When Clinical Trials began in the 1950s, investigators knew the patients and because of this could spot changes in them for the better or the worse. The expectation was that they would make a judgement call about things happening in a trial and, in many cases, would link the drug to an event – good or bad.
Company Strategy 101
Starting in 1990 with Prozac, and becoming ever more hard-line after that, the company line changed to – only RCTs can tell if a drug has caused something. See Vampire Medicine. This means that we should wait until after the trial is over and see if there are statistically significantly more events on treatment than on placebo before deciding a drug can cause an event.
However, if the raw data suggested there were more events on treatment, between coding strategies and statistics companies could find creative ways to make that disappear. Study 329 – Children of the Cure – offers a compendium of some of these strategies.
The new company line was that no matter how compelling an individual case might be even to a doctor who knows you well, it is only if there is a statistically significant increase in the number of such events is it possible to say that treatment has likely caused it. Your story might be compelling but you became an anecdote.
Company Strategy 102
More recently, as outlined in Harmatology, after a number of doctors in India linked deaths in young women to HPV vaccines, companies running trials set up programs to educate investigators. This was co-ordinated by MRCT, an organization set up by Pfizer in 2010 after they had resolved an action with the US Department of Justice for over $ 2 Billion.
Few if any clinical trial investigators, or doctors in the US, Europe, India or elsewhere, have any clinical training in how to establish adverse events. Making a link to a drug was a matter of common sense.
The absence of formal training gave MRCT a blank slate to work on and the aim of the new program was to ensure investigators would be forced to look at any possible cause other than the vaccine – it’s tempting to suggest almost down to preferring abduction by and injury on an alien spacecraft.
Later WHO Guidance on adverse events in vaccine trials now close to prohibits investigators from making a linkage.
This is a perversion of the traditional medical approach to establishing a Cause and Effect, where every day of the week doctors and patients decide between them if a drug is causing a problem or is working. If these judgements aren’t mostly right medicine’s ability to save lives would be severely compromised.
It is no surprise that attempting to change the way both doctors and patients make links to treatment has led to a fall in life expectancies – see Shipwreck and Salvage.
Double-Blind Double-Bind
A double-bind refers to a communication style where a parent perhaps gives a verbal message to a child – daddy or mommy loves you – while their physical posture or facial expression says the opposite.
Having spent three decades undermining the views of investigators, it comes as a surprise to find that Pfizer and other companies lay great store on the investigators views as the vignette below and vignettes to come illustrate.
This vignette is drawn from a file of Narratives, supposedly authored by investigators in the Pfizer trial, with someone in Pfizer reviewing the investigators judgement about whether there was any link between the event being reported and their vaccine.
The fact that there is a narrative means that what the investigator appears to think remains important, indeed central – for Pfizer and FDA – but not for the original reasons such as knowing the patient and being able to spot a difference. Just the opposite.
The investigator in this and other instances – see Miracle in Buenos Aires – never links the vaccine to the injury. But because he or she is on the ground and is clinically trained, it is semi-assumed s/he is the one best placed to give a steer on whether there is a link.
As a result, in close to all cases, Pfizer concur with the investigator, even when the diagnosis remains Suspected Covid in the face of multiple negative tests.
Why is the investigator important? Well, if s/he rules out a link to treatment, it makes it hard for some remote individual in FDA to go against him/her and claim there is a link. And if the investigator, the company, and the regulator all rule out a link, it is easier to exclude this event from analyses.
In the real rather than the digital world, truth does not emerge from adding up columns of figures. Patterns that might emerge as in the increased rate of fractures on placebo in Pfizer’s trial do not prove placebo causes fractures – they call for more investigation. Who knows what is happening. Perhaps suspecting they are on placebo, people in the trial were taking something else to ward off risks which led to car crashes or other accidents etc.
We ideally need to be able to ask the investigator what s/he was thinking before crediting a link. In study 329, one investigator blamed placebo for an attempted suicide. He did so after the blind was broken – his thinking was that this child was on nothing and their illness would not have caused them to attempt suicide had s/he been on treatment. There is a certain logic here. The point is we need details of what the investigator knew and understood rather than just figures.
Patient 10131084
Here is the clinical information Mike Dever, the investigator, reported about Subject C4591001 1013 10131084, a 49-year-old white female.
She enrolled in site 1013 – Clinical Neuroscience Solutions Inc. run by Michael Dever MD in Orlando, Florida, who received $5 Million for his work for Pfizer in 2020.
The only pertinent medical history recorded was of a right renal aneurysm and right renal stent insertion, both in Feb 2020. She received Dose 1 of BNT162b2 on 05 Aug 2020 and Dose 2 on 26 Aug 2020 (Day 22). Hereafter the days are counted from the second vaccine.
On day 6 in her e-diary she reported vomiting and on day 7 severe vomiting.
On day 6, she presented to the emergency room (ER) with vomiting and abdominal pain. A computerized tomogram was performed which revealed a ‘clogged’ stent. The subject was given fluids (unspecified) and observed in the ER, and later, was sent home.
On day 7, she was diagnosed with an obstructed renal artery stent.
On day 9, she developed fever (body temperature was not reported) and went to the ER again with symptoms consistent with urinary tract infection. Subsequently, she was hospitalized and was given antibiotics (unspecified). She was discharged home on day 11. There is no more clinical information.
Facts from other Pfizer sources.
The A/E is dated from Day 7 and “continues”
Toxicity grade 2 = “Moderate; minimal, local or noninvasive intervention indicated”
The AE was classed as “not vaccine related” and not due to any other concomitant treatment.
The event was classed as “recovering/resolving” and as SAE but not an immune AE
This is the causality assessment in the FDA submission.
The vascular stent occlusion was ongoing at the time of last available report. In the opinion of the investigator, there was no reasonable possibility that the vascular stent occlusion was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to the renal stent. Pfizer concurred with the investigator’s causality assessment.
FDA Review
FDA primarily review Suspected Unexpected Serious Adverse Events (SUSARs). Events like this one that are not flagged up as Suspected will not get reviewed.
