Meet the criminal corporations developing COVID-19 vaccines

14 December 2020

In last week’s article, COVID-19 vaccines: Magic bullets or mirages?, I drew attention to some key questions about vaccines against SARS-CoV-2 – namely, whether they will achieve outcomes that actually matter, including prevention of transmission of the virus associated with COVID-19 (hint: the CEO of Pfizer, the company whose vaccine the UK government has already begun injecting into its citizens, has commented “I think that’s something that needs to be examined. We’re not certain about that right now,”), and whether they will reduce the risk of serious illness and death.

Another key question has been brought to the fore by an article published in the November 17 edition of the Journal of the American Medical Association (JAMA): Can we trust pharmaceutical companies to produce safe and effective vaccines, and to tell the public the truth about the outcomes of their research into those vaccines’ effects?

The article, titled ‘Financial Penalties Imposed on Large Pharmaceutical Firms for Illegal Activities’, analysed data on fines imposed on pharmaceutical firms included in the Global 500 or Fortune 1000 lists between January 2003 and December 2016.

The researchers identified 26 pharmaceutical companies that had been on either or both of these lists for at least 7 years, and found that only 4 of them had not been convicted of any illegal activity during the study period.

Illegal activities for which drug companies were fined included:

• Adulterated drugs: Manufacturing and distributing adulterated or unapproved drugs.
• Bribery: Bribery to foreign officials, suppliers, or other entities.
• Competition: Fraudulently delaying market entry of competitors, antitrust, monopoly.
• Disclosure: Failure to disclose negative information about a product or about poor drug development.
• Environmental violations: Violations of environmental regulation (e.g. Clean Air Act).
• Financial violations: Tax fraud and insider trading.
• Kickbacks: Offering kickbacks to suppliers or customers to purchase and sell their product(s).
• Misleading marketing: Misleading or deceptive marketing practices.
• Off-label marketing: Advertising a product for uses other than approved by the US Food and Drug Administration.
• Pricing: Overpricing drugs reimbursed or paid for by government, underpaying rebate obligations, fraudulent pricing or billing, or other pricing illegalities.
• Uncategorised: Violations that do not fit the other reported categories.

The most prolific offender was the British-based multinational pharmaceutical behemoth GlaxoSmithKline (GSK), which racked up 27 convictions during the study period, amounting to a mind-boggling US$9 775 419 000 in fines (adjusted for inflation to 2016 values).

What’s even more mind-boggling is that this nigh-on $10 billion in financial penalties amounted to only 1.55% of the company’s total revenues, suggesting that crime really does pay for pharmaceutical giants.

GSK, demonstrating its talents as a criminal all-rounder, spread its illegal activities across the entire field, being convicted of 11 pricing violations, 5 each of disclosure and misleading marketing, 3 each of competition and environmental violations and off-label marketing, 2 counts each of selling adulterated drugs, bribery and kickbacks, and 1 count each of financial and uncategorised violations. (Some convictions covered multiple categories of illegal activity, hence the total number of illegal activities exceeds the number of penalties levied.)

The average duration of the illegal activities for which GSK was eventually convicted and fined was 7.22 years, suggesting an ingrained culture of rank disregard for all laws and regulations intended to ensure public safety and a competitive marketplace.

Great moments in GSK’s history include:

• Illegally promoting Paxil for treatment of depression in children while suppressing evidence that the drug was no more effective than placebo, but promoted suicidal thoughts and behaviour.
• Actively concealing evidence that their diabetes drug Avandia increased the risk of heart attacks and cardiac deaths.
• Promoting off-label use of the antinausea drug Zofran (ondansetron) to pregnant women; a slew of birth defects resulted from this unapproved application of a drug intended for people undergoing cancer treatment.

US-based Pfizer ran a poor second to GSK (although they did win the prize for the largest health care fraud settlement in US history, paying out a record US$2.3 billion for fraudulent marketing of their anti-inflammatory drug Bextra), amassing 18 penalties which amounted to US$2 910 581 000.

This eye-popping sum – just shy of US$3 billion – represented only 0.36% of the company’s total revenue. Well done to Pfizer for limiting the impact of its criminal activities on the corporate bottom line.

