Making medicines safer for all of us

War is the realm of uncertainty; three quarters of the factors on which action in war is based are wrapped in a fog of greater or lesser uncertainty. A sensitive and discriminating judgment is called for; a skilled intelligence to scent out the truth.   Carl von Clausewitz

Special Medical Operation

This is the first of two posts on the Special Medical Operation to rollout the Pfizer COVID vaccine.

This Table appears in the first article reporting on the Pfizer Trial, with Fernando Polack as first author.  A few weeks earlier, Albert Bourla, the Pfizer CEO,  told the world the Pfizer vaccine was 95% effective.  Effective here means if you have had the vaccine, you are less likely to have a lab confirmed test for symptoms of COVID.  It does not mean that you will be saved from death or hospital and may not mean you won’t catch COVID.

While Pfizer (and other companies) claimed their vaccines worked extraordinarily well, Governments did not mandate the vaccines to defend people against getting a mostly mild infection, but to reduce transmission which they do not but above all to reduce COVID deaths and hospitalizations.  We were told we needed to prevent admissions in order avoid our health services collapsing.

The Table shows 2 deaths on the Vaccine and 4 on Placebo. Not impressive but multiply it up by millions and maybe countries and politicians can claim there is a mandatable something there.  The companies, especially Astra-Zeneca, showed us COVID deaths only, which is what everyone is interested in.

Pfizer also claimed variously that 5 placebo volunteers were hospitalized with COVID and none of the vaccinated.  The figures vary with figures like 8 v 1 but also are quite low, unless multiplied by millions.

Pfizer is an honorable company.  They are all honorable companies.  So when reading the entries below remember to keep to the rules and do not link any problem to Comirnaty that happened after dose one and before seven days after dose two.  Or any problem that happened more than four weeks after the seven day period is over.  These do not get counted as being linked to the vaccine, even though all the ones below were in those who had the vaccine.

Any problems, especially hospitalizations of course can be multiplied by millions.

