Terminal Incompetence or Fraud?

Propaganda Fairytale for Terminally Gullible... ahem... Case Study on Moderna Published by Harvard Business School

I friend sent me a published case study from Harvard Business School describing Moderna’s “success story”.  As a graduate of another business school (Dartmouth College), I am familiar with HBS case studies – they are teaching materials used for discussion in class, and mostly deal with business problems or managerial issues.  The document that I read is a nauseating PR puff piece, empty of real content and full of hot air.  Moderna’s product is a massive scientific and regulatory fraud, a bio-chemical warfare agent forced on people through lies, propaganda and “mandates” with catastrophic consequences, but the HBS writers seem oblivious to it.  They seem to believe the fairytale about making of a safe and effective cure for a “terrible novel virus” in just 40 days by a company with no previous products but a long proven history of well-funded failures.

The level of reckless disregard for product safety, rational drug design, rigorous testing and quality control in biologics manufacturing is astounding.  The strangely unchecked behavior by a publicly owned company is represented as some sort of an achievement worthy of accolades, as if any company that follows laws, regulatory requirements and ethical standards is simply silly, doesn’t know how to compete, and is not run by “visionaries”.    

HBS famously produced Jeffrey Skilling of Enron.  In a surprisingly self-aware article on its website, HBS states that: IF YOU LOOK AT A LOT OF THE FRAUD CASES, BEFORE FRAUD THERE WAS TERMINAL INCOMPETENCE. https://hbswk.hbs.edu/item/enrons-lessons-for-managers

I couldn’t agree more. 

The case study paper starts by breathlessly recounting how CEO of Moderna, Stephane Bancel learned about covid-19 coronavirus in January 2020, and the whole vaccine design took just a few days afterwards.  

That timeline is of course a lie.  From the FDA Regulatory History summary for SPIKEVAX we know that this product has two co-owners and two Investigational New Drug applications with the FDA: Moderna and DMID/NIH (headed by Anthony Fauci).  It was the DMID IND#19635 that was opened first on behalf of Moderna and only months later the company opened their own IND#19745 with the FDA. 

It is notable that the first IND was opened on February 20, 2020 - almost a month before the global pandemic was announced by WHO on March 11, 2020.  This extremely unusual co-ownership of the product is different from normal IP-licensing arrangements (which still require disclosure) and represents a very large conflict of interest which is yet to be explained to the American public.  It is also impossible to form, negotiate and document such complex partnership which would involve numerous intellectual property, cost, revenue, profit sharing issues, as well as ethical concerns between a federal agency and a private business in just a couple of weeks. 

Moderna and NIH (NIAID) had entered into numerous Material Transfer Agreements and Confidentiality Disclosure Agreements as well as licensing arrangements since at least 2015.

Clearly, the reason Stephane Bancel called Anthony Fauci was not to “learn” about the new virus.  They had been working on it together for some time and had already established a close profit-sharing arrangement that would shortly get a giant windfall from an orchestrated bioterrorism operation, colloquially known as “covid pandemic and response”. 

A package of non-clinical summaries (part of the formal FDA BLA for SPIKEVAX) obtained through FOIA by Judicial Watch revealed that DMID was conducting several R&D studies on Moderna’s product mRNA-1273 in parallel with Phase 1 study initiated in February 2020:

Interestingly, while BARDA and DARPA partnerships are disclosed on Moderna’s website, there is no mention of the DMID-owned IND# for SPIKEVAX or the fact that DMID performed Phase 1 study and non-clinical studies of mRNA-1273 which were subsequently used to grant the EUA and the FDA approval.  This omission is also quite surprising in my opinion.  https://www.modernatx.com/partnerships/strategic-collaborators

Going back to the Harvard case study: prior relationship with “luminary immunologist” Anthony Fauci (aka “I am science!”) is disclosed, describing his involvement with the “factory” in 2019 that was sitting empty and doing nothing but diligently waiting for THE pandemic to hit.

In 2019 Moderna did not have products even close to late phases of human trials.  There was absolutely no need to own a biologics manufacturing factory.  The volumes of product made for preclinical studies are tiny and generally made in a lab. For example, Pfizer manufacturing documents show 1000 times smaller production volumes between preclinical studies and late stage clinical.  Production lines for biological manufacturing are also highly specialized and custom designed for a particular product.  Furthermore, a factory ready to manufacture a marketed product must be Good Manufacturing Practice compliant – this is a very time-consuming and expensive undertaking.  Why did they have a full factory in advance of any products? Were they that incompetent? Was their board of directors negligent in their fiduciary duties to authorize such a big investment “at risk” before any late-stage products would be even tested in clinical trials?   

There are more timeline problems which HBS writers do not understand, and why would they – they clearly have zero experience in pharmaceutical R&D:

Manufacture of a “clinical batch” of product before an Investigational New Drug application is opened with the FDA (see comments about IND above) is a violation of regulatory rules and cGMP laws.  Yet, disregard for rules and laws appears to be business as usual for Moderna and its accomplices at FDA, NIH, DOD and the soup of alphabet agencies.  The opening of the IND itself is a multi-months process by which a drug sponsor meets with the FDA to request formal feedback to their proposed product and clinical trials plan, and then incorporates the feedback. 

“…paired with proven track record in vaccines” – that must be satire!  Which vaccines? None of their drugs or vaccines ever made it past Phase 1 testing.  Their “previous 9 vaccines” never made it to market and were not approved anywhere in the world.

