'Pfizer admits to fraud in court'
'Their defense to the fraud claims against them is that because the government was in on it, it isn't fraud. Pfizer whistleblower Brook Jackson's attorney, Robert Barnes, isn't buying the argument.'
Please read Steve Kirsch’s blog which I have reposted below.
Pfizer admits to fraud in court
Their defense to the fraud claims against them is that because the government was in on it, it isn't fraud. Pfizer whistleblower Brook Jackson's attorney, Robert Barnes, isn't buying the argument.
June 15, 2022
You really can’t make this stuff up. You gotta watch this video… it’s only 2 minutes. And it will be a key piece of evidence in my next move which you’ll learn about shortly.
In a nutshell, Pfizer admits in court to fraud, but says it isn’t fraud because the government was in on it. I bet you never heard that defense before.
According to attorney Robert Barnes in the video above, this is Pfizer’s defence:
❝It doesn’t matter if they submitted fraudulent certifications to the government. It doesn’t matter if they submitted false statements under penalty of perjury to the government. It doesn’t matter if they lied about the safety and efficacy of these drugs, mis-labelled in my opinion as vaccines, because the government was in on it with them. The government knows what’s going on and the government is still giving them the cheque anyway. So is it really fraud if the government is their co-conspirator?
That is in essence Pfizer’s defence so far to the case.❞
What follows is some background information regarding the Pfizer fraud.
The BMJ published the following report November 2, 2021. Please watch the BMJ’s 6:23min interview clip with whistleblower, Brook Jackson which is included.
Feature BMJ Investigation
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports
In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1
But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson (video 1), emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.
Whistleblower Brook Jackson tells The BMJ about her experience working on the Pfizer covid-19 vaccine trial
Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.
Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.
In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”
Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”
Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.
At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.
Box 1
A history of lax oversight
When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.
In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5
“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.
Ventavia and the FDA
A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.
“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.
In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7
The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.
Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.
Concerns raised
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:
Participants placed in a hallway after injection and not being monitored by clinical staff
Lack of timely follow-up of patients who experienced adverse events
Protocol deviations not being reported
Vaccines not being stored at proper temperatures
Mislabelled laboratory specimens, and
Targeting of Ventavia staff for reporting these types of problems.
Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.
In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”
Other employees’ accounts
In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”
Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.
“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”
She added that during her time at Ventavia the company expected a federal audit but that this never came.
After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)
“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”
A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.
Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.
Footnotes
Provenance and peer review: commissioned; externally peer reviewed.
Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.
This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.
https://bmj.com/coronavirus/usage
References
↵Bourla A. An open letter from Pfizer chairman and CEO Albert Bourla. Pfizer. https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla.
↵Ventavia. A leading force in clinical research trials. https://www.ventaviaresearch.com/company.
↵Citizens for Responsible Care and Research Incorporated (CIRCARE). http://www.circare.org/corp.htm.
↵Public Citizen. Letter to Scott Gottlieb and Jerry Menikoff. Jul 2018. https://www.citizen.org/wp-content/uploads/2442.pdf.
↵Food and Drug Administration. Letter to John B Cole MD. MARCS-CMS 611902. May 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021.
↵Department of Health and Human Services Office of Inspector General. The Food and Drug Administration’s oversight of clinical trials. Sep 2007. https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.
↵Food and Drug Administration. Bioresearch monitoring. https://www.fda.gov/media/145858/download.
↵FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Dec 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.
The following is a reposting of Stephen Lendman’s blog the original of which I was not able to access online for some reason.
Pfizer Fraud
by Dylan Eleven for Truth11
Original blog by Stephen Lendman published June 11, 2022
Last year, Dr. Michael Yeadon, former Pfizer chief scientist for allergy and infectious diseases/current chief science officer for America’s Frontline Doctors (AFLDS) accused his former employer of fraud, saying:
Claims by the firm of 95% effectiveness of its mRNA flu/covid jabs are fraudulent.
Doctors for (Flu)Covid Ethics documented “evidence of (Pfizer’s) scientific and regulatory fraud,” explaining the following:
“(N)o comprehensive assessment of (its mRNA drug) safety (was) made on the basis of (how the firm conducted its) studies.”
“A key determinant of a drug’s toxicity is its distribution within the body.”
“However, with the mRNA active ingredient of Pfizer’s (flu/covid jabs), this crucial aspect was never studied.”
