Covid testing in schools is hugely disruptive and should be suspended, experts have said, as it emerged that up to 60 per cent of “positive” tests a week are coming back negative when checked.
Under plans to keep schools open, more than 50 million lateral flow tests have been carried out on youngsters, leading to thousands of pupils and their social bubbles being forced to self-isolate for 10 days.
Innova tests’ performance not proven and they should be returned to manufacturer or thrown in bin, says FDA
The US Food and Drug Agency (FDA) has raised significant concerns about the rapid Covid test on which the UK government has based its multibillion-pound mass testing programme.
In a scathing review, the US health agency suggested the performance of the test had not been established, presenting a risk to health, and that the tests should be thrown in the bin or returned to the California-based manufacturer Innova.
…In its report, the agency accused the company of “false or misleading” estimates of the clinical performance of certain configurations of the test, saying the estimates did not accurately reflect the performance of the diagnostic devices during clinical studies.
A higher-than-expected number of young men have experienced heart inflammation after their second dose of the mRNA COVID-19 shots from Pfizer/BioNTech and Moderna, according to data from two vaccine safety monitoring systems, the U.S. Centers for Disease Control and Prevention (CDC) said on Thursday.
…There were 283 observed cases of heart inflammation after the second vaccine dose in those aged 16 to 24 in the VAERS data. That compares with expectations of 10-to-102 cases for that age range based on U.S. population background incidence rates, the CDC said.
Scientists from the Cleveland Clinic, USA, have recently evaluated the effectiveness of coronavirus disease 2019 COVID-19) vaccination among individuals with or without a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
The study findings reveal that individuals with previous SARS-CoV-2 infection do not get additional benefits from vaccination, indicating that COVID-19 vaccines should be prioritized to individuals without prior infection. The study is currently available on the medRxiv* preprint server.
Conclusions Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination, and vaccines can be safely prioritized to those who have not been infected before.
Published August 2015
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2 with recommendations on how to conduct shedding studies during preclinical and clinical development. For purposes of this guidance, the term “shedding” means release of VBGT or oncolytic products from the patient through one or all of the following ways: excreta (feces); secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds). Shedding is distinct from biodistribution because the latter describes how a product is spread within the patient’s body from the site of administration while the former describes how it is excreted or released from the patient’s body. Shedding raises the possibility of transmission of VBGT or oncolytic products3 from treated to untreated individuals (e.g., close contacts and health care professionals). This guidance represents FDA’s current thinking on how and when shedding data should be collected for VBGT and oncolytic products during preclinical and clinical development and how shedding data can be used to assess the potential for transmission to untreated individuals. This guidance finalizes the draft guidance of the same title dated July 2014.
Hard to justify right now for most children in most countries
Following widespread vaccination against SARS-CoV-2 of older adults and other highly vulnerable groups, some high income countries are now considering vaccinating children; just days ago, the US Food and Drug Administration authorized the use of the Pfizer/BioNTech vaccine in children 12-15 years of age. Young people have been largely spared from severe covid-19 so far, and the value of childhood vaccination against respiratory viruses in general remains an open question for three reasons: the limited benefits of protection in age groups that experience only mild disease; the limited effects on transmission because of the range of antigenic types and waning vaccine induced immunity; and the possibility of unintended consequences related to differences in vaccine induced and infection induced immunity. We discuss each in turn.
Published 9 September 2009
WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.
Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari
Wikipedia snapshot from 9 March 2021:
|Year||Company||Settlement||Violation(s)||Product(s)||Laws allegedly violated |
|2012||GlaxoSmithKline||$3 billion ($1B criminal, $2B civil)||Criminal: Off-label promotion, failure to disclose safety data. |
Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program
|Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex||False Claims Act, FDCA|
|2009||Pfizer||$2.3 billion||Off-label promotion, kickbacks||Bextra, Geodon, Zyvox, Lyrica||False Claims Act, FDCA|
|2013||Johnson & Johnson||$2.2 billion||Off-label promotion, kickbacks||Risperdal, Invega, Nesiritide||False Claims Act, FDCA|
|2012||Abbott Laboratories||$1.5 billion||Off-label promotion||Depakote||False Claims Act, FDCA|
|2009||Eli Lilly||$1.4 billion||Off-label promotion||Zyprexa||False Claims Act, FDCA|
|2001||TAP Pharmaceutical Products||$875 million||Medicare fraud, kickbacks||Lupron||False Claims Act, Prescription Drug Marketing Act|
|2012||Amgen||$762 million||Off-label promotion, kickbacks||Aranesp||False Claims Act, FDCA|
|2010||GlaxoSmithKline||$750 million||Poor manufacturing practices||Kytril, Bactroban, Paxil CR, Avandamet||False Claims Act, FDCA|
|2005||Serono||$704 million||Off-label promotion, kickbacks, monopolistic practices||Serostim||False Claims Act|
|2008||Merck||$650 million||Medicare fraud, kickbacks||Zocor, Vioxx, Pepsid||False Claims Act, Medicaid Rebate Statute|
|2007||Purdue Pharma||$601 million||Off-label promotion||Oxycontin||False Claims Act|
|2010||Allergan||$600 million||Off-label promotion||Botox||False Claims Act, FDCA|
|2010||AstraZeneca||$520 million||Off-label promotion, kickbacks||Seroquel||False Claims Act|
|2007||Bristol-Myers Squibb||$515 million||Off-label promotion, kickbacks, Medicare fraud||Abilify, Serzone||False Claims Act, FDCA|
|2002||Schering-Plough||$500 million||Poor manufacturing practices||Claritin||FDA Current Good Manufacturing Practices|
|2006||Mylan||$465 million||Misclassification under the Medicaid Drug Rebate Program||EpiPen (epinephrine)||False Claims Act|
|2006||Schering-Plough||$435 million||Off-label promotion, kickbacks, Medicare fraud||Temodar, Intron A, K-Dur, Claritin RediTabs||False Claims Act, FDCA|
|2004||Pfizer||$430 million||Off-label promotion||Neurontin||False Claims Act, FDCA|
|2008||Cephalon||$425 million||Off-label promotion||Actiq, Gabitril, Provigil||False Claims Act, FDCA|
|2010||Novartis||$423 million||Off-label promotion, kickbacks||Trileptal||False Claims Act, FDCA|
|2003||AstraZeneca||$355 million||Medicare fraud||Zoladex||Prescription Drug Marketing Act|
|2004||Schering-Plough||$345 million||Medicare fraud, kickbacks||Claritin||False Claims Act, Anti-Kickback Statute|
A request for Emergency Use Authorization in the US was submitted the same month; and the vaccine was then authorized in the US on December 11 (shortly after UK authorization on December 2).
The trial is not over, however: as all subjects are monitored for a further two year period. And the next step is to test the vaccine in groups that cannot currently receive the vaccine due to a lack of data – such as pregnant women and children (Pfizer has already started a trial in pregnant women and one in children is set to follow later this year).
- A third of all military personnel are refusing the COVID-19 vaccine
- Some are citing the rushed rollout of the anthrax vaccine in the 1990s as the reason why they do not want to receive the new COVID jab
- In 1997, the military made it mandatory for service personnel to receive the anthrax shot; thousands subsequently complained of debilitating side effects
- A lengthy legal battle ensued, before the courts determined that the FDA hadn’t ‘adequately studied’ how effective the shot was against the inhalation anthrax
- Commanders concede they need to do a better job of messaging and allaying fears among military members that they are being used as ‘testers’ for the jab
- Other personnel are citing wild conspiracy theories about the vaccine, including one who refused the shot for fear it was implanting a tracking device
Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy.
A critical appraisal of phase III clinical trial data for the Pfizer/BioNTech vaccine BNT162b2 and Moderna vaccine mRNA-1273 shows that absolute risk reduction measures are very much lower than the reported relative risk reduction measures. Yet, the manufacturers failed to report absolute risk reduction measures in publicly released documents. As well, the U.S FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273 vaccines for emergency use. Such examples of outcome reporting bias mislead and distort the public’s interpretation of COVID-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.
