Cause and Effect Case 2: Augusto Roux

This post will have breaking news featured below.  See entry for March 2,

Augusto is a fit 36-year-old man from Buenos Aires. He doesn’t smoke or drink alcohol. He runs frequently and does Cross-Fit.  He wanted to get vaccinated because his mother has emphysema, a lung disease, and he was worried about making things worse for her.  He volunteered to participate in the clinical trial of the BioNTech – Pfizer vaccine, the biggest centre for which was in Buenos Aires.  He was a very early volunteer.

Gemma Torrell interviewed him on January 6 2022, with Joan-Ramon Laporte in support. See Credentials on Cause and Effect.  Augusto has excellent English but it seemed more sensible to have a Spanish-speaking doctor do the interview.

Augusto sent Dr Torrell his medical reports and test results done after the second dose of vaccination and the clinical notes of his follow-up while he was in the trial.

The central medical history and assessment of Augusto’s condition hinges on the interview and assessment by Gemma and Joan-Ramon.  There is additional material after that which hinges on emails between Augusto and me and documents he sent.

Past Medical History

Augusto has the Z phenotype of alpha-1-antitrypsin deficiency.  He inherited this from his mother who has emphysema and it is likely linked to her emphysema.  It will likely not cause Augusto problems, unless for instance it affects something like a response to vaccines.

Gastroesophageal reflux for which he takes one pill of famotidine per day (for which there is some evidence for benefit in Covid).

He occasionally takes loperamide for diarrhea. His doctor prescribed propinox clorhidrato (Sertal) for gut colic after the vaccine. He now takes Thioctic acid (Biletan Forte), a hepatoprotective treatment, and silymarin – a herbal anti-oxidant.

Vaccination History

He volunteered for the trial and had a first dose on August 21, 2020.  He felt pain and swelling in his arm right after the injection. Later that day he had nausea, difficulty on swallowing, and felt hungover.

Over the next 5-6 days, his sense of smell was more sensitive, which he linked to something happening in his liver. He changed diet for a few days to steamed food. His stools were frequent and white, which he thought was linked to Sertal. His urine in the morning was darker than usual but not coluric.

During those days he took one famotidine per day, two loperamide pills and one Sertal pill.

On August 23, in the clinical trial visits, he is classified as a “toxicity grade 1 adverse effect”.

He had his second dose on September 9 at 1800. He stayed in observation for 40 minutes and went out feeling well.

On the way home by taxi, he started feeling unwell. At 1930, he was short of breath, had a burning pain in his chest and was extremely fatigued. He lay on his bed and fell asleep. He woke up at 2100 with nausea and fever (38-39 C) and was unable to get out of bed due to the fatigue.

Over the next two days, he reports a high fever (41 C) and feeling delirious. He only had access to one and three quarters of a bottle of water to hydrate, which made urinating more difficult and frequent than usual. He took 2 pills of paracetamol during those two days.

On September 11, he was able to get out of bed and go to the bathroom when he observed his urine to be dark (like Coca-Cola). He felt as if his heart expanded, had a sudden lack of breath and fell unconscious on the floor for approximately 3 hours.

Once he recovered, he felt tired, was uncomfortable, had a high heart rate on minor movement, was dizzy when changing posture. He had a chest pain which radiated to his left arm and back. He contacted a friend who recommended he go to the hospital.

Hospital Alemán

He was admitted to the Hospital Alemán for two days (September 12 to 14). The admission report notes no fever and no tachycardia.  It was initially thought he had Covid and he was isolated.

A Chest X-Ray on Sept 12 showed subtle decrease in right basal transparency at the pericardiac level that could correspond to a faint ground glass opacity of an infectious inflammatory nature.  In the light of a negative SARS-CoV-2 PCR test on September 12, the conclusion was these findings do not meet typical radiological criteria for viral pneumonia.

A CT scan on Sept 13 showed left basal atelectasis with two posterior nodules. His heart was normal size but with a lamellar pericardial effusion.

Blood test September 12:

• Creatinine 1.21mg/dl (laboratory standard 1.20mg/dl)
• ALT/GPT  53 UI/L (laboratory standard: 0-41)
• Normal Bilirubin, AST/GOT, Alkaline phosphatase, serum proteins and serum albumin.
• C-reactive protein 1.1mg/dl (laboratory standard 0-0, 5.0 mg/l).

Blood test September 14:

• Creatinine 1.40mg/dl (laboratory standard 1.20mg/dl),
• leucocytes 6,53 (laboratory standard 4-11), neutrophiles 2,68 (laboratory standard 2-7).
• Platelet 249 mil/mm3 (laboratory standard 150-410).