As part of the FDA Clinical Review Memo, August 23, 2021 – COMIRNATY – only unsolicited adverse events reported by at least 1% of participants (i.e. >200) in any treatment group are presented, unless they are of predetermined clinical interest. Deep Vein Thrombosis (DVT) and Other Venous Thromboembolic Events are “of clinical interest” but arterial events are not.
This event has not apparently been reviewed by FDA.
Coding
If reviewing this event as unrelated does not eliminate it, the MedDRA coding system used in this trial will dump this clotting event into a General Bodily Disorder category rather than into a thrombosis category because the clots happened in an artery rather than a vein. These clots will be lost in GBD.
While it is not unreasonable to file this event under GBD, the clinical investigator in a trial has also got the discretion to code it under several different headings within MedDRA and the Brighton Collaborative Project files it under Haematologic Thrombo-embolism Thrombosis heading. But it is unlikely that Mide Dever did any coding as such.
When he was working out what to write and what linkages to make, Dr Dever will have been shepherded by trial monitors from ICON and other companies. Queries will have been raised by email and phone perhaps from as far afield as Japan. There were many players who would have had the wherewithal to get hold of this lady’s records.
Given how scanty the details are, none of these queries seem likely to have asked for much extra detail or if they ask for and got more details, no-one suggested including those details in this narrative.
There is nothing in the narrative that suggests Dr Dever or anyone liaising with him had any interest in establishing what actually happened.
Objectivity and credibility comes with evidence of input from others, from awkward questions asked, not from statistical significance tests performed on numbers.
Consent Form
A further problem with this bare narrative is that the Consent form this lady signed for this trial said that Pfizer would cover all harms linked to the trial. She will have been given Dr Dever’s number to contact in the event of anything going wrong. Dr Dever is acting as her clinician not just as an ‘investigator’.
It is unlikely Dr Dever is her family doctor and quite possibly he did not even see her in the trial.
We don’t know what Dr Dever knows about renal artery stents? Between half and two-thirds of these stents are patent after 5 years. They are usually done for renal artery stenosis, and it is the artery that begins closing not that the stent gets filled with clots. This lady didn’t have renal artery stenosis.
Chances are this is not Dr Dever’s area. There is no sign though that he has consulted either the team looking after this lady in hospital or anyone who knew anything about renal stents. The lady’s renal aneurysm is unusual – why was a stent put in? This is not common. What if anything was done to clear the thrombosis?
People given these vaccines quite commonly have blood in their urine afterwards and other kidney reactions. This lady was recorded as having a suspected urinary tract infection, but tests for infection proved negative. An immune reaction post vaccine seems a possible alternate cause of this lady’s kidney changes – both the suspected infection and her thrombosis.
See React19.org 1250 studies which contains many reports of kidney injuries following vaccination
Dr Dever
There are all sorts of things that readers can help us with. Dr Dever could do with being researched to find out how much weight we should put on his clinical investigation.
He is 73 years old. The CNS site lists him as someone who also does missionary work.
The certificate he is holding cites him for exceptional input to this trial.
The ideal person to interview would be the lady herself but we seem unlikely to catch up with her.
The bottom line is not – did the vaccine or the stent cause the clots? The stent may have made a clot more likely with the vaccine the trigger – without the vaccine there would have been no clot.
The situation is like that of a woman with osteoporosis who is a passenger in a car that is crashed into and suffers a fractured femur. We don’t absolve the driver of the other car from causing her injury. We hold him responsible. The osteoporosis may have made the fracture more likely, or her bisphosphonate drugs may also have done so, but we view the crash as the cause.
There are interesting cause and effect issues here but this is not our primary question.
Our question is whether based on the data we have, Dr Dever’s judgement that there was no linkage to the Pfizer vaccine is credible?
You can help us by linking to https://vaccines.shinyapps.io/
Postscript
Courtesy of Johanna Ryan:
As I read Dr. Dever’s CV, he has not been regularly treating patients since 1997. From 1998 through 2011 he made his living in the insurance industry as a Medical Consultant, haggling with claimants over amounts and terms of structured settlements. “Insurance Medicine.” It ain’t exactly a field that attracts the best.
Since 2012 he has worked in the clinical-trial industry (with maybe one finger still in the insurance pie). His listing on the Orlando Regional Health System site gives CNS as his office address.
As for the University of Central Florida, he is apparently part of their unpaid “affiliated and volunteer faculty.” There are gazillions of them — half the doctors in Orlando must be involved. The Med School itself was launched in 2009 and achieved accreditation in 2013.
But of course, the Man has been on TV. Check it out (I love the way the news anchor just tosses that box of pills at the viewer!)
Dr Devers experience and interests include:
Acne, Alcohol dependence, Alzheimer’s disease, Asthma, Autism, Attention-deficit hyperactivity disorder (ADHD), Chemical dependence, Chronic idiopathic constipation, Chronic pain, Constipation, Dementias, Depressive disorders, Diabetes, Diabetic peripheral neuropathy, Diarrhea, Diverticulitis, Epilepsy, Fatigue, Female sexual arousal disorder, Fibromyalgia, Flu treatment, Flu vaccine, Gambling cessation, Generalized Anxiety, Gastrointestinal disorders, Gout, Hot flashes, Hyperlipidemia,
Hypertension, Hyposexual arousal disorder, Infectious diseases, Influenza, Insomnia, Irritable bowel syndrome, Lower back pain, Metabolic and Endocrine disorders, Migraine, Mild cognitive impairment, Mood disorders, Musculoskeletal disorders, Obesity, Obsessive-compulsive disorder, Opioid
induced constipation, Opioid withdrawal, Oppositional defiant disorder, Panic disorder, Parasitic diseases, Post-herpetic neuralgia, Post-traumatic stress disorder, Rheumatoid disorders, Schizophrenia, Sexual dysfunction, Skin disorders, Sleep disorders, Smoking cessation, Social phobia, Stuttering, Tropical diseases and Women’s Health.
