Since 2022 the TGA, just like the WHO and FDA, have updated their website and deleted many pages, which makes it difficult to locate information, so be aware many links below are web archived pages. You’d think public health were trying to make it difficult for the public to find vaccine information!

There is no legal definition for “vaccine”

• IMPORTANT: No where in Therapeutic Goods Act or Regulations is there a definition for what constitutes a “vaccine” product, as such there is no legal definition. Yet the regulations call for an Advisory Committee on Vaccines (ACV)!
  • According to the regulations “vaccines” fall under the category of “Biological Medicine“, but not the blood/tissue product type of Biological.
  • The regulations have a definition for “gene therapy” products, yet mRNA “vaccines” some how escaped that category, yet fit the definition perfectly.
  • It appears if a sponsor refers to their product as a “vaccine” then it is considered a vaccine by the regulator!
  • It appears if the mRNA code encodes for an antigen protein, that is all that is needed for it to be considered a “vaccine”, if it encodes a human derived protein it will likely be considered a “drug”. It’s all in the code (as far as I can work out! – Totally shocking!)

To fully understand the TGA we need to also look at the history of the Department of Health in Australia, of which the TGA falls under.

Australian Register for Therapeutic Goods (ARTG) – HERE, ARCHIVE

Read more for youreself:

• History of TGA – PDF

• History of Clinical Trials regulation Australia – HERE

Brief History of TGA

1911- Commonwealth Vaccine Depot (CVD) was established

1916 – CVD became Commonwealth Serum Laboratories (CSL) during war time to provide a source of anti-toxins and other biological agents, it took over manufacture of smallpox vaccine. [1, 5]

• CSL is privatised in 1991, sold in 1994 to private investors for $299 million [2] now worth $145 billion [3]
• 1956 CSL mass produced polio vaccine [6]

1921 – Department of Health was established [4]

1937 – Therapeutic Substances Act 1937 giving Minister of Health drug control powers

1953 – Therapeutic Substances Act 1953 administered by Dept of Health

1953 – National Biological Standards Laboratory (NBSL) established to monitor imported products

1989 – Therapeutic Goods Act 1989 – HERE

1989 – Therapeutics Goods Administration (TGA) was created as a Division of the Department of Health equivalent

1990 – Therapeutic Goods Regulations 1990 – HERE

2001 – Office of Gene Technology Regulator (OGTR) established out of Act and Regulation – MORE

TGA: Definition of Gene Therapy

Documents and links below help provide a thread of understanding of the local and global regulatory web and “justification” for consolidation, which they call “harmonisation”. It all sounds good to streamline the regulation of the same product around the world, until you realise the decisions are distantly related to “health” but closely controlled or influenced by those who profit.

Listed in reverse chronological order

This timeline is a work in progress, content will be added as time permits

2024

January 17, 2024 – The European lobby Kangaroo Group, hosted a lunch in the European Parliament with Members with BioNTech and Moderna as key speakers, to discuss the forthcoming revision of “European Commission’s proposal for a reform of the EU General Pharmaceutical Legislation (GPL)”. EU- ARCHIVE, KG – ARCHIVE, PDF, CREDIT

• Their objective to effecttively change the definition of gene therapy, underwhich their COVID-19 mRNA vaccines are classified, and to create a “definition of Platform Technologies, as well as a clear demarcation between Gene Therapies Medicinal Products that alter human genomes, and those that do not (e.g. mRNA).”
• [If it is happening in the EU, it’s likely happening with all regulators]

2023

February 24, 2023 TGA – Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process – submissions – READ, Priority review – WEB, Priority Review of Biologicals – READ, Application Process – READ

• [It’s unclear when the Priority Review legislation was updated as the TGA no longer add dates to their web pages, like they’re trying to hide something, at the very least make it harder to track their changes.]
• Consultation opened March 28, 2022 – REA

2022

August 1, 2022 – Journal of Law and Medicine: A new priority pathway for biologicals in Australia: contextualising and evaluating the proposed reforms by Rudge et al – READ, READ

• Examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the “New Frontier” of reform envisioned in a report completed by the Commonwealth Government in 2021….identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.

July 4, 2022 – TGA Advanced Therapies: Report on ‘Cell, Gene and Tissue Regulatory Framework in Australia – A stakeholder engagement report on Advanced Therapies prepared for the Therapeutic Goods Administration – READ, Report – PDF, ARCHIVE

• In November 2021 the Therapeutic Goods Administration (TGA) commissioned Medical Technologies and Pharmaceuticals Growth Centre (MTP Connect) to conduct a stakeholder review of the regulatory framework for gene, cell and tissue therapies in Australia.

May 23, 2022 – ARCS Annual Conference 2022: Regulation of cell and gene therapies in Australia – Presentation – PDF

• Biological Medicines (prescription medicines) – vaccines (that do not contain viable human cells)
• February to April 2022 – TGA initiated a public consultation – support the introduction of a new Priority Review pathway for biologicals
  • Consideration for priority – the biological is to be used for treatment, prevention [AKA VACCINE!] or diagnosis of a life threatening disease or seriously debilitating condition (as described by the TGA)

January 10, 2022 – TGA – New catagory appears called Advanced Therapies, under which gene therapies suddenly appears! – ARCHIVE, READ, Quitely added to the website with NO press release or statement – ARCHIVE, unable to find regulatory change around this time – READ

2021

June 4, 2021 – June 4, 2021 – Legislation: Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument 2021 – ARCHIVE – It is now “legal” or permissible to advertise COVID-19 vaccines “safe” in Australia – TIMELINE

• Australia’s Therapeutic Goods Advertising Code is amemded to be able to claim COVID-19 vaccines as “safe” – (Dr Philip Altman) – REF [As I am not a legal person it is unclear which instrument brought this advertising permission into effect, it appears to be June 4, 2021 set off the snowball]

• June 4, 2021 – Dept Health: Therapeutic Goods (Restricted Representations – COVID-19 Vaccines) Permission 2021 – Skerritt’s letter – (now Repealed) READ, no early ARCHIVE
  • “These arrangements have been enabled by the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2021 made on 4 June 2021. . An amendment to the Therapeutic Goods Advertising Code (No.2) 2018 – external site) has also been made to remove the requirement for self-developed advertising to comply with the Code, as the critical requirements have been covered in the above Permission.”
  • relevant COVID-19 vaccines means registered goods – where “registered” includes experimental provisional goods!
• June 7, 2021 – Dept Health: New regulatory arrangements support businesses and health professionals to communicate and incentivise COVID-19 vaccination – READ, ARCHIVE,
• September 23, 2021 – Legislation change: Therapeutic Goods (Restricted Representations – COVID-19 Vaccines) Permission (No. 4) 2021 – READ , ARCHIVE
  • Authority: This instrument is made under section 42DK of the Therapeutic Goods Act 1989
  • “In recognition of the importance of responsible communications regarding the COVID-19 vaccination program, the TGA has issued a subsequent legal permission (the 2021 permission) that allows advertisers such as health professionals, participating vaccination sites, corporate entities, media outlets and others to develop their own materials to communicate publicly about COVID-19 vaccines subject to the conditions below.” – REF

• November 8, 2021 – TGA: Communicating about COVID-19 vaccines – ARCHIVE
  • The following guidance explains how parties can lawfully provide communications about COVID-19 vaccines to support the Government’s COVID-19 vaccine roll-out.
• November 29, 2021 – Legislation: Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 – ARCHIVE
• July 1, 2022 – The Therapeutic Goods Advertising Code (the Code) is the cornerstone of the therapeutic goods advertising regulatory framework – ARCHIVE
  • “From 1 July 2022, advertisers must ensure their advertisements comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021 Advertising Code).”

April 21, 2021 – Monash Uni: Monash supports Australia’s first mRNA vaccine facility – ARCHIVE

• The Victorian government has announced it will put $50 million towards the first domestic production of mRNA COVID-19 vaccines, such as Pfizer and Moderna…
• Experts from Monash University’s Biomedicine Discovery Institute will also work on the project, including mRNA specialists from the fields of biotechnology, infectious disease, immunity and cancer.
• The proven scalability and comparative low-cost vaccine manufacturing potential of mRNA vaccines and nanomedicines secures them as the critical technology platform for vaccines and medicines of the future.
• Increasingly, mRNA nanomedicine can also be used in the treatment of cancer, rare diseases, cellular engineering and protein-replacement therapy, so this investment will help accelerate mRNA projects and develop new treatments to save lives.

2019

November 21, 2019 : Good Manufacturing Practice (GMP) for new and emerging technologies: Advanced Therapy Medicinal Products (ATMPs) – Presentation – ARCHIVE, PDF

September 27, 2019 – TGA business plan 2019-20 – ARCHIVE, PDF

• “The Business Plan sets out our product regulation, regulatory reform, international engagement and regulatory compliance agenda for 2019-20 and the steps we will take to achieve our vision.”

Better health and wellbeing for all Australians through regulatory excellence

TGA Vision statement

• Our priorities are derived from:…TGA International Engagement Strategy 2016-2020 – READ (which began in 2013)
• TGA “proactively responding to innovations in therapeutic goods, which may require updates to regulation all identifiable opportunities for international work sharing and harmonisation.”
• “The TGA annual budget is approximately $165 million and we operate predominantly on a cost recovery basis. The regulatory costs are recovered through fees and charges levied on sponsors and manufacturers of therapeutic goods…” – REF

• The Australia-Canada-Singapore-Switzerland (ACSS) Consortium‘s work sharing pilot on New Chemical Entities is a unique global collaboration between regulatory authorities and the pharmaceutical industry.

August 12, 2019 – Dept Health: Australian Health Management Plan for Pandemic Influenza (AHMPPI) – READ, ARCHIVE, PDF

• AHMPPI, the national government health sector pandemic influenza plan, outlines the agreed arrangements between the Australian Government and State and Territory Governments for the management of an influenza pandemic. This agreement was ignored a few months later when another respriatory virus pandemic was declared in 2020!
• The previous version of this plan was 2008, which conincidentally a year later the 2009 H1N1 pandemic was declared. The Australian govt did successfully utilised the plan that year.

June 2019 – TGA Annual performance statistics report: July 2018 to June 2019 – “provides detailed statistical information on our performance to our stakeholders.” – ARCHIVE, (2016-2019) – ARCHIVE

• “At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added during the reporting period. All therapeutic goods registered on the ARTG can be lawfully manufactured and supplied in Australia and include prescription medicines, over-the-counter medicines, complementary medicines, biologicals, and medical devices.” [curiously no mention of vaccines, which are a separate category called biological medicines, separate from bioligicals]
  • Thus 36% of all registered products listed on ARTG were added in one financial year!

February 8, 2019 – Prescription medicine major variation: discretionary power to reduce fees in exceptional circumstances – ARCHIVE

• The sponsors fee reduction is only intended for safety related changes in certain circumstances.

2018

December 2018 – TGA release a promotional video below, … they’re “looking out for you.” – WATCH, ARCHIVE

August 2, 2018 -TGA: Priority review pathway: prescription medicines- Information on the priority review pathway for the registration of novel prescription medicines – READ

June 29, 2018 – TGA Advertising Code opens up definition for a “serious form of a disease” “to be anything deemed “medically accepted” as a serious disease or a diagnostic test available” – TIMELINE

March 29, 2018 – Provisional Registration added to TGA legislation – TIMELINE

• “On March 29, 2018 the Australian government added a Provisional Registration (PR) amendment  to the Therapeutic Goods Act (1989), of which the TGA Secretary now has overriding power to send a product application through the registration process with only preliminary clinical data.”

March 23, 2018 – TGA: Completing a designation or determination extension application form in TGA Business Services – A step-by-step guide for agents and sponsors who wish to apply for an extension of a previously approved provisional determination – ARCHIVE, SOURCE

March 21, 2018 – TGA: Australian Regulatory Guidelines for Prescription Medicines (ARGPM) -UPDATE: Implementation of a Provisional approval pathway for the time limited registration of eligible prescription medicines now avaliable – ARCHIVE

March 20, 2018 – TGA announce time-limited provisional registration pathway is now available – ARCHIVE, TIMELINE

• ” The provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG)
• “As part of the Government’s response to the Review of Medicines and Medical Devices Regulation (MMDR review), we are implementing a pathway for the provisional registration of prescription medicines. Approval through the provisional pathway will be on the basis of preliminary clinical data where there is the potential for a substantial benefit to Australian patients.
• The provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG). It provides access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.”
  

March 6, 2018 – TGA legislations change sets up for government to advertise “vaccines” on TV in the interest of public health –TIMELINE

January 2, 2018 – TGA announce Comparable overseas regulators (CORs) for prescription medicines – Criteria, COR report-based process and work-sharing – ARCHIVE, SOURCE

• “In response to the Medicines and Medical Devices Review (MMDR) we are reforming the way we collaborate with comparable overseas regulators” – and “implementing a formal process for work-sharing with CORs on prescription medicines applications.”
• Under this process, multiple regulators would be able to work simultaneously on different parts of a dossier submitted for evaluation in each jurisdiction. A joint evaluation report would then be provided to each agency to allow independent decision-making.”
• They began with re-assessing generic medicines – Nov 2017 ACSS Consortium and the Generic Medicines Work-Sharing Trial presentation – ARCHIVE

2017

June 26, 2017 – TGA: Priority review pathway for the registration of novel prescription medicines for Australian patients, providing “faster assessment of vital and life-saving prescription medicines” – ARCHIVE, ARCHIVE

• The very pathway all COVID-19 vaccine entered to gain regulatory handshake
• Sponsors lodge their application first for TGA Secretary to determine whether the medicine/vaccine is eligible for registration via the Priority review pathway, once approved it enters the provisional pathway.

March 2017 – TGA: Expert Panel Review of Medicines and Medical Devices Regulation 2016 – Streamlining Statutory TGA advisory committees – ARCHIVE

• Efficiencies will be achieved through reducing the number of statutory advisory committees that provide independent expert advice to the TGA. – i.e. Advisory Committee for Vaccines (ACV) funded by the sponsor “cost arrangement” – TIMELINE

January 2, 2017

2016

September 15, 2016 – TGA: Australian Government Response to the Review of Medicines and Medical Devices Regulation – The case for reform presented by the Expert Panel – ARCHIVE, Reforms proposed – ARCHIVE

• “The Expert Panel identified several significant trends in the regulation of medicines and medical devices internationally. In particular,…allowing earlier access to medicines … through the development of provisional approval pathways” There are “benefits of harmonising international regulatory frameworks”.
• “TGA has a strong reputation as a regulator both domestically and internationally, and benchmarks well against comparable overseas regulators. However, …there are opportunities for reform and improvement in the regulation of therapeutic goods.”
• “…allowing for greater flexibility in approval pathways …(including greater use of overseas assessment reports and provisional approvals in certain circumstances) would expedite access to market without compromising the safety, quality and efficacy or performance of medicines and medical devices.” [Bold claim!]
• “The Panel also identified areas of regulation where a more risk-based approach could be adopted to more appropriately align regulation with the risk posed by regulated products” [Do you sense they are suggesting vaccines here, which are believed to be, by default of their name, safe and effective” ?]

May 2016 – The Australian Government Response to the Review of Medicines and Medical Devices Regulation – PDF, ARCHIVE

• Recommendation 10 – Provisional: “Subject to the provision of clear advice to consumers and health practitioners that the medicine has been granted provisional approval and the implications of that for the consumer/health practitioner”
  • [Was it made clear th the pubic and health practitioners that the COVID-19 vaccines in Australia were “Provisional” when released in 2021?]

