https://childrenshealthdefense.org/defender/moderna-history-failure-covid-vaccine/
Before COVID-19, Moderna was in danger of hemorrhaging investors, as persistent safety concerns and other doubts about its mRNA delivery system threatened its entire product pipeline.
Fear caused by the pandemic crisis made those concerns largely evaporate, even though there is no proof that they were ever resolved. Those analyzing the COVID-19 crisis and its effects have mostly focused on how its disruptive nature has led to major shifts and recalibrations throughout society and the economy. Such disruption has also lent itself to a variety of agendas that had required an event of “reset” potential in order to be realized.In the case of the vaccine industry, COVID-19 has led to dramatic changes in how federal agencies manage the approval of medical countermeasures during a declared crisis, how trials for vaccine candidates are conducted, how the public perceives vaccination and even how the term “vaccine” is defined.
Such shifts, though obvious, have provoked praise from some and sharp criticism from others, with the latter category being largely censored from public discourse on television, in print and online.However, in objectively analyzing such seismic changes, it’s clear that most of these shifts in vaccine development and vaccine policy dramatically favor speed and the implementation of new and experimental technology at the expense of safety and thorough study. In the case of vaccines, it can be argued that no one benefited more from these changes than the developers of the COVID-19 vaccines themselves, particularly the pharmaceutical and biotechnology company Moderna.
Not only did the COVID-19 crisis obliterate hurdles that had previously prevented Moderna from taking a single product to market, it also dramatically reversed the company’s fortunes.Indeed, from 2016 right up until the emergence of COVID-19, Moderna could barely hold it together, as it was shedding key executives, top talent and major investors at an alarming rate. Essentially, Moderna’s promise of “revolutionizing” medicine and the remarkable salesmanship and fund-raising capabilities of the company’s to executive, Stéphane Bancel, were the main forces keeping it afloat.
In the years leading up to the COVID-19 crisis, Moderna’s promises — despite Bancel’s efforts — rang increasingly hollow, as the company’s long-standing penchant for extreme secrecy meant that — despite nearly a decade in business — it had never been able to definitively prove that it could deliver the “revolution” it had continually assured investors was right around the corner.This was compounded by major issues with patents held by a hostile competitor that threatened Moderna’s ability to turn a profit on anything it might manage to take to market, as well as major issues with its mRNA delivery system that led them to abandon any treatment that would require more than one dose because of toxicity concerns.
The latter issue, though largely forgotten and/or ignored by media today, should be a major topic in the COVID-19 booster debate, given that there is still no evidence that Moderna ever resolved the toxicity issue that arose in multi-dose products.
In this first installment of a two-part series, the dire situation in which Moderna found itself immediately prior to the emergence of COVID-19 is discussed in detail, revealing that Moderna — very much like the now disgraced company Theranos — had long been a house of cards with sky-high valuations completely disconnected from reality.
Part 2 will explore how that reality would have come crashing down sometime in 2020 or 2021 were it not for the advent of the COVID-19 crisis and Moderna’s subsequent partnership with the U.S. government and the highly unusual processes involving its vaccine’s development and approval.
Despite the emergence of real-world data challenging the claims that Moderna’s COVID-19 vaccine is safe and effective, Moderna’s booster is being rushed through by some governments, while others have recently banned the vaccine’s use in young adults and teens due to safety concerns. As this two-part series will show, safety concerns about Moderna were known well before the COVID crisis, yet they have been ignored by health authorities and the media during the crisis itself. In addition, in order to stave off collapse, Moderna must keep selling its COVID-19 vaccine for years to come.
In other words, without the approval of its booster, which has caused great controversy even among the country’s top vaccine officials, Moderna faces a massive financial reckoning.
While the COVID-19 crisis threw the company a lifeboat, the administration of its COVID-19 vaccine, in which the U.S. government has now invested nearly $6 billion, must continue into the foreseeable future for the bailout to be truly successful.
Otherwise, a company now worth $126.7 billion, with major investments from the U.S. government, U.S. military and ties to the world’s wealthiest individuals, will crumble in short order.
A new Theranos?
In September 2016, Damian Garde, the national biotech reporter for the medical media company STAT, wrote a lengthy exposé of the “ego, ambition, and turmoil” plaguing “one of biotech’s most secretive startups.” The article focused on the company Moderna, which had been founded in 2010 to commercialize the research of Boston Children’s Hospital cell biologist Derrick Rossi.
The effort to turn a profit by creating Moderna, which intimately involved controversial scientist and close Bill Gates associate Bob Langer as well as Cambridge, Massachusetts–based Flagship Ventures (now Flagship Pioneering), began soon after Rossi published a report on the ability of modified RNA to turn skin cells into different types of tissue.
Between the time of Moderna’s founding and Garde’s 2016 investigation, the buzz around Rossi’s research and its potential to create medical breakthroughs had waned, as had the buzz around its potential to make its investors very wealthy. Despite teaming up with pharmaceutical giants like AstraZeneca and raising record amounts of funding, Moderna still had no product on the market six years after its founding, and, as STAT revealed, the “company’s caustic work environment” had led to a persistent hemorrhaging of top talent, though little of its internal conflicts was publicly known due to “its obsession with secrecy.”
Most troubling for the company that year, however, was that Moderna appeared to have “run into roadblocks with its most ambitious projects.”