His industry contacts include
Abbott, Actavis, Afferent, Alcobra, Alder, Alkermes, Allergan, Alvin, Amylin, Arbor, Arena, AssureRX, Avanir, Axsome, BioDelivery, Biogen, Braintree, Bristol Myers Squibb, Cerecor, Collegium, CoLucid, Covance, Covidien, Cubist, Daiichi, Depomed, Dr. Reddy’s Laboratories, Edgemont, Eisai, Endo Pharmaceuticals, Eli Lilly, Esperion, Forest, Furiex, Genomind, Gilead, Jassen, Labrys, Lundbeck, Medgenics, Merck, Neuralstem, Novan, Novartis, Novo Nordisk, ONO, Otsuka, Pfizer, Purdue, Regeneron, Roche, Sanofi, Shionogi, Shire, Sunovion, Synergy, Takeda, Teva, Tonix, US WorldMeds, Vertex, and Wyeth.
Pfizer recruited a huge network of private clinical-trial centers—and fast–for its Covid vaccine trials. A number of the biggest ones are psychiatrist-headed, and had made most of their money on psych med trials until recently.
That includes CNS Healthcare. It has 3 locations, in Orlando and Jacksonville FL and Memphis TN. Each has two psychiatrists (3 in Jacksonville), a clinical psychologist, and an internal-medicine doc as investigators. All 3 internal-med docs seem to have spent a lot of their time on psych-adjacent problems like addiction, obesity, eating disorders and sexual dysfunction.
Other centers like this include Indago Research and Research Centers of America in Florida, Collaborative Neuroscience in California, and Atlanta Center for Clinical Research in Georgia. Some only recently hired an internist (or recruited one away from a rival trial center), others had one on tap already.
Together, these places account for several thousand subjects. How prepared are they to handle complex kidney, liver, circulatory or other issues the vaccine might potentially cause? Not very prepared at all, I’m guessing. Which means they would probably defer to any “expert opinion” e-mailed to them from ICON, the CRO in charge.
Fernando Polack was a walk in the Rio, with an ice-cream, compared to Dr. Michael E. Dever and his position as investigator.
Doximity
Summary
Dr. Michael Dever is a researcher in Orlando, FL and is affiliated with multiple hospitals in the area, including Orlando Regional Medical Center and Health Central Hospital. He received his medical degree from University of Kentucky College of Medicine and has been in practice 35 years. He is experienced in travel and tropical medicine, clinical research, and insurance medicine.
https://www.doximity.com/pub/michael-dever-md
Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine.
Moreira ED, Kitchin N, Xu X, Dychter SS, Lockhart S, Gurtman A, Perez JL, Zerbini C, Dever ME, Jennings TW, Brandon DM, Cannon KD, Koren MJ, Denham DS, Berhe M, Fitz-P…> ;The New England journal of medicine. 2022-03-23
Michael E Dever
https://pubmed.ncbi.nlm.nih.gov/35320659/
Robert F. Kennedy Jr
@RobertKennedyJr
The Biden administration plans to shift distribution of COVID-19 therapeutics to the private sector by January 2023 — despite preparing to extend its COVID-19 public health emergency.
This is of particular significance considering COVID-19 vaccines that are “fully licensed” by the FDA, including Pfizer’s Comirnaty and Moderna’s Spikevax, continue to be largely or wholly unavailable throughout the U.S., with vaccines issued under EUA being administered instead.
https://childrenshealthdefense.org/defender/biden-covid-vaccine-distribution-private-sector/
However, Holland added her view that perhaps, above all, there is simply a great deal of confusion within the Biden administration regarding its next steps pertaining to COVID-19.
She told The Defender:
“I would be hesitant to ascribe too much coherence to any of this. I think the narrative has fallen apart because the shots don’t work and they’re incredibly dangerous. They don’t stop transmission or infection.
“The evidence that they’ve now stopped collecting data overwhelmingly supports the idea that these shots are causing all-cause excess mortality.
“I think it’s just an incoherent situation in a sense. I would tend to think there are some people in control who don’t really know exactly what to do next.”
As I read Dr. Dever’s CV, he has not been regularly treating patients since 1997. From 1998 through 2011 he made his living in the insurance industry as a Medical Consultant, haggling with claimants over amounts and terms of structured settlements. “Insurance Medicine.” It ain’t exactly a field that attracts the best.
Since 2012 he has worked in the clinical-trial industry (with maybe one finger still in the insurance pie). His listing on the Orlando Regional Health System site gives CNS as his office address.
As for the University of Central Florida, he is apparently part of their unpaid “affiliated and volunteer faculty.” There are gazillions of them — half the doctors in Orlando must be involved. The Med School itself was launched in 2009 and achieved accreditation in 2013.
But of course, the man has been on TV. Check it out (I love the way the news anchor just tosses that box of pills at the viewer!)
https://www.wftv.com/news/local/testing-possible-covid-19-vaccine-heading-orlando/UTELDJBYCBEMBISIFHG4PKTN54/?fbclid=IwAR1lf4ENgJNLOazZDdE6_jdIU5nLPnShZP9-xPOncJVCt0JgUV0Bfc946sw
Currently, (that may be out of date) he is Assistant Professor of Internal Medicine at University of Central Florida School of Medicine, Orlando, FL and continues to enjoy medical missionary work with New Missions – Sanford, FL and First Baptist Church of Orlando.
He has extensive experience as an Investigator on over 50 phase I-IV clinical trials in child, adolescent, adult and geriatric populations and is well-known and respected for his attention to patient care and safety.
There’s some pretty weird stuff going on at the church where’ he enjoys missionary work’ including the never ending sex scandals https://www.vox.com/culture/23131530/southern-baptist-convention-sexual-abuse-scandal-guidepost…
Recently, news broke that Ligonier Ministries scheduled their 2022 National Conference at First Baptist Orlando, which concludes this weekend. This was alarming due to the recently exposed heretical teachings espoused by First Baptist. Danny de Armas, the senior associate pastor, infamously offered a full-blown ecumenical statement devoid of any Gospel truth and antithetical to the teachings of Scripture by highlighting how many illegal immigrants, pro-choice demoncrats, and LGBTQ folk were ‘serving’ in his church.
Danny de Armas, First Baptist Orlando make idol of diversity
Published on : February 7, 2022 Published by : Capstone Report
HOME2022FEBRUARY7DANNY DE ARMAS, FIRST BAPTIST ORLANDO MAKE IDOL OF DIVERSITY
but nothing connected to him re church scandals and scoundrels
Pfizer makes a bit of a fetish about diversity but guess that’s to promote their image and encourage recruitment Though cant find anything about how the recruiters are recruited except that there’s a general troll for interest in conducting trials. With such a massive network how the heck do those at the top keep tabs on everything I would have though some at least would go rogue or report misdeeds..
