Regulations

Browse the articles related to this topic below.

The illusion of evidence based medicine – BMJ

Post author By EvidenceNotFear
Post date 16 March 2022

Evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia, argue these authors

The advent of evidence based medicine was a paradigm shift intended to provide a solid scientific foundation for medicine. The validity of this new paradigm, however, depends on reliable data from clinical trials, most of which are conducted by the pharmaceutical industry and reported in the names of senior academics. The release into the public domain of previously confidential pharmaceutical industry documents has given the medical community valuable insight into the degree to which industry sponsored clinical trials are misrepresented. Until this problem is corrected, evidence based medicine will remain an illusion.

https://web.archive.org/web/20220316191824/https://www.bmj.com/content/376/bmj.o702

Tags Academia, BMJ, Communication, Corporations, Evidence-based medicine, Financial Incentives, Karl Popper, Key Opinion Leaders, Pharmaceutical Industry, Philosophy, Regulations, Science, Society, Suppression

News

Sajid Javid tells medical regulators to insist staff get jabs – The Times

Post author By EvidenceNotFear
Post date 7 February 2022

Medical regulators must crack down on unvaccinated staff, the health secretary has said as he tries to deal with the fallout from abandoning compulsory jabs.

Sajid Javid has rebuked regulators and demanded that they send a “clear message” to healthcare workers that they must get a coronavirus vaccine.

http://archive.today/2022.02.08-001721/https://www.thetimes.co.uk/article/sajid-javid-tells-medical-regulators-to-insist-staff-get-jabs-q5z6wzv2f

Tags Coercion, COVID-19, Employment, General Medical Council, Government, Health Care Workers, Mandatory Vaccination, Nursing and Midwifery Council, Omicron Variant, Policy, Regulations, The Times, UK, Vaccination

Publications

Covid-19 vaccines and treatments: we must have raw data, now – BMJ

Post author By EvidenceNotFear
Post date 26 January 2022

In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.

https://web.archive.org/web/20220120011239/https://www.bmj.com/content/376/bmj.o102

News

FDA report finds all-cause mortality higher among vaccinated – Israel Nation News

Post author By EvidenceNotFear
Post date 17 November 2021

FDA report shows Pfizer’s clinical trials found 24% higher all-cause mortality rate among the vaccinated compared to placebo group.

The clinical trials of Pfizer’s coronavirus vaccine found that the all-cause mortality rate of the vaccinated group was higher than that of the control group, months after the trials were launched, according to a recently released FDA report.

According to the report, which was released by the US Food and Drug Administration to provide background information on its August 2021 decision to grant full approval for the Pfizer-BioNTech coronavirus vaccine after offering limited emergency authorization of use in last December, six months after the vaccine’s clinical trial began, the total number of deaths reported in the vaccinated group was nearly one-quarter higher than the number of deaths in the placebo group.

http://archive.today/2021.11.19-040650/https://www.israelnationalnews.com/News/News.aspx/317091

Tags All Cause Mortality, Approval, BioNTech, Clinical, Comirnaty, Control Group, COVID-19, FDA, Israel Nation News, Pfizer, Regulations, Trials, Vaccination, Vaccine Damage

Videos

Dr. Robert Malone: “This is the Largest Experiment Performed on Human Beings in the History of the World.” – The New American

Post author By EvidenceNotFear
Post date 9 November 2021

In an exclusive and explosive one-hour interview with Veronika Kyrylenko of The New American, pioneering mRNA scientist Dr. Robert Malone explains the intensely corrupt workings of the government regulatory bodies that have mismanaged the pandemic, discusses the problems with the vaccine program and delves into potentially explosive and game-changing revelations about the shady origins of the Covid-19 pandemic in Wuhan, China.

Tags Agriculture, Aspirin, Assasination, Aviation Industry, Biological Warfare, Boeing, Bureaucracy, Cardiac Arrhythmia, CDC, Celebrex, Censorship, Children, Conflicts of Interest, Corruption, COVID-19, Delta Plus, Diamond Princess, Dr. Robert Malone, Drones, Early Treatment Protocols, Economy, Ethnic Groups, Event 201, FDA, Financial Incentives, Funding, Gain of Function, Gene Therapy, Geopolitics, Hydroxychloroquine, Immune Response, Immunity, Incapacitating Agents, Ivermectin, Johns Hopkins University, Lobbying, Luciferase, Malfeasance, Mass Media, Merck, Mismatch, Monoclonal Antibody, mRNA, Myocarditis, National Security, NIH, Off-Label, Pfizer, Pharmaceutical Industry, Propaganda, Regulations, Regulatory Capture, Risk, Safety, Side-effects, Simulations, Soviet Union, Special Operations, Studies, Suppression, Testing, The Great Reset, The New American, Treaties, Treatment, USA, Vaccination, Vaccine Damage, Variants, Warfare

Publications

November 8, 2021 Summary Basis for Regulatory Action – Comirnaty – FDA

Post author By EvidenceNotFear
Post date 8 November 2021

Introduction

BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.) submitted a Biologics License Application (BLA) STN BL 125742 for licensure of COVID-19 Vaccine, mRNA. The proprietary name of the vaccine is COMIRNATY. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine is administered intramuscularly (IM) as a series of two 30 μg doses (0.3 mL each) 3 weeks apart.

