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Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

Archive for Hiding the bodies

The Fog of a Special Medical Operation

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.

As for deaths and hospitalizations for serious cardiac events, our current figures based on Pfizer’s Serious Adverse Events Narrative file, which contains roughly 460 case records runs at roughly 50 vaccinated. Your help to explore deaths and hospitalizations in the placebo cases, along with polypharmacy, would be greatly appreciated.  Please get in touch.

VolunteerDiagnosisComment
10051293Cardiac Arrest
Heart Attack
Possible COVID
Hospitalized, lost to follow up - Dead?
10061098

Atrial FibrillationHospitalized Investigator blames Vax but Pfizer doesn't
10071101Cardiac Arrest
Heart Attack
Died
10131084Renal Artery Stent clotted and blockedHospitalized
10131517Myocardial Infarct
Heart Attack
Stent
10181132Cardiac Stress Test
? Heart Attack
Hospitalized - in need of cardiac bypass surgery
10181159Radicular ParesthesiaNot Hospital Investigator blames vaccine and Pfizer doesn't
10191037Asthenia Hospitalized
10211190Cerebrovascular Accident - CVA
Stroke
Hospitalized
10381101Ischemic Stroke
Stroke
Hospitalized
10471114CVA
Stroke
Hospitalized
10711023Blocked Coronary Stent
Heart Attack
Hospitalized
10721007Transient Ischemic Event (TIA)
Minor Stroke
Hospitalized
10791246CVA
Stroke
Hospitalized
10921015Atrial FibrillationHospitalized
10921187Congestive Cardiac Failure
Heart Failure
Hospitalized
10951101Pulmonary EmbolusHospitalized
10951173Myocardiac Infarction
Heart Attack
Hospitalized
10951180DizzynessHospitalized
10951228BreathlessnessHospitalized
10971025Myocardiac Infarction
Heart Attack
Hospitalized
11091558DyspnoeaHospitalized
11111130Subarachnoid Hemorrhage
Stroke
Hospitalized
11181074Musculoskeletal Chest Pain
Heart Attack
Pacemaker Inserted
Hospitalized
11241106Myocardiac Infarction
Heart Attack
Hospitalized
11311222Congenital Heart Disease
Likely Heart Attack
Required Cardiac Surgery
11401002Coronary Artery Dissection
Heart Attack
Hospitalized
11421247Ventricular ArrthymiaHospitalized
11461264Pulmonary EmbolusHospitalized
11521497Syncope (Fainting)Hospitalization - ICU
Died
11561006Deep Vein ThrombosisPulmonary Embolus
Hospitalized
11571134TIA - Minor Stroke
Hospitalized
11621327Arteriosclerosis
Heart Attack or Stroke
Hospital and Death
11671175CVA
Stroke
Hospitalized
11781107Lymphadenopathy
12241012TIA - Minor StrokeHospitalized
12312593Acute Coronary Syndrome
Heart Attack
Hospitalized
12312854Supraventricular TachycardiaHospitalized
12314001Acute Coronary Syndrome
Heart Attack
Hospitalized
12314035AnginaHospitalized
12315473Unstable AnginaHospitalized

 

Total Eclipse of the Heart

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!”

Shit Happens with the A Team

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 (AUC0-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.

 

 

Mike Dever and Vaccines

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 and Salvage

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.

 

 

 

 

Miracles in Buenos Aires: Water and Wine

This post is by our South American correspondent.

A Water into Wine miracle occurred in Buenos Aires in October 2020. A 66 year old volunteer, number 12315632 in Pfizer’s Comirnaty vaccine trial, had received his second vaccination of BNT162b2 (30 μg) on the nineteenth of September in the city’s Hospital Militar.

Twenty-nine days later he was admitted to hospital with chest pain.

According to the Adverse Events file released by FDA to PHMPT, this man had a serious adverse event of “Pericarditis” grade 2, which clearly someone in the trial process deemed not related to the vaccine. It apparently did not resolve.

Then a miracle occurred.

Somehow the diagnosis of pericarditis at least, maybe not the underlying condition, became “suspected covid-19”.  The Suspected Covid-19 diagnosis survived three negative covid swab tests.  Pfizer concurred with this view of the investigator or the treating doctor or someone who was involved in assembling the ‘facts’ that Suspected Covid-19 – Suspected is the key word – was the diagnosis.

(DSM could be doubled in size if we add Suspected to everything and perhaps doubled again for Suspected Martian disorder or whatever related entities we can conjure up.  The link to DSM here is very deliberate as readers are about to find out).

The Narrative for this is reproduced below. It comes from a Narrative (Sensitive) file – a different file to the Adverse Events file – that says:

Subject C4591001 1231 12315632, a 66-year-old white male with no reported medical history, received Dose 1 on 31 Aug 2020 and Dose 2 on 19 Sep 2020 (Day 20). The subject reported suspected (but not confirmed) COVID-19 on 17 Oct 2020, 28 days after receiving Dose 2.

On 17 Oct 2020 (Day 48) the subject experienced left shoulder and arm pain. On 18 Oct 2020 (Day 49), at 01:00 AM the subject experienced chest pain and dyspnea and called the emergency system. He was taken to the emergency room by ambulance where they performed: electrocardiogram with no ischemic changes, chest x-ray with unknown results, chest computerized tomogram that showed pneumonia of unknown localization. At the time of reporting the subject had presented with a temperature of 38°C. Blood/laboratory tests were done but results were unreported.

In accordance with the hospital COVID-19 pandemic protocol the subject had a SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) swab. The date of discharge from hospital is unknown, however, the site received a discharge summary on 20 Oct 2020 (Day 51) stating the result of the SARS-CoV2 RT-PCR swab was negative. The swab taken for the purposes of the study and analyzed at the central laboratory was also negative. An additional SARS-CoV-2 test performed locally on 28 Oct 2020 was also negative. The cause of the potential COVID-19 illness remains unknown as no other microbiological studies were performed. The suspected (but not confirmed) COVID-19 illness was ongoing at the time of the last available report. In the opinion of the investigator, there was no reasonable possibility that the suspected COVID-19 was related to the study intervention or clinical trial procedures. Pfizer concurred with the investigator’s causality assessment.

As we have reported, Augusto Roux was on the receiving end of a similar miracle, a short while before.  His hospital-confirmed vaccine-induced adverse reaction of pericarditis similarly disappeared into “suspected covid” and then “severe anxiety”. At the moment it looks like iTRIALS team led by Fernando Polack were responsible for this transformation.

Fernando and Stephen

We have written to Drs Polack and Thomas, lead investigators for this trial.

Dear Drs Polack and Thomas]

The writing of papers like the ones in the NEJM on which you are first authors is a well-oiled business. I realise that you did not have access to the trial data, and likely may not know the answer to the following, or if you do know the answer you may not be in a position to help me. 

I am copying FDA and ANMAT into this email for this reason, without any expectation regulatory bureaucrats are likely to do anything soon.

My query concerns a second instance of a BNT162b2 vaccinated patient from Argentina who is recorded as developing an adverse event of pericarditis 28 days after receiving his second dose.

The volunteer’s trial number is 12315632.

Page 996 of the narrative account of this event states that he had “probable covid-19 illness” (despite three negative swab tests) with no mention of pericarditis. 

The pericarditis is documented in page 286 of the Clinical Safety Report.  It is also documented in an Adverse Events document.  The mention on p 286 of the Clinical Safety report tells us that:

Pericarditis There was 1 participant in the older BNT162b2 age group with pericarditis. The event had an onset of 28 days after Dose 2, was ongoing at the data cutoff date, and was assessed by the investigator as not related to the study intervention. A narrative for this event is provided (see Section 2.7.4.2.4.4 [Subject C4591001 1231 12315632]).

