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FDA commissioners say the agency needs ways to fight online “misinformation”

By Cindy Harper | Reclaim The Net | January 10, 2023

Former and current Food and Drug Administration (FDA) commissioners said that the agency needs partners to fight public health misinformation and that patient advocates, clinicians, industry, and academic leaders have a role to play.

The commissioners made the comments at the 2023 Innovations in Regulatory Science Summit, an event that was organized by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).

“I actually believe that misinformation is the leading cause of death right now in the US because whether we’re looking at COVID or chronic disease, people are making bad choices driven by the information that they get,” said FDA Commissioner Robert Califf, as reported by regulatory focus. “We were just not prepared for what broad access to the internet would do to communication channels.”

Califf said that the academic community was not doing enough to combat misinformation and that their criticism of the FDA is having unintended consequences.

“As a public agency, we need to be critiqued but I think often the people that are doing the critiquing assume that the agency’s going to be there in the future in the way that they expect it to be there,” Califf said. “So, they’re critiquing it to make it better. But to a lot of unsuspecting people that hear it, it just completely erodes their belief in the institution.”

Mark McClellan, who served as an FDA commissioner from 2002 to 2004 said, “Realistically, FDA needs help.” He acknowledged that there is currently a lack of trust in public health agencies and officials. However, people still trust their doctors, community leaders, and others that are “close to their experience.”

Scott Gottlieb, a Pfizer board member who served as a commissioner from 2017 to 2019, said the fast response to misinformation is crucial and touted the idea of allowing the industry to counter misinformation about products.

“We’ve seen FDA weigh in, admirably, around some dangerous disinformation on specific products,” he said. “But that can’t be the business of the FDA.”

He suggested that the FDA should create a limited safe harbor to allow sponsors to directly counter misinformation. He added that the FDA would determine how and what the sponsors can respond to.

“I think sponsors need to have the ability to defend their products in the marketplace of ideas when there’s true misinformation,” Gottlieb said.

Gottlieb was under fire this week after it was revealed that Gottlieb had been flagging tweets to Twitter.

In the August 27, 2021 email, which was published by journalist Alex Berenson, Gottlieb complained to Todd O’Boyle, a senior manager on ’s Public Policy team, about a tweet that claimed natural immunity to Covid-19 was superior to vaccine immunity.

“This is the kind of stuff that’s corrosive,” Gottlieb wrote. “Here he draws a sweeping conclusion off a single retrospective study in Israel that hasn’t been peer reviewed. But this tweet will end up going viral and driving news coverage.”

January 10, 2023 Posted by | Civil Liberties, Deception, War Crimes | , , | 1 Comment

Alzheimer’s drug approval raises the alarm

Data shows treatment can lead to ‘brain shrinkage’

By Maryanne Demasi, PhD | January 9, 2023

The US Food and Drug Administration (FDA) has granted an accelerated approval of a new treatment for Alzheimer’s disease, which aims to clear toxic amyloid protein build-up in the brain.

At a cost of $26,500 per year in the US (not covered by Medicare or Medicaid), people with early Alzheimer’s disease can receive a twice-monthly monoclonal antibody infusion called lecanemab (marketed as LEQEMBI™), co-developed by Eisai, a Japanese biotech firm, and Biogen.

In the lead up to the FDA’s approval, there was intense lobbying for the drug.

A ‘consensus statement’ signed by over 200 scientists, many of whom had financial ties to the drug companies, described lecanemab as a “foundational gamechanger” for the disease, calling for “no barrier” to the widespread availability of the treatment.

Now that the drug has been approved, advocacy groups like the Alzheimer’s Association, which are heavily funded by the drug industry, have welcomed the news, saying the FDA made “the right decision.”

But critics doubt the benefits of lecanemab outweigh its harms, and are dismayed that the FDA approved the drug without input from its own advisory panel.

Kim Witczak, a drug safety advocate, and member of the FDA’s Psychopharmacologic Drugs Advisory Committee, says she is “shocked” by the latest FDA stunt.

“By approving this new drug without a public advisory committee meeting, the FDA once again has shown a lack of concern for the public, patients, and healthcare providers. Convening its advisory panel would have helped reassure everyone that the FDA’s decision was scientifically sound and transparent,” said Witczak.

“Advisory committee meetings offer the opportunity to discuss the data in an open and public forum, to challenge methods, study endpoints (surrogate vs clinically meaningful), and safety findings before the general committee member discussion. But in this case, none of that was possible,” she added.

FDA repeating its mistakes?

The FDA’s accelerated approval process used to green-light lecanemab is known for accepting lower evidentiary standards for drug efficacy, so that patients can gain access to experimental drugs sooner.

Critics say its reminiscent of the FDA’s approval of aducanumab – Biogen’s other Alzheimer’s drug. It was approved on the basis of lowering amyloid protein (a surrogate marker) in the brain, despite no clinically meaningful benefit for patients.

At the time, the controversial decision led to the resignation of FDA advisory member Aaron Kesselheim, who labelled it “probably the worst drug approval decision in recent U.S. history.”

