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Sue's Blog

Wednesday, 03/24/21 - The Makers of CV VaXX criminal and civil violations

Are you doing your homework or just blindly following what the government, drug companies, MSM and health professionals with a financial agenda are telling you to do?

FYI -  

The Forbidden COVID-19 Chronicles

The Makers of COVID-19 Vaccines: Johnson & Johnson
Pamela A. Popper, President
Wellness Forum Health

While some people enthusiastically anticipated the release of COVID-19 vaccines, others have a much more cautious view, and a significant percentage of people state that they will not receive ANY COVID-19 vaccines. The new term for people who are concerned about vaccines is "vaccine-hesitant" (medical authorities finally acknowledged that negative name-calling was not helping their cause) and health officials are concerned about this rather large and growing group of people. Why are 35-40% of Americans (depending on the survey cited) refusing to take one of these vaccines? One commonly cited reason is the track record of the vaccine makers.

Take Johnson & Johnson, for example. The company announced that it received Emergency Use Authorization for its single injection COVID-19 vaccine on February 27, 2021. The vaccine was developed by a subsidiary, Janssen Pharmaceutical Companies, and is available for individuals age 18 and older.[1]

Both Johnson & Johnson and Janssen have made and distributed drugs and vaccines for a long time in the U.S., and both have paid large fines to state and federal governments. Since 2000, J&J and its subsidiaries have been charged 55 times with criminal or civil crimes and have paid a total of $4,247,381 in fines.[2]

J&J and its subsidiaries paid over $2.2 billion in 2013 in one of the largest healthcare fraud settlements in the history of the U.S. [3] Here are just a few of the details (from Department of Justice documents):[4]

J&J subsidiary Janssen Pharmaceuticals marketed Risperdal, an antipsychotic drug, for unapproved uses. The company’s drug reps promoted Risperdal to doctors and other prescribers who treated elderly dementia patients, falsely claiming that the drug was effective for symptoms like anxiety, agitation, depression, hostility, and confusion.

 

Blatantly disregarding the fact that at the time Risperdal was only approved for the treatment of schizophrenia, Janssen created an "ElderCare sales force" to market the drug to prescribers. The company’s business plan stated that its goal was to "[m]aximize and grow Risperdal’s market leadership in geriatrics and long-term care." Written sales aids and promotional materials were developed for reps to use when calling on doctors. The company provided incentives for off-label promotion and based bonuses for its salespeople on total sales of Risperdal in their territories, not just sales for FDA-approved uses. The company also paid kickbacks to doctors who prescribed the drug. Reps told doctors that they would receive generous speaker’s fees if they were prolific prescribers.

 

The company’s illegal practices resulted in the filing of false claims with federal healthcare programs. Additionally, J&J and Janssen paid kickbacks to Omnicare, Inc., the largest pharmacy specializing in dispensing drugs to nursing home patients. These kickbacks were falsely categorized as market share rebates, data-purchase fees, grants, and educational funding. The kickbacks were designed to incentivize Omnicare’s pharmacists to promote Risperdal to nursing home patients.

 

Janssen was warned by FDA officials on several occasions that claims that Risperdal was safe and effective were misleading. FDA officials told Janssen executives that behavioral problems in elderly dementia patients were usually not due to psychotic disorders and were more likely "appropriate responses to the deplorable conditions under which some demented patients are housed…"

 

According to the Justice Department, both J&J and Janssen knew that Risperdal increased the risk of stroke in the elderly. The companies manipulated data in order to cover this up. When a J&J study showed that taking Risperdal significantly increased the risk of stroke and other adverse events, Janssen executives combined the data with other studies to make it look like the drug actually lowered the risk.

 

A second study confirmed the risk of Risperdal for elderly patients. When it looked like the company was not going to publish the data, a physician involved with the study advised Janssen that "[a]t this point, so long after [the study] has been completed…we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings."

 

Another complication of Risperdal was increased risk of diabetes. First, the company outright lied, promoting Risperdal as "uncompromised by safety concerns (does not cause diabetes)." When confronted with research showing that Risperdal increased the risk of diabetes, just like other antipsychotics, the company hired experts to re-analyze the study and to publish articles stating that Risperdal actually lowered the risk of diabetes.