Mostly Cardiac Cases

1. 10051293   Cardiac arrest likely now dead. Blamed on overdose – a term that does not mean suicide attempt but covers  taking two aspirin rather than one.  No link to the vaccine we are told.
2. 10061098   Atrial Fibrillation. The investigator wanted to blame Ciprofloxacin but Pfizer didn’t.
3. 10071101   Heart Attack 59 days after dose 2. See also Hospitalized, dead 3 days later.  Nothing to see here say Pfizer and the investigator – Robert Frenck, the doctor who denied any link between the vaccine and Maddie de Garay’s problems,
4. 10131084   See Mike Dever and Vaccines
5. 10131517   Man hospitalized for a heart attack 39 days after Dose 2. No Covid test done.  No link made to vaccine.
6. 10181132  Heart attack concealed under coding of Abnormal Cardiac Stress Test
7. 10181159  A lady with nerve root pain 4 weeks after the post-7 day observation period started.  A neurologist suggested post-viral or auto-immune syndrome – Pfizer and the investigator disagreed.
8. 10191037   Coded as asthenia (weakness) likely a cardiac event.
9. 10211190   Stroke 32 days after dose 2, hospitalized but no Covid test – See William and Kate.
10. 10381101  Stroke 6 days after dose 2, hospitalized but no Covid test – Thinking Fast and Slow.
11. 10471114   Stroke 25 days after dose 2. Not viewed as linked to vaccine. Discharged from hospital to Rehabilitation. See William and Kate. Not clear if alive or dead.  No COVID test was done.
12. 10711023  A lady’s stents blocked a week after dose 1 and she had to have a quadruple bypass – the investigator and Pfizer saw no link to the vaccine but not given dose 2 and dropped from the study.
13. 10721007  A man with a mini-stroke 8 days after dose 1. Had surgery for a blocked carotid artery and was dropped from the study but the investigator and Pfizer saw no link.  Thinking Fast and Slow.
14. 10791246   This lady had a stroke a month after dose 2.  She was hospitalized. No link was made to the vaccine but she was withdrawn from the study.  William and Kate.
15. 10921015   This man developed atrial fibrillation a week after dose 1.  He was hospitalized for several days but no link was made to the vaccine. He was given dose 2 after his atrial fibrillation was brought under control.
16. 10921187   This man developed cardiac failure two weeks after dose 1
17. 10951101   This lady developed a pulmonary embolism two months after dose two.  Neither Pfizer nor investigator made a link to the vaccine.  She was COVID negative.
18. 10951173   Healthy man had heart attack a week after dose one. Four stents were inserted. Inv. and Pfizer blamed undiagnosed coronary artery disease but dropped him from study. See Total Eclipse of the Heart.
19. 10951180  Dizziness, possible mini-stroke.  Hospitalized. No link made by investigator or Pfizer.
20. 10951228   Admitted for pneumonia 50 days post dose 2.  Negative COVID test.  No link made to the vaccine.
21. 10971025   Heart attack a day after dose 2 –  3 blocked coronary arteries. No possible link to the vaccine.
22. 11091558  Admitted to hospital with breathing problems 13 days after dose 2. A neg SARS-COV2 test and no link made to the vaccine.
23. 11111130  Healthy woman 49, hospitalized with subarachnoid hemorrhage (Stroke) 8 days after dose 2. No link made to the vaccine.
24. 11181074  Three days after dose 2, a 73-year old lady developed chest pain.  Hospitalized several times with no clear answer except not the vaccine.  Finally helped by a pacemaker.
25. 11241106   Heart attack one day after dose 2.  See Total Eclipse of the Heart.
26. 11311222  A previously healthy 56 year old lady hospitalized for Chest Pain was diagnosed with Congenital (had since birth) Heart Disease (see other case below) two weeks after dose 2.  Her anginal pain led to open heart surgery.  No link to the vaccine.
27. 11401002   A lady, with a coronary artery dissection nine months before, had a coronary artery dissection 11 days after dose 2. She was still in hospital 3 weeks later with no explanation for this. She dropped out of the study, and appears lost to follow up.
28. 11421247  A lady with a history of Supraventricular Tachycardia (SVT) and a pacemaker to contol this developed an aggressive bout of SVTs immediately after dose 2. The investigator linked this to the vaccine, Pfizer didn’t – saying there must be evidence of an inflammatory component to make a link. The inflammatory component claim occurs in several of the cases above.
29. 11461264  Twenty-five days after dose 2, this man was admitted to hospital with a pulmonary embolus. His blood tests showed hypercoagulability. This problem now linked to the vaccine was not viewed as linked by Pfizer or the investigator.
30. 11521497   This is the syncope – fainting – case in Total Eclipse of the Heart. A redacted 6 month document makes no mention of his heart and now blames his death on Shigella.  But for Shigella to kill you ordinarily, something must have compromised your immune response.  The investigator and Pfizer do not entertain this idea.
31. 11561006   This man tested positive for COVID immediately after dose 1.  He was hospitalized 11 days later with Deep Vein Thrombosis and pulmonary emboli, which, it was claimed, had no link to the vaccine, but he was nevertheless dropped from the study.
32. 11571134  Four weeks after day 7 after Dose 2, this lady had a Stroke. The extent of the stroke remains unclear.  No link conceded to the vaccine.
33. 11621327   This man was found at home dead 3 days after dose 1.  The trial narrative said he died of arteriosclerosis – not previously diagnosed. Arteriosclerosis is not a cause of death.   See Shit Happens with the A Team.
34. 11671175  This man had multiple Strokes 3 weeks after dose 2, and was hospitalized. The company and investigator did not link this to the vaccine – the record didn’t know how long he was in hospital or whether he was still alive.
35. 11781107    A lady had immediate arm pain and fever after dose 1. Two weeks later her covered her arm, shoulder and chest and when examined in hospital had nodes in her armpit giving a diagnosis of lymphadenopathy.  Cancer had to be ruled out and was.  The oncologist said this was a reaction to the vaccine.  The investigator agreed.  Pfizer didn’t but discontinued her from the study.
36. 12241012   A 75 year old lady with longstanding Parkinsons had a mini-Stroke 6 days after dose 1 that led to a fall and fracture of her ankle.  The investigator figured there was no link to the vaccine – with no comment from Pfizer.  She was withdrawn because of an adverse event.
37. 12312593  Six days after dose 2, a 45 year old man had chest pain and a heart attack. He had a bundle branch block.  He was hospitalized and had one stent inserted. Dr Polack and Pfizer agreed no link.
38. 12312854  Six days after dose 2, a man, 44, with chest pain and heart attack was hospitalized for a Supraventricular Tachycardia (SVT – see case above).  No COVID test was done. Dr Polack viewed this as life-threatening, but neither he nor Pfizer linked it to the vaccine.
39. 12314001  Eight weeks after dose 2, a 56 year old lady was hospitalized for chest pain and was later given 4 coronary stents.  Her problems were ongoing at the time of discharge.  Dr Polack and Pfizer made no link to the vaccine.
40. 12314035   A man with a background cardiac history developed angina 6 days after dose 2.  He was hospitalized, and was stented. Dr Polack and Pfizer saw no link to the vaccine.
41. 12315473  A 50 year old man developed unstable angina 25 days after dose 2. He was admitted to ICU.  No COVID test was done. Neither Dr Polack nor Pfizer saw a link to the vaccine.
42.  See Disappeared in Argentina and Fishy Business on the Rio de la Plata.  A very healthy man developed fever, respiratory and chest problems the dose 2 day.  He was hospitalised and diagnosed with pericarditis, which his treating doctors viewed as a reaction to the vaccine. Dr Polack diagnosed Augusto Roux as crazy. Pfizer didn’t dare to concur with Polack.
43. We know with these Buenos Aires cases – 1231 was the site number – Fernando Polack was quite capable of getting pretty nasty with anyone who crossed him