Linda Furlini, a research ethics advisor based in Montreal, Canada says it essentially gives the rubber stamp to similar drugs down the track. “Once you grant accelerated approval of a drug in that class, then it’s easier to get the second drug, and then the third drug approved.”

Jessica Adams, an expert in drug regulatory affairs, agrees. She said, “Lecanemab’s approval shows the power of precedent in regulatory approvals. This is why I scoff whenever the FDA says it still reviews drugs on a case-by-case basis.”

What are the benefits?

The industry-funded study published in the New England Journal of Medicine, involving almost 1800 people with early Alzheimer’s disease, found that lecanemab could slow the decline of cognition and function by 27% over 18 months compared to placebo.

They used a “Clinical Dementia Rating” scale to show lecanemab patients declined by 1.21 points compared to 1.66 point in the placebo group – a 0.45 point difference in lecanemab’s favour.

But experts question whether the small difference will have any impact on how the patient actually feels.

Madhav Thambisetty, a neurologist at Johns Hopkins University and the National Institute on Aging said, “The benefit appears to be quite small, and it’s unclear how meaningful this might be for patients.”

In fact, the FDA’s own statistician Dr Tristan Massie was uncertain whether “the treatment effect on amyloid is reasonably likely to predict change on the clinical outcome” and considered the results of the study to be “exploratory”.

The harms?

As a physician who cares for people with Alzheimer’s disease, Thambisetty spoke about the harms of the drug. “These patients can experience headaches, falls, confusion, vision disturbances and it’s unclear if patients will be able to see obvious benefits on a day-to-day basis,” he said.

The data showed an increased risk of brain bleeds and swelling, i.e. amyloid-related imaging abnormalities (ARIA) occurred in 126 (14.0%) of subjects in the lecanemab group and only 69 (7.7%) of subjects in the placebo group.

This prompted the FDA to include a warning on the drug about the risk of swelling and bleeding in the brain.

The drugmakers have also highlighted that people carrying two copies of the APOE4 gene (which predisposes someone to Alzheimer’s) puts them at a particularly “high risk of life-threatening brain haemorrhage.”

Three deaths have been reported in people taking lecanemab; an 80-yr old phase 3 trial participant who suffered intracranial haemorrhage, a 65-yr old who experienced brain swelling and bleeding and a 79-yr old who reportedly had seizures and brain bleed in the open-label phase of the trial.

Two of the three people who died were taking blood thinners, and experts who reviewed the lecanemab death cases suggested that anticoagulant use may have exacerbated the fatal outcomes.

Furlini’s research career has focused on the need to educate and support caregivers of people with dementia-type illnesses.

“You read the list of side effects – you might have gait problems, you might have brain swelling, visual disturbances… I mean, what are we doing here?” asks Furlini, “The patient is already confused and losing their cognitive capacity. How are these serious side effects helping them? It runs counter to any ethical semblance of what is wanted or expected.”

What about brain shrinkage?

Thambisetty has also expressed concerns about the “brain shrinkage” seen in trial participants taking either lecanemab or aducanumab – increasing doses of the drug correlate to a decrease in brain volume.

“The observation of brain shrinkage is worrisome because, in the absence of compelling evidence to the contrary, it suggests a potential worsening of degenerative changes in the brains of people with Alzheimer’s disease,” wrote Thambisetty in a recent opinion piece for STAT.

The observation has been explained away by researchers who say that a reduced brain volume is due to the clearance of amyloid protein from the brain. But Thambisetty says there is little empirical evidence to support this theory.

Instead, he points to an Australian study which calculated that the clearance of amyloid plaque from the brain was too small to represent a plausible explanation for the loss of brain volume.

Another blow to FDA credibility

US lawmakers launched an investigation into the FDA after the agency’s controversial approval of aducanumab. Last month, a US House of Representatives panel released the report following an 18-month investigation.

The report said the process was “rife with irregularities” and that FDA officials “inappropriately collaborated” with the drugmaker during the approval process which “exceeded the norm in some respects.”

Representatives from the FDA and Biogen engaged in over 100 phone calls or meetings dating back to 2019 in order to expedite the drug’s approval, which lawmakers say, “consisted of atypical procedures and deviated from the agency’s own guidance.”

The congressional report recommended the agency “must take swift action to ensure that its processes for reviewing future Alzheimer’s disease treatments do not lead to the same doubts about the integrity of FDA’s review.”

But critics now say, it’s too late for an agency that has not taken accountability for its actions.

“These drug approvals have just created confusion, uncertainty, fear and misinformation. Then they wonder why people have no trust in their institutions, like the FDA. The world looks to the FDA for leadership. That it does not fulfill its responsibilities, remains the challenge of our times,” said Furlini.

A new direction?

Furlini has followed this area of research for decades and says the drug industry needs to move on from the ‘amyloid theory’ of Alzheimer’s disease and refocus its attention on other causes.

“After so many years, I’m fed up with the exclusive focus on the amyloid theory to the exclusion of other research theories, it’s a disservice to people with Alzheimer’s, and their families,” said Furlini

“There are a lot of buzzwords and marketing propaganda being put out there. And they justify it by saying that you have to give people hope. But you’re giving people false hope. It plays with people’s emotions, which I find horrendous,” added Furlini.