2015

November 2015 – Australian Goverment establishes Medical Technologies and Pharmaceuticals Growth Centre (MTP Connect) – as part of the $248 million Industry Growth Centres Initiative, an alleged independent, not-for-profit organisation – ARCHIVE , Gov- ARCHIVE, Factsheet – PDF

• MTP Connect Chair, Dr Bronwyn Evans – was from 2009-2012, the Chair of the Medical Technology Association of Australia (MTAA), a national peak industry body representing companies in the medical technology industry…for a healthier Australia..and “also play a vital role in providing healthcare professionals with essential education and training” – of non-pharmaceutical products. REF

July 31, 2015 – Review of Medicines and Medical Devices Regulation: Recommendations to the Minister for Health on the Regulatory Frameworks for Medicines, Medical Devices, Complementary Medicines and Advertising of Therapeutic Goods – Stage TWO Review report – PDF, PDF, ARCHIVE

• “The rapid pace of innovation and change in the health sector confers both benefits and risks. The Government’s deregulation agenda is based on the core principle that well-designed regulation has a role in achieving the greatest net benefit for the Australian community….positioning Australia to effectively respond to emerging opportunities for, and manage challenges to the health and safety of the public”

March 31, 2015 – Expert Panel Stage ONE Review report and discussion papers – PDF, ARCHIVE

2015 – TGA Acronyms & Glossary – Definitions – ARCHIVE, READ

• Active Ingredient
• Anticeptic
• Bacterial endotoxin limit 
• Bioburden
• Biological
• Biological Medicine (vaccine)
• Cochrane review
• Common Technical Document (CTD) format – An internationally agreed set of specifications for a submission dossier….
• Disease
• Drug – See medicine (Section 3(1) of TG Act
• Genetically Modified Organism (GMO)
• Homoeopathic preparation   
• Informed consent
  • “In relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment”
• Medicine
• (no definition for “Gene Therapy” but can be found in the TG Regulations)
• (no definition for vaccine, can’t be found anywhere!)
• Medical Device – READ
• New chemical entity (NCE) – could be anything!
• Placebo
  • “An inactive substance or treatment that supposedly has no treatment value. It is given to participants in clinical trials as a control against which to compare the effects of the test substance. In practice, placebos may also have positive or negative effects on trial participants.” 
• Control
  • “In clinical trials comparing two or more interventions, a control is a person in the comparison group that does not receive the medicine or treatment under evaluation. Instead that person receives a placebo, no intervention, usual care or another form of care. In case-control studies, a control is a person in the comparison group without the disease or outcome of interest.”
• Therapeutic goods     

2015 – Legislation Australian Immunisation Register Act 2015 – NEED MORE INFO

• recognised vaccination provider within the meaning of the Australian Immunisation Register Act 2015 – REF

2014

October 28, 2014 – Dept. Health: Expert Review of Medicines and Medical Devices Regulation announced – ARCHIVE, Web page ARCHVIES

• Media Release: Health Minister Peter Dutton and Assistant Minister for Health Fiona Nash announced they had appointed an Expert Panel Review of Medicines and Medical Device Regulation – PDF
  • “We need a modern regulatory framework to ensure Australians can access the latest treatments in a timely manner,” Dutton
• The scope of the Review is set out in the Terms of Reference, review report due March 31, 2015 – PDF
• The Review panel experts are Emeritus Professor Lloyd Sansom AO (chair), Professor John Horvath AO, Mr Will Delaat AM

June 5, 2014 – The Health Ministerial Advisory Council – ARCHIVE

• Health Ministerial Advisory Council (Health MAC) has been established to provide advice to the Health Ministers about opportunities to reduce regulatory and red tape burden within the Health portfolio. Health MAC falls within the Deregulation Branch, Best Practice Regulation and Deregulation Division of the Department of Health.
  • Chair: Hon Peter Dutton MP, Minister for Health and Minister for Sport
  • Deputy Chair: Senator the Hon Fiona Nash, Assistant Minister for Health

April 22, 2014 – Dept Health: Regulation and Red Tape Reduction – The deregulation agenda – ARCHIVE

• Deregulation Unit within the Department’s Best Practice Regulation and Deregulation Division has been established to promote regulatory performance across the Health portfolio

March 19, 2014 – Abbott government as part the 2014 Autumn Repeal Day: The Australian Government Guide to Regulation – Cutting Red Tape, for the Australian Public Service involved in policy making, Honourable Josh Frydenberg MP, Parliamentary Secretary to the Prime Minister – READ, PDF, WEB

• It is no mandatory that every government policy proposal designed to introduce or abolish regulation must now be accompanied by an Australian Government Regulation Impact Statement (RIS)
• Australian Government has a plan to cut $1 billion in red tape every year. Regulation is “Any rule endorsed by government where there is an expectation of compliance”.

2013

International regulatory cooperation takes hold – “harmonisation” – regulatory assessment becomes consolidated

July 2013 – TGA International Engagement Strategy 2013-2015 (it begins) – Version 1.0 July 2013 – ARCHIVE, updated versions ARCHIVE, SOURCE

• “The therapeutic goods industry is becoming increasingly globalised and the TGA must be able to assure public confidence in products no matter where they are produced. As this is occurring, international regulators are demonstrating a greater willingness to develop partnerships and share information, skills and experience to ensure more informed and consistent decisions about the quality, safety and efficacy of therapeutic products.”
• “The major return on this investment is a reduction in duplication of effort in pre and post market evaluation of therapeutic goods, leading to a more efficient and effective regulatory system.” – i.e. to drive harmonisation
• The strategy will be reviewed periodically and amended as necessary in response to the changing international environment…
• The development of the joint Australia and New Zealand Therapeutic Products Agency (ANZTPA) [which eventually failed and was disbanded]

2011

May 31, 2011 – TGA – Biologicals legislation commenced following a recommendation from Commonwealth, State and Territory health ministers to improve the regulation of human tissues and cell-based therapies. – REF Providing the regulatory framework for biologicals

• What is regulated as a biological – Human derived – ARCHIVE
• Different to blood and tissued – ARCHIVE
• Don’d confuse “biological” with “biological medicine”, the latter is where “vaccine” is placed.
• First introduced in May 2011, the regulatory framework for biologicals provides the legislative basis for the regulation of human tissue and cell-derived products as well as live animal cell, tissues or organs that are supplied, in or exported from, Australia (TGA, 2017, 2021b). For those therapeutic goods, regulated by the TGA, and which are produced by genetic manipulation (GM), the TGA is required to seek advice from Office of the Gene Technology Regulator (OGTR) (TGA, 2004) – PDF

2010

November 1, 2010 – TGA introduced a streamlined submission process for prescription medicine applications that require the evaluation of non-clinical, clinical and/or bioequivalence information (category 1 and category 2 submissions). – REF

• Jan 17, 2011 – Transition information about the streamlined submission process – ARCHIVE
• To support sponsors in meeting the regulatory requirements under the streamlined submission process, a regulatory framework of legislative instruments has been created.

2009

The year the TGA introduced Business process reforms which included – AusPAR and PI/CMI

December 2009 – The first Australian Public Assessment Report (AusPAR) was published – a Publication of a regulatory decisions – REF, Australian Public Assessment Record (AusPAR) – ARCHIVE updated 2014 – READ

• The AusPAR project, part of the Prescription medicines business process reform project (BPR program) – “is increasing the transparency of the prescription medicine regulatory process by publicly releasing (since December 2009), Australian Public Assessment Records (AusPAR) for new products of major variations to existing products.” –REF
• “AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application”
• “The TGA works with international counterparts in order to reduce the worldwide regulatory burden and increase the global uniformity of data requirements. Thus, wherever possible, the TGA’s requirements are the same as those of other major regulatory agencies.” [Thus FDA, EMA and UK medical agency important to take note of]

November 2009 – PI/CMI project launched – ARCHIVE

• “Since November 2009, the PI/CMI project provided via the TGA website “a single trusted source for product information (PI) and consumer medicine information (CMI)” to provide consumers and health professionals “enhanced access to prescription medicine information.” – REF,

April 2009 – The Industry Working Group (IWG) has provided advice and assistance on the range of business process reforms. Under the terms of reference, members of the working group are not representatives of individual sponsors, but bring specific expertise to the working group.” – REF

2009 – Streamlined Submission Process project (prescription medicines) “In early 2009, the TGA commenced a significant program of business process reforms (BPR program) for the regulation of prescription medicines in Australia” – REF

• “The key elements of the BPR program were identified during an industry consultation workshop held on 17 December 2007 which brought together representative of the TGA, Medicines Australia, and the Department of Health and Ageing. These initiatives are part of the Australian Government’s broader regulatory reform agenda.” – ARCHIVE
• There are three projects within the BPR program: –REF
  • Streamlined submission process project – ARCHIVE
  • PI/CMI project – ARCHIVE
  • AusPAR project (Dec 2009) – REF, AusPAR – ARCHIVE

2008

2008 – Department of Health and Ageing: Australian Health Management Plan for Pandemic Influenza (AHMPPI) 2008 – READ, REF,

• This plan was used the following year in the 2009 pandemic which ended up being “mild” – READ

2007

December 17, 2007 – TGA holds an industry consultation workshop – REF

• The key elements of the 2009 business process reforms (BPR program) “were identified during an industry consultation workshop held on 17 December 2007 which brought together representative of the TGA, Medicines Australia, and the Department of Health and Ageing.”

November 2007 – Biosecurity and Emergency Response: The National Health Security Act 2007 and the National Health Security Agreement – Dept Health 2007-08 Annual Report – PDF

• To improve the identification and response capacities of health authorities to national and international public health events, such as an influenza pandemic.
• N5H1 vaccines added to National Medical Stockpile
• Implemented outcomes of Oct 2006 National Pandemic Influenza Exercise — Exercise Cumpston’ 06 – READ
• Commenced revision of the Australian Health Management Plan for Pandemic Influenza (2003) to ensure that the plan is based on the latest evidence. (See 2008)

2006

October 2006 – Therapeutic Goods Administration and Biologics and Genetic Therapies Directorate (BGTD) of Health Canada – Parallel Review Pilot Project – ARCHIVE

• The project will involve the two agencies reviewing one or more submissions in parallel with an aim to enhance cooperation between regulators in various jurisdictions around the world.”
• November 8, 2006 – Health Canada:

October 16-19, 2006 – Exercise Cumpston’ 06 : Australia holds Australia’s largest ever health exercise and was one of the first major exercises on pandemic influenza conducted in any country – REPORT, READ, TIMELINE

July 10, 2006 – “On July 10, 2006, Health Canada issued a Notice of Compliance to Merck Frosst Canada Ltd. for the vaccine product Gardasil^TM – ARCHIVE

2005

2005 – “Australia had been in the pandemic “ALERT” phase since 2005 following the emergence of the avian influenza A(H5N1) virus infection in humans.” REF

2004

August 19-20, 2004 – The 9th National Public Health Association of Australia Inc (PHAA) Immunisation & 1st PHAA Asia-Pacific Vaccine Preventable Diseases Conference: ‘Immunisation at the crossroads: Challenges and Strategies‘ –READ, REF, PHA is an advocacy group – ARCHIVE

• PHAA Vaccines in Public Health Short Course before the conference!
• 1998 the 6th conference Immunisation Beyond 2000 – HERE

January 2004 – Dept Health & Ageing: Protecting Australia against Communicable Disease: Everybody’s Business – PDF (Referenced by Halton)

• “Influenza virus is a continuing global threat because it can spread easily and evolve rapidly to elude our prevention and treatment strategies.” [i.e. flu vaccines]

2003

November 5, 2003 – WHO Global Training Network (GTN) course on vaccine regulation for National Control Authorities – ARCHIVE

• “The Therapeutic Goods Administration (TGA) is one of the accredited training centres around the world that contributes to the WHO Global Training Network (GTN). The GTN was developed in 1996 as a means of providing educational resources to staff of vaccine production facilities and regulatory agencies responsible for control of vaccines.”

October 2003 – The Australian Action Plan for Pandemic Influenza was endorsed by the National Public Health Partnership and the Australian Health Ministers’ Advisory Council – Dept Health Annual Report 2003-04 – by Secretary of Department of Health and Ageing, Jane Halton – ARCHIVE, REF

• The 2003-04 outbreak of avian influenza H5N1 (bird ’flu) in Asia “was the second time in as many years that an unknown and highly contagious disease had posed a major international threat, the previous one being SARS” (a coronavirus)
• So Australia compiles an influenza plan (not a respiratory virus pandemic plan) to provide direction for the Australian, State and Territory governments and emergency services in the event of an influenza pandemic.
• “Influenza pandemics result from a major change in the structure of the influenza virus and are expected to occur about every 30 years. Experts predict that future pandemics are likely, if not inevitable.”
  • [They got their wish 6 years later, following the May 2009 definition change for what constitutes a pandemic, except there was pushback in Europe
• “The expectation of 50 years ago that humanity would soon wipe out infectious disease, has been replaced with the knowledge that we will probably never win the ‘arms race’ against ever-changing microbes and viruses” writes Jane Halton [1953 Salk polio vaccine was released], now in makes sense why she headed the organisation that would save the world with 100-day vaccines for Disease X!
  • Jane Halton became head of CEPI when it launched in 2017, in time for 2020 pandemic!

June 4, 2003 – TGA Laboratories (TGAL) are designated by the World Health Organization (WHO) as a WHO Collaborating Centre – ARCHIVE, ARCHIVE2

• WHO Collaborating Centre for Quality Assurance of Vaccines and other Biologicals and
• WHO Collaborating Centre for Drug Quality Assurance
• WHO Vaccine Self Sufficiency Program in the Western Pacific Region – REF

2002

January 29, 2002 – TGA Media Release: TGA sweeps Internet for false claims – ARCHIVE

• Australian Internet Sweep Day, coordinated by the Australian Competition and Consumer Commission (ACCC), is part of an international evaluation of web sites, aimed at protecting consumers and promoting fair trading in the global market. Linked through the International Marketing Service Network (IMSN) of of consumer protection authorities.

May 2002 – NCIRS: Vaccine preventable diseases and vaccination coverage in Australia 1999 to 2000 – PDF, SOURCE, CREDIT

2000

November 26-28, 2002 – WHO/IVR: Ethical considerations arising from vaccine trials conducted in paediatric populations with high disease burden in developing countries – PDF

• “Each year, millions of children in developing countries suffer from infectious diseases. Of these, more than 2.7 million children under five (WHO 2001 estimate) die from diseases that are potentially preventable by vaccines. In light of these unacceptable rates of morbidity and mortality, the development or improvement of vaccines to meet the needs of children in developing countries continues to be one of the highest priorities, with the attendant requirement for an increasing number of trials to evaluate new vaccines.”
  • [This is an important claim which is parroted by WHO yet supply without citation]
• A cautious approach is appropriate in the conduct of vaccine trials among children in any circumstances because of their particular vulnerability in view of their inability to give informed consent and their sometimes greater potential to adverse reaction to vaccines.”

July 14, 2000 – Australian Children’s Hospital at Westmead and Children’s Medical Research Institute joint initiative: Gene Therapy Research Unit – ARCHIVE, REF

1998

January 1998 – TGA commenced an orphan drug program – ARCHIVE, PDF

• The “program aimed at encouraging sponsors of prescription medicines for treatment of rare diseases to register and market these medicines in Australia. Because these medicines are for a very limited number of patients, they are less likely to be commercially attractive to sponsors than medicines with a larger market. If the sponsor can substantiate that a medicine meets orphan drug criteria, the TGA will waive the cost of evaluating the medicine.”
• [Think ivermectin for COVID-19!]