The firm’s claimed “absence of potential for (jab) elicited disease enhancement” was based on studies of animal species not vulnerable to coronavirus illness.
In cahoots with each other, the Pharma-controlled CDC, FDA and Pfizer “lied about” the mRNA drug “staying at the injection site.”
They knew but concealed that it circulates throughout the bodies of jabbed individuals.
“Pfizer skipped major categories of safety testing altogether.”
The profiteering firm “used dishonest and self-serving interpretation of regulatory guidelines to (unjustifiably) justify shortcuts it took in routine safety testing.”
The FDA and Pfizer concealed evidence of “major toxicities associated with” mRNA gene altering mass-jabbing.
It was done to rush an experimental, inadequately tested, health destroying drug into mass distribution — with wanting mass casualties in mind.
Pfizer and Pharma controlled anti-public health agencies defrauded the public by rushing to market a new technology “without carrying out a single well designed safety assessment.”
Ignored was that drugs or other biological products should never be approved for human use unless and until proved to be safe and effective by peer-reviewed studies.
Pharma firms are “required to assess the safety of all components” of new drugs or biological products before they’re permitted to sell them.
“(S)tudies conducted with versions of the product that don’t conform to exact specification(s) of the final version may serve only as supporting information for the approval of the latter.”
They “should never be deemed definitive and sufficient tests for claims of safety or efficacy pertaining to the final product.”
Yet the FDA permitted unprecedented deviations of longstanding regulatory practices to expedite the availability of Pfizer, Moderna and J & J flu/covid jabs — knowing the hazards and ineffectiveness of these drugs.
While limited toxicity studies were conducted, “the complete pharmacokinetics of the active ingredient mRNA was never studied.”
Claims of safety and effectiveness by Pfizer, Moderna and J & J were scientifically and ethically dishonest.
According to Pfizer’s own explanation of test results, animals used “experienced appetite and weight loss, had fever, clinical pathology and laboratory parameter changes consistent with inflammation.”
They had “enlarged spleens and lymph nodes.”
“Pathological findings in liver, spleen, bone marrow and lymph nodes were noted but not described in detail…just waived off as not significant.”
Pfizer and the FDA have gone all-out to keep toxicology data secret for good reason.
Evidence shows that its mRNA jabs destroy health, not the other way around as falsely promoted.
“Pfizer skipped major categories of safety testing altogether.”
The firm “used dishonest and self-serving interpretation of regulatory guidelines to avoid routine safety testing.”
Prior FDA experience with gene altering drugs showed that it knew about the following hazards:
“Multi-organ failure and death.
Induction of tumors and cancers.
Late-onset T-cell leukemia.
Uncontrollably prolonged gene expression even after single administration.
Autoimmunity.
Altered expression of host cell genes.
Migration of product to undesired organ systems, and
Shedding of transgenic viral particles that could be transmitted to other individuals.”
Pre-2020, gene altering drugs — called gene therapy — “were being developed for extremely severe, often fatal illnesses like terminal cancer and Huntington’s disease.”
Healthy individuals were not to be used as test subjects because of the risks these drugs pose.
Yet they’ve been mass-marketed throughout the US/West and elsewhere —without regard for the hazards they pose.
The FDA, CDC and other US/Western anti-public health agencies are beholden to Pharma’s profit-making interests — public health and well-being be damned.
Everyone jabbed with Pfizer, Moderna and J & J flu/covid kill shots were irreparably harmed, their lifespans shortened.
Based on officially reported VAERS and European Medicines Agency data, millions experienced adverse events from flu/covid jabs.
Tens of thousands died.
The true toll throughout the West and elsewhere is infinitely higher than reported numbers.
Protecting and preserving health requires shunning kill shots.
Once taken, there’s no way to reverse their harm.
The more jabs gotten, the greater the destruction of health, the shorter the lifespan of individuals getting them.
Since seasonal flu/influenza was renamed covid, we’ve been lied to and scammed by ruling regimes, their anti-public health agencies, Pharma and their MSM press agents.
All things flu/covid is the mother of all state-sponsored scams.
Noted physician Vernon Coleman stressed that US/Western dark forces “faked a pandemic, faked a test and faked a cure.”
He called flu/covid “the greatest hoax in history” for good reason.
Original Article: https://stephenlendman.org/2022/06/11/pfizer-fraud/
Please note this United States Department of Justice News publication dated September 2, 2009.
For ease of reference, here is the text of the U.S. Department of Justice press release.