January 10, 2023 Posted by | Corruption, Science and Pseudo-Science | , , | 1 Comment

FDA Study: Pfizer Vaccine increases risk of Blood Clots in the lungs by 54% in the over 65s

The Naked Emperor’s Newsletter | January 9, 2023

The FDA recently published a study which looked at the COVID-19 vaccine safety among elderly persons aged 65 years and older. Today it was published in the Vaccine Journal.

The study looked at 30,712,101 individuals who had received various doses of the Pfizer, Moderna and Johnson & Johnson vaccines between 11 December 2020 and 15 January 2022.

Worryingly they identified four statistical signals for elevated risk of acute myocardial infarction (ACI), pulmonary embolism (PE), disseminated intravascular coagulation (DIC) and immune thrombocytopenia following the Pfizer vaccine. They didn’t find any statistical signals for the Moderna or Johnson & Johnson vaccines for the 14 outcomes they were monitoring.

PEs (blood clots on the lungs) were 54% more likely, ACIs (heart attacks) were 42% more likely, DICs (blood clotting disorder) were 91% more likely and ITPs (platelet disorder) 44% more likely.

However, they say that after further evaluation the rate ratios for AMI, DIC and ITP no longer met the statistical threshold for a signal. But, even after their further evaluation, the rate ratio for PE still met the statistical threshold.

Comically/Tragically, after more than two years of injecting people, they call their monitoring study an “early warning safety system”!

They conclude that this FDA “early warning safety system is working to rapidly identify potential new and important safety concerns following COVID-19 vaccination”. Wow, I’m glad they didn’t use their slower system because then we’d be in real trouble!

As usual and as you would expect, they go to great lengths to say that the four outcomes aren’t necessarily caused by the vaccine and may be related to other factors.

Furthermore, even though their own study has just shown the increased risks to the elderly, they say they BELIEVE the potential benefits of the vaccines outweigh the potential risks of Covid infection. Since when has ‘believe’ been a scientific way of analysing things? It sounds more like a religious conviction.

As a result, they won’t be taking any regulatory actions based on these signals, because they are still under investigation and require more robust study. So in the meantime, keep taking your boosters and we’ll let you know in maybe another two years that yes the blood clots in your lungs were from the vaccine. But we still BELIEVE your blood clots were better than your Covid infection, which you still got five times anyway – Amen.

I wonder which MSM outlets will report on the FDAs own study?

January 9, 2023 Posted by | Science and Pseudo-Science, War Crimes | , | Leave a comment

US regulator fast-tracks dementia drug

RT | January 6, 2023

The US Food and Drug Administration (FDA) on Friday fast-tracked  the approval of lecanemab, a drug to treat the early stages of Alzheimer’s disease. Made by Japanese drugmaker Eisai and Biogen and marketed as Leqembi, the drug allegedly delays cognitive decline caused by the disease, though trials have shown some alarming side effects.

While a clinical trial of lecanemab’s efficacy in early Alzheimer’s published in November found it slowed cognitive and functional decline better than a placebo, the researchers noted that it was “associated with adverse events” and recommended “longer trials” to “determine the efficacy and safety of lecanemab in early Alzheimer’s disease” – an unusual call for caution in a study co-funded by the drug’s manufacturers.

Around 17% of those who took lecanemab experienced brain bleeding during the trials, while nearly 13% suffered brain swelling or effusions, compared to 9% and 2% in the placebo group respectively, according to the New England Journal of Medicine study. Some 7% of the trial participants stopped taking the drug due to the side effects.

Lecanemab’s high price point – $26,500 for a year’s worth of treatment – has also raised concerns. The Institute for Clinical and Economic Review suggested $20,600 as the price ceiling, arguing a cost-effective rate could be as low as $8,500. The company suggested it could lower the dosing frequency to cut costs.

Biogen is no stranger to controversy over its Alzheimer’s drugs. In 2021, several FDA board members resigned over concerns that Aduhelm, which the company had developed as the first drug designed to target the plaque buildup then believed to be the underlying cause of Alzheimer’s, had not demonstrated sufficient efficacy in treating moderate-to-severe dementia. While not a single member of the advisory panel responsible for reviewing the drug supported its approval, the FDA did so anyway, side effects and $56,000 annual price tag notwithstanding.

A congressional investigation that concluded last week found the approval process “rife with irregularities,” noting the FDA had “inappropriately collaborated” with the company it was supposed to be regulating.

Last year, it emerged that parts of the research that established the current plaque-based disease model of Alzheimer’s were possibly fraudulent, suggesting that the amyloid plaques found in the patients could be a symptom, rather than the cause, of the illness.

January 7, 2023 Posted by | Corruption, Science and Pseudo-Science | , | 2 Comments

How to hide adverse events

FDA compared apples and oranges

Health Advisory & Recovery Team | December 24, 2022

The FDA have finally conceded that the mRNA vaccinations increase the risk of pulmonary embolism. The study that led to this conclusion had a very odd methodology. Using this same methodology other risks were dismissed in an unjustified way. There are two FDA studies which use this same methodology. The first reported on people vaccinated aged 12-64 years and the more recent publication was for those aged 65 years and over. The study on the younger population used insurance databases whereas for the older population it was a medicare database.The studies are repeatedly described as being “rapid” and even “near-real time monitoring” even though nearly two years had passed before they were published.

