Making medicines safer for all of us

Linguas Bifidas © Nina Otulakowski July 2022

An Adverse Event is anything that happens while a trial is happening – even a nuclear war.  There were lots of traffic accidents and broken bones in Buenos Aires during the Pfizer trial – mostly on placebo.  Maybe Covid vaccines prevent fractures or accidents.  Not impossible if you are too sick to get out and about.

An Adverse Reaction is something caused by a drug.  Very few Events are Reactions or so the powers that be would have you think.

Then there are side effects of drugs or vaccines, many of which are far more common than the so-called main effect – the thing companies blaze from rooftops is going to save you even transport you onto a new plane. To translate – you not supposed to be aware that there are common effects that get in the way of us making money, like the obliteration of your ability to make love on SSRIs, and there are rarer ones we want you to focus on because we make money while you’re looking where we want you to look.

Harmatology outlined how a scheme has been carefully crafted over decades to make it close to impossible for any investigator to link a treatment induced harm or death to a drug or vaccine.  The one thing trial investigators do not now do is investigate.  The word has become an oxymoron.

The Covid Vaccine trials mark the finest achievement of this scheme to create a set of Medical Admirable Nelsons, fit for twenty-first century clinical trials.  In the Pfizer trial, there were deaths from myocarditis and other problems we now accept the vaccine causes. These were reported to FDA and EMA. But in no case did the ‘investigator’ link the deaths or harms to treatment. The regulators did not take issue with the visual problems these Nelsons were having.

January 6 Storming Pfizer Day

On January 6, 2022, Justice Mark Pittman ruled that FDA and Pfizer’s efforts to block access to the documents behind the Pfizer vaccine trial for 75 years were inappropriate and the paperwork would have to be released at a rate of 90,000 pages per month.

Efforts to get the documents out were initiated by Aaron Siri and a group called Public Health and Medical Professionals for Transparency.  The story was told by Michelle Moluske last March.

Several hundred thousand pages of documents are now available on the PHMPT site with more to come. Most readers will likely feel intimidated by all this – I’ve waded through hundreds of thousands of pages before and I feel intimidated.  But there are ways in to the material and even people with no background in any of this stuff can make a huge difference.

For those of you who are good with gadgets and geekery, unlike me, there is what appears to be an amazing gadget – Abstractor.  The gadget folk I know drool about this.  It allows anyone to search hundreds of thousands of pages all in one go for things you are interested in – deaths, heart attacks etc.

I am more a pull a piece to thread person rather than an overview person who likes big data.  Augusto Roux has for nearly two years been shouting out to anyone else willing to listen – I’m the piece of thread you want, pull me.   See also So Long and Thanks for all the Fish.

If you’re like me, rather than the data documents you are more likely to migrate to documents called Narratives, especially if they have the word sensitive linked to them.

In the 3600 page Narrative document, linked above, there are narratives from all trial sites including site 1231 and site 4444 which are strikingly different even though both are in Buenos Aires, in the Hospital Militar and run by the same people – Fernando Polack and Gonzalo Perez Marc.

You can guess you are on to something if you are having fun.  In the case of subject 44441979, the narrative outlines a woman who has an issue that was then and still is a big problem for Pfizer.  She has become pregnant.  After outlining everything, the investigator has to assess causality and does. Pfizer also have to give a view and do:

Not So Mindless

So having had a good laugh, you might decide like me to go pull on the thread that keeps giving – Augusto’s record.  All traces of him are missing in most places they should be, but here we strike Narrative Gold.  The Narrative reads as follows.

Subject C4591001 1231 12312982 (Augusto), a 36-year-old white male with no reported medical history, received Dose 1 on 21 Aug 2020 and Dose 2 on 09 Sep 2020 (Day 20). The subject reported severe anxiety on 23 Sep 2020, 14 days after receiving Dose 2.

On 09 Sep 2020 (Day 20), the subject presented to the emergency room (ER) with fever (body temperature of 39.3 ̊centigrade [C]), malaise, myalgias, headache and nausea.

The subject had a serious adverse event of suspected COVID-19 reported on 09 Sep 2020 (Day 20) and was treated with clonixin lysinate/pargeverine hydrochloride 10 mg/125 mg for nausea since 09 Sep 2020 (Day 20).

On the same day night (Day 20), the subject presented again to the ER afebrile (body temperature of 39 ̊C), eupneic and had normal oxygen saturation with persistent moderate malaise, nausea and headache.

On 10 Sep 2020 (Day 21), the subject remained subfebrile, with nausea and reported dizziness and darker urine colour.

In the context of the severe acute respiratory syndrome (SARS) CoV2 pandemic, the physician decided to evaluate whether these symptoms were associated with SARS CoV2 infection and requested a SARS CoV2 reverse transcription polymerase chain reaction test, which was negative; laboratory tests results were normal and unremarkable except for mild incrase in creatinine of 1.21 (unit and normal range not reported), abdominal ultrasound showed no significant findings and was unremarkable, and chest x-ray showed right paracardiac opacity and a possible right lung consolidation.

On 12 Sep 2020 (Day 23), a chest x-ray there was only one showed bilateral pneumonia and the subject was hospitalized. A chest computerized tomogram scan was unremarkable and urine analysis reports were normal. On 13 Sep 2020 (Day 24), the symptoms fever, myalgia, headache, fatigue and nausea resolved during hospitalization. The COVID disease and pneumonia were ruled out and there were no other etiological causes identified for the symptoms that the subject had. The subject remained isolated in-house for suspected COVID-19 despite presenting no further fever and improving symptoms. On 14 Sep 2020 (Day 25), the suspected COVID-19 resolved and the subject was discharged from the hospital.

The anxiety occurred after this hospitalization. On 14 Oct 2020 (Day 55), the anxiety resolved. The subject requested withdrawal from the study on 23 Sep 2020.

In the opinion of the investigator, there was no reasonable possibility that the anxiety and suspected COVID-19 were related to the study intervention; anxiety was considered related to constitutive features and COVID-19 was suspected as a reactogenic systemic event. Pfizer concurred with the investigator’s causality assessment for suspected COVID-19

Almost all of this is fictitious.  There were no ER visits on September 9.

The account gives the impression a physician in the ER did a SARS-COv-2 test. No one did at that point.

Someone noted dark urine.  This can only have come from Augusto telling the doctor in the Hospital Aleman where he was admitted three days later or Diego Wapner or Fernando Polack in phone calls on September 23, or through conversations when he visited the Research HQ offering to share all test results, scans and other details with them and be followed up – for your sake and mine – not realising he was dealing with people who were only likely listening in order to use anything he said against him.

Dark urine and a fever and a raised creatinine level noted here is consistent with rhabdomyolysis, a potentially lethal disorder that the Hospital Aleman did not investigate properly when Augusto arrived there.  Luckily for him it cleared.

If you can work out what you think Fernando’s team thought the X-Rays or other radiological investigations show, you’re doing better than me.  They note and then ignore a right paracardiac opacity.

The two biggest features in this narrative are a Suspected Covid Disorder and Augusto’s Anxiety.

Covid was suspected at one point, so including a coding of Suspected Covid is not inappropriate. It is like the person in a Pfizer Geodon trial who dies of Burns but this death happened five days after, driven by Geodon induced agitation, this patient poured petrol on himself intending to kill himself but only died five days later.

Burns should be coded as one of 20 or more things that should have been coded in this case. But the diagnosis in this case is Suicide and the narrative to FDA about this Reaction should not have been headed Burns (which suggests an Event).  But it is possible for Pfizer who know nothing about what is going on to concur that deaths by burns are not an adverse reaction to Geodon.   See Clinical Trials are Unsafe.  And People are the Data in Clinical Trials.