Justice Department Announces Largest Health Care Fraud Settlement in Its History
Pfizer to Pay $2.3 Billion for Fraudulent Marketing
September 2, 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.
Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.
In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.
As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.
Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation. As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery.
The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases. The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra. The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.
"Today’s landmark settlement is an example of the Department of Justice’s ongoing and intensive efforts to protect the American public and recover funds for the federal treasury and the public from those who seek to earn a profit through fraud. It shows one of the many ways in which federal government, in partnership with its state and local allies, can help the American people at a time when budgets are tight and health care costs are increasing," said Associate Attorney General Tom Perrelli. "This settlement is a testament to the type of broad, coordinated effort among federal agencies and with our state and local partners that is at the core of the Department of Justice’s approach to law enforcement."
"This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,"said Kathleen Sebelius, Secretary of Department of Health and Human Services"The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste."
"Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars," said Tony West, Assistant Attorney General for the Civil Division. "This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare."
"The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer’s crimes," said Mike Loucks, acting U.S. Attorney for the District of Massachusetts. "Pfizer violated the law over an extensive time period. Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws. Today’s enormous fine demonstrates that such blatant and continued disregard of the law will not be tolerated."
"Although these types of investigations are often long and complicated and require many resources to achieve positive results, the FBI will not be deterred from continuing to ensure that pharmaceutical companies conduct business in a lawful manner," said Kevin Perkins, FBI Assistant Director, Criminal Investigative Division.
"This resolution protects the FDA in its vital mission of ensuring that drugs are safe and effective. When manufacturers undermine the FDA’s rules, they interfere with a doctor’s judgment and can put patient health at risk," commented Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. "The public trusts companies to market their drugs for uses that FDA has approved, and trusts that doctors are using independent judgment. Federal health dollars should only be spent on treatment decisions untainted by misinformation from manufacturers concerned with the bottom line."
"This settlement demonstrates the ongoing efforts to pursue violations of the False Claims Act and recover taxpayer dollars for the Medicare and Medicaid programs," noted Jim Zerhusen, U.S. Attorney for the Eastern District of Kentucky.
"This historic settlement emphasizes the government’s commitment to corporate and individual accountability and to transparency throughout the pharmaceutical industry," said Daniel R. Levinson, Inspector General of the United States Department of Health and Human Services. "The corporate integrity agreement requires senior Pfizer executives and board members to complete annual compliance certifications and opens Pfizer to more public scrutiny by requiring it to make detailed disclosures on its Web site. We expect this agreement to increase integrity in the marketing of pharmaceuticals."
"The off-label promotion of pharmaceutical drugs by Pfizer significantly impacted the integrity of TRICARE, the Department of Defense’s healthcare system," said Sharon Woods, Director, Defense Criminal Investigative Service. "This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system. Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its law enforcement partners to investigate and prosecute those that abuse the government’s healthcare programs at the expense of the taxpayers and patients."
"Federal employees deserve health care providers and suppliers, including drug manufacturers, that meet the highest standards of ethical and professional behavior," said Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management. "Today’s settlement reminds the pharmaceutical industry that it must observe those standards and reflects the commitment of federal law enforcement organizations to pursue improper and illegal conduct that places health care consumers at risk."
"Health care fraud has a significant financial impact on the Postal Service. This case alone impacted more than 10,000 postal employees on workers’ compensation who were treated with these drugs," said Joseph Finn, Special Agent in Charge for the Postal Service’s Office of Inspector General. "Last year the Postal Service paid more than $1 billion in workers’ compensation benefits to postal employees injured on the job."
I will leave off by sharing Kanekoae’s excellent blog published December 14, 2021.
Pfizer's History of Fraud, Corruption, and Using Nigerian Children as 'Human Guinea Pigs'
How did Pfizer manage to rebrand itself as the savior of humanity?
KanekoaTheGreat • Dec 14, 2021
One of the most significant cultural transformations of the last two years has been the newfound glorification of the pharmaceutical industry.
An industry plagued by decades of fraud, corruption, and criminality managed to quickly rebrand itself as the savior of humanity during the covid-19 crisis.
But nothing inherently changed. Big Pharma still values shareholders’ profits more than people’s lives.
The regulatory agencies still operate as revolving doors to the pharmaceutical giants they are said to regulate.
To support my work as a citizen journalist, please consider becoming a free or paid subscriber.