Last September, Pfizer’s CEO, Albert Bourla, assured the public that ‘we will develop our product, develop our vaccine, using the highest ethical standards’. And the NHS has assured us of the same rigorous standards. So let’s take a look Pfizer’s history of ‘ethical standards’.
In 1992, Pfizer agreed to pay between $165 million and $215 million to settle lawsuits arising from the fracturing of the Bjork-Shiley Convexo-Concave heart valve, which by 2012 had resulted in 663 deaths.
Court approves settlement in Shiley heart-valve case Pfizer Inc. said Wednesday a federal judge has approved the previously announced agreement for settlement of claims to patients with the Bjork-Shiley… upi.com
In 1996, Pfizer conducted an unapproved clinical trial on 200 Nigerian children with its experimental anti-meningitis drug, Trovafloxacin, without parental consent, which led to the death of 11 children from kidney failure and left dozens more disabled. http://news.bbc.co.uk/1/hi/world/africa/6768799.stm …
In 2011, Pfizer paid just $700,000 to four families who had lost a child, and set up a $35 million fund for those disabled by their drug experiment. This cover-up was the basis to the John Le Carré book and film, The Constant Gardener.
Pfizer: Nigeria drug trial victims get compensation US-based pharmaceutical giant Pfizer makes the first compensation payment to Nigerian families affected by a controversial drug trial 15 year… bbc.co.uk
In 2004, Pfizer’s subsidiary, Warner-Lambert, was fined $430 million to resolve criminal charges and civil liabilities for the fraudulent promotion of its epilepsy drug, Neurontin, paying and bribing doctors to prescribe it for uses not approved by the FDA.https://www.justice.gov/archive/opa/pr/2004/May/04_civ_322.htm …
In 2009, Pfizer spent $25.8 million lobbying Congressional lawmakers and federal agencies like the Department of Health and Human Services. Image of government building columns Pfizer Inc Lobbying Profile Pfizer Inc spent $25,819,268 lobbying in 2009. See the details. opensecrets.org
Pfizer’s expenditure on federal lobbying between 2006 and 2014 came to $89.89 million. In 2019 the second largest pharmaceutical company in the world spent $11 million lobbying the US federal government. Image of government building columns Pfizer Inc Lobbying Profile Pfizer Inc spent $11,000,000 lobbying in 2019. See the details. opensecrets.org
In 2009, Pfizer paid the largest health care fraud settlement and criminal fine ever, paying $2.3 billion to avoid criminal and civil liability for fraudulently marketing its anti-inflammatory drug, Bextra, which the FDA had refused due to safety concerns.
Justice Department Announces Largest Health Care Fraud Settlement in American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $… justice.gov
In 2009, Pfizer paid $750 million to settle 35,000 claims that its diabetes drug, Rezulin, was responsible for 63 deaths and dozens of liver failures. In 1999, an epidemiologist at the FDA said Rezulin was ‘one of the most dangerous drugs on the market’. LA Times logo
Pfizer Agrees to Settle Suit Over Diabetes Drug Rezulin Pfizer Inc. agreed Friday to settle a lawsuit over the diabetes drug Rezulin after a jury earlier in the day awarded $43 million to a Texas woman wh… latimes.com
In 2010, Pfizer was ordered to pay $142.1 million in damages for violating a federal anti-racketeering law by its fraudulent sale and marketing of its epilepsy drug Neurontin for uses not approved by the FDA, including for migraines and bi-polar disorder.
Neurontin Lawsuits – Pfizer Illegal Marketing, Injury Claims Pfizer Marketing Illegal Neurontin. Pfizer Inc. has been ordered to pay $142.1M in damages for violating a federal antiracketeering law in its marketing. yourlawyer.com
In 2010, Pfizer admitted that, in the last 6 months of 2009 alone, it had paid $20 million to 4,500 doctors in the US for consulting and speaking on its behalf, and $15.3 million to 250 academic medical centres for clinical trials.