This reference to a narrative takes us back to the account noted above, which has no mention of pericarditis.

I imagine most people reading these entries would view pericarditis as a more likely diagnosis than probable Covid-19 illness in this case.  It is also difficult to see a basis for not making a possible linkage to the vaccine in an event that is coded as Severe, toxicity grade 2.

The clinical information in the narrative summary about this volunteer’s hospital admission seems inadequate. It looks possible that the data for #12315632 might have been altered.

This case seems a replay of what happened to volunteer 12312982, Augusto Roux, whose clinically confirmed adverse event of illness with pericarditis has disappeared.

Mr Roux seems to have had a raw deal from his participation in this trial, as perhaps this other volunteer has also.  The consent form for the trial indicates that Mr Roux and this latest volunteer would get clinical support from Pfizer in the event of anything going wrong.  This didn’t happen in Mr Roux’s case. 

One plausible explanation for the disappearance of injuries to these two volunteers is that keeping them in place would jeopardise the rapid approval of this vaccine – this seems to be direct conflict with Pfizer and i-Trials obligations in this trial.

Quite aside from the injury to this volunteer, as with Mr Roux, the conflicting documents cause their own problem.  Knowing the sequence in which they were assembled and who they were written by might help. I realise there were a range of ‘fact’ checkers from Pfizer and iTrials and Icon and perhaps others involved. 

Can you send me the back and forth between these parties or otherwise help to reconcile these incompatible trial documents?  If this can be done for this volunteer, I would appreciate a similar sequence of documents and back and forth with dates and times in the case of Augusto Roux.

I realise this trial appears to have been governed by military secrecy needs in both Argentina and the United States. I imagine you might both be under orders to say nothing. The regulators may be similarly constrained. 

I have no idea whether Data Safety Monitoring Boards are also constrained in this respect and for this reason I have included the DSMB for this trial in this correspondence also.

At the end of the day, in military speak, there is an obligation to troops who have volunteered in this War, whose contracts essentially say they will be given the best possible treatment, who were provided with Dr Polack’s day and night time phone numbers in the contract they signed, but who, in this case, cannot get the right treatment, never mind the best treatment, if it is not possible to acknowledge the source and nature of their injuries. 

These volunteers are being treated as soldiers were in the days before the American Civil War.

This email will be posted publicly. I will happily also post any responses I receive from any party copied in here.  

Jorge and Miracles

On August 18, 1996 in the Church of Santa María in Almagro, Buenos Aires, Argentina, the start of a miracle occurred. A consecrated Host (bread) had been desecrated on a candle holder in the back of the Church. Unable to consume the Host, the priest, Fr. Pezet put it into a glass of water into the tabernacle so that it would dissolve.

When he opened the tabernacle on August 26, he saw that the Host had been transformed into a piece of bloody tissue which was much larger than the original Host. When Fr. Pezet informed Archbishop Bergoglio of the occurrence, the archbishop asked him to have the Host professionally photographed.

After three years, the bloody tissue had not decomposed. Archbishop Bergoglio asked that the bloody tissue be scientifically examined. The analyzed material has been shown to be a fragment of the heart muscle found in the wall of the left ventricle close to the valves.

This was reported widely in Catholic Communities as Eucharistic Miracle of Buenos Aires.  The official documentary is here.   The version we have has an opening additional paragraph.

Science and Faith

According to Fr. Robert Spitzer, a Jesuit priest and doctor of astrophysics, a recent Jesuit survey has revealed that, far and away, the greatest cause today for people losing their faith and becoming either agnostic or atheistic in our country (The US) is the perceived conflict between faith and science. In fact 93% of those who lose their faith say the claims of religion do not hold up to the scrutiny of what we know through modern science. Put another way, these individuals have simply shifted their faith in God to faith in science as the definitive way of knowing truth.

The Church position is that faith and reason are simply different ways of coming to know truth, either through divine revelation or through careful observation of the created universe. They can never truly be in conflict because God, who is The Truth, is both the creator of the ordered, observable universe and the very author of science. However, to try to reach those who have lost their faith in this way and who perhaps do not share the Church’s view on truth, Spitzer has suggested featuring miracles of the Church that have undergone intense scientific scrutiny, where “the finger of God” has stumped all scientific explanation. One definition of “miracle” is “an event that is not explicable by natural or scientific laws and is therefore considered to be the work of divine agency”. Understood in this way, the existence of miracles should lead one to faith. 

The first point to note of course is that Robert Spitzer was the architect of the modern DSM system.

Second, what gets called science these days is a ghost-written literature, a great deal of which is essentially fraudulent, one of whose functions like all organized religions is to keep the people moving together as a herd.

Third, the Bible that Bergoglio claims to adhere to gives a very different message. The Kingdom of God is in everyone you meet. Your job is not to tell them to get vaccinated – Bergoglio was later the first to mandate vaccines. Your job, like a Good Samaritan, is to recognize them when they are injured.

The people who get harmed on a drug or vaccine are the Crack through which the Science gets in.  As Spitzer would have been better placed saying – they deserve careful observation of the created universe. They are increasingly, however, as the bible put it, the Stone that the Builders have rejected.

And there are new ‘sciences’ like Harmatology conjured into being to make them disappear,

If Bergoglio wants to reconcile religion and science, rather than meeting up with the Global Elite to plan a post Covid World he should pay more heed to Augusto Roux, Brianne Dressen, volunteer 12315632  and the hundreds of others in this and other vaccine trials that have gone missing – see The Disappeared.

Spitzer seems to be struggling to say science and religion need truth not myth.  When it comes to treatment induced injuries, these days both science and religion lean toward myths rather than truth.  Bergoglio seems all too keen to reconcile ‘science’ with ‘religion’.

Yellow and Other Virus and Vaccine Perils

Big Friendly Gates

On 28 April the NEJM published the interim results of a trial of Prefusion F Protein–Based Respiratory Syncytial Virus Immunization in Pregnancy. This paper contains evidence of a neonatal jaundice hazard in the babies whose mothers had been immunised – but you’d never guess it from the way the paper is written.

Prizer’s RSVpreF Trial

Pfizer’s phase 2 trial NCT04032093, run among other placed in three Ventavia sites in Texas, enrolled 1153 pregnant women. They were either injected with RSVpreF or placebo. Antibody levels and adverse events were recorded in them and their babies.

What is Prefusion F Protein – PreF?  Who knows.  The published paper says this was an immunization trial, aimed at producing antibodies.  That’s not the same as traditional vaccination or treatment with a monoclonal antibody or an mRNA type agent.

The NEJM report names Eric Simões as first author but it is unlikely to have been written by him. It concluded:

RSVpreF vaccine elicited neutralizing antibody responses with efficient transplacental transfer and without evident safety concerns.”

Yet the supplement to Simões’s article shows more than twice as many babies developed jaundice in the vaccinated group compared with the placebo group (59/325 v 6/78). In nine of the vaccinated babies this was deemed a serious adverse event, compared to one in the placebo group.

Jaundice in new-born babies is fairly common but isn’t very nice and can be serious. Too much bile pigment (bilirubin) in the blood stains the babies’ skin and the whites of their eyes deep yellow. It’s bad news if it gets into the brain (kernicterus).

The Table below shows a statistically significant increase in Jaundice in babies of vaccinated mothers compared with placebo group. It is derived from Table S8 of the supplementary appendix to the Simoes article.

By diluting adverse events among four different vaccine formulations this chart semi-hides, a total of 11 instances of “Jaundice neonatal” in the babies of vaccinated mothers, compared with none in the placebo group.