Big Pharma still dominates lobbying efforts in Washington DC and spends billions each year advertising pharmaceutical products.
Despite the notorious corrupt nature of the pharmaceutical industry, Pfizer’s CEO Albert Bourla claimed during a November 2021 interview, that a small group of “medical professionals” who are intentionally circulating “misinformation” critical of the Pfizer vaccine narrative are “criminals”.
Bourla seemed to have forgotten about the history of his own company.
Pfizer’s Long History Of Criminal Behavior
In 1991, the federal government fined Pfizer, a then-record $3.1 million for violating the Clean Water Act at its former plant in Easton, Pennsylvania. Pfizer dumped untreated industrial wastes into the Easton Area Joint Sewer Authority's wastewater treatment plant over a six-year period. According to the EPA, Pfizer's untreated discharges were responsible for the failure of the Easton sewage treatment facility, and that led to minimally treated and untreated industrial and domestic wastes being dumped in the Delaware River for a number of years.
In 1992, Pfizer agreed to pay between $165 million and $215 million to settle lawsuits arising from the fracturing of its Bjork-Shiley Convexo-Concave heart valve, which at the time had resulted in nearly 300 deaths, and by 2012 had resulted in 663 deaths.
In 1994, Pfizer agreed to pay $10.75 million to settle Justice Department claims that the company lied to get federal approval for a mechanical heart valve that has fractured, killing hundreds of patients worldwide. Under the settlement, Pfizer also agreed to pay $9.25 million in coming years to monitor patients who received the device at Veterans Administration hospitals or pay for its removal. The deal was criticized by consumer rights activists who urged Government officials to bring criminal charges and lobbied for a steeper civil penalty for the multibillion-dollar company that had covered up safety concerns even as the device was killing patients.
In 1996, Pfizer administered an experimental drug during a clinical trial on 200 children in Nigeria but never told the parents that their children were the subjects of an experiment. Eleven of the children died and many others suffered side effects such as brain damage and organ failure. A report by Nigeria’s health ministry concluded, the experiment was "an illegal trial of an unregistered drug," a "clear case of exploitation of the ignorant," and a violation of Nigerian and international law. Pfizer did not obtain consent or inform the patients that they were the subjects of an experiment, not the recipients of an approved drug.
In 2002, Pfizer agreed to pay $49 million to settle allegations that the drug company defrauded the federal government and 40 states by charging too much for its cholesterol treatment Lipitor. Lipitor had sales of $6.45 billion in 2001.
In 2004, Pfizer agreed to plead guilty to two felonies and paid $430 million in penalties to settle charges that it fraudulently promoted the drug Neurontin for unapproved uses. Pfizer agreed that it aggressively marketed the epilepsy drug by illicit means for unrelated conditions including bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal. Pfizer’s tactics included planting company operatives in the audience at medical education events and bribing doctors with luxury trips.
In 2008, the New York Times published an article entitled, “Experts Conclude Pfizer Manipulated Studies.” Pfizer delayed the publication of negative studies, spun negative data to place it in a more positive light, and controlled the flow of clinical research data in order to promote it’s epilepsy drug Neurontin. Pfizer discontinued its marketing program for Neurontin in 2004 after the drug became available as a generic. That same year, the company paid $430 million to settle federal criminal and civil claims that one of its subsidiaries had promoted the drug for unapproved uses.
In 2009, Pfizer was fined $2.3 billion, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with "the intent to defraud or mislead", promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. The government alleged that Pfizer had paid kickbacks to compliant doctors and also promoted three other drugs illegally: the antipsychotic Geodon, an antibiotic Zyvox, and the antiepileptic drug Lyrica.
In 2009, Pfizer paid $750 million to settle 35,000 claims that its drug, Rezulin, was responsible for 63 deaths and dozens of liver failures. Rezulin’s withdrawal from the U.S. market on March 21, 2000, followed negotiations between the drug’s manufacturer and the FDA. Senior FDA officials had long stood behind the drug despite a mounting death toll and Rezulin’s absence of proven life-saving benefits. The position of the FDA officials stood in contrast to their counterparts in Britain, where Rezulin was removed effective Dec. 1, 1997.
In 2010, Pfizer was ordered to pay $142.1 million in damages for violating federal anti-racketeering law by its fraudulent sale and marketing of Neurontin for uses not approved by the FDA. The jury found that Pfizer’s marketing of ‘Neurontin’ violated both the Racketeer Influenced and Corrupt Organizations Act (RICO) and California’s Unfair Competition Law.
