece on the Newsom puzzle is worth a review if one maintains a skeptical attitude. Per The Sun, after cancelling the trip to Europe with a planned virtual appearance, the later was also cancelled. In his stead, Lieutenant Governor Kounalakis led Californian’s delegation. Regarding her boss’ absence, she said,  “The governor has a young family and we should all be understanding, especially those of us who have been there.” While still active on social media, Newsom has not provided any further explanation for his AWOL status.

Republican attorney Harmeet K. Dhillon tweeted to offer her view on the missing governor: “Good morning, California! Gas is $5/gallon, homes cost $850k, you have to take drugs to keep your job or go to school, we’re supposed to just ‘get over’ rampant crime and illegal immigration… Where’s @GavinNewsom?” she wrote. Kevin Kiley is a California politician who also tweeted his view: “I don’t know where Gavin Newsom is and won’t speculate. But it’s pretty strange for the Governor to disappear for 11 days without explanation.”

According to Fox News the California Governor’s press secretary shared he would return to work sometime this week. 

Controversies of Leading Health Regulators = Evidence of Regulatory Capture?

TrialSite has been covering the serious shortcomings in US FDA’s current policies. The phenomenon of regulatory capture can be seen in many regulatory bodies; its corruptive characteristics can have far-reaching implications, threatening the independence and priorities of public health regulatory policies. How far-reaching is this issue within the leading regulators around the world? TrialSite probes further into leading health regulatory bodies in the US, UK, and European Union.

Regulatory Capture

Regulatory capture is a form of corruption where authoritative regulatory bodies act for political or monetary gain rather than in the interests of the public. This phenomenon is characterized by the coordinated efforts of regulated entities to lift constraints, decrease oversight efforts, weaken checks and balances, and gain advantages.

To assert influence, the industry hijacks regulators’ mandates and operations, making them cognitively and culturally captive to their influence. The agency’s independence is compromised by an increased inclination to serve the interests of the industry.

Unfortunately, the US Food and Drug Administration (FDA) has been accused of regulatory capture on a number of occasions:

  • Alosetron (Lotronex) was a drug for irritable bowel syndrome. In 2000, it was withdrawn from the market for causing more harm than good, including death. FDA agreed to release it again the following year, but under strict conditions: the prescribing doctor had to be trained and certified on the drug. The drug company disagreed, as it preferred the prescribing doctor to simply self-attest on their qualification. Despite several detractors in the advisory committee warning of more deaths, the FDA adopted the drug company’s recommendation, instead of its own advisory committee’s guidelines. This case is a prime example of captive decision-making by the FDA.

  • Vioxx, a nonsteroidal anti-inflammatory drug for arthritis among other conditions, triggered congressional interrogations after pulling out of the market in 2004. It caused an estimated 30,000 – 55,000 deaths and more than 100,000 heart attacks in patients before it was withdrawn. FDA investigator at the time, Dr. David Graham, told the senate in a congressional testimony that the regulator made it difficult to adequately analyze drugs. He reported threats and intimidation from supervisors who advocated for drug companies.

  • Proton pump inhibitors have demonstrated increased risks of kidney failure and other harmful adverse events. They have remained in the market nonetheless. This has brought lawsuits against manufacturers of Prevacid, Prilosec, Nexium, and Dexilant, with 15,164 filed by 2020. One claim against Prilosec asserted that “AstraZeneca knew of kidney risks for at least 10 years before warning the public.”

  • A study on the FDA conceded that the COVID-19 pandemic shows the mode of operation of the regulator as reactive, departing from “evidence-based decision-making frameworks”. This is the case not only in emergencies but also in its regulating operations.

  • The FDA authorized convalescent plasma on an emergency use basis during the pandemic over the behind-the-scenes protestations of the NIH. TrialSite suspected undue influence of the last POTUS (Trump).

  • Most recently the FDA approved the use of Biogen’s Alzheimer’s disease drug despite a lack of compelling clinical data. This decision was so controversial that Acting Commissioner Janet Woodcock called for an independent internal review process.

The list goes on as TrialSite could offer many more examples while also showcasing the revolving door from the agency to industry. One key takeaway from these cases is that there seem to be no accountability structures in place to protect consumers from culpable drug companies often enabled by the system.

User Fees and Licensing     

The fees pharmaceutical companies pay to health regulatory bodies have been an object of debate and deliberation. This relates not only to the US FDA, but also to the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA), and the European Medicines Agency (EMA), the regulating agency within the European Union.

In the US, Daniel Carpenter, Harvard professor of government, illuminates the covert symbiotic relationship between the FDA and big pharma. A significant amount of FDA funding comes from pharmaceuticals, thus raising ethical questions of industry influence on the direction of regulating policies.

Critics have drawn attention to how fee negotiations serve the pharmaceutical’s interests, such as fast-tracking of the approval process. For instance, the user fees paid to FDA have been implicated in influencing the emergency use authorization (EUA) speed in the COVID-19 pandemic, with some approvals happening within weeks.