‘original antigenic sin’
“And basically, I would think if the antibodies wane a bit, you just get a booster shot,” Dever said.
Around the world, more than 5.5 million people have become sick with COVID-19, and more than 348,000 people have died, including 2,200 Floridians.
Maryanne Demasi, reports
A 5th jab? Implications for the immune system
FDA advisory member hints at ‘original antigenic sin’
Maryanne Demasi, PhD
7 hr ago
https://maryannedemasi.substack.com/p/a-5th-jab-implications-for-the-immune?r=z8f0i&s=r&utm_campaign=post&utm_medium=email
Now, that the FDA has authorised the new bivalent boosters – which code for the original wuhan strain plus BA4/BA5 omicron lineages – without first requiring any human data to be collected, it has left many doubting that our public health authorities are even paying attention to the science.
https://eu.usatoday.com/story/news/health/2021/01/06/death-florida-doctor-following-pfizer-covid-19-vaccine-under-investigation-gregory-michael/6574414002/
“We are actively investigating this case, but we don’t believe at this time that there is any direct connection to the vaccine,” the statement said.
There is no indication – either from large clinical trials or among people who have received the vaccine since the government authorized its use last month – that it could be connected to thrombocytopenia, the company said.
Pfizer Classified Almost All Severe Adverse Events During COVID Vaccine Trials ‘Not Related to Shots’
https://yournews.com/2022/07/08/2373708/pfizer-classified-almost-all-severe-adverse-events-during-covid-vaccine/
‘Our question is whether based on the data we have, Dr Dever’s judgement that there was no linkage to the Pfizer vaccine is credible?
Or, maybe, Dr. Dever is still working his magic…
Dr Devious
I’m just an ordinary doctor, not an “associate professor”, not receiving millions from Pfizer, and not quite as ancient as Dr D.
First, readers might like to look at the Case Report Form for this unlucky lady. All 179 pages:
https://phmpt.org/wp-content/uploads/2022/06/125742_S1_M5_CRF_c4591001-1013-10131084.pdf#page=158
There you read “SUBJECT DID NOT HAVE A URINARY TRACT INFECTION. MORE
INFORMATION WAS OBTAINED” page 158. Therefore Dever did contact her treating hospital, so could have obtained more information.
Second, on page 176 she was contacted and agreed to receive a third vaccine, so there was another opportunity to get follow up information about her probable vaccine injury.
Finally Dr Dever states “In the opinion of the investigator [himself], there was no reasonable possibility that the vascular stent occlusion was related to the study intervention.
Here we have an unusual event occurring just six days after the subject received an injection of what had a 50:50 chance of being a previously untried novel agent.
Wouldn’t the man in the street say – “Hey we ought to take a close look at this”?
Is Mike Dever putting his employer’s interests ahead of the volunteers – who are, in some respects – temporarily his patients?
Pfizer concurred with the investigator’s causality assessment.
Keeping her brood straight…
Ricell Ann Piojo (pfe.quitor)
SAE RECON 1: The question ‘Is the adverse event serious?’ for OBSTRUCTED RENAL STENT (ARTERY) was answered to No, please confirm if this should be updated to yes per query response below.Also,follow up AEM form needs to be submitted.
Ricell Ann Piojo (pfe.quitor)
SAE RECON: AER#2020345173, AE#2 ‘urinary tract infection’ was inactivated. Please clarify why the event term was removed completed as it should at a minimum be retained as a non-serious event and clarified in a follow-up SAE form
Ricell Ann Quito-Piojo, RN, CMC
https://ph.linkedin.com/in/ricell-ann-quito-piojo-rn-cmc-44335a40
Senior Clinical Data Manager at Pfizer
Metro Manila, National Capital Region, Philippines
Senior Clinical Data Manager
Okt 2019 – Kasalukuyan3 taon
Makati, National Capital Region, Philippines
• Serve as Data Manager with minimal supervision for one or more clinical trials assuming responsibility for DMM activities including selection and application of data acquisition standards, database design (including specification documentation and testing of clinical data collection tools, both CRF and non-CRF, using an EDC system and/or other data collection systems), development and maintenance of the Data Management Plan, data review and query management, data access and visualization, Data Management metrics reporting, database release, and submission related activities.
• In collaboration with the Clinical Data Scientist and Trial Lead, ensure operational excellence across all DMM deliverables.
• Ensure work carried out in accordance with applicable SOPs and working practices.
• Ensure the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
• Ensure operational excellence in collaboration with CDS & Trial Lead for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.
Annie
This is great digging. Thanks. It helps to bring out that there were people around the globe monitoring these things – but not in a fashion that was likely to lead the rest of us to agree that there seems to have been clinical concern here and a good diagnosis.
What we are seeing in paperwork management – not an exercise designed to support clinical care or science
David
Oh dear
https://www.americaoutloud.com/psychotherapist-mattias-desmet-failed-to-report-his-own-mass-murderer-patient/
“Desmet Allowed a Mass Murderer to Go Unreported in His Practice
Psychotherapist Mattias Desmet learned from one of his patients, Ivo Poppe, during therapy, that he had killed many people in the name of euthanasia; but according to news coverage of Poppe’s trial, Desmet testified under oath that he had decided not to report the patient to the authorities.2 A psychiatrist to whom Poppe later confessed killing “dozens” of people reported him to the police. After an investigation, Poppe was jailed in May 2014, on suspicion of multiple murders3 and formally charged with killing 10 people.4 In January 2018, he was found guilty of killing his mother, his two great uncles, his father-in-law, and another woman.5
The psychiatrist who reported Poppe to the authorities testified in Poppe’s case that he was “especially afraid” that Poppe would kill more people.6 But in the trial, Desmet testified as Poppe’s former therapist that he had determined his therapy had worked so well there was no need to report him.”