Further creativity is shown by distributing the diagnosis of jaundice under a range of other terms – “Hyperbilirubinaemia”, “Hyperbilirubinaemia neonatal”, “Jaundice” and “Blood bilirubin increased”. Taking all these into account, the totals become 59/325 on Pre F versus 6/78 on Placebo – more than double the rate.

Premature birth is also a lot more common in the vaccinated group.

According to the protocol the babies in this study had three “blood draws” during the first 12 months of life –  to determine antibody levels: liver function was not checked.

We have no idea what Eric Simões, Pfizer’s Internal Review Committee and the External Data Monitoring Committee for this trial make of this apparent warning signal.

It is almost for certain others have noticed this hazard and Dr Eric Rubin, editor of NEJM which published Simões’s report, must have been contacted but there has been no published correspondence to date – over three months later.

 

 

Eric Rubin                          Billy Rubin

We have not been able to find any reports of RSVpreF being tested in pregnant animals so as to monitor any effects on the offspring.

We wrote to alejandra.gurtman@pfizer.com about the animal testing and several months later have had no response.

RSV and Bronchiolitis

Before Covid was, RSV was.

Respiratory Syncytial Virus (RSV) is one of the commonest causes of Bronchiolitis, a lung disease of infants affecting about 3% of children in their first year of life, usually in the winter.  The RSV virus was isolated in 1956 from chimpanzees and then from children. By the age of two, most children have been infected with it.

Most of these infections are mild. Children recover at home without specific treatment. There is no evidence that antibiotics, steroids, bronchodilator drugs and routine oxygen therapy are of benefit. Chest X-rays are unnecessary. The most poorly children will need to be admitted to hospital for supportive care.

Since 1990, according to WHO, the all cause of death global under-5 mortality rate has dropped by 60%, from 93 deaths per 1,000 live births in 1990 to 37 in 2020, despite Covid.

This explains how studies can now claim RSV infection as the cause of an increasing proportion of childhood deaths. RSV deaths are not increasing but as other causes of death fall it can be spun as an increasing cause for concerns.

RSV is also implicated as causing pneumonia in the elderly. Several vaccines are being trialled.  In contrast to Covid, where children were vaccinated to save their grandparents, this time the propaganda will be directed at grandparents – or perhaps at mother telling her not to let grandparents visit unless they have been vaccinated.

See Reds under the Bed and this  Oh Granny  video

Raiders of the Lost Vaccine

Since the 1960s hundreds of millions of dollars have been pumped into finding a vaccine to prevent RSV infection.

A 1966 field evaluation of a formalin-inactivated RSV vaccine was conducted by the NIH in a selected US paediatric population from relatively low socioeconomic status, primarily Afro-American families, using Pfizer’s experimental RSV vaccine designated “Lot 100”. Despite good antibody responses to the immunisations there was no effect on the incidence of bronchiolitis.

Over the following two years, those children who received the vaccine were sixteen times more likely to suffer in hospitals compared to controls. Pfizer’s 1965-6 RSV vaccine had: “Disastrous results”. Two of the 31 vaccinated toddlers died from a severe form of bronchopneumonia known as Vaccine-Associated Enhanced Respiratory Disease (VAERD). It would be nice to think that the families were given compensation.

In 2016 Dr Fernando Polack, of So Long and Thanks for all the Fish fame, co-authored an article on VAERD, sponsored by BFG, stating that these toddlers died as a consequence of subsequent RSV infection, rather than due to an adverse event triggered by the vaccine. Pfizer is not mentioned.

Vaccine development stalled after the VAERD tragedy. But the “race” to make money out of RSV is back on with a vengeance.  There are currently nineteen RSV trials in children and adults listed as in progress.

The Harrison Fords of RSV research are.

Prof. Harish Nair                        Prof. Eric A F Simões                      Dr Fernando Polack

Harish Nair is Chair of Paediatric Infectious Diseases and Global Health and leads the Respiratory Viral Epidemiology research programme at the University of Edinburgh. He is the coordinator of RESCEU – see below).

Eric Simões is Clinical Professor, Pediatrics-Infectious Diseases in the University of Colorado School of Medicine. He received more than $4M from Pfizer during 2021 for research and was lead author of Pfizer’s recent antenatal RSVpreF vaccine trial.

Bi-lingual Fernando Polack runs his Florida/Argentina/Uruguay clinical trials company I-TRIALS SA.  The BFG invested $82,553,834 into Novavax’s RSV vaccine ResVax. Fernando ran the trial. ResVax turned out to be ineffective when administered to pregnant women, failing to prevent medically significant RSV in their babies.

(A rear-guard action claims that the vaccine reduced the “burden” of antimicrobial resistance as apparently the babies of immunised mothers were prescribed fewer antibiotics in the first three months of life.)

Just as the Novovax results were being announced, Covid came along and Polack side-stepped into the Prizer Covid vaccine trial.  His company hired 467 local doctors as investigators and recruited nearly 6000 volunteers in Buenos Aires for Pfizer’s Comirnaty covid trial.

I-Trials has since been looking at combination Covid. RSV and Influenza vaccines – to be given annually.

In February 2021, GSK quietly dropped out of the RSV race after their trial vaccine for babies ChAd155-RSV was found ineffective. In February 2022, GSK’s trials in pregnant women with “RSV MAT” vaccine were stopped when it flagged up safety signals.  We still don’t know what these are.

While there are nineteen vaccine trials in progress, at moment the race to scoop the RSV jackpot is between AstraZeneca/ Sanofi’s nirsemevab, the bookmakers’ favourite, and Pfizer’s RSVpreF – neither of which are vaccines.

Nirsemevab

Two recent NEJM papers describe the outcomes of “pivotal” (i.e. for FDA) trials of Nirsemevab, an injectable monoclonal antibody against RSV.

Is Nirsemevab a vaccine?  No.  See AstraZeneca explanation.

The primary endpoint in the trial is “medically attended RSV-associated lower respiratory tract infection”. This is strange as, as stated above, the majority of medical interventions take place outside of hospitals and have few, if any, benefits.

There were 3 deaths, all in the nirsemevab group.

Here are a couple of tables in the supplementary appendix of one of the trial reports.

It seems that if children who had been given Nirsemevab were admitted to hospital with RSV, their hospital stays were 50% longer than in the placebo group.

Table s6

Table S8 is an example of two recorded Grade 3 adverse events – but were they in the treatment group or the control group? Astra-Zeneca won’t say.

It looks likely that Nirsemevab is linked to the more serious events but the company say

Tabulations that present single or multiple participants with AEs in only one study arm (nirsevimab or placebo) are presented across both study groups to preserve the study blind.”

The trial actually is over and one of us reached out to tonya.villafana@astrazeneca.com and asked whether or when the results would be updated. No response.

According to several recent papers in the Lancet – see below –  there were 33.0 million RSV-associated acute lower respiratory infection episodes and 3.6 million RSV-associated hospital admissions, globally in 2019.

If the condition is so common, why did the nirsevimab trial need 215 centres in 34 countries including, for example, USA, Ukraine, Argentina and Panama (wrongly located in the Southern Hemisphere)?

This trial offers another great example of how companies hide hazards.  Well –  This comes to pass when a child is coughing.  Just like any hint of jaundice above, the cough can be coded under or later put into any of the following “preferred term” diagnostic categories?