A urine test showed an amber urine, 1-3 blood cells, 1-3 leukocytic cells.  Abdominal and renal echography were normal.

Augusto was discharged on the September 14 with a diagnosis of adverse reaction to coronavirus vaccine (high probability) – See Discharge Summary.  This was written by Gisela di Stilio – a senior specialist, not a junior doctor.

Test Results after discharge  On September 22:

• ALT 103 UI/l (normal 0-40) with no alteration in other hepatic parameters.
• Creatinine returned to a normal level
• C reactive protein still at 1 mg/l (lab standard 0-0, 5.o mg/l).
• HIV, Epstein Barr and VHC were negative. IgG for CMV was positive.

On September 25, 2020, another blood test was performed showing:

• ALT 100 UI/l, (normal 10-41)
• AST 52 UI/l, (normal 10-40), with no other altered hepatic parameter.

Total antibodies for COVID-19 were negative (ECLIA technique).

On November 13, he had negative IgG and IgM SARSCOV-2 (QML technique), which is unusual post vaccine.

On February 24, 2021, a liver scan showed a minor degree of abnormality.  In March 2021 and February 2022, his liver enzymes remained abnormal.

Subsequent Course and Vaccinations

Augusto said he was discharged feeling unwell with fever. He had difficulties eating, and loss of 14 kg over 3-4 months. His urine cleared progressively during that time.

On April-May 2021 he felt breathlessness observing a desaturation of 91%. But he had fever for only one day and no anosmia so didn’t qualify for a SARS-CoV-2 PCR test. That clinical episode resolved in 15 days.

On April 10 2021, a blood test showed negative anti-S COVID-19 antibodies (ECLIA technique), although this was half a year after vaccination

He received a first dose of Sinopharm vaccine on July 15, 2021.  On July 24, he had positive IgG and IgM anti-spike SARS-COV-2 antibodies (ECLIA technique).

He received a second dose of Sinopharm vaccine on August 25, 2021.

At the time of the interview, Augusto felt back to normal life and able to engage in his sports activities. He experiences some headache and nausea if he eats fatty meals. He has no fever or fatigue, or any fluctuant symptoms. He is waiting for a cardiac study because he occasionally feels tachycardic.

Diagnosis

On a balance of probabilities basis, the most reasonable diagnosis is that after the second vaccine dose Augusto had a vaccine induced pericarditis. He reported high fever, breathlessness, tachycardia and chest pain and a CT scan showed a pericardial effusion, which could not be attributed to COVID-19 disease given a negative SARS-COV-2 PCR.

His altered creatinine could correspond to dehydration because of the high fever and low hydration.  He had a low rise in liver enzymes (ALT) during the admission at Hospital Alemán.  His liver enzyme abnormality doubled its value during the 10 days after discharge from hospital.  A scan showed a possible low-grade hepatic fibrosis but this might not be linked to the vaccine administration.

The symptoms he experienced in April/May 2021 could correspond to a COVID-19 disease but he was not tested then.  There was evidence for SARS-COV-2 antibodies after the Sinopharm vaccine.

Augusto appears to have caught Covid for certain in January 2022 after this interview.  His four vaccinations may have made this infection more likely in that they will have trained his immune system to respond to alpha rather than omicron variants – this training is termed original antigenic sin.

It is of interest that he had several negative antibody tests after the Pfizer vaccine but several medical people researching the vaccine on themselves have had negligible antibodies after the Pfizer vaccine and this vaccine does not produce N antibodies, unlike Covid and the Sinopharm vaccine.

This raises all sorts of questions about where do vaccine induced injuries come from.  Augusto had the vaccine, and had injuries consistent with the vaccine but for some reason did not have detectable antibodies to the Pfizer vaccine while later having antibodies but no injuries to the Sinopharm vaccine.  One hunch about the injuries has been that they come from too many antibodies forming immune complexes and that prior Covid infections along with vaccinations set up a too many antibodies scenario.  This makes sense but doesn’t seem to apply to Augusto.  We are left having to make clinical sense rather than biological sense of this.

Even Augusto would say his vaccine induced problems were mild compared to Bri Dressen’s.  At least until this week when an article was published showing the Pfizer vaccine may get reverse transcribed into Liver Cell DNA within hours of its administration.  There is no way of knowing at present if this has any links to his liver enzyme elevations and if it does what that might mean.  Given how rushed this development was, no-one can tell any of us whether there is an issue here or not – which leaves Augusto and perhaps many others living with uncertainty.

These cases are meant to stand on their own.  You should make up your own mind what you think – and why you think it before reading the next paragraph.

