Disgraced CDC Director’s Tobacco Investments Overlap With Vaccine Investments
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WMP NOTE: After the recent media uproar
about the CDC Director Brenda Fitzgerald’s resignation, which focused on
the inappropriateness of her ownership in tobacco stock, the WMP team
decided to
investigate further. What we uncovered is new technology that
utilizes tobacco leaves to produce vaccines in a much shorter time
frame and clinical trials are already underway using this new technology
to produce flu vaccines here in the US. So maybe Fitzgerald’s stocks
had nothing to do with smoking tobacco cessation and everything to do
with vaccine production?
By nearly everyone’s admission, this
year’s influenza vaccine has been a colossal flop. In any given year,
flu shot effectiveness in the United States varies widely anyway, but
this year’s estimates point to rock-bottom effectiveness of 10%. The
previous low over the past five years was an estimated 19% for the
2014-2015 influenza season, when public health researchers concluded
that the shot “offered little protection” against the predominant
influenza strain. (This does not even take into account research showing
that individuals who get the flu shot year after year have diminished
protection and are at greater risk of spreading the flu to others.) The
figure below shows the flu vaccine’s inconsistent levels of
effectiveness since 2004.
Influenza vaccine effectiveness, 2004-2017 (Source: CDC)
Pharmaceutical companies and public
health officials acknowledge the issue of “suboptimal” influenza vaccine
effectiveness and blame it on a variety of factors, including the
conventional flu vaccine production process that uses eggs or cultured
mammalian cells and requires a six-month lead time. With the exponential
growth of the biotechnology industry, a search has been underway to
genetically engineer vaccines that are less cumbersome and more
cost-effective to make.
…interest in molecular farming strategies has skyrocketed in the past decade alongside the push to develop ever more vaccines.
The emerging technology of plant-based vaccine production, or “molecular farming,” inserts viral vectors that contain specific genetic information into plants; these genetic instructions tell the plants to produce target proteins that later are harvested to make vaccines. This is called recombinant protein production. Although initial attempts to produce vaccines in plants date back to the early 1990s, interest in molecular farming strategies has skyrocketed in the past decade alongside the push to develop ever more vaccines.
The emerging technology of plant-based vaccine production, or “molecular farming,” inserts viral vectors that contain specific genetic information into plants; these genetic instructions tell the plants to produce target proteins that later are harvested to make vaccines. This is called recombinant protein production. Although initial attempts to produce vaccines in plants date back to the early 1990s, interest in molecular farming strategies has skyrocketed in the past decade alongside the push to develop ever more vaccines.
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The pivotal role of military dollars
Interestingly, one of the parties most invested in the plant-based model of vaccine production is the US military. The Defense Advanced Research Projects Agency (DARPA) funded trials that showed plant-based vaccine production to be capable of making 10 million doses of flu vaccine in 30 days while bearing infrastructure costs that reportedly were 10 times lower than for other vaccine manufacturing methods. DARPA was enthusiastic about these results.
Interestingly, one of the parties most invested in the plant-based model of vaccine production is the US military. The Defense Advanced Research Projects Agency (DARPA) funded trials that showed plant-based vaccine production to be capable of making 10 million doses of flu vaccine in 30 days while bearing infrastructure costs that reportedly were 10 times lower than for other vaccine manufacturing methods. DARPA was enthusiastic about these results.
DARPA views potential pandemics and
biodefense as matters of national security and—guided by its strategic
objective of “harnessing biology as technology”—has sought to acquire
capability for quick, on-demand production of vaccines to “enable [an]
agile, robust, and rapid surge response.” After launching an Accelerated
Manufacturing of Pharmaceuticals program in 2005 to begin studying
plants as a vaccine manufacturing platform, DARPA began pouring
additional millions into these efforts in 2009 when the H1N1 influenza
virus appeared on the scene.
…consumers seemingly “like the idea of creating something positive from a plant with such negative stigma.”
Rehabilitating tobacco—and tobacco stocks
Various properties of tobacco make it an excellent vehicle for molecular farming and for influenza vaccines, in particular. Proponents of tobacco-based vaccine production cite tobacco’s “winning attributes” (including the fact that it is “robust and hearty” and grows to maturity quickly) and also report that consumers seemingly “like the idea of creating something positive from a plant with such negative stigma.”