What about Argentine Case 12315520?  Diagnosed with Ophthalmic vein thrombosis/ Venous thrombosis of the right eye, she was categorised as an Eye problem rather than thrombosis or cardiovascular problem.  We don’t classify Deep Vein Thromboses under Leg – why put her in Eye?

Cause and Effect

With the extra cases below we have 50 cardiac SAEs in the Vaccine group  and 38 in the placebo group.  It would be great if someone could work through the placebo cases for us.  Clicking on any of the links above will take you to the document with narratives for serious events happening on placebo and vaccine. 

If you need our input, send us the links and we will be happy to review placebo hospitalization and death cases or other vaccine cases with you.  There is some weird stuff there.

Do these narratives prove causality?  For Pfizer and Barbara Bierer – see Harmatology – something like 45 to 29 would be a statistically significant difference.  Until then, these accounts are anecdotes and tell us nothing – she claims.

But statistical comparisons tell us nothing about causality.  All of the placebo cases were caused by something – they were not accidents.  Equivalent figures in both groups do not prove there was no difference.  An identical number of suicidal events can happen in 2 Zoloft trial groups if Zoloft both causes suicide in some and prevents it in others.

In Zoloft trials there was an excess of suicidal events and suicides on Zoloft but these alone are not statistically significant. Looking at the narratives there is a consistent pattern of the Zoloft induced ones happening with clear agitation beforehand, and where the dose is stopped the problem clears up.

A key detail is how often Pfizer didn’t let the subject have dose 2 of the vaccine where the event happened after dose 1.  In two cases above they did let the subject go ahead but in most cases they didn’t.  This is what Astra Zeneca did to Bri Dressen and Injuries in Vaccine Trials.  It is a strong indicator of suspected and likely causality.

If you haven’t already read, see Michelle Mello’s story in Thinking Fast and Slow.

An oddity to take into account is that these 50 vaccinated narratives versus 38 or so on placebo are drawn from a group where US trial sites have double the number of sensitive narratives for placebo compared to vaccinated cases and global cases have a third more placebo cases – 288 v 199 vaccinated.   [Pay no heed to this – but 50 from 199 compared to 38 from 288 is statistically significant at a p < 0.001 level].

Given they are not having cardiac events – what is happening to the 250 other placebo cases?  Can you help us with this?

A final oddity is that only 170 of 44,000 people tested positive for COVID in the window starting 7 days post Dose 2 of the vaccine.  These came from 66 of the 153 sites.  Nearly 100 sites had no cases of COVID.  Pfizer appear to have breached their own protocol and admitted people who had a longer than specified interval between dose 1 and dose 2 to meet their target case numbers.  Statistics can cause people to fetish weird things.  More to the point, its one rule for us and another for you.

Prying Eyes

See We’re Caught in a Trap.

What about this placebo case?   Placebo Case 11671069 developed Congenital Hypertrophic cardiomyopathy. He had two doses of placebo without problems but then developed a congenital (present from birth) cardiomyopathy two months after his second catchup Comirnaty dose.

He was 77 and never had a heart issue in his life.  This case is classified as congenital because of an up till then undetected anomaly that had made no difference to him until he got the vaccine.

The way companies play these games he is classified as a placebo cardiac event – doubly hidden from prying eyes.

Also hidden from prying eyes  was 11141050, a  63 year old woman who had a sudden cardiac death 6 weeks after dose 2.  She has been put in the General Body Disorder category rather than Cardiac category.

We haven’t yet found the narrative on this lady but know her death meant she could be viewed as withdrawn.

Case 12461035 is another.  A man hospitalized with chest pain and put on treatments for angina and gastric reflux was coded as General rather than Cardiac.

Case 10011093 had angina but was not coded under Cardiac. Instead he was coded under procedures – he had cardiac catherization for possible stent. The trial monitor reviewing the paperwork told the investigator this was inappropriate, likely never expecting the comment to see the light of day.

How do Fernando Polack’s 2 vaccinated deaths compared to 4 on placebo look now?  According to the second paper on this trial (Thomas et al – NEJM March), when all events were looked at in more detail, only 1% of serious adverse events were viewed as related to the investigational agent.  This fits with WHO Guidance to never link an adverse event to a vaccine if at all possible – see Harmatology.