  • Atypical pneumonia,
  • Bronchiolitis,
  • Bronchitis,
  • Bronchitis viral,
  • Croup infectious,
  • Laryngitis,
  • Lower respiratory tract infection,
  • Lower respiratory tract infection bacterial,
  • Lower respiratory tract infection viral,
  • Nasopharyngitis,
  • Pharyngitis,
  • Pharyngotonsillitis,
  • Pneumonia,
  • Pneumonia bacterial,
  • Pneumonia parainfluenza viral,
  • Pneumonia respiratory syncytial viral,
  • Pneumonia viral,
  • Respiratory syncytial virus bronchiolitis,
  • Respiratory syncytial virus bronchitis,
  • Rhinitis,
  • Subglottic laryngitis,
  • Tonsillitis,
  • Tracheobronchitis,
  • Upper respiratory tract infection,
  • Upper respiratory tract infection bacterial,
  • Viral pharyngitis,
  • Viral rhinitis,
  • Viral upper respiratory tract infection,
  • Bronchial hyperreactivity,
  • Bronchitis chronic,
  • Bronchospasm,
  • Catarrh,
  • Pneumonia aspiration,
  • Respiratory failure,
  • Respiratory symptom,
  • Wheezing.

or

  • Cough

Let some coders loose on the job and most hazards in clinical trials disappear. You don’t even need to tell the coders you want things to disappear.

At a recent US Advisory Committee on Immunisation Practices,  trying to get nirsemevab approved, Sanofi’s Dr Christian Felter introduced a slide to show the difference between 2% and 100%.  Has he overestimated the intellect of the Committee on Immunisation Practices?

Afterwards Dr Katherine Poehling asks some searching questions about deaths and grade 4 adverse events.  Dr Amanda Leach O.B.E. for AstraZeneca does her best to fend these off.  The ticker taper says there were no fewer deaths in the vaccinated group but actually Listening to Amanda is likely to leave some of you pretty sure that nirsemevab is far from safe.

(Dr Felter’s presentation is at 55:15 in the Listerning to A Video.)

If approved Nirsemevab will not be the first monoclonal antibody approved for RSV. Palivizumab has been approved for a decade. It has a good safety record and reduces bronchiolitis.

Humanized monoclonal antibodies (palivizumab) have been used for many years for the prevention of respiratory syncytial virus infection in pediatric populations (preterm infants, infants with chronic lung disease or congenital heart disease) at high risk of severe and potentially lethal course of the infection.

Giving Pavilizumab in this way might be a sensible use for a monoclonal antibody.  Does AstraZeneca envisage restricting the use of Nirsemevab in this way?

Shi T Happens

It is hard to find data about the impact of RSV that is not tainted by drug company / BFG money.  See for example Shi T., Polack F et al, funded by BFG, another paper telling us that there are 33 million cases of RSV in children worldwide, leading to over 3 million hospitalizations and nearly 60,000 deaths.  This was also published in the Lancet.  The figures are ‘estimated’.

There are two main funding streams for RSV “research”

  • The Innovative Medicines Initiative (IMI), recently rebranded as The Innovative Health Initiative (IHI). Half of its funding comes from European Federation of Pharmaceutical Industries and Associations (EFPIA) – amounting to €1.638 billion for the period 2014-2024. In addition, EFPIA is committed to contribute €1.425 billion of “in-kind contributions”.

IMI funds PROMISE – Preparing for RSV immunisation and surveillance in Europe – to the tune of €7.024 billion as well as RESCEU – REspiratory Syncytial virus Consortium in EUrope “The RESCEU project aims to develop robust evidence on RSV disease burden and economic impact in Europe and provide infrastructure to perform future pivotal clinical trials for RSV vaccines and therapeutics” .

IMI also funds conect4children “Better medicines for babies, children and young people through a pan-European clinical trial network.”

  • The BMGF: the mellifluous Bill & Melinda Gates Foundation. This props up Fernando Polack’s Argentine Fundación Infant and also glossy RSV Gold – a Grim Reaper’s RSV Global Online Mortality Database which aims to collect as much bad news as possible about RSV in children.
  • Gates and vaccine manufacturers additionally finance the Respiratory Syncytial Virus Foundation annual conferences, as does PATH “we are a global nonprofit improving public health” which in turn receives drug company loot.

Losing the Plot ?

Children may be more at risk from current RSV vaccine trials, and in due course RSV vaccines or monoclonal antibodies, than they are from RSV:

  • Nirsemevab causes more deaths than placebo in controlled trials.
  • In the Nirsemevab trials, serious adverse effects are being hidden.
  • Neonatal jaundice and prematurity are more common in neonates born to mothers given RSVpreF.
  • Were there any safety trials of RSVpreF in pregnant animals – if so, where are they?
  • What problems did GSK’s antenatal RSV vaccine cause? These must be disclosed.
  • Researchers and Journals have stopped engaging in any discussion of concerns.

The biggest worry of all might lie in the early history of RSV vaccines – which put the concept of VAERD Vaccine Associated Enhanced Respiratory Disease on our radar

This is now recognised with Dengue and other Vaccines.  In the case of Covid and its vaccines we now have Neonatal Multi-System Inflamatory MIS-N.  See Karunya Come Home for more on MIS, and MIS-C.

The severity of RSV peaks at the age when infants have high maternal neutralising antibodies.

Vaccine Preventable

Conditions like RSV are now labeled vaccine preventable.  If something becomes VP, it seems all sense flies out the window.  No-one stops to ask whether there may be more harm in indiscriminately preventing infection than in leaving things alone or selectively intervening as with Palivizumab.

Nobody stops to ask whether there could be problems giving new treatments about which we know very little in pregnancy.  Since the mid 1970s there has been a huge increase in drugs taken in pregnancy – by wealthier, older, college educated and white women.  This looks likely to repeat with vaccines.

This gameplan maps on to the Risk Prevention approach in medicine with minimal, almost non-existent, risks like cholesterol levels targetted because we can but with no-one asking whether poisoning 100 healthy people with drugs that will injure or kill many of them is a good idea in order to save one life from a cholesterol linked risk or other risk linkage.

When we then end up with people on ten drugs to manage ten notional risks we brew up a cocktail that is shortening our lives, increasing hospitalizations, leading to health service collapse, and giving us a far worse quality of life.  See Shipwreck of the Singular.

This way madness lies.

There will almost certainly be unexpected problems with these new vaccines – like Achilles tendon ruptures on fluoroquinolone antibiotics or suicide on doxycycline – which need recognition but will now be denied as having any links to these vaccines – see Harmatology.

This way lies a destruction of healthcare from New Zealand, through Australia and Europe to North America.  Health services are on their knees with politicians telling us the answer is even more high tech.  Common Sense just doesn’t appear common any more.

####

Two days after this post went up, the Lancet carried a new BFG funded paper on the horrors of RSV and the absolute necessity to have 33 trials currently running on vaccine and monoclonal antibody development in this area – for pregnant women, infants and older adults.

BFG – Lancet – Mazur et al 

 

 

 

Military Maneuvers in the Dark

This post follows on from If You Wake at Midnight.

Military Medicine

When the history of modern medicine is laid out – See Shipwreck of the Singular – it is clear that, from Napoleon onwards, the military have been the greatest influence on its development. In Wars before 1900, more soldiers died from disease than from enemy efforts.  There was a pressing need to change this. The armies who won were the ones with the fewest soldiers dying from disease. This is how a few Spaniards defeated the mighty Aztec and later Inca empires.

Napoleon’a army created ambulance services and battlefield surgery. In the American Civil War we got the Red Cross, triage stations and hospitals behind the lines.  Syringes, opioid pain-killers, and anesthesia brought safe amputations, a management of open chest wounds, and the first plastic surgery on stream.

The military also realized the importance of treating Veterans properly which led to pensions, free healthcare, and developments in rehabilitation medicine.  The War experience led to a hospital in every American city, mostly doing surgery, with a placement of hospitals on grids to facilitate responses to emergencies along with urban ambulances and Casualty Departments.