Rehabilitating tobacco—and tobacco stocks
Various properties of tobacco make it an excellent vehicle for molecular farming and for influenza vaccines, in particular. Proponents of tobacco-based vaccine production cite tobacco’s “winning attributes” (including the fact that it is “robust and hearty” and grows to maturity quickly) and also report that consumers seemingly “like the idea of creating something positive from a plant with such negative stigma.”
The mention of tobacco’s public
relations problems is noteworthy in the context of Brenda Fitzgerald’s
January 31, 2018 resignation from her post as director of the Centers
for Disease Control and Prevention (CDC). Media reports embarrassed the
nation’s top public health official into resigning when it became
apparent that she had financial conflicts of interest, including
sizeable investments in both the tobacco and vaccine industries, among
others. Fitzgerald’s published tobacco investments include holdings in
Japan Tobacco (JT), the world’s third largest and fastest growing
tobacco company (with one-third ownership by the Japanese government).
Japan Tobacco makes leading cigarette brands such as Camel and Winston
and boasts of having “roots in many of the most famous tobacco companies
around the world,” including RJ Reynolds in the US and Gallaher Group
in the UK.
Although the media uproar about the CDC
director’s resignation focused mostly on the inappropriateness of
Fitzgerald’s tobacco investments, the news reports ignored the increased
blurring of distinctions between the tobacco and pharmaceutical
sectors. For example, recognizing the limited prospects for growth in
traditional tobacco sales, Japan Tobacco launched a pharmaceutical
division in 1987, which develops, manufactures and sells prescription
drugs for metabolic and autoimmune diseases as well as “viral
infection.” Even as JT’s tobacco market “struggles amid a tough business
climate,” its pharmaceutical arm is “growing rapidly” and shareholders
are pushing for it to become a “core operation.” JT also has been
forging strategic partnerships with biotechnology and biopharmaceutical
companies for many years, including obtaining exclusive rights in 1999
to market eventual lung cancer vaccines. All of this exemplifies two
converging global trends toward the pharmaceuticalization of the tobacco
industry and reliance by the pharmaceutical sector on vaccines as their
engine for growth. Given the CDC’s central role in vaccine production
and distribution, these types of overlapping relationships cast
Fitzgerald’s financial commitments to companies like JT in an even more
questionable light.
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Reflecting a similarly dizzying
entanglement between pharmaceutical and tobacco ambitions, another
Japanese company—Mitsubishi Tanabe Pharma Corporation (MTPC)—is one of
the industry leaders in the tobacco-to-vaccine technology. MTPC acquired
the technology in 2012-2013 when it partnered with the Quebec-based
biotech firm Medicago to develop and commercialize influenza and other
vaccines. It went on to purchase most of Medicago the following
year—with the exception of roughly 38% of the company already owned by
the tobacco giant Philip Morris! Medicago perfected the plant-based
vaccine production technology at a deluxe 97,000 square foot
DARPA-funded greenhouse in North Carolina.
MTPC expects to bring the tobacco-based
vaccine technology to market in the US (where approval standards are
less rigorous than in Japan) in fiscal 2018 or 2019. With DARPA and US
Army funding and Medicago sponsorship, the results of pre-clinical
studies and Phase I clinical trials that examined the safety and
effectiveness of the vaccines already have been published. Poised to
finalize its clinical trials this year in the U.S., MTPC anticipates
over $700 million in annual sales by fiscal 2020, a sales target that,
if achieved, would represent nearly one-fifth (18.4%) of the estimated
$3.8 billion annual market for flu shots globally.
It is difficult to ascertain whether JT
and MTPC are competitors or collaborators, but the two certainly
frequent many of the same circles. For example, Japanese drug
researchers often disclose financial and research support from both
companies, and the two businesses both are members of the Japan
Microbiome Consortium. Both also have drug development and distribution
agreements with the same third parties.
Will more collaboration be in the two
companies’ future, as JT seeks to build up its vaccine business and MTPC
looks for tobacco producers with the expertise to help tobacco-based
vaccine manufacturing come fully online? And how much of all this did
Dr. Fitzgerald know when she purchased Japan Tobacco stock shortly after
her appointment to direct the CDC’s four-billion-dollar-a-year vaccine
program?
Note: A follow-up World Mercury Project
article will examine safety considerations pertaining to these newer
vaccine technologies.
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