Finally the official record has Augusto apparently saying he is anxious on September 23.  This firmly held, perhaps delusional, belief seems to arise in the mind of Fernando Polack on September 23.  It is not difficult to see why Fernando might have been on the verge of a nervous breakdown.  Hombres al borde de un ataque de nervios.  Or perhaps time for a new version of  El secreto de sus ojos?

Cutting Polack Loose?

The causality assessment is where things come truly bizarre:

In the opinion of the investigator, there was no reasonable possibility that the anxiety and suspected COVID-19 were related to the study intervention; anxiety was considered related to constitutive features and COVID-19 was suspected as a reactogenic systemic event.  Pfizer concurred with the investigator’s causality assessment for suspected COVID-19.

Augusto according to Polack apparently had a suspected Covid-19.  This is semi-consistent with how things happened later when he went to hospital.  Thinking he might have Covid was not unreasonable. When a test came back negative and it became clear there were other ways to explain the problem, it is no longer reasonable to hang onto a Suspected Covid-19 diagnosis.

But Fernando Polack appears to develop a belief in a new illness – Suspected Covid-19 disorder. This has an onset, like any illness does, and clears up which illnesses do, letting Augusto get out of hospital.  In the classification of what Augusto has, he is recorded in other documents as having Suspected Covid Disorder. Maybe he had Suspected Martian Disorder and a few other conditions too – none of which can be linked to the vaccine – which were missed.

Except, the Covid-19 becomes real and not suspected – maybe just rushed writing – and is then characterized as a reactogenic systemic event.  The only thing around the place that people were reacting to at the time was the vaccine.

A reactogenic systemic event can only mean a severe reaction to a vaccine – but severe reaction to a vaccine or even reactogenic systemic event is not recorded as an Adverse Reaction Augusto has had.

It’s severe because it’s systemic, not local like a sore vaccinated arm, and because it leads to hospitalization.  FDA should but do not know about this.

As the narrative stands, Augusto had a vaccine induced injury and Pfizer concur with this but FDA know nothing about it.

Then we get into really interesting country.  Fernando says the anxiety was considered related to constitutive features.

Constitutive, medically speaking, means Augusto was born with this disposition. It’s part and parcel of who he is.  It’s not caused by the vaccine or being refused medical help by Fernando, it’s just who he is.

There should be clear evidence of prior Anxiety Episodes over the years before using this word and of course a constitutive disorder is not going to clear up a few weeks later.

No mention here that the consent form for the trial gave Augusto Fernando’s daytime and evening phone number and told him, and others in the trial, to call Dr Polack immediately if he had any injuries linked to the trial and that Pfizer would cover all medical expenses.

1. 12. What happens if I am injured during this study?

Sponsor Pfizer agrees that in the event that you suffer any harm, understood as an injury or adverse effects or consequences to your health, related to the study vaccine or procedures performed as part of this clinical trial, you will immediately receive the necessary medical attention and treatment.

Pfizer will cover costs for medical care and treatment.

To that end, you must communicate (in person or by telephone 24 hours a day) with:

Dr. Femando Polack, (011) 15 3036 6350. Phone 24hs (011) 4776-8084

What happens when he calls instead is Fernando calls Augusto Mad.  The coding for this event that goes to FDA is not just Anxiety but Severe Anxiety.

It’s very tempting to think it was Fernando who was having a case of Very Very Severe Anxiety – perhaps even a Holy Fuck moment.

Covering Augusto’s medical expenses for a vaccine induced event could cost – well how about $30 billion?

Covering Augusto’s medical expenses means accepting the vaccine caused the problem and reporting this through to FDA.  Neither the ‘Nelsons’ running the trial, nor Pfizer, can afford to do this – it might threaten approval or other problems.

So the consent form is lying.  Pfizer and Fernando are speaking with Forked Tongues.  The assurance that we will cover your expenses for an injury is bogus.  And unethical?  And illegal?

Lengua Bifida in Spanish.  Alberto and Fernando hablan con lenguas bifidas.

There is one other fascinating detail here that readers of this post can help with.  Unfortunately Abstractor is too algorithmic to help us out (I think).   There are a few hundred patient narratives in this Narrative document.  Are there any others, not just in Buenos Aires, where Pfizer don’t simply agree with the Admirable Nelson view?

Why? Look back  at the conclusion.  Having explicitly agreed that Augusto has a reaction to the vaccine, although phrased in a way that might fool a lot of people, Pfizer take a pass on committing a crime.

They say absolutely nothing about what they think about someone who has no background in mental health diagnosing someone with a mental condition he does not have and committing it to his medical record and spreading it across the entire world.  This is criminal behaviour.

If we can find any more trial volunteers whose injuries have led to a split in views like this, these cases would likely be all worth exploring.

As Augusto’s case makes clear, no one in Pfizer or FDA or CDC or ANMAT or EMA who doesn’t talk to Augusto can even begin to know what has happened in his case. The same holds true for all the cases among the 44,000 other people in this trial, where things went wrong.  There are hundreds of people who went missing or were disappeared.  We need your help to track them down and then invite the bureaucrats to meet with them.

Adverse Event or Adverse Reaction?

When Augusto met Fernando, things happened.  Were these Events or Reactions?

A vaccine or a drug is a chemical plus information plus the potential for making money beyond the dreams of avarice.  Events like a nuclear war might have nothing to do with any of these three.  Reactions can stem from the chemical, the information or the pursuit of lucre.

What causes tongues to fork?

Forked Tongues

Frankie says we can’t turn a blind eye to XXXX but in this case, he too manages to miss the obvious.

There is a growing trend for Forked Tongues as a Body Modification.

Dr Pedro

See Dr Pedro comment in the comment section.

To substantiate this comment, Dr Pedro sent a file he got from his friend Augusto Roux, which he has carefully translated from Spanish.  The comment is important but the entire file is as well because all of a sudden we have not only:

• Augusto’s medical records
• Augusto’s clinical research record
• Augusto’s report by Pfizer to FDA
• But also
• Another record of comments and emails held by Dr Polack and colleagues

Not surprisingly, none of the first three agree with each other.  In this case and perhaps uniquely we now have a fourth record, which agrees with none of the above.  Augusto got hold of this by making a Freedom of Information request to the Hospital Militar.

For whatever reason, the Hospital Militar seems to have gotten almost everything wrong despite repeated efforts by Augusto to call them and answer all questions and offer to make all tests available and be followed up as part of the study.

His interest was to know what he had been given in order to be treated properly rather than to withdraw from the study but they refused this – even though the consent form he signed guaranteed he would get the best possible treatment if injured.

Additional notes to visit 2  Date: 24/09/2020 00:24

On September 23, we communicated with the volunteer, since he had previously communicated with the emergency telephone to inform them that he was going to abandon the investigation protocol.

As reported on this date he received an Email from the Infectology service of the Hospital Alemán (for outpatient follow-up) where reference was made to the fact that the volunteer cannot have antibodies measured since they compromise the blind of the study.

It is clarified to the volunteer that he can carry out any complementary study that is necessary for the control of his health, be it both blood determinations of any kind and any complementary study that he requires for his management, diagnosis or treatment.

The volunteer confirms his desire to leave the study.