It flies in the face of medical common sense.

First child myocarditis ad I’ve ever seen pic.twitter.com/MtUx2PEqh3

— Anish Koka, MD (@anish_koka) September 17, 2022

Paul Pickerell

Imagine you were a healthy public-spirited 49 year-old in Texas. You volunteered to take part in Pfizer’s Covid Vaccine trial. Your medical history was just a touch of hay-fever. You went through all the check-ups to make sure you were eligible. You rolled up your sleeve on 29 August 2020. And had the first vaccine. You didn’t know whether it was vaccine or placebo. You go home feeling fine.

Seven days later you wake up with tightness across your chest and feel sick. You are rushed to the ER where an acute myocardial infarction (STEMI) is diagnosed. Heart Attack. You need four stents inserted into your coronary arteries.

The Principal Investigator logs this as a Serious Adverse Event.  How serious?  Grade 4 “life threatening or disabling adverse event”.  (Grade 5 means you’re dead.)

Five days later you are discharged. You have now become a patient, on four types of medication.

You are said to have recovered but then find that you are excluded from further participation in the trial.

You may not have been told that you had been randomized to be given the BNT162b2 vaccine.

Then you read:

“In the opinion of the investigator, there was no reasonable possibility that the acute myocardial infarction was related to the study intervention, but rather it was related to undiagnosed obstructive coronary artery disease. Pfizer concurred with the investigator’s causality assessment.”

Seven days after the “study intervention”?

You Can Not Be Serious

Disjointed thinking

This is the opinion of Principal Investigator Paul Keith Pickrell MD, a rheumatologist based in Austin, Texas at the Tekton Research Centre. Rheumatologists are into joints but what was PKP on when he wrote this?  This is one of the most blatant pieces of disinformation in the Pfizergate files.

Mind you it could all be a joke as Pickrell, a native Texan with 28 years’ experience:

“believes that humor blended with professionalism is an important approach to establishing relationships with his patients”.

Flied Lice

Rhode Island is the smallest state in the US  but has one of the longest coastlines. A 48 year-old cyclist from Rhode Island was another volunteer. Here is the Bike Path at Watchemoket Pond, Rhode Island.

Apart from a raised cholesterol for which he was taking a statin, this young man had no pertinent medical history. He took part in the Pfizer trial organised by Omega Medical Research in the southern suburbs of Providence, RI.

He received his second dose of BNT162b2 vaccine on 16 September 2020. Eleven days later whilst cycling, he fell off his bike and was found unresponsive. He had suffered a heart attack with ventricular fibrillation due to a STEMI myocardial infarction. He was fortunate to be resuscitated and was taken to hospital where coronary angiography showed his left anterior descending artery was completely blocked. A stent was inserted and he was discharged three days later on five additional medications. This too was classed as a Grade 4 Serious Adverse Event.

Omega Research is now part of the Velocity Clinical Research (which, however, has nothing to do with cycling).

Boss of Omega Research is Dr David L Fried, an internist at Coastal Medicine, who has acted as the Chief Principal Investigator on over 300 clinical trials. Omega was one of the select few trial centres that attracted a “non-routine” audit in October 2020. Fried will then have been grilled by Robert Cutler, the Director of Medical Quality Assurance at Pfizer.

David L Fried MD

Flied Lice anyone?

In Dr Fried’s opinion there was no reasonable possibility that the acute myocardial infarction was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to cardiovascular risk. Pfizer concurred with the investigator’s causality assessment.

Here is another example of an investigator cooking the what? The cyclist surely figured the vaccine might have had a part to play in his near demise.  Did he seek compensation from Pfizer?  Can we find him – this man might have a lot to gain from being found.

Flied pulled in $1,345,828.14 from Pfizer Inc. in 2020.  He looks rather prosperous in this promotional video for Theraworx to rub on your legs.  Might have been a lot better for our cyclist than the vaccine.

Death Defying

Santa Fe is the area where the train-station is in downtown San Diego.  A place where many homeless men hang out.

Subject C4591001 1152 11521497 was a 72-year-old white male. He had a pertinent medical history of type 2 diabetes mellitus (since 2010) and hypertension (since 2018). He was on metformin (since 2013) for diabetes, ibuprofen (since 2015) for osteoarthritis, lisinopril (since 2018) for hypertension, and doxazosin (since 2019) for benign prostatic hypertrophy.

He received Dose 1 of the Pfizer vaccine on October 7 2020. He reported syncope (fainting) on October 26, 19 days later.  He missed Visit 2 on October 28 (Day 22).  On November 6, the research team find out that he had been admitted to the hospital on Oct 26, the day of his ‘faint’.  He fainted in the middle of the night. On admission he was transferred to the intensive care unit.

