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.
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Liver samples were collected over time and the concentrations of ALC-0315 and ALC-0159 in each sample were measured. The conclusion As a result, ALC-0315 and ALC-0159 were shown to be rapidly distributed from the blood to the liver. Also, About 1% and about 50% of the doses of ALC-0315 and ALC-0159 are excreted in feces as unchanged drug, respectively.
https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf
Germany has recommended the AstraZeneca coronavirus vaccine should only be given to people under the age of 65, according to reports.
The country’s vaccine committee has reportedly said the jab, developed alongside the University of Oxford, should only be offered to people aged between 18 and 64.
It gave a lack of sufficient data on the effectiveness of the inoculation in older people as the reason for the decision in a draft recommendation.
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Pharmaceutical fraud – Wikipedia
$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:
There is an old saying in medicine that “the cure may be worse than the disease.” The phrase can be applied to vaccines. In the current paper the concern is raised that the RNA based COVID vaccines have the potential to cause more disease than the epidemic of COVID-19. This paper focuses on a novel potential adverse event mechanism causing prion disease which could be even more common and debilitating than the viral infection the vaccine is designed to prevent. While this paper focuses on one potential adverse event there are multiple other potential fatal adverse events as discussed below.
https://scivisionpub.com/pdfs/covid19-rna-based-vaccines-and-the-risk-of-prion-disease-1503.pdf
The European nation reported that 23 elderly people have died within days of taking the Pfizer COVID-19 vaccine, with 13 of those deaths said to be related to “side effects”. All those who suffered supposed side effects were nursing home patients and at least 80 years old.
Ivor Cummins aka the Fat Emperor – gives James the lowdown on why you can’t trust anything our governments tell us about Covid-19. If you want the facts on Coronavirus – how deadly is it? do lockdowns and masks work? how does it compare with previous pandemics? – you’ve come to the right place
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Boiling the bioethical frog – The Critic
This hunger games scenario of a middle-aged, potentially pre-infected and already immune health secretary taking a nominal, rushed, improperly trialled novel-technology vaccine after the pandemic has already passed on live TV is as unethical and obscene as any of the propaganda we have been subjected to. What have we become? If it happens, the supposed vaccinator, the TV station, the secretary of state, and the vaccine company should all be roundly condemned. It proves nothing and risks everything. Obnoxious and dangerous as he is, he hasn’t a clue what might happen to him. He is still that sacred thing: somebody’s patient. A power-crazed, ignorant man for whom the mantras “whatever it takes” and the “end justifies the means” are dear, offering himself for a macabre, televised ritual sacrifice fit for the Incas to appease his political masters. It is truly grotesque. There is no medical reason for him to have these chemicals.
The government has now approved the supply of the Pfizer-BioNTech COVID-19 vaccine. The reason they have been able to do this so quickly is because they have taken advantage of the temporary authorisation regime laid out by the Human Medicine Regulations of 2012 and 2020. The 2012 Regulations were updated in 2020 specifically to facilitate the smooth rollout of the COVID-19 vaccine. In the public consultation preceding the introduction of these updated regulations, several respondents raised concerns regarding unlicensed vaccines and immunity from civil liability. In practice, very little is known about these regulations and their application. This article seeks to shed some light on the temporary authorisation regime and suggest a means of alleviating concerns in the context of “vaccine hesitancy”.
- December 9 – UK authorities confirmed 2 cases of anaphylaxis after vaccination
- December 18*, 2020 – CDC has identified 6 case reports of anaphylaxis following Pfizer-BioNTech vaccine meeting Brighton Collaboration criteria for anaphylaxis
- Persons with anaphylaxis following COVID-19 vaccination should not receive additional doses of COVID-19 vaccine
Hospital pharmacists discovered Dec. 16 that some vials of Pfizer’s COVID-19 vaccines that are supposed to hold five doses actually contain six or seven, The New York Times reported.
The discovery may mean the U.S. supply of the vaccine is more robust than previously thought, but it has also caused confusion over whether to use the extra doses or throw them out, since the extra doses weren’t part of Pfizer’s guidance.
Federal officials have to carefully track the number of vaccine doses to make sure there’s enough for everyone who received an initial dose to receive a second dose three weeks later. The extra vials may complicate that effort, The Hill reported.
A hospital worker with no history of allergies was admitted to intensive care over a severe reaction she suffered 10 minutes after having Pfizer’s coronavirus vaccine. The unidentified female worker suffered an anaphylactic reaction shortly after receiving the injection at a hospital in Juneau, Alaska, on Tuesday.