Diego Wappner (Mat. 87.448)  (dwappner) 24SEP2020 00:27

Last night, following a call from Dr. Wappner reporting that the volunteer had decided to withdraw from the study, I contacted the former participant to inform him of the advisability of staying in the monitoring program and confirm that he could leave, should he wish, the study at will.  When asked if there was any doubt that we could solve for him, the volunteer read me an email where a medical professional from the Hospital Alemán celebrated that he is well and informed him that his laboratory analyzes were normal, with some other test still pending. Then he expressed annoyance at not being able to check these results by himself and added that he expressed his displeasure and suspicion for not being able to access his results via the web, to the Director of the Hospital Alemán. After this, he reported that he was unhappy with not being able to know if he had received a vaccine or placebo in our study. I proceeded to remind him that participation in the study is voluntary and that it is endorsed through the signing of the informed consent, and I explained that he did not have the power in this case to know neither I nor he himself said information. The volunteer was dissatisfied with not being informed of the branch of research product that was assigned to him and ratified his decision to leave the study for the fourth time (0-800, then to Dr. Name, then to Dr. Wappner and then me).

Fernando Polack (fpolack) 24SEP2020 13:03

Additional notes to visit 2  Date: 25/09/2020 02:12

Telephone contact was made with the volunteer on 23SEP2020. The volunteer refers to his decision to withdraw consent to participate inthe study. He was offered space for doubts and questions.  Upholds his decision

Sabrina Beatriz Dulce (Mat. 148,731) (sdulce) 25SEP2020 02:14

Additional notes to visit 2  Date 08/10/2020 16:10

On this date I communicated with the representatives of the sponsor, Alejandra Di Lorenzo, Ignacio Romano and Alejandra Gurtman to convey my recommendation on the non-maintenance of the blind in the ex-volunteer, who affirmed and made use of his power to leave the studio and withdraw consent to his participation some days before in four independent communications with our team. The ex-volunteer previously presented initially a period of 48 hours after the second inoculation of the research product compatible with reactogenicity and a subsequent EAS linked to a hospitalization being afebrile to investigate a possible COVID-19 that resulted in laboratory studies, computed tomography of the chest and ultrasound of the abdomen carried out at the Hospital Alemán. The doctor of that institution then communicated with the emergency room of the Military Hospital to discuss the case, and talked with a doctor who, as stated in the ER book, did not participate in the research study. That is, he conversed with a professional outside the research study and, therefore, incurred an involuntary confusion in his subsequent communications with the ex-volunteer (to whom he mistakenly wrote that he had spoken to our team). The following conversations with the participant by Dr. Wappner and I, in which we found him in a considerable degree of exaltation, suspicion, intense anxiety, and anger that led him to withdraw from the study and refuse our invitation to stay in it, were reflected in my notes of previous evolution.  The ex-volunteer requests to know the branch of randomization to which he was assigned, manifesting in the communications with me and Dr. Wappner a high degree of anxiety, concern about an alleged conspiracy hatched between the Hospital Alemán and the Military Hospital with the sponsor, and distrust towards the health providers of the Hospital Alemán and the Military Hospital (linked to the confusion of the Hospital Alemán doctor that communicated with the duty emergency doctor and not with a member of the study). This occurs despite having no known current findings (as of the time of their dropping out of the study) of clinical significance.

Likewise, the former volunteer has made complaints to the regulatory authority and demanded to be informed of his randomization branch. I have recommended to the sponsor in the three conversations described in this note to accede to the volunteer’s request, not because – in my clinical opinion – his physical health has shown to be at risk allegedly associated with the administration of the research product during his participation in the study (and therefore while we had access to its evolution), but considering that his degree of anguish and concern are considerable; Doing so would allow to reveal the branch of randomization in order to improve the link and dialogue with the ex-participant, and offer to monitor him clinically again for his safety and access -through his authorization- to the records of the Hospital Alemán that detail his previous hospitalization.

Fernando Polack  (fpolack) 080CT2020 16:11

Additional notes to visit 2 Date 09/10/2020 1208

After maintaining communication with Drs. Gurtman and Kitchin, detailing that knowledge of the allocation may be necessary to properly manage the patient’s condition, I proceeded to lift the blind in the volunteer. The volunteer received 30 mcg of BNT162b2. We will then proceed to inform the volunteer of this.

Fernando Polack  (fpolack) 090CT2020 12:13

Additional notes to visit 2 Date: 09/10/2020 14:19

Given the opening of the blind, we proceeded to communicate with the volunteer through the sub-investigator Dr. Gonzalo Perez Marc and tell the volunteer his association with the vaccine group with two doses of 30 mcg of BNT162b2, request his authorization to continue in contact monitoring his safety, and access the information of his hospitalization in the Hospital Alemán. Simultaneously, we will send the volunteer the randomization information to the vaccine group by registered letter.

Fernando Polack  (fpolack) 090CT2020 14:24

Additional notes to visit 2 Date: 09/10/2020 15:33

On this date (13:30 hours) I contacted the volunteer to notify him of his assignment to the vaccine group in the study with two doses of 30 mcg of the BNT162b2 vaccine and inform him that we will send the notification of his randomization also by registered letter. I also expressed to the volunteer our interest in continuing to contact him to monitor his clinical safety, since he voluntarily left the study previously, and requested his authorization to access the telephone number of the doctor of the German Hospital who was in contact with him after his hospitalization. The volunteer received the notification with satisfaction and expressed his intention to send me an email to my mailbox authorizing contact with the doctor of the German Hospital to request the medical history of his hospitalization.

Gonzalo Pérez Marc (Mat. 1 10.813) (gperezmarc) 090CT2020 15:34

Additional notes to visit 2 Date: 12/10/2020 16:45

(here is where Dr Pedro comments come from)

On this date, through our coordinator of studies Virgina Braem, we answered by mail the request for a certificate of illness of the ex-volunteer Augusto Germán Roux (made when contacted for the withdrawal of the electronic diary after his voluntary abandonment of the study) and we reiterate the request for authorization to communicate with the doctor of the Hospital Alemán, previously discussed between the participant and Dr. Perez Marc, for follow-up. The text of the email, available in the volunteer’s folder, states:

‘Dear Augusto,

My name is Virginia Braem, I am the General Coordinator of the COVID-19 Study. In relation to the query about the delivery of a certificate, we have sent to your home the information shared by Dr. Pérez Marc by telephone about the randomization branch assigned as a registered letter for presentation at your work if necessary.

Also, in follow-up to your conversation with Dr. Perez Marc, we remind you that we would appreciate it if you want to authorize us and provide us with the telephone number of Dr. of the German Hospital to monitor your symptoms.

Please notify me in case of any questions about these issues.

Best regards,

Virginia Braem’

Fernando Polack  (fpolack) 120CT2020 16:50

Additional notes to visit 2 Date: 13/10/2020 16:40

Yesterday, the volunteer responded in an email to the Study Coordinator Virginia Braem expressing that he missed the email of Dr. Perez Marc and, therefore, had delayed the sending of the authorization to collect his information at the Hospital Alemán. In yesterday’s email, the volunteer writes authorizing with the following words

“I authorize you to initiate all the checks of the medical history and other data that are necessary for the clarification of the facts that occurred in the study.”.

Also, we have arranged for tomorrow afternoon the meeting at the Central Military Hospital where we will give you a copy of the letter that certifies your random allocation to the vaccine group and you can return your mobile.

Fernando Polack (fpolack) 130CT2020 16:44

Additional notes to visit 2  Secha: 14/10/2020 19:28

On this date at 2 p.m. the volunteer went to this center to deliver the electronic diary (without its corresponding charger) and to sign the receipt of tracking of the registered letter sent in a timely manner to his home, in order to inform him of the result of his de-blinding. He was given a faithful copy of that same letter. He met briefly with the undersigned, and expressed regret for the situation and offered his apologies. The treatment was pleasant, and he retired in excellent spirits from the institution after approx. 35 minutes. No other developments.