There are a growing number of case reports of people with exactly the same problems as Augusto – see Circulation, Journal of Emergency Medicine, Frontiers and Clinical Infectious Diseases which show mice get the pericarditis Augusto had and the liver problems also.

Physical harms from the vaccine is only a part of Augusto’s story.

The Disappeared

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Just before Augusto was born, a Dirty War came to an end, in which up to 30,000 Argentinians disappeared at the hands of a military junta.  In the clinical trials of drugs and vaccines today, people also disappear.

Augusto was more than usually keen to make sure he was not one of the new Disappeared. He got hold of his medical notes and of the Clinical Trial Record.

Clinical Trial Records

There is a cross-talk between the Hospital Alemán medical record and the clinical trial visit record from the Hospital Militar Central – see above and the clinical trial event record – see below.   The clinical trial visit record is pretty precise and reads as though its for public review, where the event record is much looser and in Augusto’s case has another patient’s details mixed in.

After the first dose, the clinical trial visit record has an entry on August 23 2020 shows a “toxicity grade 1 adverse effect”.

After the second dose, the clinical trial visit record notes on September 14 that Augusto  contacted the research team by phone to let them know he was in hospital. The record then says the admission was for a bilateral pneumonia that has nothing to do with the product of investigation – which is not what he told them.

On September 16, the medical record indicates that after admission a negative test eliminates a SARS-COV-2 infection and the hospital interpret his symptoms as a febrile syndrome secondary to severe reactogenicity related to the investigation product.

On 17 September, another doctor records in the medical record the event is an adverse effect not related to the vaccine but to a suspected COVID-19 infection.

On 19 September, the doctor who wrote the two first annotations wrote that considering all the events, the clinical manifestations can be defined as a moderate intensity adverse effect with fever, grade 3.

On 7 October, a doctor wrote in the medical record that “at the request of the Sponsor, the term adverse event to COVID Disease is updated.

On 11 October, the medical record mentions a new adverse event registered as “severe anxiety” that started on 23 September linked to the patient wanting to know which arm of the trial he was randomized to and saying that he would opt out from the trial unless informed.

On 12 October, a note in the medical record states that the previous entry  – “the term adverse event is considered as a suspected COVID-19 disease” – doesn’t correspond because the patient presented a PCR SARS-COV-2 negative”.

COVID-19 can be diagnosed based on the symptoms even if the PCR test is negative, but it is unlikely that on the 3rd day of the beginning of the symptoms with high fever you find a negative PCR, whereas the initial symptoms started right after the second dose and there weren’t any radiological images or blood tests supporting an acute infection.

So, there is a change in the notes that implies that at some point of the follow-up and against all the evidence, the secondary adverse effect (the febrile syndrome) is changed to a COVID-19 disease in the clinical trial record.

Making a diagnosis of Covid happening within a week of the vaccine dose means that the company had to report nothing.  There is no adverse event that caused Augusto to drop out and any cases of Covid happening in this time period didn’t count against the vaccine.  Events like his just disappear.

The above entries are in the medical record.  The clinical trial visit and event records add to this picture.

The visit record has a note suggesting there was a phone call between a Dr Diego Wappner of the research team and Augusto on September 23, where Augusto asked if he had the vaccine or not and indicated he was thinking about withdrawing from the study.

There was then a note by Dr Polack, the chief investigator, pictured below, about a phone call on September 24 mentioned in a later note on October that he had talked to Augusto and said he couldn’t tell him what he was on. Augusto said he was terminating his involvement in the trial if he was not told. Dr Polack tried to persuade him to stay.

The notes in the event record are more ‘frantic’.

Augusto had made it it clear he would take his case to ANMAT, the Argentinian medicines regulator.  A hearing was scheduled for October 9 2020, which supported Augusto’s withdrawal from the trial and his right to know what he had been given.

The day before, on October 8, Dr Polack made an entry to the event record. Dr Polack was later the lead author on the first New England Journal of Medicine article reporting the results of the trial. Pictured above, he is a pediatrician and infectious disease expert.

The entry states that Augusto had an adverse event of severe anxiety starting on September 23. Dr Polack described this anxiety as not caused by the vaccine, described Augusto as suspecting a conspiracy (between the two hospitals), his anxiety as constitutional, and the ‘volunteer’s’ condition as persisting as he had now taken the matter to ANMAT.

On October 11, there is a further entry by Dr Polack saying that he should have recorded all this on September 23 but he had now transferred his October 8 entry into the ‘volunteer’s’ medical record.  This is a note stating that essentially the ‘volunteer’ developed a severe mental illness on or around September 23 and that this was not caused by the vaccine.

