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.
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.
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.
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.
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.
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?
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.
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?
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.
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.