Gonzalo Pérez Marc (Mat. 1 10.813) (gperezmarc) 140CT2020 1 9:33

Visit probable Covid-19 disease Date of visit 23/10/2020

On 13Sep2020 11:30 hrs, the Sub-investigator Dr Name, communicated by telephone with the patient who informs that he is hospitalized in the Hospital Alemán with suspicion of COVID-19 disease The interrogation shows that, the second dose of the vaccine was applied on SEP 09, 2020 and that the same day of the application at approximately 20:00 hrs began with hyperthermia 39.3°C, discomfort, myalgia, nausea and headache. The volunteer contacted his GP who instructed him to take a tablet of Sertal compound (Propinox hydrochloride 10 mg + Lysine clonixinate 125 mg). On 10 SEP 2020 the temperature was maintained between 37 and 38° C, nausea decreases and the patient additionally reports dark urine. 11 SEP 2020 continues with nausea and for adding dizziness, he consulted again his family doctor who suggests consulting the emergency service.

On 12 SEP 2020 he attends the emergency service of the hospital Alemán, where a nasopharyngeal swab for SARS-COV-2 and chest XR is performed.

On the 13Sep2020, the subject was evaluated by telephone for having reported a symptom compatible with probable Covid-19 disease (fever 39.3 ‘C) and nausea

Contact was made with the subject on 13Sep2020

Signs and symptoms of probable Covid-19 disease

The subject was initially assessed on 13Sep2020

Reports that the first symptom began on 09Sep2020

At the time of assessment the subject does not persist with the symptoms. The last symptom resolved on day 12Sep2020.

The subject reports current or past presence of: fever (T 39.3°), nausea, malaise, myalgia and headache

The subject denies current or past presence of: new or increased cough, new or increased dyspnea, dysgeusia or anosmia, new or increased odynophagia, diarrhea or vomiting.

Home visit

No home visit was made since the patient was hospitalized

Microbiological analysis

Sampling was taken for microbiological analysis on day 12Sep2020 at the Hospital Alemán. The sample was taken from the nasopharynx.

Commercial kit used is unknown.

At the moment, a specific diagnosis for his probable COVID disease was not obtained.

Has a moderate degree of intensity

The volunteer required care from the health system for his illness. He needed assistance by on-call room making a visit.

The subject required whether he required hospitalization,

Characteristics of hospitalization

The subject was admitted to the Hospital Alemán on 12Sep2020

The hospitalization ended on 13Sep2020

The subject did not need to be admitted to an Intensive Care Unit.

He was instructed to set alarm guidelines, to contact his health system, he was reminded to complete the diary, and telephone follow-up was scheduled. He was informed about the convalescent visit to the Central Military Hospital within a month.

Severe Covid-19 disease

The subject showed no signs of severe Covid-1 9 disease (significant acute renal dysfunction or significant acute hepatic dysfunction or significant acute neurological dysfunction) during the course of their illness

Respiratory treatment:

During hospitalization the subject did not require respiratory support.

Laboratory analysis – chemical:

During the course of his probable Covid-19 illness, the participant underwent physical-chemical laboratory analysis in the laboratory of the Hospital Alemán on 12Sep2020.

Results

• C-reactive protein: Unknown
• Alanine aminotrasfcrase (ALT) Unknown
• Aspartate aminotrasferase (AST) Unknown
• Unknown alkaline phosphatase
• Bilirubin: Unknown
• Urea: Unknown
• Creatinine: 1.21 mg/dL

Comments: The results are reported as without particularities.

Laboratory analysis – blood count:

During the course of his probable Covid-19 illness the subject underwent laboratory analysis of blood count in the laboratory Hospital Alemán on day 12Sep2020.

Results:

• Unknown Hemoglobin
• Unknown Hematocrit
• Erythrocytes (red blood cells) Unknown
• Unknown Platelets
• Neutrophils (absolute value) Unknown
• Eosinophils (absolute value) Unknown
• Monocytes (absolute value) Unknown
• Basophils (absolute value) Unknown
• Lymphocytes (absolute value) Unknown

Comments: They are reported as without particularities.

Vital signs of COVID disease

The subject did not present during his probable Covid-19 illness clinical signs at rest of severe systemic disease (respiratory rate > = 30/minutes, heart rate > = 125/minute) or evidence of shock

(Systolic blood pressure < 90 mm Hg, Diastolic blood pressure <60 mm Hg).

Vital Signs – Pulse-to-Ambient Air Oximetry

The subject did not present during his Covid-19 disease probable clinical signs at rest of severe systemic disease (pulse oximetry < = 93% at ambient air at sea level).

Oxygenation parameters (oxygen)

The subject had no resting clinical signs of severe systemic disease (PaO2/FiO2 <300 mm Hg) as part of his probable COVID-19 disease.

Concomitant medication – Vasopressors

The subject presented no evidence of shock (vasopressor requirement) as part of his disease

COVID-19 probable.

Images made

The subject underwent an imaging study(s) as part of their probable COVID-19 disease.

Date of completion: date unknown
Anatomical region evaluated: Thorax

Type of image study performed:

• Computed tomography
• X-ray

Interpretation: XR thorax

• Abnormal

Chest CT interpretation

• Normal

Comments: XR thorax shows right paracardiac radiopacity- Chest CT: No evidence of acute alterations.

Other information:

18Sep2020: The Deputy Investigator Dr Name states: A 36-year-old male patient with a previous history of 48 hours of fever (Tmax 39°C), malaise, myalgia and headache, followed by nausea, who consults afebrile, eupneic and with normal oxygen saturation during the night of 12 SEP 2020 to the emergency room of the Hospital Alemán, Buenos Aires, Argentina. The subject approaches the institution by his own means and reports a previous history of fever (afebrile at the time of consultation) with persistence of general malaise of moderate degree, nausea and headache. None of these symptoms—malaise, headache, nausea, and myalgia—were severe. In the context of the SARSCoV2 pandemic, the institution’s medical team decides to evaluate these symptoms (associated with SARSCoV2 infection) and requests a swab, blood tests, abdominal ultrasound and a chest X-ray. Both the ultrasound and the laboratory showed no alterations to highlight except a slight increase in the creatinine value of 1.21, and the chest x-ray was interpreted as with the presence of a probable right lung consolidation. The patient remained isolated, in hospitalization, despite not presenting more fever and improving symptoms. A chest CT scan was performed without evidence of alterations and the next day the subject is discharged.

Maria Alejandra Neira (Matt. 126,934)  (aneira) 230CT2020 12:39

If North Americans don’t know much about Asterix cartoons – see The Harmed, Europeans don’t know about MAD. This image was adapted by Nina Otulakowski from a front cover image in Mad, see below, featuring the 1969 Bob, and Carol, and Ted and Alice movie.

Born in the USA

Multi-Regional Clinical Trials (MRCT) was born in the USA in 2009. Pfizer had just resolved a case with the US Department of Justice for $2.3 billion, then one of the biggest resolutions of an action against a corporation.

The company convened a meeting of other pharmaceutical companies, contract research organizations (CROs), institutional review boards (IRBs) (ethics committees in Europe) and lawyers, especially Ropes and Gray, a Boston law firm, later involved in GSK’s defense against a Department of Justice action, resolved in 2012 with a payment of $3 billion.  This meeting created MRCT.

A later MRCT website listed Mark Barnes and Barbara Bierer as its founders. Barnes is a lawyer variously linked Ropes and Gray, Harvard, and Pfizer. Bierer is a professor of medicine (haematology) at Brigham and Women’s hospital.