There is nothing in any record that indicates that Dr Polack or any other doctor attempted on September 23 to establish whether Augusto had a mental disorder. Augusto points to the notes of October 8 and 11 as evidence that this idea was invented just around the time the ANMAT Hearing was about to happen.

He states that it is in breach of Argentinian law for Dr Polack to have diagnosed someone with a medical condition that the person does not have – and to have entered it into his medical record.

On October 30, Dr Polack wrote in the event record that the ‘volunteer’ had since been in touch with what are called the ‘Sponsors’. This might be a data monitoring body – a group that seem to have been independent of the research team,. He says that he advised them to make contact with Augusto and inform him of what treatment he had had. The note says this apparently helped and ‘the volunteer’ apparently agreed to stay in touch for monitoring purposes. [I have not seen signs of further monitoring].  Dr Polack’s October 14 note suggests there was an improvement now that Augusto knew what he had had – the active vaccine – and that for Dr Polack this concludes the adverse event (the mental disorder).

There is a gap for ten months in the event record. Then on August 12, 2021, after Augusto had taken his complaints to FDA and others, a Dr. Julieta Gelardi (an ophthalmologist – Don’t Cry for me Argentina) made this entry:

I hereby clarify that the evolution of Adverse Event 2 “Severe Anxiety” on 21/OCT/2020 of Dr.María Alejandra Neira, and from 30/OCT/2020 of Dr Fernando Polack did not need to be loaded up to the CRF since the volunteer withdrew his consent to continue participating in the study on 23/SEP/2020, at which time the event was in progress and its status was unresolved,  unrecovered. As mentioned in the Notes of V2 by Dr Polack the former volunteer gave authorization to continue monitoring in the context of security monitoring, which is why updates were made to the digital medical record.

The CRF (Clinical Record Form) is the material that went back to Icon, the Dublin-based company running the trial, analyzing the data and ghostwriting the New England Journal of Medicine articles, the first of which ends up with Dr Polack as its first author.  So neither Icon, nor FDA, nor the NEJM stand much chance of finding out that there has been an event they should ask Dr Polack more about.

The background data not provided in the Polack and later articles covering this trial state that 302 subjects dropped out from the vaccine group for protocol deviations after dose 2 and 52 on placebo dropped out.  Someone like Eric Rubin, the editor-in-chief of NEJM, or a senior honcho in FDA, you’d imagine should ideally get the contact details of these 302 who have disappeared and get their side of the story.  Augusto and a few hundred others are the real raw data.

Mandatorship

Augusto has reported the irregularities in the clinical trial procedure to ANMAT and other Argentinian and international institutions (EMA, FDA and NIH/NIAID).

He is unhappy that he had to search for medical attention, while feeling seriously unwell after the second vaccine dose.  He is unhappy that a scientific study took no account of the data he provided them showing his alpha-1-antitrypsin deficiency –  people like him he believes should know this common gene put them at greater risk from some vaccines.

He is unhappy that the study team used none of reports of tests done at the Hospital Aleman and later.

He is angry with false attribution of his symptoms to a COVID-19 disease when confirmatory tests were negative. He thinks it likely that the clinical trial record in his case has been falsified.

He is very angry at being given a mental illness he never had, with this entered into his medical record.

He and hundreds of others have disappeared from trials. Tens of thousands of people who later took the vaccine have disappeared (died), with CDC and other regulators apparently unable to state that the vaccine has caused those deaths when in many cases it almost certainly has.

Tens of thousands injured by a first dose of vaccine have been forced by mandates to take a second or booster dose and have come to grief as a result.

Many applied to their doctors for exemptions and have been stunned to find the doctor refusing.  While we live in a Mandatorship, few doctors have the backbone to stand up for their patients. Doctors blithely insist others should take their next dose – no harms can come from these vaccines.  California has just tabled a Bill 2098 which more or less says doctors should be struck off if they say anything else.

One of the real tests of Cause and Effect after a drug injury is whether you would be prepared to repeat the dose. Standard learning theory, either Pavlov’s or Skinner’s, states that we take time to learn things but for several decades we have known about one trial learning in both animals and humans.  If poisoned or physiologically challenged by something, animals, children and most of us, if free to recognise our ‘hunch’, don’t touch whatever it was again.  We would not exist without the ability to learn from one event when the stakes are high. This is science that the work by Kahneman and others on Thinking Fast and Slow, that underpins the science of nudging our doctors and us to have vaccines, ignores.  We are nudged to trust the Evidence rather than the Evident.