The subject tested negative for COVID-19 at the hospital. On an unspecified date, the syncope resolved and he was discharged from the hospital.

[Without a Diagnosis?  Not possible. You don’t get admitted to ICU for fainting.]

On November 6 it was decided he would not get Dose 2 but he remained in the study to be evaluated for safety, immunogenicity, and efficacy.

During the follow-up, the site contacted the subject’s sister, who confirmed that he had died on November 11. The cause of death was reported as unknown. It was not reported if an autopsy was performed. A death certificate might be available at a later date.

In the opinion of the investigator, there was no reasonable possibility that the syncope was related to the study intervention, concomitant medications, or clinical trial procedures. Pfizer concurred with the investigator’s causality assessment.

The investigator for site 1152 was Don Brandon MD, CRF Trials in San Diego – “Dedicated to Excellence in Medical Research Since 1966”. He is also President of Altor Medicus, Inc. based in Santa Fe.

Dr Donald Milan Brandon is a native San Diegan. He was a member of the Alpha Epsilon Delta Pre-Medical Honor Society. He did clinical research at a local hospital facility for a year and then earned his M.D. degree at the University of Southern California. He is very much a family man. He is an avid sportsman and conversationist as well as hobbyist, enjoying everything from model trains to radio-controlled aircraft. Disneyland is his second home and he makes no excuses about it.

Brandon received “associated research funding” from Pfizer totalling $5,627,954.42 in 2021 and $3,252,213.90 in 2020.

Disappearing Death

The syncope was coded as a “Nervous system disorder”.  Someone did some further investigation and found apparently  that the man had shigella, which can cause diarrhea.  But his death still does not appear.

According to the narrative, sadly this volunteer died on 11 November, 36 days after his vaccination. No further details. This was just before the cut-off date for data submitted to the FDA and Polack’s NEJM paper. Had it been included, deaths in the vaccine arm would have increased by 50% (from 2 to 3). Is this why the clinical details are so vague?

Shigella was endemic in the homeless population of San Diego at that time. But there is nothing in this account or in the CRF that fits with this diagnosis.

By our calculations, there are at least 21 deaths in the vaccine arm and 16 in the placebo arm, many involving the heart, and it is likely there are even more waiting to be found, hidden under planks like codes for cardiac investigation,

TRUE!—nervous—very, very dreadfully nervous I had been and am; but why will you say that I am mad? The disease had sharpened my senses—not destroyed—not dulled them. Above all was the sense of hearing acute. I heard all things in the heaven and in the earth. I heard many things in hell. How, then, am I mad? Hearken! and observe how healthily—how calmly I can tell you the whole story…..

…

The officers were satisfied. My manner had convinced them. I was singularly at ease. They sat, and while I answered cheerily, they chatted of familiar things. But, ere long, I felt myself getting pale and wished them gone. My head ached, and I fancied a ringing in my ears: but still they sat and still chatted. The ringing became more distinct:—it continued and became more distinct: I talked more freely to get rid of the feeling: but it continued and gained definitiveness—until, at length, I found that the noise was not within my ears.

It grew louder…

“Villains!” I shrieked, “dissemble no more! I admit the deed!—tear up the planks!—here, here!—it is the beating of his hideous heart!”

For youngsters,  the A-Team was a television program about a group of  ex-US Army dudes who used to go around tackling problems – often by blasting them out of existence.  They were a little more diverse than Pfizer’s A-Team.

Down in the Deep South in Huntsville Alabama, you will find the Medical Affiliated Research Center. Pfizer Covid Vaccine Volunteers there were in the safe hands of Urologist James Gordon McMurray MD. James McMurray came into the world in July 1940, before the USA joined the second world war then already waging in Europe, and is one of the few remaining alumni of the University of Mississippi School of Medicine Class of ‘67. He has seen 15 US Presidents come and go. The picture above is a young JGM.

McMurray had done previous research with Viagra for Pfizer but it is not clear why, in his eighties, this waterworks specialist was sought after as a Principal Investigator in the seminal BNT162b2 vaccine trial. He must however have worked hard as Pfizer slipped him $1,512,465.89 in 2021 alone.

Accident or Event?

Subject 10471114 was a 76-year-old white male with a history of congestive cardiac failure and angioplasty (in 2000). He had increased blood cholesterol, hypertension and coronary artery disease. His medication at the time included aspirin for his heart, atorvastatin for hypercholesterolemia, diltiazem and furosemide for hypertension, levothyroxine for hypothyroidism, and esomeprazole for gastrointestinal reflux disease.