Imagine you want to see if the risk of a certain condition was higher after vaccination was introduced compared to before. Data from voluntary reporting systems can act as an alarm signal but an accurate measure is better derived from comparing how common the condition is to how common it was in the past.

Ideally, the total number of people diagnosed with the condition for a period after vaccination would be compared to a similar period in a previous year. The MHRA set out to carry out such analysis once a week because of the unprecedented nature and size of the rollout. They have not published any findings.

The FDA chose to only look for 28 days for most conditions. The tally was compared to a 28 day period pre-covid. No justification is given for this short window. For comparison, when the Pandemrix vaccine was rushed out for swine flu in 2009, there was an 8 month lag between vaccination and onset of narcolepsy that was so devastating for the young people affected. (Narcolepsy is a condition where there is sudden paralysis or sleep meaning that a normal life is not possible). It is now known that the spike protein circulates for at least 4 months after vaccination and there has been a post mortem study showing characteristic vaccine induced inflammation of the coronary arteries leading to death 4 months after the last dose. The FDA only looked at the risk for the first 28 days.

Let’s say there was a condition where there were more cases in that 28 day period than in a random 28 day period used as a control. This would be very concerning because of a phenomenon called the “healthy vaccinee effect”. People tend to postpone vaccination when they are unwell such that every condition would be expected to be less common in the period immediately after vaccination. To measure the size of this effect it is important to include conditions in the analysis for which there is no expectation of an association as a control. For example, this group included coeliac disease as a control diagnosis. The FDA did not include a control condition.

The FDA methodology did not make a straightforward comparison. Instead they removed all the people who did have the condition but had not got a complete medical record for 365 days prior to the condition being noted. This might have been more justifiable if they had also removed people from the historical data who had not had an intact record for 365 days, but they did not.

They then removed all the people with the condition after the vaccine who had had a diagnosis of that condition in the 365 days prior to vaccination. They did not do the same for the control group.

If vaccination causes an increased risk of myocardial infarction, pulmonary embolism or other clotting problems then it would not be unreasonable to suspect that people who already had a propensity for those conditions would be at highest risk. Not only was their data removed but no separate analysis was reported for this group.

Having removed these people from the vaccination group the scales tipped such that there was only a slight difference between the control group (including people with bad records and previous history) and the post vaccination group (excluding those people). Even then the risk after vaccination was still higher in most of the groups analysed than in the control group.

The FDA then compared the vaccination group with data on people who had had an influenza vaccination. Again, they do not state that they excluded people who had not got an intact medical record or who had had that condition recently. Finally, they managed to tip the scale enough to claim that the vaccines were safe for myocardial infarctions and clotting issues but not pulmonary embolisms in the over 65 year olds. The rate of transverse myelitis was 4 to 7 times higher in those 12-64 year olds given Janssen (an adenovirus vaccine similar to Astrazeneca) but the FDA still concluded they “identified no safety signals.” … Full article

January 4, 2023 Posted by | Science and Pseudo-Science | , | Leave a comment

Opposition to Childhood Vaccine Mandates on the Rise, More Parents Say They Want the Right to Choose

Michael Nevradakis, Ph.D. – The Defender – December 16, 2022

A growing number of parents oppose vaccine mandates as a precondition for public school attendance, and interest among adults in receiving COVID-19 booster shots is waning, according to a national poll by the Kaiser Family Foundation (KFF).

The results of the latest KFF COVID-19 Vaccine Monitor survey, released today, show more than one-third (35%) of parents now believe they should be the ones to decide whether their children receive a slate of childhood vaccines.

The poll encompassed a nationally representative sample of 1,259 adults who were interviewed between Nov. 29 and Dec. 8. According to The New York Times, the KFF is a “nonpartisan health care research organization.”

“It’s unfortunate that it took a wave of injuries and deaths from vaccines that never should have been released into the market — much less mandated — to draw long-overdue attention to the issue of vaccine safety,” said Robert F. Kennedy, Jr., chairman and chief litigation counsel for Children’s Health Defense.

Kennedy told The Defender :

“This latest poll is encouraging for those parents, physicians and scientists who for decades have been calling for an investigation into the relentless promotion by FDA, CDC and Big Pharma of inferior medical products without rigorous safety testing.

“As more parents begin to question the forced, routine administration of vaccines on healthy children, perhaps we will move closer to protecting children and holding vaccine makers and government agencies accountable for the harm these products cause.”

26% of parents today: ‘Risks of childhood vaccines for measles, mumps, and rubella outweigh the benefits’

According to the KFF poll, 65% of parents of children under age 18 “think healthy children should be required to be vaccinated to attend public schools.”

This represents an 11% decline from an October 2019 Pew Research Center poll showing 76% of parents supported public school vaccine mandates.