In 2010, the New York Times published an article entitled, “Pfizer Gives Details on Payments to Doctors”. Pfizer admitted that it paid about $20 million to 4,500 doctors and other medical professionals for consulting and speaking on its behalf in the last six months of 2009. Pfizer also paid $15.3 million to 250 academic medical centers and other research groups for clinical trials in the same period. The disclosures were required by an agreement that the company signed to settle a federal investigation into the illegal promotion of drugs for off-label uses.
In 2010, Blue Cross Blue Shield filed a lawsuit against Pfizer accusing the pharmaceutical giant of illegally bribing 5,000 doctors with lavish Caribbean vacations, golf games, massages, and other recreational activities in order to convince doctors to use Bextra for off-label use.
In 2010, leaked cables between Pfizer and US officials in Nigeria showed that Pfizer had hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to blackmail him to drop legal action over the controversial 1996 Trovan trial involving children with meningitis. In 2009, Pfizer agreed to pay $75 million to the families harmed during the 1996 drug trial, but the cables suggest that the US drug giant was looking for blackmail to get the Nigerian attorney general to drop the $6 billion federal suit against Pfizer. The leaks showed that Pfizer’s investigators were passing ‘damaging’ information to the local media and threatening the attorney general that much more damaging information would come out if he did not drop the suit. The $6 billion lawsuit was dropped in 2009.
In 2012, the Securities and Exchange Commission charged Pfizer Inc. with violating the Foreign Corrupt Practices Act (FCPA) when its subsidiaries bribed doctors and other health care professionals employed by foreign governments in Bulgaria, China, Croatia, Czech Republic, Italy, Kazakhstan, Russia, and Serbia in order to win business. According to the SEC, employees of Pfizer’s subsidiaries authorized and made cash payments and provided other incentives to bribe government doctors to utilize Pfizer products.
In 2012, Pfizer had paid $1.2 billion to settle claims by nearly 10,000 women that its hormone replacement therapy drug, Prempro, caused breast cancer. The Prempro settlements come after six years of trials, in which several plaintiffs were awarded tens of millions of dollars, including punitive damages for the drug maker’s actions in withholding information about the risk of breast cancer from Prempro.
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 claims by 2,700 people that its drug, Chantix, caused suicidal thoughts and severe psychological disorders. The FDA determined that Chantix is probably associated with a higher risk of a heart attack.
In 2014, Pfizer paid $35 million to settle a lawsuit accusing its subsidiary of promoting the kidney transplant drug, Rapamune, for unapproved uses, including bribing doctors to prescribe it to patients. According to New York Attorney General Eric Schneiderman, who led the probe, Wyeth got doctors to push the drug for unapproved uses, relying on "misleading presentations of data."
In 2016, Pfizer was fined a record £84.2 million for overcharging the NHS for its anti-epilepsy drug, Phenytoin, by 2,600 percent (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.
This is only a partial list of the fraud, corruption, and criminality of Pfizer. There are other examples of Pfizer unethically testing pharmaceutical products in the world’s poorest nations and participating in other criminal actions.
Whistleblowers Expose Pfizer Covid-19 Vaccine Trials
While Pfizer’s CEO believes that it is criminal to question the integrity of his pharmaceutical company, multiple whistleblowers have already come forward exposing the lack of integrity of Pfizer’s covid-19 vaccine trials.
Leading medical journal, The BMJ, published a report exposing faked data, blind trial failures, poorly trained vaccinators, and a slow follow-up on adverse reactions in the phase-three trial of Pfizer’s gene therapy shots.
When the whistleblower reported her concerns to the US Food and Drug Administration (FDA), she was fired later the same day on the basis that she was “not a good fit”. The FDA never inspected the clinical trial site of the whistleblower complaint.
Another whistleblower named, Maddie de Garay, volunteered for the Pfizer trial for 12 to 15-year-olds. 24-hours after her second dose she was in an emergency room.
She is now in a wheelchair, requires a feeding tube through her nose, and is still suffering 9-months later. Maddie was 1 of 1,131 children in Pfizer's clinical trial for children aged 12-15.
Pfizer officially recorded Maddie's adverse event as "abdominal pain" when reporting clinical trial results to the FDA. If we know Maddie's devastating, life-altering injury is recorded as "abdominal pain" in the clinical trials: what other serious adverse events have been hidden by Pfizer and ignored by the FDA?
