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.
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.
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.
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.
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 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.
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.
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
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/
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!)
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