More than one-third of parents surveyed (35%) “now believe parents should be able to decide not to vaccinate their children, up from 23% in 2019.”

The poll also revealed declines in support for specific vaccines. For instance, 71% of respondents said “healthy children should be required to get vaccinated for MMR in order to attend public schools” compared with 82% who supported the MMR vaccine mandate for healthy children in 2019.

Nearly 3 in 10 parents (28%) said parents should be able to choose whether their children receive the MMR vaccine, compared with 16% in the 2019 poll.

A similar percentage (26%) responded that the “risks of childhood vaccines for measles, mumps, and rubella outweigh the benefits.”

A smaller decline was noted in the percentage of adults (85%) who felt the benefits of childhood MMR vaccination outweigh the risk. This represented a three-percentage-point decline from the 2019 Pew Research Center poll (88%).

These declines were driven by increased vaccine “skepticism” and a growing movement toward parental choice, on the part of Republicans and Republican-leaning independents — 44% of whom responded that parents should have a choice about whether or not their children receive the MMR vaccine, up from 20% in 2019.

Only 11% of Democrats provided the same response.

Moreover, only 56% of Republicans and Republican-leaning independents said “healthy children should be required to be vaccinated to attend public schools,” a decline of 23 percentage points compared to 2019.

A similar divide was apparent among respondents in reference to their COVID-19 vaccination status. While 83% of vaccinated respondents said healthy children should be required to be vaccinated in order to attend public schools, 63% of unvaccinated parents said parents should instead decide.

‘Tepid’ interest in COVID ‘boosters’ and flu vaccine

Interest in the updated COVID-19 booster is “tepid,” according to the KFF poll, which showed only 1 in 5 adults (22%) surveyed said they have received the updated bivalent booster and an additional 16% said they plan to receive it “as soon as possible.”

However, 12% of respondents said they would “wait and see” before deciding whether to get the new booster, 13% said they would get it only if required and 9% said they would “definitely not” get it.

An additional 27% were unvaccinated or only “partially” vaccinated, which means they are not eligible to get the booster.

Interest in the bivalent booster was highest among adults 65 and older (39%) and Democrat voters (38%), though both figures fall significantly short of a majority. Conversely, only 12% of Republicans and 11% of young adults under 30 said they had received a dose of the updated booster.

Also, 36% of “fully vaccinated” adults 65 and older said they don’t think they need the updated booster, while a “similar percentage,” according to KFF, said they did not think the benefit of the updated booster was worth it.

Overall, fewer than half of parents of children under 18 said their child has received the updated booster or is likely to do so.

Combined with children who have not been vaccinated and who are therefore ineligible for the booster, 58% of parents of 12- to 17-year-olds and 70% of parents of 5- to 11-year-olds responded in this manner.

Republicans and Republican-leaning independents, even if vaccinated, expressed skepticism toward the updated booster, with 64% stating they do not think they need it, and 61% saying they did not believe the benefit was worth it.

Even among Democrats, a majority (51%) said they were too busy or hadn’t had the time to get the updated booster, indicating it was not a high priority for them.

Even in the face of a so-called “tripledemic” of COVID-19, flu and RSV (respiratory syncytial virus) this fall and winter, and despite the majority of parents saying they are worried their children will get sick from RSV (56%, and 73% of parents of children under the age of 5), only 34% of parents said their child has gotten a flu shot this season.

Parents’ rights movement growing in prominence

According to The Times, “The shift in positions appears to be less about rejecting the shots than a growing endorsement of the so-called parents’ rights movement.”

Dr. Sean O’Leary, chairman of the American Academy of Pediatrics’ Committee on Infectious Diseases told The Times :

“The talking point that has been circulated is the concept of taking away parents’ rights. And when you frame it that simply, it’s very appealing to a certain segment of the population.”

O’Leary said he worried that the parental rights movement might slow down compliance with state-mandated childhood immunization schedules, telling The Times “We do have a global dip in vaccine coverage. So this is not a time to be considering a rollback of these laws.”

Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”

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.

December 17, 2022 Posted by | Civil Liberties, Full Spectrum Dominance | , , , , | 1 Comment

Mercury/Alzheimer’s – Boyd Haley interviewed by James Delingpole

James Delingpole | November 19, 2022

In 1967, Haley obtained an M.S. degree from the University of Idaho. He then entered a doctoral program at Washington State University, where he worked to make chemical modifications on ATP to try to identify how and exactly where ATP binds to cause muscle movement. In 1971, WSU granted him his Ph.D. degree in chemistry-biochemistry.
https://emeramed.com/about/

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December 15, 2022 Posted by | Corruption, Science and Pseudo-Science, Timeless or most popular, Video | , | 2 Comments

U.S. Lawyers Claim Ivermectin was never prohibited for treating COVID-19. FDA merely recommended not using it.

No legal prohibition authorized or justified hospitals to withhold the drug from dying patients. Let the lawsuits begin.