1997

1997 – National Centre for Immunisation Research and Surveillance (NCIRS) of Vaccine Preventable Diseases was established by the National Centre for Disease Control, Commonwealth Department of Health and Aged Care as an initiative under the Seven Point Plan for the “Immunise Australia” program. – (lots of ref) ARCHIVE, Research – ARCHIVES, Vaccine trials – ARCHIVE

• NCIRS has provided editorial and scientific support for the production of the Australian Immunisation Handbook and provided support to the Australian Technical Advisory Group on Immunisation (ATAGI)
• NCIRS 2002 report: Vaccine preventable diseases and vaccination coverage in Australia, 1999 to 2000 – PDF
• NCIRS 2001 edition: Immunisation – Myths & Realities. Responding to arguments against immunisation – a guide for providers (first pub. October 1994) – PDF
  • Look at charts on pg 10 & 11, and compare the dates on the Y-axis to comparable graphs found, and the Y-axis units – HERE, this is how they “debunk”.

February 1997 – Australian Government Immunise Australia Program: Population Health Division: The Seven Point Plan – ARCHIVE

• The Seven Point Plan was approved by Cabinet and launched by the Minister for Health and Family Services, the Hon Dr Michael Wooldridge, in February 1997
  • Initiatives (incentives) for Parents.
  • A bigger role for General Practitioners.
  • Monitoring & Evaluation of Immunisation Targets.
  • Immunisation Days.
  • Measles Eradication.
  • Education and Research.
  • School Entry Requirements

1995

October 1, 1995 – Therapeutic Goods Regulations – Definitions antiseptic, fungicide, viricide etc added – PDF, READ

1992

August 18, 1999 – Therapeutic Goods Administration Laboratories Branch – The TGA laboratories (TGL)were first occupied in the spring of 1992. – REF, ARCHIVE

• “TGAL is responsible for evaluating the chemistry, quality control and manufacturing data submitted by the manufacturer in support of: vaccines, cytokines, blood products, hormones and enzymes, other biological medicines, monoclonal antibodies”
• Laboratory Information Bulletin Vol. 6, no. 1 (September 1994) – ARCHIVE, SOURCE

1989

1989 – The Therapeutic Goods Act 1989 came into effect in 1991 giving the Commonwealth more clearly defined regulatory authority. – READ Followed by the Therapeutic Goods Regulations 1990 – READ

• The Therapeutics Goods Administration (TGA) was created as a Division of the (then) Department of Community Services and Health – history – READ
• The legislation was to streamline Commonwealth and State legislation and to allow the Government to charge fees to industry to meet the costs of therapeutic goods regulation – REF

1983

1983 – A New Pandemic emerges HIV/AIDS- Much of the world’s optimism about the state of health was shattered by a new, mysterious pandemic, HIV/AIDS. In Australia, the virus was first identified in a patient in Sydney in 1983 – REF

1981

1981 – WHO: World Health Day with the ‘Health for all by the year 2000‘ – REF

1966

1966 – Therapeutic Goods Act (1966) – READ, CREDIT

• Therapeutic Goods Regulations (1970) – READ
• This Act and Regulations held until the big overhaul happened in 1989.

1953

1953 – Therapeutics Substances Act (1953) passed – READ, CREDIT

• The regulations were not enacted until 1956 , after the polio vaccine Cutter incident debacle in the USA – READ

1937

1937 – The Federal Health Council (1925) is expanded to become the National Health and Medical Research Council (NHMRC) with State and Federal representatives, now to include members of the medical establishment – REF

1937 – The Commonwealth Government passed a Therapeutic Substances Act in 1937, giving the Minister for
Health power to control the importation and exportation of substances which were declared in the Gazette
to be therapeutic substances. – (more history) – REF

1936

1936 – Therapeutics Substances Act (1936) signed, followed then by 1937, neither Act were proclaimed because of WWII – TGA History – REF

1926

1926 – Australia hosted the first League of Nations’ international conference on health – REF

• The delegates discussed early warning systems for epidemics and quarantine issues, as well as various medical problems… then the Great Depression hit followed by World War II, after which the World Health Organisation is formed, under the umbrella of the United Nations

1925

1925 – Federal Health Council to promote Federal-State cooperation established following a Royal Commission Commonwealth health system – REF

1921

March 1921 – The Commonwealth Department of Health was established – ARCHIVE

• “The panicked response to the 1919 influenza pandemic was a catalyst for founding the Commonwealth Department of Health in March 1921 .
• Other factors included recommendations from the State Premiers, the British Medical Association of Australia (the forerunner of the Australian Medical Association) and a blunt appeal to the Prime Minister, Billy Hughes, by Dr Victor Heiser from the Rockefeller Foundation’s International Health Board. Heiser told Hughes that Australia would be considered backward until it acquired a national health department.
• Rockefeller Foundation provided the “Government the financial incentives of temporary expertise in industrial hygiene, public health engineering and administration, as well as training scholarships” – REF
• Billy Hughes would go on to become Minister for Health and Repatriation – REF

–

1919

1919 – “Spanish influenza” was brought to Australia by returning servicemen. “The epidemic killed 12,000 Australians. It caused widespread panic. Troops were quarantined before being reunited with their families. Public meeting places such as hotels and theatres were closed, and masks had to be worn on the streets. The authorities’
response to the crisis was chaotic, with police being stationed along State borders to try to prevent the disease from spreading. – REF, HISTORY

• The panicked response to the 1919 influenza pandemic was a catalyst for founding the Commonwealth Department of Health in March 1921 – REF

1919 – The first international flight to Australia by Ross and Keith Smith, pointed to the need for improved quarantine and health services – REF

1916

1916 – Australia work with the Rockefeller-funded International Health Board to extend its hookworm eradication campaign to Australia – REF

1916 – WWI prompted the establishment in 1916 of the government Commonwealth Serum Laboratories to provide a source of anti-toxins and other biological agents, should overseas, supplies become scarce… – REF

1909

1909 – The Federal Quarantine Service within the Department of Trade and Customs is established – REF

• Commonwealth quarantine officers became part of an informal network of health officials and doctors operating at all levels around the country. It’s members started the public health movement leading to the Department of Health
• In 1900, life expectancy for men was 52 and 55 for women – REF
• In 1984 the quarantine responsibilities of the Department of Health,which was once its very nucleus, were transferred to the Department of Primary Industry – REF

1901

January 1, 1901 – Birth of the Commonwealth of Australia – TIMELINE

The post TGA Regulation Timeline first appeared on Totality of Evidence.

He joined the pharmaceutical industry, become head of a medical department for a major drug company before starting his own consultancy contract research organisation called the Association of Regulatory and Clinical Scientists (ARCS). His company employed more than 2,000 scientists, clinicians, associated health professionals, statisticians, pharmacists and health economists all involved in both clinical trial work and regulatory affairs projects, in both Australia and New Zealand. Consulting for “probably more than half of the multi-nationals in Australia”.

Over 4 decades working with the TGA

For over 40 years, Dr Altman has been designing, managing and reporting clinical trials and dealing with the Australian drug regulator, the Therapeutic Goods Administration (TGA) on behalf of his pharmaceutical clients. He is intimately aware of their regulations and standards. He used to compile dossier’s to submit to the TGA for drug evaluation, including meeting with them face to face. Back then, Altman says, the TGA were “world class” in terms of their standards and quality of evaluation, and highly regarded internationally.

Most conventional drugs take 8 to 10 years. “You start off with 10,000 compounds, and if you’re lucky you end up with one that gets across the line.” Drug development is a very risky and expensive business, and along the way you generate an enormous amount of data. Dr Altman used to receive dossiers that were so large they had to be delivered by truck.

Red Flag Awakening

When covid began, and the well know, essential drugs like hydroxychloroquine and ivermectin were attacked, he was awakened to something wasn’t right. Ivermectin is a miraculous drug, it is widely used in Africa and is one of the reasons they’ve faired extremely well in this pandemic, despite a low vaccination rate – they used both HCQ and ivermectin.

Dr Altman turned to looking at the COVID-19 vaccines. Knowing they were a new class of drug, a new delivery system, they were “really blue sky, brave new world technology”. Historically they were investigating mRNA gene-based therapies for use in very rare genetic diseases.

These products were developed in record breaking time, like 10 MONTHS [for all 3 phases!]. They only did a single trial to get provisional approval! “Provisional approval is very sketchy approval…they had the slimmest of efficacy and safety data to support that use.”

“We’re now one and half years into this deal and there’s no question the wheels have fallen off the vaccines…they haven’t lived up to expectations, they aren’t efficacious and they’re not safe, and the excess death rates around the world are sky rocketing…and our so-called health experts have not shifted one iota in light of all this” [WATCH]

Interviews and reports in reverse chronological order

2025

February 18, 2025 – Australian Senator Malcolm Roberts with Dr David Martin and Dr Phillip Altman – WATCH, CREDIT

2024

October 4, 2024 – Club Grubbery: Panel discussion w/ Prof Gigi Foster and Dr Philip Altman who discuss the (Misinformation and Disinformatin (MAD) bill and the state of our Australia – WATCH

• Dr Altman reveals a legislation change in June 2021 allowed COVID-19 vaccines to be claimed as “safe” something which is illegal to do for any therapeutic good. I’ve added a timeline data point with the likely legislation – HERE

2023

December 7, 2023 – Club Grubbery: Graham discuss with Karen Fox and Philip Altman current issues…- WATCH, from Australia Exits the WHO – HERE

October 18, 2023 – Too Many Dead and Australian excess deaths inquiry – Dr Phil Altman – WATCH, READ

August 26, 2023 – Phillip Altman Substack: HERE WE GO AGAIN !- The global control playbook works – READ

• Also “Patient Zero” Ben Hu virology grant 2018 to make humanised mice reference

August 17, 2023 – Cafe Locked Out: Join Dr Phillip Altman as he addresses several of Dr Dan’s Claims – LISTEN

June 22, 2023 – Club Grubbery: Graham and John Speak this week with Dr Phillip Altman – WATCH

April 30, 2023 – Philip Altman Substack: Q: WHEN IS A “VACCINE” NOT A “VACCINE” – A: When it does not prevent infection or transmission of infection – READ

• It appears “many batches containing dangerous levels of contaminants including circular DNA called plasmids”
• “…other contaminants which are also of great concern and these include compounds called endotoxins which are lipopolysaccharides in the cell wall of Gram negative bacteria”
• TGA Batch release assessment of COVID-19 vaccines – READ
  • “It shows no details of limits of specifications or actual results.”

April 9, 2023 – ExCandidates Ep 55: Dr. Phillip Altman Interview – Analysing Vaccine Efficacy – WATCH, SUBSTACK

March 14, 2023 – Club Grubbery: Graham and John interview Dr Phillip Altman – He details how he has been called into public service and reviews what he has encountered in his research – WATCH

February 22, 2023 – The Malcolm Roberts Show #3 – Dr Phillip Altman – WATCH

2022

October 14, 2022 – Club Grubbery with Rowan Dean [Sky News] and Philip Altman – WATCH

August 24, 2022 – Graham Hood’s Club Grubber: Doctors With Voices #8 interview with Dr Phillip Altman – WATCH, FB

Two TGA statements that are patently false claims Dr Altman: [@14min]

• 1) “TGA has identified 13 reports where the cause of death was linked to vaccination from 900 reports received and reviewed.” – READ
• 2) “The 13 deaths likely to be related to vaccination occurred in people aged 34-81 years old. There have been no deaths in children, adolescents or younger adults determined to be linked to COVID-19 vaccination.” – READ
• The DAEN has an under reporting factor estimated between 10% to 100%! Given the pressure doctors are under [AHPRA threat] it is likely the passive reporting is more towards 100% says Altman, which means 900 death reports could be as high as 90,000!
• [Doctors likely are not aware that any adverse event should be reported to TGA, as ALL Provisional products are part of the black triangle scheme.] – IMG
• US VAERS reports shows death or developed symptoms leading to their death, have mostly occurred within 48 hours following vaccination, “that is very strong evidence that there is a cause and effect relationship“
• Canadian Medical Association in Memoriam – “cause unknown“! – WATCH, CMA, SUBSTACK

It is obvious by now that the authorities are “willfully blind” to what is happening

There’s hardly anything that the so-called “experts’ have told us in the past, that has been shown to be true – Examples:

1. The vaccines would prevent infection and stop transmission – FALSE – breakthrough infections
2. The vaccines were 95% effective – FALSE, that was a relative efficacy in a very small group of people
3. They said the vaccines provided durable protection – FALSE as endless boosters prove no immune durability
4. Cloth masks are effective in preventing infection – FALSE – no scientific evidence, quite the contrary
5. They called it a pandemic of the unvaccinated – it’s the complete opposite [definition manipulation]
6. They said young children are at significant risk of COVID-19 – FALSE
7. The vaccine mandates have no scientific basis at all – no community benefit, yet forced on our healthcare workers etc.
8. PCR can diagnose COVID-19 – FALSE, the PCR test was never diagnostic, and high cycle thresholds somewhat guarantee a positive result. [see Kary Mullis, DOCUMENTARY].
9. Asymptomatic can spread the virus – A new phenomenon which was sold on the high threshold PCR testing – historically you’d need a viral load that causes symptoms before you would be infectious. Asymptomatic demonstrated inability to spread the virus in households
10. A “case” suddenly became determined by as little as a positive PCR result – FALSE – historically a “disease case” started with an “ill-at-ease” person, not someone who is “statistically ill” but showing no symptoms and they’re not infectious
11. The vaccine stays at the site of the injection – FALSE [Japaneses FOIA from Dr Byram Bridle]
12. The mRNA degrades quickly – FALSE – [pseudouridine means it remains for an unknown period of time – Dr Malone]
13. The spike protein is short lived – FALSE [mRNA and spike found in lymph nodes for at least 60 days]
14. mRNA wouldn’t cross into the nucleus and combine with DNA – FALSE- compelling in vitro evidence shows it can potentially integrate into human DNA, and may contain insertion codons – [see Gene Drive /CRISPR Cas-9 with Dr Merrit]
15. Lockdowns will slow the spread – yet in September 2019 the WHO published systematic review that revealed the science was not there. The lockdown concept originates from a 2006 school project. Lives and economy destroyed by this public health policy not based in science.

THERE ARE RED FLAGS EVERYWHERE

Dr Altman worked on Australian Judicial Review with Julian Gillespie et al. As a result he compiled his affidavits into what is now referred to as The Altman Report. It’s not an opinion piece, he just cites factual scientific papers. Doctors aren’t getting this information, and judges need highly technical information simplified. Doctors are only getting their info from ATAGI and other “expert” – unless they are proactively looking elsewhere. The report has been distributed widely to government and health professionals forcing them to look at the data – EXCERPT, The Altman Report – HERE, Official source – AMPS

Knowing what we know now with all the available data, its time to reflect and reassess

The media is highly controlled. We’ve learnt a lot from this pandemic. “It’s really opened my eyes” says Altman
Two years ago if you had told me this I wouldn’t have believed there was an agenda. And COVID is a tool of control.

This is the biggest medical gamble in the history of mankind

We’ve taken a blue-sky group of drugs a new drug technology and applied it world wide to healthy people.

August 22, 2022 – WCH General Assembly meeting #54: New Report: The Time of Covid by Dr Phillip Altman – WATCH, READ, REPORT (not report is a living document and may not be the latest version)

August 17, 2022 – COVID Inquiry 2.0 is a cross-party, non-parliamentary inquiry which follows the March 2022 COVID Under Question inquiry – Dr Phillip Altman – WATCH, PART 2, OFFICIAL

August 14, 2022 – James Lyons-Weiler Substack: Has the Australian Medical Community Finally Come to its Senses?
The incoming president of the Australian Medical Professionals Society sounds a lot like our community a year ago in an email to AMPS members. – READ

• The Email from the Australian Medical Professionals Society – EMAIL,
• TO – RECIPIENTS,
• Dr Philip Altman “The Time of COVID” – “The Altman Report” 42 page with 110 references – REPORT, INTERVIEW, EXCERPT

“One of the chief concerns of our membership is that of medical free speech. Contingent to a joint statement received from AHPRA and the National Boards on 9 March 2021, Australian Health Professionals numbering over 825,000 were essentially forbidden from publicly questioning the science underlying the emerging COVID-19 injectables, let alone questioning any government messaging urging Australians to be vaccinated because these products were deemed ‘safe and effective’.”