Dr Malone has been in agreement with Mattias Desmet on mass formation. Peter Breggin – everyone on here knows Peter Breggin’s work for a long if not very long time – has other views on Mattias Desmet:
https://www.americaoutloud.com/mattias-desmet-demoralizes-the-freedom-movement-mass-hypnosis-expert-or-trojan-horse/
In response to this Mattias Desmet says he didn’t think Dr Breggin had fully read his book
“I just wonder: did Peter and Ginger Ross Breggin really look over these and other paragraphs in my book? Do they really believe that I claim that long term mass-formation arises in a completely spontaneous way, without someone ever intentionally steering and manipulating the masses? Did they really overlook that there is an entire chapter in my book about the leaders of the masses? I leave open all possible interpretations of their response. The onus to answer these questions rests upon them.”
https://mattiasdesmet.substack.com/p/am-i-an-expert-in-mass-formation
Dr Malone has come into the comments:
“The failure to discuss is entirely on the Breggin side. read this https://rwmalonemd.substack.com/p/is-mattias-desmet-an-expert-in-mass . I have written emails etc. to both trying to facilitate productive discussion. Mattias has offered to discuss with them. All can be documented. This is not a “both sides are guilty” or other version of “both sides”isms. This is all one way.”
“Robert Wallace Malone
2 hours ago
Professor Dr. Mattias Desmet was traveling back to Belgium yesterday, and I have just received his response the accusations in this article. I post it below to provide a counterpoint to the statements made by Breggin.
“That guy was a former nurse who killed terminally I’ll people with insuline. He came to therapy years after the facts. It was before there was an official legislation about euthanasia. Technically speaking, I was not allowed to break my professional secrecy. You can only break it when someone announces that he will commit new crimes in the future. I did exactly what I had to do. There was no official investigation. No professional action. And moreover, several doctors admitted that this happened all the time in hospitals (before the legislation was passed). It was before there was an official legislation about euthanasia. As soon as this legislation existed, he stopped doing so. But no matter what, I did what I technically speaking had to do. “
I think that most if not all medical professionals who are well versed in the relevant ethics would have done the same. The accusations are baseless.”
Dr Yeadon also in the comments:
“DrMikeYeadon
Reply to
TRH
1 day ago
Desmet does disregard what I think is unequivocally happening.
Quote: “ This is nothing like a streamlined execution of a pre-established plan. If these are conspiracy theorists, they are the lousiest ones ever. “
That’s a very concerning remark. You see, if I’m right, Desmet would be speaking against me. That’s an upsetting possibility.”
Dr. Xavier Figueroa in the comments:
“Dr. Breggin cites Desmet’s work in a very scholarly fashion (see Mass Formation and Mass Psychosis: A False and Dangerous Concept that Threatens Our Freedom – America Out Loud). He does not take Professor Desmet out of context and builds his case assiduously. From your comments, Monica, you have read “The Psychology of Totalitarianism”? In what specific way is Dr. Breggin “utterly absurd”? Please keep in mind that we are talking about a man (Dr. Breggin) who has spent his entire career exposing the very egregious and illegal acts that members of the psychiatric, cybernetic and MK Ultra funded programs were perpetrating on the US and international community. When you look up Informed Consent, there should be a picture of Peter and Ginger next to it.
These programs did not happen in a vacuum and were very carefully hidden and funded. If Dr. Breggin has an ego to stoke, it has been well tempered by the fact that he has seen what happens when you are the only one defending the defenseless that nobody wants to think about.
There is room for disagreement between well-meaning people. Dr. Breggin is pointing out the weakness in Dr. Desmet’s construct of the mass psychosis phenomenon…this surrender to totalitarianism is not a spontaneous event, it is an engineered event. If you believe that the global COVID lockdowns were a natural occurrence and not an engineered event, then I think this is where the dissonance is occurring. Dr. Desmet may be well-meaning, but if these ideas take hold, they will make it much harder to take corrective action.
There is a great deal of danger to ascribe what has happened as a naturally occurring phenomenon due to the passions/mental state of the masses. Remember, the proto-Nazis engineered the Reichstag fire, stoked the hatred towards the untermench after attaining power, bombarded the German populace with fear, ensured that all media was in service to the state and no dissenting voices could be heard (I’m sure that it doesn’t sound familiar now).
As for Dr. Yaedon having doubts about Dr. Desmet’s position on the events that have occurred globally, let’s also keep in mind that he has experienced (first-hand) what bucking the majority will do to you. Dr. Yeadon’s reasoning and explanation are eminently reasonable.
I was grateful when Dr. Desmet and Dr. Malone spoke out and pushed back on the absurd COVID narrative, but we must guard against excusing too much. This was a coordinated global attack, as was well documented in Dr. Breggin’s book, Dr, Ealy’s filing for a grand jury and Dr. Chris Martin’s legal challenge. It is not unreasonable that there are groups stocking division and using groups to do so.
Disagreements must arise for the truth to really come forth.
As for needing to read Dr. Desmet’s book, I am working through it now…but I have also listened and watched many of his interviews and I am seeing a great deal of overlap, which concerns me. Maybe in the future Dr. Desmet may expand on his work and clarify where he stands: engineered or conspiracy theory delusion?”
Well done! Well done! Very moderate tone. (I would have been an ape throwing feces.)
(But I would have mentioned the Event 201 website and the fact that DeSmet refers to people who mention it as “conspiracy theorists.”)
Calling people “conspiracy theorists” works well to quiet the professional class, but I grew up in a blue collar neighborhood, so I’m immune to anything but sticks or stones.
Specialities…
MICHAEL EDWARD DEVER, MD
INVESTIGATOR
CNS Healthcare, Orlando
Clinical Trial Investigator on over 105 phase I-IV clinical trials in pediatric, adolescents
A top health fraud prosecutor recently announced that clinical trial fraud will be a major priority of the U.S. Department of Justice (DOJ).
https://sciencebasedmedicine.org/department-of-justice-prioritizes-prosecution-of-clinical-trial-fraud-but-systemic-reform-is-needed/
According to the DOJ, Unlimited Medical Research, a Miami, Florida, company, was one of several firms hired by a pharmaceutical firm (identified elsewhere as GlaxoSmithKline [GSK]) to conduct a clinical trial designed to investigate the safety and efficacy of an asthma medication in children.