The Germans copied the Americans, and the Japanese copied the Germans and against all expectations beat the Russians in 1904 in great part because they were the first to have fewer soldiers die from traditional wartime killers like dysentery and typhoid.

The Great War, World War II, and later Wars built on these developments. Military needs now drive telemedicine, remote surgery and everything that might be needed for space exploration.

DARPA, BARDA and OBAMA

In 1958, Dwight Eisenhower, who bowed out of office in 1960 warning us about the military industrial complex, created DARPA – the Defense Advanced Research Projects Agency. DARPA laid a basis for supporting research for military purposes, created the internet, which has led to the surveillance society we now have. All these have had a huge influence on medicine,

In 2006 George W Bush and the War on Terror gave us BARDA – Biomedical Advanced Research and Development Authority – among whose briefs is to defend us against bioweapons. BARDA supported the idea of Emergency Use Authorization of equipment and drugs and vaccines in emergencies like pandemics.

On the day before the Trump-Clinton vote in 2016, Barack Obama signed Executive Order 13747

Advancing the Global Health Security Agenda to Achieve a World Safe and Secure From Infectious Disease Threats

This order aimed at creating a coordinated international network to respond to threats like novel infections, whether arising by accident or from a laboratory.

The Pandemic

A year and half ago, Brook Jackson attempted to alert FDA and later others to serious violations of good clinical trial practice in the Pfizer Covid Vaccine trial at the sites in Texas being run by Ventavia.

When some of us here outlined the difficulties Brook had had in Eric Rubin Boston Strangler, we only knew a part of her story.  We knew she had taken a False Claims action alerting the US Government to a situation in which they were essentially being defrauded. We knew the US Government yawned and rolled over in its sleep.

The Pfizer Motion to Dismiss says that:

  1. Jackson couldn’t point to any injuries.
  2. FDA were aware of her complaint but still authorized and later fullly approval Comirnaty. A thousand Ventavia patients, 2% of the trial participants, were unlikely to influence the overall result.
  3. Pfizer made no false claims. They simply sent in invoices for billions of dollars based on FDA Emergency Use Authorization and later approval. The invoices made no claims this was for a vaccine or that it worked or that it was safe.

Pfizer’s invoices were/are sent to the Department of Defense, not as you might have thought the Department of Health.

This arrangement appears to have been put in place under an Other Transaction Authority (OTA).  OTAs were created with DARPA in 1958. When the military wanted to get something done fast without having to go through Red Tape, bidding wars or ethics committees, it can use an OTA. This is ostensibly when speed is needed rather than secrecy.

In a recent interview, Brook brings all this out and the dilemmas it poses for her lawyers and perhaps the lawyers on the Government’s side also.

The rudiments of Emergency Use Authorizations date back to the 1938 Food, Drugs and Cosmetics Act but EUAs formally came into being with Project Bioshield in 2004. This laid a basis for using unapproved agents in an emergency.  Before Covid the only vaccine administered under EUA was an already approved anthrax vaccine.  The Covid vaccines where the first new and previously unused vaccines to be EUA’d.

But not the first drugs.  Hundreds of EUAs were used in the early phase of the pandemic for all sort of devices and tests aimed at tracking the virus and protecting people.  And FDA issued EUAs for chloroquine and hydroxychloroquine apparently at Donald Trump’s insistence.  These EUAs were revoked within two months.

Both the issuing and revoking illustrate that FDA has not been operating as normal – it’s doing as it’s told.  It’s normal these days for FDA to approve drugs that don’t work and are dangerous like Aduhelm for Alzheimers but even on an accelerated approval track this takes ages.

What is not normal is for a trial to end in mid-November and FDA essentially to approve the treatment four weeks later before it had a chance to make sure these new agents don’t work and are dangerous.

Where could the problem be in approving treatments that are about to appear in press any moment now in the Holy of Holies – The New England Journal of Misinformation – with a distinguished first author Stephen Thomas.  A military man no less. Who says he hasn’t seen the data and doesn’t reply to email queries about this.

The Brits

This is not some unique US perversion. The UK has done exactly the same – whether told to by the US under the auspices of a Global Health Security Agenda or by its own military-industrial complex. The Brits took a DARPA style Task-Force approach to the pandemic chaired by a venture Capitalist, Kate Bingham, that channeled vast amounts of money to friends in order to save time, with estimates that billions have been squandered.

The UK government brought in Emergency Use Authorization in the Autumn of 2020. Authorization and later vaccine approval was granted by MHRA, whose boss June Raine now tells the world, MHRA switched From Watchdog to Enabler.  You can hear Kate and June in the Watchdog link.

June proudly gushes that MHRA has now developed regulatory flexibilities it didn’t have before.  When challenged by Boris Johnson to please don’t stop us from killing people, she tells us she said of course we won’t – we will help you save lives.

It’s likely the same in Europe where the EC are refusing to release the text messaging between Ursula von der Leyen and Albert Bourla – see The Handmaid’s Vaccine.

Argentina

What about Argentina?  Well, the answer has been staring us all in the face from the first post.

The Special Mission (let’s not call it a trial or a study) was carried out at the Hospital Militar in Buenos Aires.  Checking this out, Johanna Ryan stumbled on an article about Hospital Militar with great photos, like the one above, and an interview with Jorge Leyendo, about persecution of union workers there:

“There is an underlying problem, very serious. More than 600 private companies work at the Military Hospital through the Argentine Army Health Foundation, FUSEA. The director is Ariel Guzmán, a retired colonel, who was the Hospital’s Operations Director until very recently. What I wanted to explain is that during working hours with a state salary, workers are forced to work for these companies.  These companies have work at zero cost, it is slave labor at zero cost that goes unnoticed because the worker receives his salary as a state worker, fights for his parity, fights for his extras, tries to earn better, but he is doing work for private, in addition It clearly violates the Public Ethics Law (Law 25,188).

But this is not the most serious thing, they tell you that you have to do it because there is an agreement. Now we as a union have been asking for these agreements for years, they are never shown to the workers. We workers have an agreement, in a sectoral sector, we have a general agreement, which is from 2006, we have the public employment framework law. But it turns out that there is another secret rule that nobody sees. So we are in a situation that is totally opaque, totally unclear economically and legally. This is happening.

… We had been talking about this issue, but Colonel Roberto Ramón Bieneski, head of HR, blew up the negotiations with these document letters, with these summaries, with these folders that they are putting together, with these violations of the laws and, well, they force us to make public the topic. Besides, we have to make it public because it is our right as a group of workers.”

This is exactly the problem Augusto Roux has run into. A secret law blocks him from being able to access all his records and establish just what has happened to him.

Mandates and Malefizer

Malefizer © Nina Otulakowski July 2022

Mandates for vaccines or anything else are a very military thing.  As Andrew Marriott outlines in If You Wake at Midnight the troops were lined up and given Lariam, and you were essentially drummed out of the service if you talked about problems the drug was causing you.

Earlier this year there was a controversy about deaths, injuries and harms the vaccines had caused US troops. It looked like the figures were showing dramatic increases in harms, and then it looked like they were corrected or fiddled – hard to tell which. Matthew Crawford from Rounding The Earth was heavily involved in raising these issues and believes fiddled is the right word.

You don’t have to take a position on this to be alarmed at what appears to be a linked development. Adam Schiff, a leading Democrat, has recently introduced an amendment to the US National Defense Authorization Act that would prohibit the use of military information as:

“evidence in any trial, hearing, or other proceeding in or before any court, grand jury, department, officer, agency, regulatory body, legislative committee, or other authority of the United States, a State, or a political subdivision thereof.”

This, as Crawford notes, appears to move the military to a realm outside of government.  A state within a state.

Given our increasing inability to find out what is going on, it is as though Malefizer has swooped down and put us all to sleep.  Maybe we will all wake up as the Germans did in 1968 wondering about the bad dream people kept telling them about.