July 26, 2022 – Dr Ron Ehrlich interview with Dr Phillip Altman: Reflections on the Pandemic, Two Years On – LISTEN & TRANSCRIPT, YouTube

April 5, 2022 – Zeee Media: Dr. Phillip Altman – The Fraud of the TGA & Corruption of the Australian Health Authorities – WATCH

March 23, 2022 – COVID UNDER QUESTION a cross-party inquiry into the Government’s response to COVID hosted by Senator Malcolm Roberts – Dr Phillip Altman segment – WATCH, CHANNEL

2021

September 30, 2021 – Quadrant: A Plea for the Use of Ivermectin Against COVID-19 by Phillip M Altman – READ

August 31, 2021 – Quadrant: Ivermectin: Chemists Come Between Doctor and Patient by Phillip M Altman – READ

“According to both the AHPRA and the minister, doctors have every right to recommend the cheap, off-patent drug when and as they see fit.” but “the Pharmaceutical Society of Australia [PSA], which has decided your local neighbourhood chemists can trump prescribing doctors if they suspect the drug is being used for other than its primary designated purpose, the treatment of roundworm parasites.”

Included in the article includes bot the August 29, 2021 alert letter from PSA to it’s members, along with Dr Altman’s response.

August 22, 2021 – Quadrant: ‘A Total Lack of Therapeutic Perspective’ by Phillip M Altman – READ

July 25, 2021 – Quadrant: The Who, How and Why of COVID-19 by Phillip M Altman – READ

“The new genetic vaccine technology used in the mRNA-based vaccine of Pfizer (and Moderna) and the DNA- based adenovirus AstraZeneca and J&J vaccines have never been previously approved for use as any new pharmaceutical”

The post Dr Phillip Altman first appeared on Totality of Evidence.

Hundreds of thousands of previously healthy people across the world have experienced serious and life altering health outcomes following their submission/acceptance/coercion to receiving the COVID-19 vaccines, too many have resulted in permanent disablement or death – AKA Vaccine Injury and Death!

There have been millions of adverse events reported post vaccination globally, which should be a major red flag signal that something is wrong – why are the authorities ignoring this?

Define “Serious Adverse Event” – Code of Federal Regulations on CDC website:

If vaccine side effects were so “rare” why would the search term “vaccine side effects” spike December 2020?
And other search terms – HERE. Though Steve Kirsch does caution one on the interpretation of these spikes.

COVID-19 vaccination is the leading cause of coincidences!

The RESOURCE LINKS below have captured the testimony of thousands of people who submitted to the jab. You won’t hear this on main stream media, as testimonies goes against the narrative. It’s so sad that people have to suffer in order to wake up to the risks temporally associated with the TGA Provisionally Registered experimental products.

The more data that is collected the greater the signal of warning – EXAMPLES:

1) In an October 22, 2020 FDA VRBPAC meeting, the presenter skipped over a slide containing the potential side effects we could experience following the COVID-19 injections.

2)Then it was discovered amongst the Pfizer FOIA documents released in March 2022 there were 9 pages of potential adverse events which Pfizer had submitted to the FDA following authorization of their mRNA “vaccine” product.

3) Reporting to the US Vaccine Adverse Events Reporting System (VAERS) is not a quick and easy task and the hospital administrators strongly discourage it! – Deborah Conrad’s story – WATCH

4) Nurses experienced live changing adverse event following vaccination and they didn’t even know VAERS existed – WATCH, BACKUP

Vaccine Adverse Events in Children – HERE

ALL Adverse Events SHOULD Be Reported to Authorities

ANY adverse event following these “authorised” or “provisionally approved”, or “conditionally approved” vaccines SHOULD BE REPORTED “even if it is not clear that a vaccine caused the adverse event”. That is how post-marketing surveillance should be done!

US CDC: “Adverse events that occur in a reported after COVID-19 vaccination are REQUIRED to be reported to…VAERS…Reporting is encouraged…even if …not clear that the vaccine caused the adverse event” [emphasis added]

Australian TGA: “Adverse events are ANY unfavorable and unintended sign, symptom or disease associated with the use of a medicine and these should be reported, in particular serious adverse events and those NOT listed... All reports help to build a picture of the safety profile” [emphasis added]

CDC: Possible Side Effects After Getting a COVID-19 Vaccine – READ,
(Dec 2020 – ARCHIVE, Jan 2021 – ARCHIVE, Jun 2022 – ARCHIVE)

Adverse Events Testimonies

Jab Injuries Global – LINK

REAL Not RARE – LINK

No More Silence – LINK

The Testimonies Project- LINK

COVID Vaccine Reactions – LINK

Covid Vaccine Injuries – LINK

Covid Vaccine Victims – LINK

C19 Vax Reactions – LINK

Vaccine Injuries – HERE & Deaths – HERE

Circle of Mamas – Social Media aggregation of Reports, LINK

American Conversations With Vaccine Injured – LINK

Athletes Collapse and Die on the field 2021 – WATCH, LINK1, LINK2, WATCH2, SOCCER

Healthcare workers injured & speak out – WATCH1, WATCH 2

Vaccine injured speak at US senate hearing – WATCH

Documentary: ‘I Am Not Misinformation’ | Covid-19 Vaccine Adverse Events – WATCH

Unprecedented numbers of athlete collapsing or dying since 2021 – READ

The COVID blog – READ

No More Silence. World – ARCHIVE, Stories from Australia

Can We Talk About It? – A campaign helping people who are suffering from COVID-19 vaccine injuries – READ

ReAct 19 – Stories – HERE

Vax Justice – HERE

UK CV Family – COVID Vaccine injured – HERE

COVID-19 Humanity Betrayal Memory Project – cases – HERE

Adverse Events Statistics

CDC V-safe self reporting App post-vaccine rollout – ICAN obtained data via FOIA:

• Oct 3, 2022 – ICAN obtained V-Safe check-box data – HERE, TIMELINE

• Feb 15, 2024 – ICAN obtain first batch V-Safe “free-text” field data – READ, WATCH, DASHBOARD
  (where the vaccine recipient described their adverse event that wasn’t covered by th check-box)

Vaccine associated injury – case report list – READ, SPREADSHEET

REACT19 Scientific Publications & Case Reports – HERE

John Platinum Goss – COVID-19 Stats – LINK

Sharyl Attkisson – Tracking US adverse reports – LINK

Health Impact New: European Database of Adverse Drug Reactions for COVID-19 “Vaccines” – REPORT

Scientific and Medical Research, Data, & Reports by Mathematician Kathy Dopp – LINK

US Military Database – Whistleblower leak alarming increases in medical reports – LINK, INFO

HOW BAD IS MY BATCH – vaccine injuries by batch number! – LINK

How Bad is my Batch look up tool – HERE

MatchYourBatch.org VAERS search tool – HERE

Search AE Reporting databases – OPEN VAET – HERE

Medalert VAERS Wayback Machine (reveals deleted entries) – HERE
MedAlert VAERS current database search – HERE

VAERS Aware: “The Parking lot Deaths” – VAERS reports – Dead in under 3 hours of receiving COVID-19 vaccine – READ

Informed Consent Advocacy

Physicians for Informed Consent – Epowering the public with scientific information about infectious diseases and vaccines – HERE

Informed Consent Action Network (ICAN) – HERE

A Million Mums for Informed Consent – HERE

Summary of Adverse Events

Swiss Policy Research – Aggregating Covid Vaccine Adverse Events information. First published June 2021 – HERE

At the above link you will find information on all these adverse events reported following COVID-19 injections:

• Neurological disorders
• Menstrual disorders, miscarriages, birth defects
• Heart inflammation, heart attacks, cardiac arrest
• Blood clots and strokes
• Severe skin reactions
• Eye disorders and blindness
• Bell’s palsy (facial paralysis)
• Shingles and other virus reactivations
• Tinnitus, hearing loss, dizziness and vertigo
• Anaphylactic shock
• Tumor growth and cancer
• Appendicitis
• Children: PIMS, myocarditis, blood clots
• Diabetes and diabetic ketoacidosis
• Other autoimmune diseases
• Booster toxicity
• Lymphadenopathy
• Organ failure
• “Long Covid” symptoms
• Creuzfeldt-Jakob disease (CJD)
• Histopathological findings

Epoch Times: Timeline Sept 2020- Sept 2023: COVID-19 Vaccines and Myocarditis – ARCHIVE

Official Adverse Event Reporting Systems following vaccination

Australia – TGA DAEN, Run REPORT, all Provisionally Approved products are subject t Black Triangle designation.

America – VAERS

UK – Yellow Card system

EU EudraVigilance – LINK, Summary

WHO VigiAccess – LINK

IRELAND: Health Products Regulatory Agency – LINK

July 8, 2021: CHD: How to Report an Adverse Reaction to Any Vaccine: CHD International Vaccine Adverse Event Tracking System – VaxxTracker – READ

Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) – LINK, REPORTS
March 18, 2022 – Rebel News: Trudeau gov’t commits $75M to vaccine injury compensation program – READ

Canada: Independent Canadian Adverse Events Reporting System (CAERS) – LINK, ARTICLE

Scientific Papers

June 2022 – World Council for Health (WCH) COVID-19 Vaccine Pharmacovigilance Report: – READ, PDF

Conclusion: Signal detected:

• Unprecedented numbers of adverse events
• Serious adverse events and death
• COVID-19 product recall indicated

June 17, 2022 – Andrology: Covid-19 vaccination BNT162b2 temporarily impairs semen concentration and total motile count among semen donors – READ

April 15, 2022 – Journal of Clinical Medicine: The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated Patients—A Large Population-Based Study – PAPER
This Israeli cohort study involving 196,992 unvaccinated adults found “no increase in the incidence of myocarditis and pericarditis” after COVID infection. – REF

February 20, 2022 – COVID Vaccine Injuries.com: More than 1,000 peer reviewed papers on covid vaccine injuries – READ, ANOTHER

February 20, 2022 – List Of Over 100 Studies Proving How COVID Vaccines Are More Harmful Than What We’re Being Told – LINK

August, 2021 – Health Impact News: Estimating the number of COVID vaccine deaths in America by Jessica Rose et al – READ

Abstract: Analysis of the Vaccine Adverse Event Reporting System (VAERS) database can be used to estimate the number of excess deaths caused by the COVID vaccines. A simple analysis shows that it is likely that over 150,000 Americans have been killed by the current COVID vaccines as of Aug 28, 2021

FOIA document release by FDA

November 17, 2021 – FOIA document release by FDA to PHMPT shows 1295 vaccine side effects – DOCUMENT, VIDEO, READ, LIST of 1295

Naomi Wolf coverage of the Pfizer document findings – HERE

Government Death Payment Schemes – Compensation

Should you die or become disabled from the COVID-19 experimental injections, you could be eligible for government funds.

UK government – Vaccine Damage Payment Scheme – benefits and financial support if you’re disabled or have a health condition up to 120,000 pounds – HERE

SA government – Deceased COVID-19 vaccine recipient payments and funeral costs – HERE

Canadian Government – Canadian Vaccine Injury Support Program (VISP)
June 22, 2022 – Rebel News: Vaccine Injury Program estimates CAPPED halfway through the first year – WATCH

September 15, 2022 – Expose News: British Columbian Woman One of the First to Receive Compensation in Canada for Mother’s Death Caused by a Covid Injection – READ

August 26, 2022 – National Pulse: The British Government Has Begun Paying $140,000 for COVID-19 Vaccine Damage Victims. – Which seems to be getting no coverage in the American media. Wonder why – READ

July 6, 2022 – Epoch Times Facts Matter: Woman Receives $148K Vaccine Injury Compensation; Explanation of USA’s Vaccine Compensation Program – READ

Post-Jab Testimonies & Stories

I’ve created a new page for capturing individual stories and new articles about injury or death following the COVID-19 vaccinations – Post-Jab Stories – HERE

August 17, 2022 – Australian News: Clots and Deaths following the “safe & effective” COVID-19 Vaccine – Montage – WATCH

TIME-LAPS: Australia vs Niger: As vaccination rates go up in Australia, so to does the death toll, compare that to Niger with low vaccination uptake, and a population about the same – GETTR

Vaccine Documentaries

Swiss Policy Research have put together a page of vaccine successes and controversies Documentaries – HERE

VAXXED from coverup to catastrophe The Movie – Released free to the public on The Highwire March 2022 – The film they don’t want you to see, but should you choose just click – HERE

The post Adverse Events following COVID-19 injections first appeared on Totality of Evidence.

[Sept 2024 – Note that this page was not started as a timeline, unlike other pages, so many of the pre 2023 data points are not complete but are still being populated. This Sept 9,2024 article HERE , provides an excellent summary of what happened with HCQ, along with comments by Dr Malone HERE]

So why is hydroxychloroquine suddenly “dangerous”?

Some facts to consider about HCQ:

• Chloroquine and HCQ are listed as an essential medicine by the WHO.
• HCQ is relatively less “toxic” than Chloroquine when you look at the potential side effect profile.
• The patents for both Chloroquine and it’s derivative HCQ have expired, which means they can be manufactured generically, which in turn means cheaply.
• Hydroxychloroquine has been on the FDA’s list of approved drugs since 1955
• In 2005 an in vitro study of Chloroquine on SARS virus showed prohibitive viral properties when used early.
  August 22, 2005 – Viroolgy Journal: Chloroquine is a potent inhibitor of SARS coronavirus infection and spread – Vincent et al – READ
• In malaria prone countries, HCQ can be bought over the counter – no doctor’s script necessary.  In CDC fact sheet they recommend purchase before and deems it safe for adults and children, except those prone to psoriasis.
• HCQ acts as an ionophore, meaning it opens up a transport channel for zinc to enter the cell and it is the zinc that stops viral replication.
• A 200mg oral dose of hydroxychloroquine has a half life of 537 hours or 22.4 days in blood, longer in plasma.
• Experts agree that “chloroquine has a small toxic to therapeutic margin“, meaning the right dose is effective, too high and it is toxic, even fatal.
• In Taiwan December 2020 a manufacturing plant that makes the precursor to HCQ was damaged, and in May 2020, possibly 2 other plants that also make or store magnesium stearate were also damaged.  Coincidence?
• Since 1968 very few deaths attributed to hydroxychloroquine

Fact, if an effective early treatment was “found” for COVID-19:

• The pandemic would be over
• States of Emergency would no longer be ‘justifiable’
• Experimental vaccine’s would not be necessary or justifiable
• Emergency Use Authorisation or Provisional Registrations of vaccines would need to be stopped
• Vaccine manufacturers would loose hundreds of billions of dollars in profits.

Other questions to consider:

• Is HCQ a potential, broadspectrum anti-viral, in particular when used in combination with zinc?
• If HCQ is safe for adults, children and pregnant women for weekly treatment for malaria, they why is the same/similar dose suddenly “dangerous” in the middle of a pandemic, as a demonstrated effective early treatment measure?
• Why did health authorities design clinical trials for HCQ in late stage, hospitalised patients only, and at rates in excess of that used by frontline doctors for early treatment?
• If a broad spectrum anti-viral medication was “discovered” what would this do to the profitability of the vaccine industry?
• What would happen to the childhood vaccination program?
• Do you think Big Pharma and it’s “soldiers” would do everything they can to stop such information from coming to light?
• What tools do Big Pharma have to control the narrative?  Media? Lobby groups? Health authorities? Grant funding? Medical journal funding?