It seems clear that industry and its advisors/consultants were aware that transparency was a coming issue. A fraud action taken by New York State against GSK in 2004, centered on the mismatch between a company publication and the underlying Study 329 trial data, demanded an industry answer to the transparency problem.

Responsible Access

In early 2013, MRCT convened a meeting with 36 people present. One third were company people, one third lawyers or regulators and the remainder a mixed group of Brigham and Women’s staff, MRCT staff, along with Jeffrey Drazen editor of the NEJM, a business consultant, and a patient advocate (if that is the right name for someone from a company whose business involved selling patient conversations about drugs to pharmaceutical companies). It is difficult to know if there were even two people at the meeting in regular clinical practice.

Later in 2013, the New England Journal of Medicine (NEJM), which in the form of Drazen was party to MRCT, published a paper on Responsible Access to Clinical Trial data that advocated the same model of clinical trial data sharing as AllTrials (see below).

Preparing for Responsible Sharing of Clinical Trial Data, the 2013 NEJM article, had six authors – four lawyers, Michelle Mello JD, Jeff Francer JD, Mark Wilenzick JD, Mark Barnes JD, one doctor Barbara Bierer MD, and one business consultant. All had been present at the earlier meeting.

In 2014, MRCT held a meeting on access to clinical trial data. There was a general enthusiasm for the idea.  Bierer was the only medical author on the Responsible Sharing of Clinical Trial Data papers. Her take on data sharing was that:

I don’t think most people appreciate how much we know as a result of clinical research. To gain that knowledge – to determine treatments that are safe and effective – we are dependent on people who volunteer for clinical trials. If you get a therapy today that was based on years of study, you’re the beneficiary of other people’s volunteerism. We’re all in this together.,

Presentations at this MRCT meeting talked about data generators, a term that broadly speaking includes industry and non-industry trials. Some presenters (academics) at these meetings argue for the same set of rules for all data generators, as would be appropriate for science.

A neutral term like data generators conceals the conflicting interests data generators can have. Barnes above made this conflict explicit:

We need to remember the role of directly involved commercial interests as funders. It may be great to share data – let a thousand flowers bloom – let’s share everything. This may be true for academic research but if commercial funders believe their commercial interests will be affected the funding will dry up. The capital will go elsewhere. They won’t fund it.

MRCT Special Missions

Between 2009 and 2014, key MRCT players were grappling with Pfizer’s growing difficulties in Nigeria over Trovan and other problems.

All Western pharmaceutical companies were faced with problems in India, which had become an important center for clinical trials.  In 2010, the deaths of 7 girls in HPV vaccine trials led the Indian government to clamp down on clinical trials and introduce a stricter code of practice.

This new stricter code of practice led to a 2014 MRCT workshop in India, a central feature of which was to review what could be said about causality assessments in the event of adverse effects.  This will be outlined in a forthcoming Harmatology post.

MRCT materials from 2014 emphasize that clinical trials have become global and different jurisdictions can throw up issues ‘investigators’ and companies have never confronted before. The use of ‘investigators’ in texts like this refers to clinicians like Stephen Thomas, first author of the Pfizer vaccine trial in adults but it is as ornamental as having a ‘patient advocate’ at an MRCT workshop. Other than rhetorically, no medical academic has been an investigator in a company trial for decades.

On one level what was at stake in 2014 was the outsourcing of an industrial development process to India, China and Africa.  The more recent development of virtual trials opens up a path to ignoring these countries.

In 2017, MRCT launched Vivli, notionally a Center for Global Data Sharing.  Company trials however had been run in Africa, Latin America and Asia for two decades before Vivli, so running trials outside the US was not new. What was new was the idea of responsible sharing of trial data, as was an embrace of data sharing more generally, which a decade earlier companies resisted and then reluctantly tolerated.

There was another factor – which will run as a separate post ‘Harmatology’.

Responsible Access to Clinical Trial Data sounds as difficult to object to as motherhood and apple pie. Suspicions that Responsible Sharing of assay data, if supported by pharmaceutical companies and their lawyers, cannot be as good for us as motherhood and apple pie have, however, some basis.

RCTs necessarily have a primary outcome, without which the statistics do not make sense. This outcome is only one of more than a hundred things a drug may be doing, and quite often the effect of commercial interest will not be the most common effect.

Focusing on one uncommon and uncertain effect often renders other effects invisible. In the case of antidepressant RCTs, for instance, the benefit is uncertain compared with the effect of these drugs on sexual function, which is immediate, and close to universal, but the intense focus of an RCT means that these sexual effects vanished in antidepressant trials.

This focus on one effect means that, despite rhetoric claiming RCTs offer gold standard knowledge, they are not a good way to evaluate a drug.  See The Fault Lies in our Stars and Fawlty Stars.

The focus also means that the entire RCT is primarily structured to provide certain datapoints. An emphasis on responsible access with an approved analytic plan means any subsequent investigators can essentially only come to much the same answer as the company already has.

It is possible, as in Study 329, that a new set of investigators might find a benefit claimed in the original publication doesn’t stack up, but, if so, responsible access to assays can come to the rescue. Quite predictably, when all 30 RCTs done of antidepressants in children who are depressed are negative, stacking them all together can pull out a positive effect, which can then be used to claim these drugs work, despite every single trial being negative.

The current proliferation of meta-analyses on pediatric antidepressant trials shows just this, which is ironically being sold as precision medicine.

It will come as no surprise then to find that MRCT-Vivli aim to facilitate data sharing across comparable trials.

The Pfizer input on data sharing to the Vivli platform needs to be read against this background. The company will support data sharing and will evaluate proposals under the following heads:

• Is the research question clearly defined with a scientifically valid rationale?
• Is there a well-documented and rigorous statistical analysis plan?
• If the proposal includes combining data across different Pfizer trials, is there a clear plan to standardize data sets to ensure they are comparable?

There is little here about Vivli making trials possible in non-Western settings and everything about data-sharing as optimizing the assay function of company trials.

Translating  what is being said for lay people, you are being told you can access this data for efficacy purposes but if you are interested in treatment harms forget it.

The New England Journal of Misinformation under Drazen and now Rubin, Eric Rubin Boston Strangler, has essentially devolved into an outlet for efficacy studies.  Eric made this point clearly in a lecture he gave on March 29 2022, for the Berkshire District of the Masachusetts Medical Society.

What has happened is perhaps best caught in this screenshot of a recent NEJM initiative.

NEJM is dragging the Massachusetts Medical Society along with it – see So Long and thanks for all the Fish, which brings Carole Allen into the frame.  She was then the President of the MMS, which has some responsibility for the NEJM – although insiders say very little influence.

Shared DNA or Shared mRNA?

MRCT shares DNA (Do Not Access), or perhaps mRNA (messenger Responsible Non-Access), in common with AllTrials.

All Trials began in the UK in 2013, immediately after GSK, defended by Ropes and Gray resolved a Department of Justice case for $3 billion.

AllTrials was a coalition involving BMJ, the Cochrane Collaboration, the Centre for Evidence Based Medicine, GSK and Sense about Science.  Sense about Science set up in 2002 and is effectively an outsourced PR department for the pharmaceutical and other industries.  See SaS 1, SaS 2, SaS 3, SaS 4.

All sorts of people normally critical of the pharmaceutical industry signed up and donated money to AllTrials.  The BMJ put the CEO of GSK on its front cover as the acceptable face of the pharmaceutical industry – just 3 months after the then biggest resolution payment in corporate history.

