From our South American correspondent
For David and Goliath read Augusto Roux and Albert Bourla – Pfizer (who might just be in Trouble)
Readers who read earlier posts – Disappeared in Argentina – Fishy Business in the Rio de la Plata – So Long and Thanks for all the Fish – will remember the unsavoury account of Augusto Roux at the hands of Dr Fernando Polack, boss of iTrials, who pushed him and 5000 other unsuspecting volunteers through Pfizer’s Cominarty trial in Buenos Aires.
To recap – shortly after his second dose of what later was shown to be the active vaccine, Augusto became feverish and his urine turned the color of coca cola. Once admitted to hospital he was diagnosed as having a pericardial effusion and his treating doctor diagnosed this was an adverse reaction to the vaccine.
Polack however decided Augusto had a probable COVID infection despite all his tests for this being negative.
Augusto, still unwell, telephoned Polack, begging to be told whether he was in the vaccine or placebo group, only to be told that he could only be told if he was actually dying. Furthermore Polack, a pediatrican, diagnosed Augusto as having severe anxiety and paranoid tendencies and kicked him out of the trial.
Augusto’s pericarditis vanished from the record. Polack, by now a celebrity in Argentina, then guest authored the ghost-written article in the New England Journal of Medicine that shared the results (well some of them) with the waiting world. The rest is history.
Augusto, before he became ill, and Dr Fernando Polack
Except history, as Richard III, a while back, and Liz Truss, more recently, found, can get derailed for want of a nail. Augusto started asking for more information. He was given lots and lots of redacted stuff like this.
But after marching lots of times around the Walls of Jericho, some parts of the Walls seem to be crumbling.
In the last month he has been officially informed that the Ethics Committee of the Military Hospital in Buenos Aires – the epicentre of the Pfizer trial – lost its accreditation in 2021.
CIREC – the Argentine Clinical Trials approval committee – conducted inspections in March 2021 and found serious irregularities in how it was handling the trial and suspended its accreditation for 90 days.
Two days ago, Augusto was notified that the Argentine Government Audit office – which reports to Parliament – would start an investigation into the Pfizer Trial
There is a very rough translation into English of this letter below.
One man seems to have taken on the combined resources of a $244.98B multinational and held his ground. There is something funny about what went on in Buenos Aires and other sites in this trial and follow-up posts will include more detailed accounts of the Fish that can be spotted in the Rio de la Plata is you are wearing the right gear to see in the murk.
Auditor General M of the Nation
Mr. Augusto Germán Roux
Autonomous City of Buenos Aires
ACTION N° 310/2022-AGN
NOTE NO | | &O/22-SLel
I am writing to you attentive to the presentation made before this Auditor General of the Nation (AGN) related to alleged irregularities in all regulations referring to their effective compliance by the officials who make up the different administrative areas of ANMAT.
Through the aforementioned presentation, a management audit is requested within the scope of the National Administration of Drugs, Food and Medical Technology (ANMAT), given powers established in article 119 of Law 24,156. and that, the work focuses exclusively on the orbit of medicines, taking into consideration the actions of the ANMAT oriented in the fulfillment of the current legal provisions framed in Law 16,463 (of Medicines), evidencing the relevance of prioritizing the analysis of the procedures of registration and marketing authorization of medicines, plus the control tasks derived from them. Establishing what the objectives of the requested audit should be.
In addition, it refers mainly to the area of Inspections of the ANMAT with regard to clinical trials of medicines and that if necessary authorizes the AGN to unrestricted access to any that file is registered in different areas of the State and that contains personal data as provided in Law 25,326, regarding your participation, communicating that different requests were made for plausible reports to be glossed in the investigation, this includes Medical History, Medical Records, personal documentation. In addition to other issues raised in his presentation.
Likewise, it reports that the case is having enormous international relevance according to these irregularities detected.
In this regard, it is informed that this supervisory body, in accordance with article 85 of the National Constitution, has functional autonomy and technically assists the National Congress in the exercise of external control of the National Public Sector.
To carry out its mission, it exercises control over the legality, management and audit of all the activity of the centralized and decentralized public administration, whatever its modality of organization, and the other functions that the law grants it and necessarily intervenes in the approval process. Rejection of the accounts of perception and investment of public funds.
The aforementioned control covers those entities that are within the auditable universe of the AGN in accordance with article 8 of Law 24,156 and that have been included in the Annual Action Program. In this sense, it is made known that ANMAT integrates the auditable bodies by this AGN.
On the other hand, Resolution No. 320/16-AGN that regulates the procedure of the presentations made by individuals who denounce alleged irregularities in the bodies and / or entities subject to the control of the AGN, aims to establish a mechanism of citizen participation that allows the exercise of the right of control of the actions of the National State.
The presentations of individuals contribute to the system of government control, as they enable citizens to contribute their knowledge about the acts, facts or omissions of the bodies that are within the auditable universe of this AGN, whether legitimate or irregular, and that deserve to be taken into consideration for the Audit tasks that are carried out in accordance with the constitutional mandate.
In turn, we inform you that, according to the analysis carried out by the substantive area of this AGN, two audit reports approved by Resolution 116/2021- AGN emerge whose purpose was “Subprogram 01 “Control and Control of Medicines, Cosmetics and Products for Diagnosis” whose executing unit is the National Institute of Medicines “; and others approved by Resolution 229/2012- AGN that aimed to “Audit the management of ANMAT, based on the fulfillment of objectives and goals foreseen in the control and supervision of medicines. The activities surveyed correspond to the year 2010” which are available for public consultation and can be viewed on page https://www.aqn. qob.ar
As for its presentation, it was considered admissible (point 6 paragraph C.1 of Annex I of Resolution No. 320/2016- AGN) and was referred to the competent substantive area that informed that if an audit of the ANMAT, the information that may be taken into account will be taken into account as a background of audit work taking into account the possibilities, Relevance, economic significance and/or relevance of the aforementioned facts.
I greet you sincerely.
Dr. Gerj Manuel N oldes
”Q- Legal ílnstHuc >nal íorla General de TtrJJ ición