Pfizer admits paying $35 million to doctors over last 6 months Pfizer among other large pharmaceutical companies recently disclosed payments to doctors and other medical professionals for consulting and … news-medical.net
In 2012, Pfizer paid $45 million to settle charges of bribing doctors and other health-care professionals employed by foreign governments in order to win business. https://www.sec.gov/news/press-release/2012-2012-152htm …
The Chief of the Foreign Corrupt Practices Act Unit said: ‘Pfizer subsidiaries in several countries had bribery so entwined in their sales culture that they offered points and bonus programs to improperly reward foreign officials who proved to be their best customers’.
By 2012, Pfizer had paid $1.226 billion to settle claims by nearly 10,000 women that its hormone replacement therapy drug, Prempro, caused breast cancer.
In 2013, Pfizer agreed to pay $55 million to settle criminal charges of failing to warn patients and doctors about the risks of kidney disease, kidney injury, kidney failure and acute interstitial nephritis caused by its proton pump inhibitor, Protonix.
In 2013, Pfizer set aside $288 million to settle 2,700 claims that its stop-smoking drug, Chantix, caused suicidal thoughts and psychological disorders. The FDA subsequently determined that Chantix is probably associated with a higher risk of heart attack.
In 2013, Pfizer absolved itself of claims that its antidepressant, Effexor, caused congenital heart defects in the children of pregnant woman by arguing that the prescribing obstetrician was responsible for advising the patient about the medication’s use. https://europepmc.org/article/PMC/6424813 …
In 2014, Pfizer paid a further $325 million to settle a lawsuit brought by health-care benefit providers who claimed the company marketed its epilepsy drug, Neurontin, for purposes unapproved by the FDA.
In 2014, Pfizer paid $35 million to settle a law suit accusing its subsidiary of promoting the kidney transplant drug, Rapamune, for unapproved uses, including bribing doctors to prescribe it to patients.
In 2016, Pfizer was fined a record £84.2m for overcharging the NHS for its deregulated anti-epilepsy drug, Phenytoin, by 2,600% (from £2.83 to £67.50 a capsule), increasing the cost to UK taxpayers from £2 million in 2012 to about £50 million in 2013.
In May 2018, Pfizer had 6,000 lawsuits pending against claims that its testosterone replacement therapy products cause strokes, heart attacks, pulmonary embolism and deep vein thrombosis, and were marketed at healthy men for uses not approved by the FDA.
$3 billion GSK settlement. On 2 July 2012, GlaxoSmithKline pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud case in the U.S. and the largest payment by a drug company. The settlement is related to the company’s illegal promotion of prescription drugs, its failure to report safety data, bribing doctors, and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses. Those and the drugs Imitrex, Lotronex, Flovent, and Valtrex were involved in the kickback scheme. The government investigation of GSK was launched largely on the basis of information provided by four whistleblowers who filed two qui tam (whistleblower) lawsuits against the company under the False Claims Act. GSK settled the whistleblowers’ lawsuits for a total of $1.017 billion out of the $3 billion settlement, the largest civil False Claims Act settlement to date.
Pfizer $2.3 billion settlement: Pfizer settled multiple civil and criminal allegations for $2.3 billion in the largest case of pharmaceutical and health care fraud in US history. The drugs involved were Bextra (an anti-inflammatory drug), Geodon (an anti-psychotic drug), Lipitor (a cholesterol drug), Norvasc (anti-hypertensive drug), Viagra (erectile dysfunction), Zithromax (antibiotic), Zyrtec (antihistamine), Zyvox (an antibiotic), Lyrica (an anti-epileptic drug), Relpax (anti-migraine drug), Celebrex (anti-inflammatory drug), and Depo-provera (birth control).
Merck $650 million settlement: Merck settled a nominal pricing fraud case in which the company was accused of taking kickbacks and violating Medicaid best price regulations for various drugs.
