April is the cruellest month,
breeding Lilacs out of the dead land,
mixing Memory and desire,
stirring Dull roots with spring rain.
T.S. Eliot: The Waste-Land

In August 1914, the First World War took shape.  In August 1939, the Second World War was in preparation with Germany launching the first attacks on September 1.

At the end of July 2020, the first patient in the US was were recruited to the Pfizer – ICON trial. It really got going in August.  On August 6, the first patient was recruited in Buenos Aires., with 9 others that day.

This post follows on from Vaccine Rag and Vaccine Tango as well as Two to Tango.

Dose 1

Augusto Roux had his first vaccine dose at 6.50 PM on August 21, three days after his 36th birthday.  Younger people were being seen in the afternoon with older individuals in the mornings.

The photo above captures the scene. Travel to and from the clinic was by Taxi.  At the height of the epidemic, many were very cautious, wearing as a comprehensive a set of masks as we could find. Augusto was particularly concerned about causing problems for his mother, who was in an at risk group.

Augusto had pain at the injection site, with pale feces and dark urine for four days afterwards. He was intolerant of fatty foods. Putting all this together, he figured he had a liver problem. He contacted the research team by phone on August 23, who classified his difficulties as Toxicity Grade 1 – see Disappeared in Argentina.

The trial monitors seem to have viewed the problem primarily as pain at the injection site. They took care to rule out any error in the way the vaccine was administered.

This urine sample was taken a few days after Dose 2, when the coca-cola effect was wearing off.

Everyone was being treated virtually in Argentina just like in North America and Europe.  Augusto’s family doctor suggested a liver scan but denied that his problems were likely to be linked to the vaccine.

Dose 2

We now know Augusto had received the active vaccine.

He had Dose 2 on September 9.  Several hours later he became violently ill with coca-cola colored urine, fever, breathlessness, chest pain, and other problems.  He was out of action, mostly unconscious for nearly three days.  At one point he collapsed on his bathroom floor.

When able to, he made his way to the Hospital Alemán, where he was admitted for three days. His investigations show pericarditis.  His view was that he had a liver problem.  His liver function was not investigated thoroughly perhaps because he was not obviously jaundiced.  The tests showed mildly raised hepatic (liver) enzymes.  These kept rising after he left hospital.  To this day he has difficulties with fatty food.

He was discharged from Alemán on September 14 with a diagnosis of an adverse reaction to the Pfizer vaccine.  But in the Pfizer/ICON research record, based at the Hospital Militar, he was listed as Suspected COVID 19.

He remained unwell and worried at home.  On September 22, some blood test results, which he had done privately, came back. His liver enzymes had doubled – see Disappeared in Argentina for the results.  They were now distinctly high.

He contacted the Hospital Alemán, asking about his liver, who responded by email saying several things that didn’t help.

They congratulate him on being well and say his liver tests were normal (which they almost were at the time of discharge – but his results now are inconsistent with that).  They can’t run tests on him or help because this will interfere with the vaccine research – it would involve breaking the blind.  He finds he cannot download the tests they have done on him from the hospital portal.  It crashes.

In an email, Alemán also say: “We spoke with the Hospital Militar’s research team to inform them of your case, as well as that of other patients we had last week, our job is to respect and not compromise the study in which you are voluntarily participating. We have been instructed not to intervene as far as antibody monitoring is concerned. I would ask you to communicate with the relevant investigator”.

His medical friends tell him he has a problem and they can’t believe how he is being treated.  There is scope here for things to fall apart.

Hanging on the Telephone

On September 23, Augusto calls the research team.  The consent form he signed opened this door to medical care if he was unwell.  But the picture is rapidly getting more complicated.  He now needs to know what is wrong with him but also whether the vaccine caused it?

He also needs a letter signed for work, as he had been too ill to return there and would require medical certification of absence.  He is told the doctors will call him.

He had a phone call close to midnight from Diego Wappner, who had just come off his shift running the research clinic, which at this point was recruiting over 250 people per day.  They had talked once before when Augusto was in hospital, when Wappner got the impression Augusto was admitted for Coronavirus.

Augusto’s email from Alemán suggests they were being told what to do by the Research Team.  Wappner has heard about this and is mystified.  He wonders if Alemán have been contacted by the military.

Augusto says he went to hospital to have his liver investigated but Alemán put him on a COVID protocol without even taking steps to minimise the spread of infection.  This was unacceptable.  Augusto’s brother has liver disease – if Augusto’s reaction is caused by the vaccine what if this reaction happened to his brother?   What about Augusto’s mother who has respiratory problems?

Wappner repeatedly assures Augusto he has a case and says that he will get Polack to call him and straighten things out.

Diego Wappner is on the right in this photo with Fernando Polack in the middle.

Boss of  Bosses

The following day, again late at night, Augusto got a phone call from Fernando Polack.

Polack seems sympathetic.  He seems to think Augusto’s doctors should be able to help him and should be willing to do tests to diagnose his liver condition.  Augusto tells him he is not a doctor and has no idea what tests would be appropriate but he does know something is wrong and it is not right that he is not being looked after.

Why is he being tied up in bureaucratic madness? Polack says there is nothing fishy going on but the research team cannot do anything to make a diagnosis, run tests or offer treatment.