Two healthcare workers in the UK suffered an anaphylactic reaction to the Pfizer injection after being given it last week, although the vaccine has been widely tested and analysed, with government experts in both the US and Great Britain deeming it safe.
A promising Australian candidate for a coronavirus vaccine has been abandoned after trial participants returned false HIV positive results.
Australia had previously agreed to buy 51 million doses of the vaccine being developed by Australian firm CSL and the University of Queensland (UQ).
The government said orders of other vaccines would now fill the shortfall.
CSL and UQ stressed that the positive results were false – meaning trial participants’ health was not at risk.
http://archive.today/2020.12.11-112743/https://www.bbc.com/news/world-australia-55269381
More than 100,000 patients will not be able to get the Covid vaccine from their family doctor after their GP surgeries decided not to take part in its deployment, the Guardian can reveal.
White House chief of staff Mark Meadows told the head of the Food and Drug Administration on Friday to either sign off on Pfizer’s coronavirus vaccine by the end of the day or hand in his resignation, the Washington Post reported, another push by the White House to approve the vaccine as quickly as possible after a panel of scientists ruled it safe this week.
The UK government has granted pharmaceutical giant Pfizer a legal indemnity protecting it from being sued, enabling its coronavirus vaccine to be rolled out across the country as early as next week.
The Department of Health and Social Care has confirmed the company has been given an indemnity protecting it from legal action as a result of any problems with the vaccine.
Ministers have also changed the law in recent weeks to give new protections to companies such as Pfizer, giving them immunity from being sued by patients in the event of any complications.
NHS staff providing the vaccine, as well as manufacturers of the drug, are also protected.
Most people will escape “severe” side effects, defined as those that prevent daily activity. Fewer than 2% of recipients of the Pfizer and Moderna vaccines developed severe fevers of 39°C to 40°C. But if the companies win regulatory approvals, they’re aiming to supply vaccine to 35 million people worldwide by the end of December. If 2% experienced severe fever, that would be 700,000 people.
Other transient side effects would likely affect even more people. The independent board that conducted the interim analysis of Moderna’s huge trial found that severe side effects included fatigue in 9.7% of participants, muscle pain in 8.9%, joint pain in 5.2%, and headache in 4.5%. In the Pfizer/BioNTech vaccine trial, the numbers were lower: Severe side effects included fatigue (3.8%) and headache (2%).
But that’s a higher rate of severe reactions than people may be accustomed to. “This is higher reactogenicity than is ordinarily seen with most flu vaccines, even the high-dose ones,” says Arnold Monto, an epidemiologist at the University of Michigan School of Public Health.
https://web.archive.org/web/20201126203444/https://science.sciencemag.org/content/370/6520/1022
- Vaccine produced by a partnership between a University of Oxford research institute, Vaccitech, and AstraZeneca, does not need to be stored at freezing temperatures.
- Cheaper and easier to produce than the high-efficacy vaccines produced by BioNTech-Pfizer and Moderna.
- The price of AstraZeneca’s shares dropped on the news, and an analysis from an investment bank concluded, “We believe that this product will never be licensed in the US.”
- A closer look at the the Oxford-AstraZeneca trials reveals some very shaky science.
- Cherry-picked the data
- Dosing issues
- Opaque planning and data analysis procedures
- Age group selection
https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/
Two major U.S. pharmaceutical companies racing to develop novel coronavirus vaccines have announced that their vaccines have been confirmed to be over 90% effective. But Masayuki Miyasaka, a leading immunologist at Osaka University, told the Mainichi Shimbun in a recent interview that even after these vaccines become available, he does not plan to receive them for the time being.
At a meeting of the Committee on Health, Labor and Welfare of Japan’s House of Representatives on Nov. 17, Miyasaka stated, “There’s no doubt that their effectiveness is quite high, but their safety is not guaranteed at all,” sounding a word of caution about expectations for the vaccines.
https://mainichi.jp/english/articles/20201120/p2a/00m/0na/008000c
Article date: Monday 6 April 2009
At stake at one point last year was more than $8bn in punitive damages being sought in a string of cases, as well as potential jail terms in Nigeria for several Pfizer staff. “There has been a complex web of cases with proceedings in Connecticut, New York, Lagos, Abuja and Kano,” Mr Etigwe said. “The strategy of big companies when they are dealing with smaller opponents is to stretch the process, to overwhelm us until we are ready to accept whatever they want to offer.” Trovan never became the blockbuster that Pfizer had hoped for and it is no longer in production. The EU has banned the drug and it has been withdrawn from sale in the US.