He volunteered at Huntsville and was given the first injection of BNT162b2 on 2 Sep 2020 and Dose 2 on 23 Sep 2020 (Day 22).

He was diagnosed with a cerebrovascular accident– a stroke – on 18 Oct 2020, 25 days after receiving the second dose.  Strokes are typically called CVAs in healthcare.

He presented to the emergency room with increased weakness and pain for several days and was hospitalized. He fell the night before this visit and was seen in another hospital, where it was reported that the subject had a cervical (neck) fracture because of the fall. On the day of admission a computerized tomography (CT) of the head without contrast was essentially normal. On the same day the subject was diagnosed with a cerebrovascular accident. The next day, a magnetic resonance imaging (MRI) of the brain showed multifocal acute to subacute infarcts within the bilateral cerebral and right cerebellar hemispheres, suspicious for underlying embolic phenomenon.  A repeat CT scan showed acute and subacute infarct and an MRI of the cervical spine showed an acute fracture only in the anterior inferior corner of C4. The subject also reported headache, slight chest pain, and slurred speech.

An echocardiogram showed mobile echogenic calcified annulus and ejection fraction of 45%. Carotid Doppler showed no hemodynamically significant stenosis. The subject was started on antibiotics for possible culture negative endocarditis. Cervical collar was placed. No immediate intervention was planned due to acute stroke. He failed a swallow test and had a gastric tube placed. The subject had a peripherally inserted central catheter line placed for long-term antibiotics. Cefepime was discontinued because of concerns of medication encephalopathy.

A SARS-CoV-2 test performed on 05 Nov 2020 was negative. He was discharged to a rehabilitation center on an unspecified date.

The CVA was ongoing at the time of the last available report.

“In the opinion of the investigator, [JGM], there was no reasonable possibility that the cerebrovascular accident was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to hypertension and congestive heart failure. Pfizer concurred with the investigator’s causality assessment.”

JGM’s company is now into vaccine trials – or perhaps companies are into him.

Cerebrovascular Accident?

Cerebrovascular means the blood vessels supplying the brain.

Accident means an event that happens by chance or that is no one’s fault. Was this by chance? Or is there just a possibility that the experimental vaccine could be implicated in this thromboembolic event less than a month after being given?

There are other problems with McMurray’s report – the stroke was probably the cause for the fall and fractured neck vertebra, both of which should have been recorded as additional adverse events.

Secondly the CVA was shown to be due to emboli (blood clots), which should have been coded as such and recorded as adverse events.

Subject 10471114 seems seriously ill and probably did not live for long after this “accident”. A caring physician, albeit an eighty year-old urologist, should have made enquiries about his recovery.

This case goes to the heart of the Cause and Effect debate.  If I am taking a monoamine oxidase inhibiting (MAOI) antidepressant and eat cheese or drink wine, I am likely to have a CVA – a stroke.  This combination can cause my blood pressure to rise precipitously and give me – an accident?

My stroke would not have been an accident.  Shit would not have just happened.  We can trace a cause and effect chain.

In healthcare, we tend to tell people with raised blood pressure, and raised cholesterol levels, you are an accident waiting to happen.  But elevated blood pressure only leads to a stroke when it is malignant – that is steadily rising and has reached 200/140 or higher as in Franklin D Roosevelt’s case.   A blood pressure of 150 over 100 is not going to cause a stroke even in an older person – in fact as we age some elevation of BP becomes protective.

A raised cholesterol level never causes a stroke. The drugs we take to manage it are more likely to cause problems.

Shit doesn’t just happen.  There has to be trigger.  Before we discovered malignant hypertension and a link to strokes in the 1940s,  authors like Balzac regularly described people in novels as having an apoplectic attack (stroke) on receipt of bad news.

Stress causes heart attacks and strokes.  Stress though is usually a physical thing – exposure to some physically punishing circumstances like infections, temperatures, immobility which causes clots, or drugs.

But emotional shocks can cause similar problems. See Parts one and two of Antidepressants and the Tell-Tale Heart.  And Heart Attack and Vine and Plavix and The Reverse Dodo Effect.

The word Accident stops people thinking and steers the Dr McMurrays of this world toward figuring Shit has just happened even though the vaccine in this case is known to cause blood clots and lots of other things that could have, perhaps likely, caused 1114 to have an Event.

Marching from Alabama to Atlanta

Robert R and Brains from Thunderbirds

Thunderbirds was a 1960s British television puppet series.

Subject 11621327, a 60-year-old white male, with a pertinent medical history of obesity (since 2010), traumatic brain injury (in 2011, recovered), depression (since 2011), and hip replacement (in 2015), was a volunteer in the Atlanta Centre for Medical Research in Georgia run by psychiatrist Robert Riesenberg, MD who currently has “over 47 years’ experience”.