He says there is a lot of confusion in the research because they are dealing with so many cases and perhaps messages have got crossed.  Another patient’s notes did end up being mixed up in Augusto’s record, so it is possible the wrong email was sent to the wrong person – See Welcome to Mondor.  But it doesn’t look like this is what is happening here.

Augusto mentions the Research App is useless – it only lets him record problems as COVID.  It does not let him link problems to the vaccine. [If he goes blind after the vaccine, which the vaccine can cause, he could not record this but he could record loss of taste or smell – well known features of COVID].

Polack says this is because reactions to the vaccine are rare and predictable – they do not include unusual events like Augusto’s which, if linked to the vaccine, are exceedingly rare.  They’ve recruited tens of thousands of people and seen nothing like this.  [This App could easily have had a free text spot for unusual events].

Augusto chases the topic of links between the Hospital Alemán and Militar.  Polack says there are none except they have to call if someone in the trial is admitted to any hospital to get the details of any tests and diagnoses.

Augusto makes it clear that the trial broke down when he was sick after the second dose. No-one contacted him to find out if he was alive or dead or to organize care of him if he was having problems. At this point, he needs to know if he got the active vaccine.

Polack says they cannot break the trial blind to tell him this.  They can only break it if he is at risk of dying.  Augusto asks to be shown the form and the part of the protocol that says this.

If the research team cannot do this and cannot break the blind in his case, Augusto wants this written down to show at work and he indicates he will be taking the matter up legally.

Forked Tongues

On August 23, the day Augusto reported his Dose 1 reactions to the research team, 287 volunteers were injected with Dose 1 in the Hospital Militar. The first 102 went fine. Something then happened in late morning, perhaps after lunch, starting with volunteer 103 that day.

Of those vaccinated after that, 52 ended up being unblinded on August 31. Of those who were unblinded, 31 did not have Dose 2 of the vaccine.  Despite refusing the second dose, some of these volunteers opted to stay in the trial for monitoring purposes.  Some of those not taking Dose 2 are recorded as opting to stay in and others are not recorded as opting to stay in but appear to have stayed in.  Others are clearly recorded as not opting to stay in.

Twenty-three (23) stayed in the research and opted to have the second vaccine.  Four of these had significant adverse events, after the second dose.

While something was happening to the 52, who were later unblinded, another 39 were getting the correct dose or at least were not told of any problems and were not unblinded on August 31.

Of the 52 unblinded, in one document the reason given is a mix up in the dose, but in the same document all are recorded in the randomization log as being randomized to Vaccine and as having been given the correct dose for Dose 1.  In other files a wrong dose is listed or a wrong product.  Three different Pfizer files give three different explanations for what happened – none of which make sense.

There is nothing like this at any other centre in the trial – few if any other centres were processing 52 people per day.

There were other strange events on August 23. The volunteers that day contributed 3 cases of COVID after placebo to the 170 cases that provided the basis for FDA to approve this vaccine under Emergency Use Authorization.  The NAB test was negative in two of these and Not Done in the third – so the most specific test did not support a diagnosis of COVID in these three.  See Two to Tango.

August 31 was the last day on which Site 1231 recruited new patients,  Three weeks later it re-opened as Site 4444.  The sole positive COVID case after vaccine from Buenos Aires in the 170 cases came from the 4444 group.  Without this, the vaccine would have had 100% efficacy in Buenos Aires.

So it makes some sense that Site 1231 took stock on August 31 and for some reason opted to unblind 52 subjects from August 23.  Unblinding is what was recorded but what did this mean?  Everyone administering the dose appears to have known who was getting what – the placebo and vaccine looked different.

The only people who were blind were the volunteers but they only seem to have been told two weeks later.

Around the time Augusto is in Alemán, the researchers appear to have told some people coming for Dose 2 that something has gone wrong, and presumably tell them they have had the active vaccine.

A week later, Polack tells Augusto there is no way they can break the blind in any case unless the person is dying.  Augusto says this is crazy and asks for this statement in writing. Polack backs down – maybe they could break the blind if a person is very ill.  Augusto asks for that in writing but never gets it.

He gets nothing.  He makes a complaint to the Argentine Regulator, ANMAT.  Polack then writes his version of their conversation in the research record and in Augusto’s medical record and states that Augusto has a constitutional anxiety toppling into paranoia – in other words that he is mentally ill.

Despite what Polack says in their conversation, there are now good grounds to think these mRNA vaccines can cause liver and gall-bladder problems – see  Tales of the Unexpected.

It is easy to see in this sequence of events how wires might have gotten crossed.  Augusto had a set of problems after the second dose of vaccine that were clearly linked to the vaccine, but the system from the COVID trial app to the information given to companies like iTrials was close to useless. This study was happening on a wing and prayer without detailed studies on the possible problems beside local vaccine reactogenicity that might arise.

The failure of investigators like Wappner and Polack to pay any heed to things happening to volunteers like Augusto meant the trials were written up as demonstrating the vaccines were astonishingly effective and very safe and publications claiming this in the New England Journal of Misinformation were then used to dismiss people who were injured.

An atmosphere was created where doctors were likely to lose jobs for recognizing obvious problems. The  injured ended up being treated as contagious and were shunned like lepers.  It wasn’t their injuries that were contagious. Their existence, which testified to the reality of harms, was contagious

There is scope for crossed wires in these events – but what’s up with Polack unblinding 52 people at one point and then telling Augusto a short while later that there is no way they can unblind him?

The post August is the Cruellest Month first appeared on Dr. David Healy.

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