FDA tweet against using ivermectin. Not a prohibition, merely a recommendation.
By Dr. McCullough & John Leake · Courageous Discourse · November 22, 2022

The Epoch Times recently reported an astonishing statement by a U.S. government lawyer in a federal court in Texas, where the FDA is being sued by Dr. Paul Marik of Virginia, Dr. Mary Bowden of Texas, and Dr. Robert Apter of Arizona. The three plaintiffs claim the FDA illegally prohibited them from prescribing the drug to their patients. At a November 1 hearing, U.S. lawyer Isaac Belfer argued for the defendant:

The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”

If Belfer’s assertion is true, it raises a very urgent question: On what legal grounds did hospitals all over the United States refuse to administer ivermectin to severely ill COVID-19 patients, even when patients and their family members begged for the drug to be administered?

If ivermectin was not prohibited by the FDA or any other U.S. medical authority for treating COVID-19, why did Dr. Paul Marik’s hospital prohibit him from administering the drug to his dying patients? Why was Dr. Mary Bowden reported to the Texas Medical Board for disciplinary action when she prescribed it? Why did many pharmacists fear losing their licenses if they filled ivermectin prescriptions for treating COVID-19?

In our book, The Courage to Face COVID-19: Preventing Hospitalization and Death While Battling the Bio-Pharmaceutical Complex, Dr. McCullough and I document numerous instances of hospitals flatly refusing to grant the wishes of dying patients and their family members for ivermectin.

All these patients asked for was to be allowed to try the drug (FDA-approved for River Blindness, Elephantiasis, and Scabies) for COVID-19. The patients and their kin gladly indemnified the hospitals and arranged to have their independent primary care doctors deliver and administer the drug. Nevertheless:

  • Hospital administrators absolutely refused to grant this wish.
  • Hospital attorneys fought tooth and nail against using ivermectin to treat COVID-19 patients, doing everything in their power to challenge patient lawsuits and appeal court orders to administer the drug.
  • Even when hospital doctors acknowledged that the patients were dying, they insisted it was better to let the disease take its natural course rather than allow patients to try ivermectin.
  • Even when patients’ families succeeded in getting a court orders to administer the drug, many hospitals still refused, even at the risk of being held in contempt of court.

Several readers have told us that our chapters covering this shameful scandal— Chapters 38: Begging for the Wonder Drug and Chapter 40: Graduating into Eternity—are horrifying beyond belief.

Now we hear U.S. government lawyers arguing in court that the FDA never prohibited using ivermectin to treat COVID-19 patients, but merely recommended not using it. This indicates that hospitals had no legal grounds for denying sick patients a drug that could have helped them. How is withholding medicine from a sick man any different from withholding a life ring from a man who has fallen overboard in high seas?

For families who watched their loved ones slip away after being denied the right to try ivermectin, U.S. attorney Isaac Belfer’s statement may be interpreted as declaring open season for lawsuits against hospital administrators and doctors.

November 22, 2022 Posted by | Civil Liberties | , , , , | 2 Comments

For the Love of Money

Pfizer’s quest for blockbusters by hook or by crook

Author’s Note: The following post is an excerpt from The Courage to Face COVID-19: Preventing Hospitalization and Death While Battling the Bio-Pharmaceutical Complex, by John Leake and Peter A. McCullough, MD, MPH. Please note that a special and very handsome hardcover edition, published by Skyhorse with a forward by Robert F. Kennedy, Jr., will be released tomorrow (November 22).

By John Leake

Long before COVID-19 arrived, I was a close observer of the pharmaceutical industry. My great grandparents believed that pharmaceutical labs were at the forefront of progress, relieving suffering and extending life, and for the most part they were right. My paternal great grandfather owned a large chain of drugstores and was a benefactor of UT Southwestern Medical School. At the time of my birth, my maternal great grandmother gave me a generous gift of Pfizer stock. She had been impressed by Pfizer’s key role in discovering how to mass produce penicillin during World War II (in which her son was killed in action). Eighteen years later her gift paid for my university education. And then, in 1998, Pfizer received FDA approval to sell Viagra.

Pfizer initially developed the drug to treat high blood pressure and angina pectoris. However, as Pfizer’s researchers discovered in clinical trials, the drug was better at inducing erections than managing angina. And so, the company repurposed the drug for erectile dysfunction and launched a massive, global PR and marketing campaign—including seeking moral approval from Pope John Paul II and contracting the war hero and 1996 presidential candidate Bob Dole to be the brand’s poster gentleman—that succeeded in making Viagra a blockbuster. Fortunately for me, I still owned a large chunk of Pfizer stock. The price spiked in late 1998 and reached an all-time high in April of 1999. I sold my entire remaining position, which financed my early years as a freelance author, before my first book was published.

So, I learned firsthand why pharmaceutical companies seek to develop blockbuster drugs with fanatical zeal. Formulating a safe and effective new medicine to address a large, unmet need is very difficult and expensive. Performing clinical trials and obtaining FDA-approval is an arduous process that normally takes several years. Thus, if an opportunity for a new blockbuster presents itself, a big drug company like Pfizer will go to extreme lengths to seize it.