Born in 1949, Bob has been the Brains behind and the Medical Director of the Atlanta Center for Medical Research since Jan 1978.

[Riesenberg and the ACMR was one of only six USA centres to receive a “non-routine” inspection by Pfizer’s auditors from 30 Nov 2020 to 04 Dec 2020.]

Volunteer 1327 received Dose 1 BNT162b2 on 10 Sep 2020. Concomitant medications reported within the previous 2 weeks included venlafaxine hydrochloride (from 2015) and aripiprazole (from 2011), both for depression.

On 13 Sep 2020 (Day 4), the study site received a police report indicating that the police visited the subject’s home to perform a welfare check and found him dead. It was reported that the subject’s body was cold and had visible lividity.

According to the medical examiner, the probable cause of death was progression of atherosclerotic disease. Relevant tests were unknown. Autopsy results were not available at the time of this report.

In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to suspected underlying disease. Pfizer concurred with the investigator’s causality assessment.

Stop Right There – Before we go any Further –  I gotta know right now what the Diagnosis is  – The Diagnosis forever:

How can a disease not previously diagnosed be known to have progressed?

As with 1114 above, saying the person had atherosclerotic disease doesn’t tell us how they died.  Wise pathologists used to say – autopsies more often tell us what a person can live with rather than what they died from.  We don’t die unless an event happens.  Might 1327 have had a Pulmonary Embolus?

We have no autopsy results.  Not even a psychological autopsy – remember Bob is a psychiatrist.  Volunteer 1327 has been written off as Shit Happens.

Brexit for Chickadees

Readers will be pleased to know Bob had plenty to occupy him after the Vaccine trial ended.  It was back to psychiatry.  Experimenting on teenagers who have just given birth.  On February 2, 2022, his latest research was presented at the Society of Maternal and Fetal Medicine.

Brexanolone in Adolescent Patients with Postpartum Depression (PPD):
Results from the Phase 3, Open-Label CHICKADEE Study

Objective: Brexanolone (BRX) has a well-defined safety profile in PPD that supported its FDA approval in adults. The open-label CHICKADEE Study evaluated the safety, tolerability, and pharmacokinetics (PK) of BRX in adolescent patients with PPD.

Study Design: Patients with PPD (N=20) aged 15-17 years received a continuous 60-h intravenous infusion of BRX, with titration up to 90 µg/kg/h. The primary and secondary endpoints were incidence of TEAEs and PK parameters, respectively. Other endpoints included change from baseline (CFB) in 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, patients achieving HAMD-17 response (≥50% CFB), and remission (HAMD-17 total score ≤7).

Results: 19/20 (95%) patients receiving BRX completed the study with 1 prematurely lost to follow-up. Similar to the overall BRX HUMMINGBIRD program, the mean (SD) CFB in HAMD-17 total score at 60-h was -17.6 (7.07) and -20.6 (6.20) at Day 30. HAMD-17 response and remission were achieved by 75.0% and 60.0% of patients at 60-h, and 89.5% and 68.4% at Day 30, respectively. At least 1 TEAE was reported in 8/20 (40%) patients; most were mild in severity. The most common TEAEs (≥10%) were dizziness (15%), infusion site pain (15%), nausea (10%), and sedation (10%). Consistent with the known safety profile of BRX, one patient experienced 2 serious AEs (dizziness followed by transient loss of consciousness), the infusion was interrupted immediately, and the patient regained consciousness within 30 min. The patient resumed BRX the following day and completed the trial without additional complications. The median (range) for overall systemic exposure (AUC_0-inf), maximum plasma concentration, and time to maximum plasma concentration were 4040 (3090-5010) ng*h/mL, 83.5 (63.4-102) ng/mL, and 52.3 (52.0-54.9) h, respectively (n=19 for all).

Conclusion: BRX was generally well-tolerated; with safety and PK profiles consistent with trials to date in adults with PPD. CFB in HAMD-17 total score at the end of infusion and Day 30 were comparable with results from previous PPD studies in adults.

Authors:  Robert Riesenberg, MD Atlanta Center for Medical Research

Kemi Bankole, MBBCH,  Svetlana Garafola, MD Min Qin, PhD, Ethan Hoffmann, BA, Colville Brown, MD, Robert Lasser, MBA, MD, Stephen Kanes, MD, PhD –  All of whom work for Sage Therapeutics.

Holy Shit Batman

A 60-hour intravenous infusion?

The conclusion is almost identical to the phrasing of the conclusion of trials of SSRIs, like paroxetine in teenagers:

generally well-tolerated; with safety and PK profiles consistent with trials to date in adults

Brex comes at $35,000 for a treatment course and that’s not including the hospital costs.