These are all questions to ponder as you dive into this controversial topic.  The greater number of people who know this information, the quicker a corrections can be made – assuming they do something about it!

HCQ and COVID-19

As the COVID-19 pandemic took hold in early 2020, some key doctors highlighted the life saving benefits of the HCQ drug for treating the symptoms of COVID-19 as well as potentially reducing the replication of the disease agent SARS-CoV-2.

We’ve capture their story here, along with the science and the mode of action this drug has against this virus.  We’ll also look at the focus of the clinical trials that the “expert medical authorities” conducted using HCQ, and how they determined that the drug failed to be beneficial and was deemed to be potentially dangerous.  There is so much to unravel for this drug and its controversy.

In the mean time if you want an excellent summary read this article from Jun 2020:  How a False Hydroxychloroquine Narrative Was Created

HCQ Timeline

In March 2020, Australia’s Clive Palmer through his foundation donated 32,900,000 doses of HCQ to the people of Australia, because of the positive information coming from independent doctors, virologists and scientists.

For an excellent timeline of event surrounding HCQ the Palmer Foundation website has been keeping track of since April 2020, below we’ll share our own discoveries of which there will be overlaps.  It appears the general public is not aware of much of this information.

This web page will be updated, it is set up to build the story in chronological order.

Scroll to the bottom of this page for the most recent videos

Dr Vladimir Zelenko’s Story

Zelenko “discovers” HCQ combination as an effective treatment for COVID-19

This story is a movie in the making.  Dr Vladimir Zelenko is a family doctor for around 30,000 residents in New York area.  He himself was suffering with cancer, undergoing treatment and surgery during the pandemic.  He claims to have never worn a mask while with his patients (many coming to him with COVID-19 symptoms) and he takes his prophylaxis treatment daily to protect himself against contracting the disease – by late 2020 he as yet hasn’t contracted COVID-19 but has assisted many hundreds of patients through the disease process, with only 2 hospitalisations, and 2 deaths, one with late stage cancer (as of end 2020).

It is highly recommended you listen to his story (below) yourself as he shares how he discovered HCQ + Zinc + Azithromycin combination for the treatment of his patients who came to him presenting with COVID-19 symptoms.  Listen to what he says and compare that to trials the “authorities” designed that  “proved” the drug to be “ineffective”.

Since the media won’t show you this, you’ll have to discover it for yourself.

Dr Zelenko share’s his treatment protocol for COVID-19

This video was first aired 2 July 2020 on The Highwire  which has since been deleted from YouTube.  Below is a part of this episode that features Dr Zelenko.

The Zelenko Protocol

Zelenco Protocol information with publication links and links to more videos

The Zelenko Protocol

Find the Zelenko Protocol here, the whole purpose is to prevent symptoms from escalating and preventing hospitalisation.

Dr Zelenko mentions virologist Professor Didier Raoult from France.  Over time as these two doctors communicated and they refined their treatment, Dr Raoult started to use zinc in combination, and thus decreased his dosage of hydroxychloroquine.

Watch Medcram episode 34 explaining the mechanisms of zinc with an ionophore such as choloroquine, referenced by Dr Z.

www.VladamirZelenkoMD.com

Dr Zelenko’s Letter to President Trump

In March 2020 Dr Zelenko wrote a letter to President Trump to inform him about his success with the hydroxychloroquine combination treatment protocol for the COVID-19 pandemic.  Just as an aside it was claimed by the media that Trump owned shares in Sanofi, one of the companies that makes the generic drug, but that was taken out of context and thus fake news.

Video has been removed:
President Trump On Using Dr. Vladimir Zelenko’s Hydroxychloroquine Protocol
https://www.youtube.com/watch?v=92pDKwloEEk

What the media didn’t tell you

An informative interview with Dr Zelenko

Dr Zelenko’s interview with the Corona Investigation Committee July22, 2021 – Session 62

Interesting statement by Dr Zelenko: “I’ve noticed, what ever the FDA decides, the rest of the world follows”.   Why this is interesting is that our TGA does refer to international regulatory bodies to assist in making recommendations and decisions.

He talks about how HCQ went from being available to everyone under Executive Order to being thwarted by FDA/HHS EUA for use in hospital settings only – the one setting it was never going to work in based on existing experience!

“In America, any drug that’s FDA approved can be used off-label for any reason” stated Dr Zelenco (within registered dose rates)

Combination treatment has provided the best results

The combination of HCQ with Zinc, is more effective than either used alone.  Zinc needs an ionophore to help it get into the cells, once in there it works to block the replication of the virus by inhibiting an enzyme called RNA-dependent RNA polymerase also called RNA replicase (see video below).
In addition, HCQ has multiple modes of action (see Dr Shiva video below) but when used in combination with zinc there is a synergistic effect.  Zinc is the bullet, HCQ (an ionophore) is the gun or the delivery tool.

Alternative Ionophores

If HCQ is not available Quercetin and EGCG (green tea extract) are also efficient zinc ionophores as discussed by Dr Zelenko.  All the front line doctors have stated, you need to get in early, the moment symptoms appear.

How Zinc and an ionophore work together

The paper referenced in this video: “Zn(2+) inhibits coronavirus and arterivirus RNA polymerase activity in vitro and zinc ionophores block the replication of these viruses in cell culture”.

Early treatment is key to the success with HCQ

The medical establishment (clinical trials) and media choose ONLY TO FOCUS  on advanced disease (hospitalisation) where HCQ  has demonstrated to offers little if any benefit based on front line experience.  The trials are designed to fail from the outset – timing, dose, used alone, not in combination.  This is not conspiracy, this is fact.

Early treatment is where all the front line doctors are having success in preventing hospitalisation.  But strangely this information is being censored.

The health establishment are doing garbage science.

April 16, 2020 – Unbreaking Science with Dr James Lyons-Weiler: Coronavirus: Mortality Rates, Hidden Information, Witheld Drugs w/ Meryl Nass, MD – withholding hydroxychloroqine early treatment – WATCH

HCQ: How It Works, benefits and side effects

Dr Shiva extracts the information from the scientific literature

Multiple mechanisms of action of hydryoxychloroqine against coronavirus:

1. Inhibits virus entry into the cell by inhibiting the viral particle binding to ACE2 receptor, this leads to reduced viral entry into the cell (Vincent et. al. 2005 CDC)
2. Inhibits viral replication of RNA via inhibition of RdRP in coronavirus.
3. Inhibits viral assembly
4. Inhibits new particle transport out of the cell
5. It acts as an ionophore for zinc, allowing zinc access into the cell, which in turn stops viral replication.

(note: Remdezivir, which is still under patent and costs around USD $3000 per dose, only inhibits viral replication, meaning one mode of action)

Mode of Action and Side Effects of HCQ

Dr Zelenko discusses COVID-19 outpatient management with Dr Been

American Front Line Doctor’s Summit

The summit videos were deleted from YouTube and web host provide deleted their site within 24 hours!

Massive censorship of Frontline Doctors led by Dr Simone Gold, where she and many other front line professionals shared their experience and treatment success stories along with other literature based presentations to help get the word out about all things COVID-19 related.  Their YouTube video’s and website was taken down by the hosting company (Square.com) within 24 hours of the summit – unheard of censorship.

But they have a new site here.  With their COVID-19 treatment’s page here and video page here including their Summit on July 27, 2020 covering many topics including hydroxychloroquine.

Doctor’s experience with HCQ:

Dr Anthony Cardillo explains that in his ER, they’ve found that HCQ really only works in combination with zinc.

Dr Zelenko has published his studies to share with everyone.  This was on the original Frontline Doctors website

Dr Simone Gold – White Paper on HCQ

The heart of the “problem”

Cardiologist at Mayo Clinic in March 2020 claim QT issues with hydroxychloroquine.  Why wait for now to raise this issue, when the drug has been handed out effectively like candy for malaria prevention to adults and children? Why now?

Then comes the VA Study

On 21st April 2020, the paper titled “Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19” was published.  This is refereed to as the VA Study.

The media then grabbed hold of it’s conclusions and began to shout higher mortality rates with hydroxychloroquine (1, 2) or Fox news claiming HCQ has no benefit.  Though what they don’t tell you is it is an observational study who’s conclusions have not been put into context.

That is HCQ was use on patients who’s immune system was already shot, they were hospitalised in ICU on ventilators, it was not a randomised trial, the study didn’t report the doses of the drugs used, plus 30% of the control group received a treatment that itself could help reduce mortality.  Plus one of the authors Scott Sutton received funding from the Remdezivir manufacture Gilead.  So a case of bad science, conflicts of interest and another attack on a drug that still has potential as an early treatment!

Then on 24th April 2020, the FDA cautioned the use of HCQ due to the risk of heart rhythm problems – but only for COVID-19 suspected patients, not for Lupus or RA or for malaria treatment!

French virologist, Dr Didier Raoult responds to the flawed VA study here.

Del Bigtree unpacks the FDA and the two factions of the HCQ

(that YouTube deleted)

Laura Ingram on US Fox News reports on this VA study

Dr Raoult’s study

Dr Patrice Harris the President of the American Medical Association claimed on CNN in April 2020 that there was no evidence to support the use of hydroxychloroquine for COVID-19.  Understanding at this time, the front line doctors were successfully accumulating thousands of case studies, they’re using rates that are commonly used for malaria, they’re using it at the first sign of symptoms for at risk patients, and they are successfully preventing patients from having to go to hospital.

Fraudulent Peer Reviewed Lancet Study

Published on 22nd May 2020, the Lancet published a damning paper looking at 96,000 patients, and concluding the HCQ group were dying at high rates and with more heart related complications! –

The “…study did not examine the QT interval but instead directly analysed the risk of clinically significant ventricular arrythmias. We showed an independent association of the use of either hydroxychloroquine or chloroquine with the occurrence of de-novo ventricular arrhythmias. We also note that the hazard of de-novo ventricular arrhythmias increased when the drugs were used in combination with a macrolide” [such as azithromyicin].

On 25 May 2020, this lancet study gave justification for the World Health Organisation to temporarily pause it’s SOLIDARTY trials on HCQ.  A fraudulent, supposedly peer reviewed study caused the WHO, in the middle of a pandemic, to stop trials because of the heart problems supposedly caused by hydroxychloroquine.

But then two weeks later on the 4th June, 2020 after doctors and scientist started questioning this peer reviewed scientific paper it was retracted by The Lancet  and the US based company Surgisphere [1] that allegedly collected the data for this study from all over the world, including Australia, was completely fake!

WHO then resumed it’s study of HCQ.

Then on 15th June 2020 the FDA revokes the EUA for the use of HCQ and CQ to treat COVID-19 and referenced the already retracted lanced paper and refers to it as evidence for their decision!  So the FDA reference fraudulent science as evidence to not use a potentially life saving early treatment drug.

A second paper associated with Surgisphere has also been retracted from another peer review journal.

Australia’s TGA used Lancet study as a reason to restrict hydroxychloroquine in Australia

How much damage did these fraudulent study do to the HCQ treatment narrative?

Who else has lost faith in the “authorities”?

Clinical trials appear set-up to fail

Must read overview by Dr Meryl Ness “WHO and UK trials use potentially lethal hydroxychloroquine dose–according to WHO consultant” – HERE

August 13, 2020 – Unbreaking Science: Dr. Meryl Nass on lethal doses used in the HCQ trials – 2400 mg (2.4 mg) of HCQ is a lethal dose. So why did key studies of HCQ use 6 times the normal dose and when 35% increase mortality occur in hospitalized (late-stage) patients did the cease the trial instead of reduce the dose? – WATCH

All HCQ clinical trials designed by “medical experts” focused on late stage COVID-19, contrary to what was experienced in the field.

The key to HCQ’s success is treating the patient early and using the drug in low dose, with zinc.  Yet the international “safety and efficacy” clinical trails were designed to use the drug as a stand alone (without zinc), and in exceedingly high doses plus only in hospitalised patients.  In this setting the virus has finished its replication, and the symptoms have escalated, beyond what the drug could hope to benefit. This is contrary to the way the front line doctors are using the drug, and are achieving a high degree of success.

This is shown when you read the paper from the RECOVERY trial published November 2020 where it states in the discussion “Hydroxychloroquine has been proposed as a treatment for Covid-19 largely on the basis of its in vitro SARS-CoV-2 antiviral activity and on data from observational studies reporting effective reduction in viral loads.”

If these health officials that designed the large scale international clinical trials heard the doctors in the field they would know that the antiviral affects of HCQ have been shown not to be enough when used alone, that it is when used with zinc that the best results are had.

Its almost as though the trials were designed to fail!

The dose rate between therapeutically effective and that of being toxic, is small for chloroquine, and likely too hydroxychloroquine.  In the frail and already sick and weakened hospitalised COVID-19 patients, how would these trial doses of HCQ make them fair?

This graph below shows the relative dose of HCQ between various treatments up to 10 days of use based on the table above.   As you can see the early treatment protocol dosage is within the common Malaria and Arthritis treatment rates, where as two of the trials conducted in sick hospitalised patients were at toxic and possibly lethal doses!

HCQ Key clinical trials list:

• WHO – SOLIDARITY trial protocol
  Published – interim
• Oxford University – the RECOVERY trial
  Published here
• NIH – ORCHID study
  Published here
• Henry Ford Health System HCQ study
  Published here

Compare this to early treatment protocol doses

•  Zelenko Protocol, Out-patient (not hospital) for only moderate to high risk patients – combination treatment zinc, azitromycin + HCC
  (200mg x twice daily for 5-7 days = 400mg in first 24 hrs, cummulative 2000mg – 2800mg in 5 to 7 days respectively, max 400mg/day)

These studies above have been highlighted because these are what the Australian Therapeutic Goods Administration specifically referred to when they claimed the data shows “ no more effective than standard care in treating patients with COVID-19″.  Standard care should start at the GP’s office and not in hospital!  HCQ has performed poorly in clinical trials because it was used too late, in high doses and alone, not as a combination drug treatment.

Further still, based on these late stage clinical trials, the health officials and regulatory agencies deemed all use of HCQ ineffective and potentially dangerous!
If an early treatment was found the pandemic would be over and a vaccine would not be necessary, or at least mandating couldn’t be justified.

Australia’s TGA’s position on HCQ

The TGA claim use restrictions due to supply issues, yet the Palmer Foundation stocked us up in April 2020 with nearly 33 million doses, on top of what we already had in stock.

24 March 2020 – New restrictions on prescribing hydroxychloroquine for COVID-19

26 August 2020 – Amendments to the new restrictions on prescribing hydroxychloroquine for COVID-19

In this amemdment the National COVID-19 Clinical Evidence Taskforce  (NCCET) recommended against the use of hydroxychloroquine for the treatment of COVID-19.

Their media release states: “Taskforce Executive Director, Associate Professor Julian Elliott said the evidence indicates that hydroxychloroquine is potentially harmful and no more effective than standard care in treating patients with COVID-19.”  further “The pooled results show the drug does not reduce mortality, or shorten the amount of time a sick person spends in hospital. It also exposes them to side effects including cardiactoxicity.”

We are more than a year into this pandemic and they have not completed an early combination treatment study with HCQ, zinc and azithromycin or similar broad spectrum antibiotic.  “There are ongoing prevention trials investigating the use of hydroxychloroquine to reduce the risk of contracting COVID-19″ and they’ll get back to us.  Will they be in combination, and why so long?

Update: Dr Fauci’s emails have been sourced under FOI request

Dr Anthony Fauci, head of US NIAID in late May 2021 had about 3,200 of his January to June 2020 emails released under the Freedom of Information Act (FOIA), and they reveal much about what he knew.