Three years after the release of Viagra, I learned that Pfizer was not the entirely respectable company my great grandmother had believed it to be. I arrived at this realization through my interest in British spy novels. In 2001 I lived in Vienna, around the corner from the Burgkino (Burg Cinema) which still played the 1949 film noir classic The Third Man on its big screen every weekend. I spent many a dreary winter Sunday afternoon watching the film. Based on the novella and screenplay by Graham Greene, The Third Man is a crime story about Harry Lime—an American running a medical charity in Vienna, who makes a killing selling penicillin on the bombed out, impoverished city’s black market. To increase his profits, he cuts the drug with other substances, thereby destroying its efficacy and causing the patients (including children) to die horribly from their infections.

In the film’s most iconic scene, the good guy (played by Joseph Cotton) meets his old friend Harry Lime (played by Orson Welles) on the Giant Ferris wheel in the Vienna Prater amusement park and tries to appeal to his conscience. At the wheel’s apex, the charismatic Harry opens the door, points down to people walking on the ground below, and says:

Look down there. Would you really feel any pity if one of those dots stopped moving forever? If I offered you twenty thousand pounds for every dot that stopped, would you really, old man, tell me to keep my money, or would you calculate how many dots you could afford to spare? Free of income tax, old man. Free of income tax. … Nobody thinks in terms of human beings. Governments don’t, why should we? They talk about the people and the proletariat; I talk about the suckers and the mugs. It’s the same thing. They have their five-year plans, and so have I.

I sensed that Graham Greene might have based the story on something he’d witnessed or heard about. Doing some research, I learned that Harry Lime was probably based on the British spy Harold “Kim” Philby, with whom Greene worked in British intelligence during World War II. Greene, it seems, discovered that Philby was a Soviet double agent long before he was exposed as such in 1963. Instead of ratting out his friend, he kept it to himself and left the intelligence service in 1944. Several pieces of evidence suggest that when he wrote The Third Man a few years later, he based it on his conflicted friendship with Philby.

John le Carré was also fascinated by Graham Greene and Kim Philby, and his thriller Tinker, Tailor, Soldier, Spy—one of my all-time favorites—was inspired by the Philby story. His novel The Constant Gardener was published in 2001, and I read it with great interest. The story wasn’t set in Cold War Europe, but in Kenya, where a British diplomat’s wife is brutally raped and murdered. Upon closer examination, the diplomat realizes that she was about to reveal a horrifying crime committed by a pharmaceutical company, which murdered her in order to prevent the exposure.

The novel’s plot was reminiscent of a controversial drug trial performed by Pfizer in Kano, Nigeria in 1996 during a meningococcal outbreak. For the trial of its new antibiotic, trovafloxacin, Pfizer gave 100 children this new drug. The control group of 100 other children received the standard anti-meningitis treatment at the time—a drug called ceftriaxone. However, for the control group, Pfizer administered a substantially lower dose of ceftriaxone than the drug’s FDA-approved standard.

When the reduced dosing in the control group was discovered, it raised the suspicion that Pfizer did this in order to skew the trial in favor of its new drug. Five of the children who received trovafloxacin died, while six who received the reduced dose of ceftriaxone died. Other children apparently suffered grave injuries from the administration of the experimental antibiotic without their informed consent. The investigation and litigation that ensued was the stuff of a thriller, involving private investigators, bribery, blackmail attempts, and disappearing records. Thirteen years later, in 2009, Pfizer settled out of court with the plaintiffs.

In his author’s note, le Carré claimed that nobody and no corporation in the novel was based on an actual person or corporation in the real world.

But I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.

In 2009, the same year that Pfizer settled with the trovafloxacin plaintiffs, the New York Times reported that a U.S. federal judge assessed Pfizer with the “largest health care fraud settlement and the largest criminal fine of any kind ever” for its illegal marketing of Bextra and three other drugs. The U.S. Department of Justice was unequivocal in characterizing Pfizer’s officers as guilty of grave criminal conduct at the expense of the American public.

November 21, 2022 Posted by | Book Review, Corruption, Deception, Timeless or most popular, War Crimes | , | 1 Comment

US FDA Willfully Blind on the Safety of COVID-19 Vaccination

How Our Regulatory Agency Got Out of the Way from the Beginning

By Dr. Peter McCullough | Courageous Discourse | November 18, 2022

When the US HHS invoked the Emergency Use Authorization and the Department of Defense offered COVID-19 vaccination to be administered by the US FDA and CDC, it was clear the FDA was going to play no role in stopping the vaccination freight train that was about to steamroll America. A recent paper from Dr. Maryanne Demasi points out that the FDA “checked-out” early in the COVID-19 pandemic:[i] “Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected. Now, facing a backlog of site inspections, experts have criticized the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated covid-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified—effectively keeping scientific misconduct from the medical establishment. The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and was then appointed as a senior adviser to the FDA commissioner in 2019-21.”