From about 2013 to 2016, employees of the company falsified records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical Research, received physical exams from a clinical investigator, took study drugs as required, and received payments for their participation. Actually, none of this happened: children were not given exams, they did not take the study drugs, and they were not paid. In fact, there were no children at all. Employees, including a medical doctor who served as the primary investigator for the trial, fabricated the entire thing in a scheme to defraud the pharmaceutical company. The doctor used patients’ personal information from her private medical practice to create false information to be entered into case histories for the trial.
The purpose of the study was to measure the long-term safety of the inhaled asthma medication Advair Diskus in patients 4-11 years old. Results were published in the New England Journal of Medicine. According to GSK, once it became aware of possible misfeasance by Unlimited Medical Research, it excluded the fraudulent data from studies and reports and reported its suspicions to the FDA and Institutional Review Boards, hence the prosecutions.
There’s more than meets in eye in that published study and GSK’s response to the fraud, as you shall see.
Five individuals were charged in the scheme. The medical doctor plead guilty to one count of conspiracy to commit wire fraud and was sentenced to 60 months in prison and ordered to pay a $174,000 forfeiture. The study coordinator also plead guilty to conspiracy to commit wire fraud and was sentenced to 30 months in prison. At least one other person is scheduled for trial this year.
Two additional recent incidents of alleged criminal clinical trial fraud not mentioned in Rao’s speech came to light in researching this post, courtesy of an international group of experts who run Rxisk.org,
Blog posts on Rxisk.org, the website I mentioned earlier, offer an interesting insight into how such egregious fraud can happen in the first place:
It’s good to know that the DOJ is prioritizing clinical trial fraud, but if Ryan is correct in her analysis, the drug trial system is ripe for abuse by unethical players.
Until that system is reformed, the DOJ can only come in and mop up the crime scene, and that’s only for the ones who get caught.
PFIZER IS LOBBYING TO THWART WHISTLEBLOWERS FROM EXPOSING CORPORATE FRAUD
Pfizer is among the Big Pharma companies trying to block legislation strengthening whistleblowers’ ability to report corporate fraud.
Lee Fang
November 29 2021, 7:05 p.m.
PFIZER AND OTHER large pharmaceutical corporations are pushing to block legislation that would make it easier for whistleblowers to hold companies liable for corporate fraud.
, major corporate interests, including Pfizer, are fighting an update to the False Claims Act, a Civil War-era law that rewards whistleblowers for filing anti-fraud lawsuits against contractors on behalf of the government.
The law has historically returned $67 billion to the government, with whistleblowers successfully helping uncover wrongdoing by military contractors, banks, and pharmaceutical companies.
The law has been particularly thorny for Pfizer. In 2009, Pfizer paid $2.3 billion in criminal and civil fines to settle allegations that the company illegally marketed several drugs for off-label purposes that were specifically not approved by the Food and Drug Administration. The company instructed its marketing team to advertise Bextra, which was approved only for arthritis and menstrual cramps, for acute and surgical pain issues. The lawsuit, brought under the False Claims Act through the actions of six whistleblowers, ended in one of the largest health care fraud settlements in history.
” In 2016, the Supreme Court ruled in Universal Health Services v. United States ex rel. Escobar that a fraud lawsuit could be dismissed if the government continued to pay the contractor.
The court reasoned that if the government continues to pay a company despite fraudulent activity, then the fraud is not “material” to the contract. That ruling functionally neutered application of the False Claims Act against many companies that are so large that the government cannot abruptly sever payments, especially against large health care interests and defense contractors.
What’s more, the federal government has taken an active role in discouraging cases. In 2018, the Trump administration’s Justice Department issued the “Granston Memo,” which encouraged the dismissal of more whistleblower-initiated suits under the False Claims Act.
In October, Attorney General Merrick Garland officially rescinded the “overly restrictive” memo, a move widely seen as designed to promote greater False Claims Act enforcement.
THE EROSION OF the statute has brought together a bipartisan push, led by Sen. Chuck Grassley, R-Iowa, to update the law to give whistleblowers greater protection against potential industry retaliation and make it more difficult for companies charged with fraud to dismiss cases on procedural grounds.
“A Pentagon bureaucrat is rarely motivated to recognize fraud. That’s because the money doesn’t come out of their pocket.”
The legislation, the False Claims Amendments Act of 2021, adjusts the materiality standard to include instances in which the government made payments despite knowledge of fraud “if other reasons exist” for continuing the contract. The bill also expands the anti-retaliation protections of the law, which currently only cover current whistleblower employees of a company. The bill seeks to prevent an industry from blacklisting former whistleblowers seeking employment.
That push has run into a buzzsaw of corporate opposition, some of it disclosed and some of it shrouded from public view. Pfizer hired Hazen Marshall, a former policy director for Senate Minority Leader Mitch McConnell, R-Ky., to lobby on the issue, along with the law firm Williams & Jensen, a powerhouse that employs an array of former congressional staffers.
Pfizer, which has cast itself as a hero in the fight against Covid-19 and a trustworthy corporate citizen, did not respond to a request for comment.
In an initial test vote, the bill was blocked. In August,
In October, the legislation again found a hearing. Sen. Tom Cotton, R-Ark., attempted to erase most of the bill in a Judiciary Committee meeting. The amendment Cotton proposed sought to strike all substantive lines of the bill except for the first title, which is simply the description of the legislation. During committee debate, Cotton argued that the Supreme Court “made the right decision” in the Escobar case and the “continued payment” standard for materiality. The legislation “potentially could increase health care costs,” the senator argued, echoing industry claims that litigation from the False Claims Act would force health care interests to raise prices.
The American Hospital Association reportedly lobbied to delay a vote, but the bill eventually passed 15-7 out of the Senate Judiciary Committee, with the support of Grassley and his main co-sponsor, Sen. Patrick Leahy, D-Vt.
“This is a very concerted lobbying effort that really took our supporters on Capitol Hill by surprise,” said Stephen Kohn, a whistleblower attorney with the law firm Kohn, Kohn & Colapinto.
Many of the companies engaged in the lobbying fight have chosen to conceal their efforts through undisclosed third-party groups such as the U.S. Chamber of Commerce, which has made the Grassley bill one of its primary targets for defeat. The chamber does not disclose its membership or which corporations direct its advocacy, but previous reporting suggests companies such as Halliburton, Lockheed Martin, and JPMorgan Chase, among others that have faced False Claims Act violations in the past.