On February 29, 2020 he was copied in on a high priority email to the vice president regarding the potential use of the cheap drug hydroxychloroquine to prophylax high risk patients.  The email even quoted the safe use rate of up to 6.5 mg/kg, a rate which Fauci’s NIH clinical trials exceeded, they used a one-dose-fits-all rate, but more importantly they used it in hospitalised patients when it was too late to be effective, and they knew it.

This is important for Australia, because our TGA referenced Fauci’s NIH ORCHID study as a “supporting” reason for them to make a blanket statement to NOT recommend hydroxychloroquine here in Australia even for it’s demonstrated benefit of early use with zinc.

Read Fauci’s email from February 2020

Articles and websites relating to HCQ

Medical Misinformation, Part 1: Hydroxychloroquine, 30 April 2020

NY Doctor Proved Everyone Wrong About Hydroxychloroquine – article by State of the Nation, a retrospective look at Dr Zelenko’s plea for truth

Tracking: HCQ studies for COVID-19: Real-time meta analysis for 245 studies and counting, and CV19-HCQ

WHO SOLIDARITY and UK RECOVERY trials use potentially lethal hydroxychloroquine dose, article by Meryl Nass, MD

COVID-19 and Coronavirus Resource Center

Countries in RED: DO NOT use or have LIMITED use of HCQ

More from Dr Zelenko and other doctors on HCQ

For the record.

April 2021 Part 1 of 4

Part 2 of 4
Part 3 of 4
Part 4 of 4

Interview with Dr Mercola

July 16, 2021

Dr Zelenko Interviewed by the Corona Investigation Committee

July 22, 2021

https://youtube.com/watch?v=XO4BmDEE8zw%3Fstart%3D18252

Corona Investigation committee interview – Session 62 Watch @4:45:50

Dr Zelenko nominated for the Presidential Medal of Freedom & Nobel Prize

August 2021

August 14, 2021 – Stew Peters: Dr. Zev Zelenko SLAYS Globalists, Exposes “Global Genocidal Event” – WATCH,

September 2, 2021 – Stew Peters: Dr. Zev Zelenko COVID Genocide “Very Nefarious, Sinister Purpose” WATCH

Dr Zelenko exposes how Dr Rick Bright (BARDA) sabotaged early COVID-19 treatment with HCQ, killing masses

September 2021 – Dr Zelenko exposes how Dr Rick Bright’s Very Bad move sabotaged early Covid treatment killing masses – WATCH

Hydroxychloroquine data points in reverse chronological order

Note this timeline is not complete and only started in this format approx 202. It continues to be updated.

2024

September 24, 2024 – PLOS Medicine: Evaluation of hydroxychloroquine or chloroquine for the prevention of COVID-19 (COPCOV): A double-blind, randomised, placebo-controlled trial – Schilling et al – READ, Craig Kelly – CREDIT, University of Oxford ClinicalTrials.gov NCT04303507

• “In this large placebo-controlled, double-blind randomised trial, HCQ and CQ were safe and well tolerated in COVID-19 chemoprevention, and there was evidence of moderate protective benefit in a meta-analysis including this trial and similar RCTs. ….. they [Hydroxychloroquine & Chloroquine] could have been deployed with benefit earlier, and they might have value in future pandemics…

September 9, 2024 – Brownstone Institute: Trump’s 63 Million Doses of Hydroxychloroquine Could Have Been Great for America by David Gortler, Pharm. D – READ

• Dr Robert Malone: What Happened to Trump’s 63 Million Doses of Hydroxychloroquine? – CREDIT

June 4, 2024 – Gateway Pundit: KILLER FAUCI: On March 16, 2020, Dr. Fauci Received Email Cheering Hydroxychloroquine Treatment of COVID in China – 4 Days Later He Publicly Rebuked President Trump at WH Presser For Suggesting It a Valid COVID Treatment – READ

March 31, 2024 – Meryl Nass: “How a false hydroxychloroquine narrative was created, and more”–republishing because we must never forget this evidence of a terrible crime – our-de-force paper on the 50+ ways HCQ was suppressed during 2020 – READ

March 26, 2024 – Broken Truth: Didier Raoult Francesoir Interview – Woodcock and Q Fever Treatment – WATCH, An explosive interview with Dr Didier Raoult reveals a possible motive behind the FDA acting commissioner’s refusal to discuss Coxiella Burnetti. READ

February 20, 2024 – Broken Truth presents documentary: Epidemic of Fraud – the coverup story of hydroxychloroquine – WATCH, READ, Press READ

February 2024 – Biomedicine & Pharmacotherapy: Deaths induced by compassionate use of hydroxychloroquine during the first COVID-19 wave: an estimate by Pradelle et al – READ

• The Latest Attempts to Discredit Hydroxychloroquine as a Treatment for COVID-19 – READ

I challenge the authors of this study to send me 1 out of the supposed 17000 people who died from HCQ…

We are all tired of Egocentric maniacs running our lives and allowing articles like this one with a conclusion that says “ Although our “estimates are limited by their imprecision” Who in their right mind published a conclusion like this? I give this paper a ZERO.

Dr Sabine Hazen

January 16, 2024 – Meryl Nass Substack: Here is the evidence (from 2004-2014) that our governments tried to kill us by restricting HCQ. WHY? Hydroxychloroquine doesn’t kill people unless you overdose. But it does kill coronaviruses.
This is critically important evidence that our governments deliberately harmed us by suppressing this drug. – READ

January 4, 2024 – Politico: Hydroxychloroquine could have caused 17,000 deaths during Covid, study finds – ARCHIVE, CREDIT

• “Nearly 17,000 people may have died after taking hydroxycholoroquine during the first wave of Covid-19, according to a study by French researchers.” – [Another HCQ “study” retracted[
• RETRACTED Biomedicine & Pharmacotherapy: Deaths induced by compassionate use of hydroxychloroquine during the first COVID-19 wave: An estimate by Pradelle et al – READ, ARCHIVE, RETRACTED – READ

2023

December 15, 2023 – Bannons War Room: Episode 3251: Censorship In Peer Review Journals w/ Dr Steven Hatfill – a COVID-19 pandemic advisor to the Trump Administration – WATCH, EXCERPT

• December 2023 – Journal of American Physicians and Surgeions: The COVID Debacle: Merging Criminal Law and Medical Science for Accountability by Steven Hatfill – READ, PDF, EXCERPT
• Robert Kadlac helped acquire 62 million doses of hydroxychloroquine, FDA’s Janet Woodcock thwarted it’s use – EXCERPT
• mRNA vaccines should not have happened because there were safe early treatment options – EXCERPT

November 3, 2023 – Epoch Times: Hydroxychloroquine Associated With Lower COVID-19 Mortality: Study – The French study included 30,202 patients – READ, Vigilant Fox – CREDIT

• People who received hydroxychloroquine were less likely to die than those who did not – 0.8% vs 4.8%

“This study represents the largest single-center study evaluating HCQ-AZ in the treatment of COVID-19. Similarly, to other large observational studies, it concludes that HCQ would have saved lives,”

Dr. Didier Raoult

September 24, 2023 – Gateway Pundit: Mayo Clinic Website Now Says Hydroxychloroquine CAN Be Used to Treat COVID-19 Patients, Previously Claimed It Was Not Effective – READ

• May Sep 2023: “Hydroxychloroquine may be used to treat coronavirus (COVID-19) in certain hospitalized patients.” – ARCHIVE,
  • The webpage was deleted in 2 days – HERE, but has been live since 2014! – ARCHIVES

• Mayo Oct 2021: “Using this medicine alone or with other medicines (eg, azithromycin) may increase your risk of heart rhythm problems (eg, QT prolongation, ventricular fibrillation, ventricular tachycardia). Hydroxychloroquine should only be used for COVID-19 in a hospital or during clinical trials. Do not take any medicine that contains hydroxychloroquine unless prescribed by your doctor“.- ARCHIVE, Also READ

July 27, 2023 – Meryl Nass Substack: Treating COVID-19 in 2023 and update on HCQ & Ivermectin – READ

April 4, 2023 – Pre Print: Early Treatment with Hydroxychloroquine and Azithromycin: A ‘Real-Life’ Monocentric Retrospective Cohort Study of 30,423 COVID-19 Patients – Million & Didier Raoult et al – READ

• “retrospective study from France (30,000+ patients) has found that HCQ + Azithromycin was REDUCING DEATHS by 71% when given early and by 45% when given in hospital – before they banned it” CREDIT SpeedOfScience in comments

March 15, 2023 – United Australia Party (UAP) hosts Australian Covid Vaccines & Effects Tour – Clive Palmer introduction and speaks about his HCQ donation to Australia – WATCH, Palmer’s HCQ donation to Australia – TIMELINE

2022

2021

June 13, 2021 – Hydroxychloroquine: Just the facts and a Follow the Money investigation by Sharyl Attkisson – READ

• “…two new studies that show the inexpensive drug works. A new study in MedRxiv found that hydroxychloroquine and zinc increased Covid-19 survival by almost three times. And a recent study published in the Journal of The Association of Physicians of India also found hydroxychloroquine is an effective treatment for Covid-19.”

June 10, 2021 – The US Sun: Hydroxychloroquine drug touted by Trump as Covid treatment can increase survival rates by 200%, study finds – READ

June 10, 2021 – Fox News | Ingraham Angle: Ingraham: Fauci ‘routinely’ acted against science – “Study: 100K lives could have been saved” with using HCQ – WATCH, FULL

June 9, 2021 – The Washington Times: Follow the money: Big Pharma, Dr. Fauci and the death of hydroxychloroquine – The $2.45 million Gilead spent in the first quarter of 2020 lobbying the federal government was well spent – READ

• “HCQ is cheap (costing under $10 for the course of a COVID-19 treatment), well-understood by physicians having been prescribed for more than 80 years, and can be taken orally. Yet, Dr. Anthony Fauci and others at the National Health Institute of Allergy and Infectious Diseases preferred remdesivir, a proprietary, intravenous drug manufactured by Gilead Sciences, costing about $3,500 per treatment, with unknown side effects.”

June 1, 2021 – Fox News | The Ingraham Angle – Dr Stephen Smith, Fauci on variants nad Dr Scott Atlas – ARCHIVE, We could have saved 100K lives – EXCERPT

April 13, 2021 – Rounding the Earth w/ Mathew Crawford: How to Rig Research: Surgisphere Part I – READ

A lot of the observations that took Surgisphere down were me emailing other people, or writing in forums, under names other than my own.

Mathew Crawford – REF

February 26, 2021 – The Lancet: Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial – Johnson et al – READ [NO ZINC?, ], Clinical Trial # NCT04354428 – READ, trial HISTORY

• “The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator….”
• “placebo” was vitamin C (1000mg/day1, then 500mg/day) and folic acid – so not inert placebo! -clinical trial – ARCHIVE
• HCQ 400 mg orally twice on Day 1 [800mg total], followed by 200 mg orally twice daily [400mg/day] ( for an additional 9 days

February 22, 2021 – The Guardian: Melbourne doctors under review for promoting discredited Covid treatment – Covid Medical Network doctors – READ,

• References peer reviewd paper in Reviews in Cardiovascular Medicine: Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19) by McCullough et al – ARCHIVE, READ

2020

December 30, 2020 – Reviews in Cardiovascular Medicine: Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-CoV-2 infection (COVID-19) by McCullough et al – ARCHIVE, READ (and image source)

December 20, 2020 – Taiwan News: Pharmaceutical factory on fire after explosion: 2 injured – makers of HCQ precursor – READ, worlds second largest HCQ supplier – SOURCE

• “Liberty Times reported that the factory produces hydroxychloroquine APIs, and is the world’s second largest HCQ raw material supplier.“

December 2020 – International Journal of Antimicrobial Agents: COVID-19 outpatients: early risk-stratified treatment with zinc plus low-dose hydroxychloroquine and azithromycin: a retrospective case series study – by Derwand, Zelenko et al – READ, TWEET

October 1, 2020 – The Scientist: The Surgisphere Scandal: What Went Wrong? – READ, CREDIT

August 30, 2020 – COVID-19 Real-Time Learning Network (sponsored by CDC grant): Hydroxychloroquine – information for doctors, links to “evidence” – ARCHIVE

• Explore the many references to clinical trials in HOSPITAL settings
• “One RCT suggests increased risk of QT prolongation among patients treated with HCQ+AZ compared to those not receiving HCQ” still hospitalised – July 23, 2020 – READ

July 2, 2020: Science: One U.K. trial is transforming COVID-19 treatment. Why haven’t others delivered more results? – trial design (hospital use in large doses) rules out HCQ by authorities – READ

June 17, 2020 – WHO: World Health Organization announces it was dropping hydroxychloroquine from the Solidarity trial – REF

• “Update (June 18): The World Health Organization announced yesterday that it was dropping hydroxychloroquine from the Solidarity trial after new data suggest the drug is ineffective as a COVID-19 treatment or prophylaxis.” – REF

June 17, 2020 – CNN: US stockpile stuck with 63 million doses of hydroxychloroquine …now that the US Food and Drug Administration has revoked permission for the drug to be distributed to treat coronavirus patients – READ, CREDIT

June 15, 2020 – CNN: FDA revokes authorization of drug Trump touted – ARCHIVE

• “Doctors can continue to legally prescribe the drugs off-label, as they can with any drug that’s approved for other conditions. The FDA’s emergency use authorization for hydroxychloroquine and chloroquine was narrow in scope, applying only to hospitalized Covid-19 patients and only to drugs donated to the Strategic National Stockpile.” !

June 15, 2020 – FDA: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems – Does not affect FDA-approved uses for malaria, lupus, and rheumatoid arthritis [!!!] – READ, CNN- CREDIT

• FDA July 1, 2020 Update: “A summary of the FDA review of safety issues with the use of hydroxychloroquine and chloroquine to treat hospitalized patients with COVID-19 is now available.” – PDF

June 15, 2020 – FDA LETTER from Denise M. Hinton, Chief Scientists FDA to Gary Disbrow, Deputy Assistant Secretary of BARDA – PDF, ARCHIVE, CNN – CREDIT

• This letter in response to BARDA requesting the FDA “revoke the Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be distributed from the Strategic National Stockpile (SNS) issued on March 28, 2020”
• Letter has “Attachment: Memorandum Explaining Basis for Revocation of Emergency Use Authorization for Emergency Use of Chloroquine Phosphate and Hydroxychloroquine Sulfate”

June 15, 2020 – FDA: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine [but the product is still licensed!]- READ, ARCHIVE, FDA letter – PDF, Wired – ARTICLE

• “…the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.” – off-label use (which is legal) does not require EUA for a licensed product!
• “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use. This is the statutory standard for issuance of an EUA.”
• The Emergency Use Authorization (EUA) for HCQ was issued on March 28, 2020
• “Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks.”
• CNN: FDA revokes authorization of drug Trump touted – ARCHIVE

June 13, 2020 – The Lancet | Comment: Expression of concern: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis – by The Lancet Editors – READ

• To “alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information.”