With AllTrials input fronted by Ben Goldacre,  a UK House of Commons Select Committee stated that:

We are not in favour of placing anonymized individual patient-level data (IPD) in the public domain in an unrestricted manner… specific individuals should be provided with controlled access to IPD through carefully managed and secure “safe havens”.

Access should be facilitated by an independent “gatekeeper” responsible for insuring that the data … makes a useful contribution to scientific understanding.

This is identical to the MRCT position. AllTrials is blind and deaf to the idea that medicines might cause harms. Its leading figures went out of their way to rubbish efforts to restore Study 329 – as did the New England Journal of Medicine.

AllTrials is not heard of so much now but Vivli actively promotes itself as a global data-sharing platform, supported by all major pharmaceutical companies.

The Originals

The images in the post come from Nina Otulakowski, from an original Dr Pedro idea.

Which was in turn adapted from the promotional material for the 1969 movie, billed as a comedy.  In c 1970 Ireland, a ‘sophisticated’ image like this, in the Tom Lehrer sense of this word, was beyond shocking – which is perhaps part of some Divine or other Comedy.

This image of Jorge Mario Bergoglio and Augusto Roux with Augusto as Obelix (of Asterix and Obelix fame), in the Roman Colliseum, will have to wait for a full explanation.  It will make sense in Argentina and Europe but not in North America.  A detailed explanation for North Americans will come next week.  The posts are out of sequence owing to the interest that blew up about Fernando Polack in the last days.

So Long and Thanks for all the Fish is the fourth book of six in the Hitchhiker’s Guide to the Galaxy trilogy.

Funny Smell in City of Sweet-Smelling Aires

Recently, in Fishy Business in the Rio de la Plata, a bunch of us tried to shine a light on a notable Argentine medical entrepreneur, the amazing Fernando Polack, and the murky world of Buenos Aires politics, made murkier when you stir in vaccine politics.  This world has Trump, Putin, Gates, Alfredo Fernandez, Jorge Mario Bergoglio (the pope) and Fernando mixing cheek by jowl.

If you’re still looking for a coven of Knights Templar, this might be a good spot to look.

An explosive tweet last Tuesday splattered murky water and fish from the Rio de la Plata far and wide.  Lots of people have discovered Fernando and the fact that he recruited an amazing 4490 people to the Pfizer Comirnaty trial in 3 weeks.  The question on many lips was how can one investigator do all this on his own?  We can answer this one but there are other mysteries readers might be able to help with.

The two masked warriors, Fernando and Sergio, symbolically touch elbows in July 2020 after signing a mutual cooperation agreement for Polack’s trial to be held in Sergio Maldonado’s Hospital Militar Centro.

Fernando didn’t do all this on his own. He and his gang (see Fishy Business) run an SMO and had 467 doctors around Buenos Aires linked into the operation.  They had been running other trials for several years, heavily funded by Gates and other players.

There is a Fernando operation in Panama, perhaps just an empty office linked to money-laundering but who knows.  We are way out of our depth here and need investigative journalists to join in.

His SMO company i-Trials was opening up branches in Florida earlier this year but coincident with our “Fishy Business” blog, the iTRIALS website disappeared and reverted to being “Under Construction”. The original version can be seen Here – complete with imported clip art.

Letter to Reviewers

When the Eric Rubin Boston Strangler post ran, followed by Fishy Business, we fished out the names and contact details for all New England J of Misinformation peer reviewers for the first half of 2021 – roughly 350 people – and emailed them as follows:

This email is being sent to all living reviewers listed by NEJM for the first half of 2021.  It will also be sent to 140 participants on a listserve interested in pharma-related matters, who are close in profile to the NEJM reviewers.

Attached is a letter I have sent to Dr Carol Allen, President of the Massachusetts Medical Society, who are responsible for the journal, outlining general concerns made more specific in the links below.

My general concerns center on a lack of access to clinical trial data for all drugs and the ghostwriting of the clinical trial literature.  The Pfizer vaccine has made many people aware that there is no access to the data from trials or that access might take decades. The published NEJM trials also make it clear that medical writers wrote the articles. 

The phrase fraud on the court in the letter to Dr Allen is used imprecisely. Strictly speaking it would refer to a lawyer commissioning a study known to be misleading in order to defend a case in court. We are not however far removed from this scenario.

Eric Rubin Boston Strangler

Fishy Business in the Rio de la Plata

I hope you will not be put off by the Lurid title and opening image in the first link. This is driven by the critical pass we have reached and the tone of some NEJM responses on these issues.

I try to ensure posts are fact-checked, but mistakes on issues as complex as these can slip through. I will correct anything pointed out that is obviously wrong.

I invite you to email any comments to me on any aspect of this material. You can also comment publicly on one or other of these postings and if indicated I can ensure your name and contact details do not appear.

Anonymous or not, no linkage will be made by me between your name and any comment you send unless you make it clear you are happy for a link to be made. 

I have no plans to publish any comments. At most I may offer an indication of the rate of response and offer an aggregate assessment of the tenor or tenors of comments.

You can also contact me independently of this exercise  David Healy

No reviewers disputed that most of the literature on vaccines and drugs is ghostwritten. It would be difficult to do so when the NEJM vaccine trial articles state clearly they are ghostwritten.

No reviewers disputed the claim there is no access to the trial data.  It would be difficult to do so given the world knows Pfizer didn’t want to release anything for 75 years and Stephen Thomas, lead influencer in this trial, has made it clear he has not seen the raw data.

No reviewers have made contact, bar one wondering when the fraud on the court article will appear.

Elizabeth Loder and Michelle Mello both of whom have an interest in clinical trial data – the responsible access version – didn’t respond.

A Fernando auto-response said he was on sabbatical.

Guardian Angels

  An Angelfish

A fascinating wrinkle has now appeared on Snow White’s face and seems to be extending. Do any of the 350 dwarves gathered around her glass casket have an inkling about how the story goes from here?

In Fishy Business, we were under the impression there was one mega site in Buenos Aires, Fernando’s.  The NEJM article on which he is first author gives the impression that he recruited an astonishing 5,764 patients.

Except some of the dumped Pfizer papers now show he actually only recruited 4490 at his 1231 site. This was in 3 weeks – so 1500 per week or 20 per hour in a 10-hour day. With a network like Fernando’s, this is doable. Augusto Roux, who was there, however, says it was chaotic and he was nearly given two vaccines on the same day.

While all this frantic activity was going on in August 2021, Fernando found time to set up a new enterprise in Buenos Aires – Gana(te) La Vida S.A. (Get a Life) with his son, Leandro, to provide gastronomic delights for pubs, clubs and bars with a capital of $100,000.

All this has been ‘out there’ for a while. Now though a new site 4444 has swum into view, as spotted by @Jikkyleaks on May 9 2022.

Angel Numbers can be associated with many spiritual attributes. For instance, “The angel number 4444 is associated with difficulties. It is difficult for us to accept the fact that we will face hardships in life, but our Guardian Angels are here for support and guidance in overcoming these obstacles.”

Is site 4444 a Guardian Angel? Like Guardian Angels, it does not exist according to the site data so far released. The sites are numbered consecutively from 1001 to 1270.  We need to explain 270 – given there were only 152 or 153 sites for phase 2/3.  Have phase 1 trial sites also been listed here?  See Comprehensive (sic) List of All (sic) Clinical Sites

Ghost Site 4444 reeled in 1274 volunteers in just 5 days in late September 2020. Why the rush?

Of these volunteers ninety-nine per cent are coded white “Hispanic/Latino”. Reported adverse events from the ghost site come from subjects in Argentina.

