The Argentine Anomalies

One Pfizer trial site is the nexus for many issues

There is more than one important story about the Argentinian trial site and I want to pull them together here. This one site features disproportionately high recruitment numbers, unexplained participant dropouts, allegations of ethical violations and hidden adverse events raising serious questions about the integrity of the trial data and its human cost.

The joint lead author of the main Pfizer/BioNTech publication on their covid vaccine was Dr Fernando Polack. He was also the lead researcher for the clinical trial site at the Central Military Hospital in Buenos Aires which had two site numbers: 1231 for the first tranche and 4444 for the second. This site recruited in a massively disproportionate manner. The chart below shows the number of people recruited each day and has a different colour for each site. Orange shows people recruited into 1231 (almost all the weekend recruitment apparently happened at this one site). Blue shows those recruited at the same site but labelled 4444.

It seems they were disproportiontely good at recruiting ramping up to around 250 per day with half at weekends. On the last day they recruited, Sunday 27th September, they managed weekday rates and then stopped. Site 1231 had 5,896 subjects, which is 12% of the trial subjects. This is four times higher than the most ever recruited at this site for other trials. The other joint lead author managed to recruit 364 patients.

Sites were issued with consequetive numbers but there are none after 1270 except site 4444. The week that 4444 recruited happens to be the final week of possible recruitment in time for the submission cut off of 14th November 2020.

They also had disproportionate drop out rates. 161 participants were recorded in the data at one point but then disappeared. 200 participants at the Argentinian site who withdrew after the second dose out of a total of only 302 across the whole trial.

When a patient is registered on the trial system they are given an identifier by the computer system. These are sequential. It would be very odd for numbers that were allocated not to have some record for why that person did not continue. The Argentina site 1231 had 37% of all skipped subject IDs. The rate of missing ID numbers was four times higher than the other sites combined.

Seventeen of these missing people disappeared on the same day. That was the day that Augusto Roux, a 35 year old lawyer and Pfizer trial participant, had his first dose. He was found collapsed, unconscious at home after his second dose and needed a hospital admission for pericarditis (inflammation of the outer lining of the heart). His trial notes incorrectly described the problem as “bilateral pneumonia” then corrected to “febrile syndrome,” then “suspected covid illness” then “covid illness” then back to suspected covid but with a negative test. This allowed Pfizer-BioNTech to claim the illness was covid related and therefore not a direct effect of the vaccine which would raise concerns about safety. Calling it covid, despite no positive test, meant that there would be no impact on efficacy as it would not count towards the covid numbers in the vaccinated group.

Roux later discovered that his research team was trying to dictate to his clinical team what diagnostic testing should be done. He reported this ethical violation to the authorities who initiated an audit of the research site. Consequently the ethics committee of the Military Hospital was suspended.

Two days after Augusto Roux was vaccinated there were 52 vaccine participants said to have been given too large a dose who were told what they’d received a week later. Three contradictory reports are included in the documentation: they all received the correct dose, there was a dosage error for all of them and there were unspecified irregularities for all of them. Fewer than half took a second dose. Of the 23 who did, 4 then had a significant adverse event.

There is one further strange case from Argentina. A man died of a heart attack. When inspectors visited the hospital to investigate the trial cases his death was hidden from them. He was ultimately recorded as having had the placebo.

Augusto Roux filed a criminal complaint against Pfizer and three doctors. They are all accused of hiding adverse reactions and deaths from the vaccine and inventing false clinical diagnoses. After this trial seemed to stall, suspicions arose about possible ties between the assigned judge and Pfizer, so the case was transferred. The next judge dismissed the case saying there was no crime. A higher court overturned this decision. The beautiful part is that Augusto Roux himself has been appointed as the prosecutor representing the government in the case.