 

The company’s behavior seems particularly egregious since the targeted population for the unlawful prescribing of the drug were some of the most vulnerable people. In addition to elderly nursing home patients, Janssen promoted the drug to children and adults who had developmental disabilities. Records show that both J&J and Janssen executives knew that there were several risks associated with prescribing Risperdal to children. These included the risk of elevated levels of prolactin, a hormone that stimulates breast development and milk production. Nonetheless, Janssen’s "Key Base Business Goals" included growing and protecting market share for children and adolescents for Risperdal. Reps were instructed to call on psychiatrists and facilities that treated children, and to promote Risperdal as a safe and effective drug for children with attention deficit disorder, oppositional defiant disorder, obsessive-compulsive disorder, and autism. The company was warned repeatedly by FDA not to promote the drug for use in children.


It is important to note that there are other side effects of Risperdal that are quite concerning, including tardive dyskinesia, fatigue, drowsiness, fever, weight gain, dry mouth, restlessness, anxiety, insomnia, vomiting, stomach pain, constipation, cough, sore throat, and skin rash.[5]

Drug companies make so much money that multi-billion-dollar fines for criminal behavior are just a cost of doing business. Thus it is not surprising that in 2019, an Oklahoma judge ruled that J&J had intentionally minimized the risks and misrepresented the benefits of opioid drugs. The judge wrote that J&J had used "false, misleading and dangerous marketing campaigns" that "caused exponentially increasing rates of addiction, overdose deaths, and babies born exposed to opioids." The company was ordered to pay the state $572 million.[6]

I’ve presented here just a couple of the episodes in which J&J and/or its subsidiaries were caught committing criminal fraud and engaging in activities that resulted in considerable harm and even death for large numbers of people. The company is a serial offender, yet the federal government continues to allow it to do business in the U.S., and routinely approves new products submitted by the company, such as its new COVID-19 vaccine.

I can’t fathom that anyone who knows about J&J and its prior bad acts would agree to any medical intervention produced and marketed by it. I certainly won’t.

Pam Popper
Author of 'Covid Operation'

 

WellnessForumHealth.com
 


[1] https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic


[2] https://violationtracker.goodjobsfirst.org/parent/johnson-and-johnson


[3] https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations


[4] IBID


[5] https://www.rxlist.com/risperdal-side-effects-drug-center.htm


[6] https://www.statnews.com/2019/08/26/oklahoma-judge-finds-johnson-johnson-fueled-opioid-crisis/

 

Part 2 - Pfizer's track record -

 

The Forbidden COVID-19 Chronicles
The Makers of COVID-19 Vaccines: Pfizer
Pamela A. Popper, President
Wellness Forum Health


Since the year 2000, Pfizer has been charged 74 times with criminal and civil violations and paid a total of $4,660,896,333 in fines. The top offenses to which the company plead guilty are unapproved marketing of products, bribery, making false claims, safety violations, environmental violations, racketeering, and violations of the Foreign Corrupt Practices Act.[1]

In spite of a very long list of criminal convictions, Pfizer and BioNTech were given an emergency use authorization for a COVID-19 vaccine on December 1, 2020.

Here are just a few of the episodes in which Pfizer and its subsidiaries have been found guilty of egregious acts:

In 2001, thirty Nigerian families sued Pfizer, claiming that the company conducted an unauthorized clinical trial of an untested antibiotic on their children without their consent in 1996 during a meningitis epidemic. Eleven children died as a result, and others had brain damage or became partially paralyzed or deaf.[2] In 2009 the company reached an out-of-court settlement with the Kenyan government for $75 million dollars, and in August 2011 the company paid $175,000 to each family to settle the claims.[3]

In 2004, Pfizer’s Warner-Lambert subsidiary paid $430 million to settle criminal and civil charges that it paid doctors to prescribe Neurontin, an epilepsy drug, for conditions for which it was never approved.[4] In 2008 it was discovered that Pfizer suppressed research showing that Neurontin did not work for these conditions and that the company routinely spun negative data about the drug to place it a more positive light. Additionally, the company combined negative studies with positive studies to neutralize negative findings and hide the fact that Neurontin did not work for unapproved uses.[5] A judge ordered the company to pay $142 million to settle racketeering charges.[6]

In 2005, Pfizer agreed to stop advertising Celebrex on television and subsequently admitted that a 1999 clinical trial showed that Celebrex increased the risk of heart disease in elderly patients.[7]

Pfizer and its subsidiary company Pharmacia and Upjohn can boast that in 2009 it paid the largest criminal fine ever in the history of the U.S. (at that time) for any matter - $1.195 billion dollars. The reason for the fine – the company’s reps were marketing Bextra, a pain reliever, for uses and doses specifically prohibited by the FDA. Additionally, the company was forced to forfeit $105 million which brought the total settlement of criminal charges to $1.3 billion.