And if you add 1,274 to 4,490 you get 5,764 which is exactly the number recruited from Argentina reported in NEJM – more exact, that is, than almost anything else reported in this trial.

And the beautiful Alejandra Herrera Jure, an Argentine ophthalmologist, who now works for Pfizer, says she worked at both 1231 and 4444 sites.

There were 466 doctors other than Alejandra listed in the data dump – someone reading this must know one of them who can shed light on what’s up.  They are listed HERE in an 81 page document, their names taking up pages 58 to 71

Why this extraordinary effort to chuck another 1274 volunteers into the mix, three weeks after normal recruitment had stopped, just before data closure in the trial?  Was this a Special Military Operation, also run from the Hospital Militar?

It may be innocent. A lot of Media Hype in July 2021 in Argentina resulted in:

“Just two days ago the call for trials of the coronavirus vaccine was opened and there are already more than 15,000 volunteers who requested to be part of the experiment. The figure exceeds the amount required for Phase 3 of the clinical trial to be carried out in Argentina.” [28 Jul 2020]

Perhaps thinking that being part of the trial might protect them from Covid, as Augusto thought, they were falling over themselves to get in the trial.

Maybe after the 1231 caravan rolled on Pfizer said to Polack “hey we could do with a few more subjects” or Polack said to Pfizer “hey I’ve got another couple of thousand begging to be in the trial” and they made a deal for a rush job in a new trial centre 4444.

At the moment, we have a mystery to rival Pfizer’s B2 or not B2 agonies – as related by Alberto Moonshot – over whether to proceed with BNT162b1, on which they had lots of data or jettison all this data in favour of a slightly different BNT162b2.  Astonishingly they dumped b1 and ran with b2. We still don’t know why.

Augusto Contra Mundum

Fernando is fascinating but we have been more concerned with and for Augusto Roux, who volunteered for the trial and was clearly injured but who ended up being told no he wasn’t – he had Covid even though the test was negative. And then not just told he was mad but had madness recorded in his medical notes diagnosed by Fernando – a pediatrician and infectologist. – is there no end to the man’s skills?

See Disappeared in Argentina.

On April 6, I wrote to Peter Marks of FDA and to the Argentine regulatory authority ANMAT as follows:

Dear Dr Marks

I refer to the report by Ramachandra Naik, PhD, Review Committee Chair, DVRPA/OVRR on the COVID-19 Vaccine, mRNA, Proprietary Name: COMIRNATY

Section 7. “Safety and Pharmacovigilance” pages 23-24 under Myocarditis/Pericarditis states

“During the time from Dose 1 to unblinding in Study C4591001, one report of pericarditis was identified in the COMIRNATY group, occurring in a male participant ≥55 years of age, with no medical history, 28 days after Dose 2; the event was assessed by the investigator as not related to the study intervention and was ongoing at the time of the data cutoff. One report of myocarditis was identified in a male participant <55 years of age in the placebo group, occurring 5 days after his second placebo dose.”

I wish to report one further incident of confirmed pericarditis in a participant in this trial.

Augusto Roux, male, aged 36, study number 12312982, was enrolled on 21 August 2020 into trial centre 1231 in Buenos Aires, Argentina, Principal Investigator Fernando Pedro Polack MD.

He received two injections as part of the trial on 21 August 2020 and 9 September 2020. Both injections were later shown to have contained the active vaccine BNT162b2 (30 μg).

After his second injection, he became unwell over three days with a fever and vomiting. On 12 September, he was admitted as an emergency to Hospital Alemán in Buenos Aires, ref 677259. Investigations for Covid-19 infection were negative. A CAT scan of the thorax performed on 13 September was reported as showing a laminar pericardial effusion. His illness was diagnosed as an adverse effect from vaccination. He was discharged on 14 September.

He made a slow recovery. The pericardial effusion spontaneously resolved.

Four doctors including myself, two with considerable pharmacovigilance expertise, have examined Mr Roux and both his medical and clinical trial record. We are of the view that he clearly had a pericardial effusion, most probably due to a pericarditis and that this was triggered by his vaccination with Comirnaty.

It is not within the remit of Dr Naik’s report to discuss why this adverse event was not reported to the FDA by the sponsors of the trial. As it stands, however, Dr Naik’s report is incorrect, and this should be remedied.

Mr Roux reported his injuries to ANMAT (National Administration of Drugs, Foods and Medical Devices), the Argentine equivalent of FDA. ANMAT held a hearing concerning his case on October 8. There was input to this hearing from Pfizer. The Buenos Aires site was the only site in the study that had both a routine audit, as well as a non-routine audit, the latter in the week of October 13th to 20th, conducted by a Pfizer employee, Andrea Mohr, shortly after the ANMAT hearing into Mr. Roux’s case.

Given the trial records and clinical records I have, and the ANMAT hearing information, it seems clear that Mr Roux received the active vaccine in the trial, and was injured, but has since disappeared from it.

Is he one of the 311 participants who were excluded because of an important protocol deviation after dose 2? Have FDA been informed of just why these 311 were excluded and have FDA had a chance to decide whether events such as a pericarditis in this case should have been included in the final representations to them even though the subject was excluded for efficacy purposes?

Mr Roux has stated that he would be willing to supply FDA with further information, including his clinical and trial records, in order that the true facts are acknowledged and recorded.

I would be grateful for whatever light you can shed on this situation.

Yours sincerely       David Healy

In the letter to ANMAT I made it clear I did not want to be saying anything incorrect about this case and so would welcome any other detail they could provide.  There was an email auto-acknowledgement from FDA, and nothing from ANMAT.

The image above is from a Pfizer trial on a new RSV vaccine.  It is heavily redacted as is typical for the documents being released by Pfizer.  Fernando Polack is a leading RSV expert.

The document below is from ANMAT’s hearing on Augusto’s complaint about how his case in the Pfizer trial has been handled.

Which of them shows evidence of Dr Polack?

The second one. The Polack signature is second from the left on the top line.

Ave Jorge

Argentine Society is tightly interwoven. Many of the key people know Augusto and he them. This includes Jorge Mario, now based in Rome. Hence the image above.  If Augusto had never met Jorge, he might have said Ave Abba, which for other reasons might be a good way for Fernando to address Jorge or perhaps Jorge, if he has a sense of humor, to address Fernando.

Jorge does not have a track record in helping the Disappeared from Drugs or Vaccines. This is odd given his mission to remind the faithful that the cornerstone the builders rejected is the cornerstone the mission of the faithful is built upon.

I wrote to Jorge about these matters 6 months ago not mentioning Augusto by name but with him in mind. See Healy to Bergoglio. There was no response.

Perhaps having Augusto clearly named and in the frame or mention of an UFA or UFF will spark Jorge’s interest – Unidentified Flying guardian Angel or Unidentified Flying Fish?

Data Dumps

Let’s have a closer look at some of the other data from Polack’s Hospital Militar Central site in Buenos Aires.

You would expect the distribution of something like Height to follow a normal distribution curve, especially when there are thousands of data points.  The data here come from a PHMPT document that is over 3000 pages long.

Not in Fernando’s trial. There are twice as many men 170cm tall compared to 169 or 171cm. This means the subjects have not had their heights measured, as would have been required by the protocol.

Just plotting out basic data like this is one of the ways to detect fraud.  In this case, the fraud may have a simple explanation and may be excusable.  People were asked their heights and volunteered 170 rather than 169 or 171.  The same happens at the 180 point.  It shows actual measurements were not taken or were hurried – but so what.

The cornerstone data below from Jikkyleaks are more interesting than ours. In this case, adverse events are plotted and you’d expect the scatter of data points that the rest of the graph shows – except for Germany and Turkey.