Other trade groups — including the American Hospital Association, the Healthcare Leadership Council, the Pharmaceutical Research and Manufacturers of America, and the American Bankers Association — have lobbied against the bill without disclosing the companies directing their actions.
The known corporate interests lobbying on the Grassley bill include Pfizer, Amgen, AstraZeneca, Merck, and Genentech. These companies listed the legislation on lobbying disclosures. All five have paid nine-figure settlements over health care fraud brought to light through the False Claims Act.
“Drug companies are notorious for paying kickbacks, giving benefits in exchange for a competitive advantage. Drug companies and health care firms are about 80 percent of the False Claim[s] Act recoveries for a reason,” said Kohn.
In the case of Pfizer’s record settlement, whistleblowers charged that the company promoted Bextra for uses that were not approved by the FDA, placing patients at risk for heart attack and stroke. The company allegedly paid doctors kickbacks for off-label uses. The False Claims Act, like other “qui tam” laws, awards whistleblowers a portion of the money the government recovers from lawsuits.
“Drug companies are notorious for paying kickbacks, giving benefits in exchange for a competitive advantage.”
“The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,” said John Kopchinski, one of the Pfizer whistleblowers, following the settlement.
Robert F. Kennedy Jr
@RobertKennedyJr
This is huge!
Judge Gives Fauci 21 Days to Turn Over Emails With Social Media Giants
A federal judge on Tuesday ordered Dr. Anthony Fauci and the White House Press Secretary to hand over their communications with five social media giants. The ruling stems from a lawsuit alleging the Biden administration colluded with the companies to censor COVID-19 viewpoints that weren’t aligned with the administration’s official narrative.
https://childrenshealthdefense.org/defender/fauci-biden-administration-covid-censorship-emails-big-tech/
Robert F. Kennedy Jr
@RobertKennedyJr
An analysis by two German university professors of government data implicates COVID-19 vaccination as a factor in excess deaths in Germany, however, public health officials in Germany, the U.S. + elsewhere continue to ignore safety signals.
COVID Vaccines Linked to Excess Deaths in Germany — Where’s the Investigation?
An analysis by two German university professors of government data implicates COVID-19 vaccination as a factor in excess deaths in Germany, however, public health officials in Germany, the U.S. and elsewhere continue to ignore safety signals.
https://childrenshealthdefense.org/defender/covid-vaccines-excess-deaths-germany/
Robert F. Kennedy Jr
@RobertKennedyJr
Pfizer predicted $32 billion in profits from its COVID-19 shots and another $22 billion from Paxlovid — a pill used to treat COVID-19 but can cause the virus to rebound — for a total of $54 billion.
Pfizer to Make Record $54 Billion From COVID Shots and Treatment
Pfizer predicted $32 billion in profits from its COVID-19 shots and another $22 billion from Paxlovid — a pill used to treat COVID-19 but can cause the virus to rebound — for a total of $54 billion.
https://childrenshealthdefense.org/defender/pfizer-covid-vaccine-treatment-sales-record-high-revenue-cola/
Senator Ron Johnson Retweeted
Fox News
@FoxNews
@SenRonJohnson
on ‘Faulkner Focus’: Biden admin spread more COVID ‘misinformation’ than anyone
@FaulknerFocus
Ron Johnson on ‘Faulkner Focus’: Biden admin spread more COVID ‘misinformation’ than anyone
Johnson applauds judge ordering Karine Jean-Pierre, Dr. Fauci to turn over emails on social media censorship
https://www.foxnews.com/media/ron-johnson-faulkner-focus-biden-admin-spread-covid-misinformation-anyone?intcmp=tw_fnc
‘This is huge!’
Gentleman, Ron…
Seeking Potential Plaintiffs in Legal Action Against Pfizer
https://dailyclout.io/seeking-potential-plaintiffs-in-legal-action-against-pfizer/
“We are looking for somebody who owns Pfizer stock and would be willing to be a plaintiff in an action seeking access to books and records regarding the company’s COVID-related business.
Qualifications:
Individuals who have owned Pfizer stock from October 1st, 2021 – present. Further qualification is you must own the shares directly, i.e. not in a mutual fund.
Robert F. Kennedy Jr
@RobertKennedyJr
Yep! Huge problem… Analysis of 27 years of “ongoing, systematic wrongdoing” by Big Pharma shows DOJ levied billions of $ worth of fines against pharma. The fines support government budgets but do nothing to reform the industry’s criminal behavior.
Pharma’s Criminal Business Model — and How the U.S. Government Benefits From It
An analysis of 27 years of “ongoing, systematic wrongdoing” by the pharmaceutical industry reveals the U.S. Department of Justice has levied billions of dollars worth of fines against pharma companies, often under the False Claims Act. The fines support government budgets but do nothing to reform the industry’s criminal behavior.
https://childrenshealthdefense.org/defender/big-pharma-criminal-business-model-us-government/
As Public Citizen noted a few years ago, pharma penalties over the 1991-2017 period represented a paltry 5% of the 11 largest global drug companies’ net profits “during just 10 of those 27 years,” amounting to little more than a slap on the wrist.
Emphasizing the “stark imbalance” between penalties and profits, the consumer group concluded that without more sincere and active enforcement — including prosecution and jail sentences for executives overseeing systemic fraud — “illegal but profitable activities will continue to be part of [pharmaceutical] companies’ business model.”
Your Shout –
Business Pharmaceutical giant GlaxoSmithKline has agreed to pay £1.9 billion (US$3 billion) to US courts for three counts of fraud relating to the marketing of medicines, bringing to an end what the company described as “difficult, long-standing matters for GSK”.
https://www.chemistanddruggist.co.uk/CD015445/GlaxoSmithKline-fined-US3-billion-for-largest-healthcare-fraud-in-US-history
In 2009, Pfizer was fined £1.45 billion (US$2.3 bn) for improperly marketing 13 drugs, making GSK’s £1.9 billion (US$3 bn) fine the largest case in US history.
Why now? Well the vaccine booster roll out has started in the UK …..