Pfizer was convicted of 7 counts of misleading marketing, 5 of off-label marketing, 4 environmental and 3 pricing violations, 2 counts of bribery, and 1 each of disclosure violations and kickbacks.

The average duration of the illegal activities for which Pfizer was penalised was 5.67 years.

Aside from the Bextra scandal, other highlights (or lowlights?) of Pfizer’s criminal activities include:

• Conducting an unapproved clinical trial of their antibiotic Trovan on Nigerian children with meningitis; the drug killed 11 children and left dozens more disabled.
• Contaminating at least two lots of its antidepressant drug Effexor XR with Tikosyn, an antiarrhythmic drug; the combination of the two different drugs could be fatal.

Johnson & Johnson – that trusted purveyor of asbestos-laced baby powder and addiction-fuelling opioid drugs – won third prize in the Pharma Dirty Tricks Derby, amassing 15 penalties which amounted to US$ 2 668 326 000 (just 0.28% of the company’s total revenues), including 9 for off-label marketing, 5 for disclosure violations, 4 each for kickbacks and misleading marketing, 2 pricing violations and 1 count each of selling adulterated drugs and bribery.

The average duration of J&J’s illegal activities was 6.08 years.

While all the major pharmaceutical companies that produce the drugs and vaccines that many Australians take every day – including Bayer, Bristol Myers Squibb, Merck, Novartis, AstraZeneca, Eli Lilly and Sanofi-Aventis – earned their places in this Pharma Hall of Shame, dishonourable mentions belong to:

• Actavis (Watson), convicted of 2 pricing violations that lasted an average of 11 years (the longest-running criminal activity identified in the study);
• Schering-Plough, which won the prize for highest percentage of revenue paid out in penalties for illegal activity (2.05% of revenue, representing 12 fines totalling US$1 645 186 000); and
• Allergan, which took out the award for the highest average penalty amount, stumping up US$660 604 000 for its single off-label marketing violation.

Here is the league table, in all its inglory:

It should also be borne in mind that these financial penalties were only levied on criminal activity that has actually been discovered; one can only hazard a guess at how many violations were not detected or prosecuted.

Now let’s look at these criminal companies’ involvement in the development of SARS-CoV-2 vaccines.

GSK has partnered with several other pharmaceutical companies to develop SARS-CoV-2 vaccines, including China-based Clover Pharmaceuticals, French pharma giant Sanofi-Aventis (which garnered 10 financial penalties amounting to US$535 923 000), and Canadian biopharmaceutical company Medicago, which is – with no evident sense of irony – backed by tobacco company Philip Morris.

In each case, GSK will be contributing its “Adjuvant System 03” (AS03), a squalene-based immunologic adjuvant (that is, a substance which elicits an immune response to the viral genetic material contained in a vaccine), which has been linked to a 13-14 fold higher risk of developing the disabling neurological condition narcolepsy among Finnish and British children who received the AS03-adjuvanted vaccine, Pandemrix, during the 2009 H1N1 swine flu pandemic-that-wasn’t.

A petition calling for urgent judicial review of the UK drug regulator’s approval of the Pfizer/BioNTech SARS-CoV-2 vaccine has been filed by Drs Wolfgang Wodarg and Michael Yeadon.

Wodarg blew the whistle on the viper’s nest of corruption that drove the World Health Organization’s (WHO’s) decision to designate the exceptionally mild 2009 swine flu a ‘pandemic’ – a decision that activated highly lucrative contracts that obligated countries to purchase vaccines and antiviral drugs from pharmaceutical companies, with whom WHO was colluding.

Yeadon is a former Vice President and Chief Science Officer of Pfizer Global R &D, whose primary expertise is in the development of allergy and respiratory therapeutics.