In addition, Pfizer agreed to pay $1 billion more to resolve charges brought under the False Claims Act that the company illegally promoted four drugs – Bextra, Geodon (an anti-psychotic), Zyvox (an antibiotic) and Lyrica (an anti-epileptic drug) for off-label uses. The company was also found to have bribed doctors, paying kickbacks as incentives to prescribe these and other drugs.[8]

Subsequently, Bextra was withdrawn from the market after the FDA mandated a black box warning about cardiovascular and gastrointestinal side effects.[9] The company set aside $894 million dollars to settle claims for both Bextra and Celebrex.[10]

One of Pfizer’s biggest scandals involved defective heart valves sold through one of its subsidiaries that killed over 100 people. An investigation of this matter showed that the company deliberately misled regulators while seeking approval for the product. The company agreed to stop making the valves, but they had already been implanted in tens of thousands of people who were now at risk.[11] In 1994, the company paid $10.75 million to settle charges brought by the Justice Department that it lied to regulators about risks associated with these valves.

In 2012 the company settled charges related to a multi-million-dollar bribery scheme involving payments to government officials, health regulators, doctors, and hospital administrators in Bulgaria, Croatia, Kazakhstan and Russia. Pfizer used sham consulting contracts, exclusive distributorships and improper travel and cash payments in order to gain market share, and earned over $7 million in profits as a result of its illegal behavior. The fine – only $15 million.[12]

During one 3-year period, Pfizer Italy provided free cell phones, copy machines, printers and televisions to doctors; gave them paid vacations with companions; and made direct cash payments to doctors which were falsely categorized as speaker fees and professional training. The company paid a fine of $60.2 million which represents about one half of one percent of the company’s annual profits.[13]

And this is the problem. For Pfizer and other drug companies, paying billions of dollars in criminal and civil fines for misrepresentation and hurting and killing people is just a cost of doing business. Employees of Pfizer and its subsidiaries are not indicted and prosecuted, so there really is no reason for the company’s management to stop doing these things.

Would you purchase any product made by this company? I wouldn’t – not even mouth wash. Why? Because Pfizer could not even play it straight with a product like this. The company paid $70,000 in fines to 10 states to settle charges concerning misleading advertising for a mouth rinse called Plax in 1991.[14]

What on earth would possess regulators to allow a company like this to continue to do business in the United States? Or to grant an Emergency Use Authorization to a Pfizer vaccine? Regulators would not allow it, but business partners, of course, would. And it is abundantly clear that U.S. government agencies like the FDA and CDC are not regulators, but rather business partners for drug and vaccine makers.
  


[1] https://violationtracker.goodjobsfirst.org/parent/pfizer


[2] Tamar Lewin. Families Sue Pfizer on Test of Antibiotic. New York Times August 30 2001


[3] David Smith. Pfizer pays out to Nigerian families of meningitis drug trial victims. The Guardian August 12 2011


[4] https://www.justice.gov/archive/opa/pr/2004/May/04_civ_322.htm


[5] Stephanie Saul. Experts Concluded Pfizer Manipulated Studies. New York  Times Oct 8 2008


[6] Jef Feeley and Janelle Lawrence. Pfizer to Pay $142.1 Million Over Neurontin Marketing. Bloomberg Jan 28 2011


[7] Alex Berneson and Gardiner Harris. Pfizer Says 1999 Trials Revealed Risks With Celebrex. New York Times Feb 1 2005


[8] https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history


[9] Anna Wilde Mathews and Scot Hensley. FDA Stiffens Painkiller Warnings, Pushes Pfizer to Suspend Bextra. Wall Street Journal April 8 2005


[10] Stephanie Saul. Pfizer to Settle Claims Over Bextra and Celebrex. New York Times Oct 17, 2008


[11] Manufacturer Ends Production of Heart Valve. New York Times November 28 1986


[12] https://www.justice.gov/opa/pr/pfizer-hcp-corp-agrees-pay-15-million-penalty-resolve-foreign-bribery-investigation


[13] Paul Knaggs. Coronavirus: what do we know about ‘Pfizer’ and can we trust them with a vaccine. Labour Heartlands November 10 2020


[14] The Media Business: Advertising; Pfizer’s Pact on Plax Ads. New York Times Feb 21 1991




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