I wrote to Joe Biden in September 2021 as Covid Vaccine Mandates were introduced – Love in a Time of Covid – saying

You are telling us we are at War with the Virus, but you haven’t put a Red Cross in the field to pick up even our own troops who are wounded. You have created an atmosphere of joy when enemy troops (the unvaccinated) end up in the hands of our healthcare staff who openly sneer at them, and say they feel inclined to let them die. There are no convalescent hospitals or rehabilitation facilities for our troops to go to, no effort to sustain our morale by treating our troops decently.

You are drafting US citizens under terms and conditions that predate the American Civil War.

The Global Health Security Agenda means he has drafted all the rest of us as well – Europeans, Canadians, and others.

It’s only in fairy tales that a Prince turns up on horseback and cuts through a Forest of Thorns to set us free.  Besides one of today’s princes is among the last people anyone would now want to meet.  Putin on horseback might be a better bet.

A fairy tale noir might see someone sitting down with Malefizer, who must be getting bored with how easy it has all got to make a $100 Billion, challenging her/him to a high stakes card game – the soul of humanity for the winner.

In the real world, hoping for the military to wake up is a better bet.  But, like the rest of us, whether because of the tech element or the propaganda element, drugs and vaccines seem to cast a deep spell on them also.

If You Wake at Midnight

Andrew Marriott’s  recently published If You Wake at Midnight is a compelling read.  It would have been a great candidate for inclusion on the recent list of Books on Medical Treatments Gone Wrong.

It tells the story of Lariam – mefloquine – a treatment to ward off malaria. A drug that for over 40 years has been causing suicides, homicides, depression, and a wide range of neurotoxic symptoms.   There are many RxISK posts about Lariam – see Sanctuary Trauma.

Ministering Angels

But If You Wake is not just about Lariam and the problems it causes, it’s about the bureaucrats, FDA, EMA, MHRA and others who have blocked recognition of these problems, when recognition could have saved lives.  Bureaucrats who have been perfidious in the way they have treated the families left behind or destroyed in the wake of Lariam induced problems who came to them looking for answers – thinking the regulators of medicines were an obvious first port of call.

Phrases like economical with the truth come to mind. Or the old joke: How do you know they’re lying – when their lips move.  Perhaps updated now to – when their fingers touch a keyboard.

To many who came to them looking for help, Peter Marks of FDA, June Raine from MHRA or Guido Rasi of EMA can look like ministering angels. They are warm and sympathetic far removed you think from the juggling fiends Macbeth had to deal with it. But his words apply in spades here

Be these ministering angels no more believed that palter with us in a double sense.  That keep the word of promise to our ear and break it to our hope.

Again, and Again, and Again, people damaged by Lariam, Isotretinoin, Finasteride, SSRIs, Antipsychotics, thinking they are being listened to by these ministering angels, instead have found and find and will find themselves gaslit, jilted, let down, betrayed.

And so it will be Tomorrow, and Tomorrow, and Tomorrow to the last syllable of recorded time.  See Harmatology.

Roche

If you Wake is also not just about Lariam, or ministering bureaucrats, it’s about Roche. Hoffman la Roche.

Up till recently we have had survivors of the Second World War present at ceremonies to celebrate a defeat of fascism. So too we have had a generation of people badly damaged by benzodiazepines, in particular Valium, aka diazepam.  By the 1970s, Valium was the best-selling drug in the world and the boss of Roche, Adolf Jann, asked whether the company had any responsibility to the public said:

I would say no.  Because it is in my opinion absolutely logical that my task, my responsibility is to develop Hoffman La Roche. And why are we doing that?  We are doing it because it is absolutely clear that the only chance for the social security or social health service is to make economies by finding new drugs.  

See Antidepressant Story at 19.31 if you want to see Jann get all worked up about this and thump the desk in front of him.

The people who were collateral damage in Roche’s Special Mission, don’t call it a War, were left to face Roche alone with no support from doctors or politicians or the media.  They got nowhere. Their claims of harms were dismissed by the establishment – it was easy in those days before we had health pages in newspapers or anything to do with health on television to ignore people who had been harmed, who were even more invisible than now – See Nearly Invisible, Drug Traffic Accidents.

Recognition of the harms being caused by the benzodiazepines only came when the pharmaceutical companies developed a new generation of drugs that would make them more money than the old off-patent drugs. Companies sponsored academics like Malcolm Lader to do the benzos in and promote first of all Buspar and later the SSRIs – completely corrupting psychiatry in the process.

Lader and others seemed like good guys to many of Us. They may have been well-intentioned but just duped.  Willing dupes – who knows?

The result was that many people now made a point of telling their doctors that they didn’t want anything dangerous like Valium or Ativan or drugs like that, drugs that could hook you, but they’d take Paroxetine, Fluoxetine, Sertraline instead – those happy pills, the ones that made you Better than Well.

Or doctors would point blank refuse to give Valium for fear of being struck off or sued  Valium ended up widely regarded by doctors as more dangerous (to them) than Heroin.  When the patent ran out Roche stopped marketing it.  While lots of brand name companies were making money selling branded generics – life Pfizer selling Zoloft, Roche eliminated the word Valium.  You could get diazepam but not Valium.

This too is leading to injuries because Diazepam and other benzodiazepines are often much safer and more appropriate than the SSRIs or antipsychotics or anticonvulsants people get given now.

Diazepam was a twentieth century War.  Isotretinoin and Lariam were the Special Missions Roche embarked on after those injured by benzos, were rendered invisible.  The dogs bark the caravan moves on.

Those whom Accutane (isotretinoin) has caused to kill themselves or others, or who have had their ability to make love wiped out by this drug will know exactly what Andrew Marriott and others working with him to bring the truth of Lariam to light have been through trying to get hold of documents they know to exist, trying to assist families at inquests into a death, trying to grapple with the double-speak of doctors and company people and bureaucrats.

A health warning is in order.  Anyone who has been injured by a drug or lost a loved one to a drug should know, you are likely to feel homicidal reading If You Wake.

Another Circle of Hell

If You Wake has another circle of hell to it – not found with benzos or SSRIs.

Lariam is a military drug.  It was developed by the US Military and did not go through the usual clinical trial or FDA approval process before being deployed for use and then handed over to Roche to commercialise it and get it used by you and me traveling to malaria risk zones.  As the risks became clear, Roche began to scale back its use by you and me but the military, especially the British, Canadian and Australian military kept using it in Sierra Leone and West Africa as well as Afghanistan.

Accounts from soldiers bring out the horrific dreams, and the paranoia it caused, make it a racing certainty that some of the senseless acts of violence there have been, like soldiers running amok and wiping out innocent families and children, were caused by it.

The Americans decided this was definitely the case in Afghanistan. Even so, Marriott makes a strong case it was used in Guantanamo Bay by the Americans and British (yes you read that right) to break detainees down, some of whom appear to have been held not because of crimes committed but as guinea pigs in exercises to see whether Lariam could soften them up.   Not just Guantanamo but Diego Garcia also.

There are telling vignettes.  One name that crops up is Johnny Mercer whom RxISK readers will know from What’s a Life Worth and Once We Were Warriors.  Mercer made a big deal about becoming a politician to help the comrades he had fought with. Those suffering from Lariam toxicity hoped for better things when they took their case to him.  But like Tracey G found, he was all talk, all promise but bailed out when asked to do something.

In the Lariam case, he all of a sudden got a ministerial post, which rather than making it look like he was even better placed to help his comrades looks instead to have been a bribe to get him to keep his mouth shut.