United States et al., ex rel. Jim Conrad and Constance Conrad v. Forest Pharmaceuticals, Inc, et al. involved a drug manufacturer selling a drug, Levothroid, that had never been approved by the FDA. These allegations settled for $42.5 million due to multiple whistleblowers stepping forward to provide detailed information on the alleged fraud. The collective reward to the relators in this case was over $14.6 million.
Wikipedia snapshot from 28 January 2021:
None of this, however, explains the 40 years of medical
misinformation and suppression of the pharmaceutical truth.
To have covered up the knowledge for four decades that
viruses could potentially be treated by antimicrobials required
• Censorship. It is likely that some scientists were never
published again after authoring one paper on the antiviral benefits of CQ.
• Buying silence of news media. This is evident from the
blackout across the political news spectrum concerning
vaccine adverse effects. Pharmaceutical manufacturers
provide the most lucrative advertising for both written
and broadcast news programs.
• Misdirection. For years, pharmacology professors in
medical schools have perpetuated lies of omission.
• Lies by drug companies. Merck was caught publishing its
own “peer reviewed” journal to promote its drugs.54
• Regulatory capture. “Big Pharma” essentially owns the
FDA by being its biggest funder and employing more
than 58 percent of the FDA’s upper-level regulators and
administrators either before or after their tenure.55,56
• Research funding. Big Pharma is the major funder of
nearly all “independent” drug research, and there is no
incentive to research cheap/ less profitable solutions.
The COVID-19 pandemic is calling attention to the
potential for treating viral diseases with currently available
drugs, and exposing long-available but ignored research.
The implications of all this are very disturbing. Where have
the virologists been, and the CDC “experts” who claim to care
about influenza deaths? Has the burgeoning nearly trilliondollar vaccine industry been built at the expense of patients’
The Recovery trial has steadfastly ignored Professor Didier Raoult and a string of countries that have implemented his protocol, early use of HCQ with Azythromycin in safe doses, despite the fact that, after treating 3,737 patients — the single largest study in the world —Raoult has lost only 0.6 per cent, while Horby and Landray are presiding over carnage —a fatality rate of 25 per cent.
- The Recovery trial has steadfastly ignored Professor Didier Raoult in the early use of HCQ with Azythromycin in safe doses.
- Raoult has lost only 0.6 per cent, while Horby and Landray are presiding over carnage —a fatality rate of 25 per cent.
- Landray admitted to an investigative journalist at FranceSoir ‘these are quite high doses to… have a chance of killing the virus.’ Or killing the patient.
- Recovery is not the only trial delivering dangerously elevated doses of HCQ to Covid patients. Dosage in the international Solidarity trial was four times greater than the dose being used in India.
- WHO has been working for years with Gilead Sciences trying to get the pharmaceutical company’s lacklustre drug Remdesivir to show efficacy at curing first Ebola, with poor results, and now Covid-19.
- Landray revealed Gilead pays scientists 20 to 50 times more to conduct a clinical trial than Horby and Landray were paid to conduct the Recovery trial.
- Horby is the executive director of the International Severe Acute Respiratory and Emerging Infection Consortium which received 4.5 million pounds for research into vaccines.
- Horby established the Epidemic Research Group which is promised up to 14 million pounds from AstraZeneca and Zuckerberg/Chan of Facebook fame for the development of a Covid-19 vaccine which is being trialled by Oxford University.
- AstraZeneca is interested in merging with Gilead Sciences, which, if it went through, would create the biggest Big Pharma ever.
- Horby and Landray have announced that dexamethasone, a low-cost steroid which is also being tested has reduced the mortality rate of Covid-19 patients on ventilators from a scandalous 41 per cent to a still appalling 32 per cent.
- Raoult has pointed out that in his hospital, of the 0.6 per cent who die, a mere 16 per cent were in ICU
- In Britain, where almost 42,000 people have died of Covid, the only thing randomised, controlled trials have achieved, is to blind people to the evidence that 40,000 of those deaths could have been avoided.