Moderna had a long history of well-funded failure.  It was founded in 2010, by Flagship Ventures (later Flagship Pioneering) – a Boston based venture fund with seemingly limitless access to capital and a portfolio of small companies obsessed with gene editing and digital control of food and agriculture.  They are prolific at IPOs that nosedive immediately and trade as penny stocks thereafter, just like Moderna did prior to its marvelous “Cinderella story” in 2020.  The HBS case quite truthfully stated that despite a gigantic investment over 10 years, Moderna had no products on the market or even close to it.  It strains the imagination exactly how $5 billion would be spent by a small biotech that never had any product in late human testing.      

Meaningless strings of vocabulary, pleasantly sounding nonsense dominate the HBS paper. For example, “digital biotech company” – empty buzzwords, which mean absolutely nothing.  “Platform technology” – also empty buzzwords, as every startup calls themselves a platform.  For new drugs, it makes no difference whether something comes off a platform - it requires a unique IND, NDA or BLA and its own dossier of preclinical and clinical testing.  All of this is currently described as a set of laws that regulate pharmaceutical products.  No professional investor in this space would be fooled by the statements about “platform technology”, and I question those who invested in Moderna – a company notorious for secrecy and not publishing any peer-reviewed studies.  While the papered transaction may appear like a set of private venture deals, the de-facto “lead” funding for Moderna since at least 2015 came from the investors that did not require any real disclosure since they did not risk any capital: the US Government/Defense machine can simply print more of it.  The “add-on” capital following the lead investors was a conglomerate of private, sovereign and government (wrapped in private) funds, but this does not matter much. They were told to invest (or pass) without due diligence.

Several pages describe that Moderna is “all digital” and emphasize the use of unspecified “AI” to do unspecified functions.  This is gibberish and describes nothing.  The only thing I can tell is that if they automate all functions in their biologics manufacturing, it is likely unstable, uncontrollable and there are no humans to ask questions of quality and regulatory compliance, which would be convenient if one wanted to commit manufacturing fraud.  The results of batch-to-batch variability of their product with respect to the adverse events and deaths in VAERS database indicate just that. 

HBS writers are of course confused about “messenger RNA”:

The mRNA in SPIKEVAX is not “messenger” it’s “modified RNA” – there is a big difference.  The modifications made to the mRNA to overcome the body’s natural defense mechanisms against foreign nucleic acids are such that the result is like a cellphone tower disguised as a pine tree vs a real pine tree.  They have nothing in common other than some superficial aspects.  Stephanie Seneff did an outstanding review of these issues.

While HBS writers maybe excused for not understanding the nuances of bioengineering, Melissa Moore, the CSO of Moderna should know better.  Yet, she does not seem to be aware of the mechanism of reverse transcription by which mRNA or shorter RNAs can incorporate into the host DNA.  The now famous paper by Alden at al from Sweden showing that Pfizer’s BNT162 did just that in a hepatic cell line in a matter of 6 hours mediated by Long INterspersed Element-1 (LINE-1).  The paper was forced to be retracted after an unspecified “expression of concern”; however, it is well-established in literature that LINE-1 sequences comprise the bulk of retrotransposition activity in the human genome. Note: I have written on the currently questionable evidence of the mRNA with precise coding instructions being included in every shot of Pfizer or Moderna. That issue aside however, the CSO of Moderna shows large gaps in the theoretical knowledge of genetic mechanisms and the possibility of reverse transcription of RNA material, by her statements.

The description of Flagship Pioneering, the venture fund which funded Moderna for years and whose founder Noubar Afeyan is currently the Chairman of the Board of Moderna reads almost like satire, but I don’t think that was intended.

I doubt any adult attending an ivy-league MBA program thinks that “what if” question had never been asked before Noubar Afeyan invented it, and even for him for some reason it took 10 years and $5 billion before it “worked”.  Why didn’t he cast that magic “what if” spell right away in 2010?  The return on investment would have been so much better. 

Same goes for the rest of his quotes which are pompous empty strings of gobbledygook.  It seems that Flagship funded Moderna, and other companies in its portfolio “from cradle to IPO”.  This is not against any rules, however, one fund continuing to invest in the same company in multiple rounds becomes suspect in financial circles.  They are setting the value of the company’s stock themselves, which means they are marking up their own previous investments arbitrarily with each subsequent round of investment.  Typically, VC funds seek other later stage funds/investors to form a syndicate for new rounds of investment, so that the value of the private stock is more objectively set (and that also protects them from any future investor lawsuits). 

A little bit of truth is stated however: nobody needed mRNA as a drug.  There was no unmet medical need or a breakthrough technical solution.  They simply forced this technology onto unsuspecting people by lies.  The “crisis” was needed and conveniently created to accomplish this.  Here is some relevant material on Anthony Fauci and his BARDA co-conspirators in 2019 lamenting “slow” drug development process and how it needed to be “blown up”. 

Above are examples of obvious fraud, but the scientific and professional community at large remains blind to it and continues believing the “Cinderella” story of Moderna.  It is not necessarily because all of them are terminally incompetent.  The evolutionary psychologist William von Hippel found that humans use large parts of thinking power to navigate social world rather than perform independent analysis and decision making.   For most people it is the mechanism that, in case of doubt, will prevent one from thinking what is right if, in return, it endangers one’s social status.  This phenomenon occurs more strongly the higher a person’s social status.  Another factor is that the more educated and more theoretically intelligent a person is, the more their brain is adept at selling them the biggest nonsense as a reasonable idea, as long as it elevates their social status.  The upper educated class tends to be more inclined than ordinary people to chase some intellectual boondoggle. 

This explains why Stephane Bancel can spout naïve gibberish such as “hacking software of life”, “updating humans”, “installing new [mRNA] apps like on an iPhone”, etc. (he also giggles when he says these things), and Harvard cohorts breathlessly record these statements.    

 Some more relevant information on Moderna’s history can be found here.

Art piece for today: Still Life with Fish, oil on panel, 12x16.