Part One: The Meeting
To fully appreciate the importance of the Covid Era to the Pharmaceutical Industry we revisit the “Future of Health Summit” held at the Milken Institute on Oct. 28-29, 2019.
The conference, hailed as an event to “[bring] together thought leaders and decision-makers to confront some of the world’s most significant health challenges by matching human, financial, and educational resources with the most innovative and impactful ideas”, convened “health experts” from across multiple disciplines.
The most notable discussion of this two-day affair occurred on the 29th at a workshop titled, “Making Influenza History: The Quest for a Universal Vaccine.” At this workshop a panel of powerful “health experts” gathered to discuss “scientific and technological prospects of an effective universal influenza vaccine.”
Featured speakers at this plenary session included Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases; Margaret Hamburg, former FDA commissioner; Bruce Gellin, President, Global Immunization, Sabin Vaccine Institute; Casey Wright, CEO, FluLab; Michael Specter, New Yorker staff writer and adjunct professor of bioengineering at Stanford University; and Rick Bright, the former director of HHS Biomedical Advanced Research and Development Authority (BARDA).
The full video of their hour-long presentation can be seen here on C-SPAN.
The stated purpose of the discussion was, “the need for more funding for research, better collaboration between the private and government sectors, advances in technology in flu research and the goal of a universal flu vaccine.” [Emphasis added.]
Outside the stated purpose, the substance of the meeting addressed the need for a radically new Pharmaceutical marketing model concentrating specifically on the dream of a revolutionary vaccine framework.
Looming over the disquisition was the unspoken but urgent need to address the current state of affairs within the Pharmaceutical Industry which, despite substantial revenues, has been experiencing a steady decline in rates of profit in recent years.
The cause for this existential crisis within the Pharmaceutical Industry has historically been placed on the exigencies of high development costs, lengthy clinical trials and soaring marketing expenditures.
For years one of the principal goals of the Pharmaceutical Industry has been to find a way to greatly reduce or altogether eliminate these ‘sunk’ costs.
It is particularly in the realm of new “blockbuster drugs” where Pharma has sought to change the development, regulatory and marketing landscape. Pharma relies heavily on these “blockbuster drugs” to remain profitable and appealing to investors.
According to the Pharma imperative anything that impedes the rapid commercialization of these new drugs, such as safety testing, is seen as cutting into their profits and a burden to be abolished.
It is these ‘high reward’ drugs which entice investors, enhance stock prices and generate huge profits. It is not an exaggeration to say that without these “blockbuster drugs” the Pharma Leviathan is reduced to a standard business enterprise.
Vaccines present a particularly attractive business proposition as they can be administered to every healthy person on the planet, as opposed to a drug which treats the ill.
If a vaccine maker succeeds in adding their product to the CDC’s recommended vaccine schedule, it then carries the additional bonus of being virtually liability free for the manufacturer.
That is a business model other industries can only dream about.
To address these persistent problems two overall themes emerged at this meeting. They first highlighted the desire for a new way of producing vaccines that would reduce time and costs of vaccine production and commercialization.
Moderator Michael Specter kicked off the workshop by boldly stating that somehow the current system of vaccine development and procurement, seen as an antiquated medical model in need of a technological update, needs to be “blown up”: [Emphasis added]
Why don’t we blow the system up? I mean obviously, we can’t just turn off the spigot on the system we have and then say, hey everyone in the world should get this new vaccine that we haven’t given to anyone yet. But there must be some way… that we grow vaccines mostly in eggs the way we did in 1947. We live in a world where I can download whatever song I want onto my phone on command and we grow vaccines the way we did 70 years ago.
Specter’s reference to “blowing up the system” highlighted the desire for a new way of producing vaccines which would sidestep substantial capital investments required to bring new drugs to market.
Specter’s conflation of vaccine production with ‘downloadable songs’ is a conspicuous allusion to the “need” for vaccine production to ‘get up to speed’ from the old ‘egg-based model’ to the more technologically advanced mRNA delivery system.
A move towards an mRNA-based vaccine model would ‘allow’ the Industry to achieve this goal of ‘blowing up the system’, opening up the door for the mRNA delivery systems to become Pharma’s new vaccine model and subsequent cash cow.
Once approved and accepted the technology could be plugged in, enabling Pharma to go down the list of medical conditions and install new mRNA vaccines for each new ‘emerging’ disease – similar to a Windows update.
Once implemented, the mRNA delivery system could utilize a similar mechanism for each new mRNA vaccine against any pathogen in existence. Antiquated development processes, lengthy clinical trials and nettlesome regulations (and the time and costs that come with each of them) wiped out in the blink of an eye.
Rick Bright captured the spirit of the designs for a Pharmaceutical utopia suggesting such miscellaneous problems could be sidestepped if, “there were an urgent call for an entity of excitement that is completely disruptive and is not beholden to bureaucratic strings and processes.” [Emphasis added.]
In accord with Bright’s sentiment Anthony Fauci lamented that the predicament facing them was that it would take at least a decade, “if everything goes perfectly”, to bring in a new type of vaccine, such as an mRNA vaccine.
From this dilemma arose the second theme of the discussion, the “need” for something new and more frightening to emerge, as the flu no longer created enough fear in the population to warrant such a “universal vaccine” and a wholesale change in the current system.
Anthony Fauci addressed this quandary:
“So we really do have a problem of how the world perceives influenza and it’s going to be very difficult to change that unless you do it from within and say, I don’t care what your perception is, we’re going to address the problem in a disruptive and in an iterative way because she does need both.” [Emphasis added]
The hauntingly prescient Rick Bright foreshadowed the coming storm in his response to Fauci’s proposition:
“But it is not too crazy to think that an outbreak of a novel avian virus could occur in China somewhere.[Emphasis added]. We could get the RNA sequence from that to a number of regional centers if not local, if not even in your home at some point, and print those vaccines on a patch of (sic) self-administer.”
(In Part Two the entire session is deconstructed at length, delineating what that portends for Big Pharma’s business model and its investors and what that means for public health.)