One of the other features that came into play that lies in between the lines of the Lariam story is how the Army embraced – PTSD.  The soldiers with dreams, who were depressed or suicidal, were told they had Post-Traumatic Stress Disorder, even if they had seen no action.  They could get compensation or treatment for this – but not for Lariam induced problems.

Trying to decide whether the medicines regulators or the military command – all the way up to serial Ministers of Defence – would have been more inclined to keep sending troops over the top as in the Great War is a difficult call.  Hard to say who would blink first in the face of drug induced carnage.

The extraordinary thing is that the military otherwise have a code of honour which requires them to look after their troops if injured.  The pension schemes we have today, injury compensation schemes, developments in rehabilitation medicine – all come from the military.  But none of these enlightened moves apply to injuries from drugs like Lariam.

What’s happening? Marriott leaves us wondering what it is that has made cowards of so many otherwise brave men.  Leaves us wondering how the senior military command expect us to trust them to organize anything, if all the post and emails to them on issues like this somehow get lost, or they are prepared to lie so blatantly.

There is no Chapel on the Day They Hang a Man

If You Wake looks forward to a day when the troops killed by Lariam on duty, or who die after suffering Lariam induced agonies for years after returning home, are also remembered in Memorial Settings and on Memorial Days.  There are no ceremonies now for them or their families or comrades to attend, where the truth about what happened and their sacrifice is recognized.

It is as though they are criminals.

This is something everyone who has been seriously drug injured – ordinary folk who are heroes – will recognize.

On the day that is in it (July 12), perhaps the best way to put it is that at the moment it seems more likely we will seen Green and Orange marching arm in arm in a twelfth of July parade than we are to see the Military embrace its mistakes about Lariam (and other medical interventions – see next week) and honour the troops who have died or been tortured beecause of these mistakes.

Someone to whom all of the above applies was talking to me recently and said:

This is not Worthy of Western Democracy – or Western Medicine.

He is right.

Over ten years ago now, a group of men broke into the offices of Charlie Hebdo in Paris and gunned down the staff who had printed cartoons of the Prophet.

As War on Civilization outlined,  Nikolas Sarkozy stood on the steps of the Elysee Palace and said

This is a declaration of a war on civilization and it is the responsibility of civilization to defend itself.

A ghostwritten literature with all the hazards of drugs hidden is also a declaration of war on civilization and it is our responsibility to defend ourselves.

I have thought this for a long time and cautioned the editors of journals like Eric Rubin and Kamran Abbasi to beware of the injured breaking into their offices and gunning them all down because they have published caricatures of science that have killed and maimed tens of thousands of people.

Regulators and Ministers of Health and Medical politicians, no matter how good they are, or think they are, should see the movie CalvaryFather Munchausen I Presume – should beward too.  Sometimes it can be more effective to make an example of a good guy than tackle the villain.

Just last week in Sweden a man murdered Ing-Marie Wieselgren. She was a prominent face for mental health – but became the target for a man who believes psychiatry has failed us.  The week before a young man in Copenhagen gunned down three people – to draw attention to the fact that psychotropic drugs don’t work.

Soldiers sitting in a mess just following orders perhaps should beware too – they all knew what was going on but didn’t seem able to get their act together and sort out a military command that has been on this issue – complicit in ordering a modern Charge of the Light Brigade – see The Valley of Death.

One of the most extraordinary things about the Lariam story is this.  It is normal, healthy even, to have homicidal feelings in the wake of injuries like those Lariam causes you and your friends and the suffering it brings to families. No-one trained to take action, however, has put on Warpaint.

This book by one of their own should be very uncomfortable reading for anyone in or linked to the military but better this than donning Warpaint.

To Be Continued

Harmatology: a New Science

In 2008-2009, 7 young women died in a HPV vaccine trial in India. There was a backlash against the clinical trial industry.  Quite apart from Pharma trials, the National Institutes of Health (NIH) had 70 ongoing trials that were abandoned.

It was clear, Indian investigators had to be taught how to assess awkward events properly.

Barbara Bierer, a Haematologist, and founder of MRCT travelled to India in 2014 to help the new Indian Society for Clinical Research (ISCR) with causality assessment. ISCR had been set up by Pfizer in 2010 and company support made the ISCR journal open access.

Causality assessment refers to the ways to assess possible links between a drug or vaccine and harms happening in company trials or other studies, or just clinical practice.

At this MRCT workshop investigators were encouraged to distinguish between adverse events and adverse reactions and to establish if:

  • there were similar reports previously linking the drug or vaccine to an event
  • there were similar reports in the label of related drugs or vaccines
  • the event appeared in the investigator brochure
  • the event was consistent with the pharmacological mode of action of the drug
  • the event was consistent with the pharmacokinetic profile of the drug
  • the event was consistent with peak plasma or overall concentration of the drug
  • the event might be consistent with the first sign of a latent illness
  • whether there were concomitant drugs
  • whether there were concomitant conditions
  • whether anything else was happening at the time of the event
  • if none of the above consider that the event might have happened but be unrelated to the drug.

In the world of company trials, nothing ever steers an investigator toward linking a harm with a treatment. The entire trial process hinges on a mantra that trials rather than an assessment of individual cases by a clinician offer true cause and effect information. Unless an event has been demonstrated to happen to a statistically significant extent in a controlled trial there is no good evidence that the drug or vaccine has caused it.

WHO guidance on establishing causality for adverse events in vaccine trials now goes even further and states that every effort must be made to link an event following a vaccine to factors other than the vaccine.  See Bellavita and Pulliyel.

The result – death after death from myocarditis, stroke or other cause, in Pfizer’s and other Covid vaccine trials that appear in the paperwork companies send to FDA and EMA feature as investigator codes as not-related.  FDA reviewers close to universally agree with the ‘investigator’,

If anyone now rooting through any vaccine trials finds a death or serious injury that an investigator or regulator has linked to the vaccine, please send us news of where we can view this unicorn.

Harmatology

Wondering about Bierer, who had no background in adverse events or causality assessment, I texted a Haematology friend to ask if she had ever heard of BB. The predictive text on my phone converted Haem to Harm and a new science was born .

Circe Surrounded by Porkers © Nina Otulakowski June 2022

Harmatology is the science centered on making the harms of treatments disappear. It is key to transformating RCTs into a vehicle to provide a smooth assay system for drug licensing.

Harmatologists convert valid and criticial information about vaccines and drugs into anecdotes and misinformation. They transform the truth we need for our journey through life’s perils, the forced navigations between a Scylla and Charybdis, into ‘porkers’ or ‘porkies’- a porker is London slang for a lie – because it rhymes with the pie in pork-pie.

Porkers conjures up Circe, who famously magicked Odysseus’ men into pigs.

The precision of Harmatology 1.0 processes to ensure efficacy and eliminate harms developed steadily from the 1980s to the point where by 2000 companies could confidently claim that there is no evidence of any harms on any of their drugs.

We have moved on Harmatology 2.0, glimpses of which you can get below.

Step 1:

Embrace Randomized Controlled Trials (RCTs). Without much gaming, RCTs ensure company interests in seeing harms disappear are realized. RCTs necessarily focus on a primary endpoint and hypnotized by this the 99 other effects of a drug are gathered so haphazardly that they disappear even when these effects are immediate and all but universal like the sexual side effects of antidepressants.  Mission Accomplished.

In the very first RCT of streptomycin in 1948, deafness and tolerance were missed. And in a 1960 RCT, run by Louis Lasagna, thalidomide showed up as effective and harmless. If only there had been more RCTs then to counter all that misinformation about that great drug.  Lasagna was quite a visionary when he pushed to have RCTs incorporated into the 1962 Food and Drugs Act.