June 8, 2020 – Science: Who’s to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal – Author partnership on coronavirus papers is “completely bizarre” and should have been a red flag, former journal editor says – READ (presents overview of authors) – Regading the RETRACTED Lancet Study

• Mehra “provided the kind of gravitas that can fast-track papers to leading journals.”
• Amit Patel (co-author) had introduced Mehra to Sapan Desai, a vascular surgeon and founder of Surgisphere, the tiny company that supplied the data.
• Mehra received compensation from Triple-Gene [3GTx.com], a gene therapy company Patel co-founded [and Clinical Director] to develop cardiovascular treatments.
  • “Triple-Gene LLC is a clinical stage cardiovascular gene therapy company and majority owned subsidiary of Precigen Inc. (NASDAQ: PGEN).” – REF

June 7, 2020 – STAT News: Researcher involved in retracted Lancet study has faculty appointment terminated, as details in scandal emerge – READ, Amit Patel – TWEET, The only author to be “punished” – CREDIT

• University of Utah has “mutually agreed” to terminate the [unpaid adjunct appointment with the Department of Biomedical Engineering] faculty appointment of Amit Patel,..who appears to have played a key role in involving a little-known company that has ignited a firestorm of controversy.”

June 5, 2020 – Oxford University RECOVERY Trial: PRESS Statement from the Chief Investigators of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial on hydroxychloroquine : No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19 – READ, This statement was used by WHO to help justify shutting down HCQ – CREDIT

• “‘On Thursday 4 June, in response to a request from the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the independent Data Monitoring Committee conducted a further review of the data. Last night, the Committee recommended the chief investigators review the unblinded data on the hydroxychloroquine arm of the trial.
• ‘We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalised with COVID-19. We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY Trial with immediate effect. We are now releasing the preliminary results as they have important implications for patient care and public health. “
• Trial primary endpoint was 28-day mortality for hospitalised COVID-19 patients. “There was also no evidence of beneficial effects on hospital stay duration or other outcomes.”…‘These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalised with COVID-19″

‘Hydroxychloroquine and chloroquine have received a lot of attention and have been used very widely to treat COVID patients despite the absence of any good evidence. The RECOVERY Trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalised with COVID-19. Although it is disappointing that this treatment has been shown to be ineffective, it does allow us to focus care and research on more promising drugs.” [remdesivir?]

Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, and Chief Investigator for the RECOVERY HCQ trial

June 4, 2020 – MedScape: Two Journals Retract Studies on HCQ, Heart Disease in COVID-19 – READ, TIMELINE

• “The Lancet announced today [June 4, 2020] that it has retracted a highly cited study that suggested hydroxychloroquine may cause more harm than benefit in patients with COVID-19. Hours later, the New England Journal of Medicine announced that it had retracted a second article by some of the same authors, also on heart disease and COVID-19.”

June 4, 2020 – NY Times: Two Huge Covid-19 Studies Are Retracted After Scientists Sound Alarms -The reports, published in two leading journals, were retracted after authors could not verify an enormous database of medical records – READ (Hydroxychloroquine is not mentioned in the title, read down to find it!), Med City News – READ

• “Both studies were led by a professor at Harvard, and both depended on a huge international database of patient medical records that few experts had ever heard of.”
• “On Wednesday, after the journals [NEJM & The Lancet] noted concerns about the studies, the World Health Organization announced that it would resume trials of the medications”!

“It is now clear to me that in my hope to contribute to this research during a time of great need, I did not do enough to ensure that the data source was appropriate for this use…For that, and for all the disruptions — both directly and indirectly — I am truly sorry.”

Dr. Mandeep Mehra, lead author of the two studies, said in a statement to The New York Times.

June 4, 2020 – The Guardian: Surgisphere: governments and WHO changed Covid-19 policy based on suspect data from tiny US company – READ

• “Surgisphere, whose employees appear to include a sci-fi writer and adult content model, provided database behind Lancet and New England Journal of Medicine hydroxychloroquine studies”

June 4, 2020 – Med City News: Randomized trial shows hydroxychloroquine doesn’t prevent Covid-19 as questions arise about earlier study – A randomized, placebo-controlled trial published in NEJM found the malaria drug was not effective as a post-exposure prophylaxis against coronavirus disease. However, questions have arisen about data used in a large observational study about the drug published last month – READ

• Uni Minnesota trial “data showed that 11.8% of participants who received hydroxychloroquine developed Covid-19, compared with 14.3% who received a vitamin pill as a placebo….the result did not reach statistical significance…there is no way to rule out whether the result was due to chance alone.” Thus it was concluded no difference.
• Note COVID-19 was self reported by patient and not PCR confirmed [as far as I can tell] the trial objective was to “to prevent disease” i.e. any symptoms, not hospitalisation or death!
• “The study provides the most definitive evidence yet that hydroxychloroquine is not effective against Covid-19.”

June 3, 2020 – University of Minnesota: University of Minnesota Trial Shows Hydroxychloroquine Has No Benefit Over Placebo in Preventing COVID-19 – READ, ARCHIVE, CREDIT, Trial used by WHO to stop HCQ – REF

• June 3, 2020 – NEJM: A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19 – Boulware et al – READ, Clinical Trial NCT04308668 – READ [No PCR confirmatory testing done, huge doses used]
  • “We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis….We enrolled 821 asymptomatic participants”
  • Treatment dose “hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days)” [High dose rate and without zinc, contrary to those finding success]. “The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.”
  • “The incidence of new illness compatible with Covid-19 did not differ significantly between participants…” [So they DIDN’T PCR test to confirm that an “illness” was COVID-19???] BUT
• “40% of trial participants taking hydroxychloroquine developed non-serious side effects — predominantly nausea, upset stomach or diarrhea.” [Maybe because to the excessive dosage they prescribed!! Normal dose 200-400mg/day, they gave a huge dose of 1400mg on day 1, and 3 times normal daily dose (200mg) on days 2-5]
• “However, the trial [even with excessive doses] found no serious side effects or cardiac complications from taking hydroxychloroquine”
• The WHO use this Boulware et al study to further justify dropping HCQ from their clinical trials because” the study found “the drug did not prevent people exposed to SARS-CoV-2 from becoming sick” [yet the study looked at COVID-19 (self assessed symptoms) not SARS-CoV-2 (the virus, which would require PCR confirmatory testing)] – The Scientist – REF

May 30, 2020 – The Scientist: Disputed Hydroxychloroquine Study Brings Scrutiny to Surgisphere – READ, CREDIT

• “Scientists have raised questions about the dataset published in The Lancet last week that triggered the suspension of clinical trials around the world—and about Surgisphere Corporation, the company behind the study.”

May 28, 2020 – The Guaridan: Questions raised over hydroxychloroquine study which caused WHO to halt trials for Covid-19 – Exclusive: Australian researchers query origin of data used for Lancet study, but stress there is no evidence drug is a safe or effective treatment – READ

May 28, 2020 – Zenodo: An open letter to Mehra et al and The Lancet (Richard Horton (editor) – Concerns regarding the statistical analysis and data integrity – by James Watson on behalf of 201 signatories – READ, PDF, CREDIT

• “This impact has led many researchers around the world to scrutinize in detail the [Lancet] publication in question. This scrutiny has raised both methodological and data integrity concerns.” – 10 concerns listed

May 27, 2020 – CNN: Fauci: Science shows hydroxychloroquine is not effective as a coronavirus treatment – ARCHIVE

“The scientific data is really quite evident now about the lack of efficacy for it,”…[ there’s likelihood of] “adverse events with regard to cardiovascular.”

Dr Anthony Fauci told CNN’s Jim Sciutto on “Newsroom”

• “Fauci.. is the first Trump administration official to say the drug is not effective in treating the virus based on scientific data.” [in hospitalised patients, not where the drug is being used by frontline doctors!]

May 27, 2020 – CNN: France halts use of hydroxychloroquine on Covid-19 patients – READ

• “French Health Ministry revoked its authorization for the drug to be given to those with coronavirus…suggest a link between the use of hydroxychloroquine and “cardiac toxicity,” particularly when used in combination with the azithromycin…”
• “Some context: The announcement comes after the World Health Organization (WHO) on Monday said it had temporarily halted the study of hydroxychloroquine as a potential Covid-19 treatment in its Solidarity Trial, due to safety concerns” [Based on The Lancet, soon-after RETRACTED fraudulent paper]

Our data has very convincingly shown that across the world in a real-world population that this drug combination, whichever way you slice it or dice it, does not show any evidence of benefit, and in fact is immutably showing a signal of grave harm

Dr. Mandeep Mehra, CNN passed this off as a direct quote – REF, more powerful than that quoted by TIME –HERE (See May 22, 2020)

May 27, 2020 – The Scientist: WHO Halts Hydroxychloroquine Testing Over Safety Concerns – based on The Lancet study – READ,

May 26, 2020 – The Guardian: Australian hydroxychloroquine trial to treat Covid-19 under review after WHO safety concern – READ

• “The AustralaSian Covid-19 trial (Ascot) has been recruiting patients in more than 70 hospitals in every state and territory, and 11 hospitals in New Zealand.”
• “Meanwhile, the Therapeutic Goods Administration granted former federal politician Clive Palmer a contract to import 1m doses of the drug [hydroxychloroquine] to add to the national medical stockpile.”

May 26, 2020 – The Guaridian: WHO halts hydroxychloroquine trial for coronavirus amid safety fears- READ

May 25, 2020 – Medical News: Zero benefit of Hydroxychloroquine or Chloroquine in COVID-19, says extensive study – READ

May 25, 2020 – CNN: WHO temporarily pauses hydroxychloroquine study due to safety concerns – READ

• WHO Director-General Tedros Adhanom Ghebreyesus said during a media briefing in Geneva – the decision was made after The Lancet observational study was published where the “authors reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate”

May 25, 2020 – WHO Director-General’s opening remarks at the media briefing on COVID-19 – 25 May 2020 – READ, ARCHIVE

• “The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the data is reviewed by the Data Safety Monitoring Board.”…”I wish to reiterate that these drugs [HCQ & CQ] are accepted as generally safe for use in patients with autoimmune diseases or malaria”

May 22, 2020 – CNN: Sales of drug touted by Trump have been soaring – READ,

• “Amid the growing public attention on the medication, its sales doubled from March 2019 to more than $50 million in March [2020]”
• Following FDA’s “caution”…more than 830,000 prescriptions for the drug were filled for the generic and name-brand version of the drug, Plaquenil, in March – up from roughly 460,000 prescriptions written during the same time last year….The IQVIA data did not yet include April figures and did not capture prescriptions administered to patients in nursing homes through long-term care pharmacies or at hospitals.”
• FDA aware of reports of “serious heart-related adverse events and death in patients with COVID-19” taking HCQ or CQ. [Why are all the arthritis (adults and children up to 400mg/day) and malaria (400mg/week) patients taking the drug on a daily basis, not suffring the same alleged concern?]

May 22, 2020 – Forbes: All The Times Trump Has Promoted Hydroxychloroquine – A TIMELINE- (NOTE this article references The Lancet study, but they’ve not updated their article since then to reflect the The Lancet RETRACTED that fraudulent paper) – READ, ARCHIVE

May 22, 2020 – Time Magazine: Large Study Finds No Benefit — and Potential Harm — in Using Hydroxychloroquine for COVID-19 – ARCHIVE, MD Edge – READ,

• “…scientists in the U.S. and Switzerland report on an analysis of more than 96,000 people hospitalized with confirmed COVID-19 in 671 hospitals on six continents. Nearly 15,000 patients were treated…”
• ““However we sliced and diced the data, the results were identical,” says Dr. Mandeep Mehra, chair of cardiovascular medicine at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, who led the study. “There was no evidence of benefit, and a consistent signal of harm — and in particular, harm linked to heart rhythm disturbances.”…“Why would you risk harm when there is so much consistent data showing lack of benefit [with hydroxychloroquine]?”
• “In fact, as the evidence continues to suggest that hydroxychloroquine may not provide much benefit, and instead might increase the risk of harm to the heart, Mehra says doctors may shift from considering hydroxychloroquine to other drugs being studied as COVID-19 treatments, like remdesivir. Studies indicate that remdesivir, an antiviral that has not yet been approved to treat any disease, may help people with COVID-19 to recover faster..”

May 22, 2020 – The Lancet: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis by Prof Mandeep Mehra (Brigham and Women’s Hospital & Harvard), Sapan Desai (founder and chief executive of Surgisphere Corporation, Chicago, IL, USA) et al – ARCHIVE, now RETRACTED – READ, Brigham’s PRESS RELEASE – READ

“However we sliced and diced the data, the results were identical,… “There was no evidence of benefit, and a consistent signal of harm — and in particular, harm linked to heart rhythm disturbances.””

Dr. Mandeep Mehra, chair of cardiovascular medicine at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, who led the study

• “The data [a mammoth private database of patient medical records] came from a company called Surgisphere, which claims to have granular patient-level information shared by 1,200 hospitals and health facilities on six continents.” – REF
• “Critics were quick to point out anomalies in both pieces of research, including implausible findings that should have been detected during the peer review process — like the registry’s apparent inclusion of a large number of Covid-19 cases very early on in the pandemic, even in Africa, where few hospitals have electronic health records….Many researchers were astonished to find out that such a database could exist, or that the gathering and analysis of tens of thousands of medical records on multiple continents could have been carried out so quickly.” – REF
• “Dr. Desai vigorously defended the Surgisphere database, saying that he was “all for transparency” but was bound to secrecy by contractual agreements with the hundreds of hospitals that are his clients, and therefore could not show anyone the raw data from his registry..”…”until February, [2020, Desai] worked as a vascular surgeon at Northwest Community Hospital in Arlington Heights, Ill.” – REF
• June 8, 2020 – Science: Who’s to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal -Author partnership on coronavirus papers is “completely bizarre” and should have been a red flag, former journal editor says – READ

May 19, 2020 – FDA: Pharmacovigilance Memorandum for Hydroxychloroquine and Chloroquine for All adverse events in the setting of COVID-19 from the FDA Adverse Event Reporting System (FAERS) – PDF, an “uncharacteristically brief 15-page safety review memorandum of HCQ” – CREDIT

• Brownstone: “a methodologically questionable report criticizing HCQ’s safety. The FDA’s narrative was based on preliminary and time-compartmentalized findings, and not a reflection of historical safety or based on the appropriate clinical use of HCQ dosing, prescribing, timing, and duration. The FDA then seemed to label its findings as conclusive, figuratively slamming the door shut on the consideration of new findings.” – REF
• “According to its uncharacteristically brief 15-page safety review memorandum of HCQ published on May 19, 2020, the FDA considered data from the National Poison Data System (NPDS) which means it seems to have included the use of non-pharmaceutical-grade and/or self-administered HCQ and/or overdose data in its clinical evaluation. “
• “…Table 6 only contained around 256 applicable adverse event reports [possibly associated with HCQ/CQ] over a five-month period in the entire world when administered for Covid-19″ With doses “anywhere from 2x to 6x the recommended maximum maintenance dose of HCQ for any clinical indication per FDA and manufacturer’s dosing recommendations.” Also “it did not appear to investigate or report patient weights”
• “92 of the 109 serious cardiac cases (84%) reported concomitant use of at least one other medication that prolongs the QT interval.”…”In other words, the FDA included well-known, clinically unsound, long-established, drug-drug interactions, contraindicated uses, and/or prescribing errors in denigrating HCQ’s safety.”
• And so many more oversights by this FDA’s report – REF

May 19, 2020 – CNN: Trump says he is taking hydroxychloroquine though health experts question its effectiveness – ARCHIVE

• Trump consulted his Whitehouse doctor
• “The admission was a dramatic development in Trump’s attempts to promote hydroxychloroquine as a treatment for coronavirus, which began earlier in the outbreak and has been met with resistance from medical professionals”

May 18, 2020 – Med City News: Report: VA still using hydroxychloroquine for Covid-19; mounting data indicate no effect …Meanwhile, two large studies from hospitals in the New York City area indicated that the drug did not improve rates of mortality among hospitalized patient – READ

May 16, 2020 – AP: VA says it won’t stop use of unproven drug on vets for now – READ, CREDIT

May 14, 2020 – The Guardian: Drug imported for Covid-19 trials won’t be given to Australians who need it for other conditions – Clive Palmer bought millions of doses of hydroxychloroquine – READ, Palmer Foundation – READ

• 33 million doses of hydroxichloroquine imported by Palmer and made freely available to Australias national stockpile – TIMELINE
• Clive Palmer’s donation – WATCH, he tells his story 2024 – WATCH

May 11, 2020 – Politico: Hydroxychloroquine shows no benefit against coronavirus in N.Y. study – READ, CNN – ARCHIVE, The JAMA STUDY

• “University at Albany looked at 1,438 patients with coronavirus who were admitted to 25 New York City area hospitals.” [Not pre-hospitalisation!]
• HCQ+azithromycin “…the patients who took the drug combination were more than twice as likely to suffer cardiac arrest during the course of the study. Heart issues are a known side effect of hydroxychloroquine.”