Demasi goes on to point out the FDA suspended inspections and despite having vast resources, does not utilize their discretionary budget to protect Americans from product safety threats. “With a total budget of $6.1bn in 2021, he [Gortler] suggests the agency needs to be leaner and more efficient, with employees interested in improving public health.” “The bottom line is that the FDA has over 18,000 full time employees, more than any other drug regulatory agency by far, so it could have retrained and retooled anybody to tackle the need for increased inspections,” he says. “Half of its budget, about $3bn, is discretionary, which means it could have hired contractors, retirees, or repurpose existing workers. It chose not to. The FDA was just yawning its way through the pandemic. The entire agency is broken.” “The lack of full transparency and data sharing does not allow physicians and other medical scientists to confirm the data independently and make comprehensive risk-benefit assessments,” continues Gortler, who is now a fellow at the Ethics and Public Policy Center thinktank in Washington DC.”

The most egregious example of FDA malfeasance is the intent to withhold release of the Pfizer regulatory dossier on its COVID-19 vaccine for 55 years knowing it contained reports of 1,223 deaths shortly after administration of their vaccine. In a continued set of historic blunders, the FDA approved the COVID-19 bivalent vaccines with no randomized trials powered for clinical outcomes with Omicron, and no information on safety. I believe Drs Demasi and Gortler are correct, the FDA is broken beyond repair, officials and staff involved in malfeasance should be named as targets in federal investigations since so many lives have been impacted by their malfeasance.

[i] Demasi M. FDA oversight of clinical trials is “grossly inadequate,” say experts BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o2628 (Published 16 November 2022) Cite this as: BMJ 2022;379:o2628

November 18, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , , , | 1 Comment

Swissmedic and Vaccinating Doctors Criminally Sued for Authorizing and Administering Covid-19 mRNA Jabs

Do not underestimate the Swiss diligence

By Andreas Oehler | Live To Fight Another Day | November 14, 2022

The detail-oriented Swiss are taking their medical establishment to task in a big way for authorizing and administering the Covid-19 mRNA jabs, in a formal criminal complaint.

“That is what the criminal complaint against Swissmedic is about” (SRF, 2022.11.14):

That’s what it’s all about: On July 14, 2022, a lawyer submitted a 300-page criminal complaint to the responsible cantonal public prosecutor’s office on behalf of six people allegedly injured by mRNA vaccinations. It is directed against three representatives of the Swiss licensing and supervisory authority for medicinal products and medical devices (Swissmedic) and five vaccinating doctors from the Inselspital in Bern. A criminal investigation is to be opened against them. The lawyer has now gone public with a media conference.

These are the plaintiffs: The lawyer for those affected, Philipp Kruse, is a declared opponent of vaccination and Covid measures. He represented people who refused to wear masks or parents who didn’t want their children to take part in pool tests. Doctors who were noticed as corona skeptics also appeared at the media conference.

This is what the indictment says: The defendants are accused of violating basic drug law due diligence by allowing and administering the Covid 19 vaccination. There are a number of other charges listed, including intentional or possibly negligent bodily harm, endangering life, killing and abortion.

These are the alleged damages: According to lawyer Kruse, the damages range from circular hair loss, derailment of the menstrual cycle to polyarthritis, muscle weakness and chronic exhaustion to the death of a 20-year-old person. Some of the six victims listed are still unable to work. The connection to the Covid 19 vaccination was confirmed by experts in five cases. In the case of the deceased, the causal connection must be proven on the basis of pathological examinations. However, these investigations are not yet complete.

What Swissmedic says: Nothing. Swissmedic does not want to comment on the ongoing court proceedings. The Federal Office of Public Health and the Federal Vaccination Commission also do not want to comment.

What may fly under the radar in other countries, in terms of the lack of accountability and responsibility for Covid-19 jabbing injuries, is unlikely to pass muster in Switzerland. The Swiss pride themselves on being OBJECTIVE, diligent, thorough and just. Because of these very high public expectations, it is impossible to sweep under the carpet, gaslight, or outright ignore the laws on the books over there, let’s hope:

It is about these articles of the Medicines Act

Art. 3 Duty of care 1 Anyone who handles medicinal products must take all the necessary measures based on the current state of science and technology to ensure that the health of humans and animals is not endangered.

Chapter 8: Penal Provisions Art. 86233 Crimes and misdemeanors 1 Anyone who willfully: a. manufactures, places on the market, uses, prescribes medicinal products without the necessary authorization or authorization, contrary to the terms and conditions associated with an authorization or authorization or contrary to the due diligence obligations stipulated in Articles 3, 7, 21, 22, 26, 29 and 42, imports, exports or trades abroad; (…).

Link to the Medicines Act .

Also of note here is that Swissmedic is the key conduit of the global vaccination programmes in partnership with Bill&Melinda Gates Foundation and WHO, and also FDA.

Good luck in court!

November 16, 2022 Posted by | Civil Liberties, Science and Pseudo-Science, War Crimes | , , , | 2 Comments

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

By Maryanne Demasi, PhD | November 10, 2022

History shows that hiding clinical trial data can be deadly.

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

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

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

Europe ahead of the pack

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

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

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

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

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

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

It was a bitter-sweet moment for Gøtzsche.

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

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

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

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

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

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

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

Canadian regulator in the cross hairs

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

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

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

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

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

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

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

What about the US FDA?

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

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

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

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

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

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

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

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

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

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

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

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

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