Step 2:

Healthy volunteer trials, or Phase one trials as they are called, offer the perfect opportunity to see the hazards your drug or vaccine causes, leaving you time to think, for example, about how to just not collect any information on sexual function in an antidepressant trial or any indications of dependence.  These trials are never published so no-one will ever see what has disappeared.  Mission ongoing.

Step 3:

Having eliminated anything occurring with any degree of frequency, insist that only effects occurring to a statistically significant extent in trials are viewed as having been established as linked to a treatment. Mission Accomplished.

Given that statistics strictly speaking should only be applied to a primary outcome, this gets rid of any possibility that any event other than the primary outcome can become statistically significant. Statistics can only be applied meaningfully to events that have been measured precisely.  Nothing in a clinical trial, other than the primary outcome, is measured precisely.

Step 4:

Some people found it hard to believe when we said our drugs have no adverse events, as in Harmatology 1.0.  Vatican 2 (Harmatology 2.0) has come to the rescue.

The vaccine trials have let us roll-out a development we’ve been working on – prepopulated lists of effects other than the primary outcome.  These lists of immediate vaccine side effects like a sore arm are delivered on electronic devices for individuals in trials to complete in the comfort of their own homes – see Virtual Research.

The fact that they are collected on all individuals in the trial means that statistics can be applied to them. As a result, it can be claimed that vaccines give rise and only give rise to headaches, mild fevers, aches and pain – all the features of vaccine reactogenicity. The Apps have no space for the registration of other effects. If these are reported in letters or emails, they can be declared reported, they can be reported as expected reports, without conceding evidence for a linkage.  Mission Accomplished.

Step 5:

Train investigators in both developing and developed world settings on the lines of the training offered by Bierer above.  Mission Accomplished.

Step 6:

Introduce coding dictionnaries.  These let us code suicides as nausea, emotional lability or burns. No one spots that they are the first line of authorship.  Once the coding is in place, the paper writes itself. Mission Accomplished.

No paper appearing in any medical journal has ever in its methods section dealt with coding bar one – Study 329.

Step 7:

Brand careful analyses of cases that appear to establish that a drug or vaccine has on a balance of probabilities caused a harm as porkers (anecdotes, misinformation).  Do this to the extent that journals like the BMJ or NEJM that used to publish case reports stop doing so.  Do this with the stick of legal actions for publishing porkers harmful to your company’s interests and with the truffle of large amounts of money for reprints of published RCTs and meta-analyses of RCTs.  Mission Accomplished.

Step 8:

Abolish Drugs Bulletins, which mention the harms of treatments, or make their lives harder by for instance requiring doctors to buy them, which the skinflints won’t rather than have them made available for free by health services.  Mission Accomplished.

Step 9:

Get legal systems to accept that the only reliable information about drugs comes from clinical trials. When doctors report a harm, who knows how reliable that information is whereas with harms in RCTs we can tell the courts what the margin of error is. We can help courts to get away from prejudiced experts and offer information that every expert has to adopt. Mission still in the Balance.

Step 10:

Create Evidence-Based-Medicine. Mission Accomplished in 1991 by Eli Lilly and the BMJ working in conjunction. See Vampire Medicine.

Step 11:

Relentlessly exhort doctors to practice in accordance with the evidence. Begun in 1965 and continuing.

Step 12:

Outsource the running of Drug Trials to Contract Research Organizations (CROs) who shuttle between investigation centers and return the data from each site to a central repository linked to the CRO and probably offshore.  Mission Accomplished.

Where before 1990, all of the assay data was in the lead investigator’s filling cabinet, after 1990 it was sequestered – goodness only knows where.

Step 13:

Embrace Guidelines. We don’t have to write them.  The guidelines are based on the published literature, which is ghostwritten, and the bulk of which comes from our ‘trials’, with no access to the data.  The guidelines write themselves and health services pay academics to convene and put their names to these standards that promote our drugs.  Its a great business model and the greatest concentration of Fake literature on earth.  Mission Accomplished.

Relentlessly exhort doctors to practice in accordance with Standards of Care, a.k.a. Guidelines.

Step 14:

Ensure medical trainees in all specialties learn the standards of care. Make it so that they need to parrot these to pass their exams and qualify in the specialty of their choosing. Mission Accomplished.

Even now few young doctors can imagine how a drug or vaccine could cause a problem. If a young aspiring medical student wants to engage with the ‘customer’ enourage them to think about something else – like hairdressing.

Step 15:

Ensure that Patients with Rare Diseases have a place in any forums where access to assay data is being discussed.  None of these patient advocates will support access to assay data because the risks of people with a rare disease then being identified is too great.  6ission Accomplished.

Step 15:

One of our greatest weapons has been informed consent forms.  They began as a way to inform people they were taking part in an experiment on one of our drugs.  We turned them into something that tells people we will never let anyone see their data – not even regulators.  Mission Accomplished.

This sounds good to those simple volunteers who think they are participating in a scientific exercise that will advance the health of their families, friends and communities but in fact will create a state of legal jeopardy for their family, friends and community who will not be able to get access to the evidence that our drug caused harms in the assays in which it was tested.

Step 17:

The data are the figures and the boxes ticked, right?  Stick to that.

Never admit that people are the data.  When we remove their names and contact details, we can invent figures and tick whatever boxes we want. No-one can ever find out that we have airbrushed problems out of existence or created non-existent trial participants

In our trials people come out apparently cured of severe illnesses like depression but commit suicide a few days later or have their sex lives wiped out forever and wish they had never had the drug or become dependent on the drug and are still on it a decade later. We do not want anyone to be able to contact these people.  Mission still in the Balance.

Step 18:

Ensure people’s names figure nowhere. Named people willing to come into court and talk about their injuries and be cross-examined are like garlic or crucifixes to us.  Mission Accomplished.

Step 19:

Fairly soon all trials will be Virtual.  People will participate from their homes on electronic media and we will be able to monitor what is going on in the background and discontinue them from the trial before anything goes seriously wrong.  See Virtual ResearchMission in Progess and looks unstoppable.

Step 20:

The Virtual Trial ‘data’ will feed straight through to Artificial Intelligence A.I. enabled medical writing systems who will report the results of the trials without a human hand going near anything.  Pure objectivity. The finished article will appear in the New England J of Medicine two weeks after the trial has finished.  See Albert Bourla’s MooningMission in Progress – looks unstoppable.

In the meantime, we have Eric and a few others dotted about in all major journals. Every medical journal should have one. Eric rejects any request for access to the data, and all reports of an adverse event – New England Journal.

Step 21:

One of the worries is ensuring that doctors do not spot that if harms disappear they too will disappear – replaced by nurses with both soon replaced by robots – see Caught in the Firing Line.  At the moment, with their snouts in the trough they show no signs of noticing what has happened.

Step 22:

American English rules. Make sure we keep spelling it Hematology.

Step 23:

Women-wash.  Step up Barbara, Rebecca, Liz and others.

Circe

Circe is one of the more impressive women in Greek mythology. The way she dealt with smitten men and women rivals was impressive.  One king was turned into a woodpecker and one rival was turned into Scylla who is mentioned above.

A 2020 book by Madeleine Miller that has had rave reviews seeks to rehabilitate Circe and make her a twenty-first century icon for women.

It will take a really strong woman or group of women to restore truth and dismantle Harmatology 1.0 and 2.0. But women mobilized by harms to their children, parents or friends (partners are a different matter) are perhaps the most powerful force on earth and capable of creating Harmatology 3.0 – the science needed to cut through all the misinformation and recognize harms.

Footnote

Without intervention, ‘superpigs’ could soon invade Alberta cities, researcher warns

This is wonderfully apposite; Alberta has been the Canadian province most concerned about Covid and Vaccine related porkers.