The two have urged the European Medicines Agency for a stay of action on the Pfizer-BioNTech vaccine until several urgent questions and concerns pertaining to the vaccine are addressed in properly-designed clinical trials:

1. The potential of the vaccine to cause antibody dependent enhancement (ADE) – a condition in which vaccine-induced antibodies trigger the immune system to react more violently than usual when it encounters the SARS-CoV-2 virus, potentially resulting in organ damage and death.
2. Potential cross-reaction of antibodies against spike proteins of SARS-CoV-2 with syncytin-1, a human endogenous retrovirus-derived protein that is necessary for formation of the placenta in women who become pregnant. This cross-reaction, if it occurs, would render women receiving the vaccine infertile.
3. The possibility of allergic reactions to polyethylene glycol (PEG), found in the fatty lipid nanoparticle coating around the messenger RNA in the Pfizer vaccine. Seventy percent of people make antibodies to PEG but most do not know it, raising the possibility of potentially deadly allergic reactions to a PEG- containing vaccine.
4. A bioluminescent ingredient derived from a marine invertebrate, mNeonGreen, is included in the Pfizer vaccine. The effects of this ingredient on immune system activity are unknown, as is the reason for its inclusion in the vaccine.
5. The clinical trials for the Pfizer vaccine (along with all the other SARS-CoV-2 vaccine candidates) are not designed to measure the effectiveness of the vaccine in preventing viral spread, or serious illness or death from infection.
6. The clinical trials use the RT-qPCR test as primary evidence of infection, despite the design flaws in this test that render it useless for diagnostic purposes (see my previous article COVID-19: To test or not to test for more details, along with a detailed review of these flaws included in the petition itself).

AstraZeneca, which racked up 10 fines totalling US$1 172 185 000, has co-developed its vaccine candidate with the University of Oxford. Aside from being associated with transverse myelitis (a serious spinal inflammatory disorder), concerns have been raised about the Oxford-AstraZeneca vaccine’s use of a genetically-engineered common cold virus to shuttle the surface protein gene of SARS-CoV-2 into cells in order to elicit an immune response.

An adenovirus vector called Ad5 was previously found to increase the risk of becoming infected with the human immunodeficiency virus, HIV, associated with AIDS.

Johnson & Johnson’s vaccine candidate also uses an adenovirus vector, while China-based CanSino Biologics’ SARS-CoV-2 vaccine uses the same Ad5 vector that was previously found to increase the risk of HIV infection.

The bottom line:

1. The major players in the race to bring SARS-CoV-2 vaccines to market are serial corporate criminals, who have paid out billions of dollars in financial penalties for their violations of every regulation intended to safeguard the public from their depraved activities. (Moderna, a front-runner in the race, has never brought a pharmaceutical product to market and therefore has never been convicted of any violations, but no doubt they’ll make up for this in no time flat.)
2. The clinical trials for SARS-CoV-2 vaccines are a farce, with no attempt having been made to determine whether any of the vaccines achieve meaningful outcomes; in Dr William Haseltine’s words, they are “designed to succeed” – that is, succeed in gaining rapid approval by drug regulators, without any attention paid to clinically meaningfully outcomes including prevention of viral transmission or reduction in the risk of serious illness or death from infection with SARS-CoV-2.
3. The rushed and inadequate trials are incapable of identifying outcomes with serious and/or life-threatening consequences, including allergic reactions, antibody dependent enhancement, infertility, and increased risk of HIV infection.
4. The pharmaceutical companies manufacturing these vaccines have been granted indemnity from prosecution for any side effects their products cause – side effects that even vaccine advocates admit are “inevitable“. Furthermore, the Australian Federal government has explicitly ruled out setting up a no-fault vaccine injury compensation scheme to provide medical care for people who suffer vaccine injuries, or financial assistance for family members of people who are killed by vaccines. Such no-fault schemes exist in Canada, New Zealand, the United States, the United Kingdom, Austria, Denmark, Finland, France, Germany, Hungary, Iceland, Italy, Norway, Russia, Latvia, Slovenia, Sweden, Switzerland, China, Japan, South Korea, Vietnam, Nepal and Thailand. Anyone who suffers an injury from a SARS-CoV-2 vaccine would effectively have to sue the government to receive compensation.

If you wish to receive a SARS-CoV-2 vaccine even after considering the above information, you have a perfect right to do so. However, any attempt by governments or corporations to mandate any products produced by these criminal corporations should be strenuously resisted.

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