Attorney Aaron Siri and a group of more than 30 scientists, medical professionals, and journalists, asked the FDA for “all data and information for the Pfizer vaccine,” including safety and effectiveness data, adverse reaction reports and a list of active and inactive ingredients.
The FDA managed to consider all 329,000 pages of data and grant emergency approval of the Pfizer vaccine within just 108 days, but is now asking for 75 years to fully release that information to the public.
Siri wrote on his Substack, “So, let’s get this straight. The federal government shields Pfizer from liability. Gives it billions of dollars. Makes Americans take its product. But won’t let you see the data supporting its product’s safety and efficacy. Who does the government work for?”
In a December 2021 interview, World Bank President, David Malpass, said that Pfizer will not give mRNA shots to countries where they face legal liabilities for side effects.
Malpass shared, “Pfizer has been hesitant to go into some of the countries because of the liability problems, they don’t have a liability shield.” This clearly shows that Pfizer is not operating from some moral high road of the betterment of society. This is about profit and the people of the world have every right to question the integrity of Pfizer based upon its criminal history and current actions.
As I have written in previous articles, this is still a pandemic of the untreated due to the fact that captured regulatory agencies refuse to provide early treatment protocols featuring cheap and effective off-patent medications.
How much of this refusal to treat patients is due to Big Pharma’s leverage over captured regulatory agencies?
And, by all accounts, the covid mRNA gene therapy shots are failing to stop the spread all around the world, but Pfizer expects to bring in $33.5 billion in vaccine revenue in 2021 and expects even more profits in 2022 if it is able to continue to convince the world that its pharmaceutical products are the savior of humanity.
THE DOWNLOAD:
Joe Rogan Experience #1747 - Dr. Peter McCullough: Dr. Peter A. McCullough, MD, MPH, is a board-certified cardiologist who has testified before committees of the US and Texas Senate regarding the treatment of COVID-19 and management of the ongoing pandemic. He joins Joe Rogan to discuss early treatment, vaccines, and all things covid-19 in the most important podcast episode of 2021. Watch here.
Doctor’s Orders - A Documentary By DefendingTheRebuplic.Org: Defending The Republic has produced a documentary, Doctors Orders, on covid-19 issues. The documentary features Dr. Vladimir Zelenko, Dr. Bradley Meyer, Dr. Ted Fogarty, and other medical professionals talking about how our medical system has failed the American people by blocking safe and effective early treatment options for covid-19. Watch here.
Dr. Robert Malone Puts Out Statement Against Vaccinating Healthy Children: Before you vaccinate your child, which is irreversible and potentially permanently damaging, find out why 15,000 physicians and medical scientists around the world signed a declaration publicly declaring that healthy children should NOT be vaccinated for COVID-19. On behalf of these MDs and PhDs, Dr. Robert Malone, who has devoted his career to vaccine development, provides parents a clear statement outlining the scientific facts behind this decision. Watch here.
Huge New Study Shows Zero COVID Deaths Among Healthy German Children: German physician-scientists reported Monday that not a single healthy child between the ages of 5 and 18 died of Covid in Germany in the first 15 months of the epidemic. Not one. Serious illness was also extremely rare. The odds that a healthy child aged 5-11 would require intensive care for Covid were about 1 in 50,000, the researchers found. For older and younger children, the odds were about 1 in 8,000. Read here.
More Than 400 Studies On The Failure Of Compulsory Covid Interventions: The great body of evidence shows that COVID-19 lockdowns, shelter-in-place policies, masks, school closures, and mask mandates have failed in their purpose of curbing transmission or reducing deaths. These restrictive policies were ineffective and devastating failures, causing immense harm especially to the poorer and vulnerable within societies. The research indicates that mask mandates, lockdowns, and school closures have had no discernible impact on virus trajectories. Read here.
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Hunter Biden laptop investigation solved:
https://ragnarforseti.substack.com/p/urgent-hunter-biden-laptop-investigation?r=hjhbr&s=w&utm_campaign=post&utm_medium=web
Can anyone, please, locate the contract between Pfizer and the government that specifically allowed Pfizer to skirt industry-standard FDA regulations with regard to its COVID vaccines. Isolating the exact portion of the contract, behind which Pfizer attempts to defend itself, is critically important. Let's have a look at that. Thanks, Doc