Teenagers who have given birth do not have post-partum depression.  Problems yes, maybe lots of them but not something that Brexit is going to put right.

Kim Witczak, who regularly features in these columns as well as on RxISK, was on an FDA panel reviewing this drug pre-approval. She rejected the application but most didn’t.

Sales of Brexit so far have been disappointing.  The amount of money made would only just about cover the going rate for investigators like JGM and RR in these trials these days.

Sage are trying desperately to get a related oral drug zuranolone on the market for general nerves – depression, anxiety, bipolar – whatever is wrong with you we have the answer.

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/abstractor/  and searching on patient 10131084.

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.

Shipwreck of the Singular was written before before Covid landed and published just as the vaccines began to roll out.

It’s central messages are that

• Life expectancy is now falling and this is linked to polypharmacy
• People injured by treatment are the crack through which the science gets in
• The use of antidepressants for children and teens illustrates just how far wrong we have gone
• With the marketing of drugs and vaccines we see business and government policy masquerading as science.

On the first point, this week the CDC has reported that American Life Expectancy is tumbling – with Americans depending on what you read now having life expectancies last seen in 2003 or 1996 depending on which figures you pick.

See Stat News, New York Times, and CDC.

On the third point, very unusually, this week, the New York Times and New York Post carried articles about how we are poisoning our children and especially teenagers with psychopolypharmacy.   Both the Democrats and Republicans agree on what is also the central message of Children of the Cure.

The Crack Though Which the Light Gets In

On the second point there have also been developments.

India

Bri Dressen flagged up an Indian Supreme Court decision to consider issues surrounding the cases of two young women in India whose deaths have been linked to the Astra-Zeneca vaccine.

One of the cases is Karunya Govindam who featured in the Cause and Effect forum some months ago – See Karunya Come Home.

Buenos Aires 

There are ongoing events in Buenos Aires. Augusto continues to chase the President of the Republic and all other bodies. At present though, its not possible to put definite shape on what is happening there.

I-Trials remains a key piece of the jigsaw.  Why would it park USD $91 million across the Rio de la Plata in Uruguay?

Some of the developments in the last few weeks have already appeared in comments.

For anyone who wants to see Augusto tell his story in English, along with Bri Dressen, Olivia Tesinar, who had the Moderna Vaccine, and Stephanie de Garay who tells Maddies’ Story.  These videos are available on React19 – Here.

Vaccine Article

Yesterday, a paper widely circulated as a preprint, written by Peter Doshi and colleagues, Fraiman et al, was published in Vaccine.  From the start, Peter has perhaps done more than anyone to counter the Master Narrative sold by the media, Governments and academia.

The first bit of news is that a mainstream journal agreed to publish this paper which is so much at odds with the Master Narrative.

The paper has a stellar cast of authors but even this would not these days enable an article with the conclusion that in the mRNA trials double the number of people with adverse events from the vaccines ended up in hospital compared with those being hospitalized for Covid.

If the point was to reduce the burden on health services these trials did not show that.

Israeli Trials

A week earlier there had been a startling piece of news from Israel claiming that the Israeli Ministry of Health had underplayed the risks from the Pfizer vaccine despite being warned of these risks by some experts.  The ignored expert views potentially open up the Israeli government to legal actions by those harmed.  See Article Here.

At almost the same time, an article on Vaccine Censorship by Israeli researchers including Josh Guetzkow and colleagues appeared outlining the difficulties in getting a piece published that runs counter to the master narrative.

Brook Jackson

Finally, there is an extended interview with Brook Jackson and others on Rounding the Earth, a forum set up by Matthew Crawford.  Warner Mendenhall, one of the lawyers in her Qui Tam case was also there and made some striking posts.

Mendenhall downplayed the chances of success in this case.  Very few Qui Tam cases succeed.  But in this case, there is an extra factor.  The hit to Pfizer should they lose could be of the order of $3.4 Trillion.  This is by several orders of magnitude the largest corporate legal case ever filed.

RSV

The fourth point still applies.  While the above developments hold out fragments of hope that the injured may get recognition and decent treatment, the RSV bandwagon , outlined in Yellow Peril, continues to gather pace.  This will need another post, but the shape of this post remains uncertain.

Some months ago several Baronnesses contributed to a debate in the British House of Lords claiming how awful RSV is to children and older adults and how something desperately needs doing in order to prevent the NHS collapsing – see RSV Hansard

Meanwhile Pfizer, as they did with their Covid vaccine, have press-released apparently great results from their RSV trial but not everyone is convinced they are as good as claimed.

So the seas are still stormy. Whether it is possible to make dry land and salvage anything from the wreck remains to be seen.