In 2020, FDA received 2.7 billion dollars in user fees from the pharmaceutical industry, meeting 45% of its overall budget. This is in line with the Prescription Drug User Fee Act of 1992.  During the negotiation rounds for the fee (every five years), the pharmaceutical industry calls the shots by setting up performance measures. This dictates certain compliances the regulator has to meet in order to qualify for the fees, including response time, approval speed, and efficiency.

In the UK, the MHRA requires drug manufacturers to remit licensing and authorization fees. This in turn covers the cost of regulating the medicines from the payer. The House of Commons has made attempts in the past to point out the irony of the situation by highlighting the barriers it has created.

The EMA, the health agency regulating the industry in the European Union, has raised concerns among independent health consumer groups. They are alarmed by signs of regulatory capture in the agency. The consumer groups called for a review of EMA’s policies including fee-for-service from the pharmaceuticals, provision of “customized, confidential scientific advice” during the approval process to pharmaceuticals, lack of transparency, and access of clinical trial data.

Revolving Door Phenomenon: coincidental or calculated move?

The revolving door phenomenon among FDA high-ranking officials dates several years back as covered by TrialSite. Additionallyover 50% of former FDA medical reviewers work or consult for the pharmaceutical companies after departing the agency, as found in a study published in BMJ. Sometimes they go on to work for the drug company the FDA expert was assigned to review. The absence of statutory mandates for FDA employees in this regard creates conditions rife with conflict of interest.

In 2020, Stephen Lightfoot took on the role of chair of the UK’s MHRA. A 30-year pharmaceutical veteran, he worked at one point as an executive for Schering, a pharmaceutical associated with the infamous Primodos (more on this later). Prior to Lightfoot’s appointment was Ian Hudson, who had been a GlaxoSmithKline executive for years before getting into the health agency.

However, these are not isolated cases. Some of the division heads in the UK’s regulating body have previous ties in the pharmaceutical industry. These include:

  • Gerald Heddell, appointed as Director of the Inspection, Enforcement & Standards Division, was a former executive at GlaxoSmithKline.

  • Stephen Inglis, appointed as Director of the National Institute for Biological Standards and Control, was a former research director at Cantab Pharmaceuticals.

  • John Parkinson who was appointed as Director of Clinical Practice Research was a former consultant for pharmaceuticals.

Some repercussions of regulatory capture

The implications of regulatory capture can perhaps be understood best by examining some avoidable mishaps and pro-industry decisions.

Primodos in the UK

Primodos prompted a long-overdue hearing by the House of Commons and an expert panel work group (EWG) inquiry to investigate the drug. The final report showed MHRA’s culpability in approving Primodos – a drug that had caused birth defects for years. The UK government then agreed to amend that error promptly. One of the key decisions made was to place Stephen Lightfoot at the helm of MHRA in September 2020. Ironically, he had close ties with the manufacturer of Primodos as a former commercial director in the company.   

Seroquel in the US

Dr. Thomas Laughren, a former director of FDA’s psychiatric products, became a consultant to psychiatric manufacturers after leaving FDA.  While working in the FDA, he was pro-industry and fiercely defended controversial antipsychotic drugs. At one time he ran interferences on behalf of AstraZeneca at the FDA advisory committee meetings. Seroquel, the drug by AstraZeneca, was approved; it was later discovered to have a risk of sudden cardiac attack. This was not news to the FDA, as it had received the reports prior to approval.

Biogen

TrialSite has closely followed Biogen’s progress since 2019.  Eyes are on the ongoing investigations of the FDA over the Biogen’s Alzheimer’s brand drug, Aduhelm. Not only did FDA’s own commissioner Janet Woodcock make the call to the watchdog, but the agency also lacked independence as a regulator. It departed from the norm during the approval by preparing a joint document with the manufacturer, as well as disallowing inquiry on data. It will be interesting to see what the FDA investigation turns up.

Ivermectin narrative

There seems to be an institutional bias against ivermectin, as TrialSite has widely covered. Regulatory health bodies around the world have changed their previous pro-ivermectin stances to align with FDA and WHO. Is this indicative of totalitarianism in regulatory capture?  The recent scandalous email from an agency external affairs executive to Acting Commissioner Woodcock revealed an unacceptable initiative at the agency to initiate a disinformation campaign seeking to confuse markets and consumers—that ivermectin was simply a horse deworming drug but it is also an antiparasitic treatment that won a Nobel Prize, eradicated some major tropical-born disease and has been tested in 65 studies targeting COVID-19 to date.  The U.S. government is funding a major ivermectin study in the ACTIV-6 study although critics fret the study protocol underdoses the regimen possibly purposely.

Is Monopoly the endgame?

Health agencies are mandated to serve the public’s best interest without fear or favor. However, what happens if loopholes are exploited to get special interest ahead? The due process of objective regulation and inspection is compromised, and consequently, the public interest is left at the mercy of the unbridled ambition of industry such as large pharmaceutical companies.