2 of 2
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Robert F. Kennedy Jr
@RobertKennedyJr
·
1h
An Indian court ordered Bill Gates, the Indian government + Serum Institute of India—world’s largest vaccine manufacturer—to provide formal responses relating to case filed by father of a 33-year-old doc who died after receiving AstraZeneca COVID vaccine.
https://childrenshealthdefense.org/defender/bill-gates-indian-government-lawsuit-snehal-lunawat-death-astrazeneca-vaccine/
Defendants in the case include Adar Poonawalla, CEO of the Serum Institute; Bill Gates, in his role as partner in the development of the Covishield vaccine; the Indian Ministry of Health and Family Welfare; the Indian State of Maharashtra; India’s drug controller general; the former director of the All India Institute of Medical Science and others.
Snehal’s death is not the only high-profile Indian legal case concerning vaccine injuries or seeking damages against Gates and others.
EXCLUSIVE: FDA Refuses to Provide Key COVID-19 Vaccine Safety Analyses
https://www.theepochtimes.com/mkt_app/exclusive-fda-refuses-to-provide-key-covid-19-vaccine-safety-analyses_4722586.html
“The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak, who sits on one of the FDA’s outside advisory panels, told The Epoch Times.
“What’s the point of having VAERS if you’re not releasing it to the public?” she added.
Witczak said her concerns about vaccine safety were heightened by a recent paper from Dr. Joseph Fraiman and others that found a higher incidence of serious adverse events in vaccinated participants in the original Pfizer and Moderna vaccine trials than in placebo recipients. She noted that the FDA’s 2004 warning for antidepressants that the drugs could increase the risk of suicidal thoughts and behavior came over 10 years after the trials on which it was based.
“If this data is available, shame on you for not making it known to the public,” Witczak said. “It’s as if they don’t trust the people to make their own best decision for what’s good for them and their families.”
Stop Vaccinating Children for Covid: It’s Neither Medically Justified Nor Ethical
As time passes, Covid policy is proving to be a bigger threat than Covid disease. Promoted as an initial protection measure to buy much-needed time against a once-in-a-century pandemic, it became a way of life to which health bureaucrats and autocratically-inclined leaders became addicted and are having trouble letting go.
https://brownstone.org/articles/stop-vaccinating-children-for-covid/
Ramesh Thakur
Ramesh Thakur, a former United Nations Assistant Secretary-General, is emeritus professor in the Crawford School of Public Policy, The Australian National University.
Directing attention and resources without age-stratified discrimination – because “everyone is equally at risk” – made no medical or policy sense, unless, as Lerman postulates, the primary goal was to inculcate a self-sustaining state of mass panic. So even the children had to be routinely tested, isolated, deschooled, masked and vaccinated as part of what Swedish Dr. Sebastian Rushworth called the “Covid mania” and “collective state of hysteria.”. Universal vaccines is like the drunk looking for car keys near the light from the street lamp instead of where he lost them.
Against the extremely low serious risk from Covid with a survival rate of 99.99% for 0-19 year olds, the likely greater risk from vaccines, and the completely unknown long-term effects of the new-technology vaccines, if I had young children, I’d resist attempts to jab them, to the death if necessary.
There’s no sick bucket big enough.
Josh Guetzkow from Jackanapes Junction Unsubscribe
9:53 AM (1 hour ago)
Sep 14
The Epoch Times reported yesterday that the FDA had responded to its FOIA request for its safety monitoring of VAERS using Empirical Bayesian data mining techniques. The FDA told them to take a hike.
Quick background: when we FOIA’d the CDC for their data mining efforts using a method called Proportional Reporting Ratios, they initially told us that they weren’t doing that (even though they said they would). They said it was the FDA’s job (which wasn’t true), and so we should ask the FDA for their safety monitoring analyses using a method called Empirical Bayesian data monitoring, which they claimed was superior (it isn’t).
The Epoch Times beat us to it and already got a response from the FDA:
Not. Gonna. Happen.
What reason did they give? From the Epoch Times article:
The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”
The agency also pointed to the Code of Federal Regulations, which says that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”
I say, if they won’t share it because they don’t have to unless they’re sued, I’d take that as in invitation to sue them!
The Epoch Times article is worth a read, because they did a thorough search for times when the FDA referenced the lack of signal for COVID vaccines from its Bayesian monitoring, including myocarditis. If they aren’t picking up on the myocarditis signal then no wonder they can’t pick up on any others! (Though I don’t believe they didn’t.)
Beyond that, I don’t have more to say. I’m sick to my stomach.
“She noted that the FDA’s 2004 warning for antidepressants that the drugs could increase the risk of suicidal thoughts and behavior came over 10 years after the trials on which it was based.”
A heck of a lot of people died in those 10 years and more suffered horrifically under the guise of “mental illness”
“I say, if they won’t share it because they don’t have to unless they’re sued, I’d take that as in invitation to sue them!”
Yep!
Remember, remember, the 15th of September…
WHO says:
Page 6, upper left-hand column, Scotsman, Thursday 15 September 2022.
https://holeousia.com/2022/09/15/who-says/
End of COVID pandemic is ‘in sight’ — WHO chief
September 15, 2022 | 1:02 pm
https://www.bworldonline.com/world/2022/09/15/474763/end-of-covid-pandemic-is-in-sight-who-chief/
With over 1 million deaths this year alone, the pandemic remains an emergency globally and within most countries.
US health officials have said that the pandemic is not over, but that new bivalent vaccines mark an important shift in the fight against the virus. They predict that a single annual vaccine akin to the flu shot should provide a high degree of protection and return the country closer to normalcy. — Reuters
Today I received a Royal Blue Envelope with instructions to attend the local primary school for my annual flu (never have) and covid-19 booster jab. Wading through all the instructions, along with ‘safe and effective’, it was left to me to send an email to NHS Highland politely cancelling the appointment.
By reply, kind regards for notifying them of my decisions…
Brook Jackson
@IamBrookJackson
·
3h
Coming soon to an injection site near you – a potential EUA product that may be effective to mitigate a disease or condition caused by an FDA-regulated product.
This stops when our government and the people want it to.
I will ask a vascular surgeon whom I know to comment about this post.