As one of those who suffered as a result of  being refused an exemption by a doctor put it to me – you know it felt like he and I were not the only people in the room.

Jorge Mario Bergoglio’s role in Argentina’s Dirty War in the 1980s has been pondered over, or at least his lack of visible backbone in standing up for his people. As the first Head of State to put a vaccine mandate in place, he has led the way in making people Disappear in 2021 and 2022.

Its extraordinary that two men who claim missions to heal division, Jorge Bergoglio and Jose Biden, have managed to sow so much division.

Fernando

According to Fernando Pollack, the Covid-19 virus is not too smart – July 14 2020

The infectologist is one of those responsible for the study that will test the Pfizer and BioNTech vaccine in Argentines and detailed what is known about the virus that has the world in a pandemic.

The announcement that the country will be part of the clinical trials that seek to find a vaccine against the coronavirus generated expectations regarding the end of the pandemic. The joint research between the North American laboratory Pfizer and BioNTech is in a position to be tested in humans shortly, and as President Alberto Fernández was informed, once the National Administration of Medicines, Food and Medical Technology (ANMAT) approves the protocol. Fernando Pollack, a prominent Argentine scientist, is behind this advance, and explained details of the trials in the country. “The intention is that the evaluation of phase 2/3 of the effectiveness of the vaccine will be carried out reflecting the diversity of the population, in a range of 18 to 80 years, in people who have not been infected and we aim to look first at the essential workers, especially the health population, but later it will be expanded, ” he said.

“I can’t answer about the possibility of success, but there are data from this vaccine in a previous trial that are published that show that with two doses it generates antibody responses 10 to 20 times better than a normal coronavirus infection,” Pollack said. In journalistic statements, about the selection of Argentina to carry out this study, Polack assured that “it was a huge competition between many other countries and researchers who were interested in having the place that our country occupies today.” If the vaccine works, Argentina will be “in a privileged position” to help immunize the world.

Regarding the virus, he maintained that the Covid-19 virus is “silly, not too intelligent or subtle” and considered that they will find “many vaccines to stop it.” He said that the advantage of the virus is that “it is new” and that although few defenses are needed to prevent contagion, “there are none” to prevent infection. He explained that before the end of the year he will have a “verdict” on whether the vaccine generated protection against the virus and that, if approved, the first shipments should be available prior to that period. He stressed that if the antidote is successful, Argentina will be able to “position itself better in getting” the vaccines, as it is one of the countries that will analyze it.

I was so afraid Fernando
We were young and full of life and none of us prepared to die

There was something in the air that night
The stars were bright, Fernando
They were shining there for you and me
For liberty, Fernando

Sung to the Music of Abba

In a Texan lawsuit Brooke Jackson lays out the systematic and shocking breaches of the Pfizer trial protocol, and outright falsification of the data, caused she claims because Ventavia, the company running the study in East Texas centers, was trying to cash in on the extra money Pfizer were offering to win the race to be the first vaccine licensed.

Between July 27 and November 14 2020, 43,548 patients were recruited to the trial with Ventavia looking like they broke multiple regulations to recruit 1500.  Dr Polack and his team recruited nearly 6000 patients.  By far the biggest centre in the trial.

The first New England Journal of Medicine article about the trial was published on December 10, with Dr Polack as first author – the day before FDA gave Emergency Use Authorization for use of this vaccine. This put Pfizer on course to make $35 Billion in the following year and the rest of us on course to goodness only knows what.

If we had to do the same again
Would we, my friend, Fernando?

NEJM-GATE

Unless something changes drastically in places like the New England Journal of Misinformation and New England Journal of Medicine Baden et al, Injuries in Vaccine Trials – it looks like we would do it again.  Either that or mandators from Jorge down would happily see us disappear. Our choice they tell us.

Mandatorship: A dictatorship variant where there is no Duce, no Leader.  But there is one Voice. Those making the inconvenient disappear are a followership rather than a leadership.  They claim to follow science – as found in NEJM. They claim to have no option when the public good is at stake.  Una Subditi, Una Voce (one people, one voice – subditi is the people or the subdued).

The public good is certainly at stake when there is no access to clinical trial data, and the articles purporting to represent that science are ghostwritten, with doctors likely to be disbarred from practice for mentioning this.

Breaking News

March 2:

The clinical safety data for the Pfizer trial states 302 people on the active vaccine dropped out for protocol violations.  A recently released document giving dropouts lists over 200 dropouts for the Buenos Aires site – but this does not include Augusto.  This appears to mean Augusto is registered with Pfizer and FDA as a case of Covid within the 7 days of dose 2.