For commentary, see FDA report finds all-cause mortality higher among vaccinated – Israel Nation News.

http://archive.today/2021.10.11-032110/https://www.fda.gov/media/151733/download

Tags All Cause Mortality, Approval, BioNTech, BNT162b2, Clinical, Comirnaty, Control Group, COVID-19, FDA, Israel Nation News, mRNA, Pfizer, Regulations, Trials, Vaccination

Videos

AstraZeneca shots should be halted for over-60s- EMA official – Reuters

Post author By EvidenceNotFear
Post date 14 June 2021

Countries should also avoid giving the Astrazeneca coronavirus vaccine to people over 60, the head of the EU drug regulator’s COVID-19 task force was quoted on Sunday as saying, amid fears over rare blood clotting and as more vaccines become available. Emer McCarthy reports.

https://www.reuters.com/video/watch/idRCV009UM3

Tags AstraZeneca, Blood Clots, COVID-19, Elderly, European Medicines Agency, Regulations, Reuters, Side-effects, Vaccination, Vaccine Damage

Publications

MHRA awarded over £980,000 for collaboration with the Bill and Melinda Gates Foundation and the World Health Organisation – Gov.uk

Post author By EvidenceNotFear
Post date 7 June 2021

Published 15 December 2017

MHRA today announced a partnership worth over £980,000 to improve the safety monitoring of medicines in low and middle-income countries.

https://www.gov.uk/government/news/mhra-awarded-over-980000-for-collaboration-with-the-bill-and-melinda-gates-foundation-and-the-world-health-organisation

Tags Adverse Drug Reaction, Bill & Melinda Gates Foundation, Conflicts of Interest, Financial Incentives, Government, International Drug Monitoring, LMIC, MHRA, Monitoring, Project 3-S, Project Smart Safety Surveillance, Regulations, UK, WHO

News

EU Approves Sale of Mealworm for Human Consumption – Bloomberg

Post author By EvidenceNotFear
Post date 4 May 2021

Frog legs rolled in worm flour could be the next culinary delight for European haute cuisine after the European Union gave its blessing for the first time for an insect food.

Dried yellow mealworm can now be sold across the 27-nation bloc after a Monday decision from EU governments and a food safety assessment, the European Commission said on Tuesday.

EU officials suggest it could be used as a protein boost for cookies, pasta or baked goods, as they try to reassure fussy eaters that millions of people around the world already eat insects. It’s also a more environmentally friendly alternative to rearing cattle and other larger sources of protein. The market for edible insects is set to reach $4.6 billion by 2027, according to one report earlier this year.

https://www.bloomberg.com/news/articles/2021-05-04/worm-cuisine-set-to-hit-europe-s-dinner-tables-as-eu-gives-nod

Tags Bloomberg, EU, Food, Insects, Regulations, The Great Reset

Publications

Vaccine Development, Testing, and Regulation – The History of Vaccines

Post author By EvidenceNotFear
Post date 21 April 2021

Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

Tags Development, Government, History, Regulations, Testing, Trials, Vaccination

News

COVID-19: Human Medicine Regulations amended to support vaccine rollout – Thomson Reuters Practical Law

Post author By EvidenceNotFear
Post date 19 October 2020

On 16 October, the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) entered into force. The Regulations cover temporary authorisations for vaccines, civil liability and immunity for participants in vaccination programmes, expansion of the healthcare workforce who can administer vaccines, promotion of vaccines and an exemption to wholesale licensing requirement.

https://uk.practicallaw.thomsonreuters.com/w-027-9751?transitionType=Default&contextData=(sc.Default)&firstPage=true

Tags COVID-19, Department of Health and Social Care, Human Medicine Regulations of 2012, Human Medicine Regulations of 2020, Law, Liability, Regulation 174, Regulations, Reuters, Thomson Reuters Practical Law, Vaccination

Opinion

Concern about powers in new UK Coronavirus laws – may include compulsory detention of children

Post author By EvidenceNotFear
Post date 11 April 2020

Lawyers at the Russell Cooke law firm express concerns about new Coronavirus Regulations.

Background:

The Health Protection (Coronavirus) Regulations 2020 passed 10 Feb 2020
Regulations were made without a draft being laid and approved by Parliament and came into effect immediately.
This was permitted under the claim that it was necessary due to threat to human health from COVID-19.

Regulations:

Allow the Secretary of State or a registered public health consultant to impose compulsory detention and isolation of people suspected of having COVID-19.
Allow forced testing and screening for 48 hours.
Power to restrict a person’s travel and other activities and to restrict a person’s contact with specified people.
The police are given power under to enforce the regulations where a person is not willing to be isolated voluntarily using ‘reasonable force’.
An isolated or detained individual will not be free to leave.
Refusal to comply is a criminal offence punishable by a fine of up to £1,000.
There are also powers in the regulations which envisage the detention of children, which could present its own issues.

Source:

https://www.russell-cooke.co.uk/insight/briefings/2020/new-coronavirus-regulations-quarantine-measures-to-contain-the-virus/

Tags Children, Civil Liberties, COVID-19, Crime, Law, Regulations, Response, The Health Protection (Coronavirus) Regulations 2020, UK