Although lacking a background in mRNA and the science behind its use as a therapeutic, Bancel has made up for it by becoming Moderna’s salesman par excellence. Under his leadership, Moderna became “loath to publish its work in Science or Nature, but enthusiastic to herald its potential on CNBC and CNN.” In other words, under Bancel, the company came to promote its science through media publicity and public relations rather than by publishing actual data or scientific evidence. When two of its vaccine candidates entered phase 1 human trials in 2016 (trials that ultimately went nowhere), the company declined to list them on the public federal registry ClinicalTrials.gov.
The decision not to list, which deviates from common practice by Moderna’s competitors and other more traditional vaccine companies, meant that the information on the safety of these vaccine candidates would likely never be publicly available after the trial’s conclusion. Moderna also refused to publicly comment on what diseases these vaccines were meant to target.
Such secrecy became commonplace at Moderna after Bancel took the helm, with the company having published no data “supporting its vaunted technology” by the time STAT’s 2016 exposé was published. Insiders as well as investors that had committed millions to the company were only granted “a peek” at the company’s data.
According to former Moderna scientists who spoke to STAT, the company was “a case of the emperor’s new clothes.” Former employees further charged that Bancel was actually “running an investment firm” and “then hop[ing] it also develops a drug that’s successful.”
Perhaps this is why Bancel was deemed the best executive to steer Moderna. As an ambitious salesman running a highly overvalued company, he would prioritize the company’s image and its finances regardless of any issues with the science underpinning it all. Perhaps it was for that reason that Bancel, per former employees, “made it clear [from the beginning] that Moderna’s science simply had to work. And that anyone who couldn’t make it work didn’t belong.”
As STAT noted in 2016, the people who were tasked with making “the science work” were those who most frequently resigned, which led to Moderna losing two heads of chemistry within a single year, followed shortly by losing its chief scientific officer and its head of manufacturing. Many top executives, including the heads of its cancer research and rare disease research branches, ended up lasting fewer than eighteen months in their respective positions.
The abrupt resignations weren’t exclusive to Moderna’s science-focused executive positions either, as the chief information officer and top financial executive role were also affected. Bancel ultimately sought advice from the human resources departments of Facebook, Google and Netflix on employee retention. Particularly telling was the abrupt and mysterious resignation of Moderna’s head of research and development, Joseph Bolen, after about two years at the company. A company insider at the time told STAT that the only reason Bolen would have resigned was if “there was something wrong with the science or the personnel.”
In other words, Bolen either left because the science underpinning Moderna’s massive valuation did not live up to the hype or Bancel had forced him out, with the additional possibility that both were key in Bolen’s resignation. Speculation at the time pointed the finger at Bancel, though it’s not clear why the rift between the two men emerged. Bancel asserted that he tried to convince Bolen to stay, though there were contrasting assertions from anonymous employees, and that Bolen had “voted himself off the island.”
Whatever the exact cause of the resignation of the head of R & D, it only added to the mystique around Moderna’s inner workings and its ability to deliver on its promise to “revolutionize” medicine. It also reveals more than a few similarities between Moderna and the now-disgraced company Theranos.
Theranos, whose former top executive, Elizabeth Holmes, is now on trial for fraud, was known for its extreme culture of secrecy that kept investors and business partners in the dark, forced nondisclosure agreements on everyone who came in contact with the company and kept employees “siloed” through an extremely strict need-to-know policy.
Like Moderna, Theranos had been praised as revolutionary and poised to “change the medical industry forever.” Similarly, its top executive had no professional health-care or science experience, yet both fired or forced the resignations of employees who disagreed with their perspective or were unable to provide “positive” results
Both companies also failed to publish any evidence in peer-reviewed journals that the science behind their multibillion-dollar valued companies was more than just fantasy and a well-devised sales pitch. Arguably, the most critical difference between Moderna and Theranos is that Moderna, whose numerous issues and challenges only came to light after the collapse of Theranos had begun, has never faced the same degree of scrutiny from the U.S. government or mainstream investigative journalists.
There are many possible reasons for this, including Moderna’s close relationship with the U.S. Department of Defense through the Defense Advanced Research Projects Agency (DARPA), or concern that its exposure post-Theranos would bring scrutiny to any company existing at the intersection of Silicon Valley and the health-care industry.
However, such a reckoning would likely have been inevitable for Moderna had it not been for the COVID-19 crisis, which could not have come at a more convenient time for the company.
Moderna’s ‘software’ encounters bugs
Many of the problems with Moderna that Garde identified in 2016 continued to plague the company right up until the beginning of the COVID-19 crisis. Chief among these was Moderna’s struggle to prove that its technology worked and that it was safe.
Concerns about the safety and efficacy of the company’s products, which were publicly reported beginning in 2017, evaporated in the wave of panic surrounding COVID-19 and the simultaneous “Warp Speed” race for a vaccine that would “end the pandemic.”
Yet, there is little, if any, evidence that these once-well-recognized concerns were addressed prior to the U.S. government’s emergency use authorization of Moderna’s COVID-19 vaccine and its now widespread use in many countries around the world. To the contrary, there is evidence that these concerns were covered up both prior to and during the development of its vaccine.
Voir aussi :
https://childrenshealthdefense.org/defender/part-2-moderna-history-failure-covid-vaccine/?utm_source=salsa&eType=EmailBlastContent&eId=1e136d6b-935c-4d69-bb79-a2efb38fa242
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