May 11, 2020 – JAMA: Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State by Rosenberg et al – PAPER, READ

May 7, 2020 – NEJM: Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19 – Geleris et al – READ, Large study finds no benefit from hydroxychloroquine in Covid-19- CREDIT

• Study in New York-Presbyterian Hospital—Columbia University Irving Medical Center, – Of 1446 consecutive patients, 70 patients were intubated, died, or discharged within 24 hours after presentation and were excluded from the analysis.
• Hydroxychloroquine dose – 600mg twice on day 1 (total 1200mg), then 400 mg daily for a median of 5 days. Started 24-48 hrs upon admittance to hospital. “Hydroxychloroquine-treated patients were more severely ill at baseline than those who did not receive hydroxychloroquine”

May 6, 2020 – Med City News: The eye-popping allegations in ousted BARDA Director Rick Bright’s whistleblower complaint – READ

• “In the complaint, Bright alleges that he faced retaliation after resisting efforts to promote broad use of hydroxychloroquine and chloroquine on the basis of their safety problems and lack of scientific support for such use…”
• April 23, 2020 – Ex-BARDA director says he was ousted for questioning hydroxychloroquine for Covid-19 – READ

May 5, 2020 – Washington Post: Ousted vaccine official alleges he was demoted for prioritizing ‘science and safety’ – Rick Bright says in a whistleblower complaint that he resisted pressure from HHS leaders to make ‘potentially harmful’ antimalarial drugs more widely available – READ, COMPLAINT

• Biomedical Advanced Research and Development Authority (BARDA) Director Rick Bright alleged he was demoted due to his resistance to Trump’s promotion of the unproven drug

May 1, 2020 – FDA issued EUA for the patented, more expensive competitor drug remdesivir – REF

April 30, 2020 – The Highwire Ep 161: CORONAVIRUS: A NATION DIVIDED – segment on Chloroquine vs. Remdesivir – WATCH, FULL

April 28, 2020 – James Todaro MD on Twitter: The Italian Society of Rheumatology studied 65,000 patients on longterm hydroxychloroquine for RA and Lupus. – Only 20 patients tested positive for COVID-19, No ICU, no deaths – This is a 90% reduction in infection rate compared to the rest of Italy – No Archive, READ, Gateway Pundit – READ The Highwire – WATCH

April 28, 2020 The Italian – ARTICLE

• “primary care doctors and general practitioners contacted during this research, many have admitted – under their breath – to use the drug [hydroxychloroquine] as a “prophylaxis”, …Health professionals who are in close contact with contagious patients take the drug in advance, precisely to decrease the probability of contracting the infection.”
• Italian Society of Rheumatology (SIR) questioned 1,200 rheumatologists throughout Italy to collect statistics on infections. Out of 65,000 chronic rheumatoid patients (Lupus and Rheumatoid Arthritis), who systematically take Plaquenil / hydroxychloroquine, only 20 patients tested positive for the virus. Nobody died, nobody is in intensive care, according to the data collected so far.

April 28, 2020 – Fox News: Ingraham Angle: Infectious disease expert slams study that panned hydroxychloroquine as COVID-19 treatment: ‘It’s a sham‘ – WATCH

• Dr. Stephen Smith – the study published last week indicating the antimalarial drug hydroxychloroquine showed no benefit [and potentially harmful] for coronavirus patients in U.S. veterans hospitals was a “sham.” [the VA STUDY]
• A New study by French doctor Didier Raoult show correct way to use HCQ

April 24, 2020 – PRESS RELEASE: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trail due to risk of heart rhythm problems – Does not affect FDA-approved used for malaria, lupus and rheumatoid arthritis – READ, ARCHIVE, The Highwire – WATCH

April 22, 2020 – Fox News: COVID-19 treatment hydroxychloroquine showed no benefit, more deaths in VA virus study – READ (see paper below)

April 21, 2020 – University of Melbourne: Clinical trial into two potential COVID-19 treatments commences – AustralaSian COVID-19 Trial (ASCOT) – READ, CREDIT

• “Laboratory tests have shown that lopinavir/ritonavir, which is currently used to treat HIV, and hydroxychloroquine, used to treat arthritis and prevent and treat malaria, can stop SARS-CoV-2, the virus that causes COVID-19, in its tracks.”
• “A clinical trial aimed at testing the effectiveness and safety of two existing drugs in patients hospitalised with COVID-19 has opened at the first site, the Royal Melbourne Hospital.
• “The aim of ASCOT is to test whether using these drugs will prevent patients deteriorating to the point of needing a ventilator in the intensive care unit (ICU),” said Associate Professor Steven Tong

April 21, 2020 – PrePrint : Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19 by Magagnoli et al – READ, PDF , The Highwire – WATCH

• This was NOT a randomised study, and had other flaws such administering the drug to only the severely ill and those ventilated – too late to be effective, yet they concluded it increased mortality!
• The dosages for either drug are NOT even listed!
• 31% of the “control” group received azithromycin!
• Dr Stephen Smith calls this study “a sham”!
• Pharma-backed mainstream media picked up on this studies “conclusions” and used it to disqualify HCQ as a treatment, and the unsuspecting public, and healthcare community simply believe them

April 17, 2020 – Int J of Antimicrobial Agents: Can post-exposure prophylaxis for COVID-19 be considered as one of outbreak response strategies in long-term care hospitals? by Lee et al – READ
Post-exposure prophylaxis using hydroxychloroquine was provided to 211 persons, Disease development was successfully prevented without severe adverse events.

April 2, 2020 – Fox News | Ingraham Angle: Dr. Stephen Smith on effectiveness of hydroxychloroquine: ‘I think this is the beginning of the end of the pandemic’ – WATCH

March 31, 2020 – Washington Post: FDA authorizes widespread use of unproven drugs to treat coronavirus, saying possible benefit outweighs risk – READ

March 30, 2020: KHN: FDA Approves Emergency Use Of Malaria Drug Trump Touted Despite Scant Evidence That It Works – READ, and this on March 27 – HERE

March 29, 2020 – HHS: HHS accepts donations of medicine to Strategic National Stockpile as possible treatments for COVID-19 patients – 30 million doses of hydroxychloroquine sulfate donated by Sandoz and and one million doses donated by Bayer Pharmaceuticals – ARCHIVE

March 28, 2020 – The Register: Remember that clinical trial, promoted by President Trump, of a possible COVID-19 cure? So, so, so many questions… – Scientists pull coronavirus treatment study apart after rushed publication – ARCHIVE

March 28, 2020 – LA Times: Doctors and experts warn of the risks of using malaria drugs to treat COVID-19 – heart rhythm QT interval – READ, what is QT interval – READ

• “An article published this week in the Mayo Clinic Proceedings warns that both drugs could prompt dangerous and potentially deadly heart arrhythmias in the 3 million people worldwide who have a congenital cardiac condition — called long QT syndrome — that can cause the heart to beat erratically and lead to sudden death.” – Mayo Clinic preprint – PDF, Long QT syndrome – READ
• [Yet it’s ok to take for malaria!]

March 27, 2020 – Gateway Pundit: HUGE! Second French Study by Dr. Raoult finds Hydroxychloroquine and Azithromycin Helped EVERY PATIENT in Study Group of 80 Minus One – READ

March 27, 2020 – Fox News | The Ingraham Angle: Dr. Stephen Smith on effectiveness of hydroxychloroquine: ‘I think this is the beginning of the end of the pandemic’ – with Dr. Stephen Smith & Dr. Amesh Adalja – TRANSCRIPT

March 26, 2020: Newsday: Cuomo limits prescriptions for two drugs to active virus cases – READ, Dr Oz lift ban – READ

• An executive order issued by Gov. Andrew Cuomo limits prescriptions of hydroxychloroquine and chloroquine to only COVID-19 patients in state-approved clinical trials…

March 25, 2020 – Tech Startups: Doctor Vladimir Zelenko: I treated 350 coronavirus patients with 100% success using Hydroxychloroquine Sulfate – READ, Mar. 28, 2020 that number rose to 699 – READ

March 24, 2020 – FDA Drug Safety Communication on Hydroxychloroquine begins – READ

• FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems – PDF

March 24, 2020 – NBC News: Man dies after taking chloroquine in an attempt to prevent coronavirus – A husband and wife in Arizona took chloroquine phosphate, an ingredient of fish parasite killers rather than the anti-malaria medication, following the President’s recommendation. The man died soon after ingesting the toxic chemical. His spouse was left in a critical condition. – READ

March 24, 2020 – Time Magazine: President Trump Called Hydroxychloroquine a ‘Game Changer,’ But Experts Warn Against Self-Medicating With the Drug. Here’s What You Need to Know – ORIGINAL, READ, Article archives – HERE

• “For the past few weeks President Trump has continually expressed great confidence in the promise of a new COVID-19 therapy involving two drugs—azithromycin and hydroxychloroquine”…
• “But in those few days, a few people [2, husband and wife who took fish tank cleaner – not hydroxychloroquine] who began self medicating with the drugs in an effort to prevent COVID-19 [misleading] have died, and others have been hospitalized. These tragedies have raised questions about the safety of the drug combo [from fish tank cleaner!!!], and how valid they are as a possible solution to treating COVID-19.”

“What do you have to lose? Take it,” … “I really think they should take it. But it’s their choice. And it’s their doctor’s choice or the doctors in the hospital. But hydroxychloroquine. Try it, if you’d like.”

President Trump – White House briefing April 4, 2020 (Time article updated, but not acknowledged in date)

March 23, 2020 – Time Magazine: Arizona Man Dies After Taking Chemical in Coronavirus Treatment Touted by President Trump – ARCHIVE

• “A Phoenix-area man has died and his wife was in critical condition after the couple took chloroquine phosphate, an additive used to clean fish tanks…It’s unclear if the couple took it specifically because of COVID-19″,
• Now Banner Poison and Drug Information Center “is warning everyone to avoid self-medicating”

March 21, 2020 – President Trump on Twitter re HYDROXYCHLOROQUINE & AZITHROMYCIN – TWEET, ARCHIVE

March 20, 2020 – AP FACT CHECK: Trump falsely claims drug approval for virus – READ

• “Technically, doctors can already prescribe the drug to patients with COVID-19, a practice known as off-label prescribing.”
• “Drug trials typically require hundreds or thousands of patients and, even when accelerated, take weeks or months to complete”
  • [This is deceptive, as HCQ has already gone through those safety trials before registration, and has an established 60 year risk profile for the doses used by the frontline doctors, so such huge trials “safety” trials are not required and is misleading to state this]
• “no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19”
• [Note during the pandemic the media the word “approved” instead of the correct phrase “Emeregency Use Authroised” – yet they attack Trump for saying apporved for and EUA “indication” approval – The drug is already registered – but BARDA got in and killed that EUA – WATCH]

March 20, 2020 – NBC News: Trump, promoting unproven drug treatments, insults NBC reporter at coronavirus briefing – READ

March 20, 2020 – ABC News: Chloroquine, an old malaria drug, may help treat novel coronavirus, doctors say – READ

• FDA approves compassionate use of chloroquine – President Donald Trump held a teleconference with state governors on Thursday at FEMA headquarters and discussed possible treatments for coronavirus.
• “The way that it worked against SARS was by preventing of the attachment of the virus to the cells. Chloroquine interfered with the attachment to that receptor on the cell membrane surface,” Horovitz said. “So it’s disrupting a lock and key kind of mechanism of attachment.”

March 20, 2020 – International Journal of Antimicrobial Agents: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial by Gautret and Didier Raoult et al – READ, Preprint – READ

• “However, [this] study was too small to be of significance, and there was no control group of patients to compare the outcome of the drugs.” – REF [reminder the FDA/ACIP considered 8 mice enough to justify injecting an experimental “vaccine”]

March 19, 2020 – President Trump mentions chloroquine/hydroxychloroquine as a potential treatment for COVID-19 based on feedback he had received from doctors using it on the frontline – WATCH,
Tony Fauci said “no” to being effective for COVID-19! – READ

March 18, 2020 – Cell Discovery: Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro – Liu et al – READ

March 11, 2020 – MedCram: Coronavirus Epidemic Update 34: US Cases Surge, Chloroquine & Zinc Treatment Combo, Italy Lockdown – WATCH, Korea using HCQ – EXCERPT

March 10, 2020 – J Critical Care: A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19 – Cortegiani et al – READ

• “There are more than 20 ongoing clinical trials in China and more scheduled to start in England, Thailand, South Korea and the United States” – REF

February 18, 2020 – Clinical Trials Arena: Coronavirus: Chloroquine yields positive data in covid-19 trial – Early data from clinical trials being performed in China has revealed that chloroquine phosphate could help treat the new coronavirus disease, Covid-19 – READ, WATCH

• Chloroquine was selected after screening thousands of existing drugs

February 11, 2020 (received as preprint) – International Journal of Antimicrobial Agents: Chloroquine for the 2019 novel coronavirus SARS-CoV-2 – Colson, Didier Raoult et al – READ, READ

2017

2019 – CDC: Medicines for the Prevention of Malaria While Traveling – Hydroxychloroquine (Plaquenil) – Brochure – PDF

• CDC promotes use of Hydroxychloroquine as safe and “a relatively well tolerated medicine.”
• The CDC in referencing the long-term use of HCQ for chronic disease treatments states “HCQ can be prescribed to adults and children of all ages. It can also be safely taken by pregnant women and nursing mothers.”

2014

October 1, 2014 – PLOS: Chloroquine is a zinc ionophore – Xue et al – READ, WATCH

2003

November 2003 – The Lancet | Infectious Disease: Effects of chloroquine on viral infections: an old drug against today’s diseases – Savarino et al – READ, CREDIT

• Chloroquine is a 9-aminoquinoline known since 1934…”Chloroquine/hydroxychloroquie can impair the replication of several viruses by interacting with the endosome-mediated viral entry or the late stages of replication of enveloped viruses”
• “Chloroquine has been shown to inhibit different viruses requiring a pH-dependent step for entry”
  • 2021- “Influenza hemagglutinin (HA) is a viral membrane bound protein that plays a critical role in the viral life cycle by mediating entry into target cells” – PAPER
  • May 2023 – pH-dependent endocytosis mechanisms for influenza A and SARS-coronavirus – PAPER
• “ Of particular interest for human pathology is the report that chloroquine inhibits uncoating of the hepatitis A virus, thus blocking its entire replication cycle”

October 30, 2003 – Antimicrobial Agents and Chemotherapy : Effect of zinc salts on respiratory syncytial virus replication by Suara et al – READ, The Highwire – CREDIT

1994

1994 – BOOK: Vaccines and world health : science, policy, and practice by Faul F. Basch (1994) – (Borrow online) – READ, Credit Dr Judy Wilyman – Vaccination – HERE

• “The Effect of Infection-Controlling Drugs on the Immune Response to Vaccines” – Chloroquine can inhibit the antibody production to vaccine antigens! – READ

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