There is a tradition in Germany of only having the adverse events you are told you can have but still this is extreme. Whatever about Germany, you’d expect Turkey to be more sensible.

Suny Side Up

Fernando’s co-joint author on these papers was Dr Stephen Thomas of SUNY Upstate Medical University and fellow at the Trudeau Institute in Saranac Lake, where he is a big fish in the world of infectious diseases.

In the last millennium he would have been called a KOL – key opinion leader. An “Influencer” in todays parlance. So much so that he was hauled in as lead researcher to coordinate the Pfizer COVID-19 vaccine trial and several other antiviral drug developments.

Egg on his face?                               Suny side up

In an interview this is how he describes his role:

Q: In terms of communication, how do you go about coordinating teams and information globally?
A: My role as the coordinating principal investigator for the Pfizer-BioNtech vaccine trial is not an operational position. Meaning, I’m not actually coordinating the different sites participating in the trial, this is accomplished by Pfizer and Pfizer’s partners. My role, in addition to leading the Upstate site, is to be an external reviewer of the data, which will be submitted to regulatory agencies for consideration of emergency use authorization or licensure. Coordinating principal investigators provide a fresh set of eyes and help to identify any potential questions about the data or how to interpret the data.

We wrote a nice letter to Dr Thomas, as principal investigator for Pfizer’s trial and joint lead author of an NEJM paper on the safety and efficacy of their vaccine – although he claimed not to have access to the original data. The two points we raised were first, the discrepancy in the number of dropouts from the trial after the second vaccination. According to the chart published as “Figure 1. Screening, Randomization, and Follow-up”, 11 subjects in the active group and 24 in the placebo groups dropped out, whereas the recently released FDA data stated that comparable numbers were 311 in the BNT162b2 group and 60 in the placebo group.

Our other query was to see whether there was an explanation why, having trawled through the data, there were no recorded instances of pericarditis documented, despite the clear evidence that volunteer number 12312982 from Argentina was diagnosed with this condition 3 days after his second injection of the Pfizer trial vaccine.

(We didn’t mention that Fernando, a co author, knew all about this adverse event).

Dr Thomas has not responded.  He is well placed to know something about 4444 – which as we’ve said above may have an innocent explanation.  Maybe he’s doing the Guardian Angel Tango.  There is one. This is the most respectable image:

There is also a Tango 44 option. And there is this fabulous 1904 image of men doing the tango in the Rio de la Plata.

This post is by Mary Lynch – see Credentials in Cause and Effect.  A neuropathic arm sounds like something terrible from an Edgar Allan Poe horror story. 

Anette Diamond (name changed) is a 66 year-old woman. She has approved this post.

She had been living with chronic low back pain and fibromyalgia for several years when she was referred to me.  She was very motivated in pursuing active strategies for pain management suggested by the team at the pain clinic and had made good progress in living with her pain.

I saw her for a routine follow-up appointment in September 2021. At that time she presented as very distressed and her first request of me was “Doctor please tell me I don’t have to have another one of those vaccines”.

Anette and I had never discussed the vaccines. She was referring to the Moderna vaccine, which she had received in August 2021.

She described severe pain in her vaccinated arm along with a widespread rash, which developed shortly after the injection. These were new symptoms that had not previously been an issue for her. She had lost lost function in the previously fully functional arm and could not move it without experiencing severe pain. On examination her range of motion at the shoulder was quite restricted, and she exhibited the sensory findings one would expect for neuropathic pain.

I am a psychiatrist and have worked in the field of pain management for over thirty years. In September of 2012, I was granted Founder status in Pain Medicine at the Royal College of Physicians and Surgeons, Canada, meaning that I have been recognized as a Fellow who has been instrumental in the creation of a new discipline approved by the Royal College. I have seen thousands of patients with chronic pain and thousands with mental health disorders.

I made a diagnosis of post vaccine neuropathic pain in Anette’s vaccinated arm. There was no evidence that this was caused by a psychiatric disorder and she had not reported these symptoms prior to the vaccine.  I contacted her family doctor suggesting Anette be supported for a medical exemption from having a second vaccination until she had fully recovered, at which point we could reassess the situation.

Her family physician agreed and completed an adverse event following immunization (AEFI) report form, supporting a medical exemption until December when I was scheduled to see her again for follow-up.

Anette contacted me several weeks later indicating that she had been advised that she should go ahead and have the second vaccination. She was very upset and anxious about this. I contacted her family doctor again who provided me with a copy of correspondence he had received from the Physician Lead with AEFI Management, Provincial Health and Wellness.

In this correspondence dated October 15, 2021, this public health doctor stated:

“I recommend that she is medically safe to receive a second dose. Post vaccine neuralgia in the face of pre-existing complex chronic pain and depressive illness is difficult to predict. I cannot tell her whether this will happen again, but the response is not specific to COVID vaccine, and could be caused by any kind of IM injection. She has several options-she can take the second dose in her opposite shoulder, or in her thigh or gluteal region if she prefers”

I saw Anette for follow-up in December 2021. She continued to experience severe pain in the vaccinated arm and could barely move it. I diagnosed continued neuropathic pain dating back to the vaccination and advised her not to have another vaccine as there was a significant risk she would experience a similar reaction to a similar vaccine.

In all of my years of practice I have never seen a patient present with regional neuropathic pain that started after a vaccination. I was concerned about her losing the use of another limb if she were to receive another.

During the Summer and Fall of 2021, I had several other patients who reported adverse events following the Covid vaccine and yet, as of when I saw each of them they indicated that an adverse event form had not been completed. I completed AEFIs on 3 and contacted their family doctors and in one case the rheumatologist to ask them if they would be completing an AEFI.  After discussion they agreed to do so.  See Table below.

On December 8, 2021, I contacted the Physician Lead for AEFI Management who had advised Anette to have a second dose and gave her my opinion.

While I had this doctor on the phone I asked a few questions.  My understanding previously was that adverse events following receipt of the vaccine should be reported, regardless of attribution, so that appropriate signals could be picked up by Health Canada regarding vaccine safety.

She said that it was “not regardless of attribution”, that they do make a judgement at the provincial level and that “anything serious” is reported to Health Canada.  I asked if there had been any serious adverse events that had been reported and the physician said yes and mentioned:

“we knew going into this that the vaccines might exacerbate inflammation and autoimmune illnesses”

I asked if there had been others and how these were being addressed. She listed acute renal failure, hepatitis and MS and indicated that a public health nurse would be the first contact and that there were physicians from several specialties who had been identified to help, these included infectious disease, immunology and allergy, neurology and others.

My understanding at the end of the phone call was that my patient was not going to be pressured to have another vaccine.

Anette’s post vaccine neuropathic arm pain persists to this date, nine months later. It has continued to be extremely distressing to her.

Other Cases

All patients were 50-70 years old. All were seen in Summer/Fall of 2021.

MS: multiple sclerosis

SAPHO: A chronic inflammatory disorder of bone, joint, skin characterized by synovitis, osteitis, hyperostosis, enthesitis with pain, swelling, and tenderness and skin acne and pustulosis

In the comments below there are multiple references to Parsonage-Turner Syndrome.  The link gives a recent update on this syndrome that may help some people.

The Raven

You’d have to wonder if any of the public health doctors who have been denying any possible links to vaccines, and denying clearly indicated exemptions, will, like the dying Cardinal Wolsey (in his Orson Welles Man for All Seasons incarnation), wonder if they had served people half so well as they served their public health masters, whether they would have ended up dying so isolated and guilt-ridden.

Will they find like Edgar Allan Poe that: